Clinician Reviews

Skin reactions at insulin pump infusion sites are common among people with type 1 diabetes who use the devices and can lead to delivery failure, new research suggests.
 

Insulin pump use is increasingly common, but many patients experience infusion-site failure that in some cases leads to discontinuation. In a novel investigation, researchers at the University of Washington, Seattle, used biopsies and noninvasive imaging to compare insulin pump sites with control sites in 30 patients. Several differences were found at pump sites in comparison with control sites, including fibrosis, inflammation, eosinophils, and increased vessel density.

“These findings support allergic sensitization as a potentially common reaction at [insulin pump] sites. The leading candidates causing this include insulin preservatives, plastic materials, and adhesive glue used in device manufacturing,” wrote Andrea Kalus, MD, of the university’s dermatology division, and colleagues. The findings were published recently in Diabetes Care.

The inflammatory response, they wrote, “may result in tissue changes responsible for the infusion-site failures seen frequently in clinical practice.”

Such infusion site problems represent an “Achilles heel” of these otherwise highly beneficial devices, lead author Irl Hirsch, MD, professor of medicine in the division of metabolism, endocrinology, and nutrition, said in a statement. “It doesn’t really matter how good the technology is. We still don’t understand what is happening with the infusion sites, much less to [be able to] fix it.”
 

Significant differences between pump and nonpump sites

In the cross-sectional study, Dr. Kalus and colleagues used noninvasive optical coherence tomography (OCT) immediately prior to performing punch biopsies at three sites: the site currently in active use, the “recovery site” used 3-5 days prior to the procedures, and control sites never used for pump infusion. Punch biopsies were also performed at those sites.

The mean age of the patients was 48.3 years, the mean diabetes duration was 30.4 years, and the mean duration of pump use was 15.8 years. Nearly all patients (93.3%) reported itchiness at the site, and 76.7% reported skin redness.

Of the 25 patients for whom OCT imaging was successful, statistical analysis showed significant differences in vascular area density and the optical attenuation coefficient, a surrogate for skin inflammation, between the pump and control sites and between recovery sites and current pump sites. The greater vessel density is likely a result of injury and repair related to catheter insertion, the authors said.

In the biopsy samples, both current and recovery sites showed increased fibrosis, fibrin, inflammation, fat necrosis, vascularity, and eosinophils, compared with the control sites, but no significant differences were found between current and recovery sites.

Eosinophils: ‘The most surprising histologic finding’

Eosinophils were found in 73% of skin biopsy specimens from current sites and in 75% of specimens from recovery sites, compared with none from the control sites (for both, P < .01). In all study participants, eosinophils were found in at least one current and/or recovery infusion site deep in the dermis near the interface with fat. The number of eosinophils ranged from 0 to 31 per high-power field, with a median of 4.

The number of eosinophils didn’t vary by type of insulin or brand of pump, but higher counts were seen in those who had used pumps for less than 10 years, compared with more than 20 years (P = .02).

The prevalence and degree of eosinophils were “the most surprising histologic finding,” the authors wrote, adding that “eosinophils are not typically present as a component of resident inflammatory cells in the skin.”

While eosinophils may be present in normal wound healing, “the absolute number and density of eosinophil in these samples support a delayed-type hypersensitivity response, which is typically observed between 2 and 7 days after exposure to an allergen. ... Eosinophils are often correlated with symptoms of itchiness and likely explain the high percentage of participants who reported itchiness in this study,” Dr. Kalus and colleagues wrote.
 

Correlation found between inflammation and glycemic control

All participants used the Dexcom G6 continuous glucose monitor as part of their usual care. Inflammation scores were positively correlated with insulin dose (P = .009) and were negatively correlated with time in range (P = .01).

No other OCT or biopsy findings differed by duration of pump use, previous use of animal insulin, or type of insulin.

The reason for these findings is unclear, Dr. Hirsch said. “How much was the catheter or the insulin causing the irritation around the sites? How much was it from the preservatives, or is this because of the insulin pump itself? All these questions need to be answered in future studies. ... The real goal of all of this is to minimize skin damage and improve the experience for our patients.”

The study was funded by the Leona M. and Harry B. Helmsley Charitable Trust. Dr. Hirsch reported grants and contracts from Insulet, Medtronic, and Dexcom outside the submitted work; consulting fees from Abbott Diabetes Care, Lifescan, and Hagar outside the submitted work; and honoraria for lectures, presentations, participation on speaker’s bureaus, manuscript writing, or educational events as section editor for UpToDate outside the submitted work. Dr. Kalus has no disclosures.

A version of this article first appeared on Medscape.com.

Skin reactions at insulin pump infusion sites are common among people with type 1 diabetes who use the devices and can lead to delivery failure, new research suggests.
 

Insulin pump use is increasingly common, but many patients experience infusion-site failure that in some cases leads to discontinuation. In a novel investigation, researchers at the University of Washington, Seattle, used biopsies and noninvasive imaging to compare insulin pump sites with control sites in 30 patients. Several differences were found at pump sites in comparison with control sites, including fibrosis, inflammation, eosinophils, and increased vessel density.

“These findings support allergic sensitization as a potentially common reaction at [insulin pump] sites. The leading candidates causing this include insulin preservatives, plastic materials, and adhesive glue used in device manufacturing,” wrote Andrea Kalus, MD, of the university’s dermatology division, and colleagues. The findings were published recently in Diabetes Care.

The inflammatory response, they wrote, “may result in tissue changes responsible for the infusion-site failures seen frequently in clinical practice.”

Such infusion site problems represent an “Achilles heel” of these otherwise highly beneficial devices, lead author Irl Hirsch, MD, professor of medicine in the division of metabolism, endocrinology, and nutrition, said in a statement. “It doesn’t really matter how good the technology is. We still don’t understand what is happening with the infusion sites, much less to [be able to] fix it.”
 

Significant differences between pump and nonpump sites

In the cross-sectional study, Dr. Kalus and colleagues used noninvasive optical coherence tomography (OCT) immediately prior to performing punch biopsies at three sites: the site currently in active use, the “recovery site” used 3-5 days prior to the procedures, and control sites never used for pump infusion. Punch biopsies were also performed at those sites.

The mean age of the patients was 48.3 years, the mean diabetes duration was 30.4 years, and the mean duration of pump use was 15.8 years. Nearly all patients (93.3%) reported itchiness at the site, and 76.7% reported skin redness.

Of the 25 patients for whom OCT imaging was successful, statistical analysis showed significant differences in vascular area density and the optical attenuation coefficient, a surrogate for skin inflammation, between the pump and control sites and between recovery sites and current pump sites. The greater vessel density is likely a result of injury and repair related to catheter insertion, the authors said.

In the biopsy samples, both current and recovery sites showed increased fibrosis, fibrin, inflammation, fat necrosis, vascularity, and eosinophils, compared with the control sites, but no significant differences were found between current and recovery sites.

Eosinophils: ‘The most surprising histologic finding’

Eosinophils were found in 73% of skin biopsy specimens from current sites and in 75% of specimens from recovery sites, compared with none from the control sites (for both, P < .01). In all study participants, eosinophils were found in at least one current and/or recovery infusion site deep in the dermis near the interface with fat. The number of eosinophils ranged from 0 to 31 per high-power field, with a median of 4.

The number of eosinophils didn’t vary by type of insulin or brand of pump, but higher counts were seen in those who had used pumps for less than 10 years, compared with more than 20 years (P = .02).

The prevalence and degree of eosinophils were “the most surprising histologic finding,” the authors wrote, adding that “eosinophils are not typically present as a component of resident inflammatory cells in the skin.”

While eosinophils may be present in normal wound healing, “the absolute number and density of eosinophil in these samples support a delayed-type hypersensitivity response, which is typically observed between 2 and 7 days after exposure to an allergen. ... Eosinophils are often correlated with symptoms of itchiness and likely explain the high percentage of participants who reported itchiness in this study,” Dr. Kalus and colleagues wrote.
 

Correlation found between inflammation and glycemic control

All participants used the Dexcom G6 continuous glucose monitor as part of their usual care. Inflammation scores were positively correlated with insulin dose (P = .009) and were negatively correlated with time in range (P = .01).

No other OCT or biopsy findings differed by duration of pump use, previous use of animal insulin, or type of insulin.

The reason for these findings is unclear, Dr. Hirsch said. “How much was the catheter or the insulin causing the irritation around the sites? How much was it from the preservatives, or is this because of the insulin pump itself? All these questions need to be answered in future studies. ... The real goal of all of this is to minimize skin damage and improve the experience for our patients.”

The study was funded by the Leona M. and Harry B. Helmsley Charitable Trust. Dr. Hirsch reported grants and contracts from Insulet, Medtronic, and Dexcom outside the submitted work; consulting fees from Abbott Diabetes Care, Lifescan, and Hagar outside the submitted work; and honoraria for lectures, presentations, participation on speaker’s bureaus, manuscript writing, or educational events as section editor for UpToDate outside the submitted work. Dr. Kalus has no disclosures.

A version of this article first appeared on Medscape.com.

Skin reactions at insulin pump infusion sites are common among people with type 1 diabetes who use the devices and can lead to delivery failure, new research suggests.
 

Insulin pump use is increasingly common, but many patients experience infusion-site failure that in some cases leads to discontinuation. In a novel investigation, researchers at the University of Washington, Seattle, used biopsies and noninvasive imaging to compare insulin pump sites with control sites in 30 patients. Several differences were found at pump sites in comparison with control sites, including fibrosis, inflammation, eosinophils, and increased vessel density.

“These findings support allergic sensitization as a potentially common reaction at [insulin pump] sites. The leading candidates causing this include insulin preservatives, plastic materials, and adhesive glue used in device manufacturing,” wrote Andrea Kalus, MD, of the university’s dermatology division, and colleagues. The findings were published recently in Diabetes Care.

The inflammatory response, they wrote, “may result in tissue changes responsible for the infusion-site failures seen frequently in clinical practice.”

Such infusion site problems represent an “Achilles heel” of these otherwise highly beneficial devices, lead author Irl Hirsch, MD, professor of medicine in the division of metabolism, endocrinology, and nutrition, said in a statement. “It doesn’t really matter how good the technology is. We still don’t understand what is happening with the infusion sites, much less to [be able to] fix it.”
 

Significant differences between pump and nonpump sites

In the cross-sectional study, Dr. Kalus and colleagues used noninvasive optical coherence tomography (OCT) immediately prior to performing punch biopsies at three sites: the site currently in active use, the “recovery site” used 3-5 days prior to the procedures, and control sites never used for pump infusion. Punch biopsies were also performed at those sites.

The mean age of the patients was 48.3 years, the mean diabetes duration was 30.4 years, and the mean duration of pump use was 15.8 years. Nearly all patients (93.3%) reported itchiness at the site, and 76.7% reported skin redness.

Of the 25 patients for whom OCT imaging was successful, statistical analysis showed significant differences in vascular area density and the optical attenuation coefficient, a surrogate for skin inflammation, between the pump and control sites and between recovery sites and current pump sites. The greater vessel density is likely a result of injury and repair related to catheter insertion, the authors said.

In the biopsy samples, both current and recovery sites showed increased fibrosis, fibrin, inflammation, fat necrosis, vascularity, and eosinophils, compared with the control sites, but no significant differences were found between current and recovery sites.

Eosinophils: ‘The most surprising histologic finding’

Eosinophils were found in 73% of skin biopsy specimens from current sites and in 75% of specimens from recovery sites, compared with none from the control sites (for both, P < .01). In all study participants, eosinophils were found in at least one current and/or recovery infusion site deep in the dermis near the interface with fat. The number of eosinophils ranged from 0 to 31 per high-power field, with a median of 4.

The number of eosinophils didn’t vary by type of insulin or brand of pump, but higher counts were seen in those who had used pumps for less than 10 years, compared with more than 20 years (P = .02).

The prevalence and degree of eosinophils were “the most surprising histologic finding,” the authors wrote, adding that “eosinophils are not typically present as a component of resident inflammatory cells in the skin.”

While eosinophils may be present in normal wound healing, “the absolute number and density of eosinophil in these samples support a delayed-type hypersensitivity response, which is typically observed between 2 and 7 days after exposure to an allergen. ... Eosinophils are often correlated with symptoms of itchiness and likely explain the high percentage of participants who reported itchiness in this study,” Dr. Kalus and colleagues wrote.
 

Correlation found between inflammation and glycemic control

All participants used the Dexcom G6 continuous glucose monitor as part of their usual care. Inflammation scores were positively correlated with insulin dose (P = .009) and were negatively correlated with time in range (P = .01).

No other OCT or biopsy findings differed by duration of pump use, previous use of animal insulin, or type of insulin.

The reason for these findings is unclear, Dr. Hirsch said. “How much was the catheter or the insulin causing the irritation around the sites? How much was it from the preservatives, or is this because of the insulin pump itself? All these questions need to be answered in future studies. ... The real goal of all of this is to minimize skin damage and improve the experience for our patients.”

The study was funded by the Leona M. and Harry B. Helmsley Charitable Trust. Dr. Hirsch reported grants and contracts from Insulet, Medtronic, and Dexcom outside the submitted work; consulting fees from Abbott Diabetes Care, Lifescan, and Hagar outside the submitted work; and honoraria for lectures, presentations, participation on speaker’s bureaus, manuscript writing, or educational events as section editor for UpToDate outside the submitted work. Dr. Kalus has no disclosures.

A version of this article first appeared on Medscape.com.

