Andrew D. Bowser

Although nutrition therapy is pivotal in the management of patients with diabetes or prediabetes, there’s no one correct eating pattern appropriate for all patients, according to a consensus report from an expert panel convened by the American Diabetes Association.

A one-size-fits-all eating plan would be an unrealistic expectation, given the diversity of cultural issues, personal preferences, comorbidities, and other factors that are unique to individual patients with diabetes or prediabetes, according to the report, which was published in Diabetes Care.

Instead, authors of the report outlined nine different eating patterns, along with the evidence supporting their use and their reported benefits in patients with diabetes or prediabetes.

The report reflects a commitment to developing evidence-based guidelines that are “achievable and meet people where they are” to formulate individualized nutrition plans, William T. Cefalu, MD, chief scientific, medical, and mission officer for the ADA, said in a statement.

“The importance of this consensus also lies in the fact it was authored by a group of experts who are extremely knowledgeable about numerous eating patterns, including vegan, vegetarian, and low carb,” Dr. Cefalu added.

The expert panel of 14 individuals included registered dietitians, diabetes educators, endocrinologists, a primary care physician, and a patient advocate who all answered a national call for experts, according to the ADA.

The panel reviewed more than 600 nutrition manuscripts published between 2014 and 2018 to develop the new consensus statement, which updates the ADA 2014 position statement on nutrition therapy for adults with diabetes and has been incorporated into the association’s Standards of Medical Care in Diabetes–2019 supplement as a living standards update.

All adults with type 1 or 2 diabetes should be referred to individualized, diabetes-focused medical nutrition therapy, the panel members wrote in their report.

There is no evidence suggesting an ideal percentage of calories from carbohydrate, protein, and fat in patients with prediabetes or diabetes, so macronutrient distribution should also be individualized, according to the panel.

Likewise, a variety of eating patterns are acceptable for managing diabetes, according to the report, which describes evidence for eating patterns including Mediterranean, vegetarian or vegan, low fat and very low fat, low carbohydrate and very low carbohydrate, and paleo, as well as the Dietary Approaches to Stop Hypertension diet and the Department of Agriculture Dietary Guidelines for Americans.

Not all diets have the same level of evidence, however. For prevention of prediabetes or type 2 diabetes, for example, the most robust research is available for Mediterranean-style, low-fat, and low-carbohydrate eating patterns, the panel said.

Until there’s better comparative evidence between eating patterns, health care providers should concentrate on several key factors common to a number of the eating patterns, such as limiting sugars and refined grains, emphasizing nonstarchy vegetables, and choosing whole foods over processed foods, the experts wrote.

Consensus panel participants reported disclosures with the ADA, the National Institutes of Health, the Academy of Nutrition and Dietetics, the American Medical Group Association, the University of Michigan, Novo Nordisk, Merck, Amgen, Gilead, BOYDSense, Janssen, Sanofi, Pfizer, Sunstar Foundation, New England Dairy and Dairy Farmer, the National Dairy Council, Kowa Company, and dietdoctor.com.

SOURCE: Evert AB et al. Diabetes Care. 2019 Apr 18. doi: 10.2337/dci19-0014.

Although nutrition therapy is pivotal in the management of patients with diabetes or prediabetes, there’s no one correct eating pattern appropriate for all patients, according to a consensus report from an expert panel convened by the American Diabetes Association.

A one-size-fits-all eating plan would be an unrealistic expectation, given the diversity of cultural issues, personal preferences, comorbidities, and other factors that are unique to individual patients with diabetes or prediabetes, according to the report, which was published in Diabetes Care.

Instead, authors of the report outlined nine different eating patterns, along with the evidence supporting their use and their reported benefits in patients with diabetes or prediabetes.

The report reflects a commitment to developing evidence-based guidelines that are “achievable and meet people where they are” to formulate individualized nutrition plans, William T. Cefalu, MD, chief scientific, medical, and mission officer for the ADA, said in a statement.

“The importance of this consensus also lies in the fact it was authored by a group of experts who are extremely knowledgeable about numerous eating patterns, including vegan, vegetarian, and low carb,” Dr. Cefalu added.

The expert panel of 14 individuals included registered dietitians, diabetes educators, endocrinologists, a primary care physician, and a patient advocate who all answered a national call for experts, according to the ADA.

The panel reviewed more than 600 nutrition manuscripts published between 2014 and 2018 to develop the new consensus statement, which updates the ADA 2014 position statement on nutrition therapy for adults with diabetes and has been incorporated into the association’s Standards of Medical Care in Diabetes–2019 supplement as a living standards update.

All adults with type 1 or 2 diabetes should be referred to individualized, diabetes-focused medical nutrition therapy, the panel members wrote in their report.

There is no evidence suggesting an ideal percentage of calories from carbohydrate, protein, and fat in patients with prediabetes or diabetes, so macronutrient distribution should also be individualized, according to the panel.

Likewise, a variety of eating patterns are acceptable for managing diabetes, according to the report, which describes evidence for eating patterns including Mediterranean, vegetarian or vegan, low fat and very low fat, low carbohydrate and very low carbohydrate, and paleo, as well as the Dietary Approaches to Stop Hypertension diet and the Department of Agriculture Dietary Guidelines for Americans.

Not all diets have the same level of evidence, however. For prevention of prediabetes or type 2 diabetes, for example, the most robust research is available for Mediterranean-style, low-fat, and low-carbohydrate eating patterns, the panel said.

Until there’s better comparative evidence between eating patterns, health care providers should concentrate on several key factors common to a number of the eating patterns, such as limiting sugars and refined grains, emphasizing nonstarchy vegetables, and choosing whole foods over processed foods, the experts wrote.

Consensus panel participants reported disclosures with the ADA, the National Institutes of Health, the Academy of Nutrition and Dietetics, the American Medical Group Association, the University of Michigan, Novo Nordisk, Merck, Amgen, Gilead, BOYDSense, Janssen, Sanofi, Pfizer, Sunstar Foundation, New England Dairy and Dairy Farmer, the National Dairy Council, Kowa Company, and dietdoctor.com.

SOURCE: Evert AB et al. Diabetes Care. 2019 Apr 18. doi: 10.2337/dci19-0014.

Although nutrition therapy is pivotal in the management of patients with diabetes or prediabetes, there’s no one correct eating pattern appropriate for all patients, according to a consensus report from an expert panel convened by the American Diabetes Association.

A one-size-fits-all eating plan would be an unrealistic expectation, given the diversity of cultural issues, personal preferences, comorbidities, and other factors that are unique to individual patients with diabetes or prediabetes, according to the report, which was published in Diabetes Care.

Instead, authors of the report outlined nine different eating patterns, along with the evidence supporting their use and their reported benefits in patients with diabetes or prediabetes.

The report reflects a commitment to developing evidence-based guidelines that are “achievable and meet people where they are” to formulate individualized nutrition plans, William T. Cefalu, MD, chief scientific, medical, and mission officer for the ADA, said in a statement.

“The importance of this consensus also lies in the fact it was authored by a group of experts who are extremely knowledgeable about numerous eating patterns, including vegan, vegetarian, and low carb,” Dr. Cefalu added.

The expert panel of 14 individuals included registered dietitians, diabetes educators, endocrinologists, a primary care physician, and a patient advocate who all answered a national call for experts, according to the ADA.

The panel reviewed more than 600 nutrition manuscripts published between 2014 and 2018 to develop the new consensus statement, which updates the ADA 2014 position statement on nutrition therapy for adults with diabetes and has been incorporated into the association’s Standards of Medical Care in Diabetes–2019 supplement as a living standards update.

All adults with type 1 or 2 diabetes should be referred to individualized, diabetes-focused medical nutrition therapy, the panel members wrote in their report.

There is no evidence suggesting an ideal percentage of calories from carbohydrate, protein, and fat in patients with prediabetes or diabetes, so macronutrient distribution should also be individualized, according to the panel.

Likewise, a variety of eating patterns are acceptable for managing diabetes, according to the report, which describes evidence for eating patterns including Mediterranean, vegetarian or vegan, low fat and very low fat, low carbohydrate and very low carbohydrate, and paleo, as well as the Dietary Approaches to Stop Hypertension diet and the Department of Agriculture Dietary Guidelines for Americans.

Not all diets have the same level of evidence, however. For prevention of prediabetes or type 2 diabetes, for example, the most robust research is available for Mediterranean-style, low-fat, and low-carbohydrate eating patterns, the panel said.

Until there’s better comparative evidence between eating patterns, health care providers should concentrate on several key factors common to a number of the eating patterns, such as limiting sugars and refined grains, emphasizing nonstarchy vegetables, and choosing whole foods over processed foods, the experts wrote.

Consensus panel participants reported disclosures with the ADA, the National Institutes of Health, the Academy of Nutrition and Dietetics, the American Medical Group Association, the University of Michigan, Novo Nordisk, Merck, Amgen, Gilead, BOYDSense, Janssen, Sanofi, Pfizer, Sunstar Foundation, New England Dairy and Dairy Farmer, the National Dairy Council, Kowa Company, and dietdoctor.com.

SOURCE: Evert AB et al. Diabetes Care. 2019 Apr 18. doi: 10.2337/dci19-0014.

PHILADELPHIA – Intermittent fasting may help improve weight status and metabolic health, but it is very challenging to adhere to and is possibly associated with certain risks, a physician with expertise in obesity and nutrition said during a presentation.

Andrew D. Bowser/MDedge News

“I do not necessarily recommend intermittent fasting to my patients, but I do have a lot of patients that will come to me asking about intermittent fasting,” said Fatima Cody Stanford, MD, MPH, of Massachusetts General Hospital Weight Center and Harvard Medical School, both in Boston, at the annual meeting of the American College of Physicians.

Intermittent fasting, which can take several forms including partial-day fasting, every-other-day fasting, or fasting two days per week, has been associated with positive physiological effects in an increasing number of recent studies, Dr. Stanford said.

Those physiological effects, reported in animals or humans, have included a potentially increased lifespan, decreased mortality related to cancers or cardiovascular disease, an improved insulin sensitivity, and reduced oxidative stress and inflammation, she said.

Additionally, weight loss and improvement in other health indicators, including insulin resistance, have been demonstrated in some studies of intermittent fasting that included normal weight or overweight human subjects.

In one systematic review and meta-analysis, intermittent fasting was found to be comparable with continuous energy restriction in overweight and obese adults for short-term weight loss.

Compared with no treatment, intermittent energy restriction was associated with a 4.14-kg drop in weight (95% confidence interval, 6.30-1.99; P less than or equal to 0.001), according to that meta-analysis.

In patients with type 2 diabetes, 12 months of intermittent energy restriction resulted in glycemic control comparable with continuous energy restriction, according to results of a randomized, 137-patient, noninferiority trial.

