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Home-based transcranial stimulation succeeds for MDD
Major depressive disorder (MDD) remains a leading cause of disability and a significant predictor of suicide worldwide, Rachel D. Woodham, PhD, of the University of East London and colleagues wrote.
Transcranial direct current stimulation (tDCS) has demonstrated effectiveness as a noninvasive therapy for MDD, but requires frequent sessions, and repeat visits to treatment centers are a barrier for many patients, they noted. The tDCS procedure involves delivery of a weak direct electric current via placement of electrodes, usually with the anode over the left dorsolateral prefrontal cortex and the cathode over the right dorsolateral prefrontal cortex, suborbital, or frontotemporal region.
“The current changes neuronal membrane potential and facilitates discharge,” but “in contrast to rTMS and ECT, tDCS does not directly trigger an action potential,” the researchers wrote. The most common side effects reported with tDCS are tingling, itching, burning sensation, skin redness or headache.
The researchers proposed that tDCS could be provided at home under real-time remote supervision.
In an open-label feasibility study published in the Journal of Psychiatric Research, they recruited 26 adults with MDD in current depressive episodes of moderate to severe severity. In addition to maintaining their current treatment regimens of medication, psychotherapy, or cognitive behavioral therapy, participants used tDCS at home in 30-minute sessions, for a total of 21 sessions over 6 weeks. A researcher was present in person or on a real-time video call for each at-home session.
The primary outcome of Hamilton Rating Scale for Depression (HAMD) score improved significantly, from a mean of 19.12 at baseline to 5.33 after 6 weeks. At 3 months, the mean HAMD score was 5.65, and 78.2% of patients met the criteria for clinical remission (HAMD score less than 9). At 6 months, patients maintained this improvement, with a mean HAMD score of 5.43 and 73.9% of the participants in clinical remission. The majority of participants (24 of 26) completed the full 6-week treatment.
Clinical assessments were conducted at baseline, at the end of the 6-week treatment period, at 3 months, and at 6 months, and included not only the HAMD, but also the Hamilton Anxiety Rating Scale (HAMA), Sheehan Disability Scale (SDS), Patient Health Questionnaire–9 (PHQ-9), and Young Mania Rating Scale. All participants showed significant improvements in HAMA, SDS, and PHQ-9 scores from baseline that endured from the end of the treatment period to the 6 months’ follow-up.
The tDCS involved a bilateral frontal montage, F3 anode, F4 cathode, 2mA, and two different devices were used.
All participants reported the acceptability of at-home tDCS as either “very acceptable” or “quite acceptable.”
The results were limited by the open-label feasibility design and lack of a sham control treatment; therefore, the findings of efficacy are preliminary, the researchers emphasized. “Having real-time supervision for each session likely contributed to symptom improvement.”
However, the results support the feasibility of at-home tDCS to improve outcomes both short- and long-term in patients with moderate to severe MDD, the researchers said. Larger, sham-controlled trials are needed to show efficacy, and additional assessment of feasibility should include the use of app-based devices, which may be more feasible for individuals with lower socioeconomic status.
The study received no outside funding. The study was supported by the Rosetrees Trust. The researchers had no financial conflicts to disclose.
Major depressive disorder (MDD) remains a leading cause of disability and a significant predictor of suicide worldwide, Rachel D. Woodham, PhD, of the University of East London and colleagues wrote.
Transcranial direct current stimulation (tDCS) has demonstrated effectiveness as a noninvasive therapy for MDD, but requires frequent sessions, and repeat visits to treatment centers are a barrier for many patients, they noted. The tDCS procedure involves delivery of a weak direct electric current via placement of electrodes, usually with the anode over the left dorsolateral prefrontal cortex and the cathode over the right dorsolateral prefrontal cortex, suborbital, or frontotemporal region.
“The current changes neuronal membrane potential and facilitates discharge,” but “in contrast to rTMS and ECT, tDCS does not directly trigger an action potential,” the researchers wrote. The most common side effects reported with tDCS are tingling, itching, burning sensation, skin redness or headache.
The researchers proposed that tDCS could be provided at home under real-time remote supervision.
In an open-label feasibility study published in the Journal of Psychiatric Research, they recruited 26 adults with MDD in current depressive episodes of moderate to severe severity. In addition to maintaining their current treatment regimens of medication, psychotherapy, or cognitive behavioral therapy, participants used tDCS at home in 30-minute sessions, for a total of 21 sessions over 6 weeks. A researcher was present in person or on a real-time video call for each at-home session.
The primary outcome of Hamilton Rating Scale for Depression (HAMD) score improved significantly, from a mean of 19.12 at baseline to 5.33 after 6 weeks. At 3 months, the mean HAMD score was 5.65, and 78.2% of patients met the criteria for clinical remission (HAMD score less than 9). At 6 months, patients maintained this improvement, with a mean HAMD score of 5.43 and 73.9% of the participants in clinical remission. The majority of participants (24 of 26) completed the full 6-week treatment.
Clinical assessments were conducted at baseline, at the end of the 6-week treatment period, at 3 months, and at 6 months, and included not only the HAMD, but also the Hamilton Anxiety Rating Scale (HAMA), Sheehan Disability Scale (SDS), Patient Health Questionnaire–9 (PHQ-9), and Young Mania Rating Scale. All participants showed significant improvements in HAMA, SDS, and PHQ-9 scores from baseline that endured from the end of the treatment period to the 6 months’ follow-up.
The tDCS involved a bilateral frontal montage, F3 anode, F4 cathode, 2mA, and two different devices were used.
All participants reported the acceptability of at-home tDCS as either “very acceptable” or “quite acceptable.”
The results were limited by the open-label feasibility design and lack of a sham control treatment; therefore, the findings of efficacy are preliminary, the researchers emphasized. “Having real-time supervision for each session likely contributed to symptom improvement.”
However, the results support the feasibility of at-home tDCS to improve outcomes both short- and long-term in patients with moderate to severe MDD, the researchers said. Larger, sham-controlled trials are needed to show efficacy, and additional assessment of feasibility should include the use of app-based devices, which may be more feasible for individuals with lower socioeconomic status.
The study received no outside funding. The study was supported by the Rosetrees Trust. The researchers had no financial conflicts to disclose.
Major depressive disorder (MDD) remains a leading cause of disability and a significant predictor of suicide worldwide, Rachel D. Woodham, PhD, of the University of East London and colleagues wrote.
Transcranial direct current stimulation (tDCS) has demonstrated effectiveness as a noninvasive therapy for MDD, but requires frequent sessions, and repeat visits to treatment centers are a barrier for many patients, they noted. The tDCS procedure involves delivery of a weak direct electric current via placement of electrodes, usually with the anode over the left dorsolateral prefrontal cortex and the cathode over the right dorsolateral prefrontal cortex, suborbital, or frontotemporal region.
“The current changes neuronal membrane potential and facilitates discharge,” but “in contrast to rTMS and ECT, tDCS does not directly trigger an action potential,” the researchers wrote. The most common side effects reported with tDCS are tingling, itching, burning sensation, skin redness or headache.
The researchers proposed that tDCS could be provided at home under real-time remote supervision.
In an open-label feasibility study published in the Journal of Psychiatric Research, they recruited 26 adults with MDD in current depressive episodes of moderate to severe severity. In addition to maintaining their current treatment regimens of medication, psychotherapy, or cognitive behavioral therapy, participants used tDCS at home in 30-minute sessions, for a total of 21 sessions over 6 weeks. A researcher was present in person or on a real-time video call for each at-home session.
The primary outcome of Hamilton Rating Scale for Depression (HAMD) score improved significantly, from a mean of 19.12 at baseline to 5.33 after 6 weeks. At 3 months, the mean HAMD score was 5.65, and 78.2% of patients met the criteria for clinical remission (HAMD score less than 9). At 6 months, patients maintained this improvement, with a mean HAMD score of 5.43 and 73.9% of the participants in clinical remission. The majority of participants (24 of 26) completed the full 6-week treatment.
Clinical assessments were conducted at baseline, at the end of the 6-week treatment period, at 3 months, and at 6 months, and included not only the HAMD, but also the Hamilton Anxiety Rating Scale (HAMA), Sheehan Disability Scale (SDS), Patient Health Questionnaire–9 (PHQ-9), and Young Mania Rating Scale. All participants showed significant improvements in HAMA, SDS, and PHQ-9 scores from baseline that endured from the end of the treatment period to the 6 months’ follow-up.
The tDCS involved a bilateral frontal montage, F3 anode, F4 cathode, 2mA, and two different devices were used.
All participants reported the acceptability of at-home tDCS as either “very acceptable” or “quite acceptable.”
The results were limited by the open-label feasibility design and lack of a sham control treatment; therefore, the findings of efficacy are preliminary, the researchers emphasized. “Having real-time supervision for each session likely contributed to symptom improvement.”
However, the results support the feasibility of at-home tDCS to improve outcomes both short- and long-term in patients with moderate to severe MDD, the researchers said. Larger, sham-controlled trials are needed to show efficacy, and additional assessment of feasibility should include the use of app-based devices, which may be more feasible for individuals with lower socioeconomic status.
The study received no outside funding. The study was supported by the Rosetrees Trust. The researchers had no financial conflicts to disclose.
FROM THE JOURNAL OF PSYCHIATRIC RESEARCH
Novel head-up CPR position raises odds of survival of out-of-hospital heart attacks
Individuals who experience out-of-hospital cardiac arrest (OHCA) with nonshockable presentations have a better chance of survival when first responders use a novel CPR approach that includes gradual head-up positioning combined with basic but effective circulation-enhancing adjuncts, as shown from data from more than 2,000 patients.
In a study presented at the annual meeting of the American College of Emergency Physicians, Paul Pepe, MD, medical director for Dallas County Emergency Medical Services, reviewed data from five EMS systems that had adopted the new approach. Data were collected prospectively over the past 2 years from a national registry of patients who had received what Dr. Pepe called a “neuroprotective CPR bundle” (NP-CPR).
The study compared 380 NP-CPR case patients to 1,852 control patients who had received conventional CPR. Control data came from high-performance EMS systems that had participated in well-monitored, published OHCA trials funded by the National Institutes of Health. The primary outcome that was used for comparison was successful survival to hospital discharge with neurologically intact status (SURV-NI).
Traditional CPR supine chest compression techniques, if performed early and properly, can be lifesaving, but they are suboptimal, Dr. Pepe said. “Current techniques create pressure waves that run up the arterial side, but they also create back-pressure on the venous side, increasing intracranial pressure (ICP), thus compromising optimal cerebral blood flow,” he told this news organization.
For that reason, a modified physiologic approach to CPR was designed. It involves an airway adjunct called an impedance threshold device (ITD) and active compression-decompression (ACD) with a device “resembling a toilet plunger,” Dr. Pepe said.
The devices draw more blood out of the brain and into the thorax in a complementary fashion. The combination of these two adjuncts had dramatically improved SURV-NI by 50% in a clinical trial, Dr. Pepe said.
The new technology uses automated gradual head-up/torso-up positioning (AHUP) after first “priming the pump” with ITD-ACD–enhanced circulation. It was found to markedly augment that effect even further. In the laboratory setting, this synergistic NP-CPR bundle has been shown to help normalize cerebral perfusion pressure, further promoting neuro-intact survival. Normalization of end-tidal CO2 is routinely observed, according to Dr. Pepe.
In contrast to patients who present with ventricular fibrillation (shockable cases), patients with nonshockable presentations always have had grim prognoses, Dr. Pepe said. Until now, lifesaving advances had not been found, despite the fact that nonshockable presentations (asystole or electrical activity with no pulse) constitute approximately 80% of OHCA cases, or about 250,000 to 300,00 cases a year in the United States, he said.
In the study, approximately 60% of both the NP-CPR patients and control patients had asystole (flatline) presentations. The NP-CPR group had a significant threefold improvement in SURV-NI, compared with patients treated with conventional CPR in the high-functioning systems (odds ratio, 3.09). In a propensity-scored analysis matching all variables known to affect outcome, the OR increased to nearly fourfold higher (OR, 3.87; 95% confidence interval, 1.27-11.78), Dr. Pepe said.
The researchers also found that the time from receipt of a 911 call to initiation of AHUP was associated with progressively higher chances of survival. The median time for application was 11 minutes; when the elapsed time was less than 11 minutes, the SURV-NI was nearly 11-fold higher for NP-CPR patients than for control patients (OR, 10.59), with survival chances of 6% versus 0.5%. ORs were even higher when the time to treatment was less than 16 minutes (OR, 13.58), with survival rates of 5% versus 0.4%.
The findings not only demonstrate proof of concept in these most futile cases but also that implementation is feasible for the majority of patients, considering that the median time to the start of any CPR by a first responder was 8 minutes for both NP-CPR patients and control patients, “let alone 11 minutes for the AHUP initiation,” Dr. Pepe said. “This finally gives some hope for these nonshockable cases,” he emphasized.
“All of these devices have now been cleared by the Food and Drug Administration and should be adopted by all first-in responders,” said Dr. Pepe. “But they should be implemented as a bundle and in the proper sequence and as soon as feasible.”
Training and implementation efforts continue to expand, and more lives can be saved as more firefighters and first-in response teams acquire equipment and training, which can cut the time to response, he said.
The registry will continue to monitor outcomes with NP-CPR – the term was suggested by a patient who survived through this new approach – and Dr. Pepe and colleagues expect the statistics to improve further with wider adoption and faster implementation with the fastest responders.
A recent study by Dr. Pepe’s team, published in Resuscitation, showed the effectiveness of the neuroprotective bundle in improving survival for OHCA patients overall. The current study confirmed its impact on neuro-intact survival for the subgroup of patients with nonshockable cases.
One other take-home message is that head-up CPR cannot yet be performed by lay bystanders. “Also, do not implement this unless you are going to do it right,” Dr. Pepe emphasized in an interview.
Advanced CPR Solutions provided some materials and research funding for an independent data collector. No other relevant financial relationships have been disclosed.
A version of this article first appeared on Medscape.com.
Individuals who experience out-of-hospital cardiac arrest (OHCA) with nonshockable presentations have a better chance of survival when first responders use a novel CPR approach that includes gradual head-up positioning combined with basic but effective circulation-enhancing adjuncts, as shown from data from more than 2,000 patients.
In a study presented at the annual meeting of the American College of Emergency Physicians, Paul Pepe, MD, medical director for Dallas County Emergency Medical Services, reviewed data from five EMS systems that had adopted the new approach. Data were collected prospectively over the past 2 years from a national registry of patients who had received what Dr. Pepe called a “neuroprotective CPR bundle” (NP-CPR).
The study compared 380 NP-CPR case patients to 1,852 control patients who had received conventional CPR. Control data came from high-performance EMS systems that had participated in well-monitored, published OHCA trials funded by the National Institutes of Health. The primary outcome that was used for comparison was successful survival to hospital discharge with neurologically intact status (SURV-NI).
Traditional CPR supine chest compression techniques, if performed early and properly, can be lifesaving, but they are suboptimal, Dr. Pepe said. “Current techniques create pressure waves that run up the arterial side, but they also create back-pressure on the venous side, increasing intracranial pressure (ICP), thus compromising optimal cerebral blood flow,” he told this news organization.
For that reason, a modified physiologic approach to CPR was designed. It involves an airway adjunct called an impedance threshold device (ITD) and active compression-decompression (ACD) with a device “resembling a toilet plunger,” Dr. Pepe said.
The devices draw more blood out of the brain and into the thorax in a complementary fashion. The combination of these two adjuncts had dramatically improved SURV-NI by 50% in a clinical trial, Dr. Pepe said.
The new technology uses automated gradual head-up/torso-up positioning (AHUP) after first “priming the pump” with ITD-ACD–enhanced circulation. It was found to markedly augment that effect even further. In the laboratory setting, this synergistic NP-CPR bundle has been shown to help normalize cerebral perfusion pressure, further promoting neuro-intact survival. Normalization of end-tidal CO2 is routinely observed, according to Dr. Pepe.
In contrast to patients who present with ventricular fibrillation (shockable cases), patients with nonshockable presentations always have had grim prognoses, Dr. Pepe said. Until now, lifesaving advances had not been found, despite the fact that nonshockable presentations (asystole or electrical activity with no pulse) constitute approximately 80% of OHCA cases, or about 250,000 to 300,00 cases a year in the United States, he said.
In the study, approximately 60% of both the NP-CPR patients and control patients had asystole (flatline) presentations. The NP-CPR group had a significant threefold improvement in SURV-NI, compared with patients treated with conventional CPR in the high-functioning systems (odds ratio, 3.09). In a propensity-scored analysis matching all variables known to affect outcome, the OR increased to nearly fourfold higher (OR, 3.87; 95% confidence interval, 1.27-11.78), Dr. Pepe said.
The researchers also found that the time from receipt of a 911 call to initiation of AHUP was associated with progressively higher chances of survival. The median time for application was 11 minutes; when the elapsed time was less than 11 minutes, the SURV-NI was nearly 11-fold higher for NP-CPR patients than for control patients (OR, 10.59), with survival chances of 6% versus 0.5%. ORs were even higher when the time to treatment was less than 16 minutes (OR, 13.58), with survival rates of 5% versus 0.4%.
The findings not only demonstrate proof of concept in these most futile cases but also that implementation is feasible for the majority of patients, considering that the median time to the start of any CPR by a first responder was 8 minutes for both NP-CPR patients and control patients, “let alone 11 minutes for the AHUP initiation,” Dr. Pepe said. “This finally gives some hope for these nonshockable cases,” he emphasized.
“All of these devices have now been cleared by the Food and Drug Administration and should be adopted by all first-in responders,” said Dr. Pepe. “But they should be implemented as a bundle and in the proper sequence and as soon as feasible.”
Training and implementation efforts continue to expand, and more lives can be saved as more firefighters and first-in response teams acquire equipment and training, which can cut the time to response, he said.
The registry will continue to monitor outcomes with NP-CPR – the term was suggested by a patient who survived through this new approach – and Dr. Pepe and colleagues expect the statistics to improve further with wider adoption and faster implementation with the fastest responders.
A recent study by Dr. Pepe’s team, published in Resuscitation, showed the effectiveness of the neuroprotective bundle in improving survival for OHCA patients overall. The current study confirmed its impact on neuro-intact survival for the subgroup of patients with nonshockable cases.
One other take-home message is that head-up CPR cannot yet be performed by lay bystanders. “Also, do not implement this unless you are going to do it right,” Dr. Pepe emphasized in an interview.
Advanced CPR Solutions provided some materials and research funding for an independent data collector. No other relevant financial relationships have been disclosed.
