The Food and Drug Administration has announced that Teva is expanding its recall to certain lots of losartan potassium distributed by Golden State Medical Supply, according to a release.

The recall for this and other angiotensin II receptor blockers was initiated by Teva on April 25, 2019, because of detection of unacceptable levels of the possibly cancer-causing impurity N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). Teva expanded this recall on June 10, with another update issued on June 12.


Losartan is not the only ARB found to contain NMBA; a full list of all ARBs affected can be found on the FDA website and currently includes more than 1,100 lots being recalled. The list can be searched and sorted by such considerations as medicine in question, company involved, and lot number.

[email protected]

The Food and Drug Administration has announced that Teva is expanding its recall to certain lots of losartan potassium distributed by Golden State Medical Supply, according to a release.

The recall for this and other angiotensin II receptor blockers was initiated by Teva on April 25, 2019, because of detection of unacceptable levels of the possibly cancer-causing impurity N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). Teva expanded this recall on June 10, with another update issued on June 12.


Losartan is not the only ARB found to contain NMBA; a full list of all ARBs affected can be found on the FDA website and currently includes more than 1,100 lots being recalled. The list can be searched and sorted by such considerations as medicine in question, company involved, and lot number.

[email protected]

The Food and Drug Administration has announced that Teva is expanding its recall to certain lots of losartan potassium distributed by Golden State Medical Supply, according to a release.

The recall for this and other angiotensin II receptor blockers was initiated by Teva on April 25, 2019, because of detection of unacceptable levels of the possibly cancer-causing impurity N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). Teva expanded this recall on June 10, with another update issued on June 12.


Losartan is not the only ARB found to contain NMBA; a full list of all ARBs affected can be found on the FDA website and currently includes more than 1,100 lots being recalled. The list can be searched and sorted by such considerations as medicine in question, company involved, and lot number.

[email protected]

MADRID – An observational study that includes adults and children with cryopyrin-associated periodic syndromes and related diseases has provided real-world evidence that clinical improvement accrues on canakinumab (Ilaris) years after treatment was initiated, according to Norbert Blank, MD, of the division of rheumatology at the University of Heidelberg (Germany).

Summarizing data he presented at the European Congress of Rheumatology, Dr. Blank explained in an interview that the observational study has accrued more than 50 patients so far, with the goal of reaching 300 patients with cryopyrin-associated periodic syndromes and related rare diseases that have responded to anti–interleukin-1 therapy, such as Muckle-Wells syndrome, familial cold autoinflammatory syndrome, and familial Mediterranean fever.

Most of the patients participating in the observational study, called RELIANCE, were already on canakinumab at the time of enrollment, often for several years. Yet in follow-up so far – which exceeds 1 year for some of the participants – improvement from the time of entry has been seen for some outcomes, such as activity level, according to Dr. Blank.

Canakinumab has been well tolerated with no new or unexpected adverse events emerging in the follow-up so far. Although these data remain limited, Dr. Blank considers them reassuring.

With detailed characterization of these rare diseases at baseline, observational studies like RELIANCE provide valuable real-world data about disease presentation, according to Dr. Blank. He believes that further follow-up will provide a rich source of information about disease course in response to anti-IL-1 therapy, which is being individualized according to response.

MADRID – An observational study that includes adults and children with cryopyrin-associated periodic syndromes and related diseases has provided real-world evidence that clinical improvement accrues on canakinumab (Ilaris) years after treatment was initiated, according to Norbert Blank, MD, of the division of rheumatology at the University of Heidelberg (Germany).

Summarizing data he presented at the European Congress of Rheumatology, Dr. Blank explained in an interview that the observational study has accrued more than 50 patients so far, with the goal of reaching 300 patients with cryopyrin-associated periodic syndromes and related rare diseases that have responded to anti–interleukin-1 therapy, such as Muckle-Wells syndrome, familial cold autoinflammatory syndrome, and familial Mediterranean fever.