Nonalcohol substance use disorder (SUD) was 2.5 times more common in people who had gastric bypass surgery, compared with a control group who received usual obesity care, a new prospective study has found.

The findings suggest that the risk for nonalcohol SUD should be carefully explained to patients getting a gastric bypass and that the risk should be considered in care before and after the surgery, said the study authors and editorialists.

Though alcohol use disorder is a well-known side effect for some bariatric procedures, little is known about the link between the procedures and other substance abuse, wrote the study authors, led by Per-Arne Svensson, PhD, with the department of molecular and clinical medicine, Institute of Medicine, at the University of Gothenburg (Sweden).

The study was published online in Obesity.

The researchers analyzed data from the SOS study. It was originally designed to compare bariatric surgery with usual obesity care, with overall mortality as the primary outcome. The protocol also called for reporting negative effects of included treatments.

The study was conducted throughout Sweden at 25 public surgical departments and 480 primary health centers. Participants were between ages 37 and 60 years and had a body mass index of at least 34 kg/m² for men and 38 for women.

After people with previous nonalcoholic SUD were excluded, the study population included 1,990 patients who had undergone bariatric surgery between September 1987 and January 2001, as well as 2,030 matched controls who received usual obesity care. The three types of bariatric surgery were gastric bypass (264 patients), vertical banded gastroplasty (1,353), and gastric banding (373), as chosen by the surgeons.

The follow-up was nearly 24 years.
 

Link found only with gastric bypass

The researchers identified participants who had nonalcoholic SUDs using the ICD from the Swedish National Patient Register covering hospital treatment (hospital stays or hospital-based outpatient care) but not primary care.

Only gastric bypass was associated with an increased incidence of nonalcoholic SUD (adjusted hazard ratio, 2.54; 95% confidence interval, 1.14-5.65), compared with controls during the follow-up period.

Among those who had gastric bypass surgery, three developed opioid-related disorders; three had sedative-, hypnotic-, or anxiolytic-related disorders; and three had other psychoactive substance–related disorders, the study authors wrote.

The researchers found no statistical difference in the incidence of nonalcoholic SUD when the groups who had undergone different surgical procedures were compared with each other.

“It is important to acknowledge that the number of affected patients was relatively low, in the single digits,” Jihad Kudsi, MD, a bariatric surgeon and chairman of surgery at Duly Health and Care, Oak Brook, Ill., said in a press release.

The findings “highlight the critical role of bariatric behavioral health clinicians in the comprehensive evaluation and care of patients both before and after weight loss surgery,” added Dr. Kudsi, who was not associated with the research.
 

Bariatric surgery candidates should be warned, monitored

The data indicate that patients who are candidates for bariatric surgery should be “carefully warned” about risks for nonalcoholic SUD and be monitored after the procedure, wrote James E. Mitchell, MD, a psychiatrist with the department of psychiatry and behavioral science, University of North Dakota, Fargo, and Devika Umashanker, MD, with Obesity Medicine, Hartford (Conn.) Health Care, in an accompanying editorial.

They acknowledged, however, that monitoring can be difficult given the typical low rate of follow-up of these patients.

Though the reasons for the rise in nonalcoholic SUD are not clear, Dr. Mitchell and Dr. Umashanker said biologic and psychosocial issues may be contributors to the increase.

The persistence of medical comorbidities and a lack of noted improvement in quality of life or physical mobility after the surgery has been addressed in a paper on suicide risk after bariatric surgery, the study authors also noted.

Dr. Svensson said in an interview that a mechanism for alcohol abuse after gastric bypass surgery is more evident, as measured by “increased blood alcohol levels after the surgery for a given amount of alcohol.” However, for other addictive substances, the mechanism is not obvious and needs further study.

The editorialists reminded clinicians that measuring phosphatidylethanol can be very useful in identifying and quantifying recent alcohol intake, suggesting that all clinicians, not just those in bariatric surgery clinics, should be aware of the connection between the procedures and subsequent alcohol abuse and monitor those patients carefully.

Both the study authors and the editorialists pointed out that the SOS cohort was recruited when vertical banded gastroplasty and banding were commonly used, and both methods are now rarely, if ever, used. Gastric sleeve procedures are now the most common approach, and those patients were not included in the study.

“However, gastric bypass surgery patients were included, albeit in a minority of the sample,” Dr. Mitchell and Dr. Umashanker wrote. In addition, the sample size of patients with SUD was too small to determine the drugs that were being abused.

Dr. Svensson said in an interview the main limitation is that SUD events were identified in the Swedish National Patient Register, which misses nonhospitalized patients.

“This register is very complete for hospitals, but it does not include SUD events detected in the primary health care setting,” he said. “Hence, the absolute number of events is probably a clear underestimation. However, it is unlikely that this limitation would affect the study groups (control group vs. groups with different surgical procedures) in different ways and hence the conclusions from this study are most likely valid.”

The study authors and the editorialists reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Nonalcohol substance use disorder (SUD) was 2.5 times more common in people who had gastric bypass surgery, compared with a control group who received usual obesity care, a new prospective study has found.

The findings suggest that the risk for nonalcohol SUD should be carefully explained to patients getting a gastric bypass and that the risk should be considered in care before and after the surgery, said the study authors and editorialists.

Though alcohol use disorder is a well-known side effect for some bariatric procedures, little is known about the link between the procedures and other substance abuse, wrote the study authors, led by Per-Arne Svensson, PhD, with the department of molecular and clinical medicine, Institute of Medicine, at the University of Gothenburg (Sweden).

The study was published online in Obesity.

The researchers analyzed data from the SOS study. It was originally designed to compare bariatric surgery with usual obesity care, with overall mortality as the primary outcome. The protocol also called for reporting negative effects of included treatments.

The study was conducted throughout Sweden at 25 public surgical departments and 480 primary health centers. Participants were between ages 37 and 60 years and had a body mass index of at least 34 kg/m² for men and 38 for women.

After people with previous nonalcoholic SUD were excluded, the study population included 1,990 patients who had undergone bariatric surgery between September 1987 and January 2001, as well as 2,030 matched controls who received usual obesity care. The three types of bariatric surgery were gastric bypass (264 patients), vertical banded gastroplasty (1,353), and gastric banding (373), as chosen by the surgeons.

The follow-up was nearly 24 years.
 

Link found only with gastric bypass

The researchers identified participants who had nonalcoholic SUDs using the ICD from the Swedish National Patient Register covering hospital treatment (hospital stays or hospital-based outpatient care) but not primary care.

Only gastric bypass was associated with an increased incidence of nonalcoholic SUD (adjusted hazard ratio, 2.54; 95% confidence interval, 1.14-5.65), compared with controls during the follow-up period.

Among those who had gastric bypass surgery, three developed opioid-related disorders; three had sedative-, hypnotic-, or anxiolytic-related disorders; and three had other psychoactive substance–related disorders, the study authors wrote.

The researchers found no statistical difference in the incidence of nonalcoholic SUD when the groups who had undergone different surgical procedures were compared with each other.

“It is important to acknowledge that the number of affected patients was relatively low, in the single digits,” Jihad Kudsi, MD, a bariatric surgeon and chairman of surgery at Duly Health and Care, Oak Brook, Ill., said in a press release.

The findings “highlight the critical role of bariatric behavioral health clinicians in the comprehensive evaluation and care of patients both before and after weight loss surgery,” added Dr. Kudsi, who was not associated with the research.
 

Bariatric surgery candidates should be warned, monitored

The data indicate that patients who are candidates for bariatric surgery should be “carefully warned” about risks for nonalcoholic SUD and be monitored after the procedure, wrote James E. Mitchell, MD, a psychiatrist with the department of psychiatry and behavioral science, University of North Dakota, Fargo, and Devika Umashanker, MD, with Obesity Medicine, Hartford (Conn.) Health Care, in an accompanying editorial.

They acknowledged, however, that monitoring can be difficult given the typical low rate of follow-up of these patients.

Though the reasons for the rise in nonalcoholic SUD are not clear, Dr. Mitchell and Dr. Umashanker said biologic and psychosocial issues may be contributors to the increase.

The persistence of medical comorbidities and a lack of noted improvement in quality of life or physical mobility after the surgery has been addressed in a paper on suicide risk after bariatric surgery, the study authors also noted.

Dr. Svensson said in an interview that a mechanism for alcohol abuse after gastric bypass surgery is more evident, as measured by “increased blood alcohol levels after the surgery for a given amount of alcohol.” However, for other addictive substances, the mechanism is not obvious and needs further study.

The editorialists reminded clinicians that measuring phosphatidylethanol can be very useful in identifying and quantifying recent alcohol intake, suggesting that all clinicians, not just those in bariatric surgery clinics, should be aware of the connection between the procedures and subsequent alcohol abuse and monitor those patients carefully.

Both the study authors and the editorialists pointed out that the SOS cohort was recruited when vertical banded gastroplasty and banding were commonly used, and both methods are now rarely, if ever, used. Gastric sleeve procedures are now the most common approach, and those patients were not included in the study.

“However, gastric bypass surgery patients were included, albeit in a minority of the sample,” Dr. Mitchell and Dr. Umashanker wrote. In addition, the sample size of patients with SUD was too small to determine the drugs that were being abused.

Dr. Svensson said in an interview the main limitation is that SUD events were identified in the Swedish National Patient Register, which misses nonhospitalized patients.

“This register is very complete for hospitals, but it does not include SUD events detected in the primary health care setting,” he said. “Hence, the absolute number of events is probably a clear underestimation. However, it is unlikely that this limitation would affect the study groups (control group vs. groups with different surgical procedures) in different ways and hence the conclusions from this study are most likely valid.”

The study authors and the editorialists reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Nonalcohol substance use disorder (SUD) was 2.5 times more common in people who had gastric bypass surgery, compared with a control group who received usual obesity care, a new prospective study has found.

The findings suggest that the risk for nonalcohol SUD should be carefully explained to patients getting a gastric bypass and that the risk should be considered in care before and after the surgery, said the study authors and editorialists.

Though alcohol use disorder is a well-known side effect for some bariatric procedures, little is known about the link between the procedures and other substance abuse, wrote the study authors, led by Per-Arne Svensson, PhD, with the department of molecular and clinical medicine, Institute of Medicine, at the University of Gothenburg (Sweden).

The study was published online in Obesity.

The researchers analyzed data from the SOS study. It was originally designed to compare bariatric surgery with usual obesity care, with overall mortality as the primary outcome. The protocol also called for reporting negative effects of included treatments.

The study was conducted throughout Sweden at 25 public surgical departments and 480 primary health centers. Participants were between ages 37 and 60 years and had a body mass index of at least 34 kg/m² for men and 38 for women.

After people with previous nonalcoholic SUD were excluded, the study population included 1,990 patients who had undergone bariatric surgery between September 1987 and January 2001, as well as 2,030 matched controls who received usual obesity care. The three types of bariatric surgery were gastric bypass (264 patients), vertical banded gastroplasty (1,353), and gastric banding (373), as chosen by the surgeons.

The follow-up was nearly 24 years.
 

Link found only with gastric bypass

The researchers identified participants who had nonalcoholic SUDs using the ICD from the Swedish National Patient Register covering hospital treatment (hospital stays or hospital-based outpatient care) but not primary care.

Only gastric bypass was associated with an increased incidence of nonalcoholic SUD (adjusted hazard ratio, 2.54; 95% confidence interval, 1.14-5.65), compared with controls during the follow-up period.

Among those who had gastric bypass surgery, three developed opioid-related disorders; three had sedative-, hypnotic-, or anxiolytic-related disorders; and three had other psychoactive substance–related disorders, the study authors wrote.

The researchers found no statistical difference in the incidence of nonalcoholic SUD when the groups who had undergone different surgical procedures were compared with each other.

“It is important to acknowledge that the number of affected patients was relatively low, in the single digits,” Jihad Kudsi, MD, a bariatric surgeon and chairman of surgery at Duly Health and Care, Oak Brook, Ill., said in a press release.

The findings “highlight the critical role of bariatric behavioral health clinicians in the comprehensive evaluation and care of patients both before and after weight loss surgery,” added Dr. Kudsi, who was not associated with the research.
 

Bariatric surgery candidates should be warned, monitored

The data indicate that patients who are candidates for bariatric surgery should be “carefully warned” about risks for nonalcoholic SUD and be monitored after the procedure, wrote James E. Mitchell, MD, a psychiatrist with the department of psychiatry and behavioral science, University of North Dakota, Fargo, and Devika Umashanker, MD, with Obesity Medicine, Hartford (Conn.) Health Care, in an accompanying editorial.

They acknowledged, however, that monitoring can be difficult given the typical low rate of follow-up of these patients.

Though the reasons for the rise in nonalcoholic SUD are not clear, Dr. Mitchell and Dr. Umashanker said biologic and psychosocial issues may be contributors to the increase.

The persistence of medical comorbidities and a lack of noted improvement in quality of life or physical mobility after the surgery has been addressed in a paper on suicide risk after bariatric surgery, the study authors also noted.

Dr. Svensson said in an interview that a mechanism for alcohol abuse after gastric bypass surgery is more evident, as measured by “increased blood alcohol levels after the surgery for a given amount of alcohol.” However, for other addictive substances, the mechanism is not obvious and needs further study.

The editorialists reminded clinicians that measuring phosphatidylethanol can be very useful in identifying and quantifying recent alcohol intake, suggesting that all clinicians, not just those in bariatric surgery clinics, should be aware of the connection between the procedures and subsequent alcohol abuse and monitor those patients carefully.

