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SUDs are almost always comorbid with other disorders
SAN DIEGO – Substance use disorders rarely ride alone, a psychiatrist told colleagues, and it’s crucial to treat the accompanying mental illness that is almost always present.
“If you’re really depressed and you’re smoking marijuana, the smoking could have made it worse, but you were probably depressed before,” said Timothy E. Wilens, MD, of Harvard Medical School and Massachusetts General Hospital, both in Boston. Dr. Wilens spoke at the annual Psych Congress.
He pointed to numbers supporting the link between substance use and mental illness. He also offered several tips about treating substance use disorder (SUD).
In ADHD, consider the big picture. If a person has both ADHD and SUD, treat both if the level of substance abuse is lower. But focus on the SUD in more severe cases, he said, and realize that “most likely your treatment for ADHD isn’t going to work as well.”
The same goes for the anxiolytic buspirone (Buspar) in patients with depression and SUD.
Consider N-acetyl cysteine in cannabis use disorder. N-acetyl cysteine, a nutraceutical used as an asthma medication, has shown promise in trials as a treatment for cannabis use disorder, Dr. Wilens said. It helps patients avoid the temptation to smoke. “They won’t say they’ve lost all their cravings, but you’ll hear, ‘I just didn’t need to do it; I’m not smoking as much.’ If you hear that from your patients, you know it’s working. It’s a subtle effect, but it can help.”
Scamming’ drugs shouldn’t be your main worry. Substance use research suggests that users of pharmaceutical drugs for nonmedical uses rarely get them directly from practitioners (7%), but instead mainly get them through friends, Dr. Wilens said. “If you work with this population and treat ADHD or anxiety, you’re paranoid that everyone coming in wants to scam medicines. Be more concerned about oversupplying them with immediate-release medications and not [taking] them to task about keeping the medication safely stored.”
Interventions such as Alcoholics Anonymous are as “effective as any other treatment for substance abuse, and it’s not costly,” Dr. Wilens said. He added that the Rational Recovery program, an alternative to Alcoholics Anonymous, also seems to work well. The approaches to ending substance use differ in that Alcoholics Anonymous’s orientation is spiritual and Rational Recovery’s is cognitive.
Dr. Wilens reported various disclosures, including consulting relationships with Ironshore Pharmaceuticals, KemPharm, and Neurovance/Otsuka.
SAN DIEGO – Substance use disorders rarely ride alone, a psychiatrist told colleagues, and it’s crucial to treat the accompanying mental illness that is almost always present.
“If you’re really depressed and you’re smoking marijuana, the smoking could have made it worse, but you were probably depressed before,” said Timothy E. Wilens, MD, of Harvard Medical School and Massachusetts General Hospital, both in Boston. Dr. Wilens spoke at the annual Psych Congress.
He pointed to numbers supporting the link between substance use and mental illness. He also offered several tips about treating substance use disorder (SUD).
In ADHD, consider the big picture. If a person has both ADHD and SUD, treat both if the level of substance abuse is lower. But focus on the SUD in more severe cases, he said, and realize that “most likely your treatment for ADHD isn’t going to work as well.”
The same goes for the anxiolytic buspirone (Buspar) in patients with depression and SUD.
Consider N-acetyl cysteine in cannabis use disorder. N-acetyl cysteine, a nutraceutical used as an asthma medication, has shown promise in trials as a treatment for cannabis use disorder, Dr. Wilens said. It helps patients avoid the temptation to smoke. “They won’t say they’ve lost all their cravings, but you’ll hear, ‘I just didn’t need to do it; I’m not smoking as much.’ If you hear that from your patients, you know it’s working. It’s a subtle effect, but it can help.”
Scamming’ drugs shouldn’t be your main worry. Substance use research suggests that users of pharmaceutical drugs for nonmedical uses rarely get them directly from practitioners (7%), but instead mainly get them through friends, Dr. Wilens said. “If you work with this population and treat ADHD or anxiety, you’re paranoid that everyone coming in wants to scam medicines. Be more concerned about oversupplying them with immediate-release medications and not [taking] them to task about keeping the medication safely stored.”
Interventions such as Alcoholics Anonymous are as “effective as any other treatment for substance abuse, and it’s not costly,” Dr. Wilens said. He added that the Rational Recovery program, an alternative to Alcoholics Anonymous, also seems to work well. The approaches to ending substance use differ in that Alcoholics Anonymous’s orientation is spiritual and Rational Recovery’s is cognitive.
Dr. Wilens reported various disclosures, including consulting relationships with Ironshore Pharmaceuticals, KemPharm, and Neurovance/Otsuka.
SAN DIEGO – Substance use disorders rarely ride alone, a psychiatrist told colleagues, and it’s crucial to treat the accompanying mental illness that is almost always present.
“If you’re really depressed and you’re smoking marijuana, the smoking could have made it worse, but you were probably depressed before,” said Timothy E. Wilens, MD, of Harvard Medical School and Massachusetts General Hospital, both in Boston. Dr. Wilens spoke at the annual Psych Congress.
He pointed to numbers supporting the link between substance use and mental illness. He also offered several tips about treating substance use disorder (SUD).
In ADHD, consider the big picture. If a person has both ADHD and SUD, treat both if the level of substance abuse is lower. But focus on the SUD in more severe cases, he said, and realize that “most likely your treatment for ADHD isn’t going to work as well.”
The same goes for the anxiolytic buspirone (Buspar) in patients with depression and SUD.
Consider N-acetyl cysteine in cannabis use disorder. N-acetyl cysteine, a nutraceutical used as an asthma medication, has shown promise in trials as a treatment for cannabis use disorder, Dr. Wilens said. It helps patients avoid the temptation to smoke. “They won’t say they’ve lost all their cravings, but you’ll hear, ‘I just didn’t need to do it; I’m not smoking as much.’ If you hear that from your patients, you know it’s working. It’s a subtle effect, but it can help.”
Scamming’ drugs shouldn’t be your main worry. Substance use research suggests that users of pharmaceutical drugs for nonmedical uses rarely get them directly from practitioners (7%), but instead mainly get them through friends, Dr. Wilens said. “If you work with this population and treat ADHD or anxiety, you’re paranoid that everyone coming in wants to scam medicines. Be more concerned about oversupplying them with immediate-release medications and not [taking] them to task about keeping the medication safely stored.”
Interventions such as Alcoholics Anonymous are as “effective as any other treatment for substance abuse, and it’s not costly,” Dr. Wilens said. He added that the Rational Recovery program, an alternative to Alcoholics Anonymous, also seems to work well. The approaches to ending substance use differ in that Alcoholics Anonymous’s orientation is spiritual and Rational Recovery’s is cognitive.
Dr. Wilens reported various disclosures, including consulting relationships with Ironshore Pharmaceuticals, KemPharm, and Neurovance/Otsuka.
REPORTING FROM PSYCH CONGRESS 2019
Preventing suicide in the military
Is limiting firearms access a possible intervention?
It with sadness that I read the new Department of Defense report documenting an increasing number of suicides in the military. And also, cynicism about the proposed remedies.
According the DoD report, the rate of suicide among active-duty military increased from 18.5 per 100,000 service members in 2013 to 24.8 suicides per service members in 2018.
For context, I was in the Army for a career and at the office of the Army surgeon general from 2005 to 2010. That was when the suicide rate began to rise from the normal 10 per 100,000 soldiers per year to almost double that rate.
I led conferences within the Army Medical Command aimed at reducing suicides. Later, when the problem escalated, I participated in a variety of efforts to lower it. I went to Iraq to consult.
There was a Department of the Army task force on suicide prevention. Later, a DoD task force.
Numerous recommendations were made. If I remember right, the Army task force had almost 200 recommendations. They ranged from tightening accession standards, to providing more mental health care. The issues of shaming and blaming commanders also were a key topic of discussion.
Resiliency training was big. At some point, there were more than 200 resilience programs in the DoD. There were no data (to my knowledge) showing that they work.
An emphasis was the message: “It is a sign of strength to ask for help.”
For a while, the suicide rate flattened among active-duty soldiers, although the rate continued to climb among National Guard and reservists.
The solutions were similar to those proposed in this article. The leaders in the Army and DoD were not shy about asking for help. The Army Study to Assess Risk and Resilience in Servicemembers (STARRS) program was created to examine risk factors for suicide.
The STARRS program had data to show us what we already knew. The majority of suicides are in young, enlisted men with access to firearms. Often, but not always, they had a history of suicide ideation or attempts.
The trigger was usually, but not always, precipitated by a humiliating event, such as breaking up with a partner, driving while intoxicated, or getting in trouble at work.
Now, almost 10 years into retirement from the military, I feel sorry for my former colleagues. They have tried everything they can think of.
One solution, which is out of the control of military mental health workers, is to limit access to guns. Consistently, about two-thirds of suicides in the military are by gunshot.
So, as we continue to look for ways to bring an end to these losses, we must not blame the military. After all, they have tried all they can think of. However, I can think of one factor we can blame: the all-too-easy access to firearms.
Dr. Ritchie is chair of psychiatry at Medstar Washington Hospital Center and professor of psychiatry at Georgetown University, Washington.
Is limiting firearms access a possible intervention?
Is limiting firearms access a possible intervention?
It with sadness that I read the new Department of Defense report documenting an increasing number of suicides in the military. And also, cynicism about the proposed remedies.
According the DoD report, the rate of suicide among active-duty military increased from 18.5 per 100,000 service members in 2013 to 24.8 suicides per service members in 2018.
For context, I was in the Army for a career and at the office of the Army surgeon general from 2005 to 2010. That was when the suicide rate began to rise from the normal 10 per 100,000 soldiers per year to almost double that rate.
I led conferences within the Army Medical Command aimed at reducing suicides. Later, when the problem escalated, I participated in a variety of efforts to lower it. I went to Iraq to consult.
There was a Department of the Army task force on suicide prevention. Later, a DoD task force.
Numerous recommendations were made. If I remember right, the Army task force had almost 200 recommendations. They ranged from tightening accession standards, to providing more mental health care. The issues of shaming and blaming commanders also were a key topic of discussion.
Resiliency training was big. At some point, there were more than 200 resilience programs in the DoD. There were no data (to my knowledge) showing that they work.
An emphasis was the message: “It is a sign of strength to ask for help.”
For a while, the suicide rate flattened among active-duty soldiers, although the rate continued to climb among National Guard and reservists.