Most of the patients participating in the observational study, called RELIANCE, were already on canakinumab at the time of enrollment, often for several years. Yet in follow-up so far – which exceeds 1 year for some of the participants – improvement from the time of entry has been seen for some outcomes, such as activity level, according to Dr. Blank.

Canakinumab has been well tolerated with no new or unexpected adverse events emerging in the follow-up so far. Although these data remain limited, Dr. Blank considers them reassuring.

With detailed characterization of these rare diseases at baseline, observational studies like RELIANCE provide valuable real-world data about disease presentation, according to Dr. Blank. He believes that further follow-up will provide a rich source of information about disease course in response to anti-IL-1 therapy, which is being individualized according to response.

MADRID – An observational study that includes adults and children with cryopyrin-associated periodic syndromes and related diseases has provided real-world evidence that clinical improvement accrues on canakinumab (Ilaris) years after treatment was initiated, according to Norbert Blank, MD, of the division of rheumatology at the University of Heidelberg (Germany).

Summarizing data he presented at the European Congress of Rheumatology, Dr. Blank explained in an interview that the observational study has accrued more than 50 patients so far, with the goal of reaching 300 patients with cryopyrin-associated periodic syndromes and related rare diseases that have responded to anti–interleukin-1 therapy, such as Muckle-Wells syndrome, familial cold autoinflammatory syndrome, and familial Mediterranean fever.

Most of the patients participating in the observational study, called RELIANCE, were already on canakinumab at the time of enrollment, often for several years. Yet in follow-up so far – which exceeds 1 year for some of the participants – improvement from the time of entry has been seen for some outcomes, such as activity level, according to Dr. Blank.

Canakinumab has been well tolerated with no new or unexpected adverse events emerging in the follow-up so far. Although these data remain limited, Dr. Blank considers them reassuring.

With detailed characterization of these rare diseases at baseline, observational studies like RELIANCE provide valuable real-world data about disease presentation, according to Dr. Blank. He believes that further follow-up will provide a rich source of information about disease course in response to anti-IL-1 therapy, which is being individualized according to response.

The Food and Drug Administration has approved Amgen’s trastuzumab-anns as a trastuzumab biosimilar for the treatment of HER2-positive breast cancer and gastric cancer.

Olivier Le Moal/Getty Images

This biosimilar, to be marketed as Kanjinti, is the fifth trastuzumab biosimilar to be approved by the agency, according to the FDA.

Approval was based in part on the LILAC study, which demonstrated that the biosimilar, previously called ABP-980, had similar efficacy and comparable cardiac safety with trastuzumab.

In the phase 3 study, 725 patients with HER2-positive early breast cancer were randomized to neoadjuvant treatment with trastuzumab-anns or trastuzumab, plus paclitaxel, for four cycles following four cycles of chemotherapy. The primary pathological complete response endpoint was achieved in 48% of those in the biosimilar arm, compared with 40.5% in the trastuzumab arm. Patients then went on to receive adjuvant treatment with ABP 980 or trastuzumab every 3 weeks for up to 1 year following surgery.

Grade 3 or worse adverse events during the neoadjuvant phase occurred in 15% of patients in the ABP 980 group and 14% in the trastuzumab group. The most frequent grade 3 event in both study arms was neutropenia. In the adjuvant phase, grade 3 or worse adverse events occurred in 9% of those continuing ABP 980 and in 6% of those continuing trastuzumab. The most frequent events in both arms were infections, infestations, and neutropenia.

Trastuzumab-anns is indicated for adjuvant treatment of HER2-overexpressing node positive or node negative breast cancer, first-line treatment of HER2-overexpressing metastatic breast cancer, and first-line treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. The FDA indicates patients should be selected based on an FDA-approved companion diagnostic for a trastuzumab product.

The biosimilar includes a boxed warning for cardiomyopathy, infusion reactions, embryo-fetal toxicity, and pulmonary toxicity.

[email protected]

The Food and Drug Administration has approved Amgen’s trastuzumab-anns as a trastuzumab biosimilar for the treatment of HER2-positive breast cancer and gastric cancer.