Both the study authors and the editorialists pointed out that the SOS cohort was recruited when vertical banded gastroplasty and banding were commonly used, and both methods are now rarely, if ever, used. Gastric sleeve procedures are now the most common approach, and those patients were not included in the study.

“However, gastric bypass surgery patients were included, albeit in a minority of the sample,” Dr. Mitchell and Dr. Umashanker wrote. In addition, the sample size of patients with SUD was too small to determine the drugs that were being abused.

Dr. Svensson said in an interview the main limitation is that SUD events were identified in the Swedish National Patient Register, which misses nonhospitalized patients.

“This register is very complete for hospitals, but it does not include SUD events detected in the primary health care setting,” he said. “Hence, the absolute number of events is probably a clear underestimation. However, it is unlikely that this limitation would affect the study groups (control group vs. groups with different surgical procedures) in different ways and hence the conclusions from this study are most likely valid.”

The study authors and the editorialists reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Female sex, hyperlipidemia, Medicaid insurance, earlier year of biologic initiation, shorter duration of psoriasis, and prior nonbiologic systemic therapy use were associated with multiple biologic failure in patients with psoriasis, results from a prospective cohort demonstrated.

“Prior cross-sectional and single-center studies have primarily analyzed therapeutic failure of a single biologic or biologics within one class,” researchers led by Wilson Liao, MD, professor and vice chair of research in the department of dermatology at the University of California, San Francisco, wrote in the study, published in the Journal of the American Academy of Dermatology. “However, failure of multiple biologics targeting different signaling pathways is common over the course of treatment. These ‘multiple biologic failure’ patients are not well-characterized, and the patterns of biologics attempted and sociodemographic or clinical features that may predict difficult treatment are incompletely studied.”

To bridge this gap, the researchers conducted a prospective cohort study from the CorEvitas Psoriasis Registry, which collected data from dermatologist-diagnosed patients with psoriasis who started or switched to a Food and Drug Administration (FDA)–approved systemic therapy for psoriasis during routine dermatology visits from April 15, 2015, to May 10, 2022. This period included data from 17,196 patients across 259 private and 209 academic sites from 580 physicians in the United States and Canada.

From this registry, Dr. Liao and colleagues identified 1,039 patients with 24 months or more of follow-up data, a confirmed index biologic start date, and valid baseline assessment data, and categorized them into three cohorts:

• 490 (47.2%) with good response (GR), defined as patients with 24 months or more of continued index biologic use by the last registry visit.
• 65 (6.3%) with multiple biologic failure (MBF), defined as patients administered two or more biologic agents of different mechanistic classes who discontinued these biologics because of physician-reported “inadequate initial response,” “failure to maintain initial response,” or “active disease” despite 90 or more days of use per biologic.
• 484 (46.6%) categorized as “other,” defined as patients failed by one biologic or who discontinued treatment for nonmedical reasons.

The researchers used multivariable logistic regression to identify sociodemographic, clinical, and patient-reported outcomes that differed between the MBF and GR groups. The mean age of the patients in the study was 49.1 years, 44.2% were female, 77.9% were White, 9.7% were Hispanic, and the mean duration of psoriasis was 11.5 years.

On multivariable logistic regression, factors associated with MBF, compared with those with GR, included female at birth (odds ratio [OR] = 2.29; confidence interval [CI], 1.11-4.72), history of hyperlipidemia (OR = 3.14; CI, 1.35-7.30), Medicaid insurance (OR = 4.53; CI, 1.40-14.60), prior nonbiologic systemic therapy (OR = 2.47; CI, 1.16-5.25), higher psoriasis duration (OR = 0.60 per standard deviation [SD]; CI, 0.38-0.94), and later index biologic initiation (OR = 0.37 per year; CI, 0.27-0.52). Sensitivity analysis revealed that the duration of prior nonbiologic systemic therapy use was not associated with MBF (OR = 0.99; CI, 0.94-1.02; P = 0.56).

“Interestingly, health-related behaviors (e.g., smoking, alcohol use) and location/extent of psoriasis were not important differentiators between MBF and GR,” the authors noted. “We might suspect these features to correlate with MBF, as numerous observational studies found associations between health-related behaviors or psoriasis severity and presence at difficult-to-treat locations, which often relates to biologic use.”

They acknowledged certain limitations of their study, including underrepresentation of ethnoracial minorities and male sex at birth relative to reported psoriasis epidemiology, “possibly reflecting participation bias and reduced access to specialty care, given that patients were enrolled into the registry by dermatologists,” they wrote. “Patient adherence to prescribed biologic regimens between registry visits was not evaluated.”

Raj Chovatiya, MD, PhD, assistant professor of dermatology at Northwestern University, Chicago, who was asked to comment on the study, said that despite the rapid expansion in biologic therapies for psoriasis, “analysis of real-world use patterns and patient characteristics has been limited – particularly for those who have failed multiple treatments. These findings suggest that there indeed may be some key differences between patients who have had to cycle through multiple biologics versus those who have had a sustained satisfactory response on a single therapy, such as disease duration and previous nonbiologic treatments.”

Dr. Chovatiya

Female sex, hyperlipidemia, Medicaid insurance, earlier year of biologic initiation, shorter duration of psoriasis, and prior nonbiologic systemic therapy use were associated with multiple biologic failure in patients with psoriasis, results from a prospective cohort demonstrated.

“Prior cross-sectional and single-center studies have primarily analyzed therapeutic failure of a single biologic or biologics within one class,” researchers led by Wilson Liao, MD, professor and vice chair of research in the department of dermatology at the University of California, San Francisco, wrote in the study, published in the Journal of the American Academy of Dermatology. “However, failure of multiple biologics targeting different signaling pathways is common over the course of treatment. These ‘multiple biologic failure’ patients are not well-characterized, and the patterns of biologics attempted and sociodemographic or clinical features that may predict difficult treatment are incompletely studied.”

To bridge this gap, the researchers conducted a prospective cohort study from the CorEvitas Psoriasis Registry, which collected data from dermatologist-diagnosed patients with psoriasis who started or switched to a Food and Drug Administration (FDA)–approved systemic therapy for psoriasis during routine dermatology visits from April 15, 2015, to May 10, 2022. This period included data from 17,196 patients across 259 private and 209 academic sites from 580 physicians in the United States and Canada.

From this registry, Dr. Liao and colleagues identified 1,039 patients with 24 months or more of follow-up data, a confirmed index biologic start date, and valid baseline assessment data, and categorized them into three cohorts:

• 490 (47.2%) with good response (GR), defined as patients with 24 months or more of continued index biologic use by the last registry visit.
• 65 (6.3%) with multiple biologic failure (MBF), defined as patients administered two or more biologic agents of different mechanistic classes who discontinued these biologics because of physician-reported “inadequate initial response,” “failure to maintain initial response,” or “active disease” despite 90 or more days of use per biologic.
• 484 (46.6%) categorized as “other,” defined as patients failed by one biologic or who discontinued treatment for nonmedical reasons.

The researchers used multivariable logistic regression to identify sociodemographic, clinical, and patient-reported outcomes that differed between the MBF and GR groups. The mean age of the patients in the study was 49.1 years, 44.2% were female, 77.9% were White, 9.7% were Hispanic, and the mean duration of psoriasis was 11.5 years.

On multivariable logistic regression, factors associated with MBF, compared with those with GR, included female at birth (odds ratio [OR] = 2.29; confidence interval [CI], 1.11-4.72), history of hyperlipidemia (OR = 3.14; CI, 1.35-7.30), Medicaid insurance (OR = 4.53; CI, 1.40-14.60), prior nonbiologic systemic therapy (OR = 2.47; CI, 1.16-5.25), higher psoriasis duration (OR = 0.60 per standard deviation [SD]; CI, 0.38-0.94), and later index biologic initiation (OR = 0.37 per year; CI, 0.27-0.52). Sensitivity analysis revealed that the duration of prior nonbiologic systemic therapy use was not associated with MBF (OR = 0.99; CI, 0.94-1.02; P = 0.56).

“Interestingly, health-related behaviors (e.g., smoking, alcohol use) and location/extent of psoriasis were not important differentiators between MBF and GR,” the authors noted. “We might suspect these features to correlate with MBF, as numerous observational studies found associations between health-related behaviors or psoriasis severity and presence at difficult-to-treat locations, which often relates to biologic use.”

They acknowledged certain limitations of their study, including underrepresentation of ethnoracial minorities and male sex at birth relative to reported psoriasis epidemiology, “possibly reflecting participation bias and reduced access to specialty care, given that patients were enrolled into the registry by dermatologists,” they wrote. “Patient adherence to prescribed biologic regimens between registry visits was not evaluated.”

Raj Chovatiya, MD, PhD, assistant professor of dermatology at Northwestern University, Chicago, who was asked to comment on the study, said that despite the rapid expansion in biologic therapies for psoriasis, “analysis of real-world use patterns and patient characteristics has been limited – particularly for those who have failed multiple treatments. These findings suggest that there indeed may be some key differences between patients who have had to cycle through multiple biologics versus those who have had a sustained satisfactory response on a single therapy, such as disease duration and previous nonbiologic treatments.”

Dr. Chovatiya

Female sex, hyperlipidemia, Medicaid insurance, earlier year of biologic initiation, shorter duration of psoriasis, and prior nonbiologic systemic therapy use were associated with multiple biologic failure in patients with psoriasis, results from a prospective cohort demonstrated.

“Prior cross-sectional and single-center studies have primarily analyzed therapeutic failure of a single biologic or biologics within one class,” researchers led by Wilson Liao, MD, professor and vice chair of research in the department of dermatology at the University of California, San Francisco, wrote in the study, published in the Journal of the American Academy of Dermatology. “However, failure of multiple biologics targeting different signaling pathways is common over the course of treatment. These ‘multiple biologic failure’ patients are not well-characterized, and the patterns of biologics attempted and sociodemographic or clinical features that may predict difficult treatment are incompletely studied.”

To bridge this gap, the researchers conducted a prospective cohort study from the CorEvitas Psoriasis Registry, which collected data from dermatologist-diagnosed patients with psoriasis who started or switched to a Food and Drug Administration (FDA)–approved systemic therapy for psoriasis during routine dermatology visits from April 15, 2015, to May 10, 2022. This period included data from 17,196 patients across 259 private and 209 academic sites from 580 physicians in the United States and Canada.

From this registry, Dr. Liao and colleagues identified 1,039 patients with 24 months or more of follow-up data, a confirmed index biologic start date, and valid baseline assessment data, and categorized them into three cohorts:

• 490 (47.2%) with good response (GR), defined as patients with 24 months or more of continued index biologic use by the last registry visit.
• 65 (6.3%) with multiple biologic failure (MBF), defined as patients administered two or more biologic agents of different mechanistic classes who discontinued these biologics because of physician-reported “inadequate initial response,” “failure to maintain initial response,” or “active disease” despite 90 or more days of use per biologic.
• 484 (46.6%) categorized as “other,” defined as patients failed by one biologic or who discontinued treatment for nonmedical reasons.

The researchers used multivariable logistic regression to identify sociodemographic, clinical, and patient-reported outcomes that differed between the MBF and GR groups. The mean age of the patients in the study was 49.1 years, 44.2% were female, 77.9% were White, 9.7% were Hispanic, and the mean duration of psoriasis was 11.5 years.

On multivariable logistic regression, factors associated with MBF, compared with those with GR, included female at birth (odds ratio [OR] = 2.29; confidence interval [CI], 1.11-4.72), history of hyperlipidemia (OR = 3.14; CI, 1.35-7.30), Medicaid insurance (OR = 4.53; CI, 1.40-14.60), prior nonbiologic systemic therapy (OR = 2.47; CI, 1.16-5.25), higher psoriasis duration (OR = 0.60 per standard deviation [SD]; CI, 0.38-0.94), and later index biologic initiation (OR = 0.37 per year; CI, 0.27-0.52). Sensitivity analysis revealed that the duration of prior nonbiologic systemic therapy use was not associated with MBF (OR = 0.99; CI, 0.94-1.02; P = 0.56).

“Interestingly, health-related behaviors (e.g., smoking, alcohol use) and location/extent of psoriasis were not important differentiators between MBF and GR,” the authors noted. “We might suspect these features to correlate with MBF, as numerous observational studies found associations between health-related behaviors or psoriasis severity and presence at difficult-to-treat locations, which often relates to biologic use.”

They acknowledged certain limitations of their study, including underrepresentation of ethnoracial minorities and male sex at birth relative to reported psoriasis epidemiology, “possibly reflecting participation bias and reduced access to specialty care, given that patients were enrolled into the registry by dermatologists,” they wrote. “Patient adherence to prescribed biologic regimens between registry visits was not evaluated.”

Raj Chovatiya, MD, PhD, assistant professor of dermatology at Northwestern University, Chicago, who was asked to comment on the study, said that despite the rapid expansion in biologic therapies for psoriasis, “analysis of real-world use patterns and patient characteristics has been limited – particularly for those who have failed multiple treatments. These findings suggest that there indeed may be some key differences between patients who have had to cycle through multiple biologics versus those who have had a sustained satisfactory response on a single therapy, such as disease duration and previous nonbiologic treatments.”

Dr. Chovatiya

Drinking just one alcoholic beverage a day is enough to raise blood pressure (BP) in healthy adults, results of a “dose-response” meta-analysis suggest.

“A vexing question has been whether usual intake of small amounts of alcohol is associated with a higher level of BP. We identified a continuous, more or less linear association, with no evidence of a threshold for the association,” study coauthor Paul Whelton, MD, of Tulane University School of Public Health and Tropical Medicine, New Orleans, said in an interview.

copyright Fuse/Thinkstock

For systolic BP (SBP), “the most important BP risk indicator for CVD [cardiovascular disease], the association was robust, being present in both men and women and in both North America as well as Asia,” Dr. Whelton noted.