On the flip side, intermittent fasting has been associated with possible health risks, including having “a deleterious impact on fertility” and “a negative impact on bone health,” according to Dr. Stanford.

“These are things that I bring up with my patients,” she told her audience.

Lean mass may also be in jeopardy in intermittent fasters, according to authors of one systematic review and meta-analysis of randomized controlled trials published in the International Journal of Obesity.

Those investigators found that lean mass was decreased in intermittent dieters as compared with continuous dieters in the 9 trials they included. The mean difference was –0.86 kg (95% CI, –1.62 to –0.10; P = 0.03).

Even if intermittent fasting is comparable with continuous energy restriction in weight loss, getting to that point may be more difficult because of increased hunger, at least according to researchers in one randomized 1-year trial, Dr. Sanford noted.

Subjective hunger scores were higher at 4.7 for intermittent fasters versus 3.6 for continuous restriction participants (P = 0.002), results of that trial showed.

“It’s very difficult for most of us to sustain this,” Dr. Stanford said.

Dr. Stanford reported no relevant disclosures.

PHILADELPHIA – Intermittent fasting may help improve weight status and metabolic health, but it is very challenging to adhere to and is possibly associated with certain risks, a physician with expertise in obesity and nutrition said during a presentation.

Andrew D. Bowser/MDedge News

“I do not necessarily recommend intermittent fasting to my patients, but I do have a lot of patients that will come to me asking about intermittent fasting,” said Fatima Cody Stanford, MD, MPH, of Massachusetts General Hospital Weight Center and Harvard Medical School, both in Boston, at the annual meeting of the American College of Physicians.

Intermittent fasting, which can take several forms including partial-day fasting, every-other-day fasting, or fasting two days per week, has been associated with positive physiological effects in an increasing number of recent studies, Dr. Stanford said.

Those physiological effects, reported in animals or humans, have included a potentially increased lifespan, decreased mortality related to cancers or cardiovascular disease, an improved insulin sensitivity, and reduced oxidative stress and inflammation, she said.

Additionally, weight loss and improvement in other health indicators, including insulin resistance, have been demonstrated in some studies of intermittent fasting that included normal weight or overweight human subjects.

In one systematic review and meta-analysis, intermittent fasting was found to be comparable with continuous energy restriction in overweight and obese adults for short-term weight loss.

Compared with no treatment, intermittent energy restriction was associated with a 4.14-kg drop in weight (95% confidence interval, 6.30-1.99; P less than or equal to 0.001), according to that meta-analysis.

In patients with type 2 diabetes, 12 months of intermittent energy restriction resulted in glycemic control comparable with continuous energy restriction, according to results of a randomized, 137-patient, noninferiority trial.

On the flip side, intermittent fasting has been associated with possible health risks, including having “a deleterious impact on fertility” and “a negative impact on bone health,” according to Dr. Stanford.

“These are things that I bring up with my patients,” she told her audience.

Lean mass may also be in jeopardy in intermittent fasters, according to authors of one systematic review and meta-analysis of randomized controlled trials published in the International Journal of Obesity.

Those investigators found that lean mass was decreased in intermittent dieters as compared with continuous dieters in the 9 trials they included. The mean difference was –0.86 kg (95% CI, –1.62 to –0.10; P = 0.03).

Even if intermittent fasting is comparable with continuous energy restriction in weight loss, getting to that point may be more difficult because of increased hunger, at least according to researchers in one randomized 1-year trial, Dr. Sanford noted.

Subjective hunger scores were higher at 4.7 for intermittent fasters versus 3.6 for continuous restriction participants (P = 0.002), results of that trial showed.

“It’s very difficult for most of us to sustain this,” Dr. Stanford said.

Dr. Stanford reported no relevant disclosures.

PHILADELPHIA – Intermittent fasting may help improve weight status and metabolic health, but it is very challenging to adhere to and is possibly associated with certain risks, a physician with expertise in obesity and nutrition said during a presentation.

Andrew D. Bowser/MDedge News

“I do not necessarily recommend intermittent fasting to my patients, but I do have a lot of patients that will come to me asking about intermittent fasting,” said Fatima Cody Stanford, MD, MPH, of Massachusetts General Hospital Weight Center and Harvard Medical School, both in Boston, at the annual meeting of the American College of Physicians.

Intermittent fasting, which can take several forms including partial-day fasting, every-other-day fasting, or fasting two days per week, has been associated with positive physiological effects in an increasing number of recent studies, Dr. Stanford said.

Those physiological effects, reported in animals or humans, have included a potentially increased lifespan, decreased mortality related to cancers or cardiovascular disease, an improved insulin sensitivity, and reduced oxidative stress and inflammation, she said.

Additionally, weight loss and improvement in other health indicators, including insulin resistance, have been demonstrated in some studies of intermittent fasting that included normal weight or overweight human subjects.

In one systematic review and meta-analysis, intermittent fasting was found to be comparable with continuous energy restriction in overweight and obese adults for short-term weight loss.

Compared with no treatment, intermittent energy restriction was associated with a 4.14-kg drop in weight (95% confidence interval, 6.30-1.99; P less than or equal to 0.001), according to that meta-analysis.

In patients with type 2 diabetes, 12 months of intermittent energy restriction resulted in glycemic control comparable with continuous energy restriction, according to results of a randomized, 137-patient, noninferiority trial.

On the flip side, intermittent fasting has been associated with possible health risks, including having “a deleterious impact on fertility” and “a negative impact on bone health,” according to Dr. Stanford.

“These are things that I bring up with my patients,” she told her audience.

Lean mass may also be in jeopardy in intermittent fasters, according to authors of one systematic review and meta-analysis of randomized controlled trials published in the International Journal of Obesity.

Those investigators found that lean mass was decreased in intermittent dieters as compared with continuous dieters in the 9 trials they included. The mean difference was –0.86 kg (95% CI, –1.62 to –0.10; P = 0.03).

Even if intermittent fasting is comparable with continuous energy restriction in weight loss, getting to that point may be more difficult because of increased hunger, at least according to researchers in one randomized 1-year trial, Dr. Sanford noted.

Subjective hunger scores were higher at 4.7 for intermittent fasters versus 3.6 for continuous restriction participants (P = 0.002), results of that trial showed.

“It’s very difficult for most of us to sustain this,” Dr. Stanford said.

Dr. Stanford reported no relevant disclosures.

PHILADELPHIA – While many internists might think a switch to spironolactone would be warranted for a heart failure patient with inadequate response to oral furosemide (Lasix), transitioning to an alternative loop diuretic may be the preferable approach, a cardiologist said at the annual meeting of the American College of Physicians.

Andrew D. Bowser/MDedge News

“Lasix is associated with very high variability in terms of absorption, so torsemide and bumetanide should be considered in patients who have a poor response,” said Paul McKie, MD, MPH, a cardiologist and internist with Mayo Clinic, Rochester, Minn., in a session at the meeting.

When polled, only 22% of attendees at the session picked “transition to torsemide” as the best approach for restoring fluid balance with the lowest adverse potential in a 74-year-old woman with nonischemic cardiomyopathy on furosemide 80 mg twice daily who has been hospitalized for fluid overload three times in the year.

The majority of attendees (41%) said they would have added spironolactone. Dr. McKie disagreed with this approach. Instead, Dr. McKie said he would have transitioned this person to an alternative loop diuretic.

“I think spironolactone is a great medication in heart failure with reduced ejection fraction, but the doses we typically use are generally suboptimal to achieve diuresis,” he added.

The rationale for considering an alternative loop diuretic in this patient hinges on bioavailability, which is “highly variable” for oral furosemide, at 10%-100%, while by contrast, torsemide and bumetanide have a very consistent bioavailability of 80%-100%, according to Dr. McKie.

“For this reason, I think about using torsemide or bumetanide in patients who are not responding to oral Lasix,” he said.

Dr. McKie described an algorithm that he and his colleagues use in clinic to intensify outpatient therapy for patients not achieving diuresis.

The first step is to ensure adherence and ask patients whether they are following sodium and fluid restriction: “I always ask about that first,” he said. “I tell patients, ‘You can out-eat and out-drink any diuretic regimen.’ ”

The next step is to double the dose of the loop diuretic and, sometimes, triple the dose if the double dose is not effective.

“If they’re diuresing but it’s just not adequate, then I’ll move to twice-daily dosing,” he said. “A practical tip is I tell patients to take their first dose as soon as they wake up and the second dose around 1:00 PM so that they’re not urinating all night.”

If twice-daily dosing doesn’t help, then that’s the point where an alternative loop diuretic would be warranted, according to Dr. McKie’s algorithm.

“Then I add a thiazide like metolazone, but I only do that after I’ve increased the dose of the loop diuretic,” he added.

If all else fails, then outpatient IV diuretics can be considered, according to the algorithmic approach.

Dr. McKie reported no relevant disclosures.

PHILADELPHIA – While many internists might think a switch to spironolactone would be warranted for a heart failure patient with inadequate response to oral furosemide (Lasix), transitioning to an alternative loop diuretic may be the preferable approach, a cardiologist said at the annual meeting of the American College of Physicians.

Andrew D. Bowser/MDedge News

“Lasix is associated with very high variability in terms of absorption, so torsemide and bumetanide should be considered in patients who have a poor response,” said Paul McKie, MD, MPH, a cardiologist and internist with Mayo Clinic, Rochester, Minn., in a session at the meeting.

When polled, only 22% of attendees at the session picked “transition to torsemide” as the best approach for restoring fluid balance with the lowest adverse potential in a 74-year-old woman with nonischemic cardiomyopathy on furosemide 80 mg twice daily who has been hospitalized for fluid overload three times in the year.

The majority of attendees (41%) said they would have added spironolactone. Dr. McKie disagreed with this approach. Instead, Dr. McKie said he would have transitioned this person to an alternative loop diuretic.

“I think spironolactone is a great medication in heart failure with reduced ejection fraction, but the doses we typically use are generally suboptimal to achieve diuresis,” he added.

The rationale for considering an alternative loop diuretic in this patient hinges on bioavailability, which is “highly variable” for oral furosemide, at 10%-100%, while by contrast, torsemide and bumetanide have a very consistent bioavailability of 80%-100%, according to Dr. McKie.

“For this reason, I think about using torsemide or bumetanide in patients who are not responding to oral Lasix,” he said.

Dr. McKie described an algorithm that he and his colleagues use in clinic to intensify outpatient therapy for patients not achieving diuresis.

The first step is to ensure adherence and ask patients whether they are following sodium and fluid restriction: “I always ask about that first,” he said. “I tell patients, ‘You can out-eat and out-drink any diuretic regimen.’ ”

The next step is to double the dose of the loop diuretic and, sometimes, triple the dose if the double dose is not effective.