The solutions were similar to those proposed in this article. The leaders in the Army and DoD were not shy about asking for help. The Army Study to Assess Risk and Resilience in Servicemembers (STARRS) program was created to examine risk factors for suicide.
The STARRS program had data to show us what we already knew. The majority of suicides are in young, enlisted men with access to firearms. Often, but not always, they had a history of suicide ideation or attempts.
The trigger was usually, but not always, precipitated by a humiliating event, such as breaking up with a partner, driving while intoxicated, or getting in trouble at work.
Now, almost 10 years into retirement from the military, I feel sorry for my former colleagues. They have tried everything they can think of.
One solution, which is out of the control of military mental health workers, is to limit access to guns. Consistently, about two-thirds of suicides in the military are by gunshot.
So, as we continue to look for ways to bring an end to these losses, we must not blame the military. After all, they have tried all they can think of. However, I can think of one factor we can blame: the all-too-easy access to firearms.
Dr. Ritchie is chair of psychiatry at Medstar Washington Hospital Center and professor of psychiatry at Georgetown University, Washington.
It with sadness that I read the new Department of Defense report documenting an increasing number of suicides in the military. And also, cynicism about the proposed remedies.
According the DoD report, the rate of suicide among active-duty military increased from 18.5 per 100,000 service members in 2013 to 24.8 suicides per service members in 2018.
For context, I was in the Army for a career and at the office of the Army surgeon general from 2005 to 2010. That was when the suicide rate began to rise from the normal 10 per 100,000 soldiers per year to almost double that rate.
I led conferences within the Army Medical Command aimed at reducing suicides. Later, when the problem escalated, I participated in a variety of efforts to lower it. I went to Iraq to consult.
There was a Department of the Army task force on suicide prevention. Later, a DoD task force.
Numerous recommendations were made. If I remember right, the Army task force had almost 200 recommendations. They ranged from tightening accession standards, to providing more mental health care. The issues of shaming and blaming commanders also were a key topic of discussion.
Resiliency training was big. At some point, there were more than 200 resilience programs in the DoD. There were no data (to my knowledge) showing that they work.
An emphasis was the message: “It is a sign of strength to ask for help.”
For a while, the suicide rate flattened among active-duty soldiers, although the rate continued to climb among National Guard and reservists.
The solutions were similar to those proposed in this article. The leaders in the Army and DoD were not shy about asking for help. The Army Study to Assess Risk and Resilience in Servicemembers (STARRS) program was created to examine risk factors for suicide.
The STARRS program had data to show us what we already knew. The majority of suicides are in young, enlisted men with access to firearms. Often, but not always, they had a history of suicide ideation or attempts.
The trigger was usually, but not always, precipitated by a humiliating event, such as breaking up with a partner, driving while intoxicated, or getting in trouble at work.
Now, almost 10 years into retirement from the military, I feel sorry for my former colleagues. They have tried everything they can think of.
One solution, which is out of the control of military mental health workers, is to limit access to guns. Consistently, about two-thirds of suicides in the military are by gunshot.
So, as we continue to look for ways to bring an end to these losses, we must not blame the military. After all, they have tried all they can think of. However, I can think of one factor we can blame: the all-too-easy access to firearms.
Dr. Ritchie is chair of psychiatry at Medstar Washington Hospital Center and professor of psychiatry at Georgetown University, Washington.
FDA approves trifarotene for treating acne
The Food and Drug Administration has approved trifarotene cream 0.005% for the treatment of acne vulgaris. The product is manufactured by Galderma under the brand name Aklief.
The approval was based on data from a pair of phase 3, randomized trials including 2,420 patients aged 9 years and older. The trials evaluated the effectiveness of the cream in a once-daily topical dose for facial and truncal acne at 12 weeks. Patients showed a significant reduction in the number of inflammatory lesions as early as 2 weeks on the face (including forehead cheeks, nose, and chin) and as early as 4 weeks on the trunk (including back, chest, and shoulders), compared with a control cream. The most common treatment-emergent adverse events were pain, dryness, discoloration, or rash at the site of application. Some patients also reported sunburn.
The complete study findings were published in the June issue of the Journal of the American Academy of Dermatology.
The studies, funded by Galderma, “showed that once-daily trifarotene cream appears effective and safe, with manageable local tolerability, for the treatment for facial and truncal acne,” wrote lead author Jerry Tan, MD, of the University of Western Ontario, London, and colleagues. “The studies provide substantial evidence to support use of this new topical retinoid in facial and truncal acne,” the researchers wrote.
Trifarotene is designed to target the retinoic acid receptor gamma, the most common retinoic acid receptor in the skin, and is the first new retinoid to be approved by the FDA in approximately 2 decades, according to a press release from Galderma.
The product is expected to be available in the United States in November 2019 in a 45-g pump.
The Food and Drug Administration has approved trifarotene cream 0.005% for the treatment of acne vulgaris. The product is manufactured by Galderma under the brand name Aklief.
The approval was based on data from a pair of phase 3, randomized trials including 2,420 patients aged 9 years and older. The trials evaluated the effectiveness of the cream in a once-daily topical dose for facial and truncal acne at 12 weeks. Patients showed a significant reduction in the number of inflammatory lesions as early as 2 weeks on the face (including forehead cheeks, nose, and chin) and as early as 4 weeks on the trunk (including back, chest, and shoulders), compared with a control cream. The most common treatment-emergent adverse events were pain, dryness, discoloration, or rash at the site of application. Some patients also reported sunburn.
The complete study findings were published in the June issue of the Journal of the American Academy of Dermatology.
The studies, funded by Galderma, “showed that once-daily trifarotene cream appears effective and safe, with manageable local tolerability, for the treatment for facial and truncal acne,” wrote lead author Jerry Tan, MD, of the University of Western Ontario, London, and colleagues. “The studies provide substantial evidence to support use of this new topical retinoid in facial and truncal acne,” the researchers wrote.
Trifarotene is designed to target the retinoic acid receptor gamma, the most common retinoic acid receptor in the skin, and is the first new retinoid to be approved by the FDA in approximately 2 decades, according to a press release from Galderma.
The product is expected to be available in the United States in November 2019 in a 45-g pump.
The Food and Drug Administration has approved trifarotene cream 0.005% for the treatment of acne vulgaris. The product is manufactured by Galderma under the brand name Aklief.
The approval was based on data from a pair of phase 3, randomized trials including 2,420 patients aged 9 years and older. The trials evaluated the effectiveness of the cream in a once-daily topical dose for facial and truncal acne at 12 weeks. Patients showed a significant reduction in the number of inflammatory lesions as early as 2 weeks on the face (including forehead cheeks, nose, and chin) and as early as 4 weeks on the trunk (including back, chest, and shoulders), compared with a control cream. The most common treatment-emergent adverse events were pain, dryness, discoloration, or rash at the site of application. Some patients also reported sunburn.
The complete study findings were published in the June issue of the Journal of the American Academy of Dermatology.
The studies, funded by Galderma, “showed that once-daily trifarotene cream appears effective and safe, with manageable local tolerability, for the treatment for facial and truncal acne,” wrote lead author Jerry Tan, MD, of the University of Western Ontario, London, and colleagues. “The studies provide substantial evidence to support use of this new topical retinoid in facial and truncal acne,” the researchers wrote.
Trifarotene is designed to target the retinoic acid receptor gamma, the most common retinoic acid receptor in the skin, and is the first new retinoid to be approved by the FDA in approximately 2 decades, according to a press release from Galderma.
The product is expected to be available in the United States in November 2019 in a 45-g pump.
New borderline personality disorder intervention less intensive, works for most
SAN DIEGO – A relatively new treatment approach called good psychiatric management (GPM) is available for patients with borderline personality disorder.
It’s a solid option for “environments where people may not have many resources and might not be able to deliver treatments that are more resource intensive, like dialectical behavioral therapy,” the standard intervention, said James Jenkins, MD, a psychiatrist affiliated with Massachusetts General Hospital, Boston, in a video interview at the annual Psych Congress.
“GPM is a treatment, not a psychotherapy, that’s maybe a little bit more easily adaptable to a variety of different contexts and situations,” he said.
It’s an atheoretical, pragmatic approach that focuses on helping people establish a life outside of therapy. Clinicians actively engage with patients, encouraging them to start working and building successful relationships with other people. The model emphasizes the value of educating people about the condition and giving them hope. Typically, patients participate in GPM once each week (Curr Opin Psychol. 2018 Jun;21:127-31).

For most people, it works just as well as dialectical behavioral therapy, and when it doesn’t, patients can transition to that or another more intensive approach. Training is less intensive and sometimes free. GPM is offered at McLean Hospital in Boston, where the intervention originated. McLean also is Dr. Jenkins’s former institution.
Dr. Jenkins reported that he had no disclosures.
SAN DIEGO – A relatively new treatment approach called good psychiatric management (GPM) is available for patients with borderline personality disorder.
It’s a solid option for “environments where people may not have many resources and might not be able to deliver treatments that are more resource intensive, like dialectical behavioral therapy,” the standard intervention, said James Jenkins, MD, a psychiatrist affiliated with Massachusetts General Hospital, Boston, in a video interview at the annual Psych Congress.
“GPM is a treatment, not a psychotherapy, that’s maybe a little bit more easily adaptable to a variety of different contexts and situations,” he said.
It’s an atheoretical, pragmatic approach that focuses on helping people establish a life outside of therapy. Clinicians actively engage with patients, encouraging them to start working and building successful relationships with other people. The model emphasizes the value of educating people about the condition and giving them hope. Typically, patients participate in GPM once each week (Curr Opin Psychol. 2018 Jun;21:127-31).

For most people, it works just as well as dialectical behavioral therapy, and when it doesn’t, patients can transition to that or another more intensive approach. Training is less intensive and sometimes free. GPM is offered at McLean Hospital in Boston, where the intervention originated. McLean also is Dr. Jenkins’s former institution.
Dr. Jenkins reported that he had no disclosures.
SAN DIEGO – A relatively new treatment approach called good psychiatric management (GPM) is available for patients with borderline personality disorder.
It’s a solid option for “environments where people may not have many resources and might not be able to deliver treatments that are more resource intensive, like dialectical behavioral therapy,” the standard intervention, said James Jenkins, MD, a psychiatrist affiliated with Massachusetts General Hospital, Boston, in a video interview at the annual Psych Congress.
“GPM is a treatment, not a psychotherapy, that’s maybe a little bit more easily adaptable to a variety of different contexts and situations,” he said.