A version of this article first appeared on Medscape.com.
Individuals who experience out-of-hospital cardiac arrest (OHCA) with nonshockable presentations have a better chance of survival when first responders use a novel CPR approach that includes gradual head-up positioning combined with basic but effective circulation-enhancing adjuncts, as shown from data from more than 2,000 patients.
In a study presented at the annual meeting of the American College of Emergency Physicians, Paul Pepe, MD, medical director for Dallas County Emergency Medical Services, reviewed data from five EMS systems that had adopted the new approach. Data were collected prospectively over the past 2 years from a national registry of patients who had received what Dr. Pepe called a “neuroprotective CPR bundle” (NP-CPR).
The study compared 380 NP-CPR case patients to 1,852 control patients who had received conventional CPR. Control data came from high-performance EMS systems that had participated in well-monitored, published OHCA trials funded by the National Institutes of Health. The primary outcome that was used for comparison was successful survival to hospital discharge with neurologically intact status (SURV-NI).
Traditional CPR supine chest compression techniques, if performed early and properly, can be lifesaving, but they are suboptimal, Dr. Pepe said. “Current techniques create pressure waves that run up the arterial side, but they also create back-pressure on the venous side, increasing intracranial pressure (ICP), thus compromising optimal cerebral blood flow,” he told this news organization.
For that reason, a modified physiologic approach to CPR was designed. It involves an airway adjunct called an impedance threshold device (ITD) and active compression-decompression (ACD) with a device “resembling a toilet plunger,” Dr. Pepe said.
The devices draw more blood out of the brain and into the thorax in a complementary fashion. The combination of these two adjuncts had dramatically improved SURV-NI by 50% in a clinical trial, Dr. Pepe said.
The new technology uses automated gradual head-up/torso-up positioning (AHUP) after first “priming the pump” with ITD-ACD–enhanced circulation. It was found to markedly augment that effect even further. In the laboratory setting, this synergistic NP-CPR bundle has been shown to help normalize cerebral perfusion pressure, further promoting neuro-intact survival. Normalization of end-tidal CO2 is routinely observed, according to Dr. Pepe.
In contrast to patients who present with ventricular fibrillation (shockable cases), patients with nonshockable presentations always have had grim prognoses, Dr. Pepe said. Until now, lifesaving advances had not been found, despite the fact that nonshockable presentations (asystole or electrical activity with no pulse) constitute approximately 80% of OHCA cases, or about 250,000 to 300,00 cases a year in the United States, he said.
In the study, approximately 60% of both the NP-CPR patients and control patients had asystole (flatline) presentations. The NP-CPR group had a significant threefold improvement in SURV-NI, compared with patients treated with conventional CPR in the high-functioning systems (odds ratio, 3.09). In a propensity-scored analysis matching all variables known to affect outcome, the OR increased to nearly fourfold higher (OR, 3.87; 95% confidence interval, 1.27-11.78), Dr. Pepe said.
The researchers also found that the time from receipt of a 911 call to initiation of AHUP was associated with progressively higher chances of survival. The median time for application was 11 minutes; when the elapsed time was less than 11 minutes, the SURV-NI was nearly 11-fold higher for NP-CPR patients than for control patients (OR, 10.59), with survival chances of 6% versus 0.5%. ORs were even higher when the time to treatment was less than 16 minutes (OR, 13.58), with survival rates of 5% versus 0.4%.
The findings not only demonstrate proof of concept in these most futile cases but also that implementation is feasible for the majority of patients, considering that the median time to the start of any CPR by a first responder was 8 minutes for both NP-CPR patients and control patients, “let alone 11 minutes for the AHUP initiation,” Dr. Pepe said. “This finally gives some hope for these nonshockable cases,” he emphasized.
“All of these devices have now been cleared by the Food and Drug Administration and should be adopted by all first-in responders,” said Dr. Pepe. “But they should be implemented as a bundle and in the proper sequence and as soon as feasible.”
Training and implementation efforts continue to expand, and more lives can be saved as more firefighters and first-in response teams acquire equipment and training, which can cut the time to response, he said.
The registry will continue to monitor outcomes with NP-CPR – the term was suggested by a patient who survived through this new approach – and Dr. Pepe and colleagues expect the statistics to improve further with wider adoption and faster implementation with the fastest responders.
A recent study by Dr. Pepe’s team, published in Resuscitation, showed the effectiveness of the neuroprotective bundle in improving survival for OHCA patients overall. The current study confirmed its impact on neuro-intact survival for the subgroup of patients with nonshockable cases.
One other take-home message is that head-up CPR cannot yet be performed by lay bystanders. “Also, do not implement this unless you are going to do it right,” Dr. Pepe emphasized in an interview.
Advanced CPR Solutions provided some materials and research funding for an independent data collector. No other relevant financial relationships have been disclosed.
A version of this article first appeared on Medscape.com.
FROM ACEP 2022
First they get long COVID, then they lose their health care
It’s a devastating series of setbacks for long COVID patients. First, they get the debilitating symptoms of their condition. Then they are forced to give up their jobs, or severely curtail their work hours, as their symptoms linger. And next, for many, they lose their employer-sponsored health insurance.
While not all long COVID patients are debilitated, the CDC’s ongoing survey on long COVID found a quarter of adults with long COVID report it significantly affects their day-to-day living activities.
Estimates have shown that long COVID has disrupted the lives of anywhere from 16 million to 34 million Americans between the ages of 18 and 65.
While hard data is still limited, a Kaiser Family Foundation analysis found that more than half of adults with long COVID who worked before getting the virus are now either out of work or working fewer hours.
According to data from the Census Bureau’s Household Pulse Survey, out of the estimated 16 million working-age adults who currently have long COVID, 2 million to 4 million of them are out of work because of their symptoms. The cost of those lost wages ranges from $170 billion a year to as much as $230 billion, the Census Bureau says. And given that approximately 155 million Americans have employer-sponsored health insurance, the welfare of working-age adults may be under serious threat.
“Millions of people are now impacted by long COVID, and oftentimes along with that comes the inability to work,” says Megan Cole Brahim, PhD, an assistant professor in the department of health law, policy, and management at Boston University and codirector of the school’s Medicaid policy lab. “And because a lot of people get their health insurance coverage through employer-sponsored coverage, no longer being able to work means you may not have access to the health insurance that you once had.”
The CDC defines long COVID as a wide array of health conditions, including malaise, fatigue, shortness of breath, mental health issues, problems with the part of the nervous system that controls body functions, and more.
Gwen Bishop was working remotely for the human resources department at the University of Washington Medical Centers, Seattle, when she got COVID-19. When the infection passed, Ms. Bishop, 39, thought she’d start feeling well enough to get back to work – but that didn’t happen.
“When I would log in to work and just try to read emails,” she says, “it was like they were written in Greek. It made no sense and was incredibly stressful.”
This falls in line with what researchers have found out about the nervous system issues reported by people with long COVID. People who have survived acute COVID infections have reported lasting sensory and motor function problems, brain fog, and memory problems.
Ms. Bishop, who was diagnosed with ADHD when she was in grade school, says another complication she got from her long COVID was a new intolerance to stimulants like coffee and her ADHD medication, Vyvanse, which were normal parts of her everyday life.
“Every time I would take my ADHD medicine or have a cup of coffee, I would have a panic attack until it wore off,” says Ms. Bishop. “Vyvanse is a very long-acting stimulant, so that would be an entire day of an endless panic attack.”
In order for her to get a medical leave approved, Ms. Bishop needed to get documents by a certain date from her doctor’s office that confirmed her long COVID diagnosis. She was able to get a couple of extensions, but Bishop says that with the burden that has been placed on our medical systems, getting in to see a doctor through her employer insurance was taking much longer than expected. By the time she got an appointment, she says, she had already been fired for missing too much work. Emails she provided showing exchanges between her and her employer verify her story. And without her health insurance, her appointment through that provider would no longer have been covered.
In July 2021, the U.S. Department of Health & Human Services issued guidance recognizing long COVID as a disability “if the person’s condition or any of its symptoms is a ‘physical or mental’ impairment that ‘substantially limits’ one or more major life activities.”
But getting access to disability benefits hasn’t been easy for people with long COVID. On top of having to be out of work for 12 months before being able to qualify for Social Security Disability Insurance, some of those who have applied say they have had to put up a fight to actually gain access to disability insurance. The Social Security Administration has yet to reveal just how many applications that cited long COVID have been denied so far.
David Barnett, a former bartender in the Seattle area in his early 40s, got COVID-19 in March 2020. Before his infection, he spent much of his time working on his feet, bodybuilding, and hiking with his partner. But for the last nearly 3 years, even just going for a walk has been a major challenge. He says he has spent much of his post-COVID life either chair-bound or bed-bound because of his symptoms.
He is currently on his partner’s health insurance plan but is still responsible for copays and out-of-network appointments and treatments. After being unable to bartend any more, he started a GoFundMe account and dug into his personal savings. He says he applied for food stamps and is getting ready to sell his truck. Mr. Barnett applied for disability in March of this year but says he was denied benefits by the Social Security Administration and has hired a lawyer to appeal.
He runs a 24-hour online support group on Zoom for people with long COVID and says that no one in his close circle has successfully gotten access to disability payments.
Alba Azola, MD, codirector of Johns Hopkins University’s Post-Acute COVID-19 Team, says at least half of her patients need some level of accommodations to get back to work; most can, if given the proper accommodations, such as switching to a job that can be done sitting down, or with limited time standing. But there are still patients who have been more severely disabled by their long COVID symptoms.
“Work is such a part of people’s identity. The people who are very impaired, all they want to do is to get back to work and their normal lives,” she says.
Many of Dr. Azola’s long COVID patients aren’t able to return to their original jobs. She says they often have to find new positions more tailored to their new realities. One patient, a nurse and mother of five who previously worked in a facility where she got COVID-19, was out of work for 9 months after her infection. She ultimately lost her job, and Dr. Azola says the patient’s employer was hesitant to provide her with any accommodations. The patient was finally able to find a different job as a nurse coordinator where she doesn’t have to be standing for more than 10 minutes at a time.
Ge Bai, PhD, a professor of health policy and management at Johns Hopkins Bloomberg School of Public Health, says the novelty of long COVID and the continued uncertainty around it raise questions for health insurance providers.
“There’s no well-defined pathway to treat or cure this condition,” Dr. Bai says. “Right now, employers have discretion to determine when a condition is being covered or not being covered. So people with long COVID do have a risk that their treatments won’t be covered.”
A version of this article first appeared on WebMD.com.
It’s a devastating series of setbacks for long COVID patients. First, they get the debilitating symptoms of their condition. Then they are forced to give up their jobs, or severely curtail their work hours, as their symptoms linger. And next, for many, they lose their employer-sponsored health insurance.
While not all long COVID patients are debilitated, the CDC’s ongoing survey on long COVID found a quarter of adults with long COVID report it significantly affects their day-to-day living activities.
Estimates have shown that long COVID has disrupted the lives of anywhere from 16 million to 34 million Americans between the ages of 18 and 65.
While hard data is still limited, a Kaiser Family Foundation analysis found that more than half of adults with long COVID who worked before getting the virus are now either out of work or working fewer hours.
According to data from the Census Bureau’s Household Pulse Survey, out of the estimated 16 million working-age adults who currently have long COVID, 2 million to 4 million of them are out of work because of their symptoms. The cost of those lost wages ranges from $170 billion a year to as much as $230 billion, the Census Bureau says. And given that approximately 155 million Americans have employer-sponsored health insurance, the welfare of working-age adults may be under serious threat.
“Millions of people are now impacted by long COVID, and oftentimes along with that comes the inability to work,” says Megan Cole Brahim, PhD, an assistant professor in the department of health law, policy, and management at Boston University and codirector of the school’s Medicaid policy lab. “And because a lot of people get their health insurance coverage through employer-sponsored coverage, no longer being able to work means you may not have access to the health insurance that you once had.”
The CDC defines long COVID as a wide array of health conditions, including malaise, fatigue, shortness of breath, mental health issues, problems with the part of the nervous system that controls body functions, and more.
Gwen Bishop was working remotely for the human resources department at the University of Washington Medical Centers, Seattle, when she got COVID-19. When the infection passed, Ms. Bishop, 39, thought she’d start feeling well enough to get back to work – but that didn’t happen.
“When I would log in to work and just try to read emails,” she says, “it was like they were written in Greek. It made no sense and was incredibly stressful.”
This falls in line with what researchers have found out about the nervous system issues reported by people with long COVID. People who have survived acute COVID infections have reported lasting sensory and motor function problems, brain fog, and memory problems.
Ms. Bishop, who was diagnosed with ADHD when she was in grade school, says another complication she got from her long COVID was a new intolerance to stimulants like coffee and her ADHD medication, Vyvanse, which were normal parts of her everyday life.
“Every time I would take my ADHD medicine or have a cup of coffee, I would have a panic attack until it wore off,” says Ms. Bishop. “Vyvanse is a very long-acting stimulant, so that would be an entire day of an endless panic attack.”
In order for her to get a medical leave approved, Ms. Bishop needed to get documents by a certain date from her doctor’s office that confirmed her long COVID diagnosis. She was able to get a couple of extensions, but Bishop says that with the burden that has been placed on our medical systems, getting in to see a doctor through her employer insurance was taking much longer than expected. By the time she got an appointment, she says, she had already been fired for missing too much work. Emails she provided showing exchanges between her and her employer verify her story. And without her health insurance, her appointment through that provider would no longer have been covered.
In July 2021, the U.S. Department of Health & Human Services issued guidance recognizing long COVID as a disability “if the person’s condition or any of its symptoms is a ‘physical or mental’ impairment that ‘substantially limits’ one or more major life activities.”
But getting access to disability benefits hasn’t been easy for people with long COVID. On top of having to be out of work for 12 months before being able to qualify for Social Security Disability Insurance, some of those who have applied say they have had to put up a fight to actually gain access to disability insurance. The Social Security Administration has yet to reveal just how many applications that cited long COVID have been denied so far.
David Barnett, a former bartender in the Seattle area in his early 40s, got COVID-19 in March 2020. Before his infection, he spent much of his time working on his feet, bodybuilding, and hiking with his partner. But for the last nearly 3 years, even just going for a walk has been a major challenge. He says he has spent much of his post-COVID life either chair-bound or bed-bound because of his symptoms.
He is currently on his partner’s health insurance plan but is still responsible for copays and out-of-network appointments and treatments. After being unable to bartend any more, he started a GoFundMe account and dug into his personal savings. He says he applied for food stamps and is getting ready to sell his truck. Mr. Barnett applied for disability in March of this year but says he was denied benefits by the Social Security Administration and has hired a lawyer to appeal.
He runs a 24-hour online support group on Zoom for people with long COVID and says that no one in his close circle has successfully gotten access to disability payments.
Alba Azola, MD, codirector of Johns Hopkins University’s Post-Acute COVID-19 Team, says at least half of her patients need some level of accommodations to get back to work; most can, if given the proper accommodations, such as switching to a job that can be done sitting down, or with limited time standing. But there are still patients who have been more severely disabled by their long COVID symptoms.
“Work is such a part of people’s identity. The people who are very impaired, all they want to do is to get back to work and their normal lives,” she says.
Many of Dr. Azola’s long COVID patients aren’t able to return to their original jobs. She says they often have to find new positions more tailored to their new realities. One patient, a nurse and mother of five who previously worked in a facility where she got COVID-19, was out of work for 9 months after her infection. She ultimately lost her job, and Dr. Azola says the patient’s employer was hesitant to provide her with any accommodations. The patient was finally able to find a different job as a nurse coordinator where she doesn’t have to be standing for more than 10 minutes at a time.
Ge Bai, PhD, a professor of health policy and management at Johns Hopkins Bloomberg School of Public Health, says the novelty of long COVID and the continued uncertainty around it raise questions for health insurance providers.
“There’s no well-defined pathway to treat or cure this condition,” Dr. Bai says. “Right now, employers have discretion to determine when a condition is being covered or not being covered. So people with long COVID do have a risk that their treatments won’t be covered.”
A version of this article first appeared on WebMD.com.
It’s a devastating series of setbacks for long COVID patients. First, they get the debilitating symptoms of their condition. Then they are forced to give up their jobs, or severely curtail their work hours, as their symptoms linger. And next, for many, they lose their employer-sponsored health insurance.
While not all long COVID patients are debilitated, the CDC’s ongoing survey on long COVID found a quarter of adults with long COVID report it significantly affects their day-to-day living activities.
Estimates have shown that long COVID has disrupted the lives of anywhere from 16 million to 34 million Americans between the ages of 18 and 65.
While hard data is still limited, a Kaiser Family Foundation analysis found that more than half of adults with long COVID who worked before getting the virus are now either out of work or working fewer hours.
According to data from the Census Bureau’s Household Pulse Survey, out of the estimated 16 million working-age adults who currently have long COVID, 2 million to 4 million of them are out of work because of their symptoms. The cost of those lost wages ranges from $170 billion a year to as much as $230 billion, the Census Bureau says. And given that approximately 155 million Americans have employer-sponsored health insurance, the welfare of working-age adults may be under serious threat.
“Millions of people are now impacted by long COVID, and oftentimes along with that comes the inability to work,” says Megan Cole Brahim, PhD, an assistant professor in the department of health law, policy, and management at Boston University and codirector of the school’s Medicaid policy lab. “And because a lot of people get their health insurance coverage through employer-sponsored coverage, no longer being able to work means you may not have access to the health insurance that you once had.”
The CDC defines long COVID as a wide array of health conditions, including malaise, fatigue, shortness of breath, mental health issues, problems with the part of the nervous system that controls body functions, and more.
Gwen Bishop was working remotely for the human resources department at the University of Washington Medical Centers, Seattle, when she got COVID-19. When the infection passed, Ms. Bishop, 39, thought she’d start feeling well enough to get back to work – but that didn’t happen.
“When I would log in to work and just try to read emails,” she says, “it was like they were written in Greek. It made no sense and was incredibly stressful.”
This falls in line with what researchers have found out about the nervous system issues reported by people with long COVID. People who have survived acute COVID infections have reported lasting sensory and motor function problems, brain fog, and memory problems.
Ms. Bishop, who was diagnosed with ADHD when she was in grade school, says another complication she got from her long COVID was a new intolerance to stimulants like coffee and her ADHD medication, Vyvanse, which were normal parts of her everyday life.
“Every time I would take my ADHD medicine or have a cup of coffee, I would have a panic attack until it wore off,” says Ms. Bishop. “Vyvanse is a very long-acting stimulant, so that would be an entire day of an endless panic attack.”