“If they’re diuresing but it’s just not adequate, then I’ll move to twice-daily dosing,” he said. “A practical tip is I tell patients to take their first dose as soon as they wake up and the second dose around 1:00 PM so that they’re not urinating all night.”

If twice-daily dosing doesn’t help, then that’s the point where an alternative loop diuretic would be warranted, according to Dr. McKie’s algorithm.

“Then I add a thiazide like metolazone, but I only do that after I’ve increased the dose of the loop diuretic,” he added.

If all else fails, then outpatient IV diuretics can be considered, according to the algorithmic approach.

Dr. McKie reported no relevant disclosures.

PHILADELPHIA – While many internists might think a switch to spironolactone would be warranted for a heart failure patient with inadequate response to oral furosemide (Lasix), transitioning to an alternative loop diuretic may be the preferable approach, a cardiologist said at the annual meeting of the American College of Physicians.

Andrew D. Bowser/MDedge News

“Lasix is associated with very high variability in terms of absorption, so torsemide and bumetanide should be considered in patients who have a poor response,” said Paul McKie, MD, MPH, a cardiologist and internist with Mayo Clinic, Rochester, Minn., in a session at the meeting.

When polled, only 22% of attendees at the session picked “transition to torsemide” as the best approach for restoring fluid balance with the lowest adverse potential in a 74-year-old woman with nonischemic cardiomyopathy on furosemide 80 mg twice daily who has been hospitalized for fluid overload three times in the year.

The majority of attendees (41%) said they would have added spironolactone. Dr. McKie disagreed with this approach. Instead, Dr. McKie said he would have transitioned this person to an alternative loop diuretic.

“I think spironolactone is a great medication in heart failure with reduced ejection fraction, but the doses we typically use are generally suboptimal to achieve diuresis,” he added.

The rationale for considering an alternative loop diuretic in this patient hinges on bioavailability, which is “highly variable” for oral furosemide, at 10%-100%, while by contrast, torsemide and bumetanide have a very consistent bioavailability of 80%-100%, according to Dr. McKie.

“For this reason, I think about using torsemide or bumetanide in patients who are not responding to oral Lasix,” he said.

Dr. McKie described an algorithm that he and his colleagues use in clinic to intensify outpatient therapy for patients not achieving diuresis.

The first step is to ensure adherence and ask patients whether they are following sodium and fluid restriction: “I always ask about that first,” he said. “I tell patients, ‘You can out-eat and out-drink any diuretic regimen.’ ”

The next step is to double the dose of the loop diuretic and, sometimes, triple the dose if the double dose is not effective.

“If they’re diuresing but it’s just not adequate, then I’ll move to twice-daily dosing,” he said. “A practical tip is I tell patients to take their first dose as soon as they wake up and the second dose around 1:00 PM so that they’re not urinating all night.”

If twice-daily dosing doesn’t help, then that’s the point where an alternative loop diuretic would be warranted, according to Dr. McKie’s algorithm.

“Then I add a thiazide like metolazone, but I only do that after I’ve increased the dose of the loop diuretic,” he added.

If all else fails, then outpatient IV diuretics can be considered, according to the algorithmic approach.

Dr. McKie reported no relevant disclosures.

PHILADELPHIA – While triple therapy is effective for patients with chronic obstructive pulmonary disease (COPD), not all patients actually need the inhaled corticosteroid component to reduce exacerbations, a Mayo Clinic pulmonologist said at the annual meeting of the American College of Physicians.

Andrew D. Bowser/MDedge News

“When you’re increasing therapy, we can go to a dual-bronchodilator combination before adding corticosteroids,” Megan Dulohery Scrodin, MD, of Mayo Clinic, Rochester, Minn., noted in a well-attended session.

That approach came as news to many internists, at least going by results of an audience poll in which 76% of attendees picked triple therapy for a 65-year-old male with COPD and frequent exacerbations despite having used a long-acting muscarinic antagonist (LAMA). Only 10% picked what Dr. Dulohery Scrodin said was optimal: to keep the patient on the LAMA, and add a long-acting beta-agonist (LABA).

“I would encourage you to do this as a stepwise process,” Dr. Dulohery Scrodin told attendees after seeing those poll results.

For a patient with minimal symptoms and few exacerbations, the best approach is a short-acting bronchodilator plus smoking cessation, avoidance of environmental triggers, and keeping up to date with vaccinations, she said.

For patients with more severe symptoms or frequent exacerbations, adding a LAMA or LABA would be warranted, along with considering pulmonary rehabilitation.

“There’s been studies comparing long-acting muscarinic antagonists to long-acting beta agonists, and the long-acting muscarinic antagonists like tiotropium seem to be superior,” she said. “So I always do a LAMA inhaler first.”

For patients still having exacerbations despite one long-acting bronchodilator, the best approach would be to add the second bronchodilator, and if that still doesn’t work, she said, add an inhaled corticosteroid and consider a pulmonary consultation for advanced therapy.

“If the patient doesn’t need an inhaled corticosteroid, we try to avoid it and use dual bronchodilator therapy,” said Dr. Dulohery Scrodin, noting that inhaled corticosteroids are associated with increased risk of pneumonia, along with other complications such as dysphonia and oral candidiasis.

In studies, single-inhaler triple therapy with fluticasone furoate, umeclidinium, and vilanterol does seem to reduce exacerbations more than LABA/LAMA combination therapy or LABA/inhaled corticosteroid treatment, but that doesn’t necessarily mean it should be automatically chosen over dual therapy, the presenter noted.

“Similar to asthma, I would do the least amount of therapy that your patient gets under control,” she told the audience.

Dr. Dulohery Scrodin reported that she had no relevant disclosures.

PHILADELPHIA – While triple therapy is effective for patients with chronic obstructive pulmonary disease (COPD), not all patients actually need the inhaled corticosteroid component to reduce exacerbations, a Mayo Clinic pulmonologist said at the annual meeting of the American College of Physicians.

Andrew D. Bowser/MDedge News

“When you’re increasing therapy, we can go to a dual-bronchodilator combination before adding corticosteroids,” Megan Dulohery Scrodin, MD, of Mayo Clinic, Rochester, Minn., noted in a well-attended session.

That approach came as news to many internists, at least going by results of an audience poll in which 76% of attendees picked triple therapy for a 65-year-old male with COPD and frequent exacerbations despite having used a long-acting muscarinic antagonist (LAMA). Only 10% picked what Dr. Dulohery Scrodin said was optimal: to keep the patient on the LAMA, and add a long-acting beta-agonist (LABA).

“I would encourage you to do this as a stepwise process,” Dr. Dulohery Scrodin told attendees after seeing those poll results.

For a patient with minimal symptoms and few exacerbations, the best approach is a short-acting bronchodilator plus smoking cessation, avoidance of environmental triggers, and keeping up to date with vaccinations, she said.

For patients with more severe symptoms or frequent exacerbations, adding a LAMA or LABA would be warranted, along with considering pulmonary rehabilitation.

“There’s been studies comparing long-acting muscarinic antagonists to long-acting beta agonists, and the long-acting muscarinic antagonists like tiotropium seem to be superior,” she said. “So I always do a LAMA inhaler first.”

For patients still having exacerbations despite one long-acting bronchodilator, the best approach would be to add the second bronchodilator, and if that still doesn’t work, she said, add an inhaled corticosteroid and consider a pulmonary consultation for advanced therapy.

“If the patient doesn’t need an inhaled corticosteroid, we try to avoid it and use dual bronchodilator therapy,” said Dr. Dulohery Scrodin, noting that inhaled corticosteroids are associated with increased risk of pneumonia, along with other complications such as dysphonia and oral candidiasis.

In studies, single-inhaler triple therapy with fluticasone furoate, umeclidinium, and vilanterol does seem to reduce exacerbations more than LABA/LAMA combination therapy or LABA/inhaled corticosteroid treatment, but that doesn’t necessarily mean it should be automatically chosen over dual therapy, the presenter noted.

“Similar to asthma, I would do the least amount of therapy that your patient gets under control,” she told the audience.

Dr. Dulohery Scrodin reported that she had no relevant disclosures.

PHILADELPHIA – While triple therapy is effective for patients with chronic obstructive pulmonary disease (COPD), not all patients actually need the inhaled corticosteroid component to reduce exacerbations, a Mayo Clinic pulmonologist said at the annual meeting of the American College of Physicians.

Andrew D. Bowser/MDedge News

“When you’re increasing therapy, we can go to a dual-bronchodilator combination before adding corticosteroids,” Megan Dulohery Scrodin, MD, of Mayo Clinic, Rochester, Minn., noted in a well-attended session.

That approach came as news to many internists, at least going by results of an audience poll in which 76% of attendees picked triple therapy for a 65-year-old male with COPD and frequent exacerbations despite having used a long-acting muscarinic antagonist (LAMA). Only 10% picked what Dr. Dulohery Scrodin said was optimal: to keep the patient on the LAMA, and add a long-acting beta-agonist (LABA).

“I would encourage you to do this as a stepwise process,” Dr. Dulohery Scrodin told attendees after seeing those poll results.

For a patient with minimal symptoms and few exacerbations, the best approach is a short-acting bronchodilator plus smoking cessation, avoidance of environmental triggers, and keeping up to date with vaccinations, she said.

For patients with more severe symptoms or frequent exacerbations, adding a LAMA or LABA would be warranted, along with considering pulmonary rehabilitation.

“There’s been studies comparing long-acting muscarinic antagonists to long-acting beta agonists, and the long-acting muscarinic antagonists like tiotropium seem to be superior,” she said. “So I always do a LAMA inhaler first.”

For patients still having exacerbations despite one long-acting bronchodilator, the best approach would be to add the second bronchodilator, and if that still doesn’t work, she said, add an inhaled corticosteroid and consider a pulmonary consultation for advanced therapy.

“If the patient doesn’t need an inhaled corticosteroid, we try to avoid it and use dual bronchodilator therapy,” said Dr. Dulohery Scrodin, noting that inhaled corticosteroids are associated with increased risk of pneumonia, along with other complications such as dysphonia and oral candidiasis.

In studies, single-inhaler triple therapy with fluticasone furoate, umeclidinium, and vilanterol does seem to reduce exacerbations more than LABA/LAMA combination therapy or LABA/inhaled corticosteroid treatment, but that doesn’t necessarily mean it should be automatically chosen over dual therapy, the presenter noted.

“Similar to asthma, I would do the least amount of therapy that your patient gets under control,” she told the audience.

Dr. Dulohery Scrodin reported that she had no relevant disclosures.

PHILADELPHIA – Patients concerned about the recent angiotensin II receptor blocker (ARB) recalls for trace carcinogens can be advised that the absolute risk of cancer is minimal, according to a senior officer of the National Kidney Foundation.