It’s an atheoretical, pragmatic approach that focuses on helping people establish a life outside of therapy. Clinicians actively engage with patients, encouraging them to start working and building successful relationships with other people. The model emphasizes the value of educating people about the condition and giving them hope. Typically, patients participate in GPM once each week (Curr Opin Psychol. 2018 Jun;21:127-31).

For most people, it works just as well as dialectical behavioral therapy, and when it doesn’t, patients can transition to that or another more intensive approach. Training is less intensive and sometimes free. GPM is offered at McLean Hospital in Boston, where the intervention originated. McLean also is Dr. Jenkins’s former institution.
Dr. Jenkins reported that he had no disclosures.
REPORTING FROM PSYCH CONGRESS 2019
Lifetime indoor tanning raises risk of cutaneous squamous cell carcinoma
Women who accumulated more indoor tanning sessions over time significantly increased their risk for squamous cell cancer over women who never engaged in indoor tanning, based on data from 159,419 women.
Previous research has examined associations between indoor tanning and cutaneous melanoma, but an association between indoor tanning and squamous cell carcinoma (SCC) has not been well studied, wrote Simon Lergenmuller, MSc, of the University of Oslo, and colleagues.
In a prospective cohort study published in JAMA Dermatology, the researchers surveyed 159,419 women from the Norwegian Women and Cancer study. Of these, 95,552 women (69%) reported ever use of indoor tanning. The average age at study inclusion was 50 years. During an average of 17 years’ follow-up, 597 women developed SCC.
Overall, the risk of SCC increased with increasing numbers of indoor tanning sessions. The adjusted hazard ratio for most tanning sessions versus no tanning sessions was 1.83. “The association between cumulative exposure to indoor tanning and SCC risk was the same regardless of duration of use and age at initiation,” the researchers wrote.
The risk of SCC was significantly higher both among women with 10 years or less of tanning bed use and among those with more than 10 years of use, compared with never users (HRs, 1.41 and 1.43, respectively). Similarly, researchers found a significantly higher risk of SCC among women who started indoor tanning at age 30 years or older and those who started younger than 30 years, compared with never users (HRs, 1.36 and HR, 1.51, respectively).
No significant association appeared between age at initiation of indoor tanning and age at the time of SCC diagnosis.
The study findings were limited by several factors including the variation in UV radiation among tanning devices, the lack of data on men, and the retrospective collection of UV exposure data that likely led to some misclassification, the researchers noted.
However, the results were strengthened by the large sample size and support the association between increased exposure to indoor tanning and increased risk of SCC, they wrote. “Avoidance of indoor tanning may help prevent not only melanoma but also SCC, and our results support the development of policies that regulate indoor tanning.”
The study was supported by the Institute of Basic Medical Sciences, University of Oslo, and the Norwegian Cancer Society. The researchers had no financial conflicts to disclose.
SOURCE: Lergenmuller S et al. JAMA Dermatol. 2019 Oct 2. doi: 10.1001/jamadermatol.2019.2681.
“There is a saying that ‘when prevention works, nothing happens,’ ” wrote Boris D. Lushniak, MD, in an accompanying editorial. Dermatology plays an important role in public health, most notably skin cancer prevention, and the specialty’s efforts to educate the public and raise awareness about skin cancer and its causes are paying off, in combination with government initiatives to reduce exposure to UV radiation. The current study adds to the data on risk factors for skin cancer, and is distinctive in its focus on artificial sources of UV radiation, specifically indoor tanning sources. The relationship between indoor tanning and basal cell carcinoma or squamous cell carcinoma has not been well studied, “so this study fills an important gap,” he noted.
Research on indoor tanning and other skin cancer risk factors can help expand skin cancer prevention efforts and support goals such as the Healthy People 2020 goal of “reducing the proportion of adolescents in grades 9-12 who report using artificial sources of UV light for tanning, and reducing the proportion of adults aged 18 years or older who report using artificial sources of UV light for tanning,” he wrote.
The first-ever Surgeon General’s Call to Action to Prevent Skin Cancer, released in 2014, made skin cancer prevention a priority and offered specific strategies including providing more sun protection in outdoor settings, educating the public about UV exposure, promoting polices to help prevent skin cancer, reducing harm from indoor tanning, and increasing the collection of data related to skin cancer prevention.
The strategies seem to be working, Dr. Lushniak wrote. Based on data from the 2015 Youth Risk Behavior Surveillance System, a significant linear decrease in the use of indoor tanning devices by youth occurred between 2009 and 2015. “Oftentimes we do not appreciate or celebrate the successes of prevention. ... Let’s keep on track on that bold and noble mission of preventing skin cancer,” he added (JAMA Dermatol. 2019 Oct 2. doi: 10.1001/jamadermatol.2019.2680).
Dr. Lushniak is affiliated with the University of Maryland School of Public Health, College Park. He served as acting U.S. Surgeon General from 2013 to 2014, and as U.S. Deputy Surgeon General from 2010 to 2015. He had no financial conflicts to disclose.
“There is a saying that ‘when prevention works, nothing happens,’ ” wrote Boris D. Lushniak, MD, in an accompanying editorial. Dermatology plays an important role in public health, most notably skin cancer prevention, and the specialty’s efforts to educate the public and raise awareness about skin cancer and its causes are paying off, in combination with government initiatives to reduce exposure to UV radiation. The current study adds to the data on risk factors for skin cancer, and is distinctive in its focus on artificial sources of UV radiation, specifically indoor tanning sources. The relationship between indoor tanning and basal cell carcinoma or squamous cell carcinoma has not been well studied, “so this study fills an important gap,” he noted.
Research on indoor tanning and other skin cancer risk factors can help expand skin cancer prevention efforts and support goals such as the Healthy People 2020 goal of “reducing the proportion of adolescents in grades 9-12 who report using artificial sources of UV light for tanning, and reducing the proportion of adults aged 18 years or older who report using artificial sources of UV light for tanning,” he wrote.
The first-ever Surgeon General’s Call to Action to Prevent Skin Cancer, released in 2014, made skin cancer prevention a priority and offered specific strategies including providing more sun protection in outdoor settings, educating the public about UV exposure, promoting polices to help prevent skin cancer, reducing harm from indoor tanning, and increasing the collection of data related to skin cancer prevention.
The strategies seem to be working, Dr. Lushniak wrote. Based on data from the 2015 Youth Risk Behavior Surveillance System, a significant linear decrease in the use of indoor tanning devices by youth occurred between 2009 and 2015. “Oftentimes we do not appreciate or celebrate the successes of prevention. ... Let’s keep on track on that bold and noble mission of preventing skin cancer,” he added (JAMA Dermatol. 2019 Oct 2. doi: 10.1001/jamadermatol.2019.2680).
Dr. Lushniak is affiliated with the University of Maryland School of Public Health, College Park. He served as acting U.S. Surgeon General from 2013 to 2014, and as U.S. Deputy Surgeon General from 2010 to 2015. He had no financial conflicts to disclose.
“There is a saying that ‘when prevention works, nothing happens,’ ” wrote Boris D. Lushniak, MD, in an accompanying editorial. Dermatology plays an important role in public health, most notably skin cancer prevention, and the specialty’s efforts to educate the public and raise awareness about skin cancer and its causes are paying off, in combination with government initiatives to reduce exposure to UV radiation. The current study adds to the data on risk factors for skin cancer, and is distinctive in its focus on artificial sources of UV radiation, specifically indoor tanning sources. The relationship between indoor tanning and basal cell carcinoma or squamous cell carcinoma has not been well studied, “so this study fills an important gap,” he noted.
Research on indoor tanning and other skin cancer risk factors can help expand skin cancer prevention efforts and support goals such as the Healthy People 2020 goal of “reducing the proportion of adolescents in grades 9-12 who report using artificial sources of UV light for tanning, and reducing the proportion of adults aged 18 years or older who report using artificial sources of UV light for tanning,” he wrote.
The first-ever Surgeon General’s Call to Action to Prevent Skin Cancer, released in 2014, made skin cancer prevention a priority and offered specific strategies including providing more sun protection in outdoor settings, educating the public about UV exposure, promoting polices to help prevent skin cancer, reducing harm from indoor tanning, and increasing the collection of data related to skin cancer prevention.
The strategies seem to be working, Dr. Lushniak wrote. Based on data from the 2015 Youth Risk Behavior Surveillance System, a significant linear decrease in the use of indoor tanning devices by youth occurred between 2009 and 2015. “Oftentimes we do not appreciate or celebrate the successes of prevention. ... Let’s keep on track on that bold and noble mission of preventing skin cancer,” he added (JAMA Dermatol. 2019 Oct 2. doi: 10.1001/jamadermatol.2019.2680).
Dr. Lushniak is affiliated with the University of Maryland School of Public Health, College Park. He served as acting U.S. Surgeon General from 2013 to 2014, and as U.S. Deputy Surgeon General from 2010 to 2015. He had no financial conflicts to disclose.
Women who accumulated more indoor tanning sessions over time significantly increased their risk for squamous cell cancer over women who never engaged in indoor tanning, based on data from 159,419 women.
Previous research has examined associations between indoor tanning and cutaneous melanoma, but an association between indoor tanning and squamous cell carcinoma (SCC) has not been well studied, wrote Simon Lergenmuller, MSc, of the University of Oslo, and colleagues.
In a prospective cohort study published in JAMA Dermatology, the researchers surveyed 159,419 women from the Norwegian Women and Cancer study. Of these, 95,552 women (69%) reported ever use of indoor tanning. The average age at study inclusion was 50 years. During an average of 17 years’ follow-up, 597 women developed SCC.
Overall, the risk of SCC increased with increasing numbers of indoor tanning sessions. The adjusted hazard ratio for most tanning sessions versus no tanning sessions was 1.83. “The association between cumulative exposure to indoor tanning and SCC risk was the same regardless of duration of use and age at initiation,” the researchers wrote.
The risk of SCC was significantly higher both among women with 10 years or less of tanning bed use and among those with more than 10 years of use, compared with never users (HRs, 1.41 and 1.43, respectively). Similarly, researchers found a significantly higher risk of SCC among women who started indoor tanning at age 30 years or older and those who started younger than 30 years, compared with never users (HRs, 1.36 and HR, 1.51, respectively).
No significant association appeared between age at initiation of indoor tanning and age at the time of SCC diagnosis.