In order for her to get a medical leave approved, Ms. Bishop needed to get documents by a certain date from her doctor’s office that confirmed her long COVID diagnosis. She was able to get a couple of extensions, but Bishop says that with the burden that has been placed on our medical systems, getting in to see a doctor through her employer insurance was taking much longer than expected. By the time she got an appointment, she says, she had already been fired for missing too much work. Emails she provided showing exchanges between her and her employer verify her story. And without her health insurance, her appointment through that provider would no longer have been covered.
In July 2021, the U.S. Department of Health & Human Services issued guidance recognizing long COVID as a disability “if the person’s condition or any of its symptoms is a ‘physical or mental’ impairment that ‘substantially limits’ one or more major life activities.”
But getting access to disability benefits hasn’t been easy for people with long COVID. On top of having to be out of work for 12 months before being able to qualify for Social Security Disability Insurance, some of those who have applied say they have had to put up a fight to actually gain access to disability insurance. The Social Security Administration has yet to reveal just how many applications that cited long COVID have been denied so far.
David Barnett, a former bartender in the Seattle area in his early 40s, got COVID-19 in March 2020. Before his infection, he spent much of his time working on his feet, bodybuilding, and hiking with his partner. But for the last nearly 3 years, even just going for a walk has been a major challenge. He says he has spent much of his post-COVID life either chair-bound or bed-bound because of his symptoms.
He is currently on his partner’s health insurance plan but is still responsible for copays and out-of-network appointments and treatments. After being unable to bartend any more, he started a GoFundMe account and dug into his personal savings. He says he applied for food stamps and is getting ready to sell his truck. Mr. Barnett applied for disability in March of this year but says he was denied benefits by the Social Security Administration and has hired a lawyer to appeal.
He runs a 24-hour online support group on Zoom for people with long COVID and says that no one in his close circle has successfully gotten access to disability payments.
Alba Azola, MD, codirector of Johns Hopkins University’s Post-Acute COVID-19 Team, says at least half of her patients need some level of accommodations to get back to work; most can, if given the proper accommodations, such as switching to a job that can be done sitting down, or with limited time standing. But there are still patients who have been more severely disabled by their long COVID symptoms.
“Work is such a part of people’s identity. The people who are very impaired, all they want to do is to get back to work and their normal lives,” she says.
Many of Dr. Azola’s long COVID patients aren’t able to return to their original jobs. She says they often have to find new positions more tailored to their new realities. One patient, a nurse and mother of five who previously worked in a facility where she got COVID-19, was out of work for 9 months after her infection. She ultimately lost her job, and Dr. Azola says the patient’s employer was hesitant to provide her with any accommodations. The patient was finally able to find a different job as a nurse coordinator where she doesn’t have to be standing for more than 10 minutes at a time.
Ge Bai, PhD, a professor of health policy and management at Johns Hopkins Bloomberg School of Public Health, says the novelty of long COVID and the continued uncertainty around it raise questions for health insurance providers.
“There’s no well-defined pathway to treat or cure this condition,” Dr. Bai says. “Right now, employers have discretion to determine when a condition is being covered or not being covered. So people with long COVID do have a risk that their treatments won’t be covered.”
A version of this article first appeared on WebMD.com.
Poor visual acuity linked to depression, changes in brain structure
After multiple adjustments, analysis of data from more than 114,000 participants in the UK Biobank Study showed that visual impairment was linked to a 19% higher risk for depression.
In addition, imaging results showed a significant link between deteriorating brain structures and depression in those with poor visual acuity.
“Our findings highlight the value of visual health in association with mental health,” Xiayin Zhang, PhD, Guangdong Eye Institute, department of ophthalmology, Guangdong Provincial People’s Hospital, Guangzhou, China, and colleagues write.
“Screening of vision at an early stage should be embedded in the middle-aged and older population to stratify the vulnerable population at risk for depression,” the investigators add.
The findings were published online in JAMA Network Open.
UK biobank analyses
The analysis included 114,583 participants (54.5% women; mean age, 56.8 years) from the UK Biobank who completed standardized questionnaires and underwent ocular examinations.
To test distance visual acuity, all were asked to read letters on lines from the top to the bottom of a chart while wearing prescribed optical correction. Visual impairment was defined as visual acuity worse than 0.3 logarithm of the minimum angle of resolution (LogMAR) units.
Depressive symptoms were self-reported using the two-item Patient Health Questionnaire (PHQ-2), in which a score of 3 or more indicates depression. As well, a medical practitioner conducted an assessment of depression at baseline.
Among the participants, 87.2% had no visual impairment or depression and acted as the healthy control group. In addition, 3.2% showed visual impairment, 10% reported a diagnosis of depression, and 0.4% had both.
Researchers adjusted for age, sex, race, ethnicity, education, smoking, alcohol consumption, physical activity, family history of severe depression, obesity, hypertension, diabetes, hyperlipidemia, and deprivation on the Townsend index.
Among those with visual impairment, 12.4% had depression, compared with 9.9% without visual impairment.
Structure deterioration
After adjusting for potential confounders, visual impairment was associated with a 19% higher risk for depression (odds ratio, 1.19; 95% confidence interval, 1.05-1.34; P = .003). In addition, 1-line–worse visual acuity was associated with 5% higher odds of depression (OR, 1.05; 95% CI, 1.04-1.07; P < .001).
The association between visual acuity and depression was found in both younger (39-58 years) and older (59-72 years) groups, as well as in both men and women.
The researchers also explored the association between depressive symptoms and brain structure using MRI scans from a subset of 7,844 individuals (51% women; 2% with visual impairment).
Results showed linear associations between PHQ-2 scores and the left volume of gray matter in the supracalcarine cortex (coefficient, 7.61; 95% CI, 3.9-11.3; adjusted P = .006).
The investigators note that the supracalcarine cortex is spatially connected to the primary visual cortex, suggesting the visual cortex may be involved in the pathogenesis of depression.
PHQ-2 scores were also associated with mean isotropic volume fraction (ISOVF) in the right fornix (cres) and/or stria terminalis (coefficient, .003; 95% CI, 0.001-0.004; adjusted P = .01).
The links “could be moderated by visual acuity, whereby increased PHQ score was associated with higher ISOVF levels only among those with poorer visual acuity (P = .02 for interaction),” the investigators report.
These results “suggest that poorer visual acuity was associated with greater depressive symptoms and may have contributed to the related deterioration of the fornix and stria terminalis,” they add.
They note that previous studies have supported the hypothesis that the fornix and stria terminalis are involved in the pathophysiology of other brain-related conditions, including schizophrenia, bipolar disorder, and autism spectrum disorder.
However, the investigators did not have information on how long the participants had experienced visual impairment, so they couldn’t investigate whether results were affected by time. Additional study limitations cited were that depression may affect vision and that a large proportion of the participants (89.3%) were White.
Study ‘adds nuance’
Commenting on the study, Ipsit V. Vahia, MD, of the department of psychiatry at Harvard Medical School, Boston, and associate chief of geriatric psychiatry at McLean Hospital, Belmont, Mass., said the study “adds nuance to our understanding” of the well-established relationship between vision deficits and depression.
“It indicates that even mild visual deficits may be associated with depression,” said Dr. Vahia, who was not involved with the research.
The investigators validated this association by showing that visual acuity was also associated with neuroimaging markers of depression, he added.
Although the study was not designed to demonstrate causal relationships between mood and vision and its findings do not confirm that correcting visual acuity deficits will resolve depressive symptoms, “the large study sample and high quality of data should give clinicians confidence in the study’s findings,” Dr. Vahia said.
“Correcting visual acuity deficits can be considered standard care for older adults worldwide, and this study suggests that providing this standard care could also benefit mental health,” he concluded.
The study was supported by the National Natural Science Foundation of China, the China Postdoctoral Science Foundation, the Outstanding Young Talent Trainee Program of Guangdong Provincial People’s Hospital, the Guangdong Provincial People’s Hospital Scientific Research Funds for Leading Medical Talents and Distinguished Young Scholars in Guangdong Province, the Talent Introduction Fund of Guangdong Provincial People’s Hospital, the Science and Technology Program of Guangzhou, China, the Project of Special Research on Cardiovascular Diseases, the Research Foundation of Medical Science and Technology of Guangdong Province, the University of Melbourne at Research Accelerator Program, and the CERA (Centre for Eye Research Australia) Foundation and Victorian State Government for the Centre for Eye Research Australia. The investigators and Dr. Vahia have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
After multiple adjustments, analysis of data from more than 114,000 participants in the UK Biobank Study showed that visual impairment was linked to a 19% higher risk for depression.
In addition, imaging results showed a significant link between deteriorating brain structures and depression in those with poor visual acuity.
“Our findings highlight the value of visual health in association with mental health,” Xiayin Zhang, PhD, Guangdong Eye Institute, department of ophthalmology, Guangdong Provincial People’s Hospital, Guangzhou, China, and colleagues write.
“Screening of vision at an early stage should be embedded in the middle-aged and older population to stratify the vulnerable population at risk for depression,” the investigators add.
The findings were published online in JAMA Network Open.
UK biobank analyses
The analysis included 114,583 participants (54.5% women; mean age, 56.8 years) from the UK Biobank who completed standardized questionnaires and underwent ocular examinations.
To test distance visual acuity, all were asked to read letters on lines from the top to the bottom of a chart while wearing prescribed optical correction. Visual impairment was defined as visual acuity worse than 0.3 logarithm of the minimum angle of resolution (LogMAR) units.
Depressive symptoms were self-reported using the two-item Patient Health Questionnaire (PHQ-2), in which a score of 3 or more indicates depression. As well, a medical practitioner conducted an assessment of depression at baseline.
Among the participants, 87.2% had no visual impairment or depression and acted as the healthy control group. In addition, 3.2% showed visual impairment, 10% reported a diagnosis of depression, and 0.4% had both.
Researchers adjusted for age, sex, race, ethnicity, education, smoking, alcohol consumption, physical activity, family history of severe depression, obesity, hypertension, diabetes, hyperlipidemia, and deprivation on the Townsend index.
Among those with visual impairment, 12.4% had depression, compared with 9.9% without visual impairment.
Structure deterioration
After adjusting for potential confounders, visual impairment was associated with a 19% higher risk for depression (odds ratio, 1.19; 95% confidence interval, 1.05-1.34; P = .003). In addition, 1-line–worse visual acuity was associated with 5% higher odds of depression (OR, 1.05; 95% CI, 1.04-1.07; P < .001).
The association between visual acuity and depression was found in both younger (39-58 years) and older (59-72 years) groups, as well as in both men and women.
The researchers also explored the association between depressive symptoms and brain structure using MRI scans from a subset of 7,844 individuals (51% women; 2% with visual impairment).
Results showed linear associations between PHQ-2 scores and the left volume of gray matter in the supracalcarine cortex (coefficient, 7.61; 95% CI, 3.9-11.3; adjusted P = .006).
The investigators note that the supracalcarine cortex is spatially connected to the primary visual cortex, suggesting the visual cortex may be involved in the pathogenesis of depression.
PHQ-2 scores were also associated with mean isotropic volume fraction (ISOVF) in the right fornix (cres) and/or stria terminalis (coefficient, .003; 95% CI, 0.001-0.004; adjusted P = .01).
The links “could be moderated by visual acuity, whereby increased PHQ score was associated with higher ISOVF levels only among those with poorer visual acuity (P = .02 for interaction),” the investigators report.
These results “suggest that poorer visual acuity was associated with greater depressive symptoms and may have contributed to the related deterioration of the fornix and stria terminalis,” they add.
They note that previous studies have supported the hypothesis that the fornix and stria terminalis are involved in the pathophysiology of other brain-related conditions, including schizophrenia, bipolar disorder, and autism spectrum disorder.
However, the investigators did not have information on how long the participants had experienced visual impairment, so they couldn’t investigate whether results were affected by time. Additional study limitations cited were that depression may affect vision and that a large proportion of the participants (89.3%) were White.
Study ‘adds nuance’
Commenting on the study, Ipsit V. Vahia, MD, of the department of psychiatry at Harvard Medical School, Boston, and associate chief of geriatric psychiatry at McLean Hospital, Belmont, Mass., said the study “adds nuance to our understanding” of the well-established relationship between vision deficits and depression.
“It indicates that even mild visual deficits may be associated with depression,” said Dr. Vahia, who was not involved with the research.
The investigators validated this association by showing that visual acuity was also associated with neuroimaging markers of depression, he added.
Although the study was not designed to demonstrate causal relationships between mood and vision and its findings do not confirm that correcting visual acuity deficits will resolve depressive symptoms, “the large study sample and high quality of data should give clinicians confidence in the study’s findings,” Dr. Vahia said.
“Correcting visual acuity deficits can be considered standard care for older adults worldwide, and this study suggests that providing this standard care could also benefit mental health,” he concluded.
The study was supported by the National Natural Science Foundation of China, the China Postdoctoral Science Foundation, the Outstanding Young Talent Trainee Program of Guangdong Provincial People’s Hospital, the Guangdong Provincial People’s Hospital Scientific Research Funds for Leading Medical Talents and Distinguished Young Scholars in Guangdong Province, the Talent Introduction Fund of Guangdong Provincial People’s Hospital, the Science and Technology Program of Guangzhou, China, the Project of Special Research on Cardiovascular Diseases, the Research Foundation of Medical Science and Technology of Guangdong Province, the University of Melbourne at Research Accelerator Program, and the CERA (Centre for Eye Research Australia) Foundation and Victorian State Government for the Centre for Eye Research Australia. The investigators and Dr. Vahia have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
After multiple adjustments, analysis of data from more than 114,000 participants in the UK Biobank Study showed that visual impairment was linked to a 19% higher risk for depression.
In addition, imaging results showed a significant link between deteriorating brain structures and depression in those with poor visual acuity.
“Our findings highlight the value of visual health in association with mental health,” Xiayin Zhang, PhD, Guangdong Eye Institute, department of ophthalmology, Guangdong Provincial People’s Hospital, Guangzhou, China, and colleagues write.
“Screening of vision at an early stage should be embedded in the middle-aged and older population to stratify the vulnerable population at risk for depression,” the investigators add.
The findings were published online in JAMA Network Open.
UK biobank analyses
The analysis included 114,583 participants (54.5% women; mean age, 56.8 years) from the UK Biobank who completed standardized questionnaires and underwent ocular examinations.
To test distance visual acuity, all were asked to read letters on lines from the top to the bottom of a chart while wearing prescribed optical correction. Visual impairment was defined as visual acuity worse than 0.3 logarithm of the minimum angle of resolution (LogMAR) units.
Depressive symptoms were self-reported using the two-item Patient Health Questionnaire (PHQ-2), in which a score of 3 or more indicates depression. As well, a medical practitioner conducted an assessment of depression at baseline.
Among the participants, 87.2% had no visual impairment or depression and acted as the healthy control group. In addition, 3.2% showed visual impairment, 10% reported a diagnosis of depression, and 0.4% had both.
Researchers adjusted for age, sex, race, ethnicity, education, smoking, alcohol consumption, physical activity, family history of severe depression, obesity, hypertension, diabetes, hyperlipidemia, and deprivation on the Townsend index.
Among those with visual impairment, 12.4% had depression, compared with 9.9% without visual impairment.
Structure deterioration
After adjusting for potential confounders, visual impairment was associated with a 19% higher risk for depression (odds ratio, 1.19; 95% confidence interval, 1.05-1.34; P = .003). In addition, 1-line–worse visual acuity was associated with 5% higher odds of depression (OR, 1.05; 95% CI, 1.04-1.07; P < .001).
The association between visual acuity and depression was found in both younger (39-58 years) and older (59-72 years) groups, as well as in both men and women.
The researchers also explored the association between depressive symptoms and brain structure using MRI scans from a subset of 7,844 individuals (51% women; 2% with visual impairment).
Results showed linear associations between PHQ-2 scores and the left volume of gray matter in the supracalcarine cortex (coefficient, 7.61; 95% CI, 3.9-11.3; adjusted P = .006).
The investigators note that the supracalcarine cortex is spatially connected to the primary visual cortex, suggesting the visual cortex may be involved in the pathogenesis of depression.
PHQ-2 scores were also associated with mean isotropic volume fraction (ISOVF) in the right fornix (cres) and/or stria terminalis (coefficient, .003; 95% CI, 0.001-0.004; adjusted P = .01).
The links “could be moderated by visual acuity, whereby increased PHQ score was associated with higher ISOVF levels only among those with poorer visual acuity (P = .02 for interaction),” the investigators report.
These results “suggest that poorer visual acuity was associated with greater depressive symptoms and may have contributed to the related deterioration of the fornix and stria terminalis,” they add.
They note that previous studies have supported the hypothesis that the fornix and stria terminalis are involved in the pathophysiology of other brain-related conditions, including schizophrenia, bipolar disorder, and autism spectrum disorder.
However, the investigators did not have information on how long the participants had experienced visual impairment, so they couldn’t investigate whether results were affected by time. Additional study limitations cited were that depression may affect vision and that a large proportion of the participants (89.3%) were White.
Study ‘adds nuance’
Commenting on the study, Ipsit V. Vahia, MD, of the department of psychiatry at Harvard Medical School, Boston, and associate chief of geriatric psychiatry at McLean Hospital, Belmont, Mass., said the study “adds nuance to our understanding” of the well-established relationship between vision deficits and depression.
“It indicates that even mild visual deficits may be associated with depression,” said Dr. Vahia, who was not involved with the research.
The investigators validated this association by showing that visual acuity was also associated with neuroimaging markers of depression, he added.
Although the study was not designed to demonstrate causal relationships between mood and vision and its findings do not confirm that correcting visual acuity deficits will resolve depressive symptoms, “the large study sample and high quality of data should give clinicians confidence in the study’s findings,” Dr. Vahia said.
“Correcting visual acuity deficits can be considered standard care for older adults worldwide, and this study suggests that providing this standard care could also benefit mental health,” he concluded.
The study was supported by the National Natural Science Foundation of China, the China Postdoctoral Science Foundation, the Outstanding Young Talent Trainee Program of Guangdong Provincial People’s Hospital, the Guangdong Provincial People’s Hospital Scientific Research Funds for Leading Medical Talents and Distinguished Young Scholars in Guangdong Province, the Talent Introduction Fund of Guangdong Provincial People’s Hospital, the Science and Technology Program of Guangzhou, China, the Project of Special Research on Cardiovascular Diseases, the Research Foundation of Medical Science and Technology of Guangdong Province, the University of Melbourne at Research Accelerator Program, and the CERA (Centre for Eye Research Australia) Foundation and Victorian State Government for the Centre for Eye Research Australia. The investigators and Dr. Vahia have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
Dermatologists fear effects of Dobbs decision for patients on isotretinoin, methotrexate
More than 3 months after the Dobbs decision by the U.S. Supreme Court overturned Roe v. Wade and revoked the constitutional right to an abortion, Some have beefed up their already stringent instructions and lengthy conversations about avoiding pregnancy while on the medication.
