Clinician Reviews

The US Food and Drug Administration (FDA) has approved lifileucel (Amtagvi, Iovance Biotherapeutics) for the treatment of certain adults with unresectable or metastatic melanoma, marking the first approval of a cellular therapy in the solid tumor setting.

Specifically, the tumor-derived autologous T-cell immunotherapy is indicated for adult patients previously treated with a programmed cell death protein 1 (PD-1)–blocking antibody, and if BRAF V600–positive, a BRAF inhibitor with or without an MEK inhibitor. 

The approval “offers hope to those with advanced melanoma who have progressed following initial standard of care therapies, as the current treatment options are not effective for many patients,” Samantha R. Guild, JD, president, AIM at Melanoma Foundation, stated in a press release. “This one-time cell therapy represents a promising innovation for the melanoma community, and we are excited by its potential to transform care for patients who are in dire need of additional therapeutic options.”

The approval was based on findings from the open-label single-arm global C-144-01 clinical trial, which showed an objective response rate of 31.5% in 73 patients treated within the recommended dosing rage of 7.5 x 109 to 72 x 109 viable cells. Complete responses occurred in three patients (4.1%) and partial responses occurred in 20 patients (27.4%)

Median duration of response was not reached at 18.6 months of follow-up. The median time to initial response to the therapy was 1.5 months, according to an FDA press release.

“Unresectable or metastatic melanoma is an aggressive form of cancer that can be fatal,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research stated in the FDA release. “The approval of Amtagvi represents the culmination of scientific and clinical research efforts leading to a novel T cell immunotherapy for patients with limited treatment options.”

“The melanoma community is so grateful to the patients, caregivers, and clinicians who have made the clinical trials of this therapy possible and got lifileucel to approval,” Allison Betof Warner, MD, PhD, director of Melanoma Medical Oncology at Stanford Medicine, wrote on X. “We are very excited to bring this life-saving therapy to patients ASAP! Available immediately at @StanfordCancer!!!”

For the C-144-01 trial, lifileucel was administered after a lymphodepletion regimen of 60 mg/kg/d of cyclophosphamide for 2 days followed by 25 mg/m2/d of fludarabine for 5 days. Between 3 and 34 hours after infusion, patients received 600,000 IU/Kg of the interleukin 2 aldesleukin every 8-12 hours for up to six doses to support cell expansion in vivo. 

The full prescribing information for lifileucel contains a boxed warning for treatment-related mortality, prolonged severe cytopenia, severe infection, cardiopulmonary, and renal impairment. The most common adverse reactions, which occurred in at least 20% of patients, were chills, pyrexia, fatigue, tachycardia, diarrhea, febrile neutropenia, edema, rash hypotension, alopecia, infection, hypoxia, and dyspnea.

“Patients receiving this product should be closely monitored before and after infusion for signs and symptoms of adverse reactions. Treatment should be withheld or discontinued in the presence of these symptoms, as indicated,” according to the FDA statement.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved lifileucel (Amtagvi, Iovance Biotherapeutics) for the treatment of certain adults with unresectable or metastatic melanoma, marking the first approval of a cellular therapy in the solid tumor setting.

Specifically, the tumor-derived autologous T-cell immunotherapy is indicated for adult patients previously treated with a programmed cell death protein 1 (PD-1)–blocking antibody, and if BRAF V600–positive, a BRAF inhibitor with or without an MEK inhibitor. 

The approval “offers hope to those with advanced melanoma who have progressed following initial standard of care therapies, as the current treatment options are not effective for many patients,” Samantha R. Guild, JD, president, AIM at Melanoma Foundation, stated in a press release. “This one-time cell therapy represents a promising innovation for the melanoma community, and we are excited by its potential to transform care for patients who are in dire need of additional therapeutic options.”

The approval was based on findings from the open-label single-arm global C-144-01 clinical trial, which showed an objective response rate of 31.5% in 73 patients treated within the recommended dosing rage of 7.5 x 109 to 72 x 109 viable cells. Complete responses occurred in three patients (4.1%) and partial responses occurred in 20 patients (27.4%)

Median duration of response was not reached at 18.6 months of follow-up. The median time to initial response to the therapy was 1.5 months, according to an FDA press release.

“Unresectable or metastatic melanoma is an aggressive form of cancer that can be fatal,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research stated in the FDA release. “The approval of Amtagvi represents the culmination of scientific and clinical research efforts leading to a novel T cell immunotherapy for patients with limited treatment options.”

“The melanoma community is so grateful to the patients, caregivers, and clinicians who have made the clinical trials of this therapy possible and got lifileucel to approval,” Allison Betof Warner, MD, PhD, director of Melanoma Medical Oncology at Stanford Medicine, wrote on X. “We are very excited to bring this life-saving therapy to patients ASAP! Available immediately at @StanfordCancer!!!”

For the C-144-01 trial, lifileucel was administered after a lymphodepletion regimen of 60 mg/kg/d of cyclophosphamide for 2 days followed by 25 mg/m2/d of fludarabine for 5 days. Between 3 and 34 hours after infusion, patients received 600,000 IU/Kg of the interleukin 2 aldesleukin every 8-12 hours for up to six doses to support cell expansion in vivo. 

The full prescribing information for lifileucel contains a boxed warning for treatment-related mortality, prolonged severe cytopenia, severe infection, cardiopulmonary, and renal impairment. The most common adverse reactions, which occurred in at least 20% of patients, were chills, pyrexia, fatigue, tachycardia, diarrhea, febrile neutropenia, edema, rash hypotension, alopecia, infection, hypoxia, and dyspnea.

“Patients receiving this product should be closely monitored before and after infusion for signs and symptoms of adverse reactions. Treatment should be withheld or discontinued in the presence of these symptoms, as indicated,” according to the FDA statement.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved lifileucel (Amtagvi, Iovance Biotherapeutics) for the treatment of certain adults with unresectable or metastatic melanoma, marking the first approval of a cellular therapy in the solid tumor setting.

Specifically, the tumor-derived autologous T-cell immunotherapy is indicated for adult patients previously treated with a programmed cell death protein 1 (PD-1)–blocking antibody, and if BRAF V600–positive, a BRAF inhibitor with or without an MEK inhibitor. 

The approval “offers hope to those with advanced melanoma who have progressed following initial standard of care therapies, as the current treatment options are not effective for many patients,” Samantha R. Guild, JD, president, AIM at Melanoma Foundation, stated in a press release. “This one-time cell therapy represents a promising innovation for the melanoma community, and we are excited by its potential to transform care for patients who are in dire need of additional therapeutic options.”

The approval was based on findings from the open-label single-arm global C-144-01 clinical trial, which showed an objective response rate of 31.5% in 73 patients treated within the recommended dosing rage of 7.5 x 109 to 72 x 109 viable cells. Complete responses occurred in three patients (4.1%) and partial responses occurred in 20 patients (27.4%)

Median duration of response was not reached at 18.6 months of follow-up. The median time to initial response to the therapy was 1.5 months, according to an FDA press release.

“Unresectable or metastatic melanoma is an aggressive form of cancer that can be fatal,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research stated in the FDA release. “The approval of Amtagvi represents the culmination of scientific and clinical research efforts leading to a novel T cell immunotherapy for patients with limited treatment options.”

“The melanoma community is so grateful to the patients, caregivers, and clinicians who have made the clinical trials of this therapy possible and got lifileucel to approval,” Allison Betof Warner, MD, PhD, director of Melanoma Medical Oncology at Stanford Medicine, wrote on X. “We are very excited to bring this life-saving therapy to patients ASAP! Available immediately at @StanfordCancer!!!”

For the C-144-01 trial, lifileucel was administered after a lymphodepletion regimen of 60 mg/kg/d of cyclophosphamide for 2 days followed by 25 mg/m2/d of fludarabine for 5 days. Between 3 and 34 hours after infusion, patients received 600,000 IU/Kg of the interleukin 2 aldesleukin every 8-12 hours for up to six doses to support cell expansion in vivo. 

The full prescribing information for lifileucel contains a boxed warning for treatment-related mortality, prolonged severe cytopenia, severe infection, cardiopulmonary, and renal impairment. The most common adverse reactions, which occurred in at least 20% of patients, were chills, pyrexia, fatigue, tachycardia, diarrhea, febrile neutropenia, edema, rash hypotension, alopecia, infection, hypoxia, and dyspnea.

“Patients receiving this product should be closely monitored before and after infusion for signs and symptoms of adverse reactions. Treatment should be withheld or discontinued in the presence of these symptoms, as indicated,” according to the FDA statement.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved omalizumab (Xolair, Genentech) for reducing allergic reactions to foods in adults and most children. The drug is meant to be taken regularly by patients with food allergies to reduce the risk for reactions, including anaphylaxis, in case of accidental exposure to one or more allergens. The injection is not approved for emergency treatment of an allergic reaction.

Omalizumab first was approved for persistent allergic asthma in 2003. It also is approved for chronic spontaneous urticaria and chronic rhinosinusitis with nasal polyps. 

The new indication for immunoglobulin E–mediated food allergy in adults and children aged 1 year or older makes omalizumab the first drug approved to mitigate allergic reactions to more than one food, the FDA said. Peanut-allergen powder (Palforzia) can reduce reactions to peanut, but its benefits are limited to that allergy.

“While it will not eliminate food allergies or allow patients to consume food allergens freely, its repeated use will help reduce the health impact if accidental exposure occurs,” said Kelly Stone, MD, PhD, associate director of the division of pulmonology, allergy, and critical care in the FDA’s Center for Drug Evaluation and Research, in a news release. 

The safety and efficacy of the monoclonal antibody in reducing allergic reactions was studied in a double-blind, placebo-controlled study of 168 children and adults who were allergic to peanut and at least two other foods, including milk, egg, wheat, cashew, hazelnut, or walnut. Patients received omalizumab or placebo for 16-20 weeks. At the end of the study, patients consumed peanut protein (equivalent to 2.5 peanuts). Of those who received the drug, 68% were able to consume peanut without moderate or severe allergic symptoms, versus 6% in the placebo group.

More patients who received the medication also avoided moderate or severe reactions to cashews (42% vs 3%), milk (66% vs 11%), and eggs (67% vs 0%). 

The most common side effects of omalizumab included injection site reactions and fever. The drug’s label includes warnings and precautions about anaphylaxis, cancer, fever, joint pain, rash, parasitic (worm) infection, and abnormal laboratory tests. Omalizumab comes with a boxed warning for anaphylaxis and should be started only in a healthcare setting equipped to manage anaphylaxis, according to the FDA.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved omalizumab (Xolair, Genentech) for reducing allergic reactions to foods in adults and most children. The drug is meant to be taken regularly by patients with food allergies to reduce the risk for reactions, including anaphylaxis, in case of accidental exposure to one or more allergens. The injection is not approved for emergency treatment of an allergic reaction.

Omalizumab first was approved for persistent allergic asthma in 2003. It also is approved for chronic spontaneous urticaria and chronic rhinosinusitis with nasal polyps. 

The new indication for immunoglobulin E–mediated food allergy in adults and children aged 1 year or older makes omalizumab the first drug approved to mitigate allergic reactions to more than one food, the FDA said. Peanut-allergen powder (Palforzia) can reduce reactions to peanut, but its benefits are limited to that allergy.

“While it will not eliminate food allergies or allow patients to consume food allergens freely, its repeated use will help reduce the health impact if accidental exposure occurs,” said Kelly Stone, MD, PhD, associate director of the division of pulmonology, allergy, and critical care in the FDA’s Center for Drug Evaluation and Research, in a news release. 

The safety and efficacy of the monoclonal antibody in reducing allergic reactions was studied in a double-blind, placebo-controlled study of 168 children and adults who were allergic to peanut and at least two other foods, including milk, egg, wheat, cashew, hazelnut, or walnut. Patients received omalizumab or placebo for 16-20 weeks. At the end of the study, patients consumed peanut protein (equivalent to 2.5 peanuts). Of those who received the drug, 68% were able to consume peanut without moderate or severe allergic symptoms, versus 6% in the placebo group.

More patients who received the medication also avoided moderate or severe reactions to cashews (42% vs 3%), milk (66% vs 11%), and eggs (67% vs 0%). 

The most common side effects of omalizumab included injection site reactions and fever. The drug’s label includes warnings and precautions about anaphylaxis, cancer, fever, joint pain, rash, parasitic (worm) infection, and abnormal laboratory tests. Omalizumab comes with a boxed warning for anaphylaxis and should be started only in a healthcare setting equipped to manage anaphylaxis, according to the FDA.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved omalizumab (Xolair, Genentech) for reducing allergic reactions to foods in adults and most children. The drug is meant to be taken regularly by patients with food allergies to reduce the risk for reactions, including anaphylaxis, in case of accidental exposure to one or more allergens. The injection is not approved for emergency treatment of an allergic reaction.

Omalizumab first was approved for persistent allergic asthma in 2003. It also is approved for chronic spontaneous urticaria and chronic rhinosinusitis with nasal polyps. 

The new indication for immunoglobulin E–mediated food allergy in adults and children aged 1 year or older makes omalizumab the first drug approved to mitigate allergic reactions to more than one food, the FDA said. Peanut-allergen powder (Palforzia) can reduce reactions to peanut, but its benefits are limited to that allergy.

“While it will not eliminate food allergies or allow patients to consume food allergens freely, its repeated use will help reduce the health impact if accidental exposure occurs,” said Kelly Stone, MD, PhD, associate director of the division of pulmonology, allergy, and critical care in the FDA’s Center for Drug Evaluation and Research, in a news release. 

The safety and efficacy of the monoclonal antibody in reducing allergic reactions was studied in a double-blind, placebo-controlled study of 168 children and adults who were allergic to peanut and at least two other foods, including milk, egg, wheat, cashew, hazelnut, or walnut. Patients received omalizumab or placebo for 16-20 weeks. At the end of the study, patients consumed peanut protein (equivalent to 2.5 peanuts). Of those who received the drug, 68% were able to consume peanut without moderate or severe allergic symptoms, versus 6% in the placebo group.

More patients who received the medication also avoided moderate or severe reactions to cashews (42% vs 3%), milk (66% vs 11%), and eggs (67% vs 0%). 

The most common side effects of omalizumab included injection site reactions and fever. The drug’s label includes warnings and precautions about anaphylaxis, cancer, fever, joint pain, rash, parasitic (worm) infection, and abnormal laboratory tests. Omalizumab comes with a boxed warning for anaphylaxis and should be started only in a healthcare setting equipped to manage anaphylaxis, according to the FDA.

A version of this article appeared on Medscape.com.

TOPLINE:

A cohort study of primary care patients with obesity found significant associations between weight management treatments (WMTs) and ≥ 5% weight loss for individuals.

Yet, low WMT utilization hindered population-level benefit.

METHODOLOGY:

This retrospective, population-based cross-sectional cohort study included 149,959 primary care patients from a Michigan academic health system between October 2015 and March 2020.

TAKEAWAY:

• From 2017 to 2019, the average unadjusted body mass index (BMI) increased from 29.34 kg/m2 to 29.61 kg/m2 and the prevalence of obesity from 39.2% to 40.7%.
• Among 31,284 patients with obesity in 2017, 25.9% (6665) achieved ≥ 5% weight loss at 2 years.
• Among 37,245 with obesity in either 2017 or 2019 and sufficient follow-up, 1-year WMT utilization increased from 5.3% in 2017 to 7.1% in 2019 (difference, 1.7%; 95% CI, 1.3%-2.2%), including nutritional counseling (6.3%), weight loss medication prescriptions (2.6%), and bariatric surgery (1.0%).
• In two groups of n = 5090 with and without WMT exposure who were propensity score–matched on covariates including BMI, sex, and age, the probabilities of ≥ 5% weight loss at 1 year were 15.6% without WMTs, 23.1% for nutrition counseling, 54.6% for meal replacement, 27.8% for weight loss medication, and 93% for bariatric surgery, with all approaches significant compared to no WMTs.

IN PRACTICE:

“Health systems and insurers should consider novel strategies to enhance preference-sensitive use of WMT to optimize achievement of 5% or greater weight loss among individuals and populations with obesity.”

“While we included glucagon-like peptide 1 receptor agonists for type 2 diabetes, including semaglutide 1.0 mg, in our analyses, the study period predated the [US Food and Drug Administration]-approval of semaglutide 2.4 mg for weight management. Future work should explore the potential for semaglutide 2.4 mg and other medications with substantial weight loss effectiveness to reduce weight at the population level.”