Based on the results, “the lower the better, and no consumption even better, as we did not find any indication that human health may benefit from consumption of very small amounts of alcohol,” senior author Marco Vinceti, MD, PhD, of University of Modena and Reggio Emilia University in Italy, told this news organization.

“Clearly, alcohol is not the only or necessarily the main determinant of high blood pressure, and the effects of small intakes of alcohol emerging from our pooled analysis were certainly not biologically as relevant and meaningful as those induced by high intakes,” Dr. Vinceti added.

The study was published online in Hypertension.

The researchers analyzed data from seven large, observational studies conducted in the United States, Korea, and Japan involving 19,548 adults (65% men).

Participants ranged in age from 20 years to the early 70s at baseline and were followed for a median of 5.3 years (range, 4-12 years). None of the participants had previously been diagnosed with hypertension or other CVD, diabetes, liver disease, alcoholism, or binge drinking.

Compared with nondrinkers, SBP was 1.25 mm Hg higher in adults who consumed an average of 12 grams of alcohol per day, rising to 4.90 mm Hg in adults consuming an average of 48 grams of alcohol per day.

For reference, in the United States, 12 ounces of regular beer, 5 ounces of wine, or a 1.5-ounce shot of distilled spirits contains about 14 grams of alcohol.

Diastolic BP (DBP) was 1.14 mm Hg higher in adults who consumed an average of 12 grams of alcohol per day, rising to 3.10 mm Hg in those who consumed an average of 48 grams of alcohol per day.

Subgroup analyses by gender showed an almost linear association between baseline alcohol intake and SBP changes in men and women and for DBP in men, while in women, there was an inverted U-shaped association.
 

No safe level

“From a BP perspective, it’s best to avoid alcohol intake. This is what the WHO [World Health Organization] recommends,” Dr. Whelton said.

“If someone is already drinking alcohol and does not want to stop doing so, minimizing alcohol consumption is desirable; many guidelines recommend not starting to drink alcohol but in those already drinking alcohol, consumption of two or less standard drinks per day for men and one or less standard drinks of alcohol per day for women,” Dr. Whelton noted.

Commenting on the study for this article, Alberto Ascherio, MD, of Harvard T. H. Chan School of Public Health, Boston, said it’s been known for more than 30 years that alcohol intake is associated with increased systolic and diastolic BP. The added value of this new study is a “refinement of the estimate of the dose response.”

Dr. Ascherio noted that “moderate alcohol consumption is associated with a modest increase in risk of cancer, but, in spite of the adverse association with BP, with a potentially beneficial effect on cardiovascular disease.” However, “the causality of the latter association has been questioned, but there is no consensus on this.”

Also weighing in, Timothy Brennan, MD, MPH, chief of clinical services for the Addiction Institute of Mount Sinai Health System in New York City, said this new study represents “yet another piece of evidence suggesting that there simply is no ‘healthy’ amount of alcohol use in humans.

“Even small amounts of alcohol intake can have negative health effects, as demonstrated in this study,” Dr. Brennan said. “There is still a widely held belief among people that drinking in moderation is good for you. It is becoming more and more clear that this is simply not the case. As health authorities grapple with drinking ‘recommendations,’ additional datasets like these will be helpful.”

The study had no specific funding. Dr. Whelton, Dr. Vinceti, Dr. Ascherio, and Dr. Brennan have no relevant disclosures.

A version of this article first appeared on Medscape.com.

Drinking just one alcoholic beverage a day is enough to raise blood pressure (BP) in healthy adults, results of a “dose-response” meta-analysis suggest.

“A vexing question has been whether usual intake of small amounts of alcohol is associated with a higher level of BP. We identified a continuous, more or less linear association, with no evidence of a threshold for the association,” study coauthor Paul Whelton, MD, of Tulane University School of Public Health and Tropical Medicine, New Orleans, said in an interview.

copyright Fuse/Thinkstock

For systolic BP (SBP), “the most important BP risk indicator for CVD [cardiovascular disease], the association was robust, being present in both men and women and in both North America as well as Asia,” Dr. Whelton noted.

Based on the results, “the lower the better, and no consumption even better, as we did not find any indication that human health may benefit from consumption of very small amounts of alcohol,” senior author Marco Vinceti, MD, PhD, of University of Modena and Reggio Emilia University in Italy, told this news organization.

“Clearly, alcohol is not the only or necessarily the main determinant of high blood pressure, and the effects of small intakes of alcohol emerging from our pooled analysis were certainly not biologically as relevant and meaningful as those induced by high intakes,” Dr. Vinceti added.

The study was published online in Hypertension.

The researchers analyzed data from seven large, observational studies conducted in the United States, Korea, and Japan involving 19,548 adults (65% men).

Participants ranged in age from 20 years to the early 70s at baseline and were followed for a median of 5.3 years (range, 4-12 years). None of the participants had previously been diagnosed with hypertension or other CVD, diabetes, liver disease, alcoholism, or binge drinking.

Compared with nondrinkers, SBP was 1.25 mm Hg higher in adults who consumed an average of 12 grams of alcohol per day, rising to 4.90 mm Hg in adults consuming an average of 48 grams of alcohol per day.

For reference, in the United States, 12 ounces of regular beer, 5 ounces of wine, or a 1.5-ounce shot of distilled spirits contains about 14 grams of alcohol.

Diastolic BP (DBP) was 1.14 mm Hg higher in adults who consumed an average of 12 grams of alcohol per day, rising to 3.10 mm Hg in those who consumed an average of 48 grams of alcohol per day.

Subgroup analyses by gender showed an almost linear association between baseline alcohol intake and SBP changes in men and women and for DBP in men, while in women, there was an inverted U-shaped association.
 

No safe level

“From a BP perspective, it’s best to avoid alcohol intake. This is what the WHO [World Health Organization] recommends,” Dr. Whelton said.

“If someone is already drinking alcohol and does not want to stop doing so, minimizing alcohol consumption is desirable; many guidelines recommend not starting to drink alcohol but in those already drinking alcohol, consumption of two or less standard drinks per day for men and one or less standard drinks of alcohol per day for women,” Dr. Whelton noted.

Commenting on the study for this article, Alberto Ascherio, MD, of Harvard T. H. Chan School of Public Health, Boston, said it’s been known for more than 30 years that alcohol intake is associated with increased systolic and diastolic BP. The added value of this new study is a “refinement of the estimate of the dose response.”

Dr. Ascherio noted that “moderate alcohol consumption is associated with a modest increase in risk of cancer, but, in spite of the adverse association with BP, with a potentially beneficial effect on cardiovascular disease.” However, “the causality of the latter association has been questioned, but there is no consensus on this.”

Also weighing in, Timothy Brennan, MD, MPH, chief of clinical services for the Addiction Institute of Mount Sinai Health System in New York City, said this new study represents “yet another piece of evidence suggesting that there simply is no ‘healthy’ amount of alcohol use in humans.

“Even small amounts of alcohol intake can have negative health effects, as demonstrated in this study,” Dr. Brennan said. “There is still a widely held belief among people that drinking in moderation is good for you. It is becoming more and more clear that this is simply not the case. As health authorities grapple with drinking ‘recommendations,’ additional datasets like these will be helpful.”

The study had no specific funding. Dr. Whelton, Dr. Vinceti, Dr. Ascherio, and Dr. Brennan have no relevant disclosures.

A version of this article first appeared on Medscape.com.

Drinking just one alcoholic beverage a day is enough to raise blood pressure (BP) in healthy adults, results of a “dose-response” meta-analysis suggest.

“A vexing question has been whether usual intake of small amounts of alcohol is associated with a higher level of BP. We identified a continuous, more or less linear association, with no evidence of a threshold for the association,” study coauthor Paul Whelton, MD, of Tulane University School of Public Health and Tropical Medicine, New Orleans, said in an interview.

copyright Fuse/Thinkstock

For systolic BP (SBP), “the most important BP risk indicator for CVD [cardiovascular disease], the association was robust, being present in both men and women and in both North America as well as Asia,” Dr. Whelton noted.

Based on the results, “the lower the better, and no consumption even better, as we did not find any indication that human health may benefit from consumption of very small amounts of alcohol,” senior author Marco Vinceti, MD, PhD, of University of Modena and Reggio Emilia University in Italy, told this news organization.

“Clearly, alcohol is not the only or necessarily the main determinant of high blood pressure, and the effects of small intakes of alcohol emerging from our pooled analysis were certainly not biologically as relevant and meaningful as those induced by high intakes,” Dr. Vinceti added.

The study was published online in Hypertension.

The researchers analyzed data from seven large, observational studies conducted in the United States, Korea, and Japan involving 19,548 adults (65% men).

Participants ranged in age from 20 years to the early 70s at baseline and were followed for a median of 5.3 years (range, 4-12 years). None of the participants had previously been diagnosed with hypertension or other CVD, diabetes, liver disease, alcoholism, or binge drinking.

Compared with nondrinkers, SBP was 1.25 mm Hg higher in adults who consumed an average of 12 grams of alcohol per day, rising to 4.90 mm Hg in adults consuming an average of 48 grams of alcohol per day.

For reference, in the United States, 12 ounces of regular beer, 5 ounces of wine, or a 1.5-ounce shot of distilled spirits contains about 14 grams of alcohol.

Diastolic BP (DBP) was 1.14 mm Hg higher in adults who consumed an average of 12 grams of alcohol per day, rising to 3.10 mm Hg in those who consumed an average of 48 grams of alcohol per day.

Subgroup analyses by gender showed an almost linear association between baseline alcohol intake and SBP changes in men and women and for DBP in men, while in women, there was an inverted U-shaped association.
 

No safe level

“From a BP perspective, it’s best to avoid alcohol intake. This is what the WHO [World Health Organization] recommends,” Dr. Whelton said.

“If someone is already drinking alcohol and does not want to stop doing so, minimizing alcohol consumption is desirable; many guidelines recommend not starting to drink alcohol but in those already drinking alcohol, consumption of two or less standard drinks per day for men and one or less standard drinks of alcohol per day for women,” Dr. Whelton noted.

Commenting on the study for this article, Alberto Ascherio, MD, of Harvard T. H. Chan School of Public Health, Boston, said it’s been known for more than 30 years that alcohol intake is associated with increased systolic and diastolic BP. The added value of this new study is a “refinement of the estimate of the dose response.”

Dr. Ascherio noted that “moderate alcohol consumption is associated with a modest increase in risk of cancer, but, in spite of the adverse association with BP, with a potentially beneficial effect on cardiovascular disease.” However, “the causality of the latter association has been questioned, but there is no consensus on this.”

Also weighing in, Timothy Brennan, MD, MPH, chief of clinical services for the Addiction Institute of Mount Sinai Health System in New York City, said this new study represents “yet another piece of evidence suggesting that there simply is no ‘healthy’ amount of alcohol use in humans.

“Even small amounts of alcohol intake can have negative health effects, as demonstrated in this study,” Dr. Brennan said. “There is still a widely held belief among people that drinking in moderation is good for you. It is becoming more and more clear that this is simply not the case. As health authorities grapple with drinking ‘recommendations,’ additional datasets like these will be helpful.”

The study had no specific funding. Dr. Whelton, Dr. Vinceti, Dr. Ascherio, and Dr. Brennan have no relevant disclosures.

A version of this article first appeared on Medscape.com.

The combination of heat waves and poor air quality is associated with double the risk of fatal myocardial infarction (MI), with women and older adults at greatest risk, a study from China suggests.

rottadana/Thinkstock

The researchers estimate that up to 3% of all deaths due to MI could be attributed to the combination of extreme temperatures and high levels of ambient fine particulate matter (PM2.5).

“Our findings provide evidence that reducing exposure to both extreme temperatures and fine particulate pollution may be useful to prevent premature deaths from heart attack,” senior author Yuewei Liu, MD, PhD, with Sun Yat-sen University in Guangzhou, China, said in a statement.

There is “long-standing evidence” of the harmful cardiovascular effects of air pollution, Jonathan Newman, MD, MPH, cardiologist at NYU Langone Heart in New York, who wasn’t involved in the study, said in an interview.

The added value of this study was finding an interaction between extreme hot temperatures and air pollution, “which is worrisome with global warming,” said Dr. Newman, assistant professor, department of medicine, the Leon H. Charney Division of Cardiology at NYU Langone Health.

The study was published online in Circulation.
 

Intensity and duration matter

The researchers analyzed data on 202,678 adults (mean age, 77.6 years; 52% male) who suffered fatal MI between 2015 and 2020 in Jiangsu province, a region with four distinct seasons and a wide range of temperatures and ambient PM2.5.

They evaluated the association of exposure to extreme temperature events, including both hot and cold spells, and PM2.5 with MI mortality, and their interactive effects.