The major fear is that a patient who is taking contraceptive precautions, in accordance with the isotretinoin risk-management program, iPLEDGE, but still becomes pregnant while on isotretinoin may find out about the pregnancy too late to undergo an abortion in her own state and may not be able to travel to another state – or the patient may live in a state where abortions are entirely prohibited and is unable to travel to another state.
Isotretinoin is marketed as Absorica, Absorica LD, Claravis, Amnesteem, Myorisan, and Zenatane; its former brand name was Accutane.
As of Oct. 7, a total of 14 states have banned most abortions, while 4 others have bans at 6, 15, 18, or 20 weeks. Attempts to restrict abortion on several other states are underway.
“To date, we don’t know of any specific effects of the Dobbs decision on isotretinoin prescribing, but with abortion access banned in many states, we anticipate that this could be a very real issue for individuals who accidentally become pregnant while taking isotretinoin,” said Ilona Frieden, MD, professor of dermatology and pediatrics at the University of California, San Francisco, and chair of the American Academy of Dermatology Association’s iPLEDGE Workgroup.
The iPLEDGE REMS (Risk Evaluation and Mitigation Strategy) is the Food and Drug Administration–required safety program that is in place to manage the risk of isotretinoin teratogenicity and minimize fetal exposure. The work group meets with the FDA and isotretinoin manufacturers to keep the program safe and operating smoothly. The iPLEDGE workgroup has not yet issued any specific statements on the implications of the Dobbs decision on prescribing isotretinoin.
But work on the issue is ongoing by the American Academy of Dermatology. In a statement issued in September, Mark D. Kaufmann, MD, president of the AAD, said that the academy “is continuing to work with its Patient Guidance for State Regulations Regarding Reproductive Health Task Force to help dermatologists best navigate state laws about how care should be implemented for patients who are or might become pregnant, and have been exposed to teratogenic medications.”
The task force, working with the academy, is “in the process of developing resources to help members better assist patients and have a productive and caring dialogue with them,” according to the statement. No specific timeline was given for when those resources might be available.
Methotrexate prescriptions
Also of concern are prescriptions for methotrexate, which is prescribed for psoriasis, atopic dermatitis, and other skin diseases. Soon after the Dobbs decision was announced on June 24, pharmacies began to require pharmacists in states that banned abortions to verify that a prescription for methotrexate was not intended for an abortion, since methotrexate is used in combination with misoprostol for termination of an early pregnancy.
The action was taken, spokespersons for several major pharmacies said, to comply with state laws. According to Kara Page, a CVS spokesperson: “Pharmacists are caught in the middle on this issue.” Laws in some states, she told this news organization, “restrict the dispensing of medications for the purpose of inducing an abortion. These laws, some of which include criminal penalties, have forced us to require pharmacists in these states to validate that the intended indication is not to terminate a pregnancy before they can fill a prescription for methotrexate.”
“New laws in various states require additional steps for dispensing certain prescriptions and apply to all pharmacies, including Walgreens,” Fraser Engerman, a spokesperson for Walgreens, told this news organization. “In these states, our pharmacists work closely with prescribers as needed, to fill lawful, clinically appropriate prescriptions. We provide ongoing training and information to help our pharmacists understand the latest requirements in their area, and with these supports, the expectation is they are empowered to fill these prescriptions.”
The iPLEDGE program has numerous requirements before a patient can begin isotretinoin treatment. Patients capable of becoming pregnant must agree to use two effective forms of birth control during the entire treatment period, which typically lasts 4 or 5 months, as well as 1 month before and 1 month after treatment, or commit to total abstinence during that time.
Perspective: A Georgia dermatologist
Howa Yeung, MD, MSc, assistant professor of dermatology at Emory University, Atlanta, who sees patients regularly, practices in Georgia, where abortion is now banned at about 6 weeks of pregnancy. Dr. Yeung worries that some dermatologists in Georgia and elsewhere may not even want to take the risk of prescribing isotretinoin, although the results in treating resistant acne are well documented.
That isn’t his only concern. “Some may not want to prescribe it to a patient who reports they are abstinent and instead require them to go on two forms [of contraception].” Or some women who are not sexually active with anyone who can get them pregnant may also be asked to go on contraception, he said. Abstinence is an alternative option in iPLEDGE.
In the past, he said, well before the Dobbs decision, some doctors have argued that iPLEDGE should not include abstinence as an option. That 2020 report was challenged by others who pointed out that removing the abstinence option would pose ethical issues and may disproportionately affect minorities and others.
Before the Dobbs decision, Dr. Yeung noted, dermatologists prescribing isotretinoin focused on pregnancy prevention but knew that if pregnancy accidentally occurred, abortion was available as an option. “The reality after the decision is, it may or may not be available to all our patients.”
Of the 14 states banning most abortions, 10 are clustered within the South and Southeast. A woman living in Arkansas, which bans most abortions, for example, is surrounded by 6 other states that do the same.
Perspective: An Arizona dermatologist
Christina Kranc, MD, is a general dermatologist in Phoenix and Scottsdale. Arizona now bans most abortions. However, this has not changed her practice much when prescribing isotretinoin, she told this news organization, because when selecting appropriate candidates for the medication, she is strict on the contraceptive requirement, and only very rarely agrees to a patient relying on abstinence.
And if a patient capable of becoming pregnant was only having sex with another patient capable of becoming pregnant? Dr. Kranc said she would still require contraception unless it was impossible for pregnancy to occur.
Among the many scenarios a dermatologist might have to consider are a lesbian cisgender woman who is having, or has only had, sexual activity with another cisgender women.
Perspective: A Connecticut dermatologist
The concern is not only about isotretinoin but all teratogenic drugs, according to Jane M. Grant-Kels, MD, vice chair of dermatology and professor of dermatology, pathology, and pediatrics at the University of Connecticut, Farmington. She often prescribes methotrexate, which is also teratogenic.
Her advice for colleagues: “Whether you believe in abortion or not is irrelevant; it’s something you discuss with your patients.” She, too, fears that doctors in states banning abortions will stop prescribing these medications, “and that is very sad.”
For those practicing in states limiting or banning abortions, Dr. Grant-Kels said, “They need to have an even longer discussion with their patients about how serious this is.” Those doctors need to talk about not only two or three types of birth control, but also discuss with the patient about the potential need for travel, should pregnancy occur and abortion be the chosen option.
Although the newer biologics are an option for psoriasis, they are expensive. And, she said, many insurers require a step-therapy approach, and “want you to start with cheaper medications,” such as methotrexate. As a result, “in some states you won’t have access to the targeted therapies unless a patient fails something like methotrexate.”
Dr. Grant-Kels worries in particular about low-income women who may not have the means to travel to get an abortion.
Need for EC education
In a recent survey of 57 pediatric dermatologists who prescribe isotretinoin, only a third said they felt confident in their understanding of emergency contraception.
The authors of the study noted that the most common reasons for pregnancies during isotretinoin therapy reported to the FDA from 2011 to 2017 “included ineffective or inconsistent use” of contraceptives and “unsuccessful abstinence,” and recommended that physicians who prescribe isotretinoin update and increase their understanding of emergency contraception.
Dr. Yeung, Dr. Kranc, Dr. Grant-Kels, and Dr. Frieden reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
More than 3 months after the Dobbs decision by the U.S. Supreme Court overturned Roe v. Wade and revoked the constitutional right to an abortion, Some have beefed up their already stringent instructions and lengthy conversations about avoiding pregnancy while on the medication.
The major fear is that a patient who is taking contraceptive precautions, in accordance with the isotretinoin risk-management program, iPLEDGE, but still becomes pregnant while on isotretinoin may find out about the pregnancy too late to undergo an abortion in her own state and may not be able to travel to another state – or the patient may live in a state where abortions are entirely prohibited and is unable to travel to another state.
Isotretinoin is marketed as Absorica, Absorica LD, Claravis, Amnesteem, Myorisan, and Zenatane; its former brand name was Accutane.
As of Oct. 7, a total of 14 states have banned most abortions, while 4 others have bans at 6, 15, 18, or 20 weeks. Attempts to restrict abortion on several other states are underway.
“To date, we don’t know of any specific effects of the Dobbs decision on isotretinoin prescribing, but with abortion access banned in many states, we anticipate that this could be a very real issue for individuals who accidentally become pregnant while taking isotretinoin,” said Ilona Frieden, MD, professor of dermatology and pediatrics at the University of California, San Francisco, and chair of the American Academy of Dermatology Association’s iPLEDGE Workgroup.
The iPLEDGE REMS (Risk Evaluation and Mitigation Strategy) is the Food and Drug Administration–required safety program that is in place to manage the risk of isotretinoin teratogenicity and minimize fetal exposure. The work group meets with the FDA and isotretinoin manufacturers to keep the program safe and operating smoothly. The iPLEDGE workgroup has not yet issued any specific statements on the implications of the Dobbs decision on prescribing isotretinoin.
But work on the issue is ongoing by the American Academy of Dermatology. In a statement issued in September, Mark D. Kaufmann, MD, president of the AAD, said that the academy “is continuing to work with its Patient Guidance for State Regulations Regarding Reproductive Health Task Force to help dermatologists best navigate state laws about how care should be implemented for patients who are or might become pregnant, and have been exposed to teratogenic medications.”
The task force, working with the academy, is “in the process of developing resources to help members better assist patients and have a productive and caring dialogue with them,” according to the statement. No specific timeline was given for when those resources might be available.
Methotrexate prescriptions
Also of concern are prescriptions for methotrexate, which is prescribed for psoriasis, atopic dermatitis, and other skin diseases. Soon after the Dobbs decision was announced on June 24, pharmacies began to require pharmacists in states that banned abortions to verify that a prescription for methotrexate was not intended for an abortion, since methotrexate is used in combination with misoprostol for termination of an early pregnancy.
The action was taken, spokespersons for several major pharmacies said, to comply with state laws. According to Kara Page, a CVS spokesperson: “Pharmacists are caught in the middle on this issue.” Laws in some states, she told this news organization, “restrict the dispensing of medications for the purpose of inducing an abortion. These laws, some of which include criminal penalties, have forced us to require pharmacists in these states to validate that the intended indication is not to terminate a pregnancy before they can fill a prescription for methotrexate.”
“New laws in various states require additional steps for dispensing certain prescriptions and apply to all pharmacies, including Walgreens,” Fraser Engerman, a spokesperson for Walgreens, told this news organization. “In these states, our pharmacists work closely with prescribers as needed, to fill lawful, clinically appropriate prescriptions. We provide ongoing training and information to help our pharmacists understand the latest requirements in their area, and with these supports, the expectation is they are empowered to fill these prescriptions.”
The iPLEDGE program has numerous requirements before a patient can begin isotretinoin treatment. Patients capable of becoming pregnant must agree to use two effective forms of birth control during the entire treatment period, which typically lasts 4 or 5 months, as well as 1 month before and 1 month after treatment, or commit to total abstinence during that time.
Perspective: A Georgia dermatologist
Howa Yeung, MD, MSc, assistant professor of dermatology at Emory University, Atlanta, who sees patients regularly, practices in Georgia, where abortion is now banned at about 6 weeks of pregnancy. Dr. Yeung worries that some dermatologists in Georgia and elsewhere may not even want to take the risk of prescribing isotretinoin, although the results in treating resistant acne are well documented.
That isn’t his only concern. “Some may not want to prescribe it to a patient who reports they are abstinent and instead require them to go on two forms [of contraception].” Or some women who are not sexually active with anyone who can get them pregnant may also be asked to go on contraception, he said. Abstinence is an alternative option in iPLEDGE.
In the past, he said, well before the Dobbs decision, some doctors have argued that iPLEDGE should not include abstinence as an option. That 2020 report was challenged by others who pointed out that removing the abstinence option would pose ethical issues and may disproportionately affect minorities and others.
Before the Dobbs decision, Dr. Yeung noted, dermatologists prescribing isotretinoin focused on pregnancy prevention but knew that if pregnancy accidentally occurred, abortion was available as an option. “The reality after the decision is, it may or may not be available to all our patients.”
Of the 14 states banning most abortions, 10 are clustered within the South and Southeast. A woman living in Arkansas, which bans most abortions, for example, is surrounded by 6 other states that do the same.
Perspective: An Arizona dermatologist
Christina Kranc, MD, is a general dermatologist in Phoenix and Scottsdale. Arizona now bans most abortions. However, this has not changed her practice much when prescribing isotretinoin, she told this news organization, because when selecting appropriate candidates for the medication, she is strict on the contraceptive requirement, and only very rarely agrees to a patient relying on abstinence.
And if a patient capable of becoming pregnant was only having sex with another patient capable of becoming pregnant? Dr. Kranc said she would still require contraception unless it was impossible for pregnancy to occur.
Among the many scenarios a dermatologist might have to consider are a lesbian cisgender woman who is having, or has only had, sexual activity with another cisgender women.
Perspective: A Connecticut dermatologist
The concern is not only about isotretinoin but all teratogenic drugs, according to Jane M. Grant-Kels, MD, vice chair of dermatology and professor of dermatology, pathology, and pediatrics at the University of Connecticut, Farmington. She often prescribes methotrexate, which is also teratogenic.
Her advice for colleagues: “Whether you believe in abortion or not is irrelevant; it’s something you discuss with your patients.” She, too, fears that doctors in states banning abortions will stop prescribing these medications, “and that is very sad.”
For those practicing in states limiting or banning abortions, Dr. Grant-Kels said, “They need to have an even longer discussion with their patients about how serious this is.” Those doctors need to talk about not only two or three types of birth control, but also discuss with the patient about the potential need for travel, should pregnancy occur and abortion be the chosen option.
Although the newer biologics are an option for psoriasis, they are expensive. And, she said, many insurers require a step-therapy approach, and “want you to start with cheaper medications,” such as methotrexate. As a result, “in some states you won’t have access to the targeted therapies unless a patient fails something like methotrexate.”
Dr. Grant-Kels worries in particular about low-income women who may not have the means to travel to get an abortion.
Need for EC education
In a recent survey of 57 pediatric dermatologists who prescribe isotretinoin, only a third said they felt confident in their understanding of emergency contraception.
The authors of the study noted that the most common reasons for pregnancies during isotretinoin therapy reported to the FDA from 2011 to 2017 “included ineffective or inconsistent use” of contraceptives and “unsuccessful abstinence,” and recommended that physicians who prescribe isotretinoin update and increase their understanding of emergency contraception.
Dr. Yeung, Dr. Kranc, Dr. Grant-Kels, and Dr. Frieden reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
More than 3 months after the Dobbs decision by the U.S. Supreme Court overturned Roe v. Wade and revoked the constitutional right to an abortion, Some have beefed up their already stringent instructions and lengthy conversations about avoiding pregnancy while on the medication.
The major fear is that a patient who is taking contraceptive precautions, in accordance with the isotretinoin risk-management program, iPLEDGE, but still becomes pregnant while on isotretinoin may find out about the pregnancy too late to undergo an abortion in her own state and may not be able to travel to another state – or the patient may live in a state where abortions are entirely prohibited and is unable to travel to another state.
Isotretinoin is marketed as Absorica, Absorica LD, Claravis, Amnesteem, Myorisan, and Zenatane; its former brand name was Accutane.
As of Oct. 7, a total of 14 states have banned most abortions, while 4 others have bans at 6, 15, 18, or 20 weeks. Attempts to restrict abortion on several other states are underway.
“To date, we don’t know of any specific effects of the Dobbs decision on isotretinoin prescribing, but with abortion access banned in many states, we anticipate that this could be a very real issue for individuals who accidentally become pregnant while taking isotretinoin,” said Ilona Frieden, MD, professor of dermatology and pediatrics at the University of California, San Francisco, and chair of the American Academy of Dermatology Association’s iPLEDGE Workgroup.
The iPLEDGE REMS (Risk Evaluation and Mitigation Strategy) is the Food and Drug Administration–required safety program that is in place to manage the risk of isotretinoin teratogenicity and minimize fetal exposure. The work group meets with the FDA and isotretinoin manufacturers to keep the program safe and operating smoothly. The iPLEDGE workgroup has not yet issued any specific statements on the implications of the Dobbs decision on prescribing isotretinoin.
But work on the issue is ongoing by the American Academy of Dermatology. In a statement issued in September, Mark D. Kaufmann, MD, president of the AAD, said that the academy “is continuing to work with its Patient Guidance for State Regulations Regarding Reproductive Health Task Force to help dermatologists best navigate state laws about how care should be implemented for patients who are or might become pregnant, and have been exposed to teratogenic medications.”
The task force, working with the academy, is “in the process of developing resources to help members better assist patients and have a productive and caring dialogue with them,” according to the statement. No specific timeline was given for when those resources might be available.
Methotrexate prescriptions
Also of concern are prescriptions for methotrexate, which is prescribed for psoriasis, atopic dermatitis, and other skin diseases. Soon after the Dobbs decision was announced on June 24, pharmacies began to require pharmacists in states that banned abortions to verify that a prescription for methotrexate was not intended for an abortion, since methotrexate is used in combination with misoprostol for termination of an early pregnancy.
The action was taken, spokespersons for several major pharmacies said, to comply with state laws. According to Kara Page, a CVS spokesperson: “Pharmacists are caught in the middle on this issue.” Laws in some states, she told this news organization, “restrict the dispensing of medications for the purpose of inducing an abortion. These laws, some of which include criminal penalties, have forced us to require pharmacists in these states to validate that the intended indication is not to terminate a pregnancy before they can fill a prescription for methotrexate.”
“New laws in various states require additional steps for dispensing certain prescriptions and apply to all pharmacies, including Walgreens,” Fraser Engerman, a spokesperson for Walgreens, told this news organization. “In these states, our pharmacists work closely with prescribers as needed, to fill lawful, clinically appropriate prescriptions. We provide ongoing training and information to help our pharmacists understand the latest requirements in their area, and with these supports, the expectation is they are empowered to fill these prescriptions.”
The iPLEDGE program has numerous requirements before a patient can begin isotretinoin treatment. Patients capable of becoming pregnant must agree to use two effective forms of birth control during the entire treatment period, which typically lasts 4 or 5 months, as well as 1 month before and 1 month after treatment, or commit to total abstinence during that time.