The study findings were limited by several factors including the variation in UV radiation among tanning devices, the lack of data on men, and the retrospective collection of UV exposure data that likely led to some misclassification, the researchers noted.
However, the results were strengthened by the large sample size and support the association between increased exposure to indoor tanning and increased risk of SCC, they wrote. “Avoidance of indoor tanning may help prevent not only melanoma but also SCC, and our results support the development of policies that regulate indoor tanning.”
The study was supported by the Institute of Basic Medical Sciences, University of Oslo, and the Norwegian Cancer Society. The researchers had no financial conflicts to disclose.
SOURCE: Lergenmuller S et al. JAMA Dermatol. 2019 Oct 2. doi: 10.1001/jamadermatol.2019.2681.
Women who accumulated more indoor tanning sessions over time significantly increased their risk for squamous cell cancer over women who never engaged in indoor tanning, based on data from 159,419 women.
Previous research has examined associations between indoor tanning and cutaneous melanoma, but an association between indoor tanning and squamous cell carcinoma (SCC) has not been well studied, wrote Simon Lergenmuller, MSc, of the University of Oslo, and colleagues.
In a prospective cohort study published in JAMA Dermatology, the researchers surveyed 159,419 women from the Norwegian Women and Cancer study. Of these, 95,552 women (69%) reported ever use of indoor tanning. The average age at study inclusion was 50 years. During an average of 17 years’ follow-up, 597 women developed SCC.
Overall, the risk of SCC increased with increasing numbers of indoor tanning sessions. The adjusted hazard ratio for most tanning sessions versus no tanning sessions was 1.83. “The association between cumulative exposure to indoor tanning and SCC risk was the same regardless of duration of use and age at initiation,” the researchers wrote.
The risk of SCC was significantly higher both among women with 10 years or less of tanning bed use and among those with more than 10 years of use, compared with never users (HRs, 1.41 and 1.43, respectively). Similarly, researchers found a significantly higher risk of SCC among women who started indoor tanning at age 30 years or older and those who started younger than 30 years, compared with never users (HRs, 1.36 and HR, 1.51, respectively).
No significant association appeared between age at initiation of indoor tanning and age at the time of SCC diagnosis.
The study findings were limited by several factors including the variation in UV radiation among tanning devices, the lack of data on men, and the retrospective collection of UV exposure data that likely led to some misclassification, the researchers noted.
However, the results were strengthened by the large sample size and support the association between increased exposure to indoor tanning and increased risk of SCC, they wrote. “Avoidance of indoor tanning may help prevent not only melanoma but also SCC, and our results support the development of policies that regulate indoor tanning.”
The study was supported by the Institute of Basic Medical Sciences, University of Oslo, and the Norwegian Cancer Society. The researchers had no financial conflicts to disclose.
SOURCE: Lergenmuller S et al. JAMA Dermatol. 2019 Oct 2. doi: 10.1001/jamadermatol.2019.2681.
FROM JAMA DERMATOLOGY
Nivolumab-ipilimumab nets long-term survival in advanced melanoma
Combination therapy with the immune checkpoint inhibitors nivolumab and ipilimumab has durable efficacy in patients with untreated advanced melanoma, with more than half still alive at 5 years and almost three-fourths of them no longer on any treatment, found an update of the CheckMate 067 trial. The combination also had a manageable safety profile and generally maintained health-related quality of life in the long term.
“The apparent plateau with nivolumab plus ipilimumab has continued with longer follow-up … nivolumab plus ipilimumab is … currently the only treatment for metastatic melanoma for which median overall survival has not been reached at 5 years,” noted the investigators, led by James Larkin, FRCP, PhD, a consultant medical oncologist at the Royal Marsden National Health Service Foundation Trust, London. “The current results of the CheckMate 067 trial set a new foundation on which to make improvements in long-term efficacy outcomes with the combination of nivolumab plus ipilimumab.”
The phase 3, randomized, controlled trial pitted nivolumab (Opdivo) plus ipilimumab (Yervoy) combination therapy and nivolumab monotherapy against ipilimumab monotherapy among 945 adults with previously untreated or unresectable metastatic melanoma. Initial results at a median follow-up of about 1 year showed a progression-free survival benefit of the nivolumab regimens (N Engl J Med. 2015;373:23-34), a pattern that has persisted in updates and has been augmented by an overall survival benefit, as seen most recently at a median follow-up of about 4 years (Lancet Oncol. 2018;19:1480-92).
Dr. Larkin and colleagues performed another update, now at a minimum follow-up of 5 years in all patients. This update additionally looked at subsequent therapies and health-related quality of life.
Results reported in the New England Journal of Medicine showed that median overall survival was now 19.9 months with ipilimumab. In comparison, it was not reached with nivolumab-ipilimumab (hazard ratio for death, 0.52) and was 36.9 months with nivolumab alone (HR, 0.63). The 5-year overall survival rate was 26%, compared with 52% and 44%, respectively.
In all groups, complete response rates continued an increase seen since the trial’s initial results were reported. “[T]his indicates that the best response can improve over time with immune checkpoint inhibitors,” Dr. Larkin and coinvestigators maintained.
“The treatment-free interval continued to lengthen in the nivolumab-plus-ipilimumab group, and the percentage of patients who were alive and not receiving treatment continued to increase across the groups,” they further noted. As of the update, the median treatment-free interval was 18.1 months with nivolumab-ipilimumab, 1.8 months with nivolumab, and 1.9 months with ipilimumab. The percentage of those alive who were not receiving any trial treatment or subsequent systemic therapy was 74%, 58%, and 45%, respectively.
Meanwhile, the data did not show any new safety signals. And health-related quality of life, measured with European Quality of Life 5-Dimensions 3-Level questionnaire, was generally sustained during and after treatment, with limited fluctuations outside a 0.08-point clinically meaningful boundary, in the combination-therapy group and the nivolumab group, whereas it deteriorated more often in the ipilimumab group.
Dr. Larkin disclosed grants and personal fees from numerous pharmaceutical companies. The trial was supported by Bristol-Myers Squibb, a grant from the National Cancer Institute, and a grant (to Dr. Larkin) from the National Institute for Health Research Royal Marsden–Institute of Cancer Research Biomedical Research Centre.
SOURCE: Larkin J et al. N Engl J Med. 2019 Sep 28. doi: 10.1056/NEJMoa1910836.
Combination therapy with the immune checkpoint inhibitors nivolumab and ipilimumab has durable efficacy in patients with untreated advanced melanoma, with more than half still alive at 5 years and almost three-fourths of them no longer on any treatment, found an update of the CheckMate 067 trial. The combination also had a manageable safety profile and generally maintained health-related quality of life in the long term.
“The apparent plateau with nivolumab plus ipilimumab has continued with longer follow-up … nivolumab plus ipilimumab is … currently the only treatment for metastatic melanoma for which median overall survival has not been reached at 5 years,” noted the investigators, led by James Larkin, FRCP, PhD, a consultant medical oncologist at the Royal Marsden National Health Service Foundation Trust, London. “The current results of the CheckMate 067 trial set a new foundation on which to make improvements in long-term efficacy outcomes with the combination of nivolumab plus ipilimumab.”
The phase 3, randomized, controlled trial pitted nivolumab (Opdivo) plus ipilimumab (Yervoy) combination therapy and nivolumab monotherapy against ipilimumab monotherapy among 945 adults with previously untreated or unresectable metastatic melanoma. Initial results at a median follow-up of about 1 year showed a progression-free survival benefit of the nivolumab regimens (N Engl J Med. 2015;373:23-34), a pattern that has persisted in updates and has been augmented by an overall survival benefit, as seen most recently at a median follow-up of about 4 years (Lancet Oncol. 2018;19:1480-92).
Dr. Larkin and colleagues performed another update, now at a minimum follow-up of 5 years in all patients. This update additionally looked at subsequent therapies and health-related quality of life.
Results reported in the New England Journal of Medicine showed that median overall survival was now 19.9 months with ipilimumab. In comparison, it was not reached with nivolumab-ipilimumab (hazard ratio for death, 0.52) and was 36.9 months with nivolumab alone (HR, 0.63). The 5-year overall survival rate was 26%, compared with 52% and 44%, respectively.
In all groups, complete response rates continued an increase seen since the trial’s initial results were reported. “[T]his indicates that the best response can improve over time with immune checkpoint inhibitors,” Dr. Larkin and coinvestigators maintained.
“The treatment-free interval continued to lengthen in the nivolumab-plus-ipilimumab group, and the percentage of patients who were alive and not receiving treatment continued to increase across the groups,” they further noted. As of the update, the median treatment-free interval was 18.1 months with nivolumab-ipilimumab, 1.8 months with nivolumab, and 1.9 months with ipilimumab. The percentage of those alive who were not receiving any trial treatment or subsequent systemic therapy was 74%, 58%, and 45%, respectively.
Meanwhile, the data did not show any new safety signals. And health-related quality of life, measured with European Quality of Life 5-Dimensions 3-Level questionnaire, was generally sustained during and after treatment, with limited fluctuations outside a 0.08-point clinically meaningful boundary, in the combination-therapy group and the nivolumab group, whereas it deteriorated more often in the ipilimumab group.
Dr. Larkin disclosed grants and personal fees from numerous pharmaceutical companies. The trial was supported by Bristol-Myers Squibb, a grant from the National Cancer Institute, and a grant (to Dr. Larkin) from the National Institute for Health Research Royal Marsden–Institute of Cancer Research Biomedical Research Centre.
SOURCE: Larkin J et al. N Engl J Med. 2019 Sep 28. doi: 10.1056/NEJMoa1910836.
Combination therapy with the immune checkpoint inhibitors nivolumab and ipilimumab has durable efficacy in patients with untreated advanced melanoma, with more than half still alive at 5 years and almost three-fourths of them no longer on any treatment, found an update of the CheckMate 067 trial. The combination also had a manageable safety profile and generally maintained health-related quality of life in the long term.
“The apparent plateau with nivolumab plus ipilimumab has continued with longer follow-up … nivolumab plus ipilimumab is … currently the only treatment for metastatic melanoma for which median overall survival has not been reached at 5 years,” noted the investigators, led by James Larkin, FRCP, PhD, a consultant medical oncologist at the Royal Marsden National Health Service Foundation Trust, London. “The current results of the CheckMate 067 trial set a new foundation on which to make improvements in long-term efficacy outcomes with the combination of nivolumab plus ipilimumab.”