Among the key findings:

• The risk of fatal MI was 18% higher during 2-day heat waves with heat indexes at or above the 90th percentile (ranging from 82.6° to 97.9° F) and 74% higher during 4-day heat waves with heat indexes at or above the 97.5th percentile (ranging from 94.8° to 109.4° F), compared with control days.
• The risk of fatal MI was 4% higher during 2-day cold snaps with temperatures at or below the 10th percentile (ranging from 33.3° to 40.5° F) and 12% higher during 3-day cold snaps with temperatures at or below the 2.5th percentile (ranging from 27.0° to 37.2° F).
• The risk of fatal MI was twice as high during 4-day heat waves that had PM2.5 above 37.5 mcg/m³. Days with high levels of PM2.5 during cold snaps did not have an equivalent increase in the risk of fatal MI.
• Up to 2.8% of MI deaths during the 5-year study period may be attributable to the combination of extreme temperature exposure and PM2.5 at levels exceeding World Health Organization air quality guidelines (37.5 mcg/m³).
• The risk of fatal MI was generally higher among women than men during heat waves and was higher among adults 80 years old and older than in younger adults during heat waves, cold snaps, or days with high levels of PM2.5.

The finding that adults over age 80 are particularly susceptible to the effects of heat and air pollution and the interaction of the two is “notable and particularly relevant given the aging of the population,” Dr. Newman told this news organization.

Mitigating both extreme temperature events and PM2.5 exposures “may bring health cobenefits in preventing premature deaths from MI,” the researchers write.

“To improve public health, it is important to take fine particulate pollution into consideration when providing extreme temperature warnings to the public,” Dr. Liu adds in the statement.

In an earlier study, Dr. Liu and colleagues showed that exposure to both large and small particulate matter, as well as nitrogen dioxide, was significantly associated with increased odds of death from MI.

This study was funded by China’s Ministry of Science and Technology. The authors and Dr. Newman have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The combination of heat waves and poor air quality is associated with double the risk of fatal myocardial infarction (MI), with women and older adults at greatest risk, a study from China suggests.

rottadana/Thinkstock

The researchers estimate that up to 3% of all deaths due to MI could be attributed to the combination of extreme temperatures and high levels of ambient fine particulate matter (PM2.5).

“Our findings provide evidence that reducing exposure to both extreme temperatures and fine particulate pollution may be useful to prevent premature deaths from heart attack,” senior author Yuewei Liu, MD, PhD, with Sun Yat-sen University in Guangzhou, China, said in a statement.

There is “long-standing evidence” of the harmful cardiovascular effects of air pollution, Jonathan Newman, MD, MPH, cardiologist at NYU Langone Heart in New York, who wasn’t involved in the study, said in an interview.

The added value of this study was finding an interaction between extreme hot temperatures and air pollution, “which is worrisome with global warming,” said Dr. Newman, assistant professor, department of medicine, the Leon H. Charney Division of Cardiology at NYU Langone Health.

The study was published online in Circulation.
 

Intensity and duration matter

The researchers analyzed data on 202,678 adults (mean age, 77.6 years; 52% male) who suffered fatal MI between 2015 and 2020 in Jiangsu province, a region with four distinct seasons and a wide range of temperatures and ambient PM2.5.

They evaluated the association of exposure to extreme temperature events, including both hot and cold spells, and PM2.5 with MI mortality, and their interactive effects.

Among the key findings:

• The risk of fatal MI was 18% higher during 2-day heat waves with heat indexes at or above the 90th percentile (ranging from 82.6° to 97.9° F) and 74% higher during 4-day heat waves with heat indexes at or above the 97.5th percentile (ranging from 94.8° to 109.4° F), compared with control days.
• The risk of fatal MI was 4% higher during 2-day cold snaps with temperatures at or below the 10th percentile (ranging from 33.3° to 40.5° F) and 12% higher during 3-day cold snaps with temperatures at or below the 2.5th percentile (ranging from 27.0° to 37.2° F).
• The risk of fatal MI was twice as high during 4-day heat waves that had PM2.5 above 37.5 mcg/m³. Days with high levels of PM2.5 during cold snaps did not have an equivalent increase in the risk of fatal MI.
• Up to 2.8% of MI deaths during the 5-year study period may be attributable to the combination of extreme temperature exposure and PM2.5 at levels exceeding World Health Organization air quality guidelines (37.5 mcg/m³).
• The risk of fatal MI was generally higher among women than men during heat waves and was higher among adults 80 years old and older than in younger adults during heat waves, cold snaps, or days with high levels of PM2.5.

The finding that adults over age 80 are particularly susceptible to the effects of heat and air pollution and the interaction of the two is “notable and particularly relevant given the aging of the population,” Dr. Newman told this news organization.

Mitigating both extreme temperature events and PM2.5 exposures “may bring health cobenefits in preventing premature deaths from MI,” the researchers write.

“To improve public health, it is important to take fine particulate pollution into consideration when providing extreme temperature warnings to the public,” Dr. Liu adds in the statement.

In an earlier study, Dr. Liu and colleagues showed that exposure to both large and small particulate matter, as well as nitrogen dioxide, was significantly associated with increased odds of death from MI.

This study was funded by China’s Ministry of Science and Technology. The authors and Dr. Newman have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The combination of heat waves and poor air quality is associated with double the risk of fatal myocardial infarction (MI), with women and older adults at greatest risk, a study from China suggests.

rottadana/Thinkstock

The researchers estimate that up to 3% of all deaths due to MI could be attributed to the combination of extreme temperatures and high levels of ambient fine particulate matter (PM2.5).

“Our findings provide evidence that reducing exposure to both extreme temperatures and fine particulate pollution may be useful to prevent premature deaths from heart attack,” senior author Yuewei Liu, MD, PhD, with Sun Yat-sen University in Guangzhou, China, said in a statement.

There is “long-standing evidence” of the harmful cardiovascular effects of air pollution, Jonathan Newman, MD, MPH, cardiologist at NYU Langone Heart in New York, who wasn’t involved in the study, said in an interview.

The added value of this study was finding an interaction between extreme hot temperatures and air pollution, “which is worrisome with global warming,” said Dr. Newman, assistant professor, department of medicine, the Leon H. Charney Division of Cardiology at NYU Langone Health.

The study was published online in Circulation.
 

Intensity and duration matter

The researchers analyzed data on 202,678 adults (mean age, 77.6 years; 52% male) who suffered fatal MI between 2015 and 2020 in Jiangsu province, a region with four distinct seasons and a wide range of temperatures and ambient PM2.5.

They evaluated the association of exposure to extreme temperature events, including both hot and cold spells, and PM2.5 with MI mortality, and their interactive effects.

Among the key findings:

• The risk of fatal MI was 18% higher during 2-day heat waves with heat indexes at or above the 90th percentile (ranging from 82.6° to 97.9° F) and 74% higher during 4-day heat waves with heat indexes at or above the 97.5th percentile (ranging from 94.8° to 109.4° F), compared with control days.
• The risk of fatal MI was 4% higher during 2-day cold snaps with temperatures at or below the 10th percentile (ranging from 33.3° to 40.5° F) and 12% higher during 3-day cold snaps with temperatures at or below the 2.5th percentile (ranging from 27.0° to 37.2° F).
• The risk of fatal MI was twice as high during 4-day heat waves that had PM2.5 above 37.5 mcg/m³. Days with high levels of PM2.5 during cold snaps did not have an equivalent increase in the risk of fatal MI.
• Up to 2.8% of MI deaths during the 5-year study period may be attributable to the combination of extreme temperature exposure and PM2.5 at levels exceeding World Health Organization air quality guidelines (37.5 mcg/m³).
• The risk of fatal MI was generally higher among women than men during heat waves and was higher among adults 80 years old and older than in younger adults during heat waves, cold snaps, or days with high levels of PM2.5.

The finding that adults over age 80 are particularly susceptible to the effects of heat and air pollution and the interaction of the two is “notable and particularly relevant given the aging of the population,” Dr. Newman told this news organization.

Mitigating both extreme temperature events and PM2.5 exposures “may bring health cobenefits in preventing premature deaths from MI,” the researchers write.

“To improve public health, it is important to take fine particulate pollution into consideration when providing extreme temperature warnings to the public,” Dr. Liu adds in the statement.

In an earlier study, Dr. Liu and colleagues showed that exposure to both large and small particulate matter, as well as nitrogen dioxide, was significantly associated with increased odds of death from MI.

This study was funded by China’s Ministry of Science and Technology. The authors and Dr. Newman have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

TOPLINE:

A pilot study suggests that kombucha consumption reduces blood glucose levels in adults with type 2 diabetes. The sample size was too small for statistical significance.

blanaru/iStock/Getty Images

METHODOLOGY:

• Prospective, randomized, double-blinded, crossover study at a single-center urban hospital system.
• A total of 12 participants with type 2 diabetes were randomly assigned to consume 240 mL of either a kombucha product or placebo daily with dinner for 4 weeks.
• After an 8-week washout, they were switched to the other product for another 4 weeks.
• Fasting blood glucose levels were self-determined at baseline and at 1 and 4 weeks, and questionnaires were used to assess secondary health outcomes.
• Questionnaire data were analyzed for all 12 participants, but only 7 who completed the study were included in the analysis of fasting blood glucose.

TAKEAWAY:

• Kombucha significantly lowered average fasting blood glucose levels at week 4, compared with baseline (164 vs. 116 mg/dL; P = .035), while the placebo was not associated with statistically significant change (162 vs. 141 mg/dL; P = .078).
• Among just the five participants with baseline fasting glucose > 130 mg/dL, kombucha consumption was associated with a mean fasting blood glucose decrease of 74.3 mg/dL, significantly greater than the 15.9 mg/dL drop with placebo (P = .017).
• On cultural enumeration, the kombucha contained mostly lactic acid bacteria, acetic acid bacteria, and yeast, with molds present.

IN PRACTICE:

“Kombucha is a growing part of the beverage market in the United States and the world, driven, in part, by the wide range of suggested health benefits. However, nearly all of these benefits are based on in vitro or animal studies, and human clinical trials are needed to validate biological outcomes.”

SOURCE:

The study was conducted by Chagai Mendelson, of MedStar Georgetown University Hospital, Washington, and colleagues. It was published in Frontiers in Nutrition.

LIMITATIONS:

• The number of participants was small, and attrition was high.
• Glucose levels were self-reported.
• Only one kombucha was studied.

DISCLOSURES:

One author is a cofounder of Synbiotic Health and another has a financial interest in the company. The other authors have no disclosures. Kombucha and placebo drinks were donated by Craft Kombucha, but the company did not have access to the data, and no authors have financial ties with that company.

A version of this article first appeared on Medscape.com.

TOPLINE:

A pilot study suggests that kombucha consumption reduces blood glucose levels in adults with type 2 diabetes. The sample size was too small for statistical significance.

blanaru/iStock/Getty Images

METHODOLOGY:

• Prospective, randomized, double-blinded, crossover study at a single-center urban hospital system.
• A total of 12 participants with type 2 diabetes were randomly assigned to consume 240 mL of either a kombucha product or placebo daily with dinner for 4 weeks.
• After an 8-week washout, they were switched to the other product for another 4 weeks.
• Fasting blood glucose levels were self-determined at baseline and at 1 and 4 weeks, and questionnaires were used to assess secondary health outcomes.
• Questionnaire data were analyzed for all 12 participants, but only 7 who completed the study were included in the analysis of fasting blood glucose.

TAKEAWAY:

• Kombucha significantly lowered average fasting blood glucose levels at week 4, compared with baseline (164 vs. 116 mg/dL; P = .035), while the placebo was not associated with statistically significant change (162 vs. 141 mg/dL; P = .078).
• Among just the five participants with baseline fasting glucose > 130 mg/dL, kombucha consumption was associated with a mean fasting blood glucose decrease of 74.3 mg/dL, significantly greater than the 15.9 mg/dL drop with placebo (P = .017).
• On cultural enumeration, the kombucha contained mostly lactic acid bacteria, acetic acid bacteria, and yeast, with molds present.

IN PRACTICE:

“Kombucha is a growing part of the beverage market in the United States and the world, driven, in part, by the wide range of suggested health benefits. However, nearly all of these benefits are based on in vitro or animal studies, and human clinical trials are needed to validate biological outcomes.”

SOURCE:

The study was conducted by Chagai Mendelson, of MedStar Georgetown University Hospital, Washington, and colleagues. It was published in Frontiers in Nutrition.

LIMITATIONS:

• The number of participants was small, and attrition was high.
• Glucose levels were self-reported.
• Only one kombucha was studied.

DISCLOSURES:

One author is a cofounder of Synbiotic Health and another has a financial interest in the company. The other authors have no disclosures. Kombucha and placebo drinks were donated by Craft Kombucha, but the company did not have access to the data, and no authors have financial ties with that company.

A version of this article first appeared on Medscape.com.

TOPLINE:

A pilot study suggests that kombucha consumption reduces blood glucose levels in adults with type 2 diabetes. The sample size was too small for statistical significance.

blanaru/iStock/Getty Images

METHODOLOGY:

• Prospective, randomized, double-blinded, crossover study at a single-center urban hospital system.
• A total of 12 participants with type 2 diabetes were randomly assigned to consume 240 mL of either a kombucha product or placebo daily with dinner for 4 weeks.
• After an 8-week washout, they were switched to the other product for another 4 weeks.
• Fasting blood glucose levels were self-determined at baseline and at 1 and 4 weeks, and questionnaires were used to assess secondary health outcomes.
• Questionnaire data were analyzed for all 12 participants, but only 7 who completed the study were included in the analysis of fasting blood glucose.

TAKEAWAY:

• Kombucha significantly lowered average fasting blood glucose levels at week 4, compared with baseline (164 vs. 116 mg/dL; P = .035), while the placebo was not associated with statistically significant change (162 vs. 141 mg/dL; P = .078).
• Among just the five participants with baseline fasting glucose > 130 mg/dL, kombucha consumption was associated with a mean fasting blood glucose decrease of 74.3 mg/dL, significantly greater than the 15.9 mg/dL drop with placebo (P = .017).
• On cultural enumeration, the kombucha contained mostly lactic acid bacteria, acetic acid bacteria, and yeast, with molds present.