Perspective: A Georgia dermatologist
Howa Yeung, MD, MSc, assistant professor of dermatology at Emory University, Atlanta, who sees patients regularly, practices in Georgia, where abortion is now banned at about 6 weeks of pregnancy. Dr. Yeung worries that some dermatologists in Georgia and elsewhere may not even want to take the risk of prescribing isotretinoin, although the results in treating resistant acne are well documented.
That isn’t his only concern. “Some may not want to prescribe it to a patient who reports they are abstinent and instead require them to go on two forms [of contraception].” Or some women who are not sexually active with anyone who can get them pregnant may also be asked to go on contraception, he said. Abstinence is an alternative option in iPLEDGE.
In the past, he said, well before the Dobbs decision, some doctors have argued that iPLEDGE should not include abstinence as an option. That 2020 report was challenged by others who pointed out that removing the abstinence option would pose ethical issues and may disproportionately affect minorities and others.
Before the Dobbs decision, Dr. Yeung noted, dermatologists prescribing isotretinoin focused on pregnancy prevention but knew that if pregnancy accidentally occurred, abortion was available as an option. “The reality after the decision is, it may or may not be available to all our patients.”
Of the 14 states banning most abortions, 10 are clustered within the South and Southeast. A woman living in Arkansas, which bans most abortions, for example, is surrounded by 6 other states that do the same.
Perspective: An Arizona dermatologist
Christina Kranc, MD, is a general dermatologist in Phoenix and Scottsdale. Arizona now bans most abortions. However, this has not changed her practice much when prescribing isotretinoin, she told this news organization, because when selecting appropriate candidates for the medication, she is strict on the contraceptive requirement, and only very rarely agrees to a patient relying on abstinence.
And if a patient capable of becoming pregnant was only having sex with another patient capable of becoming pregnant? Dr. Kranc said she would still require contraception unless it was impossible for pregnancy to occur.
Among the many scenarios a dermatologist might have to consider are a lesbian cisgender woman who is having, or has only had, sexual activity with another cisgender women.
Perspective: A Connecticut dermatologist
The concern is not only about isotretinoin but all teratogenic drugs, according to Jane M. Grant-Kels, MD, vice chair of dermatology and professor of dermatology, pathology, and pediatrics at the University of Connecticut, Farmington. She often prescribes methotrexate, which is also teratogenic.
Her advice for colleagues: “Whether you believe in abortion or not is irrelevant; it’s something you discuss with your patients.” She, too, fears that doctors in states banning abortions will stop prescribing these medications, “and that is very sad.”
For those practicing in states limiting or banning abortions, Dr. Grant-Kels said, “They need to have an even longer discussion with their patients about how serious this is.” Those doctors need to talk about not only two or three types of birth control, but also discuss with the patient about the potential need for travel, should pregnancy occur and abortion be the chosen option.
Although the newer biologics are an option for psoriasis, they are expensive. And, she said, many insurers require a step-therapy approach, and “want you to start with cheaper medications,” such as methotrexate. As a result, “in some states you won’t have access to the targeted therapies unless a patient fails something like methotrexate.”
Dr. Grant-Kels worries in particular about low-income women who may not have the means to travel to get an abortion.
Need for EC education
In a recent survey of 57 pediatric dermatologists who prescribe isotretinoin, only a third said they felt confident in their understanding of emergency contraception.
The authors of the study noted that the most common reasons for pregnancies during isotretinoin therapy reported to the FDA from 2011 to 2017 “included ineffective or inconsistent use” of contraceptives and “unsuccessful abstinence,” and recommended that physicians who prescribe isotretinoin update and increase their understanding of emergency contraception.
Dr. Yeung, Dr. Kranc, Dr. Grant-Kels, and Dr. Frieden reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Dermatologists embrace low-dose oral minoxidil as hair loss adjunctive therapy
It’s not a new drug – it’s been available in topical form for hair loss since 1988 and was approved as an antihypertensive in 1979 – but .
The number of scholarly publications examining its use for hair loss has grown dramatically in the last 2 years: There were 2 in 2019, and that jumped to 17 in 2020 and 20 in 2021, with another 16 published so far this year, according to a PubMed search. An August article in The New York Times touting it as a potential cheap magic bullet is likely to drum up even more interest, said dermatologists.
The low-dose formulation is especially exciting for women, as there have been few great oral options for them, clinicians said.
Female hair loss “is devastating,” said Lily Talakoub, MD, adding that topical minoxidil (Rogaine), topical serums, and supplements “really do not provide the considerable growth that women really want to see.” Oral minoxidil is not approved by the U.S. Food and Drug Administration for hair loss, but “it has been shown in studies to cause the hairs to grow,” and has become a “lifeline” for women, said Dr. Talakoub, a dermatologist who is in private practice in McLean, Va.
“For many years we haven’t had anything new to tell patients medically,” said Lynne J. Goldberg, MD, professor of dermatology and pathology at Boston University School of Medicine. “Now, all of the sudden there’s a cheap, widely available efficacious medicine. That’s huge for female-pattern hair loss,” said Dr. Goldberg, who is also the director of the Boston Medical Center’s Hair Clinic.
“I’ve been using oral minoxidil for about 4 years with great success,” said dermatologist Eva Simmons-O’Brien, MD, who is in private practice in Towson, Md. She has used it primarily in women, mainly because she sees more women than men for hair loss.
Dr. Simmons-O’Brien said the excitement about low-dose oral minoxidil follows an increasing recognition in the medical and scientific community that hair loss is more than just a cosmetic issue.
Mechanism not fully understood
When minoxidil was first brought to market as an antihypertensive, clinicians noted hair growth in “balding patients,” which led to the development of the topical form. Even though it has been used for hair growth for decades, its mechanism of action is not fully understood. It is known that minoxidil is a vasodilator; it may also increase DNA synthesis and enhance cell proliferation, according to a review published in 2019.
“The positive effect of minoxidil on hair growth is mainly due to its metabolite, minoxidil sulfate, and the enzyme responsible for this conversion is sulfotransferase, which is located in hair follicles and varies in production among individuals,” write the authors, all affiliated with Mahidol University in Bangkok, Thailand.
Writing in the American Academy of Dermatology’s Dermatology World Insights and Inquiries, Warren R. Heymann, MD, observed that “even after decades of use,” how minoxidil improves alopecia is still not completely understood. He noted that a 2020 review found that minoxidil’s vasodilatory effects “are propagated by upregulation of vascular endothelial growth factor (VEGF), increasing cutaneous blood flow with resultant increase in oxygen and growth factor delivery to the hair follicle.” The medication prolongs the anagen phase and shortens the telogen phase, added Dr. Heymann, head of dermatology at Rowan University, Camden, N.J.
As an antihypertensive, minoxidil is given at 5-40 mg daily. Those doses have produced serious side effects such as sodium and fluid retention, ischemic heart disease, pericardial effusion, and pulmonary hypertension, according to the Thai researchers.
Those side effects have appeared to be rare with low-dose oral minoxidil. However, in JAAD Case Reports, South African researchers reported a case in which low-dose oral minoxidil may have led to cardiac side effects. A healthy 40-year-old woman, who after 3 weeks of treatment with 5% topical minoxidil, tacrolimus ointment 0.1%, clobetasol propionate ointment, 100 mg of doxycycline twice daily, and 0.25 mg of oral minoxidil daily, was hospitalized with full-body edema. An ultrasound showed fluid collections in the pericardium, pleural space, and abdomen. She also had a pleural effusion. The patient was given 40 mg of intravenous furosemide daily for 4 days, and the edema resolved.
“Having excluded other causes of pericardial effusion and anasarca in the previously healthy, young woman, we concluded that LDOM [low-dose oral minoxidil] was responsible for her clinical presentation,” write the authors.
A review of 17 studies published on-line in 2020 in the Journal of the American Academy of Dermatology found low-dose minoxidil to be safe and effective. Androgenetic alopecia was the most commonly studied, with doses of 0.25-1.25 mg proving to be effective and safe. It was also safe and effective for female-pattern hair loss, traction alopecia, chronic telogen effluvium, lichen planopilaris, alopecia areata, and permanent chemotherapy-induced alopecia.
The most common adverse effect was hypertrichosis. Other adverse events included postural hypotension and dizziness, lower-limb edema, and mild blood pressure changes.
In another multicenter, 1,404-patient safety study published in 2021 in JAAD, the authors found that hypertrichosis was the most frequent adverse event, reported by 15% of patients. Systemic adverse events included lightheadedness (1.7% of patients), fluid retention (1.3%), tachycardia (0.9%), headache (0.4%), periorbital edema (0.3%), and insomnia (0.2%). Only 29 patients (1.2%) withdrew because of these side effects.
“It definitely helps, and it’s relatively safe,” said Adam Friedman, MD, professor and chair of dermatology at George Washington University in Washington. “But I wouldn’t want to call it a game-changer,” he said, adding that it works best when used in combination with other therapies. He often uses it with a 5-alpha reductase inhibitor – finasteride (Propecia) or dutasteride (Avodart) – “rather than as a monotherapy,” said Dr. Friedman.
From Australia to around the globe
The first publication on low-dose oral minoxidil for hair loss was in December 2017. The pilot study in female-pattern hair loss was published in the International Journal of Dermatology by Rodney Sinclair, MBBS, MD, a Melbourne, Australia–based dermatologist.
Amy McMichael, MD, professor of dermatology at Wake Forest University, Winston-Salem, N.C., said she first heard Dr. Sinclair present his findings at an alopecia research meeting in Japan shortly before his initial publication.
“After that, I think all of us said, ‘Huh, this is interesting, and let’s try it, because we’re always looking for something more to help our patients,’” Dr. McMichael said, adding that she’s been prescribing low-dose minoxidil to her patients for 5 years.
She and colleagues at Wake Forest, along with Jerry Cooley, MD, a dermatologist in private practice in Charlotte, published a retrospective case series in March, looking at 105 adult patients – 80 women (ages 24-80) and 25 men (ages 19-63) – who were treated for androgenetic alopecia and/or telogen effluvium with oral minoxidil (dose range of 0.625–2.5 mg) once daily for a year, matched to 105 case controls.
Efficacy was based on the clinician’s assessment of clinical response and clinical photographic evaluation using a 3-point scale (worsening, stabilization, and improvement). Half of those treated demonstrated clinical improvement and 43% demonstrated stabilization. There was a significant difference (P < .001) in clinical response between those who received minoxidil and the controls.
Ideal patients?
Given its ease of use and low cost – $4-$12 for a 30-day supply of 2.5 mg tablets, according to GoodRX – low-dose minoxidil is a good fit for many patients, said dermatologists.
The best candidate is “a woman who’s perimenopausal or menopausal who’s got what we would say is moderate to severe loss of hair that’s kind of just starting,” said Dr. Simmons-O’Brien. The medication is not likely to grow hair where there is scarring already, however, she said.
“I tend to use it in people who either don’t want to do the topical minoxidil or have used it and have a lot of potential side effects from it,” like itching and irritation, said Dr. McMichael. She said oral minoxidil can also be helpful as an adjunct in patients with alopecia areata and that it can be used after anti-inflammatory treatments in central centrifugal cicatricial alopecia.
Dr. Goldberg said low-dose minoxidil would not be her first choice for female-pattern hair loss but that it’s “a great alternative” for people who can’t tolerate the topical form. Most of the women she has prescribed it to “have been pretty happy,” she added.
“I would be a little cautious in patients on a number of other medications,” Dr. Goldberg said, noting minoxidil’s potential systemic side effects.
Clinicians said they generally consult with a patient’s internist when they are starting them on oral minoxidil. “I always want to touch base with the primary care physician first,” said Dr. Friedman.
“If they’re on oral antihypertensive medications already, then I would ask them to talk to either their primary care physician or their cardiologist to make sure it’s okay to give this low dose,” said Dr. McMichael.
At the low doses, minoxidil rarely has any blood pressure–lowering effects, dermatologists said.
Women are usually started on 1.25 mg, while men can start at a higher, 2.5-mg dose, said clinicians.
Dr. Goldberg and Dr. Simmons-O’Brien said that recent additional warnings for finasteride about sexual side effects and the potential for suicide have changed the way they approach its use in young men, and that it has highlighted the potential for oral minoxidil as an alternative.
Oral minoxidil is rarely used as a monotherapy. “It takes a village” to address hair loss, said Dr. Simmons-O’Brien, noting that she likes to evaluate nutrition, vitamin D levels, and whether a patient is anemic or has thyroid disease when determining a course of action.
Dermatologists said they use oral minoxidil in combination with spironolactone, topical minoxidil, finasteride, or dutasteride. If patients are already on antihypertensives or at risk for excessive blood pressure–lowering effects of a combination that includes spironolactone, the dermatologists said again they will consult with a patient’s primary care physician first.
For women, the main limiting factor with oral minoxidil may be unwanted hair growth, usually on the face. Most of the clinicians interviewed for this story said they did not use spironolactone to counteract that hypertrichosis.
Dr. McMichael said she cautions African American women or women of African descent – who tend to have more body hair at baseline – that they should be aware of the potential for excess hair growth associated with low-dose minoxidil. She and other dermatologists interviewed for this story said they urge patients who are bothered by the excess hair to shave or wax or use other nonpharmacologic approaches.
The excess hair growth is less bothersome for men, they said.
Not a magic wand
Despite the increased profile and interest, oral minoxidil is not a cure-all, clinicians said.
“It’s important for patients to realize that hair loss can be complicated and there is no one magic wand,” said Dr. Simmons-O’Brien. Clinicians typically “are using several things to help encourage these follicular units to not miniaturize and disappear and create scars,” she said.
Dr. Friedman said he finds that patients have a hard time hearing that to continue to maintain growth, they have to take a medication for the rest of their life. “If you stop, you will have to start again,” he said.
Oral minoxidil, when used in combination with other therapies, will improve hair growth, said Dr. Goldberg. But it will not take someone back a decade, she said. “I try to temper expectations – promise a little and achieve more,” Dr. Goldberg said.
The study was independently supported. Dr. Smith and Dr. Jones report no relevant financial relationships. Dr. Simmons-O’Brien reports that she has received speaking fees from Isdin. Dr. McMichael disclosed relationships with Eli Lilly, Pfizer, Nutrafol, Revian, and UCB Pharma. Dr. Friedman, Dr. Goldberg, and Dr. Talakoub reported no disclosures.
A version of this article first appeared on Medscape.com.
It’s not a new drug – it’s been available in topical form for hair loss since 1988 and was approved as an antihypertensive in 1979 – but .
The number of scholarly publications examining its use for hair loss has grown dramatically in the last 2 years: There were 2 in 2019, and that jumped to 17 in 2020 and 20 in 2021, with another 16 published so far this year, according to a PubMed search. An August article in The New York Times touting it as a potential cheap magic bullet is likely to drum up even more interest, said dermatologists.
The low-dose formulation is especially exciting for women, as there have been few great oral options for them, clinicians said.
Female hair loss “is devastating,” said Lily Talakoub, MD, adding that topical minoxidil (Rogaine), topical serums, and supplements “really do not provide the considerable growth that women really want to see.” Oral minoxidil is not approved by the U.S. Food and Drug Administration for hair loss, but “it has been shown in studies to cause the hairs to grow,” and has become a “lifeline” for women, said Dr. Talakoub, a dermatologist who is in private practice in McLean, Va.
“For many years we haven’t had anything new to tell patients medically,” said Lynne J. Goldberg, MD, professor of dermatology and pathology at Boston University School of Medicine. “Now, all of the sudden there’s a cheap, widely available efficacious medicine. That’s huge for female-pattern hair loss,” said Dr. Goldberg, who is also the director of the Boston Medical Center’s Hair Clinic.
“I’ve been using oral minoxidil for about 4 years with great success,” said dermatologist Eva Simmons-O’Brien, MD, who is in private practice in Towson, Md. She has used it primarily in women, mainly because she sees more women than men for hair loss.
Dr. Simmons-O’Brien said the excitement about low-dose oral minoxidil follows an increasing recognition in the medical and scientific community that hair loss is more than just a cosmetic issue.
Mechanism not fully understood
When minoxidil was first brought to market as an antihypertensive, clinicians noted hair growth in “balding patients,” which led to the development of the topical form. Even though it has been used for hair growth for decades, its mechanism of action is not fully understood. It is known that minoxidil is a vasodilator; it may also increase DNA synthesis and enhance cell proliferation, according to a review published in 2019.
“The positive effect of minoxidil on hair growth is mainly due to its metabolite, minoxidil sulfate, and the enzyme responsible for this conversion is sulfotransferase, which is located in hair follicles and varies in production among individuals,” write the authors, all affiliated with Mahidol University in Bangkok, Thailand.
Writing in the American Academy of Dermatology’s Dermatology World Insights and Inquiries, Warren R. Heymann, MD, observed that “even after decades of use,” how minoxidil improves alopecia is still not completely understood. He noted that a 2020 review found that minoxidil’s vasodilatory effects “are propagated by upregulation of vascular endothelial growth factor (VEGF), increasing cutaneous blood flow with resultant increase in oxygen and growth factor delivery to the hair follicle.” The medication prolongs the anagen phase and shortens the telogen phase, added Dr. Heymann, head of dermatology at Rowan University, Camden, N.J.
As an antihypertensive, minoxidil is given at 5-40 mg daily. Those doses have produced serious side effects such as sodium and fluid retention, ischemic heart disease, pericardial effusion, and pulmonary hypertension, according to the Thai researchers.
Those side effects have appeared to be rare with low-dose oral minoxidil. However, in JAAD Case Reports, South African researchers reported a case in which low-dose oral minoxidil may have led to cardiac side effects. A healthy 40-year-old woman, who after 3 weeks of treatment with 5% topical minoxidil, tacrolimus ointment 0.1%, clobetasol propionate ointment, 100 mg of doxycycline twice daily, and 0.25 mg of oral minoxidil daily, was hospitalized with full-body edema. An ultrasound showed fluid collections in the pericardium, pleural space, and abdomen. She also had a pleural effusion. The patient was given 40 mg of intravenous furosemide daily for 4 days, and the edema resolved.
“Having excluded other causes of pericardial effusion and anasarca in the previously healthy, young woman, we concluded that LDOM [low-dose oral minoxidil] was responsible for her clinical presentation,” write the authors.
A review of 17 studies published on-line in 2020 in the Journal of the American Academy of Dermatology found low-dose minoxidil to be safe and effective. Androgenetic alopecia was the most commonly studied, with doses of 0.25-1.25 mg proving to be effective and safe. It was also safe and effective for female-pattern hair loss, traction alopecia, chronic telogen effluvium, lichen planopilaris, alopecia areata, and permanent chemotherapy-induced alopecia.