Olivier Le Moal/Getty Images

This biosimilar, to be marketed as Kanjinti, is the fifth trastuzumab biosimilar to be approved by the agency, according to the FDA.

Approval was based in part on the LILAC study, which demonstrated that the biosimilar, previously called ABP-980, had similar efficacy and comparable cardiac safety with trastuzumab.

In the phase 3 study, 725 patients with HER2-positive early breast cancer were randomized to neoadjuvant treatment with trastuzumab-anns or trastuzumab, plus paclitaxel, for four cycles following four cycles of chemotherapy. The primary pathological complete response endpoint was achieved in 48% of those in the biosimilar arm, compared with 40.5% in the trastuzumab arm. Patients then went on to receive adjuvant treatment with ABP 980 or trastuzumab every 3 weeks for up to 1 year following surgery.

Grade 3 or worse adverse events during the neoadjuvant phase occurred in 15% of patients in the ABP 980 group and 14% in the trastuzumab group. The most frequent grade 3 event in both study arms was neutropenia. In the adjuvant phase, grade 3 or worse adverse events occurred in 9% of those continuing ABP 980 and in 6% of those continuing trastuzumab. The most frequent events in both arms were infections, infestations, and neutropenia.

Trastuzumab-anns is indicated for adjuvant treatment of HER2-overexpressing node positive or node negative breast cancer, first-line treatment of HER2-overexpressing metastatic breast cancer, and first-line treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. The FDA indicates patients should be selected based on an FDA-approved companion diagnostic for a trastuzumab product.

The biosimilar includes a boxed warning for cardiomyopathy, infusion reactions, embryo-fetal toxicity, and pulmonary toxicity.

[email protected]

The Food and Drug Administration has approved Amgen’s trastuzumab-anns as a trastuzumab biosimilar for the treatment of HER2-positive breast cancer and gastric cancer.

Olivier Le Moal/Getty Images

This biosimilar, to be marketed as Kanjinti, is the fifth trastuzumab biosimilar to be approved by the agency, according to the FDA.

Approval was based in part on the LILAC study, which demonstrated that the biosimilar, previously called ABP-980, had similar efficacy and comparable cardiac safety with trastuzumab.

In the phase 3 study, 725 patients with HER2-positive early breast cancer were randomized to neoadjuvant treatment with trastuzumab-anns or trastuzumab, plus paclitaxel, for four cycles following four cycles of chemotherapy. The primary pathological complete response endpoint was achieved in 48% of those in the biosimilar arm, compared with 40.5% in the trastuzumab arm. Patients then went on to receive adjuvant treatment with ABP 980 or trastuzumab every 3 weeks for up to 1 year following surgery.

Grade 3 or worse adverse events during the neoadjuvant phase occurred in 15% of patients in the ABP 980 group and 14% in the trastuzumab group. The most frequent grade 3 event in both study arms was neutropenia. In the adjuvant phase, grade 3 or worse adverse events occurred in 9% of those continuing ABP 980 and in 6% of those continuing trastuzumab. The most frequent events in both arms were infections, infestations, and neutropenia.

Trastuzumab-anns is indicated for adjuvant treatment of HER2-overexpressing node positive or node negative breast cancer, first-line treatment of HER2-overexpressing metastatic breast cancer, and first-line treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. The FDA indicates patients should be selected based on an FDA-approved companion diagnostic for a trastuzumab product.

The biosimilar includes a boxed warning for cardiomyopathy, infusion reactions, embryo-fetal toxicity, and pulmonary toxicity.

[email protected]

MADRID – The glucagonlike peptide–1 receptor agonist liraglutide appears to be effective for keeping weight off following an intensive weight-loss program in patients with knee osteoarthritis, according to a randomized, double-blind, placebo-controlled trial presented at the European Congress of Rheumatology.

However, even though the 8-week intensive dietary program led to substantial weight loss and significant improvement in pain, additional weight loss of nearly 2.5 kg over 52 weeks of daily liraglutide treatment did not translate into more pain control.