SOURCE:

This study was conducted by James Henderson, PhD, of the Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, and colleagues and was published online in JAMA Network Open .

LIMITATIONS:

Single health system. Electronic health record data may be subject to weight and WMT measurement error, lack of adherence data, and any information about outside WMT access. Retrospective, observational study, subject to bias. Study period occurred before FDA approval of semaglutide for weight management, and thus, the findings may understate current use and effectiveness of weight loss medications.

DISCLOSURES:

The study was supported by grants from the National Institutes of Health and National Institute of Diabetes and Digestive and Kidney Diseases, Michigan Center for Diabetes Translational Research, Michigan Nutrition Obesity Research Center, and the Elizabeth Weiser Caswell Diabetes Institute at the University of Michigan. Dr. Henderson had no further disclosures, but some of the coauthors had industry ties.

A version of this article appeared on Medscape.com.

TOPLINE:

A cohort study of primary care patients with obesity found significant associations between weight management treatments (WMTs) and ≥ 5% weight loss for individuals.

Yet, low WMT utilization hindered population-level benefit.

METHODOLOGY:

This retrospective, population-based cross-sectional cohort study included 149,959 primary care patients from a Michigan academic health system between October 2015 and March 2020.

TAKEAWAY:

• From 2017 to 2019, the average unadjusted body mass index (BMI) increased from 29.34 kg/m2 to 29.61 kg/m2 and the prevalence of obesity from 39.2% to 40.7%.
• Among 31,284 patients with obesity in 2017, 25.9% (6665) achieved ≥ 5% weight loss at 2 years.
• Among 37,245 with obesity in either 2017 or 2019 and sufficient follow-up, 1-year WMT utilization increased from 5.3% in 2017 to 7.1% in 2019 (difference, 1.7%; 95% CI, 1.3%-2.2%), including nutritional counseling (6.3%), weight loss medication prescriptions (2.6%), and bariatric surgery (1.0%).
• In two groups of n = 5090 with and without WMT exposure who were propensity score–matched on covariates including BMI, sex, and age, the probabilities of ≥ 5% weight loss at 1 year were 15.6% without WMTs, 23.1% for nutrition counseling, 54.6% for meal replacement, 27.8% for weight loss medication, and 93% for bariatric surgery, with all approaches significant compared to no WMTs.

IN PRACTICE:

“Health systems and insurers should consider novel strategies to enhance preference-sensitive use of WMT to optimize achievement of 5% or greater weight loss among individuals and populations with obesity.”

“While we included glucagon-like peptide 1 receptor agonists for type 2 diabetes, including semaglutide 1.0 mg, in our analyses, the study period predated the [US Food and Drug Administration]-approval of semaglutide 2.4 mg for weight management. Future work should explore the potential for semaglutide 2.4 mg and other medications with substantial weight loss effectiveness to reduce weight at the population level.”

SOURCE:

This study was conducted by James Henderson, PhD, of the Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, and colleagues and was published online in JAMA Network Open .

LIMITATIONS:

Single health system. Electronic health record data may be subject to weight and WMT measurement error, lack of adherence data, and any information about outside WMT access. Retrospective, observational study, subject to bias. Study period occurred before FDA approval of semaglutide for weight management, and thus, the findings may understate current use and effectiveness of weight loss medications.

DISCLOSURES:

The study was supported by grants from the National Institutes of Health and National Institute of Diabetes and Digestive and Kidney Diseases, Michigan Center for Diabetes Translational Research, Michigan Nutrition Obesity Research Center, and the Elizabeth Weiser Caswell Diabetes Institute at the University of Michigan. Dr. Henderson had no further disclosures, but some of the coauthors had industry ties.

A version of this article appeared on Medscape.com.

TOPLINE:

A cohort study of primary care patients with obesity found significant associations between weight management treatments (WMTs) and ≥ 5% weight loss for individuals.

Yet, low WMT utilization hindered population-level benefit.

METHODOLOGY:

This retrospective, population-based cross-sectional cohort study included 149,959 primary care patients from a Michigan academic health system between October 2015 and March 2020.

TAKEAWAY:

• From 2017 to 2019, the average unadjusted body mass index (BMI) increased from 29.34 kg/m2 to 29.61 kg/m2 and the prevalence of obesity from 39.2% to 40.7%.
• Among 31,284 patients with obesity in 2017, 25.9% (6665) achieved ≥ 5% weight loss at 2 years.
• Among 37,245 with obesity in either 2017 or 2019 and sufficient follow-up, 1-year WMT utilization increased from 5.3% in 2017 to 7.1% in 2019 (difference, 1.7%; 95% CI, 1.3%-2.2%), including nutritional counseling (6.3%), weight loss medication prescriptions (2.6%), and bariatric surgery (1.0%).
• In two groups of n = 5090 with and without WMT exposure who were propensity score–matched on covariates including BMI, sex, and age, the probabilities of ≥ 5% weight loss at 1 year were 15.6% without WMTs, 23.1% for nutrition counseling, 54.6% for meal replacement, 27.8% for weight loss medication, and 93% for bariatric surgery, with all approaches significant compared to no WMTs.

IN PRACTICE:

“Health systems and insurers should consider novel strategies to enhance preference-sensitive use of WMT to optimize achievement of 5% or greater weight loss among individuals and populations with obesity.”

“While we included glucagon-like peptide 1 receptor agonists for type 2 diabetes, including semaglutide 1.0 mg, in our analyses, the study period predated the [US Food and Drug Administration]-approval of semaglutide 2.4 mg for weight management. Future work should explore the potential for semaglutide 2.4 mg and other medications with substantial weight loss effectiveness to reduce weight at the population level.”

SOURCE:

This study was conducted by James Henderson, PhD, of the Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, and colleagues and was published online in JAMA Network Open .

LIMITATIONS:

Single health system. Electronic health record data may be subject to weight and WMT measurement error, lack of adherence data, and any information about outside WMT access. Retrospective, observational study, subject to bias. Study period occurred before FDA approval of semaglutide for weight management, and thus, the findings may understate current use and effectiveness of weight loss medications.

DISCLOSURES:

The study was supported by grants from the National Institutes of Health and National Institute of Diabetes and Digestive and Kidney Diseases, Michigan Center for Diabetes Translational Research, Michigan Nutrition Obesity Research Center, and the Elizabeth Weiser Caswell Diabetes Institute at the University of Michigan. Dr. Henderson had no further disclosures, but some of the coauthors had industry ties.

A version of this article appeared on Medscape.com.

How much of societal diet-related scientific illiteracy can be blamed on the publication decisions of medical journals around food studies?

That was the question I pondered when reading “Association between kimchi consumption and obesity based on BMI and abdominal obesity in Korean adults: a cross-sectional analysis of the Health Examinees study,” recently published in BMJ Open. Although I will get to the study particulars momentarily, that it’s 2024 and journals are still publishing cross-sectional studies of the impact of a single food’s subjectively reported consumption on health outcomes is mind boggling.

You might wonder why I wasn’t mind boggled by the authors rather than the journal — but the authors’ interest in publishing a study on kimchi’s supposed impact on obesity is an easy thing to explain, in that the study was funded by the World Institute of Kimchi, where two of its four authors are employed.

You might also wonder why I wasn’t mind boggled by media running with this story — but the media’s job is to capture eyeballs, and who doesn’t love a good magic food story, doubly so for one involving obesity and one with a study backing it up?

Back to this World Institute of Kimchi project looking at kimchi intake on obesity rates. No doubt if I worked for the World Institute of Kimchi, I would want kimchi to be shown to be somehow magically protective against weight gain. So how might I go about exploring that?

Well, I could look to the data from the Health Examinees (HEXA) Study. The HEXA study was a cross-sectional look at South Koreans; included in their data collection was a 106-item food frequency questionnaire (FFQ).

That questionnaire looked at 106 food items — yep, you guessed it, explicitly including kimchi. Not included in this FFQ, though, were prepared foods, meaning that it was unable to measure seasonings, spices, or cooking oils. Also perhaps problematic is that no doubt most of us consume more than 106 total food items in our diets. Perhaps this is why the validation study of HEXA’s food item–based FFQ found that it had “relatively low validity” when compared against 12-day food diaries and why its creators themselves report it to be in their study’s conclusion only “reasonably acceptable” to apply to a population. But yes, kimchi!

So for the sake of this exercise, though, let’s assume that instead of only a reasonably acceptable FFQ with low validity, the FFQ was fantastic and its data robust. How great then is kimchi at preventing obesity? Certainly, the media report it’s pretty darn good. Here’s a smattering from the literal dozens of headlines of stories covering this paper:

Eating kimchi every day could help stave off weight gain, new study says — NBC News

Eating kimchi every day may prevent weight gain, research suggests — Sky News

Want to avoid piling on the pounds? Try kimchi for breakfast — The Telegraph

But when we turn to the paper itself, suddenly things aren’t so clear.

According to the paper, men who reported eating two to three servings of kimchi per day were found to have lower rates of obesity, whereas men who reported eating three to five servings of kimchi per day were not. But these are overlapping groups! Also found was that men consuming more than five servings of kimchi per day have higher rates of obesity. When taken together, these findings do not demonstrate a statistically significant trend of kimchi intake on obesity in men. Whereas in women, things are worse in that the more kimchi reportedly consumed, the more obesity, in a trend that did (just) reach statistical significance.

So even if we pretend the FFQs were robust enough to make conclusions about a single food’s impact on obesity, and we pretend there was a well-described, plausible mechanistic reason to believe same (there isn’t), and we pretend that this particular FFQ had better than “relatively low validity,” there is no conclusion here to be drawn about kimchi’s impact on obesity.

What we can conclude is that when it comes to publishing papers purporting to find the impact of single foods on obesity, journals will still happily publish them and their publication will lead to hyperbolic headlines and stories, which in turn reinforce the scientifically illiterate notion that the highly complex multifactorial problem of obesity boils down to simple food choices, which in turn keeps weight loss grifters everywhere in business while fueling societal weight bias.

Dr. Freedhoff is Associate Professor, Department of Family Medicine, University of Ottawa; Medical Director, Bariatric Medical Institute, Ottawa, Ontario, Canada. He disclosed ties with Bariatric Medical Institute, Constant Health, and Novo Nordisk.

A version of this article appeared on Medscape.com.

How much of societal diet-related scientific illiteracy can be blamed on the publication decisions of medical journals around food studies?

That was the question I pondered when reading “Association between kimchi consumption and obesity based on BMI and abdominal obesity in Korean adults: a cross-sectional analysis of the Health Examinees study,” recently published in BMJ Open. Although I will get to the study particulars momentarily, that it’s 2024 and journals are still publishing cross-sectional studies of the impact of a single food’s subjectively reported consumption on health outcomes is mind boggling.

You might wonder why I wasn’t mind boggled by the authors rather than the journal — but the authors’ interest in publishing a study on kimchi’s supposed impact on obesity is an easy thing to explain, in that the study was funded by the World Institute of Kimchi, where two of its four authors are employed.

You might also wonder why I wasn’t mind boggled by media running with this story — but the media’s job is to capture eyeballs, and who doesn’t love a good magic food story, doubly so for one involving obesity and one with a study backing it up?

Back to this World Institute of Kimchi project looking at kimchi intake on obesity rates. No doubt if I worked for the World Institute of Kimchi, I would want kimchi to be shown to be somehow magically protective against weight gain. So how might I go about exploring that?

Well, I could look to the data from the Health Examinees (HEXA) Study. The HEXA study was a cross-sectional look at South Koreans; included in their data collection was a 106-item food frequency questionnaire (FFQ).

That questionnaire looked at 106 food items — yep, you guessed it, explicitly including kimchi. Not included in this FFQ, though, were prepared foods, meaning that it was unable to measure seasonings, spices, or cooking oils. Also perhaps problematic is that no doubt most of us consume more than 106 total food items in our diets. Perhaps this is why the validation study of HEXA’s food item–based FFQ found that it had “relatively low validity” when compared against 12-day food diaries and why its creators themselves report it to be in their study’s conclusion only “reasonably acceptable” to apply to a population. But yes, kimchi!

So for the sake of this exercise, though, let’s assume that instead of only a reasonably acceptable FFQ with low validity, the FFQ was fantastic and its data robust. How great then is kimchi at preventing obesity? Certainly, the media report it’s pretty darn good. Here’s a smattering from the literal dozens of headlines of stories covering this paper:

Eating kimchi every day could help stave off weight gain, new study says — NBC News

Eating kimchi every day may prevent weight gain, research suggests — Sky News

Want to avoid piling on the pounds? Try kimchi for breakfast — The Telegraph

But when we turn to the paper itself, suddenly things aren’t so clear.

According to the paper, men who reported eating two to three servings of kimchi per day were found to have lower rates of obesity, whereas men who reported eating three to five servings of kimchi per day were not. But these are overlapping groups! Also found was that men consuming more than five servings of kimchi per day have higher rates of obesity. When taken together, these findings do not demonstrate a statistically significant trend of kimchi intake on obesity in men. Whereas in women, things are worse in that the more kimchi reportedly consumed, the more obesity, in a trend that did (just) reach statistical significance.

So even if we pretend the FFQs were robust enough to make conclusions about a single food’s impact on obesity, and we pretend there was a well-described, plausible mechanistic reason to believe same (there isn’t), and we pretend that this particular FFQ had better than “relatively low validity,” there is no conclusion here to be drawn about kimchi’s impact on obesity.

What we can conclude is that when it comes to publishing papers purporting to find the impact of single foods on obesity, journals will still happily publish them and their publication will lead to hyperbolic headlines and stories, which in turn reinforce the scientifically illiterate notion that the highly complex multifactorial problem of obesity boils down to simple food choices, which in turn keeps weight loss grifters everywhere in business while fueling societal weight bias.

Dr. Freedhoff is Associate Professor, Department of Family Medicine, University of Ottawa; Medical Director, Bariatric Medical Institute, Ottawa, Ontario, Canada. He disclosed ties with Bariatric Medical Institute, Constant Health, and Novo Nordisk.

A version of this article appeared on Medscape.com.

How much of societal diet-related scientific illiteracy can be blamed on the publication decisions of medical journals around food studies?

That was the question I pondered when reading “Association between kimchi consumption and obesity based on BMI and abdominal obesity in Korean adults: a cross-sectional analysis of the Health Examinees study,” recently published in BMJ Open. Although I will get to the study particulars momentarily, that it’s 2024 and journals are still publishing cross-sectional studies of the impact of a single food’s subjectively reported consumption on health outcomes is mind boggling.

You might wonder why I wasn’t mind boggled by the authors rather than the journal — but the authors’ interest in publishing a study on kimchi’s supposed impact on obesity is an easy thing to explain, in that the study was funded by the World Institute of Kimchi, where two of its four authors are employed.

You might also wonder why I wasn’t mind boggled by media running with this story — but the media’s job is to capture eyeballs, and who doesn’t love a good magic food story, doubly so for one involving obesity and one with a study backing it up?

Back to this World Institute of Kimchi project looking at kimchi intake on obesity rates. No doubt if I worked for the World Institute of Kimchi, I would want kimchi to be shown to be somehow magically protective against weight gain. So how might I go about exploring that?

Well, I could look to the data from the Health Examinees (HEXA) Study. The HEXA study was a cross-sectional look at South Koreans; included in their data collection was a 106-item food frequency questionnaire (FFQ).

That questionnaire looked at 106 food items — yep, you guessed it, explicitly including kimchi. Not included in this FFQ, though, were prepared foods, meaning that it was unable to measure seasonings, spices, or cooking oils. Also perhaps problematic is that no doubt most of us consume more than 106 total food items in our diets. Perhaps this is why the validation study of HEXA’s food item–based FFQ found that it had “relatively low validity” when compared against 12-day food diaries and why its creators themselves report it to be in their study’s conclusion only “reasonably acceptable” to apply to a population. But yes, kimchi!

So for the sake of this exercise, though, let’s assume that instead of only a reasonably acceptable FFQ with low validity, the FFQ was fantastic and its data robust. How great then is kimchi at preventing obesity? Certainly, the media report it’s pretty darn good. Here’s a smattering from the literal dozens of headlines of stories covering this paper:

Eating kimchi every day could help stave off weight gain, new study says — NBC News

Eating kimchi every day may prevent weight gain, research suggests — Sky News

Want to avoid piling on the pounds? Try kimchi for breakfast — The Telegraph

But when we turn to the paper itself, suddenly things aren’t so clear.