The most common adverse effect was hypertrichosis. Other adverse events included postural hypotension and dizziness, lower-limb edema, and mild blood pressure changes.
In another multicenter, 1,404-patient safety study published in 2021 in JAAD, the authors found that hypertrichosis was the most frequent adverse event, reported by 15% of patients. Systemic adverse events included lightheadedness (1.7% of patients), fluid retention (1.3%), tachycardia (0.9%), headache (0.4%), periorbital edema (0.3%), and insomnia (0.2%). Only 29 patients (1.2%) withdrew because of these side effects.
“It definitely helps, and it’s relatively safe,” said Adam Friedman, MD, professor and chair of dermatology at George Washington University in Washington. “But I wouldn’t want to call it a game-changer,” he said, adding that it works best when used in combination with other therapies. He often uses it with a 5-alpha reductase inhibitor – finasteride (Propecia) or dutasteride (Avodart) – “rather than as a monotherapy,” said Dr. Friedman.
From Australia to around the globe
The first publication on low-dose oral minoxidil for hair loss was in December 2017. The pilot study in female-pattern hair loss was published in the International Journal of Dermatology by Rodney Sinclair, MBBS, MD, a Melbourne, Australia–based dermatologist.
Amy McMichael, MD, professor of dermatology at Wake Forest University, Winston-Salem, N.C., said she first heard Dr. Sinclair present his findings at an alopecia research meeting in Japan shortly before his initial publication.
“After that, I think all of us said, ‘Huh, this is interesting, and let’s try it, because we’re always looking for something more to help our patients,’” Dr. McMichael said, adding that she’s been prescribing low-dose minoxidil to her patients for 5 years.
She and colleagues at Wake Forest, along with Jerry Cooley, MD, a dermatologist in private practice in Charlotte, published a retrospective case series in March, looking at 105 adult patients – 80 women (ages 24-80) and 25 men (ages 19-63) – who were treated for androgenetic alopecia and/or telogen effluvium with oral minoxidil (dose range of 0.625–2.5 mg) once daily for a year, matched to 105 case controls.
Efficacy was based on the clinician’s assessment of clinical response and clinical photographic evaluation using a 3-point scale (worsening, stabilization, and improvement). Half of those treated demonstrated clinical improvement and 43% demonstrated stabilization. There was a significant difference (P < .001) in clinical response between those who received minoxidil and the controls.
Ideal patients?
Given its ease of use and low cost – $4-$12 for a 30-day supply of 2.5 mg tablets, according to GoodRX – low-dose minoxidil is a good fit for many patients, said dermatologists.
The best candidate is “a woman who’s perimenopausal or menopausal who’s got what we would say is moderate to severe loss of hair that’s kind of just starting,” said Dr. Simmons-O’Brien. The medication is not likely to grow hair where there is scarring already, however, she said.
“I tend to use it in people who either don’t want to do the topical minoxidil or have used it and have a lot of potential side effects from it,” like itching and irritation, said Dr. McMichael. She said oral minoxidil can also be helpful as an adjunct in patients with alopecia areata and that it can be used after anti-inflammatory treatments in central centrifugal cicatricial alopecia.
Dr. Goldberg said low-dose minoxidil would not be her first choice for female-pattern hair loss but that it’s “a great alternative” for people who can’t tolerate the topical form. Most of the women she has prescribed it to “have been pretty happy,” she added.
“I would be a little cautious in patients on a number of other medications,” Dr. Goldberg said, noting minoxidil’s potential systemic side effects.
Clinicians said they generally consult with a patient’s internist when they are starting them on oral minoxidil. “I always want to touch base with the primary care physician first,” said Dr. Friedman.
“If they’re on oral antihypertensive medications already, then I would ask them to talk to either their primary care physician or their cardiologist to make sure it’s okay to give this low dose,” said Dr. McMichael.
At the low doses, minoxidil rarely has any blood pressure–lowering effects, dermatologists said.
Women are usually started on 1.25 mg, while men can start at a higher, 2.5-mg dose, said clinicians.
Dr. Goldberg and Dr. Simmons-O’Brien said that recent additional warnings for finasteride about sexual side effects and the potential for suicide have changed the way they approach its use in young men, and that it has highlighted the potential for oral minoxidil as an alternative.
Oral minoxidil is rarely used as a monotherapy. “It takes a village” to address hair loss, said Dr. Simmons-O’Brien, noting that she likes to evaluate nutrition, vitamin D levels, and whether a patient is anemic or has thyroid disease when determining a course of action.
Dermatologists said they use oral minoxidil in combination with spironolactone, topical minoxidil, finasteride, or dutasteride. If patients are already on antihypertensives or at risk for excessive blood pressure–lowering effects of a combination that includes spironolactone, the dermatologists said again they will consult with a patient’s primary care physician first.
For women, the main limiting factor with oral minoxidil may be unwanted hair growth, usually on the face. Most of the clinicians interviewed for this story said they did not use spironolactone to counteract that hypertrichosis.
Dr. McMichael said she cautions African American women or women of African descent – who tend to have more body hair at baseline – that they should be aware of the potential for excess hair growth associated with low-dose minoxidil. She and other dermatologists interviewed for this story said they urge patients who are bothered by the excess hair to shave or wax or use other nonpharmacologic approaches.
The excess hair growth is less bothersome for men, they said.
Not a magic wand
Despite the increased profile and interest, oral minoxidil is not a cure-all, clinicians said.
“It’s important for patients to realize that hair loss can be complicated and there is no one magic wand,” said Dr. Simmons-O’Brien. Clinicians typically “are using several things to help encourage these follicular units to not miniaturize and disappear and create scars,” she said.
Dr. Friedman said he finds that patients have a hard time hearing that to continue to maintain growth, they have to take a medication for the rest of their life. “If you stop, you will have to start again,” he said.
Oral minoxidil, when used in combination with other therapies, will improve hair growth, said Dr. Goldberg. But it will not take someone back a decade, she said. “I try to temper expectations – promise a little and achieve more,” Dr. Goldberg said.
The study was independently supported. Dr. Smith and Dr. Jones report no relevant financial relationships. Dr. Simmons-O’Brien reports that she has received speaking fees from Isdin. Dr. McMichael disclosed relationships with Eli Lilly, Pfizer, Nutrafol, Revian, and UCB Pharma. Dr. Friedman, Dr. Goldberg, and Dr. Talakoub reported no disclosures.
A version of this article first appeared on Medscape.com.
It’s not a new drug – it’s been available in topical form for hair loss since 1988 and was approved as an antihypertensive in 1979 – but .
The number of scholarly publications examining its use for hair loss has grown dramatically in the last 2 years: There were 2 in 2019, and that jumped to 17 in 2020 and 20 in 2021, with another 16 published so far this year, according to a PubMed search. An August article in The New York Times touting it as a potential cheap magic bullet is likely to drum up even more interest, said dermatologists.
The low-dose formulation is especially exciting for women, as there have been few great oral options for them, clinicians said.
Female hair loss “is devastating,” said Lily Talakoub, MD, adding that topical minoxidil (Rogaine), topical serums, and supplements “really do not provide the considerable growth that women really want to see.” Oral minoxidil is not approved by the U.S. Food and Drug Administration for hair loss, but “it has been shown in studies to cause the hairs to grow,” and has become a “lifeline” for women, said Dr. Talakoub, a dermatologist who is in private practice in McLean, Va.
“For many years we haven’t had anything new to tell patients medically,” said Lynne J. Goldberg, MD, professor of dermatology and pathology at Boston University School of Medicine. “Now, all of the sudden there’s a cheap, widely available efficacious medicine. That’s huge for female-pattern hair loss,” said Dr. Goldberg, who is also the director of the Boston Medical Center’s Hair Clinic.
“I’ve been using oral minoxidil for about 4 years with great success,” said dermatologist Eva Simmons-O’Brien, MD, who is in private practice in Towson, Md. She has used it primarily in women, mainly because she sees more women than men for hair loss.
Dr. Simmons-O’Brien said the excitement about low-dose oral minoxidil follows an increasing recognition in the medical and scientific community that hair loss is more than just a cosmetic issue.
Mechanism not fully understood
When minoxidil was first brought to market as an antihypertensive, clinicians noted hair growth in “balding patients,” which led to the development of the topical form. Even though it has been used for hair growth for decades, its mechanism of action is not fully understood. It is known that minoxidil is a vasodilator; it may also increase DNA synthesis and enhance cell proliferation, according to a review published in 2019.
“The positive effect of minoxidil on hair growth is mainly due to its metabolite, minoxidil sulfate, and the enzyme responsible for this conversion is sulfotransferase, which is located in hair follicles and varies in production among individuals,” write the authors, all affiliated with Mahidol University in Bangkok, Thailand.
Writing in the American Academy of Dermatology’s Dermatology World Insights and Inquiries, Warren R. Heymann, MD, observed that “even after decades of use,” how minoxidil improves alopecia is still not completely understood. He noted that a 2020 review found that minoxidil’s vasodilatory effects “are propagated by upregulation of vascular endothelial growth factor (VEGF), increasing cutaneous blood flow with resultant increase in oxygen and growth factor delivery to the hair follicle.” The medication prolongs the anagen phase and shortens the telogen phase, added Dr. Heymann, head of dermatology at Rowan University, Camden, N.J.
As an antihypertensive, minoxidil is given at 5-40 mg daily. Those doses have produced serious side effects such as sodium and fluid retention, ischemic heart disease, pericardial effusion, and pulmonary hypertension, according to the Thai researchers.
Those side effects have appeared to be rare with low-dose oral minoxidil. However, in JAAD Case Reports, South African researchers reported a case in which low-dose oral minoxidil may have led to cardiac side effects. A healthy 40-year-old woman, who after 3 weeks of treatment with 5% topical minoxidil, tacrolimus ointment 0.1%, clobetasol propionate ointment, 100 mg of doxycycline twice daily, and 0.25 mg of oral minoxidil daily, was hospitalized with full-body edema. An ultrasound showed fluid collections in the pericardium, pleural space, and abdomen. She also had a pleural effusion. The patient was given 40 mg of intravenous furosemide daily for 4 days, and the edema resolved.
“Having excluded other causes of pericardial effusion and anasarca in the previously healthy, young woman, we concluded that LDOM [low-dose oral minoxidil] was responsible for her clinical presentation,” write the authors.
A review of 17 studies published on-line in 2020 in the Journal of the American Academy of Dermatology found low-dose minoxidil to be safe and effective. Androgenetic alopecia was the most commonly studied, with doses of 0.25-1.25 mg proving to be effective and safe. It was also safe and effective for female-pattern hair loss, traction alopecia, chronic telogen effluvium, lichen planopilaris, alopecia areata, and permanent chemotherapy-induced alopecia.
The most common adverse effect was hypertrichosis. Other adverse events included postural hypotension and dizziness, lower-limb edema, and mild blood pressure changes.
In another multicenter, 1,404-patient safety study published in 2021 in JAAD, the authors found that hypertrichosis was the most frequent adverse event, reported by 15% of patients. Systemic adverse events included lightheadedness (1.7% of patients), fluid retention (1.3%), tachycardia (0.9%), headache (0.4%), periorbital edema (0.3%), and insomnia (0.2%). Only 29 patients (1.2%) withdrew because of these side effects.
“It definitely helps, and it’s relatively safe,” said Adam Friedman, MD, professor and chair of dermatology at George Washington University in Washington. “But I wouldn’t want to call it a game-changer,” he said, adding that it works best when used in combination with other therapies. He often uses it with a 5-alpha reductase inhibitor – finasteride (Propecia) or dutasteride (Avodart) – “rather than as a monotherapy,” said Dr. Friedman.
From Australia to around the globe
The first publication on low-dose oral minoxidil for hair loss was in December 2017. The pilot study in female-pattern hair loss was published in the International Journal of Dermatology by Rodney Sinclair, MBBS, MD, a Melbourne, Australia–based dermatologist.
Amy McMichael, MD, professor of dermatology at Wake Forest University, Winston-Salem, N.C., said she first heard Dr. Sinclair present his findings at an alopecia research meeting in Japan shortly before his initial publication.
“After that, I think all of us said, ‘Huh, this is interesting, and let’s try it, because we’re always looking for something more to help our patients,’” Dr. McMichael said, adding that she’s been prescribing low-dose minoxidil to her patients for 5 years.
She and colleagues at Wake Forest, along with Jerry Cooley, MD, a dermatologist in private practice in Charlotte, published a retrospective case series in March, looking at 105 adult patients – 80 women (ages 24-80) and 25 men (ages 19-63) – who were treated for androgenetic alopecia and/or telogen effluvium with oral minoxidil (dose range of 0.625–2.5 mg) once daily for a year, matched to 105 case controls.
Efficacy was based on the clinician’s assessment of clinical response and clinical photographic evaluation using a 3-point scale (worsening, stabilization, and improvement). Half of those treated demonstrated clinical improvement and 43% demonstrated stabilization. There was a significant difference (P < .001) in clinical response between those who received minoxidil and the controls.
Ideal patients?
Given its ease of use and low cost – $4-$12 for a 30-day supply of 2.5 mg tablets, according to GoodRX – low-dose minoxidil is a good fit for many patients, said dermatologists.
The best candidate is “a woman who’s perimenopausal or menopausal who’s got what we would say is moderate to severe loss of hair that’s kind of just starting,” said Dr. Simmons-O’Brien. The medication is not likely to grow hair where there is scarring already, however, she said.
“I tend to use it in people who either don’t want to do the topical minoxidil or have used it and have a lot of potential side effects from it,” like itching and irritation, said Dr. McMichael. She said oral minoxidil can also be helpful as an adjunct in patients with alopecia areata and that it can be used after anti-inflammatory treatments in central centrifugal cicatricial alopecia.
Dr. Goldberg said low-dose minoxidil would not be her first choice for female-pattern hair loss but that it’s “a great alternative” for people who can’t tolerate the topical form. Most of the women she has prescribed it to “have been pretty happy,” she added.
“I would be a little cautious in patients on a number of other medications,” Dr. Goldberg said, noting minoxidil’s potential systemic side effects.
Clinicians said they generally consult with a patient’s internist when they are starting them on oral minoxidil. “I always want to touch base with the primary care physician first,” said Dr. Friedman.
“If they’re on oral antihypertensive medications already, then I would ask them to talk to either their primary care physician or their cardiologist to make sure it’s okay to give this low dose,” said Dr. McMichael.
At the low doses, minoxidil rarely has any blood pressure–lowering effects, dermatologists said.
Women are usually started on 1.25 mg, while men can start at a higher, 2.5-mg dose, said clinicians.
Dr. Goldberg and Dr. Simmons-O’Brien said that recent additional warnings for finasteride about sexual side effects and the potential for suicide have changed the way they approach its use in young men, and that it has highlighted the potential for oral minoxidil as an alternative.
Oral minoxidil is rarely used as a monotherapy. “It takes a village” to address hair loss, said Dr. Simmons-O’Brien, noting that she likes to evaluate nutrition, vitamin D levels, and whether a patient is anemic or has thyroid disease when determining a course of action.
Dermatologists said they use oral minoxidil in combination with spironolactone, topical minoxidil, finasteride, or dutasteride. If patients are already on antihypertensives or at risk for excessive blood pressure–lowering effects of a combination that includes spironolactone, the dermatologists said again they will consult with a patient’s primary care physician first.
For women, the main limiting factor with oral minoxidil may be unwanted hair growth, usually on the face. Most of the clinicians interviewed for this story said they did not use spironolactone to counteract that hypertrichosis.
Dr. McMichael said she cautions African American women or women of African descent – who tend to have more body hair at baseline – that they should be aware of the potential for excess hair growth associated with low-dose minoxidil. She and other dermatologists interviewed for this story said they urge patients who are bothered by the excess hair to shave or wax or use other nonpharmacologic approaches.
The excess hair growth is less bothersome for men, they said.
Not a magic wand
Despite the increased profile and interest, oral minoxidil is not a cure-all, clinicians said.
“It’s important for patients to realize that hair loss can be complicated and there is no one magic wand,” said Dr. Simmons-O’Brien. Clinicians typically “are using several things to help encourage these follicular units to not miniaturize and disappear and create scars,” she said.
Dr. Friedman said he finds that patients have a hard time hearing that to continue to maintain growth, they have to take a medication for the rest of their life. “If you stop, you will have to start again,” he said.
Oral minoxidil, when used in combination with other therapies, will improve hair growth, said Dr. Goldberg. But it will not take someone back a decade, she said. “I try to temper expectations – promise a little and achieve more,” Dr. Goldberg said.
The study was independently supported. Dr. Smith and Dr. Jones report no relevant financial relationships. Dr. Simmons-O’Brien reports that she has received speaking fees from Isdin. Dr. McMichael disclosed relationships with Eli Lilly, Pfizer, Nutrafol, Revian, and UCB Pharma. Dr. Friedman, Dr. Goldberg, and Dr. Talakoub reported no disclosures.
A version of this article first appeared on Medscape.com.
A White female presented with pustules and erythematous macules on the left palm
Psoriasis is an immune-mediated chronic inflammatory disease characterized by well-demarcated, scaly, erythematous plaques. Those who present with the condition often have a family history, which supports recent research uncovering various genes implicated in its pathogenesis. The disease is also associated with other systemic complications, most notably cardiovascular disease.
This condition is found in a small percentage of patients with psoriasis and presentation varies from hyperkeratotic plaques to pustular lesions. The pustular form is known as palmoplantar pustulosis and is within the spectrum of palmoplantar psoriasis.
Psoriasis is typically a clinical diagnosis and its severity can be measured using the Psoriasis Area and Severity Index. If biopsy is performed, the histology demonstrates parakeratosis, orthokeratosis, loss of the stratum granulosum, and dilated vasculature with an inflammatory cell infiltrate. The keratinocytes present with abnormal differentiation and hyperplasia, and the presence of foci of neutrophils known as “Munro’s microabscesses” in the stratum corneum serve as the hallmark of histological diagnosis. However, it is important to note that appearance can vary based on the stage of the lesion and the subtype of psoriasis present.
Palmoplantar psoriasis can be especially limiting and difficult to treat because of its distribution. Topical steroids, topical vitamin D analogues, and narrow band ultraviolet light therapy can be effective for less severe cases. Methotrexate, biologic treatments, and apremilast can be used for more extensive disease.
This patient is HLA-B27 positive and has uveitis. The presence of the HLA-B27 allele has been associated with inflammatory bowel disease, uveitis, psoriatic arthritis, and reactive arthritis. It has also been reported to be associated with pustular psoriasis. She responded well to topical steroids and vitamin D analogues.