According to study author Lars Erik Kristensen, MD, PhD, this is the first randomized trial to test the ability of liraglutide to provide a sustained weight loss in OA patients. The Food and Drug Administration indication for liraglutide is as an adjunct to diet and exercise for glycemic control in type 2 diabetes mellitus.

The study compared liraglutide against placebo in patients who had completed an intensive weight-control program in which the median loss was 12.46 kg. They were followed for 52 weeks.

At the end of follow-up, patients in the placebo group had gained a mean of 1.17 kg while those randomized to liraglutide lost an additional 2.76 kg. The between-group difference of 3.93 kg was statistically significant (P = .008).

“We believe that liraglutide is a promising agent for sustained weight loss in OA patients,” concluded Dr. Kristensen, a clinical researcher in rheumatology in the Parker Institute at Bispebjerg-Frederiksberg Hospital in Copenhagen.

In the single-center study, 156 patients were enrolled and randomized. In an initial 8-week diet intervention undertaken by both groups, an intensive program for weight loss included average daily calorie intakes of less than 800 kcal along with dietetic counseling. Patients were monitored for daily activities.

The majority of patients achieved a 10% or greater loss of total body weight during the intensive program before initiating 3 mg of once-daily liraglutide or a placebo.

Over the course of 52 weeks, the attrition from the study was relatively low. Among the 80 patients randomized to liraglutide, only 2 were lost because of noncompliance. Another 12 participants left the study before completion, 10 of whom did so for treatment-associated adverse effects. In the placebo arm, four patients were noncompliant, four left for treatment-associated adverse effects, and five left for other reasons.

Following the 8-week intensive dietary program, there was 11.86-point improvement in the pain subscale of the Knee and Osteoarthritis Outcome Score, confirming a substantial symptomatic benefit from this degree of weight loss. While this improvement in pain score was sustained at 52 weeks in both groups, the additional weight loss in the liraglutide arm did not lead to additional pain control.

The lack of additional pain control in the liraglutide group was disappointing, and the reason is unclear, but Dr. Kristensen emphasized that the persistent improvement in pain control was a positive result. In patients who are overweight or obese, regardless of whether they have concomitant OA, weight loss is not only difficult to achieve but difficult to sustain even after a successful intervention.

Dr. Kristensen reported financial relationships with multiple pharmaceutical companies. The trial received funding from Novo Nordisk.

SOURCE: Kristensen LE et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):71-2. Abstract OP0011. doi: 10.1136/annrheumdis-2019-eular.1375.

MADRID – The glucagonlike peptide–1 receptor agonist liraglutide appears to be effective for keeping weight off following an intensive weight-loss program in patients with knee osteoarthritis, according to a randomized, double-blind, placebo-controlled trial presented at the European Congress of Rheumatology.

However, even though the 8-week intensive dietary program led to substantial weight loss and significant improvement in pain, additional weight loss of nearly 2.5 kg over 52 weeks of daily liraglutide treatment did not translate into more pain control.

According to study author Lars Erik Kristensen, MD, PhD, this is the first randomized trial to test the ability of liraglutide to provide a sustained weight loss in OA patients. The Food and Drug Administration indication for liraglutide is as an adjunct to diet and exercise for glycemic control in type 2 diabetes mellitus.

The study compared liraglutide against placebo in patients who had completed an intensive weight-control program in which the median loss was 12.46 kg. They were followed for 52 weeks.

At the end of follow-up, patients in the placebo group had gained a mean of 1.17 kg while those randomized to liraglutide lost an additional 2.76 kg. The between-group difference of 3.93 kg was statistically significant (P = .008).

“We believe that liraglutide is a promising agent for sustained weight loss in OA patients,” concluded Dr. Kristensen, a clinical researcher in rheumatology in the Parker Institute at Bispebjerg-Frederiksberg Hospital in Copenhagen.

In the single-center study, 156 patients were enrolled and randomized. In an initial 8-week diet intervention undertaken by both groups, an intensive program for weight loss included average daily calorie intakes of less than 800 kcal along with dietetic counseling. Patients were monitored for daily activities.