According to the paper, men who reported eating two to three servings of kimchi per day were found to have lower rates of obesity, whereas men who reported eating three to five servings of kimchi per day were not. But these are overlapping groups! Also found was that men consuming more than five servings of kimchi per day have higher rates of obesity. When taken together, these findings do not demonstrate a statistically significant trend of kimchi intake on obesity in men. Whereas in women, things are worse in that the more kimchi reportedly consumed, the more obesity, in a trend that did (just) reach statistical significance.

So even if we pretend the FFQs were robust enough to make conclusions about a single food’s impact on obesity, and we pretend there was a well-described, plausible mechanistic reason to believe same (there isn’t), and we pretend that this particular FFQ had better than “relatively low validity,” there is no conclusion here to be drawn about kimchi’s impact on obesity.

What we can conclude is that when it comes to publishing papers purporting to find the impact of single foods on obesity, journals will still happily publish them and their publication will lead to hyperbolic headlines and stories, which in turn reinforce the scientifically illiterate notion that the highly complex multifactorial problem of obesity boils down to simple food choices, which in turn keeps weight loss grifters everywhere in business while fueling societal weight bias.

Dr. Freedhoff is Associate Professor, Department of Family Medicine, University of Ottawa; Medical Director, Bariatric Medical Institute, Ottawa, Ontario, Canada. He disclosed ties with Bariatric Medical Institute, Constant Health, and Novo Nordisk.

A version of this article appeared on Medscape.com.

Ashley Winter, MD, remembers the first time she Googled the skin condition lichen sclerosus. Most of the websites listed the autoimmune condition as a rare disease.

In the realm of genital health, some conditions remain shrouded in silence and consequently are more likely to go undercounted and underdiagnosed, said Dr. Winter, a urologist based in Los Angeles.

“I truly believe that we just miss the diagnosis a vast majority of the time because there isn’t enough training on [detecting] it,” said Dr. Winter.

Lichen sclerosus primarily affects the skin in the genital and anal regions. Estimates of the disease range between 1 in 300 and 1 in 1000 people, according to the US National Institutes of Health. The condition also more commonly occurs among women, and symptoms include hypopigmentation, itching, pain, changes in skin appearance, and skin atrophy.

“Most cases [affect the] genital [area] only, so often patients don’t bring it up because they don’t want to be examined,” said Sarah Lonowski, MD, assistant professor of dermatology and codirector of the Multidisciplinary Autoimmune Skin Disease/Derm-Rheum Program at the University of Nebraska–Lincoln. “It’s a sensitive area, it’s an uncomfortable area to have examined, so it comes with a lot of emotional burden,” for patients, Dr. Lonowski said.

Receiving a lichen sclerosis diagnosis can take 5 years or longer, in part because the condition’s symptoms can lead clinicians to first make a diagnosis of a yeast infection or bacterial vaginosis, according to Christina Kraus, MD, assistant professor of dermatology at UCI Health in Irvine, California.

“There is still limited information on this condition in medical education, and it is not uncommon for clinicians who are not in dermatology or gynecology to be unfamiliar with this diagnosis,” Dr. Kraus said.

Because no medical tests are available to confirm lichen sclerosus, clinicians diagnose the condition based on the skin’s appearance and symptoms. In some cases, a skin biopsy may help differentiate it from similar rashes that occur in the genital area.

Prepubescent children and postmenopausal women are most likely to develop genital lichen sclerosis, so pediatricians and primary care physicians may be the first to see possible cases, Dr. Lonowski said.

Patients “may not mention it unless they’re asked,” Dr. Lonowski said, adding clinicians can inquire with patients about genital health, examine bothersome areas, “and refer if you’re not sure.”

Clinicians may also miss the condition during physical exams if they do not examine the vulvar skin, she said. The exact cause also remains elusive, but researchers believe genetic and hormonal factors, as well as an overactive immune response, may contribute to development of the condition.
 

Watch Out for Presentation

While lichen sclerosus more frequently occurs in women, men are also affected by the condition. Benjamin N. Breyer, MD, professor and chair of urology at the University of California San Francisco, said lichen sclerosus is one of the most common skin conditions he treats in his male patients.

“Advanced cases can cause urethral narrowing, which is a condition I treat commonly,” said Dr. Breyer. “Lichen sclerosus is often an underrecognized cause of pain or tearing with erections and sex in men.”

Similar to women, lichen sclerosus presents as white color changes on the skin. For men, the condition can also result in fusion of the shaft skin to the head of the penis and burying or concealment of the penis, Dr. Breyer said.

“This leads to challenges with intimacy and urination and can have extensive impacts on quality of life,” said Dr. Breyer.

For women, the skin changes often extend to the perianal area and can cause scarring, said Dr. Kraus.

“Early scarring may present as adherence of the labia minora to the labia majora or inability to fully retract the clitoral hood from the clitoris,” said Dr. Kraus.

In both men and women, lichen sclerosus and another autoimmune condition known as morphea, characterized by skin hardening and discoloration, often present together, said Dr. Lonowski.

“If you have a patient with known morphea, it’s important to ask about genital symptoms,” said Dr. Lonowski. “The association between the two is fairly strong.”

Circumcision is often the first step to help prevent chronic inflammation among male patients, said Dr. Breyer. Because lichen sclerosus is associated with an increased risk for penile cancer, “it is important to biopsy suspicious lesions,” Dr. Breyer added.

Increasing awareness of lichen sclerosus is crucial for early detection and timely intervention, said Dr. Lonowski. The first-line treatment of genital lichen sclerosus is strong topical steroid ointments to reduce inflammation. Clinicians might prescribe this treatment for use twice daily for 2-3 months and then assesses the patient on their response.

“It is fairly responsive to treatment in most cases,” said Dr. Lonowski.

Once symptoms have improved, Dr. Lonowski transitions patients to a maintenance regimen, which might include using the same steroid but only three times a week, switching to a topical with a less potent steroid dosage, or using a combination of a topical steroid and a nonsteroidal anti-inflammatory cream. Despite the prolonged use of the drug, she said patients with lichen sclerosus usually do not present with side effects like discoloration or thinning of skin.

“You may achieve control or remission, but we don’t stop treatment completely because we know the natural history of the disease is to have flares and recurrence.”

If left untreated, the condition can lead to atrophy, scarring, and distortion of the genital anatomy and, in some cases, develop into squamous cell carcinoma.

“The fact that you can do a topical cream intervention and prevent cancer is huge,” said Dr. Winter.

She said open discussions surrounding genital health led by primary care providers can destigmatize conditions like lichen sclerosus and promote early detection and management.

“We need to foster an environment where individuals feel comfortable discussing their symptoms openly,” Dr. Winter said. “Increased awareness can pave the way for early detection, which is crucial for managing the condition effectively.”

The experts included in the story reported no relevant disclosures.
 

A version of this article appeared on Medscape.com.

Ashley Winter, MD, remembers the first time she Googled the skin condition lichen sclerosus. Most of the websites listed the autoimmune condition as a rare disease.

In the realm of genital health, some conditions remain shrouded in silence and consequently are more likely to go undercounted and underdiagnosed, said Dr. Winter, a urologist based in Los Angeles.

“I truly believe that we just miss the diagnosis a vast majority of the time because there isn’t enough training on [detecting] it,” said Dr. Winter.

Lichen sclerosus primarily affects the skin in the genital and anal regions. Estimates of the disease range between 1 in 300 and 1 in 1000 people, according to the US National Institutes of Health. The condition also more commonly occurs among women, and symptoms include hypopigmentation, itching, pain, changes in skin appearance, and skin atrophy.

“Most cases [affect the] genital [area] only, so often patients don’t bring it up because they don’t want to be examined,” said Sarah Lonowski, MD, assistant professor of dermatology and codirector of the Multidisciplinary Autoimmune Skin Disease/Derm-Rheum Program at the University of Nebraska–Lincoln. “It’s a sensitive area, it’s an uncomfortable area to have examined, so it comes with a lot of emotional burden,” for patients, Dr. Lonowski said.

Receiving a lichen sclerosis diagnosis can take 5 years or longer, in part because the condition’s symptoms can lead clinicians to first make a diagnosis of a yeast infection or bacterial vaginosis, according to Christina Kraus, MD, assistant professor of dermatology at UCI Health in Irvine, California.

“There is still limited information on this condition in medical education, and it is not uncommon for clinicians who are not in dermatology or gynecology to be unfamiliar with this diagnosis,” Dr. Kraus said.

Because no medical tests are available to confirm lichen sclerosus, clinicians diagnose the condition based on the skin’s appearance and symptoms. In some cases, a skin biopsy may help differentiate it from similar rashes that occur in the genital area.

Prepubescent children and postmenopausal women are most likely to develop genital lichen sclerosis, so pediatricians and primary care physicians may be the first to see possible cases, Dr. Lonowski said.

Patients “may not mention it unless they’re asked,” Dr. Lonowski said, adding clinicians can inquire with patients about genital health, examine bothersome areas, “and refer if you’re not sure.”

Clinicians may also miss the condition during physical exams if they do not examine the vulvar skin, she said. The exact cause also remains elusive, but researchers believe genetic and hormonal factors, as well as an overactive immune response, may contribute to development of the condition.
 

Watch Out for Presentation

While lichen sclerosus more frequently occurs in women, men are also affected by the condition. Benjamin N. Breyer, MD, professor and chair of urology at the University of California San Francisco, said lichen sclerosus is one of the most common skin conditions he treats in his male patients.

“Advanced cases can cause urethral narrowing, which is a condition I treat commonly,” said Dr. Breyer. “Lichen sclerosus is often an underrecognized cause of pain or tearing with erections and sex in men.”

Similar to women, lichen sclerosus presents as white color changes on the skin. For men, the condition can also result in fusion of the shaft skin to the head of the penis and burying or concealment of the penis, Dr. Breyer said.

“This leads to challenges with intimacy and urination and can have extensive impacts on quality of life,” said Dr. Breyer.

For women, the skin changes often extend to the perianal area and can cause scarring, said Dr. Kraus.

“Early scarring may present as adherence of the labia minora to the labia majora or inability to fully retract the clitoral hood from the clitoris,” said Dr. Kraus.

In both men and women, lichen sclerosus and another autoimmune condition known as morphea, characterized by skin hardening and discoloration, often present together, said Dr. Lonowski.

“If you have a patient with known morphea, it’s important to ask about genital symptoms,” said Dr. Lonowski. “The association between the two is fairly strong.”

Circumcision is often the first step to help prevent chronic inflammation among male patients, said Dr. Breyer. Because lichen sclerosus is associated with an increased risk for penile cancer, “it is important to biopsy suspicious lesions,” Dr. Breyer added.

Increasing awareness of lichen sclerosus is crucial for early detection and timely intervention, said Dr. Lonowski. The first-line treatment of genital lichen sclerosus is strong topical steroid ointments to reduce inflammation. Clinicians might prescribe this treatment for use twice daily for 2-3 months and then assesses the patient on their response.

“It is fairly responsive to treatment in most cases,” said Dr. Lonowski.

Once symptoms have improved, Dr. Lonowski transitions patients to a maintenance regimen, which might include using the same steroid but only three times a week, switching to a topical with a less potent steroid dosage, or using a combination of a topical steroid and a nonsteroidal anti-inflammatory cream. Despite the prolonged use of the drug, she said patients with lichen sclerosus usually do not present with side effects like discoloration or thinning of skin.

“You may achieve control or remission, but we don’t stop treatment completely because we know the natural history of the disease is to have flares and recurrence.”

If left untreated, the condition can lead to atrophy, scarring, and distortion of the genital anatomy and, in some cases, develop into squamous cell carcinoma.

“The fact that you can do a topical cream intervention and prevent cancer is huge,” said Dr. Winter.

She said open discussions surrounding genital health led by primary care providers can destigmatize conditions like lichen sclerosus and promote early detection and management.

“We need to foster an environment where individuals feel comfortable discussing their symptoms openly,” Dr. Winter said. “Increased awareness can pave the way for early detection, which is crucial for managing the condition effectively.”

The experts included in the story reported no relevant disclosures.
 

A version of this article appeared on Medscape.com.

Ashley Winter, MD, remembers the first time she Googled the skin condition lichen sclerosus. Most of the websites listed the autoimmune condition as a rare disease.

In the realm of genital health, some conditions remain shrouded in silence and consequently are more likely to go undercounted and underdiagnosed, said Dr. Winter, a urologist based in Los Angeles.

“I truly believe that we just miss the diagnosis a vast majority of the time because there isn’t enough training on [detecting] it,” said Dr. Winter.

Lichen sclerosus primarily affects the skin in the genital and anal regions. Estimates of the disease range between 1 in 300 and 1 in 1000 people, according to the US National Institutes of Health. The condition also more commonly occurs among women, and symptoms include hypopigmentation, itching, pain, changes in skin appearance, and skin atrophy.

“Most cases [affect the] genital [area] only, so often patients don’t bring it up because they don’t want to be examined,” said Sarah Lonowski, MD, assistant professor of dermatology and codirector of the Multidisciplinary Autoimmune Skin Disease/Derm-Rheum Program at the University of Nebraska–Lincoln. “It’s a sensitive area, it’s an uncomfortable area to have examined, so it comes with a lot of emotional burden,” for patients, Dr. Lonowski said.

Receiving a lichen sclerosis diagnosis can take 5 years or longer, in part because the condition’s symptoms can lead clinicians to first make a diagnosis of a yeast infection or bacterial vaginosis, according to Christina Kraus, MD, assistant professor of dermatology at UCI Health in Irvine, California.

“There is still limited information on this condition in medical education, and it is not uncommon for clinicians who are not in dermatology or gynecology to be unfamiliar with this diagnosis,” Dr. Kraus said.

Because no medical tests are available to confirm lichen sclerosus, clinicians diagnose the condition based on the skin’s appearance and symptoms. In some cases, a skin biopsy may help differentiate it from similar rashes that occur in the genital area.

Prepubescent children and postmenopausal women are most likely to develop genital lichen sclerosis, so pediatricians and primary care physicians may be the first to see possible cases, Dr. Lonowski said.

Patients “may not mention it unless they’re asked,” Dr. Lonowski said, adding clinicians can inquire with patients about genital health, examine bothersome areas, “and refer if you’re not sure.”

Clinicians may also miss the condition during physical exams if they do not examine the vulvar skin, she said. The exact cause also remains elusive, but researchers believe genetic and hormonal factors, as well as an overactive immune response, may contribute to development of the condition.
 

Watch Out for Presentation

While lichen sclerosus more frequently occurs in women, men are also affected by the condition. Benjamin N. Breyer, MD, professor and chair of urology at the University of California San Francisco, said lichen sclerosus is one of the most common skin conditions he treats in his male patients.

“Advanced cases can cause urethral narrowing, which is a condition I treat commonly,” said Dr. Breyer. “Lichen sclerosus is often an underrecognized cause of pain or tearing with erections and sex in men.”

Similar to women, lichen sclerosus presents as white color changes on the skin. For men, the condition can also result in fusion of the shaft skin to the head of the penis and burying or concealment of the penis, Dr. Breyer said.

“This leads to challenges with intimacy and urination and can have extensive impacts on quality of life,” said Dr. Breyer.

For women, the skin changes often extend to the perianal area and can cause scarring, said Dr. Kraus.

“Early scarring may present as adherence of the labia minora to the labia majora or inability to fully retract the clitoral hood from the clitoris,” said Dr. Kraus.

In both men and women, lichen sclerosus and another autoimmune condition known as morphea, characterized by skin hardening and discoloration, often present together, said Dr. Lonowski.

“If you have a patient with known morphea, it’s important to ask about genital symptoms,” said Dr. Lonowski. “The association between the two is fairly strong.”

Circumcision is often the first step to help prevent chronic inflammation among male patients, said Dr. Breyer. Because lichen sclerosus is associated with an increased risk for penile cancer, “it is important to biopsy suspicious lesions,” Dr. Breyer added.

Increasing awareness of lichen sclerosus is crucial for early detection and timely intervention, said Dr. Lonowski. The first-line treatment of genital lichen sclerosus is strong topical steroid ointments to reduce inflammation. Clinicians might prescribe this treatment for use twice daily for 2-3 months and then assesses the patient on their response.

“It is fairly responsive to treatment in most cases,” said Dr. Lonowski.

Once symptoms have improved, Dr. Lonowski transitions patients to a maintenance regimen, which might include using the same steroid but only three times a week, switching to a topical with a less potent steroid dosage, or using a combination of a topical steroid and a nonsteroidal anti-inflammatory cream. Despite the prolonged use of the drug, she said patients with lichen sclerosus usually do not present with side effects like discoloration or thinning of skin.