This case and photo were submitted by Mr. Shapiro at Nova Southeastern University College of Osteopathic Medicine, Davie, Fla., and Dr. Bilu Martin.
Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to [email protected].
References
1. Psoriasis: Overview and Diagnosis, in “Evidence-Based Psoriasis. Updates in Clinical Dermatology.” (Cham, Switzerland: Springer International, 2018).
2. Merola JF et al. Dermatol Ther. 2018 May;31(3):e12589.
3. Chung J et al. J Am Acad Dermatol. 2014 Oct;71(4):623-32.
Psoriasis is an immune-mediated chronic inflammatory disease characterized by well-demarcated, scaly, erythematous plaques. Those who present with the condition often have a family history, which supports recent research uncovering various genes implicated in its pathogenesis. The disease is also associated with other systemic complications, most notably cardiovascular disease.
This condition is found in a small percentage of patients with psoriasis and presentation varies from hyperkeratotic plaques to pustular lesions. The pustular form is known as palmoplantar pustulosis and is within the spectrum of palmoplantar psoriasis.
Psoriasis is typically a clinical diagnosis and its severity can be measured using the Psoriasis Area and Severity Index. If biopsy is performed, the histology demonstrates parakeratosis, orthokeratosis, loss of the stratum granulosum, and dilated vasculature with an inflammatory cell infiltrate. The keratinocytes present with abnormal differentiation and hyperplasia, and the presence of foci of neutrophils known as “Munro’s microabscesses” in the stratum corneum serve as the hallmark of histological diagnosis. However, it is important to note that appearance can vary based on the stage of the lesion and the subtype of psoriasis present.
Palmoplantar psoriasis can be especially limiting and difficult to treat because of its distribution. Topical steroids, topical vitamin D analogues, and narrow band ultraviolet light therapy can be effective for less severe cases. Methotrexate, biologic treatments, and apremilast can be used for more extensive disease.
This patient is HLA-B27 positive and has uveitis. The presence of the HLA-B27 allele has been associated with inflammatory bowel disease, uveitis, psoriatic arthritis, and reactive arthritis. It has also been reported to be associated with pustular psoriasis. She responded well to topical steroids and vitamin D analogues.
This case and photo were submitted by Mr. Shapiro at Nova Southeastern University College of Osteopathic Medicine, Davie, Fla., and Dr. Bilu Martin.
Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to [email protected].
References
1. Psoriasis: Overview and Diagnosis, in “Evidence-Based Psoriasis. Updates in Clinical Dermatology.” (Cham, Switzerland: Springer International, 2018).
2. Merola JF et al. Dermatol Ther. 2018 May;31(3):e12589.
3. Chung J et al. J Am Acad Dermatol. 2014 Oct;71(4):623-32.
Psoriasis is an immune-mediated chronic inflammatory disease characterized by well-demarcated, scaly, erythematous plaques. Those who present with the condition often have a family history, which supports recent research uncovering various genes implicated in its pathogenesis. The disease is also associated with other systemic complications, most notably cardiovascular disease.
This condition is found in a small percentage of patients with psoriasis and presentation varies from hyperkeratotic plaques to pustular lesions. The pustular form is known as palmoplantar pustulosis and is within the spectrum of palmoplantar psoriasis.
Psoriasis is typically a clinical diagnosis and its severity can be measured using the Psoriasis Area and Severity Index. If biopsy is performed, the histology demonstrates parakeratosis, orthokeratosis, loss of the stratum granulosum, and dilated vasculature with an inflammatory cell infiltrate. The keratinocytes present with abnormal differentiation and hyperplasia, and the presence of foci of neutrophils known as “Munro’s microabscesses” in the stratum corneum serve as the hallmark of histological diagnosis. However, it is important to note that appearance can vary based on the stage of the lesion and the subtype of psoriasis present.
Palmoplantar psoriasis can be especially limiting and difficult to treat because of its distribution. Topical steroids, topical vitamin D analogues, and narrow band ultraviolet light therapy can be effective for less severe cases. Methotrexate, biologic treatments, and apremilast can be used for more extensive disease.
This patient is HLA-B27 positive and has uveitis. The presence of the HLA-B27 allele has been associated with inflammatory bowel disease, uveitis, psoriatic arthritis, and reactive arthritis. It has also been reported to be associated with pustular psoriasis. She responded well to topical steroids and vitamin D analogues.
This case and photo were submitted by Mr. Shapiro at Nova Southeastern University College of Osteopathic Medicine, Davie, Fla., and Dr. Bilu Martin.
Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to [email protected].
References
1. Psoriasis: Overview and Diagnosis, in “Evidence-Based Psoriasis. Updates in Clinical Dermatology.” (Cham, Switzerland: Springer International, 2018).
2. Merola JF et al. Dermatol Ther. 2018 May;31(3):e12589.
3. Chung J et al. J Am Acad Dermatol. 2014 Oct;71(4):623-32.
Chronic Kidney Disease in People with Type 2 Diabetes
We know from the literature and in practice that type 2 diabetes (T2D) is one of the most common risk factors for developing chronic kidney disease (CKD). How prevalent is this overlap, and are certain patients more at risk than others?
Dr. McGill: That’s correct, in fact, 20% to 40% of people with T2D have identifiable CKD, and the rest are at risk for developing CKD in the future. All patients with T2D should recognize that risk and undergo annual screening for CKD. If an individual has prediabetes, then step up the screening to perhaps twice a year to see if the person has progressed. At that point, we can think about intervening with a medication to prevent the onset of diabetes, particularly if the patient is unable to adopt significant lifestyle changes.
In your day-to-day practice, what therapeutic approach do you take in managing patients with T2D and CKD?
Dr. McGill: The earliest and arguably the most important treatment for the care of CKD in T2D is glucose control. Establishing and maintaining blood glucose levels near the normal range is our strongest weapon for preventing CKD. Another treatment avenue is controlling blood pressure. The American Diabetes Association and other groups recommend that blood pressure be less than 130/80 mm Hg. It is critical that we treat hypertension effectively to achieve those numbers.
We also have therapies, such as the SGLT2 inhibitors, that offer protection from progression of CKD and from hospitalization for heart failure. Deployment of these newer agents is important for people who have more advanced diabetes or other serious health conditions.
What is the rate of disease progression, related complications, or even mortality for these patients?
Dr. McGill: People with CKD and T2D are at risk for many things. One risk is progression of kidney disease all the way to end-stage kidney disease, which requires dialysis or transplantation. Another huge risk is cardiovascular events such as myocardial infarction (MI) and stroke.
Persons with kidney disease, for reasons we don't understand, are at higher risk of MI and stroke than people who do not have kidney disease. Therefore, the risks of early mortality and events that adversely affect quality of life are greatly increased.
Can you please discuss the economic burdens associated with T2D and CKD, and whether any interventions are in place to help offset those costs?
Dr. McGill: Diabetes itself is wickedly expensive. We have excellent treatments for diabetes today, but they are very costly. The best approach for the prevention of diabetes is to be screened. When a patient presents with prediabetes, it’s important that they take important measures, such as weight loss, exercising 150 minutes per week, or reducing 500 calories a day from their diet, all of which have been shown to forestall the onset of diabetes.
Once diabetes develops, achieving near-normal glucose control can either be very inexpensive with one or more generic drugs, or it can be terribly expensive with the newer branded drugs. Both options can help with the achievement of near-normal glucose levels, but the newer drugs are better for weight loss and provide protection from heart and kidney disease.
It is important to consider where the patient is along the disease spectrum, and to educate them on the benefits of taking a proactive approach to their health. Don’t wait for diabetes to develop before doing something about it. We have to take action earlier, and more definitively.
We do everything we can to help patients with the high cost of diabetes medications. Pharma companies offer various coupons and patient assistance programs, but it's really important that we get people on the right therapy. In order for that to happen, they have to come to office visits and get lab tests done.
Is there anything else you would like to share on this topic?
Dr. McGill: Once a person has been diagnosed with diabetes, then excellent glucose control from the onset has been shown to prevent later complications, and early treatment is inexpensive. As people progress through their journey with diabetes and blood sugars go up, we have excellent therapies that help manage high glucose and help with weight loss.
We have to be realistic and rethink our approach in some ways, but as long as people develop good health care habits and visit the doctor once or twice a year specifically to address diabetes and blood pressure, we might be able to avoid long-term complications.
We know from the literature and in practice that type 2 diabetes (T2D) is one of the most common risk factors for developing chronic kidney disease (CKD). How prevalent is this overlap, and are certain patients more at risk than others?
Dr. McGill: That’s correct, in fact, 20% to 40% of people with T2D have identifiable CKD, and the rest are at risk for developing CKD in the future. All patients with T2D should recognize that risk and undergo annual screening for CKD. If an individual has prediabetes, then step up the screening to perhaps twice a year to see if the person has progressed. At that point, we can think about intervening with a medication to prevent the onset of diabetes, particularly if the patient is unable to adopt significant lifestyle changes.
In your day-to-day practice, what therapeutic approach do you take in managing patients with T2D and CKD?
Dr. McGill: The earliest and arguably the most important treatment for the care of CKD in T2D is glucose control. Establishing and maintaining blood glucose levels near the normal range is our strongest weapon for preventing CKD. Another treatment avenue is controlling blood pressure. The American Diabetes Association and other groups recommend that blood pressure be less than 130/80 mm Hg. It is critical that we treat hypertension effectively to achieve those numbers.
We also have therapies, such as the SGLT2 inhibitors, that offer protection from progression of CKD and from hospitalization for heart failure. Deployment of these newer agents is important for people who have more advanced diabetes or other serious health conditions.
What is the rate of disease progression, related complications, or even mortality for these patients?
Dr. McGill: People with CKD and T2D are at risk for many things. One risk is progression of kidney disease all the way to end-stage kidney disease, which requires dialysis or transplantation. Another huge risk is cardiovascular events such as myocardial infarction (MI) and stroke.
Persons with kidney disease, for reasons we don't understand, are at higher risk of MI and stroke than people who do not have kidney disease. Therefore, the risks of early mortality and events that adversely affect quality of life are greatly increased.
Can you please discuss the economic burdens associated with T2D and CKD, and whether any interventions are in place to help offset those costs?
Dr. McGill: Diabetes itself is wickedly expensive. We have excellent treatments for diabetes today, but they are very costly. The best approach for the prevention of diabetes is to be screened. When a patient presents with prediabetes, it’s important that they take important measures, such as weight loss, exercising 150 minutes per week, or reducing 500 calories a day from their diet, all of which have been shown to forestall the onset of diabetes.
Once diabetes develops, achieving near-normal glucose control can either be very inexpensive with one or more generic drugs, or it can be terribly expensive with the newer branded drugs. Both options can help with the achievement of near-normal glucose levels, but the newer drugs are better for weight loss and provide protection from heart and kidney disease.
It is important to consider where the patient is along the disease spectrum, and to educate them on the benefits of taking a proactive approach to their health. Don’t wait for diabetes to develop before doing something about it. We have to take action earlier, and more definitively.
We do everything we can to help patients with the high cost of diabetes medications. Pharma companies offer various coupons and patient assistance programs, but it's really important that we get people on the right therapy. In order for that to happen, they have to come to office visits and get lab tests done.
Is there anything else you would like to share on this topic?
Dr. McGill: Once a person has been diagnosed with diabetes, then excellent glucose control from the onset has been shown to prevent later complications, and early treatment is inexpensive. As people progress through their journey with diabetes and blood sugars go up, we have excellent therapies that help manage high glucose and help with weight loss.
We have to be realistic and rethink our approach in some ways, but as long as people develop good health care habits and visit the doctor once or twice a year specifically to address diabetes and blood pressure, we might be able to avoid long-term complications.
We know from the literature and in practice that type 2 diabetes (T2D) is one of the most common risk factors for developing chronic kidney disease (CKD). How prevalent is this overlap, and are certain patients more at risk than others?
Dr. McGill: That’s correct, in fact, 20% to 40% of people with T2D have identifiable CKD, and the rest are at risk for developing CKD in the future. All patients with T2D should recognize that risk and undergo annual screening for CKD. If an individual has prediabetes, then step up the screening to perhaps twice a year to see if the person has progressed. At that point, we can think about intervening with a medication to prevent the onset of diabetes, particularly if the patient is unable to adopt significant lifestyle changes.
In your day-to-day practice, what therapeutic approach do you take in managing patients with T2D and CKD?
Dr. McGill: The earliest and arguably the most important treatment for the care of CKD in T2D is glucose control. Establishing and maintaining blood glucose levels near the normal range is our strongest weapon for preventing CKD. Another treatment avenue is controlling blood pressure. The American Diabetes Association and other groups recommend that blood pressure be less than 130/80 mm Hg. It is critical that we treat hypertension effectively to achieve those numbers.
We also have therapies, such as the SGLT2 inhibitors, that offer protection from progression of CKD and from hospitalization for heart failure. Deployment of these newer agents is important for people who have more advanced diabetes or other serious health conditions.
What is the rate of disease progression, related complications, or even mortality for these patients?
Dr. McGill: People with CKD and T2D are at risk for many things. One risk is progression of kidney disease all the way to end-stage kidney disease, which requires dialysis or transplantation. Another huge risk is cardiovascular events such as myocardial infarction (MI) and stroke.
Persons with kidney disease, for reasons we don't understand, are at higher risk of MI and stroke than people who do not have kidney disease. Therefore, the risks of early mortality and events that adversely affect quality of life are greatly increased.
Can you please discuss the economic burdens associated with T2D and CKD, and whether any interventions are in place to help offset those costs?
Dr. McGill: Diabetes itself is wickedly expensive. We have excellent treatments for diabetes today, but they are very costly. The best approach for the prevention of diabetes is to be screened. When a patient presents with prediabetes, it’s important that they take important measures, such as weight loss, exercising 150 minutes per week, or reducing 500 calories a day from their diet, all of which have been shown to forestall the onset of diabetes.
Once diabetes develops, achieving near-normal glucose control can either be very inexpensive with one or more generic drugs, or it can be terribly expensive with the newer branded drugs. Both options can help with the achievement of near-normal glucose levels, but the newer drugs are better for weight loss and provide protection from heart and kidney disease.
It is important to consider where the patient is along the disease spectrum, and to educate them on the benefits of taking a proactive approach to their health. Don’t wait for diabetes to develop before doing something about it. We have to take action earlier, and more definitively.
We do everything we can to help patients with the high cost of diabetes medications. Pharma companies offer various coupons and patient assistance programs, but it's really important that we get people on the right therapy. In order for that to happen, they have to come to office visits and get lab tests done.
Is there anything else you would like to share on this topic?
Dr. McGill: Once a person has been diagnosed with diabetes, then excellent glucose control from the onset has been shown to prevent later complications, and early treatment is inexpensive. As people progress through their journey with diabetes and blood sugars go up, we have excellent therapies that help manage high glucose and help with weight loss.
We have to be realistic and rethink our approach in some ways, but as long as people develop good health care habits and visit the doctor once or twice a year specifically to address diabetes and blood pressure, we might be able to avoid long-term complications.
Vaccination tied to lower mortality in ventilated patients with COVID-19
Although COVID-19 vaccination has been demonstrated to be effective at preventing infection, breakthrough infections occur, write Eirini Grapsa, RN, of Kapodistrian University of Athens Medical School, Greece, and colleagues. The potential protective benefits of vaccination for patients who experience these breakthrough infections, especially cases severe enough to require hospitalization and the need for mechanical ventilation, have not been well studied, the investigators say.
In a study published in JAMA Network Open, the researchers reviewed data from 265 consecutive patients older than 18 years who were admitted to intensive care units at three tertiary care centers with confirmed SARS-CoV-2 infections between June 7, 2021, and Feb. 1, 2022. All patients in the study received invasive mechanical ventilation because of acute respiratory distress syndrome (ARDS). The patients were divided into two groups: 26 patients were in the full vaccination group, and 239 served as control patients. Full vaccination was defined as having completed the primary COVID-19 series more than 14 days but less than 5 months before intubation. The control group included patients who had been fully vaccinated for less than 14 days or more than 5 months, were partially vaccinated, or were not vaccinated. A total of 20 of 26 patients in the full vaccination group received the Pfizer BioNTech BNT162b2 vaccine, as did 25 of the 33 vaccinated patients in the control group.
The median age of the patients overall was 66 years; 36% were women, and 99% were White. Patients in the full vaccination group were more likely to be older and to have comorbidities. The primary outcome was the time from intubation to all-cause mortality.
Overall, mortality was lower among the patients with full vaccination status than among those in the control group (61.5% vs. 68.2%; P = .03). Full vaccination also was associated with lower mortality in sensitivity analyses that included (a) only patients who received an mRNA vaccine in the full vaccination group, and (b) only unvaccinated patients in the control group (hazard ratios, 0.47 and 0.54, respectively).
In a regression model that examined secondary outcomes, the HR was 0.40 for the association between full vaccination and 28-day mortality. No significant differences were seen in length of stay in the intensive care unit (ICU) or length of hospital stay among survivors, nor in the occurrence of bacteremia, use of vasopressors, number of vasopressor-free days, use of continuous kidney replacement therapy (CKRT), number of CKRT-free days, and the number of ventilator-free and ICU-free days.
“Our choice to take time since vaccination into consideration was based on several previous studies indicating that protection against infection from vaccination (specifically with mRNA vaccines, such as BNT162b2, which was administered to 76.9% of patients in the full vaccination group) may decrease over time,” the researchers write.
Oxygenation was higher in the full vaccination group than in the control group on the third day after intubation. Previous studies conducted before the COVID-19 pandemic have shown that oxygenation on the third day after intubation may be more strongly associated with mortality than oxygenation on the day of intubation, the researchers note. Bacteremia was higher among the control patients and could have affected mortality, although the difference between vaccinated patients and control patients was not significant, the researchers add.
The study findings were limited by several factors, including small sample size, which prevented direct comparisons of the effectiveness of different numbers of vaccine doses or vaccine types, the researchers note. Other limitations include selection bias and residual confounding variables, they say.
The results demonstrate an association between full vaccination and lower mortality and suggest that vaccination may benefit patients with COVID-19–related ARDS, beyond the need for mechanical ventilation alone, they say. “These results expand our understanding of the outcomes of patients with breakthrough infections,” they conclude.