The majority of patients achieved a 10% or greater loss of total body weight during the intensive program before initiating 3 mg of once-daily liraglutide or a placebo.

Over the course of 52 weeks, the attrition from the study was relatively low. Among the 80 patients randomized to liraglutide, only 2 were lost because of noncompliance. Another 12 participants left the study before completion, 10 of whom did so for treatment-associated adverse effects. In the placebo arm, four patients were noncompliant, four left for treatment-associated adverse effects, and five left for other reasons.

Following the 8-week intensive dietary program, there was 11.86-point improvement in the pain subscale of the Knee and Osteoarthritis Outcome Score, confirming a substantial symptomatic benefit from this degree of weight loss. While this improvement in pain score was sustained at 52 weeks in both groups, the additional weight loss in the liraglutide arm did not lead to additional pain control.

The lack of additional pain control in the liraglutide group was disappointing, and the reason is unclear, but Dr. Kristensen emphasized that the persistent improvement in pain control was a positive result. In patients who are overweight or obese, regardless of whether they have concomitant OA, weight loss is not only difficult to achieve but difficult to sustain even after a successful intervention.

Dr. Kristensen reported financial relationships with multiple pharmaceutical companies. The trial received funding from Novo Nordisk.

SOURCE: Kristensen LE et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):71-2. Abstract OP0011. doi: 10.1136/annrheumdis-2019-eular.1375.

MADRID – The glucagonlike peptide–1 receptor agonist liraglutide appears to be effective for keeping weight off following an intensive weight-loss program in patients with knee osteoarthritis, according to a randomized, double-blind, placebo-controlled trial presented at the European Congress of Rheumatology.

However, even though the 8-week intensive dietary program led to substantial weight loss and significant improvement in pain, additional weight loss of nearly 2.5 kg over 52 weeks of daily liraglutide treatment did not translate into more pain control.

According to study author Lars Erik Kristensen, MD, PhD, this is the first randomized trial to test the ability of liraglutide to provide a sustained weight loss in OA patients. The Food and Drug Administration indication for liraglutide is as an adjunct to diet and exercise for glycemic control in type 2 diabetes mellitus.

The study compared liraglutide against placebo in patients who had completed an intensive weight-control program in which the median loss was 12.46 kg. They were followed for 52 weeks.

At the end of follow-up, patients in the placebo group had gained a mean of 1.17 kg while those randomized to liraglutide lost an additional 2.76 kg. The between-group difference of 3.93 kg was statistically significant (P = .008).

“We believe that liraglutide is a promising agent for sustained weight loss in OA patients,” concluded Dr. Kristensen, a clinical researcher in rheumatology in the Parker Institute at Bispebjerg-Frederiksberg Hospital in Copenhagen.

In the single-center study, 156 patients were enrolled and randomized. In an initial 8-week diet intervention undertaken by both groups, an intensive program for weight loss included average daily calorie intakes of less than 800 kcal along with dietetic counseling. Patients were monitored for daily activities.

The majority of patients achieved a 10% or greater loss of total body weight during the intensive program before initiating 3 mg of once-daily liraglutide or a placebo.

Over the course of 52 weeks, the attrition from the study was relatively low. Among the 80 patients randomized to liraglutide, only 2 were lost because of noncompliance. Another 12 participants left the study before completion, 10 of whom did so for treatment-associated adverse effects. In the placebo arm, four patients were noncompliant, four left for treatment-associated adverse effects, and five left for other reasons.

Following the 8-week intensive dietary program, there was 11.86-point improvement in the pain subscale of the Knee and Osteoarthritis Outcome Score, confirming a substantial symptomatic benefit from this degree of weight loss. While this improvement in pain score was sustained at 52 weeks in both groups, the additional weight loss in the liraglutide arm did not lead to additional pain control.

The lack of additional pain control in the liraglutide group was disappointing, and the reason is unclear, but Dr. Kristensen emphasized that the persistent improvement in pain control was a positive result. In patients who are overweight or obese, regardless of whether they have concomitant OA, weight loss is not only difficult to achieve but difficult to sustain even after a successful intervention.