“You may achieve control or remission, but we don’t stop treatment completely because we know the natural history of the disease is to have flares and recurrence.”

If left untreated, the condition can lead to atrophy, scarring, and distortion of the genital anatomy and, in some cases, develop into squamous cell carcinoma.

“The fact that you can do a topical cream intervention and prevent cancer is huge,” said Dr. Winter.

She said open discussions surrounding genital health led by primary care providers can destigmatize conditions like lichen sclerosus and promote early detection and management.

“We need to foster an environment where individuals feel comfortable discussing their symptoms openly,” Dr. Winter said. “Increased awareness can pave the way for early detection, which is crucial for managing the condition effectively.”

The experts included in the story reported no relevant disclosures.
 

A version of this article appeared on Medscape.com.

Localized melanoma of the skin is highly curable with surgery, especially when the malignancy is in its early stages. Yet many patients with successfully resected cutaneous melanoma may live in fear of recurrence and feel highly anxious about the prospect that their next skin examination may reveal a new lesion or metastasis.

These findings come from a study of 51 patients who were treated for stage 0 (melanoma in situ) to stage IIA (Breslow thickness 1.01-2.0 mm without lymph node invasion or metastasis) disease, and who were interviewed about their experiences as survivors and their fear of recurrence.

“Consistent themes and subthemes brought up by participants included anxiety associated with follow-up skin examinations, frequent biopsy procedures attributable to screening intensity, fear of the sun, changes in sun exposure behavior, and increasing thoughts about death. Many of these experiences profoundly affected participants’ lives, despite the favorable prognosis for this group,” wrote Ayisha N. Mahama, MD, MPH, from the Dell Medical School at the University of Texas at Austin, and colleagues, in an article published online in JAMA Dermatology.
 

Interviews and Inventory

The investigators sought to characterize the psychological well-being of localized melanoma survivors who were treated in their practice. Participants took part in a semistructured interview and the Fear of Cancer Recurrence Inventory short form, with a score of 13 or greater indicating potential cases of clinically significant fear of recurrence.

The mean patient age was 48.5 years, and there were twice as many women as men (34 and 17, respectively). In all, 17 of the patients were treated for stage 0 melanoma, and the remainder were treated for stage I-IIA disease.

The interviews and survey revealed four main “themes” among the patients: anxiety surrounding follow-up appointments and relief after a normal examination; concerns about intensity of melanoma surveillance, including anxiety or reassurance about frequent biopsies and worries regarding familial melanoma risk; lifestyle changes related to sun exposure, such as limiting time outdoors, using sunscreen, and wearing protective clothing; and thoughts about life and death.

On the Fear of Cancer Recurrence Inventory short form, 38 of the 51 participants (75%) had a score of 13 or more points, indicating clinically significant fear of cancer recurrence, and when a higher threshold of 16 or more points were was applied, 34 participants (67%) still met the definition for clinically significant fear of recurrence.
 

Inform, Reassure, Counsel

“Given the crucial role that dermatologists play in diagnosing melanomas, there may be an opportunity to provide reassurance and support for patients to mitigate the psychological consequences of the diagnosis, by emphasizing the excellent life expectancy at a localized stage, particularly at stage 0. In addition, a referral to a mental health practitioner could be placed for patients with higher levels of anxiety and fear of recurrence,” Dr. Mahama and her coauthors wrote.

They also noted that their findings suggest that some individuals who undergo screening for melanoma might experience “psychological harms” from receiving a melanoma diagnosis “particularly given that many or most screening-detected early-stage melanomas will not progress.”

In an interview seeking objective commentary, a surgical oncologist who was not involved in the study said that anxiety about recurrence is common among patients with melanoma, many of whom may be unfamiliar with significant recent advances such as immunotherapy in the care of patients with more advanced disease.

“Often what we will do in addition to just sharing statistics, which are historical and don’t even necessarily reflect how much better we can do for patients now if the melanoma does recur or metastasize, is recommend close surveillance by their dermatologist,” said Sonia Cohen, MD, PhD, from the Mass General Cancer Center in Boston.

“The earlier we capture a recurrence the better we can help the patients. So that’s something we’ll recommend for patients to help give them a sense of control, and that they’re doing everything they can to capture current or new skin cancers,” she said.

Dr. Cohen and colleagues also instruct patients how to look for potential signs of recurrence, such as swollen lymph nodes or suspicious lesions. Patients who express extreme anxiety may also be referred to an oncology social worker or other support services, she said.

Also asked to comment on the results, Allison Dibiaso MSW, LICSW, a social worker at Dana-Farber Cancer Institute, Boston, Massachusetts, who specializes in melanoma, said that she often sees patients who have been successfully treated for early localized malignant melanoma who experience a fear of recurrence. “These patients frequently express feelings of uncertainty and worry, with the fear of another occurrence always on their mind. Managing this fear on a day-to-day basis can be challenging,” she told this news organization.

Moreover, patients with previous treatment for melanoma often experience significant anxiety before skin exams. “Some may feel anxious and worried a few days or weeks before their appointment wondering if something will reoccur and be discovered during the examination,” she said. “While some individuals develop coping skills to manage their anxiety beforehand, many still feel anxious about the possibility of recurrence until after the exam is over and results are confirmed.”

At Dana-Farber, patients with completely resected lesions are provided with individual counseling and have access to support groups specifically designed for patients with melanoma. In addition, a caregiver group is also available for those supporting patients with melanoma, and, “if needed, we provide referrals to therapists in their local community,” Ms. Dibiaso said.

The study was supported by awards/grants to senior author Adewole S. Adamson, MD, MPP from the Robert Wood Johnson Foundation, Dermatology Foundation, National Institutes of Health, and the American Cancer Society. All authors reported having no conflicts of interest. Dr. Cohen had no relevant conflicts of interest to disclose. Ms. Dibiaso had no relevant conflicts to disclose.

Localized melanoma of the skin is highly curable with surgery, especially when the malignancy is in its early stages. Yet many patients with successfully resected cutaneous melanoma may live in fear of recurrence and feel highly anxious about the prospect that their next skin examination may reveal a new lesion or metastasis.

These findings come from a study of 51 patients who were treated for stage 0 (melanoma in situ) to stage IIA (Breslow thickness 1.01-2.0 mm without lymph node invasion or metastasis) disease, and who were interviewed about their experiences as survivors and their fear of recurrence.

“Consistent themes and subthemes brought up by participants included anxiety associated with follow-up skin examinations, frequent biopsy procedures attributable to screening intensity, fear of the sun, changes in sun exposure behavior, and increasing thoughts about death. Many of these experiences profoundly affected participants’ lives, despite the favorable prognosis for this group,” wrote Ayisha N. Mahama, MD, MPH, from the Dell Medical School at the University of Texas at Austin, and colleagues, in an article published online in JAMA Dermatology.
 

Interviews and Inventory

The investigators sought to characterize the psychological well-being of localized melanoma survivors who were treated in their practice. Participants took part in a semistructured interview and the Fear of Cancer Recurrence Inventory short form, with a score of 13 or greater indicating potential cases of clinically significant fear of recurrence.

The mean patient age was 48.5 years, and there were twice as many women as men (34 and 17, respectively). In all, 17 of the patients were treated for stage 0 melanoma, and the remainder were treated for stage I-IIA disease.

The interviews and survey revealed four main “themes” among the patients: anxiety surrounding follow-up appointments and relief after a normal examination; concerns about intensity of melanoma surveillance, including anxiety or reassurance about frequent biopsies and worries regarding familial melanoma risk; lifestyle changes related to sun exposure, such as limiting time outdoors, using sunscreen, and wearing protective clothing; and thoughts about life and death.

On the Fear of Cancer Recurrence Inventory short form, 38 of the 51 participants (75%) had a score of 13 or more points, indicating clinically significant fear of cancer recurrence, and when a higher threshold of 16 or more points were was applied, 34 participants (67%) still met the definition for clinically significant fear of recurrence.
 

Inform, Reassure, Counsel

“Given the crucial role that dermatologists play in diagnosing melanomas, there may be an opportunity to provide reassurance and support for patients to mitigate the psychological consequences of the diagnosis, by emphasizing the excellent life expectancy at a localized stage, particularly at stage 0. In addition, a referral to a mental health practitioner could be placed for patients with higher levels of anxiety and fear of recurrence,” Dr. Mahama and her coauthors wrote.

They also noted that their findings suggest that some individuals who undergo screening for melanoma might experience “psychological harms” from receiving a melanoma diagnosis “particularly given that many or most screening-detected early-stage melanomas will not progress.”

In an interview seeking objective commentary, a surgical oncologist who was not involved in the study said that anxiety about recurrence is common among patients with melanoma, many of whom may be unfamiliar with significant recent advances such as immunotherapy in the care of patients with more advanced disease.

“Often what we will do in addition to just sharing statistics, which are historical and don’t even necessarily reflect how much better we can do for patients now if the melanoma does recur or metastasize, is recommend close surveillance by their dermatologist,” said Sonia Cohen, MD, PhD, from the Mass General Cancer Center in Boston.

“The earlier we capture a recurrence the better we can help the patients. So that’s something we’ll recommend for patients to help give them a sense of control, and that they’re doing everything they can to capture current or new skin cancers,” she said.

Dr. Cohen and colleagues also instruct patients how to look for potential signs of recurrence, such as swollen lymph nodes or suspicious lesions. Patients who express extreme anxiety may also be referred to an oncology social worker or other support services, she said.

Also asked to comment on the results, Allison Dibiaso MSW, LICSW, a social worker at Dana-Farber Cancer Institute, Boston, Massachusetts, who specializes in melanoma, said that she often sees patients who have been successfully treated for early localized malignant melanoma who experience a fear of recurrence. “These patients frequently express feelings of uncertainty and worry, with the fear of another occurrence always on their mind. Managing this fear on a day-to-day basis can be challenging,” she told this news organization.

Moreover, patients with previous treatment for melanoma often experience significant anxiety before skin exams. “Some may feel anxious and worried a few days or weeks before their appointment wondering if something will reoccur and be discovered during the examination,” she said. “While some individuals develop coping skills to manage their anxiety beforehand, many still feel anxious about the possibility of recurrence until after the exam is over and results are confirmed.”

At Dana-Farber, patients with completely resected lesions are provided with individual counseling and have access to support groups specifically designed for patients with melanoma. In addition, a caregiver group is also available for those supporting patients with melanoma, and, “if needed, we provide referrals to therapists in their local community,” Ms. Dibiaso said.

The study was supported by awards/grants to senior author Adewole S. Adamson, MD, MPP from the Robert Wood Johnson Foundation, Dermatology Foundation, National Institutes of Health, and the American Cancer Society. All authors reported having no conflicts of interest. Dr. Cohen had no relevant conflicts of interest to disclose. Ms. Dibiaso had no relevant conflicts to disclose.

Localized melanoma of the skin is highly curable with surgery, especially when the malignancy is in its early stages. Yet many patients with successfully resected cutaneous melanoma may live in fear of recurrence and feel highly anxious about the prospect that their next skin examination may reveal a new lesion or metastasis.

These findings come from a study of 51 patients who were treated for stage 0 (melanoma in situ) to stage IIA (Breslow thickness 1.01-2.0 mm without lymph node invasion or metastasis) disease, and who were interviewed about their experiences as survivors and their fear of recurrence.

“Consistent themes and subthemes brought up by participants included anxiety associated with follow-up skin examinations, frequent biopsy procedures attributable to screening intensity, fear of the sun, changes in sun exposure behavior, and increasing thoughts about death. Many of these experiences profoundly affected participants’ lives, despite the favorable prognosis for this group,” wrote Ayisha N. Mahama, MD, MPH, from the Dell Medical School at the University of Texas at Austin, and colleagues, in an article published online in JAMA Dermatology.
 

Interviews and Inventory

The investigators sought to characterize the psychological well-being of localized melanoma survivors who were treated in their practice. Participants took part in a semistructured interview and the Fear of Cancer Recurrence Inventory short form, with a score of 13 or greater indicating potential cases of clinically significant fear of recurrence.

The mean patient age was 48.5 years, and there were twice as many women as men (34 and 17, respectively). In all, 17 of the patients were treated for stage 0 melanoma, and the remainder were treated for stage I-IIA disease.

The interviews and survey revealed four main “themes” among the patients: anxiety surrounding follow-up appointments and relief after a normal examination; concerns about intensity of melanoma surveillance, including anxiety or reassurance about frequent biopsies and worries regarding familial melanoma risk; lifestyle changes related to sun exposure, such as limiting time outdoors, using sunscreen, and wearing protective clothing; and thoughts about life and death.

On the Fear of Cancer Recurrence Inventory short form, 38 of the 51 participants (75%) had a score of 13 or more points, indicating clinically significant fear of cancer recurrence, and when a higher threshold of 16 or more points were was applied, 34 participants (67%) still met the definition for clinically significant fear of recurrence.
 

Inform, Reassure, Counsel

“Given the crucial role that dermatologists play in diagnosing melanomas, there may be an opportunity to provide reassurance and support for patients to mitigate the psychological consequences of the diagnosis, by emphasizing the excellent life expectancy at a localized stage, particularly at stage 0. In addition, a referral to a mental health practitioner could be placed for patients with higher levels of anxiety and fear of recurrence,” Dr. Mahama and her coauthors wrote.

They also noted that their findings suggest that some individuals who undergo screening for melanoma might experience “psychological harms” from receiving a melanoma diagnosis “particularly given that many or most screening-detected early-stage melanomas will not progress.”

In an interview seeking objective commentary, a surgical oncologist who was not involved in the study said that anxiety about recurrence is common among patients with melanoma, many of whom may be unfamiliar with significant recent advances such as immunotherapy in the care of patients with more advanced disease.

“Often what we will do in addition to just sharing statistics, which are historical and don’t even necessarily reflect how much better we can do for patients now if the melanoma does recur or metastasize, is recommend close surveillance by their dermatologist,” said Sonia Cohen, MD, PhD, from the Mass General Cancer Center in Boston.

“The earlier we capture a recurrence the better we can help the patients. So that’s something we’ll recommend for patients to help give them a sense of control, and that they’re doing everything they can to capture current or new skin cancers,” she said.

Dr. Cohen and colleagues also instruct patients how to look for potential signs of recurrence, such as swollen lymph nodes or suspicious lesions. Patients who express extreme anxiety may also be referred to an oncology social worker or other support services, she said.

Also asked to comment on the results, Allison Dibiaso MSW, LICSW, a social worker at Dana-Farber Cancer Institute, Boston, Massachusetts, who specializes in melanoma, said that she often sees patients who have been successfully treated for early localized malignant melanoma who experience a fear of recurrence. “These patients frequently express feelings of uncertainty and worry, with the fear of another occurrence always on their mind. Managing this fear on a day-to-day basis can be challenging,” she told this news organization.

Moreover, patients with previous treatment for melanoma often experience significant anxiety before skin exams. “Some may feel anxious and worried a few days or weeks before their appointment wondering if something will reoccur and be discovered during the examination,” she said. “While some individuals develop coping skills to manage their anxiety beforehand, many still feel anxious about the possibility of recurrence until after the exam is over and results are confirmed.”

At Dana-Farber, patients with completely resected lesions are provided with individual counseling and have access to support groups specifically designed for patients with melanoma. In addition, a caregiver group is also available for those supporting patients with melanoma, and, “if needed, we provide referrals to therapists in their local community,” Ms. Dibiaso said.

The study was supported by awards/grants to senior author Adewole S. Adamson, MD, MPP from the Robert Wood Johnson Foundation, Dermatology Foundation, National Institutes of Health, and the American Cancer Society. All authors reported having no conflicts of interest. Dr. Cohen had no relevant conflicts of interest to disclose. Ms. Dibiaso had no relevant conflicts to disclose.

Jill Schneiderhan, MD, remembers only receiving one or two lectures on basic pain physiology during medical school.

That time was not enough, Dr. Schneiderhan said, who is now a primary care physician and codirector of Integrative Family Medicine at Michigan Medicine in Ann Arbor, Michigan. Medical schools in the United States spend an average of 11 hours on pain management training.

“I think that the understanding of different types of pain and the nervous system is improving,” Dr. Schneiderhan said. “But how we as primary care providers can sit with patients with complicated pain experiences, and integrate various treatments into the primary care setting, is where the system falls apart.”