The phase 3, randomized, controlled trial pitted nivolumab (Opdivo) plus ipilimumab (Yervoy) combination therapy and nivolumab monotherapy against ipilimumab monotherapy among 945 adults with previously untreated or unresectable metastatic melanoma. Initial results at a median follow-up of about 1 year showed a progression-free survival benefit of the nivolumab regimens (N Engl J Med. 2015;373:23-34), a pattern that has persisted in updates and has been augmented by an overall survival benefit, as seen most recently at a median follow-up of about 4 years (Lancet Oncol. 2018;19:1480-92).
Dr. Larkin and colleagues performed another update, now at a minimum follow-up of 5 years in all patients. This update additionally looked at subsequent therapies and health-related quality of life.
Results reported in the New England Journal of Medicine showed that median overall survival was now 19.9 months with ipilimumab. In comparison, it was not reached with nivolumab-ipilimumab (hazard ratio for death, 0.52) and was 36.9 months with nivolumab alone (HR, 0.63). The 5-year overall survival rate was 26%, compared with 52% and 44%, respectively.
In all groups, complete response rates continued an increase seen since the trial’s initial results were reported. “[T]his indicates that the best response can improve over time with immune checkpoint inhibitors,” Dr. Larkin and coinvestigators maintained.
“The treatment-free interval continued to lengthen in the nivolumab-plus-ipilimumab group, and the percentage of patients who were alive and not receiving treatment continued to increase across the groups,” they further noted. As of the update, the median treatment-free interval was 18.1 months with nivolumab-ipilimumab, 1.8 months with nivolumab, and 1.9 months with ipilimumab. The percentage of those alive who were not receiving any trial treatment or subsequent systemic therapy was 74%, 58%, and 45%, respectively.
Meanwhile, the data did not show any new safety signals. And health-related quality of life, measured with European Quality of Life 5-Dimensions 3-Level questionnaire, was generally sustained during and after treatment, with limited fluctuations outside a 0.08-point clinically meaningful boundary, in the combination-therapy group and the nivolumab group, whereas it deteriorated more often in the ipilimumab group.
Dr. Larkin disclosed grants and personal fees from numerous pharmaceutical companies. The trial was supported by Bristol-Myers Squibb, a grant from the National Cancer Institute, and a grant (to Dr. Larkin) from the National Institute for Health Research Royal Marsden–Institute of Cancer Research Biomedical Research Centre.
SOURCE: Larkin J et al. N Engl J Med. 2019 Sep 28. doi: 10.1056/NEJMoa1910836.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Questions surround ‘exciting’ intranasal esketamine
SAN DIEGO – While an “exciting” ketamine-based product is finally available and approved to treat treatment-resistant depression (TRD), there are still plenty of questions about the use of intranasal esketamine, a psychiatrist told colleagues.
“We have a lot of unmet needs in terms of research,” said Sanjay J. Mathew, MD, of Baylor College of Medicine and Michael E. Debakey Veterans Affairs Medical Center, both in Houston, at the annual Psych Congress. “What do we do in the long term? What are the dosing strategies and response predictors? What about elderly patients?”
The Food and Drug Administration approved esketamine nasal spray (Spravato) for TRD in March 2019. Patients with TRD are defined as those with major depressive disorder who have failed at least two different antidepressants.
Dr. Mathew highlighted a 2019 randomized, double-blind, controlled study of patients who reached stable remission after 16 weeks on esketamine. It revealed there’s “a significant enhancement of the time to relapse for patients who remained on ketamine [compared with placebo] – a 51% risk reduction in the median number of days to relapse” (JAMA Psychiatry. 2019;76[9]:893-903).
However, about a quarter of patients still relapsed over the time of the study, Dr. Mathew said. “While this is certainly exciting, we need to talk to our patients about this and set expectations. And we need to emphasize close vigilance, follow-up, and psychotherapy.”
Patients should understand that, if patients are doing remarkably well at 16 weeks, “you’re not out of the woods. You really need to take it long term,” he said.
Dr. Mathew emphasized that patients must take the drug under supervision in a certified facility. “It’s a quick and simple process to do it [get certified] and get registered,” he said. Patients must be monitored over 2 hours and not drive for the rest of the day.
“You need space for some privacy, so a busy [postanesthesia care unit] or ER setting may not be optimal,” he said, adding that, “if you only have one office, it’s hard to pull this off for a number of logistical reasons.”
Dr. Mathew recommended lowering the level of stimulation in the room where the drug is administered. “We have a VA setting that can be loud with code greens blasting over the speaker,” he said. “That is not optimal, but at least we have a private room for our IV infusions. Keep the lights muted, let the patient listen to peaceful music that they enjoy. Having a family member close by can be helpful and comforting to them.”
He added that “you do need a way to recline the head. Having a barber-type chair would be necessary.”
Side effects are common, he said. Sedation is a major risk (49%-61%), as is dissociation (61%-75%). “It’s primarily a sense of alteration – perceptual alterations, altered sense of time, unreality, being disconnected from body, feeling unusually big in fingers or hands, or feeling like you’re unusually tall or skinny.”
Moving forward, more data about long-term effects and ideal doses are needed. “There are many clinics that go above 0.5 milligrams per kg, and some even go to 2. We have no good data,” he said.
People aged over 65 years have lower response rates, and men seem to respond less than women. Dr. Mathew also noted that the studies into the drug generally limited the number of antidepressant failures in patients: “Are there patients too refractory to be considered for this? How refractory is too refractory?”
Dr. Mathew reported various disclosures including a relationship with Janssen, manufacturer of intranasal esketamine.
SAN DIEGO – While an “exciting” ketamine-based product is finally available and approved to treat treatment-resistant depression (TRD), there are still plenty of questions about the use of intranasal esketamine, a psychiatrist told colleagues.
“We have a lot of unmet needs in terms of research,” said Sanjay J. Mathew, MD, of Baylor College of Medicine and Michael E. Debakey Veterans Affairs Medical Center, both in Houston, at the annual Psych Congress. “What do we do in the long term? What are the dosing strategies and response predictors? What about elderly patients?”
The Food and Drug Administration approved esketamine nasal spray (Spravato) for TRD in March 2019. Patients with TRD are defined as those with major depressive disorder who have failed at least two different antidepressants.
Dr. Mathew highlighted a 2019 randomized, double-blind, controlled study of patients who reached stable remission after 16 weeks on esketamine. It revealed there’s “a significant enhancement of the time to relapse for patients who remained on ketamine [compared with placebo] – a 51% risk reduction in the median number of days to relapse” (JAMA Psychiatry. 2019;76[9]:893-903).
However, about a quarter of patients still relapsed over the time of the study, Dr. Mathew said. “While this is certainly exciting, we need to talk to our patients about this and set expectations. And we need to emphasize close vigilance, follow-up, and psychotherapy.”
Patients should understand that, if patients are doing remarkably well at 16 weeks, “you’re not out of the woods. You really need to take it long term,” he said.
Dr. Mathew emphasized that patients must take the drug under supervision in a certified facility. “It’s a quick and simple process to do it [get certified] and get registered,” he said. Patients must be monitored over 2 hours and not drive for the rest of the day.
“You need space for some privacy, so a busy [postanesthesia care unit] or ER setting may not be optimal,” he said, adding that, “if you only have one office, it’s hard to pull this off for a number of logistical reasons.”
Dr. Mathew recommended lowering the level of stimulation in the room where the drug is administered. “We have a VA setting that can be loud with code greens blasting over the speaker,” he said. “That is not optimal, but at least we have a private room for our IV infusions. Keep the lights muted, let the patient listen to peaceful music that they enjoy. Having a family member close by can be helpful and comforting to them.”
He added that “you do need a way to recline the head. Having a barber-type chair would be necessary.”
Side effects are common, he said. Sedation is a major risk (49%-61%), as is dissociation (61%-75%). “It’s primarily a sense of alteration – perceptual alterations, altered sense of time, unreality, being disconnected from body, feeling unusually big in fingers or hands, or feeling like you’re unusually tall or skinny.”
Moving forward, more data about long-term effects and ideal doses are needed. “There are many clinics that go above 0.5 milligrams per kg, and some even go to 2. We have no good data,” he said.
People aged over 65 years have lower response rates, and men seem to respond less than women. Dr. Mathew also noted that the studies into the drug generally limited the number of antidepressant failures in patients: “Are there patients too refractory to be considered for this? How refractory is too refractory?”
Dr. Mathew reported various disclosures including a relationship with Janssen, manufacturer of intranasal esketamine.
SAN DIEGO – While an “exciting” ketamine-based product is finally available and approved to treat treatment-resistant depression (TRD), there are still plenty of questions about the use of intranasal esketamine, a psychiatrist told colleagues.
“We have a lot of unmet needs in terms of research,” said Sanjay J. Mathew, MD, of Baylor College of Medicine and Michael E. Debakey Veterans Affairs Medical Center, both in Houston, at the annual Psych Congress. “What do we do in the long term? What are the dosing strategies and response predictors? What about elderly patients?”
The Food and Drug Administration approved esketamine nasal spray (Spravato) for TRD in March 2019. Patients with TRD are defined as those with major depressive disorder who have failed at least two different antidepressants.
Dr. Mathew highlighted a 2019 randomized, double-blind, controlled study of patients who reached stable remission after 16 weeks on esketamine. It revealed there’s “a significant enhancement of the time to relapse for patients who remained on ketamine [compared with placebo] – a 51% risk reduction in the median number of days to relapse” (JAMA Psychiatry. 2019;76[9]:893-903).
However, about a quarter of patients still relapsed over the time of the study, Dr. Mathew said. “While this is certainly exciting, we need to talk to our patients about this and set expectations. And we need to emphasize close vigilance, follow-up, and psychotherapy.”
Patients should understand that, if patients are doing remarkably well at 16 weeks, “you’re not out of the woods. You really need to take it long term,” he said.
Dr. Mathew emphasized that patients must take the drug under supervision in a certified facility. “It’s a quick and simple process to do it [get certified] and get registered,” he said. Patients must be monitored over 2 hours and not drive for the rest of the day.
“You need space for some privacy, so a busy [postanesthesia care unit] or ER setting may not be optimal,” he said, adding that, “if you only have one office, it’s hard to pull this off for a number of logistical reasons.”
Dr. Mathew recommended lowering the level of stimulation in the room where the drug is administered. “We have a VA setting that can be loud with code greens blasting over the speaker,” he said. “That is not optimal, but at least we have a private room for our IV infusions. Keep the lights muted, let the patient listen to peaceful music that they enjoy. Having a family member close by can be helpful and comforting to them.”