Andrew D. Bowser/MDedge News

“I’ve been telling everyone not to stop on their own,” said Joseph A. Vassalotti, MD, chief medical officer for the National Kidney Foundation and associate clinical professor of medicine at Icahn School of Medicine at Mount Sinai, New York.

“The risk of cardiovascular events acutely and the long-term risk of kidney disease progression is much more concerning to me, if they self-discontinue the ARB, than the small risk of cancer,” Dr. Vassalotti said in a meet-the-professor session at the annual meeting of the American College of Physicians.

Put in perspective, the absolute risk of cancer according to the Food and Drug Administration is one new malignancy per 8,000 patients treated with 320 mg of valsartan daily – the highest ARB dose that contained N-Nitrosodimethylamine (NDMA), one of several impurities that led to the recent recalls.

Dr. Vassalotti said that so far, he’s been able to avoid switching patients from one ARB to another by working with pharmacies to get the same medication in a different generic brand not affected by the FDA recalls.

He advised caution in switching ARBs, noting a paucity of head-to-head comparative data between ARBs.

“There may be variable effects,” he said.

If switching is thought to be warranted, he said, some extra tests or visits might be needed to ensure avoidance of hyperkalemia, undertreated hypertension, or hypotension.

Dr. Vassalotti encouraged attendees to review a perspective piece in the New England Journal of Medicine (2019 Mar 13. doi: 10.1056/NEJMp1901657) describing this hypertension “hot potato” resulting from the large-scale voluntary recalls of products containing valsartan, losartan, and irbesartan due to nitrosamine contamination.

Patients may hear about recalls of hypertension drugs, but may not know what products or manufacturers are involved, leaving the burden on clinicians, pharmacies, and health care systems to respond to their concerns, said authors of that perspective piece, led by J. Brian Byrd, MD, of the University of Michigan, Ann Arbor.

“Recalls may trigger unnecessary concern among many people receiving antihypertensive therapy – and may be ignored by people who take ARBs for heart failure or chronic kidney disease,” wrote Dr. Byrd and his colleagues.

The FDA, which said it has worked with manufacturers to “swiftly” remove ARB drug products with impurity levels above acceptable limits, is now maintaining a list of other currently marketed ARB products that are being tested for impurities.

As of the latest update on April 4, the FDA listed more than 40 products with an overall nitrosamine impurity determination of “not present” and more than 300 additional products for which assessments are not yet complete.

“Essentially, we have a safe list now of ARBs that is being developed,” Dr. Vassalotti said. “So if a patient really wanted to change, I would consult that list, and consider picking one that’s been tested already on that list, and the FDA hopefully will complete testing on all the ARB drugs in the near future.”

Dr. Vassalotti is a consultant with Merck, Janssen, and the U.S. Nephrology Advisory Board.

PHILADELPHIA – Patients concerned about the recent angiotensin II receptor blocker (ARB) recalls for trace carcinogens can be advised that the absolute risk of cancer is minimal, according to a senior officer of the National Kidney Foundation.

Andrew D. Bowser/MDedge News

“I’ve been telling everyone not to stop on their own,” said Joseph A. Vassalotti, MD, chief medical officer for the National Kidney Foundation and associate clinical professor of medicine at Icahn School of Medicine at Mount Sinai, New York.

“The risk of cardiovascular events acutely and the long-term risk of kidney disease progression is much more concerning to me, if they self-discontinue the ARB, than the small risk of cancer,” Dr. Vassalotti said in a meet-the-professor session at the annual meeting of the American College of Physicians.

Put in perspective, the absolute risk of cancer according to the Food and Drug Administration is one new malignancy per 8,000 patients treated with 320 mg of valsartan daily – the highest ARB dose that contained N-Nitrosodimethylamine (NDMA), one of several impurities that led to the recent recalls.

Dr. Vassalotti said that so far, he’s been able to avoid switching patients from one ARB to another by working with pharmacies to get the same medication in a different generic brand not affected by the FDA recalls.

He advised caution in switching ARBs, noting a paucity of head-to-head comparative data between ARBs.

“There may be variable effects,” he said.

If switching is thought to be warranted, he said, some extra tests or visits might be needed to ensure avoidance of hyperkalemia, undertreated hypertension, or hypotension.

Dr. Vassalotti encouraged attendees to review a perspective piece in the New England Journal of Medicine (2019 Mar 13. doi: 10.1056/NEJMp1901657) describing this hypertension “hot potato” resulting from the large-scale voluntary recalls of products containing valsartan, losartan, and irbesartan due to nitrosamine contamination.

Patients may hear about recalls of hypertension drugs, but may not know what products or manufacturers are involved, leaving the burden on clinicians, pharmacies, and health care systems to respond to their concerns, said authors of that perspective piece, led by J. Brian Byrd, MD, of the University of Michigan, Ann Arbor.

“Recalls may trigger unnecessary concern among many people receiving antihypertensive therapy – and may be ignored by people who take ARBs for heart failure or chronic kidney disease,” wrote Dr. Byrd and his colleagues.

The FDA, which said it has worked with manufacturers to “swiftly” remove ARB drug products with impurity levels above acceptable limits, is now maintaining a list of other currently marketed ARB products that are being tested for impurities.

As of the latest update on April 4, the FDA listed more than 40 products with an overall nitrosamine impurity determination of “not present” and more than 300 additional products for which assessments are not yet complete.

“Essentially, we have a safe list now of ARBs that is being developed,” Dr. Vassalotti said. “So if a patient really wanted to change, I would consult that list, and consider picking one that’s been tested already on that list, and the FDA hopefully will complete testing on all the ARB drugs in the near future.”

Dr. Vassalotti is a consultant with Merck, Janssen, and the U.S. Nephrology Advisory Board.

PHILADELPHIA – Patients concerned about the recent angiotensin II receptor blocker (ARB) recalls for trace carcinogens can be advised that the absolute risk of cancer is minimal, according to a senior officer of the National Kidney Foundation.

Andrew D. Bowser/MDedge News

“I’ve been telling everyone not to stop on their own,” said Joseph A. Vassalotti, MD, chief medical officer for the National Kidney Foundation and associate clinical professor of medicine at Icahn School of Medicine at Mount Sinai, New York.

“The risk of cardiovascular events acutely and the long-term risk of kidney disease progression is much more concerning to me, if they self-discontinue the ARB, than the small risk of cancer,” Dr. Vassalotti said in a meet-the-professor session at the annual meeting of the American College of Physicians.

Put in perspective, the absolute risk of cancer according to the Food and Drug Administration is one new malignancy per 8,000 patients treated with 320 mg of valsartan daily – the highest ARB dose that contained N-Nitrosodimethylamine (NDMA), one of several impurities that led to the recent recalls.

Dr. Vassalotti said that so far, he’s been able to avoid switching patients from one ARB to another by working with pharmacies to get the same medication in a different generic brand not affected by the FDA recalls.

He advised caution in switching ARBs, noting a paucity of head-to-head comparative data between ARBs.

“There may be variable effects,” he said.

If switching is thought to be warranted, he said, some extra tests or visits might be needed to ensure avoidance of hyperkalemia, undertreated hypertension, or hypotension.

Dr. Vassalotti encouraged attendees to review a perspective piece in the New England Journal of Medicine (2019 Mar 13. doi: 10.1056/NEJMp1901657) describing this hypertension “hot potato” resulting from the large-scale voluntary recalls of products containing valsartan, losartan, and irbesartan due to nitrosamine contamination.

Patients may hear about recalls of hypertension drugs, but may not know what products or manufacturers are involved, leaving the burden on clinicians, pharmacies, and health care systems to respond to their concerns, said authors of that perspective piece, led by J. Brian Byrd, MD, of the University of Michigan, Ann Arbor.

“Recalls may trigger unnecessary concern among many people receiving antihypertensive therapy – and may be ignored by people who take ARBs for heart failure or chronic kidney disease,” wrote Dr. Byrd and his colleagues.

The FDA, which said it has worked with manufacturers to “swiftly” remove ARB drug products with impurity levels above acceptable limits, is now maintaining a list of other currently marketed ARB products that are being tested for impurities.

As of the latest update on April 4, the FDA listed more than 40 products with an overall nitrosamine impurity determination of “not present” and more than 300 additional products for which assessments are not yet complete.

“Essentially, we have a safe list now of ARBs that is being developed,” Dr. Vassalotti said. “So if a patient really wanted to change, I would consult that list, and consider picking one that’s been tested already on that list, and the FDA hopefully will complete testing on all the ARB drugs in the near future.”

Dr. Vassalotti is a consultant with Merck, Janssen, and the U.S. Nephrology Advisory Board.

PHILADELPHIA – The latest published report links calcium intake from supplements to increased risk of cancer death, a nutrition specialist noted at the annual meeting of the American College of Physicians.

Andrew D. Bowser/MDedge News

The report, published (Ann Intern Med. 2019 Apr 9. doi: 10.7326/M18-2478) just 2 days before the start of the Internal Medicine meeting, found no mortality benefits associated with any reported dietary supplement use among nearly 31,000 adults in the National Health and Nutrition Examination Survey.

On the contrary, they found that excess calcium consumption was associated with increased risk for cancer-related deaths. Calcium supplements were specifically implicated in the excess of mortality, according to the investigators, with a rate ratio of 1.53 (95% confidence interval, 1.04-2.25) for intakes of 1,000 mg/day versus no intake.

“It’s better to get all of your vitamins from your food, over supplements,” said Marijane Hynes, MD, director of weight management at George Washington University, Washington, in a meet-the-professor session at the conference.

The amount of calcium patients are getting from food can be estimated with one rule of thumb: Multiply the number of dairy servings per day by 300 mg, Dr. Hynes said, who added that a serving is 8 ounces of milk or 1 ounce of hard cheese. Dark green vegetables, breads, cereals, and some nuts can provide 100-200 mg of calcium per day.

Calcium carbonate can be taken with food to enhance calcium absorption, according to Dr. Hynes, while calcium citrate can be taken without food, and is preferred for patients taking acid reflux medications.

Because calcium absorption is reduced at higher doses, patients who need more than 600 mg/day should be taking divided doses, she said.

Bone health goes beyond the dairy aisle, Dr. Hynes added. High vitamin K intake was linked to reduced hip fracture risk among the Framingham Heart Study participants. To get the recommended amount of vitamin K in the diet, patients can consume one or more servings of broccoli, kale, collard greens, or dark green lettuce.

Dr. Hynes reported she that had no relationships with entities producing, marketing, reselling, or distributing health care goods or services consumed by, or used on, patients.

PHILADELPHIA – The latest published report links calcium intake from supplements to increased risk of cancer death, a nutrition specialist noted at the annual meeting of the American College of Physicians.