Despite one in five Americans experiencing chronic pain, a gap exists in the pain management training of primary care providers (PCPs). Pain specialists are calling for the empowerment of their first-line-of-defense counterparts with the knowledge and tools necessary to navigate the intricate challenges posed by chronic pain.

Treatment beyond medication is the primary challenge — particularly with pressures and time constraints inherent in family medicine.

“It’s so difficult to teach a PCP how to treat pain because pain management is an entire fellowship,” said Shravani Durbhakula, MD, MPH, MBA, who is on the Board of Directors for the American Academy of Pain Medicine Foundation. But “we encourage a multidisciplinary approach: This includes physical therapy, medication, injections, and other methods. Those different elements coming together typically give some relief.”
 

Categories of Chronic Pain

Experts sort pain into three broad categories: Nociceptive (from tissue injury), neuropathic (from a nerve injury), and nociplastic (from a sensitized nervous system).

Tissue injury is the most common cause of pain and is characterized by aching and throbbing, while nerve injury causes more burning and shooting sensations.

Nociplastic pain, which arises from abnormal processing of pain signals without clear evidence of tissue damage, is often hardest to understand and trickier to treat. These types of conditions include fibromyalgia, irritable bowel syndrome, and nonspecific back pain, according to Dr. Durbhakula.

“One of the really big challenges is that it’s an invisible condition — you don’t have a cast on or crutches,” Dr. Durbhakula said. “We don’t have great objective measures for pain, and sometimes pain patients feel stigmatized and like their pain is dismissed.”

Primary care specialists should consider six steps to guide their pain assessments, including properly assessing the pain, identifying the pain generator, discussing sensible medications, considering appropriate procedures, recommending appropriate behavioral techniques, and focusing on multidisciplinary management, according to Dr. Durbhakula.

Persistent pain is often too complex to treat with singular methods. For instance, studies have shown pain can lead to structural changes in the brain, such as a decrease in gray matter and differences in neural areas that modulate pain. These neurologic changes illustrate the complicated nature of chronic pain and the need for a multipronged treatment plan.
 

Don’t Discount the ‘Fluffy Stuff’

One of the biggest challenges in managing chronic pain is the dearth of effective remedies, said Michael Kaplan, MD, a rheumatologist at Mount Sinai Health System in New York City.

While other debilitating conditions have seen breakthroughs — insulin for diabetes, penicillin for pneumonia — pain remains without a cure.

“In the world of centralized pains, we’re lagging behind,” Dr. Kaplan said. “Opioids didn’t work, and here we are in the aftermath of an opioid epidemic.”

Patients can make significant headway with nonpharmacologic management, or what some consider to be the “fluffy stuff,” including yoga, meditation, acupuncture, dry needling, massage therapy, and acupuncture, according to Dr. Kaplan.

But these approaches are often financially unfeasible for patients because insurance companies sporadically cover them. However, free apps can help patients practice things like better sleep and meditation.

“These things actually work, and there is very low risk in trying them,” Dr. Kaplan said. To be sure, medication has an important place in pain management. Neuropathic pain medications or nonsteroidal anti-inflammatory drugs can be effective options for some patients, said Christopher Gilligan, MD, Chief of the Division of Pain Medicine at Brigham and Women’s Hospital in Boston, Massachusetts.

Drugs that target nerve pain include gabapentin and pregabalin, certain antidepressants, and anticonvulsants, which can help dull pain signals in the nerves.

“When a patient has not responded to a first- or second-line medication in those categories, that can be a time when referral to a pain medicine physician can be helpful,” Dr. Gilligan said.

Procedural options that are less invasive than surgery may also be appropriate, Dr. Gilligan said. These include nerve ablation and restorative neurostimulators for people with lower back pain and ganglion stimulation for patients experiencing neuropathic pain.

“The efficacy of interventions for specific pain conditions has gotten better over the years,” he said.
 

Learn to Listen

The two most important activities to recommend when treating chronic pain patients also can be the most difficult: Sleeping and exercise. For people experiencing unrelenting discomfort, both can feel impossible, according to Dan Clauw, MD, professor of anesthesiology at the University of Michigan in Ann Arbor, Michigan.

“If you stop moving, your pain is going to get worse and worse and worse,” Dr. Clauw said. “But you have to be careful about how you talk about it. For example, don’t use the word ‘exercise’ when you’re talking to a chronic pain patient, use the word ‘activity.’ ”

As people become more active, they begin sleeping better, he said.

Most importantly, Dr. Clauw said, clinicians must demonstrate empathy and listening skills. Patients with chronic pain often are used to being dismissed and have become isolated in their personal lives.

“There is a lack of properly trained providers who can listen rather than do procedures,” Dr. Clauw said. “What happens is people just constrict their lives over the course of having pain, and they fall into this shell of themselves. They need their doctors to hear them.”

For primary care doctors seeking more information on pain management, online resources can be helpful, said Robert L. Rich Jr, MD, former chair of the American Academy of Family Physicians Commission on Health of the Public and Science.

“One suggestion I’d begin with is to look at pain guidelines, not just from the CDC and AAFP but also from local medical boards,” Dr. Rich said, adding that California and Washington State have done extensive work on chronic pain. “I am seeing more of a movement again toward teaching the management of chronic pain, but we still need more training.”

A version of this article appeared on Medscape.com.

Jill Schneiderhan, MD, remembers only receiving one or two lectures on basic pain physiology during medical school.

That time was not enough, Dr. Schneiderhan said, who is now a primary care physician and codirector of Integrative Family Medicine at Michigan Medicine in Ann Arbor, Michigan. Medical schools in the United States spend an average of 11 hours on pain management training.

“I think that the understanding of different types of pain and the nervous system is improving,” Dr. Schneiderhan said. “But how we as primary care providers can sit with patients with complicated pain experiences, and integrate various treatments into the primary care setting, is where the system falls apart.”

Despite one in five Americans experiencing chronic pain, a gap exists in the pain management training of primary care providers (PCPs). Pain specialists are calling for the empowerment of their first-line-of-defense counterparts with the knowledge and tools necessary to navigate the intricate challenges posed by chronic pain.

Treatment beyond medication is the primary challenge — particularly with pressures and time constraints inherent in family medicine.

“It’s so difficult to teach a PCP how to treat pain because pain management is an entire fellowship,” said Shravani Durbhakula, MD, MPH, MBA, who is on the Board of Directors for the American Academy of Pain Medicine Foundation. But “we encourage a multidisciplinary approach: This includes physical therapy, medication, injections, and other methods. Those different elements coming together typically give some relief.”
 

Categories of Chronic Pain

Experts sort pain into three broad categories: Nociceptive (from tissue injury), neuropathic (from a nerve injury), and nociplastic (from a sensitized nervous system).

Tissue injury is the most common cause of pain and is characterized by aching and throbbing, while nerve injury causes more burning and shooting sensations.

Nociplastic pain, which arises from abnormal processing of pain signals without clear evidence of tissue damage, is often hardest to understand and trickier to treat. These types of conditions include fibromyalgia, irritable bowel syndrome, and nonspecific back pain, according to Dr. Durbhakula.

“One of the really big challenges is that it’s an invisible condition — you don’t have a cast on or crutches,” Dr. Durbhakula said. “We don’t have great objective measures for pain, and sometimes pain patients feel stigmatized and like their pain is dismissed.”

Primary care specialists should consider six steps to guide their pain assessments, including properly assessing the pain, identifying the pain generator, discussing sensible medications, considering appropriate procedures, recommending appropriate behavioral techniques, and focusing on multidisciplinary management, according to Dr. Durbhakula.

Persistent pain is often too complex to treat with singular methods. For instance, studies have shown pain can lead to structural changes in the brain, such as a decrease in gray matter and differences in neural areas that modulate pain. These neurologic changes illustrate the complicated nature of chronic pain and the need for a multipronged treatment plan.
 

Don’t Discount the ‘Fluffy Stuff’

One of the biggest challenges in managing chronic pain is the dearth of effective remedies, said Michael Kaplan, MD, a rheumatologist at Mount Sinai Health System in New York City.

While other debilitating conditions have seen breakthroughs — insulin for diabetes, penicillin for pneumonia — pain remains without a cure.

“In the world of centralized pains, we’re lagging behind,” Dr. Kaplan said. “Opioids didn’t work, and here we are in the aftermath of an opioid epidemic.”

Patients can make significant headway with nonpharmacologic management, or what some consider to be the “fluffy stuff,” including yoga, meditation, acupuncture, dry needling, massage therapy, and acupuncture, according to Dr. Kaplan.

But these approaches are often financially unfeasible for patients because insurance companies sporadically cover them. However, free apps can help patients practice things like better sleep and meditation.

“These things actually work, and there is very low risk in trying them,” Dr. Kaplan said. To be sure, medication has an important place in pain management. Neuropathic pain medications or nonsteroidal anti-inflammatory drugs can be effective options for some patients, said Christopher Gilligan, MD, Chief of the Division of Pain Medicine at Brigham and Women’s Hospital in Boston, Massachusetts.

Drugs that target nerve pain include gabapentin and pregabalin, certain antidepressants, and anticonvulsants, which can help dull pain signals in the nerves.

“When a patient has not responded to a first- or second-line medication in those categories, that can be a time when referral to a pain medicine physician can be helpful,” Dr. Gilligan said.

Procedural options that are less invasive than surgery may also be appropriate, Dr. Gilligan said. These include nerve ablation and restorative neurostimulators for people with lower back pain and ganglion stimulation for patients experiencing neuropathic pain.

“The efficacy of interventions for specific pain conditions has gotten better over the years,” he said.
 

Learn to Listen

The two most important activities to recommend when treating chronic pain patients also can be the most difficult: Sleeping and exercise. For people experiencing unrelenting discomfort, both can feel impossible, according to Dan Clauw, MD, professor of anesthesiology at the University of Michigan in Ann Arbor, Michigan.

“If you stop moving, your pain is going to get worse and worse and worse,” Dr. Clauw said. “But you have to be careful about how you talk about it. For example, don’t use the word ‘exercise’ when you’re talking to a chronic pain patient, use the word ‘activity.’ ”

As people become more active, they begin sleeping better, he said.

Most importantly, Dr. Clauw said, clinicians must demonstrate empathy and listening skills. Patients with chronic pain often are used to being dismissed and have become isolated in their personal lives.

“There is a lack of properly trained providers who can listen rather than do procedures,” Dr. Clauw said. “What happens is people just constrict their lives over the course of having pain, and they fall into this shell of themselves. They need their doctors to hear them.”

For primary care doctors seeking more information on pain management, online resources can be helpful, said Robert L. Rich Jr, MD, former chair of the American Academy of Family Physicians Commission on Health of the Public and Science.

“One suggestion I’d begin with is to look at pain guidelines, not just from the CDC and AAFP but also from local medical boards,” Dr. Rich said, adding that California and Washington State have done extensive work on chronic pain. “I am seeing more of a movement again toward teaching the management of chronic pain, but we still need more training.”

A version of this article appeared on Medscape.com.

Jill Schneiderhan, MD, remembers only receiving one or two lectures on basic pain physiology during medical school.

That time was not enough, Dr. Schneiderhan said, who is now a primary care physician and codirector of Integrative Family Medicine at Michigan Medicine in Ann Arbor, Michigan. Medical schools in the United States spend an average of 11 hours on pain management training.

“I think that the understanding of different types of pain and the nervous system is improving,” Dr. Schneiderhan said. “But how we as primary care providers can sit with patients with complicated pain experiences, and integrate various treatments into the primary care setting, is where the system falls apart.”

Despite one in five Americans experiencing chronic pain, a gap exists in the pain management training of primary care providers (PCPs). Pain specialists are calling for the empowerment of their first-line-of-defense counterparts with the knowledge and tools necessary to navigate the intricate challenges posed by chronic pain.

Treatment beyond medication is the primary challenge — particularly with pressures and time constraints inherent in family medicine.

“It’s so difficult to teach a PCP how to treat pain because pain management is an entire fellowship,” said Shravani Durbhakula, MD, MPH, MBA, who is on the Board of Directors for the American Academy of Pain Medicine Foundation. But “we encourage a multidisciplinary approach: This includes physical therapy, medication, injections, and other methods. Those different elements coming together typically give some relief.”
 

Categories of Chronic Pain

Experts sort pain into three broad categories: Nociceptive (from tissue injury), neuropathic (from a nerve injury), and nociplastic (from a sensitized nervous system).

Tissue injury is the most common cause of pain and is characterized by aching and throbbing, while nerve injury causes more burning and shooting sensations.

Nociplastic pain, which arises from abnormal processing of pain signals without clear evidence of tissue damage, is often hardest to understand and trickier to treat. These types of conditions include fibromyalgia, irritable bowel syndrome, and nonspecific back pain, according to Dr. Durbhakula.

“One of the really big challenges is that it’s an invisible condition — you don’t have a cast on or crutches,” Dr. Durbhakula said. “We don’t have great objective measures for pain, and sometimes pain patients feel stigmatized and like their pain is dismissed.”

Primary care specialists should consider six steps to guide their pain assessments, including properly assessing the pain, identifying the pain generator, discussing sensible medications, considering appropriate procedures, recommending appropriate behavioral techniques, and focusing on multidisciplinary management, according to Dr. Durbhakula.

Persistent pain is often too complex to treat with singular methods. For instance, studies have shown pain can lead to structural changes in the brain, such as a decrease in gray matter and differences in neural areas that modulate pain. These neurologic changes illustrate the complicated nature of chronic pain and the need for a multipronged treatment plan.
 

Don’t Discount the ‘Fluffy Stuff’

One of the biggest challenges in managing chronic pain is the dearth of effective remedies, said Michael Kaplan, MD, a rheumatologist at Mount Sinai Health System in New York City.

While other debilitating conditions have seen breakthroughs — insulin for diabetes, penicillin for pneumonia — pain remains without a cure.

“In the world of centralized pains, we’re lagging behind,” Dr. Kaplan said. “Opioids didn’t work, and here we are in the aftermath of an opioid epidemic.”

Patients can make significant headway with nonpharmacologic management, or what some consider to be the “fluffy stuff,” including yoga, meditation, acupuncture, dry needling, massage therapy, and acupuncture, according to Dr. Kaplan.

But these approaches are often financially unfeasible for patients because insurance companies sporadically cover them. However, free apps can help patients practice things like better sleep and meditation.

“These things actually work, and there is very low risk in trying them,” Dr. Kaplan said. To be sure, medication has an important place in pain management. Neuropathic pain medications or nonsteroidal anti-inflammatory drugs can be effective options for some patients, said Christopher Gilligan, MD, Chief of the Division of Pain Medicine at Brigham and Women’s Hospital in Boston, Massachusetts.

Drugs that target nerve pain include gabapentin and pregabalin, certain antidepressants, and anticonvulsants, which can help dull pain signals in the nerves.

“When a patient has not responded to a first- or second-line medication in those categories, that can be a time when referral to a pain medicine physician can be helpful,” Dr. Gilligan said.

Procedural options that are less invasive than surgery may also be appropriate, Dr. Gilligan said. These include nerve ablation and restorative neurostimulators for people with lower back pain and ganglion stimulation for patients experiencing neuropathic pain.

“The efficacy of interventions for specific pain conditions has gotten better over the years,” he said.
 

Learn to Listen

The two most important activities to recommend when treating chronic pain patients also can be the most difficult: Sleeping and exercise. For people experiencing unrelenting discomfort, both can feel impossible, according to Dan Clauw, MD, professor of anesthesiology at the University of Michigan in Ann Arbor, Michigan.

“If you stop moving, your pain is going to get worse and worse and worse,” Dr. Clauw said. “But you have to be careful about how you talk about it. For example, don’t use the word ‘exercise’ when you’re talking to a chronic pain patient, use the word ‘activity.’ ”

As people become more active, they begin sleeping better, he said.

Most importantly, Dr. Clauw said, clinicians must demonstrate empathy and listening skills. Patients with chronic pain often are used to being dismissed and have become isolated in their personal lives.

“There is a lack of properly trained providers who can listen rather than do procedures,” Dr. Clauw said. “What happens is people just constrict their lives over the course of having pain, and they fall into this shell of themselves. They need their doctors to hear them.”

For primary care doctors seeking more information on pain management, online resources can be helpful, said Robert L. Rich Jr, MD, former chair of the American Academy of Family Physicians Commission on Health of the Public and Science.