Dr. Kristensen reported financial relationships with multiple pharmaceutical companies. The trial received funding from Novo Nordisk.

SOURCE: Kristensen LE et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):71-2. Abstract OP0011. doi: 10.1136/annrheumdis-2019-eular.1375.

If the answer is “early follow-up,” then what is the question? It could be any one of the scores of challenges facing a primary care physician. Rachel Pearson – writing in an article on the vulnerable child syndrome in The New Yorker – claims that “scheduling an early follow-up is as important as doing a detailed exam and having a broad differential diagnosis” (“The Durable Feeling That a Child is Always at Risk,” June 10, 2019) At first blush that may sound like a rather radical observation. How many medical school instructors and house office mentors would begin a teaching session by telling their trainees that doing a complete exam and developing an inclusive list of diagnoses really wasn’t all that important?

MichaelJung/Thinkstock

But I completely agree with Dr. Pearson’s observation. An early follow-up is the answer when you don’t have clue what is causing the patient’s symptoms. Or you have too many clues, but don’t have the time to sort them out. Or you have a solid diagnosis, but you don’t have the time to adequately explain it to the patient. Or maybe you have the time, but you sense that the patient is uncomfortable with your opinion. Early follow-up also is the answer when the patient’s illness is one that can worsen before it begins to improve. You may have warned the patient of this phenomenon, but scheduling an early follow-up visit can allay their concerns.

Scheduling an early follow-up may allow you to sleep better when you are concerned about the patient’s condition. Particularly in the situation in which the patient isn’t quite sick enough to warrant the risks and expense of a hospitalization. If you and your office staff feel as though you are drowning in phone calls, a liberal use of timely follow-ups can dramatically reduce your phone interruptions. Particularly if you have earned a reputation of keeping your promises. If you are worried about being sued for malpractice, early follow-ups are far better protection than shotgun ordering of lab and imaging studies. And if you are the new guy or gal in town, early follow-ups are one of the most potent practice builders I know.

Does an early follow-up have to be an office visit? It depends on the situation. Most patients quickly realize when your scheduled follow-up visits aren’t necessary. You and your staff should be sensitive to the inconvenience and expense that an office visit may create. Would a phone call be just as effective? This is a particularly knotty question when it comes to newborns. On one hand, office visits can be very disruptive to sleep and nursing schedules of sleep-deprived parents. However, I have seen too many situations in which a physician’s office has relied too heavily on the observations of inexperienced parents when an eyeball in the office or by a visiting nurse would have headed off disaster.

And who should make the call? Never underestimate the power of your voice, even if it’s just a message on an answering machine or smartphone. It leaves an impression. “You know my doctor calls me to check to see how I am?” I think whenever possible, the provider should make the first call. If you fail to connect, your staff can make subsequent attempts.

Finally, you may ask what is an “early” follow-up? The better descriptor would be “timely.” You won’t find this answer in a text book. This is another case in which art trumps medicine in the practice of medicine. The “when” of a timely follow-up depends on the patient’s illness, what is its usual course from your experience. How anxious is the patient? How anxious are you? The answer is that scheduling the follow-up should err on the early side. Another can always be scheduled if the situation is still fluid. At worst, it will demonstrate you are a caring physician.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

If the answer is “early follow-up,” then what is the question? It could be any one of the scores of challenges facing a primary care physician. Rachel Pearson – writing in an article on the vulnerable child syndrome in The New Yorker – claims that “scheduling an early follow-up is as important as doing a detailed exam and having a broad differential diagnosis” (“The Durable Feeling That a Child is Always at Risk,” June 10, 2019) At first blush that may sound like a rather radical observation. How many medical school instructors and house office mentors would begin a teaching session by telling their trainees that doing a complete exam and developing an inclusive list of diagnoses really wasn’t all that important?