Andrew D. Bowser/MDedge News

The report, published (Ann Intern Med. 2019 Apr 9. doi: 10.7326/M18-2478) just 2 days before the start of the Internal Medicine meeting, found no mortality benefits associated with any reported dietary supplement use among nearly 31,000 adults in the National Health and Nutrition Examination Survey.

On the contrary, they found that excess calcium consumption was associated with increased risk for cancer-related deaths. Calcium supplements were specifically implicated in the excess of mortality, according to the investigators, with a rate ratio of 1.53 (95% confidence interval, 1.04-2.25) for intakes of 1,000 mg/day versus no intake.

“It’s better to get all of your vitamins from your food, over supplements,” said Marijane Hynes, MD, director of weight management at George Washington University, Washington, in a meet-the-professor session at the conference.

The amount of calcium patients are getting from food can be estimated with one rule of thumb: Multiply the number of dairy servings per day by 300 mg, Dr. Hynes said, who added that a serving is 8 ounces of milk or 1 ounce of hard cheese. Dark green vegetables, breads, cereals, and some nuts can provide 100-200 mg of calcium per day.

Calcium carbonate can be taken with food to enhance calcium absorption, according to Dr. Hynes, while calcium citrate can be taken without food, and is preferred for patients taking acid reflux medications.

Because calcium absorption is reduced at higher doses, patients who need more than 600 mg/day should be taking divided doses, she said.

Bone health goes beyond the dairy aisle, Dr. Hynes added. High vitamin K intake was linked to reduced hip fracture risk among the Framingham Heart Study participants. To get the recommended amount of vitamin K in the diet, patients can consume one or more servings of broccoli, kale, collard greens, or dark green lettuce.

Dr. Hynes reported she that had no relationships with entities producing, marketing, reselling, or distributing health care goods or services consumed by, or used on, patients.

PHILADELPHIA – The latest published report links calcium intake from supplements to increased risk of cancer death, a nutrition specialist noted at the annual meeting of the American College of Physicians.

Andrew D. Bowser/MDedge News

The report, published (Ann Intern Med. 2019 Apr 9. doi: 10.7326/M18-2478) just 2 days before the start of the Internal Medicine meeting, found no mortality benefits associated with any reported dietary supplement use among nearly 31,000 adults in the National Health and Nutrition Examination Survey.

On the contrary, they found that excess calcium consumption was associated with increased risk for cancer-related deaths. Calcium supplements were specifically implicated in the excess of mortality, according to the investigators, with a rate ratio of 1.53 (95% confidence interval, 1.04-2.25) for intakes of 1,000 mg/day versus no intake.

“It’s better to get all of your vitamins from your food, over supplements,” said Marijane Hynes, MD, director of weight management at George Washington University, Washington, in a meet-the-professor session at the conference.

The amount of calcium patients are getting from food can be estimated with one rule of thumb: Multiply the number of dairy servings per day by 300 mg, Dr. Hynes said, who added that a serving is 8 ounces of milk or 1 ounce of hard cheese. Dark green vegetables, breads, cereals, and some nuts can provide 100-200 mg of calcium per day.

Calcium carbonate can be taken with food to enhance calcium absorption, according to Dr. Hynes, while calcium citrate can be taken without food, and is preferred for patients taking acid reflux medications.

Because calcium absorption is reduced at higher doses, patients who need more than 600 mg/day should be taking divided doses, she said.

Bone health goes beyond the dairy aisle, Dr. Hynes added. High vitamin K intake was linked to reduced hip fracture risk among the Framingham Heart Study participants. To get the recommended amount of vitamin K in the diet, patients can consume one or more servings of broccoli, kale, collard greens, or dark green lettuce.

Dr. Hynes reported she that had no relationships with entities producing, marketing, reselling, or distributing health care goods or services consumed by, or used on, patients.

PHILADELPHIA – There are real concerns about whether today’s direct-to-consumer (DTC) genetic tests actually test the mutations they claim to test and of how well a tested DNA sequence tracks actual disease, Andrew D. Coyle, MD, said during a podium presentation at the annual meeting of the American College of Physicians.

Many patients don’t tell their doctors the results of DTC tests, and there’s a lot of potential for misinterpretation all around, said Dr. Coyle, assistant professor of medicine and medical education in the general internal medicine division at the Icahn School of Medicine at Mount Sinai, New York.

“I wouldn’t recommend to patients that they do [DTC testing], if they asked,” he said. “I think we probably do need to be better about asking our patients whether they’re doing this on their own, to make sure that we help them interpret it correctly, that it’s a change in risk – not a diagnosis, and not an assurance they won’t get that disease process.”

High false-positive rates have been seen in recent studies that sought to confirm genotyping data from DTC genetic test results, according to Dr. Coyle. In one 2018 study in Genetics and Medicine (2018;20:1515-21) of 49 patient samples tested for previously identified genetic variants found in raw DTC data, investigators found a 40% false positive rate, which they said underscored the importance of clinical confirmation testing to assure proper patient care, he noted.

To support his claim that many patients aren’t even telling their doctors about the DTC testing they are having done in the first place, Dr. Coyle mentioned results of a survey in Annals of Internal Medicine (2016;164[8]:513-22), which showed that only 19% of patients shared their DTC results with their primary care physicians.

He also pointed out a potential problem regarding the discussions between patients and their physicians about these test results, based on another finding reported in the paper. Of those who did tell their physicians they had DTC testing, 35% said they were “very satisfied” with how that discussion went, Dr. Coyle said.

“So they don’t tell us, and they aren’t very happy when they do tell us,” he told his audience.
 

The 23andMe test and the FDA

The 23andMe test, which was first directly marketed to consumers in 2006, was one of the DTC genetic tests discussed by Dr. Coyle. The Food and Drug Administration later halted the company’s Personal Genome Service in 2013 because of a lack of demonstrated clinical validity, Dr. Coyle noted.

Subsequently, the FDA classified carrier-screening tests as medical devices, allowing such services to come back, leading to what Dr. Coyle described as an explosion over the past few years of DTC evaluation of a variety of conditions, including celiac disease, Alzheimer’s disease, hemochromatosis, and then more recently, screening for cancer risk factors.

In 2018, 23andMe began offering DTC BRCA testing, but for 3 BRCA1/2 mutations seen in individuals of Ashkenazi Jewish descent, Dr. Coyle said.

“If someone did a BRCA test which is only testing three specific mutations seen mostly in Ashkenazi Jewish populations, they may be falsely reassured that the risk of breast cancer is low, when in fact they may have other BRCA mutations,” he said.

In real life, however, many people who order genetic tests online may not even act on the results. In a 2017 study in the Journal of Clinical Oncology, customers whose DTC genetic testing results showed elevated cancer risk were no more likely than were customers without elevated risk to change diet or exercise, engage in advanced planning behaviors, or get screened.

Dr. Coyle had no relevant disclosures to report.

PHILADELPHIA – There are real concerns about whether today’s direct-to-consumer (DTC) genetic tests actually test the mutations they claim to test and of how well a tested DNA sequence tracks actual disease, Andrew D. Coyle, MD, said during a podium presentation at the annual meeting of the American College of Physicians.

Many patients don’t tell their doctors the results of DTC tests, and there’s a lot of potential for misinterpretation all around, said Dr. Coyle, assistant professor of medicine and medical education in the general internal medicine division at the Icahn School of Medicine at Mount Sinai, New York.

“I wouldn’t recommend to patients that they do [DTC testing], if they asked,” he said. “I think we probably do need to be better about asking our patients whether they’re doing this on their own, to make sure that we help them interpret it correctly, that it’s a change in risk – not a diagnosis, and not an assurance they won’t get that disease process.”

High false-positive rates have been seen in recent studies that sought to confirm genotyping data from DTC genetic test results, according to Dr. Coyle. In one 2018 study in Genetics and Medicine (2018;20:1515-21) of 49 patient samples tested for previously identified genetic variants found in raw DTC data, investigators found a 40% false positive rate, which they said underscored the importance of clinical confirmation testing to assure proper patient care, he noted.

To support his claim that many patients aren’t even telling their doctors about the DTC testing they are having done in the first place, Dr. Coyle mentioned results of a survey in Annals of Internal Medicine (2016;164[8]:513-22), which showed that only 19% of patients shared their DTC results with their primary care physicians.

He also pointed out a potential problem regarding the discussions between patients and their physicians about these test results, based on another finding reported in the paper. Of those who did tell their physicians they had DTC testing, 35% said they were “very satisfied” with how that discussion went, Dr. Coyle said.

“So they don’t tell us, and they aren’t very happy when they do tell us,” he told his audience.
 

The 23andMe test and the FDA

The 23andMe test, which was first directly marketed to consumers in 2006, was one of the DTC genetic tests discussed by Dr. Coyle. The Food and Drug Administration later halted the company’s Personal Genome Service in 2013 because of a lack of demonstrated clinical validity, Dr. Coyle noted.

Subsequently, the FDA classified carrier-screening tests as medical devices, allowing such services to come back, leading to what Dr. Coyle described as an explosion over the past few years of DTC evaluation of a variety of conditions, including celiac disease, Alzheimer’s disease, hemochromatosis, and then more recently, screening for cancer risk factors.

In 2018, 23andMe began offering DTC BRCA testing, but for 3 BRCA1/2 mutations seen in individuals of Ashkenazi Jewish descent, Dr. Coyle said.

“If someone did a BRCA test which is only testing three specific mutations seen mostly in Ashkenazi Jewish populations, they may be falsely reassured that the risk of breast cancer is low, when in fact they may have other BRCA mutations,” he said.

In real life, however, many people who order genetic tests online may not even act on the results. In a 2017 study in the Journal of Clinical Oncology, customers whose DTC genetic testing results showed elevated cancer risk were no more likely than were customers without elevated risk to change diet or exercise, engage in advanced planning behaviors, or get screened.

Dr. Coyle had no relevant disclosures to report.

PHILADELPHIA – There are real concerns about whether today’s direct-to-consumer (DTC) genetic tests actually test the mutations they claim to test and of how well a tested DNA sequence tracks actual disease, Andrew D. Coyle, MD, said during a podium presentation at the annual meeting of the American College of Physicians.

Many patients don’t tell their doctors the results of DTC tests, and there’s a lot of potential for misinterpretation all around, said Dr. Coyle, assistant professor of medicine and medical education in the general internal medicine division at the Icahn School of Medicine at Mount Sinai, New York.

“I wouldn’t recommend to patients that they do [DTC testing], if they asked,” he said. “I think we probably do need to be better about asking our patients whether they’re doing this on their own, to make sure that we help them interpret it correctly, that it’s a change in risk – not a diagnosis, and not an assurance they won’t get that disease process.”