“One suggestion I’d begin with is to look at pain guidelines, not just from the CDC and AAFP but also from local medical boards,” Dr. Rich said, adding that California and Washington State have done extensive work on chronic pain. “I am seeing more of a movement again toward teaching the management of chronic pain, but we still need more training.”

A version of this article appeared on Medscape.com.

Pretreatment testing of patients starting systemic immunomodulatory therapies for chronic skin diseases fell short of recommendations, based on an analysis of more than 120,000 individuals in a national commercial insurance claims database.

Because of concerns for the potential reactivation of tuberculosis or hepatitis B or C, or for an increased risk for infections, myelosuppression, and hepatoxicity in the wake of immunomodulator use, some medical societies recommend screening patients for hepatitis B, hepatitis C, and tuberculosis before starting these medications, wrote Maria C. Schneeweiss, MD, of Brigham and Women’s Hospital, Boston, Massachusetts, and colleagues.

“Conducting this study was crucial because of the increasing use of systemic immunomodulatory agents for chronic inflammatory skin diseases and the recognized need for pretreatment testing to prevent complications,” coauthor Denys Shay, a PhD candidate in population health sciences at Harvard University, Cambridge, Massachusetts, said in an interview.

“Despite recommendations from professional societies, there was a lack of clarity on how consistently these guidelines were being followed in the United States. This study aimed to fill that gap in knowledge, providing a comprehensive view of current practices and highlighting areas for improvement,” he said.

In the study, published online in JAMA Dermatology, he and his coauthors identified 122,308 adults in the United States with psoriasis, hidradenitis suppurativa, or atopic dermatitis who started an immunomodulatory agent, including methotrexate (28,684 patients), tumor necrosis factor (TNF)–alpha inhibitors (40,965), ustekinumab (12,841), interleukin (IL)-23 inhibitors (6116), IL-17A inhibitors (9799), dupilumab (7787), and apremilast (16,116). The data were from a commercial insurance claims database from December 31, 2002, to December 31, 2020.

The primary outcome was the proportion of patients who underwent recommended screening lab tests including tuberculosis, hepatitis, liver function, complete blood cell counts (CBCs), and lipid panels within 6 months before treatment initiation and during the first 2 years of treatment. The median age of the study population was 49 years, and 52.1% were male.

A CBC was the most common pretreatment test across treatments, performed in 41%-69% of patients before starting treatment. Tuberculosis screening occurred in 11%-59% of patients within 6 months of initiating treatment, and 3%-26% had updated tests after 1 year. Similarly, 13%-41% of patients underwent hepatitis screening prior to treatment.

The highest levels of pretreatment testing occurred for TNF-alpha inhibitors, ustekinumab, IL-17A inhibitors, and IL-23 inhibitors, with similar patterns, while the lowest levels of testing occurred with apremilast and dupilumab.

Testing prevalence before starting apremilast and after a year of treatment was 15%-45% and 9%-36%, respectively. Testing before initiation and a year into treatment with dupilumab was 11%-41% and 3%-25%, respectively.

The findings were limited by several factors including the descriptive design, which does not allow for evaluation of the testing practices, the researchers said.

However, the results show the extent of patients with chronic inflammatory skin diseases (CISDs) who do not undergo pretreatment testing, and research is needed to create testing practices on the basis of recommendations for each agent and incorporating each patient’s history and clinical profile, they concluded.

“The finding that less than 60% of patients received recommended pretreatment testing was initially somewhat surprising,” Shay said in the interview. “However, the context provided by higher rates of baseline testing within the 6-12 months before treatment initiation and the potential for additional testing not captured by the dataset — such as hospital stays — suggests that the gap may not be as large as this estimate,” he said.

“The key message for clinicians is that there are considerable variations in laboratory testing practices with regard to the initiation of systemic immunomodulatory agents in patients with CISDs,” Shay said. “This represents a divergence from existing testing guidelines.”

“Further research is needed to understand the reasons for the variations in pretreatment testing practices and whether this heterogeneity affects patient outcomes,” he added.

Resist Routine Testing

The study findings represent a call to action in the form of ongoing assessment of the safety, clinical utility, and cost-effectiveness of pretreatment testing, wrote Clinton W. Enos, MD, Ana Ormaza Vera, MD, and Abby S. Van Voorhees, MD, of the Department of Dermatology, Eastern Virginia Medical School, Norfolk, Virginia, in an accompanying editorial.

The data in the current study suggesting less frequent laboratory testing compared with current guidelines could stem from a high comfort level with many of the therapies that have been available and in use for many years, they noted. Clinicians’ lack of knowledge of the laboratory screening and monitoring guidelines also may play a role, they said.

However, the authors cautioned against routine checking of laboratory results “without purpose” and without attention to their clinical utility and cost. “A thorough medical history is essential and can serve as a sensitive indicator of which patients are more at risk for diseases such as TB or hepatitis, thereby allowing for more meaningful laboratory screening use,” they said.

Evidence supporting prescreening labs for the spectrum of systemic agents used in dermatology varies considerably, “some trapped in time and carried forward for decades until finally questioned, others rooted in treatment mechanism and clinical data,” Adam Friedman, MD, professor and chief of dermatology at George Washington University, Washington, DC, said in an interview.

The study elucidated the current state of clinical practice, said Friedman, who was not involved with the study. This includes screening even if the label says it is not necessary and letting screening slide when guidelines say otherwise — even if the guidelines are outdated and insurance requires certain metrics prior to approval, he said.

Looking ahead, “we need better consensus and even better communication/education on said guidance,” Dr. Friedman said. “Clear, concise, evidenced-based, and expert-validated guidance to ensure we are meaningfully using medical resources” is what is needed, he added. “It will certainly take a village, and close collaboration between the industry and practitioners is key to success.”

The study was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Shay had no financial conflicts to disclose. Lead author Dr. Schneeweiss disclosed grants from UCB Pharma and AbbVie to Brigham and Women’s Hospital outside the submitted work. Other authors disclosed receiving personal fees from Aetion and grants from UCB Pharma and Takeda outside the submitted work; grants from Amarin, Kowa, Novartis, and Pfizer outside the submitted work; and personal fees from Hims & Hers, AbbVie, Sun Pharmaceuticals, Pfizer, Digital Diagnostics, Lilly, Equillium, ASLAN, Boehringer Ingelheim, ACOM, Olaplex, and Legacy Healthcare during the study. No other disclosures were reported.

Editorial author Dr. Enos disclosed serving as an investigator for Amgen and Castle Biosciences and receiving grants from Arcutis Biotherapeutics outside the submitted work. Dr. Van Voorhees disclosed an honorarium outside the submitted work.

Dr. Friedman had no relevant financial conflicts to disclose.

A version of this article appeared on Medscape.com.

Pretreatment testing of patients starting systemic immunomodulatory therapies for chronic skin diseases fell short of recommendations, based on an analysis of more than 120,000 individuals in a national commercial insurance claims database.

Because of concerns for the potential reactivation of tuberculosis or hepatitis B or C, or for an increased risk for infections, myelosuppression, and hepatoxicity in the wake of immunomodulator use, some medical societies recommend screening patients for hepatitis B, hepatitis C, and tuberculosis before starting these medications, wrote Maria C. Schneeweiss, MD, of Brigham and Women’s Hospital, Boston, Massachusetts, and colleagues.

“Conducting this study was crucial because of the increasing use of systemic immunomodulatory agents for chronic inflammatory skin diseases and the recognized need for pretreatment testing to prevent complications,” coauthor Denys Shay, a PhD candidate in population health sciences at Harvard University, Cambridge, Massachusetts, said in an interview.

“Despite recommendations from professional societies, there was a lack of clarity on how consistently these guidelines were being followed in the United States. This study aimed to fill that gap in knowledge, providing a comprehensive view of current practices and highlighting areas for improvement,” he said.

In the study, published online in JAMA Dermatology, he and his coauthors identified 122,308 adults in the United States with psoriasis, hidradenitis suppurativa, or atopic dermatitis who started an immunomodulatory agent, including methotrexate (28,684 patients), tumor necrosis factor (TNF)–alpha inhibitors (40,965), ustekinumab (12,841), interleukin (IL)-23 inhibitors (6116), IL-17A inhibitors (9799), dupilumab (7787), and apremilast (16,116). The data were from a commercial insurance claims database from December 31, 2002, to December 31, 2020.

The primary outcome was the proportion of patients who underwent recommended screening lab tests including tuberculosis, hepatitis, liver function, complete blood cell counts (CBCs), and lipid panels within 6 months before treatment initiation and during the first 2 years of treatment. The median age of the study population was 49 years, and 52.1% were male.

A CBC was the most common pretreatment test across treatments, performed in 41%-69% of patients before starting treatment. Tuberculosis screening occurred in 11%-59% of patients within 6 months of initiating treatment, and 3%-26% had updated tests after 1 year. Similarly, 13%-41% of patients underwent hepatitis screening prior to treatment.

The highest levels of pretreatment testing occurred for TNF-alpha inhibitors, ustekinumab, IL-17A inhibitors, and IL-23 inhibitors, with similar patterns, while the lowest levels of testing occurred with apremilast and dupilumab.

Testing prevalence before starting apremilast and after a year of treatment was 15%-45% and 9%-36%, respectively. Testing before initiation and a year into treatment with dupilumab was 11%-41% and 3%-25%, respectively.

The findings were limited by several factors including the descriptive design, which does not allow for evaluation of the testing practices, the researchers said.

However, the results show the extent of patients with chronic inflammatory skin diseases (CISDs) who do not undergo pretreatment testing, and research is needed to create testing practices on the basis of recommendations for each agent and incorporating each patient’s history and clinical profile, they concluded.

“The finding that less than 60% of patients received recommended pretreatment testing was initially somewhat surprising,” Shay said in the interview. “However, the context provided by higher rates of baseline testing within the 6-12 months before treatment initiation and the potential for additional testing not captured by the dataset — such as hospital stays — suggests that the gap may not be as large as this estimate,” he said.

“The key message for clinicians is that there are considerable variations in laboratory testing practices with regard to the initiation of systemic immunomodulatory agents in patients with CISDs,” Shay said. “This represents a divergence from existing testing guidelines.”

“Further research is needed to understand the reasons for the variations in pretreatment testing practices and whether this heterogeneity affects patient outcomes,” he added.

Resist Routine Testing

The study findings represent a call to action in the form of ongoing assessment of the safety, clinical utility, and cost-effectiveness of pretreatment testing, wrote Clinton W. Enos, MD, Ana Ormaza Vera, MD, and Abby S. Van Voorhees, MD, of the Department of Dermatology, Eastern Virginia Medical School, Norfolk, Virginia, in an accompanying editorial.

The data in the current study suggesting less frequent laboratory testing compared with current guidelines could stem from a high comfort level with many of the therapies that have been available and in use for many years, they noted. Clinicians’ lack of knowledge of the laboratory screening and monitoring guidelines also may play a role, they said.

However, the authors cautioned against routine checking of laboratory results “without purpose” and without attention to their clinical utility and cost. “A thorough medical history is essential and can serve as a sensitive indicator of which patients are more at risk for diseases such as TB or hepatitis, thereby allowing for more meaningful laboratory screening use,” they said.

Evidence supporting prescreening labs for the spectrum of systemic agents used in dermatology varies considerably, “some trapped in time and carried forward for decades until finally questioned, others rooted in treatment mechanism and clinical data,” Adam Friedman, MD, professor and chief of dermatology at George Washington University, Washington, DC, said in an interview.

The study elucidated the current state of clinical practice, said Friedman, who was not involved with the study. This includes screening even if the label says it is not necessary and letting screening slide when guidelines say otherwise — even if the guidelines are outdated and insurance requires certain metrics prior to approval, he said.

Looking ahead, “we need better consensus and even better communication/education on said guidance,” Dr. Friedman said. “Clear, concise, evidenced-based, and expert-validated guidance to ensure we are meaningfully using medical resources” is what is needed, he added. “It will certainly take a village, and close collaboration between the industry and practitioners is key to success.”

The study was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Shay had no financial conflicts to disclose. Lead author Dr. Schneeweiss disclosed grants from UCB Pharma and AbbVie to Brigham and Women’s Hospital outside the submitted work. Other authors disclosed receiving personal fees from Aetion and grants from UCB Pharma and Takeda outside the submitted work; grants from Amarin, Kowa, Novartis, and Pfizer outside the submitted work; and personal fees from Hims & Hers, AbbVie, Sun Pharmaceuticals, Pfizer, Digital Diagnostics, Lilly, Equillium, ASLAN, Boehringer Ingelheim, ACOM, Olaplex, and Legacy Healthcare during the study. No other disclosures were reported.

Editorial author Dr. Enos disclosed serving as an investigator for Amgen and Castle Biosciences and receiving grants from Arcutis Biotherapeutics outside the submitted work. Dr. Van Voorhees disclosed an honorarium outside the submitted work.

Dr. Friedman had no relevant financial conflicts to disclose.

A version of this article appeared on Medscape.com.

Pretreatment testing of patients starting systemic immunomodulatory therapies for chronic skin diseases fell short of recommendations, based on an analysis of more than 120,000 individuals in a national commercial insurance claims database.

Because of concerns for the potential reactivation of tuberculosis or hepatitis B or C, or for an increased risk for infections, myelosuppression, and hepatoxicity in the wake of immunomodulator use, some medical societies recommend screening patients for hepatitis B, hepatitis C, and tuberculosis before starting these medications, wrote Maria C. Schneeweiss, MD, of Brigham and Women’s Hospital, Boston, Massachusetts, and colleagues.

“Conducting this study was crucial because of the increasing use of systemic immunomodulatory agents for chronic inflammatory skin diseases and the recognized need for pretreatment testing to prevent complications,” coauthor Denys Shay, a PhD candidate in population health sciences at Harvard University, Cambridge, Massachusetts, said in an interview.

“Despite recommendations from professional societies, there was a lack of clarity on how consistently these guidelines were being followed in the United States. This study aimed to fill that gap in knowledge, providing a comprehensive view of current practices and highlighting areas for improvement,” he said.

In the study, published online in JAMA Dermatology, he and his coauthors identified 122,308 adults in the United States with psoriasis, hidradenitis suppurativa, or atopic dermatitis who started an immunomodulatory agent, including methotrexate (28,684 patients), tumor necrosis factor (TNF)–alpha inhibitors (40,965), ustekinumab (12,841), interleukin (IL)-23 inhibitors (6116), IL-17A inhibitors (9799), dupilumab (7787), and apremilast (16,116). The data were from a commercial insurance claims database from December 31, 2002, to December 31, 2020.

The primary outcome was the proportion of patients who underwent recommended screening lab tests including tuberculosis, hepatitis, liver function, complete blood cell counts (CBCs), and lipid panels within 6 months before treatment initiation and during the first 2 years of treatment. The median age of the study population was 49 years, and 52.1% were male.

A CBC was the most common pretreatment test across treatments, performed in 41%-69% of patients before starting treatment. Tuberculosis screening occurred in 11%-59% of patients within 6 months of initiating treatment, and 3%-26% had updated tests after 1 year. Similarly, 13%-41% of patients underwent hepatitis screening prior to treatment.

The highest levels of pretreatment testing occurred for TNF-alpha inhibitors, ustekinumab, IL-17A inhibitors, and IL-23 inhibitors, with similar patterns, while the lowest levels of testing occurred with apremilast and dupilumab.

Testing prevalence before starting apremilast and after a year of treatment was 15%-45% and 9%-36%, respectively. Testing before initiation and a year into treatment with dupilumab was 11%-41% and 3%-25%, respectively.

The findings were limited by several factors including the descriptive design, which does not allow for evaluation of the testing practices, the researchers said.

However, the results show the extent of patients with chronic inflammatory skin diseases (CISDs) who do not undergo pretreatment testing, and research is needed to create testing practices on the basis of recommendations for each agent and incorporating each patient’s history and clinical profile, they concluded.

“The finding that less than 60% of patients received recommended pretreatment testing was initially somewhat surprising,” Shay said in the interview. “However, the context provided by higher rates of baseline testing within the 6-12 months before treatment initiation and the potential for additional testing not captured by the dataset — such as hospital stays — suggests that the gap may not be as large as this estimate,” he said.

“The key message for clinicians is that there are considerable variations in laboratory testing practices with regard to the initiation of systemic immunomodulatory agents in patients with CISDs,” Shay said. “This represents a divergence from existing testing guidelines.”

“Further research is needed to understand the reasons for the variations in pretreatment testing practices and whether this heterogeneity affects patient outcomes,” he added.