The study was supported by a grant to corresponding author Ilias I. Siempos, MD, from the Hellenic Foundation for Research and Innovation. The researchers have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Although COVID-19 vaccination has been demonstrated to be effective at preventing infection, breakthrough infections occur, write Eirini Grapsa, RN, of Kapodistrian University of Athens Medical School, Greece, and colleagues. The potential protective benefits of vaccination for patients who experience these breakthrough infections, especially cases severe enough to require hospitalization and the need for mechanical ventilation, have not been well studied, the investigators say.
In a study published in JAMA Network Open, the researchers reviewed data from 265 consecutive patients older than 18 years who were admitted to intensive care units at three tertiary care centers with confirmed SARS-CoV-2 infections between June 7, 2021, and Feb. 1, 2022. All patients in the study received invasive mechanical ventilation because of acute respiratory distress syndrome (ARDS). The patients were divided into two groups: 26 patients were in the full vaccination group, and 239 served as control patients. Full vaccination was defined as having completed the primary COVID-19 series more than 14 days but less than 5 months before intubation. The control group included patients who had been fully vaccinated for less than 14 days or more than 5 months, were partially vaccinated, or were not vaccinated. A total of 20 of 26 patients in the full vaccination group received the Pfizer BioNTech BNT162b2 vaccine, as did 25 of the 33 vaccinated patients in the control group.
The median age of the patients overall was 66 years; 36% were women, and 99% were White. Patients in the full vaccination group were more likely to be older and to have comorbidities. The primary outcome was the time from intubation to all-cause mortality.
Overall, mortality was lower among the patients with full vaccination status than among those in the control group (61.5% vs. 68.2%; P = .03). Full vaccination also was associated with lower mortality in sensitivity analyses that included (a) only patients who received an mRNA vaccine in the full vaccination group, and (b) only unvaccinated patients in the control group (hazard ratios, 0.47 and 0.54, respectively).
In a regression model that examined secondary outcomes, the HR was 0.40 for the association between full vaccination and 28-day mortality. No significant differences were seen in length of stay in the intensive care unit (ICU) or length of hospital stay among survivors, nor in the occurrence of bacteremia, use of vasopressors, number of vasopressor-free days, use of continuous kidney replacement therapy (CKRT), number of CKRT-free days, and the number of ventilator-free and ICU-free days.
“Our choice to take time since vaccination into consideration was based on several previous studies indicating that protection against infection from vaccination (specifically with mRNA vaccines, such as BNT162b2, which was administered to 76.9% of patients in the full vaccination group) may decrease over time,” the researchers write.
Oxygenation was higher in the full vaccination group than in the control group on the third day after intubation. Previous studies conducted before the COVID-19 pandemic have shown that oxygenation on the third day after intubation may be more strongly associated with mortality than oxygenation on the day of intubation, the researchers note. Bacteremia was higher among the control patients and could have affected mortality, although the difference between vaccinated patients and control patients was not significant, the researchers add.
The study findings were limited by several factors, including small sample size, which prevented direct comparisons of the effectiveness of different numbers of vaccine doses or vaccine types, the researchers note. Other limitations include selection bias and residual confounding variables, they say.
The results demonstrate an association between full vaccination and lower mortality and suggest that vaccination may benefit patients with COVID-19–related ARDS, beyond the need for mechanical ventilation alone, they say. “These results expand our understanding of the outcomes of patients with breakthrough infections,” they conclude.
The study was supported by a grant to corresponding author Ilias I. Siempos, MD, from the Hellenic Foundation for Research and Innovation. The researchers have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Although COVID-19 vaccination has been demonstrated to be effective at preventing infection, breakthrough infections occur, write Eirini Grapsa, RN, of Kapodistrian University of Athens Medical School, Greece, and colleagues. The potential protective benefits of vaccination for patients who experience these breakthrough infections, especially cases severe enough to require hospitalization and the need for mechanical ventilation, have not been well studied, the investigators say.
In a study published in JAMA Network Open, the researchers reviewed data from 265 consecutive patients older than 18 years who were admitted to intensive care units at three tertiary care centers with confirmed SARS-CoV-2 infections between June 7, 2021, and Feb. 1, 2022. All patients in the study received invasive mechanical ventilation because of acute respiratory distress syndrome (ARDS). The patients were divided into two groups: 26 patients were in the full vaccination group, and 239 served as control patients. Full vaccination was defined as having completed the primary COVID-19 series more than 14 days but less than 5 months before intubation. The control group included patients who had been fully vaccinated for less than 14 days or more than 5 months, were partially vaccinated, or were not vaccinated. A total of 20 of 26 patients in the full vaccination group received the Pfizer BioNTech BNT162b2 vaccine, as did 25 of the 33 vaccinated patients in the control group.
The median age of the patients overall was 66 years; 36% were women, and 99% were White. Patients in the full vaccination group were more likely to be older and to have comorbidities. The primary outcome was the time from intubation to all-cause mortality.
Overall, mortality was lower among the patients with full vaccination status than among those in the control group (61.5% vs. 68.2%; P = .03). Full vaccination also was associated with lower mortality in sensitivity analyses that included (a) only patients who received an mRNA vaccine in the full vaccination group, and (b) only unvaccinated patients in the control group (hazard ratios, 0.47 and 0.54, respectively).
In a regression model that examined secondary outcomes, the HR was 0.40 for the association between full vaccination and 28-day mortality. No significant differences were seen in length of stay in the intensive care unit (ICU) or length of hospital stay among survivors, nor in the occurrence of bacteremia, use of vasopressors, number of vasopressor-free days, use of continuous kidney replacement therapy (CKRT), number of CKRT-free days, and the number of ventilator-free and ICU-free days.
“Our choice to take time since vaccination into consideration was based on several previous studies indicating that protection against infection from vaccination (specifically with mRNA vaccines, such as BNT162b2, which was administered to 76.9% of patients in the full vaccination group) may decrease over time,” the researchers write.
Oxygenation was higher in the full vaccination group than in the control group on the third day after intubation. Previous studies conducted before the COVID-19 pandemic have shown that oxygenation on the third day after intubation may be more strongly associated with mortality than oxygenation on the day of intubation, the researchers note. Bacteremia was higher among the control patients and could have affected mortality, although the difference between vaccinated patients and control patients was not significant, the researchers add.
The study findings were limited by several factors, including small sample size, which prevented direct comparisons of the effectiveness of different numbers of vaccine doses or vaccine types, the researchers note. Other limitations include selection bias and residual confounding variables, they say.
The results demonstrate an association between full vaccination and lower mortality and suggest that vaccination may benefit patients with COVID-19–related ARDS, beyond the need for mechanical ventilation alone, they say. “These results expand our understanding of the outcomes of patients with breakthrough infections,” they conclude.
The study was supported by a grant to corresponding author Ilias I. Siempos, MD, from the Hellenic Foundation for Research and Innovation. The researchers have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
Cleaning indoor air ‘next frontier’ for COVID, public health
The COVID-19 pandemic is driving attention to clean indoor air like never before.
“Indoor air is that next frontier when it comes to thinking about public health for humanity,” said Ashish Jha, MD, MPH, who heads the White House COVID response team.
“This once-in-a-century pandemic has given us a moment. A moment when we can drive significant structural changes in the air that we all breathe,” he said.
The threat is immediate, Dr. Jha said, explaining that the return of influenza this year and other circulating respiratory viruses on top of COVID cases could overwhelm the health system.
“We have to bring the burden of respiratory pathogens down and the single biggest structural change we can make as a society is to do for indoor air what we’ve done for water quality,” he said.
Recent federal actions
Dr. Jha pointed to White House actions toward that end.
On Oct. 11, the White House launched a new website asking building owners and operators to sign a pledge for clean air and agree to four principles:
- Create an action plan.
- Optimize fresh air ventilation.
- Enhance air filtration and cleaning.
- Communicate with building occupants to increase awareness.
Those who pledge can download a badge to feature on their websites.
In March, the White House launched the Clean Air in Buildings Challenge as a call to action for building owners and operators to improve ventilation, filtration, and facilities for cleaner indoor air.
The government has provided funds that can be used in schools, public buildings, and other locations to improve indoor air quality, including $350 billion for state and local governments and $122 billion for schools, through the American Rescue Plan.
The Department of Energy is offering one-on-one consultations to schools to drive air quality.
Calculate your ‘indoor age’
Joseph Allen, DSc, MPH, director of the Healthy Buildings program and an associate professor at Harvard’s T. H. Chan School of Public Health in Boston, said that the indoor environment has an outsized effect on public health.
He asked people to multiply their age times 0.9 to calculate their “indoor age.”
Dr. Allen, 47, said that for him that number is 42 years spent inside spaces.
When most people realize they spend 90% of their time indoors, a startling possibility comes into play: “The person who manages your building has a greater impact on your health than your doctor,” he said. “Think about that.”
Dr. Allen led a team that published a report on four strategies every building should pursue to reduce COVID and other respiratory illnesses:
- Give every building a tune-up. “We do this for our cars, we don’t do it for our buildings,” Dr. Allen said.
- Maximize outdoor ventilation.
- Upgrade filtration. “We need to move away from filters designed to protect equipment to filters designed to protect people. MERV 13 is the new minimum.”
- Supplement with portable air cleaners.
It’s not a complete list, he said; “It’s where you should start.”
Indoor air innovations
Others are suggesting innovations in schools and businesses.
Denver (Colorado) Public School Superintendent Alex Marrero, EdD, said that the system is implementing an air quality dashboard to display performance on factors such as carbon dioxide levels, particulate matter, and volatile organic compounds in schools.
“When you’re deciding what school you’re going to visit or even enroll in, you’ll have a snapshot of what we’re able to gather. Hopefully we’ll have something up before the end of the school year,” he said.
Shelly L. Miller, PhD, professor of mechanical engineering in the environmental engineering program at the University of Colorado Boulder, said that germicidal ultraviolet disinfection, used currently in water quality, holds promise for cleaning the COVID virus and other pathogens from indoor air.
“We were looking at germicidal UV way back in the 2000s for an outbreak of tuberculosis. We continue to see that it’s effective for measles. Why can’t we put a little more emphasis on these technologies?” Dr. Miller asks, acknowledging that there is a lack of expertise in designing such systems and in training and maintenance.
“It’s not for everybody, but it’s for a lot more places than we’re using it now,” she said.
Legislation like 1970 Clean Air Act needed?
Richard Corsi, PhD, dean of the College of Engineering at the University of California, Davis, said that education is lacking on the subject and indoor air quality is taught as a class in only a few universities, including his own.
He suggested starting the education even much earlier, in high school biology, chemistry, and physics courses.
Relative to other fields, he said, research and funding for indoor air quality “has been anemic.”
Work on outdoor air quality has seen dramatic improvements over the years because of the 52-year-old Clean Air Act, he noted.
“We need something akin to the Clean Air Act for indoor air quality,” Dr. Corsi said.
The speakers declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The COVID-19 pandemic is driving attention to clean indoor air like never before.
“Indoor air is that next frontier when it comes to thinking about public health for humanity,” said Ashish Jha, MD, MPH, who heads the White House COVID response team.
“This once-in-a-century pandemic has given us a moment. A moment when we can drive significant structural changes in the air that we all breathe,” he said.
The threat is immediate, Dr. Jha said, explaining that the return of influenza this year and other circulating respiratory viruses on top of COVID cases could overwhelm the health system.
“We have to bring the burden of respiratory pathogens down and the single biggest structural change we can make as a society is to do for indoor air what we’ve done for water quality,” he said.
Recent federal actions
Dr. Jha pointed to White House actions toward that end.
On Oct. 11, the White House launched a new website asking building owners and operators to sign a pledge for clean air and agree to four principles:
- Create an action plan.
- Optimize fresh air ventilation.
- Enhance air filtration and cleaning.
- Communicate with building occupants to increase awareness.
Those who pledge can download a badge to feature on their websites.
In March, the White House launched the Clean Air in Buildings Challenge as a call to action for building owners and operators to improve ventilation, filtration, and facilities for cleaner indoor air.
The government has provided funds that can be used in schools, public buildings, and other locations to improve indoor air quality, including $350 billion for state and local governments and $122 billion for schools, through the American Rescue Plan.
The Department of Energy is offering one-on-one consultations to schools to drive air quality.
Calculate your ‘indoor age’
Joseph Allen, DSc, MPH, director of the Healthy Buildings program and an associate professor at Harvard’s T. H. Chan School of Public Health in Boston, said that the indoor environment has an outsized effect on public health.
He asked people to multiply their age times 0.9 to calculate their “indoor age.”
Dr. Allen, 47, said that for him that number is 42 years spent inside spaces.
When most people realize they spend 90% of their time indoors, a startling possibility comes into play: “The person who manages your building has a greater impact on your health than your doctor,” he said. “Think about that.”
Dr. Allen led a team that published a report on four strategies every building should pursue to reduce COVID and other respiratory illnesses:
- Give every building a tune-up. “We do this for our cars, we don’t do it for our buildings,” Dr. Allen said.
- Maximize outdoor ventilation.
- Upgrade filtration. “We need to move away from filters designed to protect equipment to filters designed to protect people. MERV 13 is the new minimum.”
- Supplement with portable air cleaners.
It’s not a complete list, he said; “It’s where you should start.”
Indoor air innovations
Others are suggesting innovations in schools and businesses.
Denver (Colorado) Public School Superintendent Alex Marrero, EdD, said that the system is implementing an air quality dashboard to display performance on factors such as carbon dioxide levels, particulate matter, and volatile organic compounds in schools.
“When you’re deciding what school you’re going to visit or even enroll in, you’ll have a snapshot of what we’re able to gather. Hopefully we’ll have something up before the end of the school year,” he said.
Shelly L. Miller, PhD, professor of mechanical engineering in the environmental engineering program at the University of Colorado Boulder, said that germicidal ultraviolet disinfection, used currently in water quality, holds promise for cleaning the COVID virus and other pathogens from indoor air.
“We were looking at germicidal UV way back in the 2000s for an outbreak of tuberculosis. We continue to see that it’s effective for measles. Why can’t we put a little more emphasis on these technologies?” Dr. Miller asks, acknowledging that there is a lack of expertise in designing such systems and in training and maintenance.
“It’s not for everybody, but it’s for a lot more places than we’re using it now,” she said.
Legislation like 1970 Clean Air Act needed?
Richard Corsi, PhD, dean of the College of Engineering at the University of California, Davis, said that education is lacking on the subject and indoor air quality is taught as a class in only a few universities, including his own.
He suggested starting the education even much earlier, in high school biology, chemistry, and physics courses.
Relative to other fields, he said, research and funding for indoor air quality “has been anemic.”
Work on outdoor air quality has seen dramatic improvements over the years because of the 52-year-old Clean Air Act, he noted.
“We need something akin to the Clean Air Act for indoor air quality,” Dr. Corsi said.
The speakers declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The COVID-19 pandemic is driving attention to clean indoor air like never before.
“Indoor air is that next frontier when it comes to thinking about public health for humanity,” said Ashish Jha, MD, MPH, who heads the White House COVID response team.
“This once-in-a-century pandemic has given us a moment. A moment when we can drive significant structural changes in the air that we all breathe,” he said.
The threat is immediate, Dr. Jha said, explaining that the return of influenza this year and other circulating respiratory viruses on top of COVID cases could overwhelm the health system.
“We have to bring the burden of respiratory pathogens down and the single biggest structural change we can make as a society is to do for indoor air what we’ve done for water quality,” he said.
Recent federal actions
Dr. Jha pointed to White House actions toward that end.
On Oct. 11, the White House launched a new website asking building owners and operators to sign a pledge for clean air and agree to four principles:
- Create an action plan.
- Optimize fresh air ventilation.
- Enhance air filtration and cleaning.
- Communicate with building occupants to increase awareness.
Those who pledge can download a badge to feature on their websites.
In March, the White House launched the Clean Air in Buildings Challenge as a call to action for building owners and operators to improve ventilation, filtration, and facilities for cleaner indoor air.
The government has provided funds that can be used in schools, public buildings, and other locations to improve indoor air quality, including $350 billion for state and local governments and $122 billion for schools, through the American Rescue Plan.
The Department of Energy is offering one-on-one consultations to schools to drive air quality.
Calculate your ‘indoor age’
Joseph Allen, DSc, MPH, director of the Healthy Buildings program and an associate professor at Harvard’s T. H. Chan School of Public Health in Boston, said that the indoor environment has an outsized effect on public health.
He asked people to multiply their age times 0.9 to calculate their “indoor age.”
Dr. Allen, 47, said that for him that number is 42 years spent inside spaces.
When most people realize they spend 90% of their time indoors, a startling possibility comes into play: “The person who manages your building has a greater impact on your health than your doctor,” he said. “Think about that.”
Dr. Allen led a team that published a report on four strategies every building should pursue to reduce COVID and other respiratory illnesses:
- Give every building a tune-up. “We do this for our cars, we don’t do it for our buildings,” Dr. Allen said.
- Maximize outdoor ventilation.
- Upgrade filtration. “We need to move away from filters designed to protect equipment to filters designed to protect people. MERV 13 is the new minimum.”
- Supplement with portable air cleaners.
It’s not a complete list, he said; “It’s where you should start.”
Indoor air innovations
Others are suggesting innovations in schools and businesses.
Denver (Colorado) Public School Superintendent Alex Marrero, EdD, said that the system is implementing an air quality dashboard to display performance on factors such as carbon dioxide levels, particulate matter, and volatile organic compounds in schools.
“When you’re deciding what school you’re going to visit or even enroll in, you’ll have a snapshot of what we’re able to gather. Hopefully we’ll have something up before the end of the school year,” he said.
Shelly L. Miller, PhD, professor of mechanical engineering in the environmental engineering program at the University of Colorado Boulder, said that germicidal ultraviolet disinfection, used currently in water quality, holds promise for cleaning the COVID virus and other pathogens from indoor air.
“We were looking at germicidal UV way back in the 2000s for an outbreak of tuberculosis. We continue to see that it’s effective for measles. Why can’t we put a little more emphasis on these technologies?” Dr. Miller asks, acknowledging that there is a lack of expertise in designing such systems and in training and maintenance.
“It’s not for everybody, but it’s for a lot more places than we’re using it now,” she said.
Legislation like 1970 Clean Air Act needed?
Richard Corsi, PhD, dean of the College of Engineering at the University of California, Davis, said that education is lacking on the subject and indoor air quality is taught as a class in only a few universities, including his own.
He suggested starting the education even much earlier, in high school biology, chemistry, and physics courses.
Relative to other fields, he said, research and funding for indoor air quality “has been anemic.”
Work on outdoor air quality has seen dramatic improvements over the years because of the 52-year-old Clean Air Act, he noted.
“We need something akin to the Clean Air Act for indoor air quality,” Dr. Corsi said.
The speakers declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.