He added that “you do need a way to recline the head. Having a barber-type chair would be necessary.”
Side effects are common, he said. Sedation is a major risk (49%-61%), as is dissociation (61%-75%). “It’s primarily a sense of alteration – perceptual alterations, altered sense of time, unreality, being disconnected from body, feeling unusually big in fingers or hands, or feeling like you’re unusually tall or skinny.”
Moving forward, more data about long-term effects and ideal doses are needed. “There are many clinics that go above 0.5 milligrams per kg, and some even go to 2. We have no good data,” he said.
People aged over 65 years have lower response rates, and men seem to respond less than women. Dr. Mathew also noted that the studies into the drug generally limited the number of antidepressant failures in patients: “Are there patients too refractory to be considered for this? How refractory is too refractory?”
Dr. Mathew reported various disclosures including a relationship with Janssen, manufacturer of intranasal esketamine.
REPORTING FROM PSYCH CONGRESS 2019
Psoriasis comorbidities: Biologics may help
SEATTLE – Psoriasis is a complex condition, made more difficult by comorbidities. Psoriatic arthritis is the most common and is frequently discussed. But mental health issues and cardiovascular events also co-occur and can present major complications, according to Jashin Wu, MD, founder and CEO of the Dermatology Research and Education Foundation, who discussed psoriasis comorbidities at the annual Coastal Dermatology Symposium.
Mental health–related issues associated with psoriasis (Psychiatr Danub. 2017 Dec;29[4]:401-6) include sleep disorders (prevalence, 62%), sexual dysfunction (46%), personality disorder (35%), anxiety (30%), adjustment (29%), and depressive disorders (28%); 25% of patients have an accompanying substance abuse disorder. Suicidal ideation and suicidal depression are particularly concerning, and a meta-analysis (J Am Acad Dermatol. 2017 Sep;77[3]:425-40.e2) showed a 44% increased risk of suicidal ideation associated with psoriasis.
Such problems aren’t surprising, since psoriasis is a lifelong disease, and many patients’ symptoms aren’t adequately controlled. “A lot of these patients get topical therapies, which is probably not enough, especially if they have severe disease,” said Dr. Wu in an interview.
Dermatologists can sometimes be nervous about biologics because of concerns over increased risk of infection or cancer. That can lead to conservative, topical treatment. Dr. Wu feels that rare side effects shouldn’t deter from aggressive treatment, when appropriate. “It’s better to treat the patient to make sure they’re clear, which may improve their comorbidities as well. In general, if you’re worried, you can send them to other specialists to do monitoring,” Dr. Wu said in the interview.
Different treatment methods may influence mental health outcomes, according to the PSOLAR study (J Am Acad Dermatol. 2018 Jan;78[1]:70-80). It examined the issue prospectively with over 12,000 psoriasis patients, and found a depression incidence of 3.01 per 100-patient years when treated with biologics, compared with 5.85 for phototherapy and 5.70 for conventional therapy. Put another way, exposure to biologics was associated with a reduced risk of depression, compared with conventional therapies (hazard ratio, 0.76; P = .0367). “It seems to show that biologics have a better improvement of depression symptoms, compared to phototherapy or oral therapy,” said Dr. Wu.
Those results suggest that dermatologists should be on the lookout for mental health issues, though that is a challenge for someone not trained in the field. Dr. Wu takes a simple approach. “I like just asking open-ended questions, like how they’re doing, and if you get a sense that maybe they’re depressed, ask more specific questions about their mood, how they’re feeling, how things are at work, how things are at home.” When things aren’t right, “the key is to try to get them on something that’s going to clear them very quickly. If it’s severe disease, use a biologic that’s going to clear it very quickly,” he added.
Unfortunately, just being clear isn’t a complete guarantee of improved mental health. Dr. Wu had two patients who committed suicide despite significant skin improvement. Patients may have between-visit flare-ups, or regular injections may be a reminder that psoriasis is an ongoing health struggle. Or patients may have other psychological concerns. That underlines the importance of awareness of mental health issues. “You don’t need to refer everyone [to a mental health specialist], but you should have a rolodex where you have someone you can send a patient to if you’re worried,” said Dr. Wu.
As with mental health issues, psoriasis patients are also at elevated risk for a wide range of cardiovascular comorbidities, such as diabetes, dyslipidemia, and high blood pressure. “As a dermatologist, you may not want to screen for these things, but you can send them to their primary care doctor or a cardiologist,” Dr. Wu said in the interview.
Also like mental health issues, there is evidence that treatment with biologics may have an outsized protective effect. One study (J Eur Acad Dermatol Venereol. 2018 Mar 24. doi: 10.1111/jdv.14951) led by Dr. Wu showed that treatment with a tumor necrosis factor (TNF)–alpha inhibitor led to a significant reduction in major adverse cardiac events, compared with topical therapy (propensity score–adjusted HR, 0.80; 95% CI, 0.66-0.98), while phototherapy or oral therapy trended towards an increased risk (adjusted HR, 1.13; 95% CI, 1.00-1.28). Another analysis (J Am Acad Dermatol. 2017 Jan;76[1]:81-90) from Dr. Wu’s group that included about 380,000 psoriasis patients found that treatment with TNF-alpha inhibitors was associated with fewer major cardiovascular events, compared with treatment with methotrexate (adjusted HR, 0.55; P less than .0001). Individual analyses showed associated reductions in stroke or transient ischemic attack (aHR, 0.55; P less than .0001), unstable angina (aHR, 0.58; P = .0024), and MI (aHR, 0.49; P = .0002). TNF-alpha inhibitors also seem to beat out phototherapy with respect to major cardiovascular events (aHR, 0.77; P = .046. J Am Acad Dermatol. 2018 Jul;79[1]:60-6).
More direct evidence of the benefit of biologics comes from the CANTOS trial (N Engl J Med. 2017 Sep 21;377[12]:1119-31), which randomized more than 10,000 patients with cryopyrin-associated periodic syndromes to receive the IL-1 beta-blocker canakinumab or placebo. Canakinumab was associated with significant reductions in nonfatal MI, nonfatal stroke, or cardiovascular death at 150 mg (HR, 0.85; P = .021) and 300 mg (HR, 0.86; P = .031), but not at 50 mg.
The bottom line, said Dr. Wu, is that psoriasis and psoriatic arthritis should be treated early with TNF-alpha inhibitors or IL-17 inhibitors in an effort to improve mental health, cardiovascular, and psoriatic arthritis outcomes.
Dr. Wu has been a consultant or speaker for, or done research on behalf of, AbbVie, Almirall, Amgen, Bristol-Myers Squibb, Celgene, Dermira, Dr. Reddy’s Laboratories, Eli Lilly, Janssen, LEO Pharma, Novartis, Regeneron, Sun Pharmaceutical, UCB, and Valeant Pharmaceuticals North America.
The meeting is jointly presented by the University of Louisville and Global Academy for Medical Education. This publication and Global Academy for Medical Education are owned by the same parent company.
SEATTLE – Psoriasis is a complex condition, made more difficult by comorbidities. Psoriatic arthritis is the most common and is frequently discussed. But mental health issues and cardiovascular events also co-occur and can present major complications, according to Jashin Wu, MD, founder and CEO of the Dermatology Research and Education Foundation, who discussed psoriasis comorbidities at the annual Coastal Dermatology Symposium.
Mental health–related issues associated with psoriasis (Psychiatr Danub. 2017 Dec;29[4]:401-6) include sleep disorders (prevalence, 62%), sexual dysfunction (46%), personality disorder (35%), anxiety (30%), adjustment (29%), and depressive disorders (28%); 25% of patients have an accompanying substance abuse disorder. Suicidal ideation and suicidal depression are particularly concerning, and a meta-analysis (J Am Acad Dermatol. 2017 Sep;77[3]:425-40.e2) showed a 44% increased risk of suicidal ideation associated with psoriasis.
Such problems aren’t surprising, since psoriasis is a lifelong disease, and many patients’ symptoms aren’t adequately controlled. “A lot of these patients get topical therapies, which is probably not enough, especially if they have severe disease,” said Dr. Wu in an interview.
Dermatologists can sometimes be nervous about biologics because of concerns over increased risk of infection or cancer. That can lead to conservative, topical treatment. Dr. Wu feels that rare side effects shouldn’t deter from aggressive treatment, when appropriate. “It’s better to treat the patient to make sure they’re clear, which may improve their comorbidities as well. In general, if you’re worried, you can send them to other specialists to do monitoring,” Dr. Wu said in the interview.
Different treatment methods may influence mental health outcomes, according to the PSOLAR study (J Am Acad Dermatol. 2018 Jan;78[1]:70-80). It examined the issue prospectively with over 12,000 psoriasis patients, and found a depression incidence of 3.01 per 100-patient years when treated with biologics, compared with 5.85 for phototherapy and 5.70 for conventional therapy. Put another way, exposure to biologics was associated with a reduced risk of depression, compared with conventional therapies (hazard ratio, 0.76; P = .0367). “It seems to show that biologics have a better improvement of depression symptoms, compared to phototherapy or oral therapy,” said Dr. Wu.
Those results suggest that dermatologists should be on the lookout for mental health issues, though that is a challenge for someone not trained in the field. Dr. Wu takes a simple approach. “I like just asking open-ended questions, like how they’re doing, and if you get a sense that maybe they’re depressed, ask more specific questions about their mood, how they’re feeling, how things are at work, how things are at home.” When things aren’t right, “the key is to try to get them on something that’s going to clear them very quickly. If it’s severe disease, use a biologic that’s going to clear it very quickly,” he added.
Unfortunately, just being clear isn’t a complete guarantee of improved mental health. Dr. Wu had two patients who committed suicide despite significant skin improvement. Patients may have between-visit flare-ups, or regular injections may be a reminder that psoriasis is an ongoing health struggle. Or patients may have other psychological concerns. That underlines the importance of awareness of mental health issues. “You don’t need to refer everyone [to a mental health specialist], but you should have a rolodex where you have someone you can send a patient to if you’re worried,” said Dr. Wu.
As with mental health issues, psoriasis patients are also at elevated risk for a wide range of cardiovascular comorbidities, such as diabetes, dyslipidemia, and high blood pressure. “As a dermatologist, you may not want to screen for these things, but you can send them to their primary care doctor or a cardiologist,” Dr. Wu said in the interview.