Resist Routine Testing

The study findings represent a call to action in the form of ongoing assessment of the safety, clinical utility, and cost-effectiveness of pretreatment testing, wrote Clinton W. Enos, MD, Ana Ormaza Vera, MD, and Abby S. Van Voorhees, MD, of the Department of Dermatology, Eastern Virginia Medical School, Norfolk, Virginia, in an accompanying editorial.

The data in the current study suggesting less frequent laboratory testing compared with current guidelines could stem from a high comfort level with many of the therapies that have been available and in use for many years, they noted. Clinicians’ lack of knowledge of the laboratory screening and monitoring guidelines also may play a role, they said.

However, the authors cautioned against routine checking of laboratory results “without purpose” and without attention to their clinical utility and cost. “A thorough medical history is essential and can serve as a sensitive indicator of which patients are more at risk for diseases such as TB or hepatitis, thereby allowing for more meaningful laboratory screening use,” they said.

Evidence supporting prescreening labs for the spectrum of systemic agents used in dermatology varies considerably, “some trapped in time and carried forward for decades until finally questioned, others rooted in treatment mechanism and clinical data,” Adam Friedman, MD, professor and chief of dermatology at George Washington University, Washington, DC, said in an interview.

The study elucidated the current state of clinical practice, said Friedman, who was not involved with the study. This includes screening even if the label says it is not necessary and letting screening slide when guidelines say otherwise — even if the guidelines are outdated and insurance requires certain metrics prior to approval, he said.

Looking ahead, “we need better consensus and even better communication/education on said guidance,” Dr. Friedman said. “Clear, concise, evidenced-based, and expert-validated guidance to ensure we are meaningfully using medical resources” is what is needed, he added. “It will certainly take a village, and close collaboration between the industry and practitioners is key to success.”

The study was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Shay had no financial conflicts to disclose. Lead author Dr. Schneeweiss disclosed grants from UCB Pharma and AbbVie to Brigham and Women’s Hospital outside the submitted work. Other authors disclosed receiving personal fees from Aetion and grants from UCB Pharma and Takeda outside the submitted work; grants from Amarin, Kowa, Novartis, and Pfizer outside the submitted work; and personal fees from Hims & Hers, AbbVie, Sun Pharmaceuticals, Pfizer, Digital Diagnostics, Lilly, Equillium, ASLAN, Boehringer Ingelheim, ACOM, Olaplex, and Legacy Healthcare during the study. No other disclosures were reported.

Editorial author Dr. Enos disclosed serving as an investigator for Amgen and Castle Biosciences and receiving grants from Arcutis Biotherapeutics outside the submitted work. Dr. Van Voorhees disclosed an honorarium outside the submitted work.

Dr. Friedman had no relevant financial conflicts to disclose.

A version of this article appeared on Medscape.com.

As more and more treatments for obesity become available, what does the future hold for these patients? Here are five things that clinicians need to know.

1. Public health officials will prioritize dietary quality over quantity.

Dietitians, healthcare providers, and scientists are already prioritizing the quality of calories, and now policymakers are aligning with this goal, with calls for more research on ultraprocessed foods (UPFs) to answer the key question, “Why do UPFs cause people to eat 500 more calories per day compared with unprocessed foods?” The food industry has taken notice of the potential “Ozempic effect” associated with reduced spending on groceries and is responding with product lines “designed to complement” glucagon-like peptide-1 receptor agonists (GLP-1 RAs) while simultaneously lobbying against any UPF reform. However, with emerging data on how sugar taxes may reduce sales and Congress honing in on the diabetes epidemic, we are hopeful that change is coming in 2024.

2. Antiobesity medications will target fat loss instead of weight loss.

Currently, the US Food and Drug Administration requires antiobesity medications to prove safe weight loss of ≥ 5% over placebo. The focus on weight has been long-standing, but with highly effective medications like tirzepatide causing about 20% weight loss, attention is shifting to body composition — namely, how do we optimize fat loss while preserving muscle? We are seeing this transition in the research community. Bimagrumab, for example, a once-monthly injection that increases muscle mass and decreases fat mass, is being tested in a phase 3 clinical trial alongside semaglutide. Agents initially designed for spinal muscular atrophy, like apitegromab and taldefgrobep alfa, are being repurposed for obesity. Watch for results of these phase 2 trials in 2024.

3. Increasing energy expenditure is the holy grail of obesity research.

The success of GLP-1 RAs, and the even greater success of dual- and triple-target agents like tirzepatide and retatrutide, tells us that obesity is, indeed, a hormone problem. These medications primarily cause weight loss by suppressing appetite and reducing caloric intake. As scientists develop more therapeutics to normalize appetite regulation, attention will shift to optimizing energy expenditure. Researchers are already investigating brown fat, mitochondrial uncouplers, and skeletal muscle metabolism, but no agent thus far has been proven to be both safe and effective in increasing energy expenditure. Of these, keep an eye on clinical trials involving brown fat and the excitement over the anti-inflammatory cytokine growth differentiating factor 15 (GDF15).

4. Chronic disease without chronic medications.

Obesity is a chronic disease, just like hypertension or diabetes. Similarly, medications that treat chronic diseases are expected to be taken long-term because discontinuation often results in disease recurrence. However, obesity research is getting closer and closer to options that require less frequent administration. Bimagrumab, for example, is a once-monthly injection. In endocrinology, the premier example is osteoporosis: Osteoporosis can be treated with just 3 years of an annual injection and never require treatment again. In obesity, anticipate more basic science discoveries aimed at developing safe and specific treatments that are truly disease-modifying — ones that reverse appetitive dysregulation, reduce proinflammatory adiposity, and optimize anabolic metabolism.

5. Barriers to access are barriers to progress.

The biggest challenge to obesity treatment today is access: drug shortages, medication costs, and lack of obesity medicine providers. Shortages of medications like semaglutide 2.4 mg are being driven by high “demand”; in other words, manufacturers failed to anticipate the massive interest in antiobesity medications.

Medicare and most state Medicaid programs don’t cover these medications; commercial payers are refusing, reversing, or limiting coverage. An out-of-pocket monthly cost over $1000 limits affordability for the majority of Americans.

Seeking care from an obesity medicine doctor is a challenge as well. Over 40% of US adults have obesity, but less than 1% of doctors are certified in obesity medicine. Meanwhile, private equity is eager to address the lack of access through compounding pharmacies, medispas, or telemedicine services, but the quality of care varies greatly. Some companies purposely avoid the term “patient,” preferring ethics-free labels like “consumers” or “members.”

The $100 billion–dollar weight loss industry unfortunately has created financial incentives that drive obesity commerce over obesity care. Because of these barriers, the epidemic of obesity, with a prevalence projected to be 50% by 2030, will not be solved or slowed despite the scientific progress in obesity treatment. A single silver lining exists among policymakers who are aiming to correct our costly sick-care system in steps, starting with pharmacy benefit manager reform. Five of these bills are the ones to track in 2024: Pharmacy Benefit Manager Reform Act, Pharmacy Benefits Manager Accountability Act, Pharmacy Benefit Manager Sunshine and Accountability Act, Pharmacy Benefit Manager Transparency Act of 2023, and Lower Costs, More Transparency Act.

I believe that these five things will have the most impact on the treatment of our patients with obesity. Stay tuned throughout the year as I share updates in obesity research, pharmacotherapy, and public policy.
 

Dr. Tchang is Assistant Professor, Clinical Medicine, Division of Endocrinology, Diabetes, and Metabolism, Weill Cornell Medicine; Physician, Department of Medicine, Iris Cantor Women’s Health Center, Comprehensive Weight Control Center, New York, NY. She disclosed ties with Gelesis and Novo Nordisk.

A version of this article appeared on Medscape.com.

As more and more treatments for obesity become available, what does the future hold for these patients? Here are five things that clinicians need to know.

1. Public health officials will prioritize dietary quality over quantity.

Dietitians, healthcare providers, and scientists are already prioritizing the quality of calories, and now policymakers are aligning with this goal, with calls for more research on ultraprocessed foods (UPFs) to answer the key question, “Why do UPFs cause people to eat 500 more calories per day compared with unprocessed foods?” The food industry has taken notice of the potential “Ozempic effect” associated with reduced spending on groceries and is responding with product lines “designed to complement” glucagon-like peptide-1 receptor agonists (GLP-1 RAs) while simultaneously lobbying against any UPF reform. However, with emerging data on how sugar taxes may reduce sales and Congress honing in on the diabetes epidemic, we are hopeful that change is coming in 2024.

2. Antiobesity medications will target fat loss instead of weight loss.

Currently, the US Food and Drug Administration requires antiobesity medications to prove safe weight loss of ≥ 5% over placebo. The focus on weight has been long-standing, but with highly effective medications like tirzepatide causing about 20% weight loss, attention is shifting to body composition — namely, how do we optimize fat loss while preserving muscle? We are seeing this transition in the research community. Bimagrumab, for example, a once-monthly injection that increases muscle mass and decreases fat mass, is being tested in a phase 3 clinical trial alongside semaglutide. Agents initially designed for spinal muscular atrophy, like apitegromab and taldefgrobep alfa, are being repurposed for obesity. Watch for results of these phase 2 trials in 2024.

3. Increasing energy expenditure is the holy grail of obesity research.

The success of GLP-1 RAs, and the even greater success of dual- and triple-target agents like tirzepatide and retatrutide, tells us that obesity is, indeed, a hormone problem. These medications primarily cause weight loss by suppressing appetite and reducing caloric intake. As scientists develop more therapeutics to normalize appetite regulation, attention will shift to optimizing energy expenditure. Researchers are already investigating brown fat, mitochondrial uncouplers, and skeletal muscle metabolism, but no agent thus far has been proven to be both safe and effective in increasing energy expenditure. Of these, keep an eye on clinical trials involving brown fat and the excitement over the anti-inflammatory cytokine growth differentiating factor 15 (GDF15).

4. Chronic disease without chronic medications.

Obesity is a chronic disease, just like hypertension or diabetes. Similarly, medications that treat chronic diseases are expected to be taken long-term because discontinuation often results in disease recurrence. However, obesity research is getting closer and closer to options that require less frequent administration. Bimagrumab, for example, is a once-monthly injection. In endocrinology, the premier example is osteoporosis: Osteoporosis can be treated with just 3 years of an annual injection and never require treatment again. In obesity, anticipate more basic science discoveries aimed at developing safe and specific treatments that are truly disease-modifying — ones that reverse appetitive dysregulation, reduce proinflammatory adiposity, and optimize anabolic metabolism.

5. Barriers to access are barriers to progress.

The biggest challenge to obesity treatment today is access: drug shortages, medication costs, and lack of obesity medicine providers. Shortages of medications like semaglutide 2.4 mg are being driven by high “demand”; in other words, manufacturers failed to anticipate the massive interest in antiobesity medications.

Medicare and most state Medicaid programs don’t cover these medications; commercial payers are refusing, reversing, or limiting coverage. An out-of-pocket monthly cost over $1000 limits affordability for the majority of Americans.

Seeking care from an obesity medicine doctor is a challenge as well. Over 40% of US adults have obesity, but less than 1% of doctors are certified in obesity medicine. Meanwhile, private equity is eager to address the lack of access through compounding pharmacies, medispas, or telemedicine services, but the quality of care varies greatly. Some companies purposely avoid the term “patient,” preferring ethics-free labels like “consumers” or “members.”

The $100 billion–dollar weight loss industry unfortunately has created financial incentives that drive obesity commerce over obesity care. Because of these barriers, the epidemic of obesity, with a prevalence projected to be 50% by 2030, will not be solved or slowed despite the scientific progress in obesity treatment. A single silver lining exists among policymakers who are aiming to correct our costly sick-care system in steps, starting with pharmacy benefit manager reform. Five of these bills are the ones to track in 2024: Pharmacy Benefit Manager Reform Act, Pharmacy Benefits Manager Accountability Act, Pharmacy Benefit Manager Sunshine and Accountability Act, Pharmacy Benefit Manager Transparency Act of 2023, and Lower Costs, More Transparency Act.

I believe that these five things will have the most impact on the treatment of our patients with obesity. Stay tuned throughout the year as I share updates in obesity research, pharmacotherapy, and public policy.
 

Dr. Tchang is Assistant Professor, Clinical Medicine, Division of Endocrinology, Diabetes, and Metabolism, Weill Cornell Medicine; Physician, Department of Medicine, Iris Cantor Women’s Health Center, Comprehensive Weight Control Center, New York, NY. She disclosed ties with Gelesis and Novo Nordisk.

A version of this article appeared on Medscape.com.

As more and more treatments for obesity become available, what does the future hold for these patients? Here are five things that clinicians need to know.

1. Public health officials will prioritize dietary quality over quantity.

Dietitians, healthcare providers, and scientists are already prioritizing the quality of calories, and now policymakers are aligning with this goal, with calls for more research on ultraprocessed foods (UPFs) to answer the key question, “Why do UPFs cause people to eat 500 more calories per day compared with unprocessed foods?” The food industry has taken notice of the potential “Ozempic effect” associated with reduced spending on groceries and is responding with product lines “designed to complement” glucagon-like peptide-1 receptor agonists (GLP-1 RAs) while simultaneously lobbying against any UPF reform. However, with emerging data on how sugar taxes may reduce sales and Congress honing in on the diabetes epidemic, we are hopeful that change is coming in 2024.

2. Antiobesity medications will target fat loss instead of weight loss.

Currently, the US Food and Drug Administration requires antiobesity medications to prove safe weight loss of ≥ 5% over placebo. The focus on weight has been long-standing, but with highly effective medications like tirzepatide causing about 20% weight loss, attention is shifting to body composition — namely, how do we optimize fat loss while preserving muscle? We are seeing this transition in the research community. Bimagrumab, for example, a once-monthly injection that increases muscle mass and decreases fat mass, is being tested in a phase 3 clinical trial alongside semaglutide. Agents initially designed for spinal muscular atrophy, like apitegromab and taldefgrobep alfa, are being repurposed for obesity. Watch for results of these phase 2 trials in 2024.

3. Increasing energy expenditure is the holy grail of obesity research.

The success of GLP-1 RAs, and the even greater success of dual- and triple-target agents like tirzepatide and retatrutide, tells us that obesity is, indeed, a hormone problem. These medications primarily cause weight loss by suppressing appetite and reducing caloric intake. As scientists develop more therapeutics to normalize appetite regulation, attention will shift to optimizing energy expenditure. Researchers are already investigating brown fat, mitochondrial uncouplers, and skeletal muscle metabolism, but no agent thus far has been proven to be both safe and effective in increasing energy expenditure. Of these, keep an eye on clinical trials involving brown fat and the excitement over the anti-inflammatory cytokine growth differentiating factor 15 (GDF15).

4. Chronic disease without chronic medications.

Obesity is a chronic disease, just like hypertension or diabetes. Similarly, medications that treat chronic diseases are expected to be taken long-term because discontinuation often results in disease recurrence. However, obesity research is getting closer and closer to options that require less frequent administration. Bimagrumab, for example, is a once-monthly injection. In endocrinology, the premier example is osteoporosis: Osteoporosis can be treated with just 3 years of an annual injection and never require treatment again. In obesity, anticipate more basic science discoveries aimed at developing safe and specific treatments that are truly disease-modifying — ones that reverse appetitive dysregulation, reduce proinflammatory adiposity, and optimize anabolic metabolism.

5. Barriers to access are barriers to progress.

The biggest challenge to obesity treatment today is access: drug shortages, medication costs, and lack of obesity medicine providers. Shortages of medications like semaglutide 2.4 mg are being driven by high “demand”; in other words, manufacturers failed to anticipate the massive interest in antiobesity medications.

Medicare and most state Medicaid programs don’t cover these medications; commercial payers are refusing, reversing, or limiting coverage. An out-of-pocket monthly cost over $1000 limits affordability for the majority of Americans.

Seeking care from an obesity medicine doctor is a challenge as well. Over 40% of US adults have obesity, but less than 1% of doctors are certified in obesity medicine. Meanwhile, private equity is eager to address the lack of access through compounding pharmacies, medispas, or telemedicine services, but the quality of care varies greatly. Some companies purposely avoid the term “patient,” preferring ethics-free labels like “consumers” or “members.”