High false-positive rates have been seen in recent studies that sought to confirm genotyping data from DTC genetic test results, according to Dr. Coyle. In one 2018 study in Genetics and Medicine (2018;20:1515-21) of 49 patient samples tested for previously identified genetic variants found in raw DTC data, investigators found a 40% false positive rate, which they said underscored the importance of clinical confirmation testing to assure proper patient care, he noted.

To support his claim that many patients aren’t even telling their doctors about the DTC testing they are having done in the first place, Dr. Coyle mentioned results of a survey in Annals of Internal Medicine (2016;164[8]:513-22), which showed that only 19% of patients shared their DTC results with their primary care physicians.

He also pointed out a potential problem regarding the discussions between patients and their physicians about these test results, based on another finding reported in the paper. Of those who did tell their physicians they had DTC testing, 35% said they were “very satisfied” with how that discussion went, Dr. Coyle said.

“So they don’t tell us, and they aren’t very happy when they do tell us,” he told his audience.
 

The 23andMe test and the FDA

The 23andMe test, which was first directly marketed to consumers in 2006, was one of the DTC genetic tests discussed by Dr. Coyle. The Food and Drug Administration later halted the company’s Personal Genome Service in 2013 because of a lack of demonstrated clinical validity, Dr. Coyle noted.

Subsequently, the FDA classified carrier-screening tests as medical devices, allowing such services to come back, leading to what Dr. Coyle described as an explosion over the past few years of DTC evaluation of a variety of conditions, including celiac disease, Alzheimer’s disease, hemochromatosis, and then more recently, screening for cancer risk factors.

In 2018, 23andMe began offering DTC BRCA testing, but for 3 BRCA1/2 mutations seen in individuals of Ashkenazi Jewish descent, Dr. Coyle said.

“If someone did a BRCA test which is only testing three specific mutations seen mostly in Ashkenazi Jewish populations, they may be falsely reassured that the risk of breast cancer is low, when in fact they may have other BRCA mutations,” he said.

In real life, however, many people who order genetic tests online may not even act on the results. In a 2017 study in the Journal of Clinical Oncology, customers whose DTC genetic testing results showed elevated cancer risk were no more likely than were customers without elevated risk to change diet or exercise, engage in advanced planning behaviors, or get screened.

Dr. Coyle had no relevant disclosures to report.

PHILADELPHIA – Medical marijuana research to date provides some support for its use in neuropathic pain, nausea and vomiting, and spasticity, some insights into adverse effects, and “a lot of the Wild West,” Ellie Grossman, MD, MPH, said here at the annual meeting of the American College of Physicians.

Andrew Bowser/MDedge News

The opioid-sparing effects of medical marijuana have been highlighted in recent reports suggesting that cannabis users may use less opioids, and that states with medical marijuana laws have seen drops in opioid overdose mortality, Dr. Grossman said.

“That’s kind of a story on pain and cannabinoids, and that’s really the biggest story there is in terms of medical evidence and effectiveness for this agent,” said Dr. Grossman, an instructor at Harvard Medical School and Primary Care Lead for Behavioral Health Integration, Cambridge Health Alliance, Somerville, Mass.

However, being the top story in medical marijuana may not be a very high bar in 2019, given current issues with research in this area, including inconsistencies in medical marijuana formulations, relatively small numbers of patients enrolled in studies, and meta-analyses that have produced equivocal results.

“Unfortunately, this is an area where there’s a lot of, shall I say, ‘squishiness’ in the data, through no fault of the researchers involved – it’s just an area that’s really hard to study,” Dr. Goodman said in her update on medical marijuana use at the meeting.

Most studies of cannabinoids for chronic pain have compared these agents to placebo, rather than the long list of other medications that might be used to treat pain, Dr. Grossman said.

There are several meta-analyses available, including a recently published Cochrane review in which authors concluded that, for neuropathic pain, the potential benefits of cannabis-based medicines may outweigh their potential harms.

“The upshot here is that there may be some evidence for neuropathic pain, but the evidence is generally of poor quality and kind of mixed,” said Dr. Grossman.

State-level medical cannabis laws were linked to significantly lower opioid overdose mortality rates in a 2014 study (JAMA Intern Med. 2014;174[10]:1668-73). In more recent studies, states with medical cannabis laws were found to have lower Medicare Part D opioid-prescribing rates, and in another study, legalization of medical marijuana was linked to lower rates of chronic and high-risk opioid use.

“It certainly seems like maybe we as prescribers are prescribing [fewer] opioids if there’s medical cannabis around,” Dr. Grossman said. “What this means for our patients in the short term and long term, we don’t totally know. But clearly, fewer opioid overdoses is a way better thing than more, so there could be something here.”

The cannabinoids approved by the Food and Drug Administration include nabilone (Cesamet) and dronabinol (Marinol), both synthetic cannabinoids indicated for cancer chemotherapy–related nausea and vomiting, along with cannabidiol (Epidiolex), just approved in June 2018 for treatment of some rare pediatric refractory epilepsy syndromes, Dr. Grossman said.

For chemotherapy-induced nausea and vomiting, evidence suggests oral cannabinoids are more effective than placebo, but there’s mixed evidence as to whether they are better than other antiemetics, Dr. Grossman said, while in terms of spasticity related to multiple sclerosis, research has shown small improvements in patient-reported symptoms.

Long-term adverse event data specific to medical marijuana are scant, with much of the evidence coming from studies of recreational marijuana users, Dr. Grossman said.

Those long-term effects include increased risk of pulmonary effects such as cough, wheeze, and phlegm that improve with discontinuation; case reports of unintentional pediatric ingestions; and lower neonatal birth weight, which should be discussed with women of reproductive age who are using or considering medical marijuana, Dr. Grossman said.

Motor vehicle accidents, development of psychiatric symptoms, and psychosis relapse also have been linked to use, she said.

Some real-world adverse event data specific to medical marijuana data are available through the Minnesota medical cannabis program. They found 16% of surveyed users reported an adverse event within the first 4 months, including dry mouth, fatigue, mental clouding, and drowsiness, Dr. Grossman told attendees.

Dr. Grossman reported that she has no relationship with entities producing, marketing, reselling, or distributing health care goods or services consumed by, or used on, patients.

SOURCE: Grossman E. ACP 2019, Presentation MTP 010.

PHILADELPHIA – Medical marijuana research to date provides some support for its use in neuropathic pain, nausea and vomiting, and spasticity, some insights into adverse effects, and “a lot of the Wild West,” Ellie Grossman, MD, MPH, said here at the annual meeting of the American College of Physicians.

Andrew Bowser/MDedge News

The opioid-sparing effects of medical marijuana have been highlighted in recent reports suggesting that cannabis users may use less opioids, and that states with medical marijuana laws have seen drops in opioid overdose mortality, Dr. Grossman said.

“That’s kind of a story on pain and cannabinoids, and that’s really the biggest story there is in terms of medical evidence and effectiveness for this agent,” said Dr. Grossman, an instructor at Harvard Medical School and Primary Care Lead for Behavioral Health Integration, Cambridge Health Alliance, Somerville, Mass.

However, being the top story in medical marijuana may not be a very high bar in 2019, given current issues with research in this area, including inconsistencies in medical marijuana formulations, relatively small numbers of patients enrolled in studies, and meta-analyses that have produced equivocal results.

“Unfortunately, this is an area where there’s a lot of, shall I say, ‘squishiness’ in the data, through no fault of the researchers involved – it’s just an area that’s really hard to study,” Dr. Goodman said in her update on medical marijuana use at the meeting.

Most studies of cannabinoids for chronic pain have compared these agents to placebo, rather than the long list of other medications that might be used to treat pain, Dr. Grossman said.

There are several meta-analyses available, including a recently published Cochrane review in which authors concluded that, for neuropathic pain, the potential benefits of cannabis-based medicines may outweigh their potential harms.

“The upshot here is that there may be some evidence for neuropathic pain, but the evidence is generally of poor quality and kind of mixed,” said Dr. Grossman.

State-level medical cannabis laws were linked to significantly lower opioid overdose mortality rates in a 2014 study (JAMA Intern Med. 2014;174[10]:1668-73). In more recent studies, states with medical cannabis laws were found to have lower Medicare Part D opioid-prescribing rates, and in another study, legalization of medical marijuana was linked to lower rates of chronic and high-risk opioid use.

“It certainly seems like maybe we as prescribers are prescribing [fewer] opioids if there’s medical cannabis around,” Dr. Grossman said. “What this means for our patients in the short term and long term, we don’t totally know. But clearly, fewer opioid overdoses is a way better thing than more, so there could be something here.”

The cannabinoids approved by the Food and Drug Administration include nabilone (Cesamet) and dronabinol (Marinol), both synthetic cannabinoids indicated for cancer chemotherapy–related nausea and vomiting, along with cannabidiol (Epidiolex), just approved in June 2018 for treatment of some rare pediatric refractory epilepsy syndromes, Dr. Grossman said.

For chemotherapy-induced nausea and vomiting, evidence suggests oral cannabinoids are more effective than placebo, but there’s mixed evidence as to whether they are better than other antiemetics, Dr. Grossman said, while in terms of spasticity related to multiple sclerosis, research has shown small improvements in patient-reported symptoms.

Long-term adverse event data specific to medical marijuana are scant, with much of the evidence coming from studies of recreational marijuana users, Dr. Grossman said.

Those long-term effects include increased risk of pulmonary effects such as cough, wheeze, and phlegm that improve with discontinuation; case reports of unintentional pediatric ingestions; and lower neonatal birth weight, which should be discussed with women of reproductive age who are using or considering medical marijuana, Dr. Grossman said.

Motor vehicle accidents, development of psychiatric symptoms, and psychosis relapse also have been linked to use, she said.

Some real-world adverse event data specific to medical marijuana data are available through the Minnesota medical cannabis program. They found 16% of surveyed users reported an adverse event within the first 4 months, including dry mouth, fatigue, mental clouding, and drowsiness, Dr. Grossman told attendees.

Dr. Grossman reported that she has no relationship with entities producing, marketing, reselling, or distributing health care goods or services consumed by, or used on, patients.

SOURCE: Grossman E. ACP 2019, Presentation MTP 010.

PHILADELPHIA – Medical marijuana research to date provides some support for its use in neuropathic pain, nausea and vomiting, and spasticity, some insights into adverse effects, and “a lot of the Wild West,” Ellie Grossman, MD, MPH, said here at the annual meeting of the American College of Physicians.

Andrew Bowser/MDedge News

The opioid-sparing effects of medical marijuana have been highlighted in recent reports suggesting that cannabis users may use less opioids, and that states with medical marijuana laws have seen drops in opioid overdose mortality, Dr. Grossman said.