Also like mental health issues, there is evidence that treatment with biologics may have an outsized protective effect. One study (J Eur Acad Dermatol Venereol. 2018 Mar 24. doi: 10.1111/jdv.14951) led by Dr. Wu showed that treatment with a tumor necrosis factor (TNF)–alpha inhibitor led to a significant reduction in major adverse cardiac events, compared with topical therapy (propensity score–adjusted HR, 0.80; 95% CI, 0.66-0.98), while phototherapy or oral therapy trended towards an increased risk (adjusted HR, 1.13; 95% CI, 1.00-1.28). Another analysis (J Am Acad Dermatol. 2017 Jan;76[1]:81-90) from Dr. Wu’s group that included about 380,000 psoriasis patients found that treatment with TNF-alpha inhibitors was associated with fewer major cardiovascular events, compared with treatment with methotrexate (adjusted HR, 0.55; P less than .0001). Individual analyses showed associated reductions in stroke or transient ischemic attack (aHR, 0.55; P less than .0001), unstable angina (aHR, 0.58; P = .0024), and MI (aHR, 0.49; P = .0002). TNF-alpha inhibitors also seem to beat out phototherapy with respect to major cardiovascular events (aHR, 0.77; P = .046. J Am Acad Dermatol. 2018 Jul;79[1]:60-6).
More direct evidence of the benefit of biologics comes from the CANTOS trial (N Engl J Med. 2017 Sep 21;377[12]:1119-31), which randomized more than 10,000 patients with cryopyrin-associated periodic syndromes to receive the IL-1 beta-blocker canakinumab or placebo. Canakinumab was associated with significant reductions in nonfatal MI, nonfatal stroke, or cardiovascular death at 150 mg (HR, 0.85; P = .021) and 300 mg (HR, 0.86; P = .031), but not at 50 mg.
The bottom line, said Dr. Wu, is that psoriasis and psoriatic arthritis should be treated early with TNF-alpha inhibitors or IL-17 inhibitors in an effort to improve mental health, cardiovascular, and psoriatic arthritis outcomes.
Dr. Wu has been a consultant or speaker for, or done research on behalf of, AbbVie, Almirall, Amgen, Bristol-Myers Squibb, Celgene, Dermira, Dr. Reddy’s Laboratories, Eli Lilly, Janssen, LEO Pharma, Novartis, Regeneron, Sun Pharmaceutical, UCB, and Valeant Pharmaceuticals North America.
The meeting is jointly presented by the University of Louisville and Global Academy for Medical Education. This publication and Global Academy for Medical Education are owned by the same parent company.
SEATTLE – Psoriasis is a complex condition, made more difficult by comorbidities. Psoriatic arthritis is the most common and is frequently discussed. But mental health issues and cardiovascular events also co-occur and can present major complications, according to Jashin Wu, MD, founder and CEO of the Dermatology Research and Education Foundation, who discussed psoriasis comorbidities at the annual Coastal Dermatology Symposium.
Mental health–related issues associated with psoriasis (Psychiatr Danub. 2017 Dec;29[4]:401-6) include sleep disorders (prevalence, 62%), sexual dysfunction (46%), personality disorder (35%), anxiety (30%), adjustment (29%), and depressive disorders (28%); 25% of patients have an accompanying substance abuse disorder. Suicidal ideation and suicidal depression are particularly concerning, and a meta-analysis (J Am Acad Dermatol. 2017 Sep;77[3]:425-40.e2) showed a 44% increased risk of suicidal ideation associated with psoriasis.
Such problems aren’t surprising, since psoriasis is a lifelong disease, and many patients’ symptoms aren’t adequately controlled. “A lot of these patients get topical therapies, which is probably not enough, especially if they have severe disease,” said Dr. Wu in an interview.
Dermatologists can sometimes be nervous about biologics because of concerns over increased risk of infection or cancer. That can lead to conservative, topical treatment. Dr. Wu feels that rare side effects shouldn’t deter from aggressive treatment, when appropriate. “It’s better to treat the patient to make sure they’re clear, which may improve their comorbidities as well. In general, if you’re worried, you can send them to other specialists to do monitoring,” Dr. Wu said in the interview.
Different treatment methods may influence mental health outcomes, according to the PSOLAR study (J Am Acad Dermatol. 2018 Jan;78[1]:70-80). It examined the issue prospectively with over 12,000 psoriasis patients, and found a depression incidence of 3.01 per 100-patient years when treated with biologics, compared with 5.85 for phototherapy and 5.70 for conventional therapy. Put another way, exposure to biologics was associated with a reduced risk of depression, compared with conventional therapies (hazard ratio, 0.76; P = .0367). “It seems to show that biologics have a better improvement of depression symptoms, compared to phototherapy or oral therapy,” said Dr. Wu.
Those results suggest that dermatologists should be on the lookout for mental health issues, though that is a challenge for someone not trained in the field. Dr. Wu takes a simple approach. “I like just asking open-ended questions, like how they’re doing, and if you get a sense that maybe they’re depressed, ask more specific questions about their mood, how they’re feeling, how things are at work, how things are at home.” When things aren’t right, “the key is to try to get them on something that’s going to clear them very quickly. If it’s severe disease, use a biologic that’s going to clear it very quickly,” he added.
Unfortunately, just being clear isn’t a complete guarantee of improved mental health. Dr. Wu had two patients who committed suicide despite significant skin improvement. Patients may have between-visit flare-ups, or regular injections may be a reminder that psoriasis is an ongoing health struggle. Or patients may have other psychological concerns. That underlines the importance of awareness of mental health issues. “You don’t need to refer everyone [to a mental health specialist], but you should have a rolodex where you have someone you can send a patient to if you’re worried,” said Dr. Wu.
As with mental health issues, psoriasis patients are also at elevated risk for a wide range of cardiovascular comorbidities, such as diabetes, dyslipidemia, and high blood pressure. “As a dermatologist, you may not want to screen for these things, but you can send them to their primary care doctor or a cardiologist,” Dr. Wu said in the interview.
Also like mental health issues, there is evidence that treatment with biologics may have an outsized protective effect. One study (J Eur Acad Dermatol Venereol. 2018 Mar 24. doi: 10.1111/jdv.14951) led by Dr. Wu showed that treatment with a tumor necrosis factor (TNF)–alpha inhibitor led to a significant reduction in major adverse cardiac events, compared with topical therapy (propensity score–adjusted HR, 0.80; 95% CI, 0.66-0.98), while phototherapy or oral therapy trended towards an increased risk (adjusted HR, 1.13; 95% CI, 1.00-1.28). Another analysis (J Am Acad Dermatol. 2017 Jan;76[1]:81-90) from Dr. Wu’s group that included about 380,000 psoriasis patients found that treatment with TNF-alpha inhibitors was associated with fewer major cardiovascular events, compared with treatment with methotrexate (adjusted HR, 0.55; P less than .0001). Individual analyses showed associated reductions in stroke or transient ischemic attack (aHR, 0.55; P less than .0001), unstable angina (aHR, 0.58; P = .0024), and MI (aHR, 0.49; P = .0002). TNF-alpha inhibitors also seem to beat out phototherapy with respect to major cardiovascular events (aHR, 0.77; P = .046. J Am Acad Dermatol. 2018 Jul;79[1]:60-6).
More direct evidence of the benefit of biologics comes from the CANTOS trial (N Engl J Med. 2017 Sep 21;377[12]:1119-31), which randomized more than 10,000 patients with cryopyrin-associated periodic syndromes to receive the IL-1 beta-blocker canakinumab or placebo. Canakinumab was associated with significant reductions in nonfatal MI, nonfatal stroke, or cardiovascular death at 150 mg (HR, 0.85; P = .021) and 300 mg (HR, 0.86; P = .031), but not at 50 mg.
The bottom line, said Dr. Wu, is that psoriasis and psoriatic arthritis should be treated early with TNF-alpha inhibitors or IL-17 inhibitors in an effort to improve mental health, cardiovascular, and psoriatic arthritis outcomes.
Dr. Wu has been a consultant or speaker for, or done research on behalf of, AbbVie, Almirall, Amgen, Bristol-Myers Squibb, Celgene, Dermira, Dr. Reddy’s Laboratories, Eli Lilly, Janssen, LEO Pharma, Novartis, Regeneron, Sun Pharmaceutical, UCB, and Valeant Pharmaceuticals North America.
The meeting is jointly presented by the University of Louisville and Global Academy for Medical Education. This publication and Global Academy for Medical Education are owned by the same parent company.
EXPERT ANALYSIS FROM COASTAL DERM
Oral beta-lactams provide noninferior postdischarge pyelonephritis treatment
WASHINGTON – Patients hospitalized for pyelonephritis and discharged after receiving intravenous antibiotic treatment who then received step-down treatment with an oral beta-lactam had 30-day outcomes that were noninferior to patients who received an oral fluoroquinolone or trimethoprim-sulfamethoxazole as their discharge regimen, in a retrospective study of 211 patients managed at either of two U.S. hospitals.
This was the largest comparison reported on oral beta-lactam drugs for postdischarge treatment of pyelonephritis relative to the standard oral agents, fluoroquinolones and trimethoprim-sulfamethoxazole (Bactrim), Athena Hobbs, PharmD, said at an annual scientific meeting on infectious diseases. The superiority of an oral fluoroquinolone or trimethoprim-sulfamethoxazole and inferiority of oral beta-lactam drugs were cited in 2010 guidelines for managing pyelonephritis from the Infectious Diseases Society of America (Clin Infect Dis. 2011 March 1;52 [5]: e103-20).
Although limited as a nonrandomized, retrospective comparison, the finding of at least similar efficacy by beta-lactam agents “opens new treatment options” that avoid issues with drug resistance and adverse effects from treatment with fluoroquinolones or trimethoprim-sulfamethoxazole, Dr. Hobbs said in a video interview. Beta-lactams have already been embraced for this indication by some hospitalists, demonstrated by their use of beta-lactam antibiotics for 122 (58%) of the 211 patients included in the study. Among the 89 patients discharged on a non–beta-lactam, 69 (78%) had fluoroquinolone treatment and the remaining 20 patients went home taking trimethoprim-sulfamethoxazole. The new finding “confirms that we are not doing harm to patients,” with this existing practice of mostly prescribing an oral beta-lactam drug, noted Dr. Hobbs, an infectious diseases pharmacy specialist at Baptist Memorial Hospital in Memphis.