The $100 billion–dollar weight loss industry unfortunately has created financial incentives that drive obesity commerce over obesity care. Because of these barriers, the epidemic of obesity, with a prevalence projected to be 50% by 2030, will not be solved or slowed despite the scientific progress in obesity treatment. A single silver lining exists among policymakers who are aiming to correct our costly sick-care system in steps, starting with pharmacy benefit manager reform. Five of these bills are the ones to track in 2024: Pharmacy Benefit Manager Reform Act, Pharmacy Benefits Manager Accountability Act, Pharmacy Benefit Manager Sunshine and Accountability Act, Pharmacy Benefit Manager Transparency Act of 2023, and Lower Costs, More Transparency Act.

I believe that these five things will have the most impact on the treatment of our patients with obesity. Stay tuned throughout the year as I share updates in obesity research, pharmacotherapy, and public policy.
 

Dr. Tchang is Assistant Professor, Clinical Medicine, Division of Endocrinology, Diabetes, and Metabolism, Weill Cornell Medicine; Physician, Department of Medicine, Iris Cantor Women’s Health Center, Comprehensive Weight Control Center, New York, NY. She disclosed ties with Gelesis and Novo Nordisk.

A version of this article appeared on Medscape.com.

Eugene Yang, MD, often confronts the complexities of weighing various medical interventions for high blood pressure. Among these is when to scale back antihypertensive drugs or stop them completely.

He considers a patient’s comorbidities, severity of symptoms, and risk factors for heart attack and stroke, among other variables. Central to this calculus is the recognition of age as a pivotal determinant of quality of life, according to Dr. Yang, the chair of the Prevention of Cardiovascular Disease Council at the American College of Cardiology.

For older adults, for example, the variance in functional status can be striking. One octogenarian may be bedbound due to severe dementia, while another might be playing pickleball three times a week.

“This happens to me in my practice all the time. I have patients who are restricted in mobility and have severe memory loss: Their functionality is quite poor,” Dr. Yang said. “In a patient where we have a limited life expectancy, where they have limited function or core memory, the goal is not to prolong life: It’s to make them more comfortable.”

Knowing when to deprescribe blood pressure medications is crucial. For some, lifestyle changes can do the trick. For others, particularly older patients, their comorbid conditions and medication regimens need to be considered.

“There’s a recognition that we need to move to a new paradigm where we need to decide when to be aggressive and when to be less aggressive,” Dr. Yang said.

The American Heart Association and the American College of Cardiology most recently released guidelines in 2017, changing the cutoff for diagnosis from 140/90 to 130/80 mm Hg. The groups have issued no updates since then, leaving primary care physicians and their colleagues to navigate this territory with caution, balancing the benefits of reduction with the potential harms of undertreatment.

One example of an area that needs updating is the consideration of the age, currently missing from current guidance on hypertension management from government and medical bodies in the United States. However, European Society of Hypertension guidelines, updated in June 2023, recommend adults over age 80 or those classified as frail should be treated when their systolic blood pressure exceeds 160.

“For the first time, we have a chapter in the guidelines on hypertension and management in older people,” Reinhold Kreutz, MD, PhD, immediate past-president of the European Society of Hypertension, said. “If a patient has low blood pressure and symptoms such as dizziness or frailty, a reduction in medication should be considered.”

High blood pressure does not always present with noticeable symptoms, and patients do not always show up for an office visit in time for early intervention. It can pave the way for severe health complications including heart failure, stroke, kidney disease, heart attack, and, ultimately, death.

Grim statistics reveal its toll: Hypertension was a primary or contributing cause of nearly 700,000 deaths in the United States in 2021, and nearly half of adults have the condition. Only about one in four adults have their high blood pressure under control.
 

New Research Provides Insight

A recent study may provide needed insights for primary care clinicians: Gradually reducing hypertensive medication may not induce the feared fluctuations in blood pressure, contrary to prior concerns.

Researchers in Seoul, South Korea, analyzed the blood pressure of 83 patients diagnosed with hypertension who reduced their use of medication. They found that the use of less medication was associated with an increase in blood pressure readings taken at home but not in the clinic nor did it appear to influence blood pressure variability. The mean age of participants was 66 years.

Research shows systolic blood pressure variability is an important predictor of cardiovascular outcomes, as well as the risk for dementia.

When crafting treatment plans, clinicians should recognize the diverse factors at play for a particular patient, particularly concerning other health conditions.

Obesity, diabetes, and hyperlipidemia are among the common comorbidities often intertwined with hypertension. Because additional conditions come with more symptoms to consider and various medications, these health profiles demand tailored approaches to hypertension treatment.

Clinicians can recommend lifestyle modifications like dietary changes and regular exercise as first steps for patients who are diagnosed with grade 1 hypertension but who do not have cardiovascular disease, chronic kidney disease, diabetes, or organ damage. However, in cases where comorbidities are present or hypertension escalates to grade 2, clinicians should turn to medications for management, according to the International Society of Hypertension.

Patients with heart failure and reduced ejection fraction have unique challenges, according to Keith C. Ferdinand, MD, the Gereld S. Berenson Endowed Chair in Preventative Cardiology at the Tulane School of Medicine in New Orleans, Louisiana.

“Patients who have heart disease, they get a pump so the blood pressure comes down — but medicine is often needed to prevent further heart failure,” Dr. Ferdinand said.

Dr. Ferdinand stressed the importance of continuous medication to stave off further cardiac deterioration. He advocated for a cautious approach, emphasizing the continued use of medications like sacubitril/valsartan, beta-blockers, or sodium-glucose transport protein inhibitors to safeguard against heart failure progression.

Patients should also self-monitor blood pressure at home and be taught how to properly fit a cuff to enable accurate measurements. This approach empowers patients to actively engage in their health management and detect any deviations that warrant further attention, he said.
 

Medications for Hypertension

The use of any of the five major drug classes — angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, beta-blockers, calcium blockers, and thiazide/thiazide-like diuretics — and their combinations are recommended as the basis of antihypertensive treatment strategies.

Dr. Yang said primary care clinicians must be careful to decrease doses slowly. Central-acting medications such as clonidine and beta-blockers ultimately reduce heart rate and dilate blood vessels.

Decreasing the dose too quickly can create a rebound effect, and medication should be means reduced and closely monitored over the course of several weeks, Dr. Yang said.

“You cannot just withdraw abruptly with certain medications — you have to wean off slowly,” because patients may experience high blood pressure again, Dr. Yang said.

A version of this article appeared on Medscape.com.

Eugene Yang, MD, often confronts the complexities of weighing various medical interventions for high blood pressure. Among these is when to scale back antihypertensive drugs or stop them completely.

He considers a patient’s comorbidities, severity of symptoms, and risk factors for heart attack and stroke, among other variables. Central to this calculus is the recognition of age as a pivotal determinant of quality of life, according to Dr. Yang, the chair of the Prevention of Cardiovascular Disease Council at the American College of Cardiology.

For older adults, for example, the variance in functional status can be striking. One octogenarian may be bedbound due to severe dementia, while another might be playing pickleball three times a week.

“This happens to me in my practice all the time. I have patients who are restricted in mobility and have severe memory loss: Their functionality is quite poor,” Dr. Yang said. “In a patient where we have a limited life expectancy, where they have limited function or core memory, the goal is not to prolong life: It’s to make them more comfortable.”

Knowing when to deprescribe blood pressure medications is crucial. For some, lifestyle changes can do the trick. For others, particularly older patients, their comorbid conditions and medication regimens need to be considered.

“There’s a recognition that we need to move to a new paradigm where we need to decide when to be aggressive and when to be less aggressive,” Dr. Yang said.

The American Heart Association and the American College of Cardiology most recently released guidelines in 2017, changing the cutoff for diagnosis from 140/90 to 130/80 mm Hg. The groups have issued no updates since then, leaving primary care physicians and their colleagues to navigate this territory with caution, balancing the benefits of reduction with the potential harms of undertreatment.

One example of an area that needs updating is the consideration of the age, currently missing from current guidance on hypertension management from government and medical bodies in the United States. However, European Society of Hypertension guidelines, updated in June 2023, recommend adults over age 80 or those classified as frail should be treated when their systolic blood pressure exceeds 160.

“For the first time, we have a chapter in the guidelines on hypertension and management in older people,” Reinhold Kreutz, MD, PhD, immediate past-president of the European Society of Hypertension, said. “If a patient has low blood pressure and symptoms such as dizziness or frailty, a reduction in medication should be considered.”

High blood pressure does not always present with noticeable symptoms, and patients do not always show up for an office visit in time for early intervention. It can pave the way for severe health complications including heart failure, stroke, kidney disease, heart attack, and, ultimately, death.

Grim statistics reveal its toll: Hypertension was a primary or contributing cause of nearly 700,000 deaths in the United States in 2021, and nearly half of adults have the condition. Only about one in four adults have their high blood pressure under control.
 

New Research Provides Insight

A recent study may provide needed insights for primary care clinicians: Gradually reducing hypertensive medication may not induce the feared fluctuations in blood pressure, contrary to prior concerns.

Researchers in Seoul, South Korea, analyzed the blood pressure of 83 patients diagnosed with hypertension who reduced their use of medication. They found that the use of less medication was associated with an increase in blood pressure readings taken at home but not in the clinic nor did it appear to influence blood pressure variability. The mean age of participants was 66 years.

Research shows systolic blood pressure variability is an important predictor of cardiovascular outcomes, as well as the risk for dementia.

When crafting treatment plans, clinicians should recognize the diverse factors at play for a particular patient, particularly concerning other health conditions.

Obesity, diabetes, and hyperlipidemia are among the common comorbidities often intertwined with hypertension. Because additional conditions come with more symptoms to consider and various medications, these health profiles demand tailored approaches to hypertension treatment.

Clinicians can recommend lifestyle modifications like dietary changes and regular exercise as first steps for patients who are diagnosed with grade 1 hypertension but who do not have cardiovascular disease, chronic kidney disease, diabetes, or organ damage. However, in cases where comorbidities are present or hypertension escalates to grade 2, clinicians should turn to medications for management, according to the International Society of Hypertension.

Patients with heart failure and reduced ejection fraction have unique challenges, according to Keith C. Ferdinand, MD, the Gereld S. Berenson Endowed Chair in Preventative Cardiology at the Tulane School of Medicine in New Orleans, Louisiana.

“Patients who have heart disease, they get a pump so the blood pressure comes down — but medicine is often needed to prevent further heart failure,” Dr. Ferdinand said.

Dr. Ferdinand stressed the importance of continuous medication to stave off further cardiac deterioration. He advocated for a cautious approach, emphasizing the continued use of medications like sacubitril/valsartan, beta-blockers, or sodium-glucose transport protein inhibitors to safeguard against heart failure progression.

Patients should also self-monitor blood pressure at home and be taught how to properly fit a cuff to enable accurate measurements. This approach empowers patients to actively engage in their health management and detect any deviations that warrant further attention, he said.
 

Medications for Hypertension

The use of any of the five major drug classes — angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, beta-blockers, calcium blockers, and thiazide/thiazide-like diuretics — and their combinations are recommended as the basis of antihypertensive treatment strategies.

Dr. Yang said primary care clinicians must be careful to decrease doses slowly. Central-acting medications such as clonidine and beta-blockers ultimately reduce heart rate and dilate blood vessels.

Decreasing the dose too quickly can create a rebound effect, and medication should be means reduced and closely monitored over the course of several weeks, Dr. Yang said.

“You cannot just withdraw abruptly with certain medications — you have to wean off slowly,” because patients may experience high blood pressure again, Dr. Yang said.

A version of this article appeared on Medscape.com.

Eugene Yang, MD, often confronts the complexities of weighing various medical interventions for high blood pressure. Among these is when to scale back antihypertensive drugs or stop them completely.

He considers a patient’s comorbidities, severity of symptoms, and risk factors for heart attack and stroke, among other variables. Central to this calculus is the recognition of age as a pivotal determinant of quality of life, according to Dr. Yang, the chair of the Prevention of Cardiovascular Disease Council at the American College of Cardiology.

For older adults, for example, the variance in functional status can be striking. One octogenarian may be bedbound due to severe dementia, while another might be playing pickleball three times a week.

“This happens to me in my practice all the time. I have patients who are restricted in mobility and have severe memory loss: Their functionality is quite poor,” Dr. Yang said. “In a patient where we have a limited life expectancy, where they have limited function or core memory, the goal is not to prolong life: It’s to make them more comfortable.”

Knowing when to deprescribe blood pressure medications is crucial. For some, lifestyle changes can do the trick. For others, particularly older patients, their comorbid conditions and medication regimens need to be considered.

“There’s a recognition that we need to move to a new paradigm where we need to decide when to be aggressive and when to be less aggressive,” Dr. Yang said.

The American Heart Association and the American College of Cardiology most recently released guidelines in 2017, changing the cutoff for diagnosis from 140/90 to 130/80 mm Hg. The groups have issued no updates since then, leaving primary care physicians and their colleagues to navigate this territory with caution, balancing the benefits of reduction with the potential harms of undertreatment.

One example of an area that needs updating is the consideration of the age, currently missing from current guidance on hypertension management from government and medical bodies in the United States. However, European Society of Hypertension guidelines, updated in June 2023, recommend adults over age 80 or those classified as frail should be treated when their systolic blood pressure exceeds 160.

“For the first time, we have a chapter in the guidelines on hypertension and management in older people,” Reinhold Kreutz, MD, PhD, immediate past-president of the European Society of Hypertension, said. “If a patient has low blood pressure and symptoms such as dizziness or frailty, a reduction in medication should be considered.”

High blood pressure does not always present with noticeable symptoms, and patients do not always show up for an office visit in time for early intervention. It can pave the way for severe health complications including heart failure, stroke, kidney disease, heart attack, and, ultimately, death.

Grim statistics reveal its toll: Hypertension was a primary or contributing cause of nearly 700,000 deaths in the United States in 2021, and nearly half of adults have the condition. Only about one in four adults have their high blood pressure under control.
 

New Research Provides Insight

A recent study may provide needed insights for primary care clinicians: Gradually reducing hypertensive medication may not induce the feared fluctuations in blood pressure, contrary to prior concerns.

Researchers in Seoul, South Korea, analyzed the blood pressure of 83 patients diagnosed with hypertension who reduced their use of medication. They found that the use of less medication was associated with an increase in blood pressure readings taken at home but not in the clinic nor did it appear to influence blood pressure variability. The mean age of participants was 66 years.

Research shows systolic blood pressure variability is an important predictor of cardiovascular outcomes, as well as the risk for dementia.

When crafting treatment plans, clinicians should recognize the diverse factors at play for a particular patient, particularly concerning other health conditions.

Obesity, diabetes, and hyperlipidemia are among the common comorbidities often intertwined with hypertension. Because additional conditions come with more symptoms to consider and various medications, these health profiles demand tailored approaches to hypertension treatment.

Clinicians can recommend lifestyle modifications like dietary changes and regular exercise as first steps for patients who are diagnosed with grade 1 hypertension but who do not have cardiovascular disease, chronic kidney disease, diabetes, or organ damage. However, in cases where comorbidities are present or hypertension escalates to grade 2, clinicians should turn to medications for management, according to the International Society of Hypertension.

Patients with heart failure and reduced ejection fraction have unique challenges, according to Keith C. Ferdinand, MD, the Gereld S. Berenson Endowed Chair in Preventative Cardiology at the Tulane School of Medicine in New Orleans, Louisiana.

“Patients who have heart disease, they get a pump so the blood pressure comes down — but medicine is often needed to prevent further heart failure,” Dr. Ferdinand said.

Dr. Ferdinand stressed the importance of continuous medication to stave off further cardiac deterioration. He advocated for a cautious approach, emphasizing the continued use of medications like sacubitril/valsartan, beta-blockers, or sodium-glucose transport protein inhibitors to safeguard against heart failure progression.

Patients should also self-monitor blood pressure at home and be taught how to properly fit a cuff to enable accurate measurements. This approach empowers patients to actively engage in their health management and detect any deviations that warrant further attention, he said.
 

Medications for Hypertension

The use of any of the five major drug classes — angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, beta-blockers, calcium blockers, and thiazide/thiazide-like diuretics — and their combinations are recommended as the basis of antihypertensive treatment strategies.

Dr. Yang said primary care clinicians must be careful to decrease doses slowly. Central-acting medications such as clonidine and beta-blockers ultimately reduce heart rate and dilate blood vessels.

Decreasing the dose too quickly can create a rebound effect, and medication should be means reduced and closely monitored over the course of several weeks, Dr. Yang said.

“You cannot just withdraw abruptly with certain medications — you have to wean off slowly,” because patients may experience high blood pressure again, Dr. Yang said.

A version of this article appeared on Medscape.com.