IN PRACTICE:

“Kombucha is a growing part of the beverage market in the United States and the world, driven, in part, by the wide range of suggested health benefits. However, nearly all of these benefits are based on in vitro or animal studies, and human clinical trials are needed to validate biological outcomes.”

SOURCE:

The study was conducted by Chagai Mendelson, of MedStar Georgetown University Hospital, Washington, and colleagues. It was published in Frontiers in Nutrition.

LIMITATIONS:

• The number of participants was small, and attrition was high.
• Glucose levels were self-reported.
• Only one kombucha was studied.

DISCLOSURES:

One author is a cofounder of Synbiotic Health and another has a financial interest in the company. The other authors have no disclosures. Kombucha and placebo drinks were donated by Craft Kombucha, but the company did not have access to the data, and no authors have financial ties with that company.

A version of this article first appeared on Medscape.com.

This transcript has been edited for clarity.

When I went to med school, we were taught to take a sexual history. Do you smoke? Do you drink? Do you do drugs? Do you have sex? Men, women, or both? And that was it. We’re telling patients that sex is a vice, something that is dangerous and that you should feel bad about. But sex is how we’re all here and how we even continue as a species. We must get comfortable as doctors talking to our patients about sexual medicine.

What if we move away from sex being in the vice category – the part of the social history that’s the bad stuff you shouldn’t be doing? Maybe we should bring it into the review of systems.

As a very basic first step, I like to ask patients four things. As a sexual medicine doctor, I deal with these four things: libido, arousal, orgasm, and pain.

Why are these important? These are the things our patients really care about; 2.3 of every 1,000 people got divorced in 2021.

Libido. Women who have distressing low sexual desire have sex on average two and a half times per month. We call this mercy sex or duty sex. I don’t know what the half time per month looks like, but people genuinely care about desire and their doctors don’t really know that.

We have a biopsychosocial toolbox to help our patients. Let me give you an example: Antidepressants can have sexual side effects. Could there be medications in our toolbox that can help our patients? Of course there can, and there are. What about education or talk therapy? We should be asking our patients what they care about and why they care about it so we can help them achieve their quality-of-life goals.

Arousal. What about arousal? Did you know that erections are a marker of cardiovascular disease in men? We know this to be true for men, and I’m certain the research would be no different for women. We know that there are many biological causes for decrease in arousal, including sleep apnea, diabetes, hypertension, and smoking. I can convince a lot of men to quit smoking because I tell them it’s bad for their penis. We have to understand what our patients care about and then advise them on why we think we can help improve these issues.

Orgasm. How about orgasm? Have you ever been asked whether you can orgasm? Have you ever been asked whether you have questions about orgasm? About 15%-20% of women report having an orgasm disorder, and we rarely talk about this in an exam room. I’ve certainly never been asked, and everybody knows what I do for a living. Not to mention all the men that I and my colleagues see who have really distressing premature ejaculation or delayed orgasm. This is pathophysiology at its finest and most complex. It is so interesting, and we have so much to learn and understand about orgasm in general.

Pain. Finally, ask about pain. It seems obvious that we should be asking our patients about their pain, which includes pelvic pain, but oftentimes we avoid talking about private parts. Pain affects not just our patients, but also their partners and their families, when our patients can’t sit without discomfort, if they can’t go and perform the daily activities that bring them joy and belonging. We have to really work with our toolbox in a biopsychosocial manner to help our patients. I often use the incredible rehabilitation specialists called pelvic floor physical therapists.

Remember, we’re talking about libido, arousal, orgasm, and pain. Sex is important to us as a species. It’s important to our patients. Please consider enhancing your sexual history–taking skills and ask patients about their desire, arousal, orgasm, and pain. Ask nonjudgmental and open-ended questions. You actually may be the only doctor to ever do so.

Dr. Rubin is an assistant clinical professor, department of urology, Georgetown University, Washington. She reported conflicts of interest with Sprout, Maternal Medical, Absorption Pharmaceuticals, GSK, and Endo.

A version of this article first appeared on Medscape.com.

This transcript has been edited for clarity.

When I went to med school, we were taught to take a sexual history. Do you smoke? Do you drink? Do you do drugs? Do you have sex? Men, women, or both? And that was it. We’re telling patients that sex is a vice, something that is dangerous and that you should feel bad about. But sex is how we’re all here and how we even continue as a species. We must get comfortable as doctors talking to our patients about sexual medicine.

What if we move away from sex being in the vice category – the part of the social history that’s the bad stuff you shouldn’t be doing? Maybe we should bring it into the review of systems.

As a very basic first step, I like to ask patients four things. As a sexual medicine doctor, I deal with these four things: libido, arousal, orgasm, and pain.

Why are these important? These are the things our patients really care about; 2.3 of every 1,000 people got divorced in 2021.

Libido. Women who have distressing low sexual desire have sex on average two and a half times per month. We call this mercy sex or duty sex. I don’t know what the half time per month looks like, but people genuinely care about desire and their doctors don’t really know that.

We have a biopsychosocial toolbox to help our patients. Let me give you an example: Antidepressants can have sexual side effects. Could there be medications in our toolbox that can help our patients? Of course there can, and there are. What about education or talk therapy? We should be asking our patients what they care about and why they care about it so we can help them achieve their quality-of-life goals.

Arousal. What about arousal? Did you know that erections are a marker of cardiovascular disease in men? We know this to be true for men, and I’m certain the research would be no different for women. We know that there are many biological causes for decrease in arousal, including sleep apnea, diabetes, hypertension, and smoking. I can convince a lot of men to quit smoking because I tell them it’s bad for their penis. We have to understand what our patients care about and then advise them on why we think we can help improve these issues.

Orgasm. How about orgasm? Have you ever been asked whether you can orgasm? Have you ever been asked whether you have questions about orgasm? About 15%-20% of women report having an orgasm disorder, and we rarely talk about this in an exam room. I’ve certainly never been asked, and everybody knows what I do for a living. Not to mention all the men that I and my colleagues see who have really distressing premature ejaculation or delayed orgasm. This is pathophysiology at its finest and most complex. It is so interesting, and we have so much to learn and understand about orgasm in general.

Pain. Finally, ask about pain. It seems obvious that we should be asking our patients about their pain, which includes pelvic pain, but oftentimes we avoid talking about private parts. Pain affects not just our patients, but also their partners and their families, when our patients can’t sit without discomfort, if they can’t go and perform the daily activities that bring them joy and belonging. We have to really work with our toolbox in a biopsychosocial manner to help our patients. I often use the incredible rehabilitation specialists called pelvic floor physical therapists.

Remember, we’re talking about libido, arousal, orgasm, and pain. Sex is important to us as a species. It’s important to our patients. Please consider enhancing your sexual history–taking skills and ask patients about their desire, arousal, orgasm, and pain. Ask nonjudgmental and open-ended questions. You actually may be the only doctor to ever do so.

Dr. Rubin is an assistant clinical professor, department of urology, Georgetown University, Washington. She reported conflicts of interest with Sprout, Maternal Medical, Absorption Pharmaceuticals, GSK, and Endo.

A version of this article first appeared on Medscape.com.

This transcript has been edited for clarity.

When I went to med school, we were taught to take a sexual history. Do you smoke? Do you drink? Do you do drugs? Do you have sex? Men, women, or both? And that was it. We’re telling patients that sex is a vice, something that is dangerous and that you should feel bad about. But sex is how we’re all here and how we even continue as a species. We must get comfortable as doctors talking to our patients about sexual medicine.

What if we move away from sex being in the vice category – the part of the social history that’s the bad stuff you shouldn’t be doing? Maybe we should bring it into the review of systems.

As a very basic first step, I like to ask patients four things. As a sexual medicine doctor, I deal with these four things: libido, arousal, orgasm, and pain.

Why are these important? These are the things our patients really care about; 2.3 of every 1,000 people got divorced in 2021.

Libido. Women who have distressing low sexual desire have sex on average two and a half times per month. We call this mercy sex or duty sex. I don’t know what the half time per month looks like, but people genuinely care about desire and their doctors don’t really know that.

We have a biopsychosocial toolbox to help our patients. Let me give you an example: Antidepressants can have sexual side effects. Could there be medications in our toolbox that can help our patients? Of course there can, and there are. What about education or talk therapy? We should be asking our patients what they care about and why they care about it so we can help them achieve their quality-of-life goals.

Arousal. What about arousal? Did you know that erections are a marker of cardiovascular disease in men? We know this to be true for men, and I’m certain the research would be no different for women. We know that there are many biological causes for decrease in arousal, including sleep apnea, diabetes, hypertension, and smoking. I can convince a lot of men to quit smoking because I tell them it’s bad for their penis. We have to understand what our patients care about and then advise them on why we think we can help improve these issues.

Orgasm. How about orgasm? Have you ever been asked whether you can orgasm? Have you ever been asked whether you have questions about orgasm? About 15%-20% of women report having an orgasm disorder, and we rarely talk about this in an exam room. I’ve certainly never been asked, and everybody knows what I do for a living. Not to mention all the men that I and my colleagues see who have really distressing premature ejaculation or delayed orgasm. This is pathophysiology at its finest and most complex. It is so interesting, and we have so much to learn and understand about orgasm in general.

Pain. Finally, ask about pain. It seems obvious that we should be asking our patients about their pain, which includes pelvic pain, but oftentimes we avoid talking about private parts. Pain affects not just our patients, but also their partners and their families, when our patients can’t sit without discomfort, if they can’t go and perform the daily activities that bring them joy and belonging. We have to really work with our toolbox in a biopsychosocial manner to help our patients. I often use the incredible rehabilitation specialists called pelvic floor physical therapists.

Remember, we’re talking about libido, arousal, orgasm, and pain. Sex is important to us as a species. It’s important to our patients. Please consider enhancing your sexual history–taking skills and ask patients about their desire, arousal, orgasm, and pain. Ask nonjudgmental and open-ended questions. You actually may be the only doctor to ever do so.

Dr. Rubin is an assistant clinical professor, department of urology, Georgetown University, Washington. She reported conflicts of interest with Sprout, Maternal Medical, Absorption Pharmaceuticals, GSK, and Endo.

A version of this article first appeared on Medscape.com.

This transcript has been edited for clarity.

Clostridioides difficile is a toxin-based infection that takes up residence in the colon due to disturbed normal bowel flora, usually after antibiotics.

Recurrent C. difficile can happen in up to a quarter of patients who receive oral vancomycin as a treatment for their infection. It can also occur with treatment with the newer agent, fidaxomicin, although possibly in fewer patients. In general, relapses are indeed common.

When I trained at Johns Hopkins under John Bartlett, he took the approach that after the second – and always after the third – relapse, an extended course of oral therapy with vancomycin could help get patients out of trouble. He used the so-called extended pulse method, where patients would take the drug for approximately 4-6 weeks and gradually reduce the dose.

This approach can also be done with fidaxomicin. However, I’m not sure it works much better than vancomycin, and there are often hurdles to using fidaxomicin because of insurers not approving it because of the expense.

What other therapies are there?

There is bezlotoxumab, which is a human monoclonal antibody targeting C. difficile toxin B. I’ve used it a few times. It is given as a one-time infusion, and there are challenges regarding cost, the logistics of setting up the infusion, and insurance approval.
 

Fecal microbiota transplant

In recent years, fecal microbiota transplants (FMT) have received a lot of attention as a different avenue of treatment that could lower the potential for relapses, with success rates usually around 80%-90%. However, in the past few years, there have been some serious safety signals because of possible transmission of dangerous pathogens, often with drug resistance, with FMT.

I’m therefore pleased to say that newer fecal microbiota products are coming in fast and furious. I thought I’d spend a few minutes speaking about these.

OpenBiome, an organization dedicated to microbiome research, offers an investigational product from screened donors that has not received Food and Drug Administration approval. It’s been around for some time. It can be used in either upper or lower GI applications, and the organization cites about an 84% success rate using this product.

There are also two new FDA-approved products I think are worth knowing about. They’ve just been approved recently and we’re a little uncertain of where they’re going to end up in the treatment landscape.

The first is from Ferring, and it goes by fecal microbiota, live-jslm (Rebyota). This is a product from qualified and screened donors, the main component of which is Bacteroides, which is given as a single dose by enema.

The company did a phase 3 trial with a Bayesian primary analysis, which I think convinced the FDA to approve this product. The success rate in people with multiple relapses was 70.6%, compared with 57.5% with placebo. The estimated treatment effect was 13.1%. Of those who did respond, over 90% were kept free of relapse over a 6-month period.

The other product, also FDA approved, is from Seres. It was previously called SER-109, and is now called fecal microbiota spores, live-brpk (Vowst). Unlike the previous product, this is orally administered, with patients taking four capsules daily for 3 days. Again, these donor-derived firmicutes have been appropriately screened and are free of potential pathogens.

The phase 3 randomized clinical trial results were published in the New England Journal of Medicine. They showed that 12% of those taking this product had a relapse, compared with 40% of those taking placebo, which is about the range we tend to see in people who have had multiple relapses. The safety profile was similar to placebo.

So, how will people use these treatments?

I think the FDA imprimatur will be attractive to people, but the products, I believe, will be priced fairly expensively, in the under $10,000 range. The first (Rebyota) is a rectal infusion; it is a one-and-done treatment but creates logistical issues. Interestingly, it could be a billable procedure for infectious disease clinicians. The ease of oral administration for Vowst, no doubt, will be very appealing. Both of these are given after completing a course of treatment with vancomycin or fidaxomicin so as not to interfere with the microbiome product.