The study included patients aged 18-89 years hospitalized during 2014-2017 for a primary diagnosis of pyelonephritis at Baptist or at a second Hospital in Austin, Tex. The study excluded patients in intensive care, with a urologic abnormality, pregnant women, and patients treated with an intravenous antibiotic other than a beta-lactam for more than 24 hours. The most commonly used intravenous drugs were cefazolin and ceftriaxone. The enrolled patients averaged just over 40 years old, and more than 90% were women.
The study’s primary outcome was the 30-day rate of either hospital readmission or an ED visit for pyelonephritis or a urinary tract infection. This occurred in 4.9% of the patients discharged on an oral course of a beta-lactam drug, and in 5.6% of those discharged on either a fluoroquinolone or trimethoprim-sulfamethoxazole, a difference that was not statistically significant and that met the prespecified criteria for noninferiority, Dr. Hobbs reported. The most commonly prescribed oral beta-lactam was cefuroxime in about half the patients, followed by cephalexin or cefadroxil in about a quarter of patients, and amoxicillin with clavulanate in 19%. The two arms of the study also showed no significant difference in infection recurrences during 90-day follow-up.
The study received no commercial funding. Dr. Hobbs had no relevant disclosures.
WASHINGTON – Patients hospitalized for pyelonephritis and discharged after receiving intravenous antibiotic treatment who then received step-down treatment with an oral beta-lactam had 30-day outcomes that were noninferior to patients who received an oral fluoroquinolone or trimethoprim-sulfamethoxazole as their discharge regimen, in a retrospective study of 211 patients managed at either of two U.S. hospitals.
This was the largest comparison reported on oral beta-lactam drugs for postdischarge treatment of pyelonephritis relative to the standard oral agents, fluoroquinolones and trimethoprim-sulfamethoxazole (Bactrim), Athena Hobbs, PharmD, said at an annual scientific meeting on infectious diseases. The superiority of an oral fluoroquinolone or trimethoprim-sulfamethoxazole and inferiority of oral beta-lactam drugs were cited in 2010 guidelines for managing pyelonephritis from the Infectious Diseases Society of America (Clin Infect Dis. 2011 March 1;52 [5]: e103-20).
Although limited as a nonrandomized, retrospective comparison, the finding of at least similar efficacy by beta-lactam agents “opens new treatment options” that avoid issues with drug resistance and adverse effects from treatment with fluoroquinolones or trimethoprim-sulfamethoxazole, Dr. Hobbs said in a video interview. Beta-lactams have already been embraced for this indication by some hospitalists, demonstrated by their use of beta-lactam antibiotics for 122 (58%) of the 211 patients included in the study. Among the 89 patients discharged on a non–beta-lactam, 69 (78%) had fluoroquinolone treatment and the remaining 20 patients went home taking trimethoprim-sulfamethoxazole. The new finding “confirms that we are not doing harm to patients,” with this existing practice of mostly prescribing an oral beta-lactam drug, noted Dr. Hobbs, an infectious diseases pharmacy specialist at Baptist Memorial Hospital in Memphis.
The study included patients aged 18-89 years hospitalized during 2014-2017 for a primary diagnosis of pyelonephritis at Baptist or at a second Hospital in Austin, Tex. The study excluded patients in intensive care, with a urologic abnormality, pregnant women, and patients treated with an intravenous antibiotic other than a beta-lactam for more than 24 hours. The most commonly used intravenous drugs were cefazolin and ceftriaxone. The enrolled patients averaged just over 40 years old, and more than 90% were women.
The study’s primary outcome was the 30-day rate of either hospital readmission or an ED visit for pyelonephritis or a urinary tract infection. This occurred in 4.9% of the patients discharged on an oral course of a beta-lactam drug, and in 5.6% of those discharged on either a fluoroquinolone or trimethoprim-sulfamethoxazole, a difference that was not statistically significant and that met the prespecified criteria for noninferiority, Dr. Hobbs reported. The most commonly prescribed oral beta-lactam was cefuroxime in about half the patients, followed by cephalexin or cefadroxil in about a quarter of patients, and amoxicillin with clavulanate in 19%. The two arms of the study also showed no significant difference in infection recurrences during 90-day follow-up.
The study received no commercial funding. Dr. Hobbs had no relevant disclosures.
WASHINGTON – Patients hospitalized for pyelonephritis and discharged after receiving intravenous antibiotic treatment who then received step-down treatment with an oral beta-lactam had 30-day outcomes that were noninferior to patients who received an oral fluoroquinolone or trimethoprim-sulfamethoxazole as their discharge regimen, in a retrospective study of 211 patients managed at either of two U.S. hospitals.
This was the largest comparison reported on oral beta-lactam drugs for postdischarge treatment of pyelonephritis relative to the standard oral agents, fluoroquinolones and trimethoprim-sulfamethoxazole (Bactrim), Athena Hobbs, PharmD, said at an annual scientific meeting on infectious diseases. The superiority of an oral fluoroquinolone or trimethoprim-sulfamethoxazole and inferiority of oral beta-lactam drugs were cited in 2010 guidelines for managing pyelonephritis from the Infectious Diseases Society of America (Clin Infect Dis. 2011 March 1;52 [5]: e103-20).
Although limited as a nonrandomized, retrospective comparison, the finding of at least similar efficacy by beta-lactam agents “opens new treatment options” that avoid issues with drug resistance and adverse effects from treatment with fluoroquinolones or trimethoprim-sulfamethoxazole, Dr. Hobbs said in a video interview. Beta-lactams have already been embraced for this indication by some hospitalists, demonstrated by their use of beta-lactam antibiotics for 122 (58%) of the 211 patients included in the study. Among the 89 patients discharged on a non–beta-lactam, 69 (78%) had fluoroquinolone treatment and the remaining 20 patients went home taking trimethoprim-sulfamethoxazole. The new finding “confirms that we are not doing harm to patients,” with this existing practice of mostly prescribing an oral beta-lactam drug, noted Dr. Hobbs, an infectious diseases pharmacy specialist at Baptist Memorial Hospital in Memphis.
The study included patients aged 18-89 years hospitalized during 2014-2017 for a primary diagnosis of pyelonephritis at Baptist or at a second Hospital in Austin, Tex. The study excluded patients in intensive care, with a urologic abnormality, pregnant women, and patients treated with an intravenous antibiotic other than a beta-lactam for more than 24 hours. The most commonly used intravenous drugs were cefazolin and ceftriaxone. The enrolled patients averaged just over 40 years old, and more than 90% were women.
The study’s primary outcome was the 30-day rate of either hospital readmission or an ED visit for pyelonephritis or a urinary tract infection. This occurred in 4.9% of the patients discharged on an oral course of a beta-lactam drug, and in 5.6% of those discharged on either a fluoroquinolone or trimethoprim-sulfamethoxazole, a difference that was not statistically significant and that met the prespecified criteria for noninferiority, Dr. Hobbs reported. The most commonly prescribed oral beta-lactam was cefuroxime in about half the patients, followed by cephalexin or cefadroxil in about a quarter of patients, and amoxicillin with clavulanate in 19%. The two arms of the study also showed no significant difference in infection recurrences during 90-day follow-up.
The study received no commercial funding. Dr. Hobbs had no relevant disclosures.
REPORTING FROM IDWEEK 2019
Lithium drug interactions not quite as bad as imagined
SAN DIEGO – You don’t have to stop prescribing lithium when patients go on ACE inhibitors or angiotensin-receptor blockers (ARBs) for blood pressure treatment.
Some might opt to do that, but there’s no need to worry. In fact, the reason both classes are known to protect the kidneys is that they were tested with lithium; it was used to measure the drug’s effects on renal clearance, according to Stephen R. Saklad, PharmD, director of psychiatric pharmacy and clinical professor at the University of Texas at Austin.
There is interaction, but “lithium is not toxic in the presence of an ACE or an RB. You just have to adjust the dose,” he said at the annual Psych Congress.
Dr. Saklad shared lithium drug interaction pearls during a video interview at the meeting, including also using lithium with diuretics and NSAIDs. “The worst offender is probably my favorite of the NSAIDs, which is ibuprofen,” he said.
Most of the time with lithium, all that’s needed is a dose adjustment up or down of either it or the coadministered medication.
The overall guiding principle, he said, is that “lithium follows sodium. Anything that alters sodium in the body is going to alter sodium.”
SAN DIEGO – You don’t have to stop prescribing lithium when patients go on ACE inhibitors or angiotensin-receptor blockers (ARBs) for blood pressure treatment.
Some might opt to do that, but there’s no need to worry. In fact, the reason both classes are known to protect the kidneys is that they were tested with lithium; it was used to measure the drug’s effects on renal clearance, according to Stephen R. Saklad, PharmD, director of psychiatric pharmacy and clinical professor at the University of Texas at Austin.
There is interaction, but “lithium is not toxic in the presence of an ACE or an RB. You just have to adjust the dose,” he said at the annual Psych Congress.
Dr. Saklad shared lithium drug interaction pearls during a video interview at the meeting, including also using lithium with diuretics and NSAIDs. “The worst offender is probably my favorite of the NSAIDs, which is ibuprofen,” he said.
Most of the time with lithium, all that’s needed is a dose adjustment up or down of either it or the coadministered medication.
The overall guiding principle, he said, is that “lithium follows sodium. Anything that alters sodium in the body is going to alter sodium.”
SAN DIEGO – You don’t have to stop prescribing lithium when patients go on ACE inhibitors or angiotensin-receptor blockers (ARBs) for blood pressure treatment.
Some might opt to do that, but there’s no need to worry. In fact, the reason both classes are known to protect the kidneys is that they were tested with lithium; it was used to measure the drug’s effects on renal clearance, according to Stephen R. Saklad, PharmD, director of psychiatric pharmacy and clinical professor at the University of Texas at Austin.
There is interaction, but “lithium is not toxic in the presence of an ACE or an RB. You just have to adjust the dose,” he said at the annual Psych Congress.
Dr. Saklad shared lithium drug interaction pearls during a video interview at the meeting, including also using lithium with diuretics and NSAIDs. “The worst offender is probably my favorite of the NSAIDs, which is ibuprofen,” he said.
Most of the time with lithium, all that’s needed is a dose adjustment up or down of either it or the coadministered medication.
The overall guiding principle, he said, is that “lithium follows sodium. Anything that alters sodium in the body is going to alter sodium.”
REPORTING FROM PSYCH CONGRESS 2019