“That’s kind of a story on pain and cannabinoids, and that’s really the biggest story there is in terms of medical evidence and effectiveness for this agent,” said Dr. Grossman, an instructor at Harvard Medical School and Primary Care Lead for Behavioral Health Integration, Cambridge Health Alliance, Somerville, Mass.

However, being the top story in medical marijuana may not be a very high bar in 2019, given current issues with research in this area, including inconsistencies in medical marijuana formulations, relatively small numbers of patients enrolled in studies, and meta-analyses that have produced equivocal results.

“Unfortunately, this is an area where there’s a lot of, shall I say, ‘squishiness’ in the data, through no fault of the researchers involved – it’s just an area that’s really hard to study,” Dr. Goodman said in her update on medical marijuana use at the meeting.

Most studies of cannabinoids for chronic pain have compared these agents to placebo, rather than the long list of other medications that might be used to treat pain, Dr. Grossman said.

There are several meta-analyses available, including a recently published Cochrane review in which authors concluded that, for neuropathic pain, the potential benefits of cannabis-based medicines may outweigh their potential harms.

“The upshot here is that there may be some evidence for neuropathic pain, but the evidence is generally of poor quality and kind of mixed,” said Dr. Grossman.

State-level medical cannabis laws were linked to significantly lower opioid overdose mortality rates in a 2014 study (JAMA Intern Med. 2014;174[10]:1668-73). In more recent studies, states with medical cannabis laws were found to have lower Medicare Part D opioid-prescribing rates, and in another study, legalization of medical marijuana was linked to lower rates of chronic and high-risk opioid use.

“It certainly seems like maybe we as prescribers are prescribing [fewer] opioids if there’s medical cannabis around,” Dr. Grossman said. “What this means for our patients in the short term and long term, we don’t totally know. But clearly, fewer opioid overdoses is a way better thing than more, so there could be something here.”

The cannabinoids approved by the Food and Drug Administration include nabilone (Cesamet) and dronabinol (Marinol), both synthetic cannabinoids indicated for cancer chemotherapy–related nausea and vomiting, along with cannabidiol (Epidiolex), just approved in June 2018 for treatment of some rare pediatric refractory epilepsy syndromes, Dr. Grossman said.

For chemotherapy-induced nausea and vomiting, evidence suggests oral cannabinoids are more effective than placebo, but there’s mixed evidence as to whether they are better than other antiemetics, Dr. Grossman said, while in terms of spasticity related to multiple sclerosis, research has shown small improvements in patient-reported symptoms.

Long-term adverse event data specific to medical marijuana are scant, with much of the evidence coming from studies of recreational marijuana users, Dr. Grossman said.

Those long-term effects include increased risk of pulmonary effects such as cough, wheeze, and phlegm that improve with discontinuation; case reports of unintentional pediatric ingestions; and lower neonatal birth weight, which should be discussed with women of reproductive age who are using or considering medical marijuana, Dr. Grossman said.

Motor vehicle accidents, development of psychiatric symptoms, and psychosis relapse also have been linked to use, she said.

Some real-world adverse event data specific to medical marijuana data are available through the Minnesota medical cannabis program. They found 16% of surveyed users reported an adverse event within the first 4 months, including dry mouth, fatigue, mental clouding, and drowsiness, Dr. Grossman told attendees.

Dr. Grossman reported that she has no relationship with entities producing, marketing, reselling, or distributing health care goods or services consumed by, or used on, patients.

SOURCE: Grossman E. ACP 2019, Presentation MTP 010.

The use of energy-based devices for vaginal rejuvenation, a practice that sparked a recent safety communication from the Food and Drug Administration, was implicated in nearly four dozen adverse event reports found in the agency’s medical device adverse event reporting database, researchers report.

The 45 unique event reports, submitted to the FDA during October 2015–January 2019, described 46 patients in total, of whom 33 reported long-term effects including pain, numbness, and burning, said the researchers, led by Jusleen Ahluwalia, MD, of the department of dermatology at the University of California, San Diego, and her coauthors. They included 31 that were reported by the patients, 8 reported by the manufacturer; 4 reported by the distributor, and 2 not specified.

These findings emphasize the need for clinical trials to evaluate the safety and efficacy of the lasers and radiofrequency devices that have been marketed and used for so-called vaginal rejuvenation procedures, they wrote in Lasers in Surgery and Medicine. The coauthors are Arisa Ortiz, MD, also with the University of California, San Diego, and Mathew M. Avram, MD, director of the Massachusetts General Hospital Dermatology Laser & Cosmetic Center, Boston. “Randomized studies are necessary to compare these therapies with standard modalities and to establish the safety of these devices,” they wrote.

In July 2018, the FDA issued a safety communication alerting patients and health care providers that the safety and effectiveness of energy-based devices has not been established for procedures described as “vaginal rejuvenation.” Scott Gottlieb, MD, FDA commissioner at the time, issued a statement decrying “deceptive health claims and significant risks” related to devices marketed for those medical procedures. In a November 2018 update, the FDA said they contacted some device manufacturers to express concerns that the devices were being marketed inappropriately and that manufacturers they had contacted so far “responded with adequate corrections.”

In their report, Dr. Ahluwalia and her associates noted that “vaginal rejuvenation” is an ill-defined term that may encompass a variety of procedures related to tightening; dyspareunia; dysuria; urinary incontinence; vulvar issues including irritation, dryness, and atrophy; and orgasmic dysfunction.

They found a total of 58 records in their review of the Manufacturer and User Facility Device Experience database, of which 25 were reported prior to the FDA’s July 2018 statement. Of 45 unique event descriptions found in those records, 39 were categorized as patient-related injuries, while 2 were operator-related injuries, 2 were device malfunctions, and 2 were not specified.

Pain was the most commonly adverse event, accounting for 19 reports in their analysis, while 11 patients reported numbness or burning.

Among the laser- and energy-based devices specifically described in the 39 patient-report injuries, the MonaLisa Touch had the highest number of adverse event reports (16), the data show. “However, this may be reflective of length of time bias as it is one of the first devices utilized to promote vaginal rejuvenation,” the authors pointed out.

In light of these findings, the authors advised clinicians to ask patients about their reasons for seeking vaginal rejuvenation procedures. “Normal variety of female genital appearances should also be reviewed when patients express cosmetic concerns,” they added. Concerns about related to genitourinary syndrome of menopause “or optimizing sexual function may be alleviated by exploring nonprocedural, conservative approaches, such as hormonal creams, if not contraindicated, and/or counseling,” they noted.

The authors provided conflict of interest disclosures related to Zalea, Inmode, Cytrellis, Zeltiq Aesthetics, Soliton, Sciton, Allergan, and Sienna Biopharmaceuticals, among others.

Adverse events related to devices and drugs can be reported to the FDA’s Medwatch program.

SOURCE: Ahluwalia J et al. Lasers Surg Med. 2019 Mar 29. doi: 10.1002/lsm.23084.

The use of energy-based devices for vaginal rejuvenation, a practice that sparked a recent safety communication from the Food and Drug Administration, was implicated in nearly four dozen adverse event reports found in the agency’s medical device adverse event reporting database, researchers report.

The 45 unique event reports, submitted to the FDA during October 2015–January 2019, described 46 patients in total, of whom 33 reported long-term effects including pain, numbness, and burning, said the researchers, led by Jusleen Ahluwalia, MD, of the department of dermatology at the University of California, San Diego, and her coauthors. They included 31 that were reported by the patients, 8 reported by the manufacturer; 4 reported by the distributor, and 2 not specified.

These findings emphasize the need for clinical trials to evaluate the safety and efficacy of the lasers and radiofrequency devices that have been marketed and used for so-called vaginal rejuvenation procedures, they wrote in Lasers in Surgery and Medicine. The coauthors are Arisa Ortiz, MD, also with the University of California, San Diego, and Mathew M. Avram, MD, director of the Massachusetts General Hospital Dermatology Laser & Cosmetic Center, Boston. “Randomized studies are necessary to compare these therapies with standard modalities and to establish the safety of these devices,” they wrote.

In July 2018, the FDA issued a safety communication alerting patients and health care providers that the safety and effectiveness of energy-based devices has not been established for procedures described as “vaginal rejuvenation.” Scott Gottlieb, MD, FDA commissioner at the time, issued a statement decrying “deceptive health claims and significant risks” related to devices marketed for those medical procedures. In a November 2018 update, the FDA said they contacted some device manufacturers to express concerns that the devices were being marketed inappropriately and that manufacturers they had contacted so far “responded with adequate corrections.”

In their report, Dr. Ahluwalia and her associates noted that “vaginal rejuvenation” is an ill-defined term that may encompass a variety of procedures related to tightening; dyspareunia; dysuria; urinary incontinence; vulvar issues including irritation, dryness, and atrophy; and orgasmic dysfunction.

They found a total of 58 records in their review of the Manufacturer and User Facility Device Experience database, of which 25 were reported prior to the FDA’s July 2018 statement. Of 45 unique event descriptions found in those records, 39 were categorized as patient-related injuries, while 2 were operator-related injuries, 2 were device malfunctions, and 2 were not specified.

Pain was the most commonly adverse event, accounting for 19 reports in their analysis, while 11 patients reported numbness or burning.

Among the laser- and energy-based devices specifically described in the 39 patient-report injuries, the MonaLisa Touch had the highest number of adverse event reports (16), the data show. “However, this may be reflective of length of time bias as it is one of the first devices utilized to promote vaginal rejuvenation,” the authors pointed out.

In light of these findings, the authors advised clinicians to ask patients about their reasons for seeking vaginal rejuvenation procedures. “Normal variety of female genital appearances should also be reviewed when patients express cosmetic concerns,” they added. Concerns about related to genitourinary syndrome of menopause “or optimizing sexual function may be alleviated by exploring nonprocedural, conservative approaches, such as hormonal creams, if not contraindicated, and/or counseling,” they noted.

The authors provided conflict of interest disclosures related to Zalea, Inmode, Cytrellis, Zeltiq Aesthetics, Soliton, Sciton, Allergan, and Sienna Biopharmaceuticals, among others.

Adverse events related to devices and drugs can be reported to the FDA’s Medwatch program.

SOURCE: Ahluwalia J et al. Lasers Surg Med. 2019 Mar 29. doi: 10.1002/lsm.23084.

The use of energy-based devices for vaginal rejuvenation, a practice that sparked a recent safety communication from the Food and Drug Administration, was implicated in nearly four dozen adverse event reports found in the agency’s medical device adverse event reporting database, researchers report.