I’ll also briefly mention a paper published in JAMA on yet another microbiome product, called VE303. This product was based on eight commensal strains of Clostridia and was given orally in a phase 2 trial. Interestingly, this worked about the same as the oral product that is already FDA approved. The study showed a recurrence rate of 13.8% in the high-dose group, compared with 45.5% in the placebo group.

I think this is exciting. Hopefully, we will have safer products that can be more reliable, although there are some concerns and logistical challenges in safely getting the products to people. And, of course, there is the expense.

But anything that can be done to help improve these patients is welcome, as once they get into the multiple-relapse phase, it is challenging to turn around. These commercialized products will hopefully become a bit more mainstream. Certainly, we’ll see how these will be utilized in the coming months and over the next few years.

Dr. Auwaerter is Clinical Director, Division of Infectious Diseases, Johns Hopkins University, Baltimore. He reported conflicts of interest with Gilead, Shionogi, and Medscape.

A version of this article first appeared on Medscape.com.

This transcript has been edited for clarity.

Clostridioides difficile is a toxin-based infection that takes up residence in the colon due to disturbed normal bowel flora, usually after antibiotics.

Recurrent C. difficile can happen in up to a quarter of patients who receive oral vancomycin as a treatment for their infection. It can also occur with treatment with the newer agent, fidaxomicin, although possibly in fewer patients. In general, relapses are indeed common.

When I trained at Johns Hopkins under John Bartlett, he took the approach that after the second – and always after the third – relapse, an extended course of oral therapy with vancomycin could help get patients out of trouble. He used the so-called extended pulse method, where patients would take the drug for approximately 4-6 weeks and gradually reduce the dose.

This approach can also be done with fidaxomicin. However, I’m not sure it works much better than vancomycin, and there are often hurdles to using fidaxomicin because of insurers not approving it because of the expense.

What other therapies are there?

There is bezlotoxumab, which is a human monoclonal antibody targeting C. difficile toxin B. I’ve used it a few times. It is given as a one-time infusion, and there are challenges regarding cost, the logistics of setting up the infusion, and insurance approval.
 

Fecal microbiota transplant

In recent years, fecal microbiota transplants (FMT) have received a lot of attention as a different avenue of treatment that could lower the potential for relapses, with success rates usually around 80%-90%. However, in the past few years, there have been some serious safety signals because of possible transmission of dangerous pathogens, often with drug resistance, with FMT.

I’m therefore pleased to say that newer fecal microbiota products are coming in fast and furious. I thought I’d spend a few minutes speaking about these.

OpenBiome, an organization dedicated to microbiome research, offers an investigational product from screened donors that has not received Food and Drug Administration approval. It’s been around for some time. It can be used in either upper or lower GI applications, and the organization cites about an 84% success rate using this product.

There are also two new FDA-approved products I think are worth knowing about. They’ve just been approved recently and we’re a little uncertain of where they’re going to end up in the treatment landscape.

The first is from Ferring, and it goes by fecal microbiota, live-jslm (Rebyota). This is a product from qualified and screened donors, the main component of which is Bacteroides, which is given as a single dose by enema.

The company did a phase 3 trial with a Bayesian primary analysis, which I think convinced the FDA to approve this product. The success rate in people with multiple relapses was 70.6%, compared with 57.5% with placebo. The estimated treatment effect was 13.1%. Of those who did respond, over 90% were kept free of relapse over a 6-month period.

The other product, also FDA approved, is from Seres. It was previously called SER-109, and is now called fecal microbiota spores, live-brpk (Vowst). Unlike the previous product, this is orally administered, with patients taking four capsules daily for 3 days. Again, these donor-derived firmicutes have been appropriately screened and are free of potential pathogens.

The phase 3 randomized clinical trial results were published in the New England Journal of Medicine. They showed that 12% of those taking this product had a relapse, compared with 40% of those taking placebo, which is about the range we tend to see in people who have had multiple relapses. The safety profile was similar to placebo.

So, how will people use these treatments?

I think the FDA imprimatur will be attractive to people, but the products, I believe, will be priced fairly expensively, in the under $10,000 range. The first (Rebyota) is a rectal infusion; it is a one-and-done treatment but creates logistical issues. Interestingly, it could be a billable procedure for infectious disease clinicians. The ease of oral administration for Vowst, no doubt, will be very appealing. Both of these are given after completing a course of treatment with vancomycin or fidaxomicin so as not to interfere with the microbiome product.

I’ll also briefly mention a paper published in JAMA on yet another microbiome product, called VE303. This product was based on eight commensal strains of Clostridia and was given orally in a phase 2 trial. Interestingly, this worked about the same as the oral product that is already FDA approved. The study showed a recurrence rate of 13.8% in the high-dose group, compared with 45.5% in the placebo group.

I think this is exciting. Hopefully, we will have safer products that can be more reliable, although there are some concerns and logistical challenges in safely getting the products to people. And, of course, there is the expense.

But anything that can be done to help improve these patients is welcome, as once they get into the multiple-relapse phase, it is challenging to turn around. These commercialized products will hopefully become a bit more mainstream. Certainly, we’ll see how these will be utilized in the coming months and over the next few years.

Dr. Auwaerter is Clinical Director, Division of Infectious Diseases, Johns Hopkins University, Baltimore. He reported conflicts of interest with Gilead, Shionogi, and Medscape.

A version of this article first appeared on Medscape.com.

This transcript has been edited for clarity.

Clostridioides difficile is a toxin-based infection that takes up residence in the colon due to disturbed normal bowel flora, usually after antibiotics.

Recurrent C. difficile can happen in up to a quarter of patients who receive oral vancomycin as a treatment for their infection. It can also occur with treatment with the newer agent, fidaxomicin, although possibly in fewer patients. In general, relapses are indeed common.

When I trained at Johns Hopkins under John Bartlett, he took the approach that after the second – and always after the third – relapse, an extended course of oral therapy with vancomycin could help get patients out of trouble. He used the so-called extended pulse method, where patients would take the drug for approximately 4-6 weeks and gradually reduce the dose.

This approach can also be done with fidaxomicin. However, I’m not sure it works much better than vancomycin, and there are often hurdles to using fidaxomicin because of insurers not approving it because of the expense.

What other therapies are there?

There is bezlotoxumab, which is a human monoclonal antibody targeting C. difficile toxin B. I’ve used it a few times. It is given as a one-time infusion, and there are challenges regarding cost, the logistics of setting up the infusion, and insurance approval.
 

Fecal microbiota transplant

In recent years, fecal microbiota transplants (FMT) have received a lot of attention as a different avenue of treatment that could lower the potential for relapses, with success rates usually around 80%-90%. However, in the past few years, there have been some serious safety signals because of possible transmission of dangerous pathogens, often with drug resistance, with FMT.

I’m therefore pleased to say that newer fecal microbiota products are coming in fast and furious. I thought I’d spend a few minutes speaking about these.

OpenBiome, an organization dedicated to microbiome research, offers an investigational product from screened donors that has not received Food and Drug Administration approval. It’s been around for some time. It can be used in either upper or lower GI applications, and the organization cites about an 84% success rate using this product.

There are also two new FDA-approved products I think are worth knowing about. They’ve just been approved recently and we’re a little uncertain of where they’re going to end up in the treatment landscape.

The first is from Ferring, and it goes by fecal microbiota, live-jslm (Rebyota). This is a product from qualified and screened donors, the main component of which is Bacteroides, which is given as a single dose by enema.

The company did a phase 3 trial with a Bayesian primary analysis, which I think convinced the FDA to approve this product. The success rate in people with multiple relapses was 70.6%, compared with 57.5% with placebo. The estimated treatment effect was 13.1%. Of those who did respond, over 90% were kept free of relapse over a 6-month period.

The other product, also FDA approved, is from Seres. It was previously called SER-109, and is now called fecal microbiota spores, live-brpk (Vowst). Unlike the previous product, this is orally administered, with patients taking four capsules daily for 3 days. Again, these donor-derived firmicutes have been appropriately screened and are free of potential pathogens.

The phase 3 randomized clinical trial results were published in the New England Journal of Medicine. They showed that 12% of those taking this product had a relapse, compared with 40% of those taking placebo, which is about the range we tend to see in people who have had multiple relapses. The safety profile was similar to placebo.

So, how will people use these treatments?

I think the FDA imprimatur will be attractive to people, but the products, I believe, will be priced fairly expensively, in the under $10,000 range. The first (Rebyota) is a rectal infusion; it is a one-and-done treatment but creates logistical issues. Interestingly, it could be a billable procedure for infectious disease clinicians. The ease of oral administration for Vowst, no doubt, will be very appealing. Both of these are given after completing a course of treatment with vancomycin or fidaxomicin so as not to interfere with the microbiome product.

I’ll also briefly mention a paper published in JAMA on yet another microbiome product, called VE303. This product was based on eight commensal strains of Clostridia and was given orally in a phase 2 trial. Interestingly, this worked about the same as the oral product that is already FDA approved. The study showed a recurrence rate of 13.8% in the high-dose group, compared with 45.5% in the placebo group.

I think this is exciting. Hopefully, we will have safer products that can be more reliable, although there are some concerns and logistical challenges in safely getting the products to people. And, of course, there is the expense.

But anything that can be done to help improve these patients is welcome, as once they get into the multiple-relapse phase, it is challenging to turn around. These commercialized products will hopefully become a bit more mainstream. Certainly, we’ll see how these will be utilized in the coming months and over the next few years.

Dr. Auwaerter is Clinical Director, Division of Infectious Diseases, Johns Hopkins University, Baltimore. He reported conflicts of interest with Gilead, Shionogi, and Medscape.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration today cleared an artificial intelligence (AI)-assisted colonoscopy device called the MAGENTIQ-COLO, according to the Israeli-based manufacturer of the same name.

The device helps identify lesions in real time and is associated with a significant increase in the adenoma detection rate (ADR), according to the press release.

The device was cleared under the FDA’s 510(k) process, and follows the European CE Mark and Israel AMAR approval, which were received in mid-2021. It will be available in the United States in the coming weeks.

In a study performed in 2022 with 29 endoscopy experts and more than 950 patients, the device was validated as “one of the best-performing AI solutions in the category, increasing ADR by 26% relatively (7% in absolute values), which translated into a 21% decrease in colorectal cancer occurrence and a 35% decrease in patient mortality,” according to the press release.

In this multicenter, randomized, controlled trial conducted at 10 hospitals in Europe, the United States, and Israel, and presented at United European Gastroenterology Week 2022, the authors noted that “apart from diminutive lesions, [MAGENTIQ-COLO] increased the detection of 6- to 9-mm adenomas, suggesting that this novel [computer-aided polyp detection] system is also able to detect more clinically relevant lesions.”

The device “takes the video out of the colonoscopy device, breaks it into frames, and analyzes them in real time with its AI engine to detect polyps in them,” Dror Zur, founder and CEO of MAGENTIQ-EYE, explained in an interview. “If a polyp is detected, then MAGENTIQ-COLO signs it with a bounding box on the video’s overlay and sends it as a video with an overlay to the display monitor so the doctor can look at it and find more polyps.”

As previously reported by this news organization, research has shown that conventional colonoscopies miss about a quarter of adenomas. Many AI systems have recently come on the market, promising to improve detection by overcoming human error in detecting polyps.

Colonoscopy has become standard in most developed countries, with 15-20 million procedures performed every year in the United States alone; however, high missed rates and undetected adenomas during the procedures mean that even patients who get regular, recommended screenings are still at risk of developing colon cancer, notes the press release.

“A missed polyp can lead to interval cancer, which accounts for approximately 8%-10% of all CRC in the U.S., translated to over 13,500 cancer cases that could be prevented every year with better detection,” the press release also states.

According to the National Institutes of Health, colorectal cancer is the third leading cause of cancer-related death in the United States.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration today cleared an artificial intelligence (AI)-assisted colonoscopy device called the MAGENTIQ-COLO, according to the Israeli-based manufacturer of the same name.

The device helps identify lesions in real time and is associated with a significant increase in the adenoma detection rate (ADR), according to the press release.

The device was cleared under the FDA’s 510(k) process, and follows the European CE Mark and Israel AMAR approval, which were received in mid-2021. It will be available in the United States in the coming weeks.

In a study performed in 2022 with 29 endoscopy experts and more than 950 patients, the device was validated as “one of the best-performing AI solutions in the category, increasing ADR by 26% relatively (7% in absolute values), which translated into a 21% decrease in colorectal cancer occurrence and a 35% decrease in patient mortality,” according to the press release.

In this multicenter, randomized, controlled trial conducted at 10 hospitals in Europe, the United States, and Israel, and presented at United European Gastroenterology Week 2022, the authors noted that “apart from diminutive lesions, [MAGENTIQ-COLO] increased the detection of 6- to 9-mm adenomas, suggesting that this novel [computer-aided polyp detection] system is also able to detect more clinically relevant lesions.”

The device “takes the video out of the colonoscopy device, breaks it into frames, and analyzes them in real time with its AI engine to detect polyps in them,” Dror Zur, founder and CEO of MAGENTIQ-EYE, explained in an interview. “If a polyp is detected, then MAGENTIQ-COLO signs it with a bounding box on the video’s overlay and sends it as a video with an overlay to the display monitor so the doctor can look at it and find more polyps.”

As previously reported by this news organization, research has shown that conventional colonoscopies miss about a quarter of adenomas. Many AI systems have recently come on the market, promising to improve detection by overcoming human error in detecting polyps.