The 45 unique event reports, submitted to the FDA during October 2015–January 2019, described 46 patients in total, of whom 33 reported long-term effects including pain, numbness, and burning, said the researchers, led by Jusleen Ahluwalia, MD, of the department of dermatology at the University of California, San Diego, and her coauthors. They included 31 that were reported by the patients, 8 reported by the manufacturer; 4 reported by the distributor, and 2 not specified.

These findings emphasize the need for clinical trials to evaluate the safety and efficacy of the lasers and radiofrequency devices that have been marketed and used for so-called vaginal rejuvenation procedures, they wrote in Lasers in Surgery and Medicine. The coauthors are Arisa Ortiz, MD, also with the University of California, San Diego, and Mathew M. Avram, MD, director of the Massachusetts General Hospital Dermatology Laser & Cosmetic Center, Boston. “Randomized studies are necessary to compare these therapies with standard modalities and to establish the safety of these devices,” they wrote.

In July 2018, the FDA issued a safety communication alerting patients and health care providers that the safety and effectiveness of energy-based devices has not been established for procedures described as “vaginal rejuvenation.” Scott Gottlieb, MD, FDA commissioner at the time, issued a statement decrying “deceptive health claims and significant risks” related to devices marketed for those medical procedures. In a November 2018 update, the FDA said they contacted some device manufacturers to express concerns that the devices were being marketed inappropriately and that manufacturers they had contacted so far “responded with adequate corrections.”

In their report, Dr. Ahluwalia and her associates noted that “vaginal rejuvenation” is an ill-defined term that may encompass a variety of procedures related to tightening; dyspareunia; dysuria; urinary incontinence; vulvar issues including irritation, dryness, and atrophy; and orgasmic dysfunction.

They found a total of 58 records in their review of the Manufacturer and User Facility Device Experience database, of which 25 were reported prior to the FDA’s July 2018 statement. Of 45 unique event descriptions found in those records, 39 were categorized as patient-related injuries, while 2 were operator-related injuries, 2 were device malfunctions, and 2 were not specified.

Pain was the most commonly adverse event, accounting for 19 reports in their analysis, while 11 patients reported numbness or burning.

Among the laser- and energy-based devices specifically described in the 39 patient-report injuries, the MonaLisa Touch had the highest number of adverse event reports (16), the data show. “However, this may be reflective of length of time bias as it is one of the first devices utilized to promote vaginal rejuvenation,” the authors pointed out.

In light of these findings, the authors advised clinicians to ask patients about their reasons for seeking vaginal rejuvenation procedures. “Normal variety of female genital appearances should also be reviewed when patients express cosmetic concerns,” they added. Concerns about related to genitourinary syndrome of menopause “or optimizing sexual function may be alleviated by exploring nonprocedural, conservative approaches, such as hormonal creams, if not contraindicated, and/or counseling,” they noted.

The authors provided conflict of interest disclosures related to Zalea, Inmode, Cytrellis, Zeltiq Aesthetics, Soliton, Sciton, Allergan, and Sienna Biopharmaceuticals, among others.

Adverse events related to devices and drugs can be reported to the FDA’s Medwatch program.

SOURCE: Ahluwalia J et al. Lasers Surg Med. 2019 Mar 29. doi: 10.1002/lsm.23084.

PHILADELPHIA – Nearly 7%-10% of the general population experiences neuropathic pain, but studies on treatments have not found a clear winner for reducing this “burning or electriclike pain,” explained Raymond Price, MD, during a presentation.

Andrew Bowser/MDedge News

“It isn’t that exciting,” said Dr. Price, associate professor of neurology at the University of Pennsylvania, Philadelphia, in reference to his review of level 1-2 evidence for treatment of neuropathic pain that was presented in a study published in JAMA (2015 Nov 24;314[20]:2172-81). a few years ago. “On a scale of 1 to 10, you can reduce their pain scale by 1-2 points more than placebo,” he told his audience at the annual meeting of the American College of Physicians.

“In general, you can use any of these medicines [for neuropathic pain]. There are very limited head-to-head data as to which one is actually better,” he explained.

Given the absence of robust head-to-head trial data, Dr. Price tends to start a lot of patients on old, cheap medications like nortriptyline.

While there aren’t many head-to-head trials to guide treatment choice, the results of one prospective, randomized, open-label study of 333 patients with cryptogenic sensory polyneuropathy was presented by Barohn and colleagues at the 2018 annual meeting of the American Academy of Neurology, he said. In that study, somewhat higher efficacy rates were seen with duloxetine, a serotonin-noradrenaline reuptake inhibitor, and nortriptyline, a tricyclic antidepressant, compared with pregabalin, Dr. Price noted. Duloxetine and nortriptyline also had slightly better tolerability, as evidenced by a lower quit rate, compared with pregabalin, he added.

There was also a systematic review and meta-analysis (Lancet Neurol. 2015 Feb; 14[2]:162-73) conducted that determined the number needed to treat for neuropathic pain treatments, Dr. Price noted. In that paper, tricyclic antidepressants had a number needed to treat of 3.6, comparing favorably to 7.7 for pregabalin, 7.2 for gabapentin, and 6.4 for serotonin-noradrenaline reuptake inhibitors, mainly including duloxetine, said Dr. Price.

Regardless of the cause of neuropathic pain, the same general approach to treatment is taken, though most of the evidence comes from studies of patients with painful diabetic peripheral neuropathy or postherpetic neuralgia, he added.

For these patients, an adequate trial of a neuropathic pain treatment should be 6-12 weeks, reflecting the length of the intervention needed to demonstrate the efficacy of these agents, he said.

If that first drug doesn’t work, another can be tried, or multiple drugs can be tried together to see if the patient’s condition improves, he said.

Dr. Price reported no conflicts of interest.
 

SOURCE: Price R Internal Medicine 2019, Presentation MSFM 002.

PHILADELPHIA – Nearly 7%-10% of the general population experiences neuropathic pain, but studies on treatments have not found a clear winner for reducing this “burning or electriclike pain,” explained Raymond Price, MD, during a presentation.

Andrew Bowser/MDedge News

“It isn’t that exciting,” said Dr. Price, associate professor of neurology at the University of Pennsylvania, Philadelphia, in reference to his review of level 1-2 evidence for treatment of neuropathic pain that was presented in a study published in JAMA (2015 Nov 24;314[20]:2172-81). a few years ago. “On a scale of 1 to 10, you can reduce their pain scale by 1-2 points more than placebo,” he told his audience at the annual meeting of the American College of Physicians.

“In general, you can use any of these medicines [for neuropathic pain]. There are very limited head-to-head data as to which one is actually better,” he explained.

Given the absence of robust head-to-head trial data, Dr. Price tends to start a lot of patients on old, cheap medications like nortriptyline.

While there aren’t many head-to-head trials to guide treatment choice, the results of one prospective, randomized, open-label study of 333 patients with cryptogenic sensory polyneuropathy was presented by Barohn and colleagues at the 2018 annual meeting of the American Academy of Neurology, he said. In that study, somewhat higher efficacy rates were seen with duloxetine, a serotonin-noradrenaline reuptake inhibitor, and nortriptyline, a tricyclic antidepressant, compared with pregabalin, Dr. Price noted. Duloxetine and nortriptyline also had slightly better tolerability, as evidenced by a lower quit rate, compared with pregabalin, he added.

There was also a systematic review and meta-analysis (Lancet Neurol. 2015 Feb; 14[2]:162-73) conducted that determined the number needed to treat for neuropathic pain treatments, Dr. Price noted. In that paper, tricyclic antidepressants had a number needed to treat of 3.6, comparing favorably to 7.7 for pregabalin, 7.2 for gabapentin, and 6.4 for serotonin-noradrenaline reuptake inhibitors, mainly including duloxetine, said Dr. Price.

Regardless of the cause of neuropathic pain, the same general approach to treatment is taken, though most of the evidence comes from studies of patients with painful diabetic peripheral neuropathy or postherpetic neuralgia, he added.

For these patients, an adequate trial of a neuropathic pain treatment should be 6-12 weeks, reflecting the length of the intervention needed to demonstrate the efficacy of these agents, he said.

If that first drug doesn’t work, another can be tried, or multiple drugs can be tried together to see if the patient’s condition improves, he said.

Dr. Price reported no conflicts of interest.
 

SOURCE: Price R Internal Medicine 2019, Presentation MSFM 002.

PHILADELPHIA – Nearly 7%-10% of the general population experiences neuropathic pain, but studies on treatments have not found a clear winner for reducing this “burning or electriclike pain,” explained Raymond Price, MD, during a presentation.

Andrew Bowser/MDedge News

“It isn’t that exciting,” said Dr. Price, associate professor of neurology at the University of Pennsylvania, Philadelphia, in reference to his review of level 1-2 evidence for treatment of neuropathic pain that was presented in a study published in JAMA (2015 Nov 24;314[20]:2172-81). a few years ago. “On a scale of 1 to 10, you can reduce their pain scale by 1-2 points more than placebo,” he told his audience at the annual meeting of the American College of Physicians.

“In general, you can use any of these medicines [for neuropathic pain]. There are very limited head-to-head data as to which one is actually better,” he explained.

Given the absence of robust head-to-head trial data, Dr. Price tends to start a lot of patients on old, cheap medications like nortriptyline.

While there aren’t many head-to-head trials to guide treatment choice, the results of one prospective, randomized, open-label study of 333 patients with cryptogenic sensory polyneuropathy was presented by Barohn and colleagues at the 2018 annual meeting of the American Academy of Neurology, he said. In that study, somewhat higher efficacy rates were seen with duloxetine, a serotonin-noradrenaline reuptake inhibitor, and nortriptyline, a tricyclic antidepressant, compared with pregabalin, Dr. Price noted. Duloxetine and nortriptyline also had slightly better tolerability, as evidenced by a lower quit rate, compared with pregabalin, he added.

There was also a systematic review and meta-analysis (Lancet Neurol. 2015 Feb; 14[2]:162-73) conducted that determined the number needed to treat for neuropathic pain treatments, Dr. Price noted. In that paper, tricyclic antidepressants had a number needed to treat of 3.6, comparing favorably to 7.7 for pregabalin, 7.2 for gabapentin, and 6.4 for serotonin-noradrenaline reuptake inhibitors, mainly including duloxetine, said Dr. Price.

Regardless of the cause of neuropathic pain, the same general approach to treatment is taken, though most of the evidence comes from studies of patients with painful diabetic peripheral neuropathy or postherpetic neuralgia, he added.

For these patients, an adequate trial of a neuropathic pain treatment should be 6-12 weeks, reflecting the length of the intervention needed to demonstrate the efficacy of these agents, he said.

If that first drug doesn’t work, another can be tried, or multiple drugs can be tried together to see if the patient’s condition improves, he said.

Dr. Price reported no conflicts of interest.
 

SOURCE: Price R Internal Medicine 2019, Presentation MSFM 002.