Colonoscopy has become standard in most developed countries, with 15-20 million procedures performed every year in the United States alone; however, high missed rates and undetected adenomas during the procedures mean that even patients who get regular, recommended screenings are still at risk of developing colon cancer, notes the press release.

“A missed polyp can lead to interval cancer, which accounts for approximately 8%-10% of all CRC in the U.S., translated to over 13,500 cancer cases that could be prevented every year with better detection,” the press release also states.

According to the National Institutes of Health, colorectal cancer is the third leading cause of cancer-related death in the United States.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration today cleared an artificial intelligence (AI)-assisted colonoscopy device called the MAGENTIQ-COLO, according to the Israeli-based manufacturer of the same name.

The device helps identify lesions in real time and is associated with a significant increase in the adenoma detection rate (ADR), according to the press release.

The device was cleared under the FDA’s 510(k) process, and follows the European CE Mark and Israel AMAR approval, which were received in mid-2021. It will be available in the United States in the coming weeks.

In a study performed in 2022 with 29 endoscopy experts and more than 950 patients, the device was validated as “one of the best-performing AI solutions in the category, increasing ADR by 26% relatively (7% in absolute values), which translated into a 21% decrease in colorectal cancer occurrence and a 35% decrease in patient mortality,” according to the press release.

In this multicenter, randomized, controlled trial conducted at 10 hospitals in Europe, the United States, and Israel, and presented at United European Gastroenterology Week 2022, the authors noted that “apart from diminutive lesions, [MAGENTIQ-COLO] increased the detection of 6- to 9-mm adenomas, suggesting that this novel [computer-aided polyp detection] system is also able to detect more clinically relevant lesions.”

The device “takes the video out of the colonoscopy device, breaks it into frames, and analyzes them in real time with its AI engine to detect polyps in them,” Dror Zur, founder and CEO of MAGENTIQ-EYE, explained in an interview. “If a polyp is detected, then MAGENTIQ-COLO signs it with a bounding box on the video’s overlay and sends it as a video with an overlay to the display monitor so the doctor can look at it and find more polyps.”

As previously reported by this news organization, research has shown that conventional colonoscopies miss about a quarter of adenomas. Many AI systems have recently come on the market, promising to improve detection by overcoming human error in detecting polyps.

Colonoscopy has become standard in most developed countries, with 15-20 million procedures performed every year in the United States alone; however, high missed rates and undetected adenomas during the procedures mean that even patients who get regular, recommended screenings are still at risk of developing colon cancer, notes the press release.

“A missed polyp can lead to interval cancer, which accounts for approximately 8%-10% of all CRC in the U.S., translated to over 13,500 cancer cases that could be prevented every year with better detection,” the press release also states.

According to the National Institutes of Health, colorectal cancer is the third leading cause of cancer-related death in the United States.

A version of this article first appeared on Medscape.com.

Clinics have been coming up with new ways to add injections to their offerings ever since a new long-acting formulation of cabotegravir has been available to treat people with HIV.

At the Whitman-Walker Health Center, Washington, community health workers see about 3,200 antiretroviral users a year. With long-acting injections now available, the clinic opted to integrate the new medications into its peer staff program.

“Our peer workers are very competent,” said Rupa Patel, MD, MPH, medical liason of the pre-exposure prophylaxis for HIV prevention program at Washington University at St. Louis.* “They do phlebotomy, they give you your meds. They’re your main doctor until you really need to see the doctor.”

In the peer staff program, workers are trained in a 4-month medical residency–style program that shows them how to test for HIV, inject long-acting formulations of new drugs, and conduct follow-up visits.

Presenting the new approach at the International AIDS Society Conference on HIV Science, Dr. Patel reported that 139 people have received long-acting injections at the clinic since the program launched with a total of 314 injections administered.

The training program includes lectures, mock injection, and client care sessions, observation and supervised administration, a written exam, and case review sessions.

Retention for the second injection was 95%, with 91% of injections given within the 14-day window. For the third injection, retention was 91%, with 63% given within the window.

The program reports a high level of client satisfaction with the peer-administered injections, which are also given in a room decorated with a beach theme and music to help calm people who might be nervous of receiving shots.

“Our retention is going to be the highest compared to other clinics because your peer, your friend, is reminding you and comforting you and telling you: ‘Don’t worry, I’m on the injection too,’ ” Dr. Patel said.

Andrew Grulich, MD, PhD, head of the HIV epidemiology and prevention program at the Kirby Institute, Sydney, pointed out there is tension between wanting to use long-acting injectables for people who are struggling with taking oral therapies daily and the need to ensure that they come back for their injections on time.

“I think it’s a potential way forward – we’re learning as we’re going with these new forms of therapy,” he said in an interview. “It is absolutely critical that people turn up on time for those injections, and if they don’t, resistance can be an issue.”

Presenting new data from another project at the HIV Clinic at San Francisco General Hospital, Monica Gandhi, MD, MPH, told the conference: “There are multiple reasons why it’s hard to take oral antiretrovirals every day.”

At the HIV Clinic in San Francisco General, people without homes, those with mental illness, and those using stimulants receive care.

The clinical trials for long-acting injectable antiretrovirals included only people who were virologically suppressed, which is also the Food and Drug Administration criteria for use. However, this clinic offered long-acting injections to patients with viremia because it was too difficult for them to take a daily pill.

In a comment, Dr. Gandhi, director of the University of California, San Francisco’s Center for AIDS Research, said: “We don’t call people hard to reach, we call them hardly reached because it’s not their fault.” There are just all of these issues that have made it harder for them to take medication consistently.

Dr. Gandhi reported that, of the 133 people being treated with long-acting injectable cabotegravir and rilpivirine at the clinic through this program, 57 had viremia at baseline.

However, only two of these patients experienced virologic failure while on the injectable antiretroviral program. The overall virologic failure rate was 1.5%, which was equivalent to that seen in clinical trials in virologically suppressed individuals.

The results presented at the conference and were also published in Annals of Internal Medicine.

The clinic found that 73% of people attended their injection appointments on time, and those who did not were followed up with telephone calls to ensure they received their injection within the 14-day window.

Dr. Gandhi said people were highly motivated to turn up for their injection appointments. “They are virologically suppressed, so it feels so amazing. They’re self-motivated for the first time to want to get an injection.”

A version of this article first appeared on Medscape.com.

*Correction, 8/4/23: An earlier version of this article misstated Dr. Patel's university affiliation.

Clinics have been coming up with new ways to add injections to their offerings ever since a new long-acting formulation of cabotegravir has been available to treat people with HIV.

At the Whitman-Walker Health Center, Washington, community health workers see about 3,200 antiretroviral users a year. With long-acting injections now available, the clinic opted to integrate the new medications into its peer staff program.

“Our peer workers are very competent,” said Rupa Patel, MD, MPH, medical liason of the pre-exposure prophylaxis for HIV prevention program at Washington University at St. Louis.* “They do phlebotomy, they give you your meds. They’re your main doctor until you really need to see the doctor.”

In the peer staff program, workers are trained in a 4-month medical residency–style program that shows them how to test for HIV, inject long-acting formulations of new drugs, and conduct follow-up visits.

Presenting the new approach at the International AIDS Society Conference on HIV Science, Dr. Patel reported that 139 people have received long-acting injections at the clinic since the program launched with a total of 314 injections administered.

The training program includes lectures, mock injection, and client care sessions, observation and supervised administration, a written exam, and case review sessions.

Retention for the second injection was 95%, with 91% of injections given within the 14-day window. For the third injection, retention was 91%, with 63% given within the window.

The program reports a high level of client satisfaction with the peer-administered injections, which are also given in a room decorated with a beach theme and music to help calm people who might be nervous of receiving shots.

“Our retention is going to be the highest compared to other clinics because your peer, your friend, is reminding you and comforting you and telling you: ‘Don’t worry, I’m on the injection too,’ ” Dr. Patel said.

Andrew Grulich, MD, PhD, head of the HIV epidemiology and prevention program at the Kirby Institute, Sydney, pointed out there is tension between wanting to use long-acting injectables for people who are struggling with taking oral therapies daily and the need to ensure that they come back for their injections on time.

“I think it’s a potential way forward – we’re learning as we’re going with these new forms of therapy,” he said in an interview. “It is absolutely critical that people turn up on time for those injections, and if they don’t, resistance can be an issue.”

Presenting new data from another project at the HIV Clinic at San Francisco General Hospital, Monica Gandhi, MD, MPH, told the conference: “There are multiple reasons why it’s hard to take oral antiretrovirals every day.”

At the HIV Clinic in San Francisco General, people without homes, those with mental illness, and those using stimulants receive care.

The clinical trials for long-acting injectable antiretrovirals included only people who were virologically suppressed, which is also the Food and Drug Administration criteria for use. However, this clinic offered long-acting injections to patients with viremia because it was too difficult for them to take a daily pill.

In a comment, Dr. Gandhi, director of the University of California, San Francisco’s Center for AIDS Research, said: “We don’t call people hard to reach, we call them hardly reached because it’s not their fault.” There are just all of these issues that have made it harder for them to take medication consistently.

Dr. Gandhi reported that, of the 133 people being treated with long-acting injectable cabotegravir and rilpivirine at the clinic through this program, 57 had viremia at baseline.

However, only two of these patients experienced virologic failure while on the injectable antiretroviral program. The overall virologic failure rate was 1.5%, which was equivalent to that seen in clinical trials in virologically suppressed individuals.

The results presented at the conference and were also published in Annals of Internal Medicine.

The clinic found that 73% of people attended their injection appointments on time, and those who did not were followed up with telephone calls to ensure they received their injection within the 14-day window.

Dr. Gandhi said people were highly motivated to turn up for their injection appointments. “They are virologically suppressed, so it feels so amazing. They’re self-motivated for the first time to want to get an injection.”

A version of this article first appeared on Medscape.com.

*Correction, 8/4/23: An earlier version of this article misstated Dr. Patel's university affiliation.

Clinics have been coming up with new ways to add injections to their offerings ever since a new long-acting formulation of cabotegravir has been available to treat people with HIV.

At the Whitman-Walker Health Center, Washington, community health workers see about 3,200 antiretroviral users a year. With long-acting injections now available, the clinic opted to integrate the new medications into its peer staff program.

“Our peer workers are very competent,” said Rupa Patel, MD, MPH, medical liason of the pre-exposure prophylaxis for HIV prevention program at Washington University at St. Louis.* “They do phlebotomy, they give you your meds. They’re your main doctor until you really need to see the doctor.”

In the peer staff program, workers are trained in a 4-month medical residency–style program that shows them how to test for HIV, inject long-acting formulations of new drugs, and conduct follow-up visits.

Presenting the new approach at the International AIDS Society Conference on HIV Science, Dr. Patel reported that 139 people have received long-acting injections at the clinic since the program launched with a total of 314 injections administered.

The training program includes lectures, mock injection, and client care sessions, observation and supervised administration, a written exam, and case review sessions.

Retention for the second injection was 95%, with 91% of injections given within the 14-day window. For the third injection, retention was 91%, with 63% given within the window.

The program reports a high level of client satisfaction with the peer-administered injections, which are also given in a room decorated with a beach theme and music to help calm people who might be nervous of receiving shots.

“Our retention is going to be the highest compared to other clinics because your peer, your friend, is reminding you and comforting you and telling you: ‘Don’t worry, I’m on the injection too,’ ” Dr. Patel said.

Andrew Grulich, MD, PhD, head of the HIV epidemiology and prevention program at the Kirby Institute, Sydney, pointed out there is tension between wanting to use long-acting injectables for people who are struggling with taking oral therapies daily and the need to ensure that they come back for their injections on time.

“I think it’s a potential way forward – we’re learning as we’re going with these new forms of therapy,” he said in an interview. “It is absolutely critical that people turn up on time for those injections, and if they don’t, resistance can be an issue.”

Presenting new data from another project at the HIV Clinic at San Francisco General Hospital, Monica Gandhi, MD, MPH, told the conference: “There are multiple reasons why it’s hard to take oral antiretrovirals every day.”

At the HIV Clinic in San Francisco General, people without homes, those with mental illness, and those using stimulants receive care.

The clinical trials for long-acting injectable antiretrovirals included only people who were virologically suppressed, which is also the Food and Drug Administration criteria for use. However, this clinic offered long-acting injections to patients with viremia because it was too difficult for them to take a daily pill.

In a comment, Dr. Gandhi, director of the University of California, San Francisco’s Center for AIDS Research, said: “We don’t call people hard to reach, we call them hardly reached because it’s not their fault.” There are just all of these issues that have made it harder for them to take medication consistently.

Dr. Gandhi reported that, of the 133 people being treated with long-acting injectable cabotegravir and rilpivirine at the clinic through this program, 57 had viremia at baseline.

However, only two of these patients experienced virologic failure while on the injectable antiretroviral program. The overall virologic failure rate was 1.5%, which was equivalent to that seen in clinical trials in virologically suppressed individuals.

The results presented at the conference and were also published in Annals of Internal Medicine.

The clinic found that 73% of people attended their injection appointments on time, and those who did not were followed up with telephone calls to ensure they received their injection within the 14-day window.

Dr. Gandhi said people were highly motivated to turn up for their injection appointments. “They are virologically suppressed, so it feels so amazing. They’re self-motivated for the first time to want to get an injection.”

A version of this article first appeared on Medscape.com.

*Correction, 8/4/23: An earlier version of this article misstated Dr. Patel's university affiliation.