MichaelJung/Thinkstock

But I completely agree with Dr. Pearson’s observation. An early follow-up is the answer when you don’t have clue what is causing the patient’s symptoms. Or you have too many clues, but don’t have the time to sort them out. Or you have a solid diagnosis, but you don’t have the time to adequately explain it to the patient. Or maybe you have the time, but you sense that the patient is uncomfortable with your opinion. Early follow-up also is the answer when the patient’s illness is one that can worsen before it begins to improve. You may have warned the patient of this phenomenon, but scheduling an early follow-up visit can allay their concerns.

Scheduling an early follow-up may allow you to sleep better when you are concerned about the patient’s condition. Particularly in the situation in which the patient isn’t quite sick enough to warrant the risks and expense of a hospitalization. If you and your office staff feel as though you are drowning in phone calls, a liberal use of timely follow-ups can dramatically reduce your phone interruptions. Particularly if you have earned a reputation of keeping your promises. If you are worried about being sued for malpractice, early follow-ups are far better protection than shotgun ordering of lab and imaging studies. And if you are the new guy or gal in town, early follow-ups are one of the most potent practice builders I know.

Does an early follow-up have to be an office visit? It depends on the situation. Most patients quickly realize when your scheduled follow-up visits aren’t necessary. You and your staff should be sensitive to the inconvenience and expense that an office visit may create. Would a phone call be just as effective? This is a particularly knotty question when it comes to newborns. On one hand, office visits can be very disruptive to sleep and nursing schedules of sleep-deprived parents. However, I have seen too many situations in which a physician’s office has relied too heavily on the observations of inexperienced parents when an eyeball in the office or by a visiting nurse would have headed off disaster.

And who should make the call? Never underestimate the power of your voice, even if it’s just a message on an answering machine or smartphone. It leaves an impression. “You know my doctor calls me to check to see how I am?” I think whenever possible, the provider should make the first call. If you fail to connect, your staff can make subsequent attempts.

Finally, you may ask what is an “early” follow-up? The better descriptor would be “timely.” You won’t find this answer in a text book. This is another case in which art trumps medicine in the practice of medicine. The “when” of a timely follow-up depends on the patient’s illness, what is its usual course from your experience. How anxious is the patient? How anxious are you? The answer is that scheduling the follow-up should err on the early side. Another can always be scheduled if the situation is still fluid. At worst, it will demonstrate you are a caring physician.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

If the answer is “early follow-up,” then what is the question? It could be any one of the scores of challenges facing a primary care physician. Rachel Pearson – writing in an article on the vulnerable child syndrome in The New Yorker – claims that “scheduling an early follow-up is as important as doing a detailed exam and having a broad differential diagnosis” (“The Durable Feeling That a Child is Always at Risk,” June 10, 2019) At first blush that may sound like a rather radical observation. How many medical school instructors and house office mentors would begin a teaching session by telling their trainees that doing a complete exam and developing an inclusive list of diagnoses really wasn’t all that important?

MichaelJung/Thinkstock

But I completely agree with Dr. Pearson’s observation. An early follow-up is the answer when you don’t have clue what is causing the patient’s symptoms. Or you have too many clues, but don’t have the time to sort them out. Or you have a solid diagnosis, but you don’t have the time to adequately explain it to the patient. Or maybe you have the time, but you sense that the patient is uncomfortable with your opinion. Early follow-up also is the answer when the patient’s illness is one that can worsen before it begins to improve. You may have warned the patient of this phenomenon, but scheduling an early follow-up visit can allay their concerns.

Scheduling an early follow-up may allow you to sleep better when you are concerned about the patient’s condition. Particularly in the situation in which the patient isn’t quite sick enough to warrant the risks and expense of a hospitalization. If you and your office staff feel as though you are drowning in phone calls, a liberal use of timely follow-ups can dramatically reduce your phone interruptions. Particularly if you have earned a reputation of keeping your promises. If you are worried about being sued for malpractice, early follow-ups are far better protection than shotgun ordering of lab and imaging studies. And if you are the new guy or gal in town, early follow-ups are one of the most potent practice builders I know.

Does an early follow-up have to be an office visit? It depends on the situation. Most patients quickly realize when your scheduled follow-up visits aren’t necessary. You and your staff should be sensitive to the inconvenience and expense that an office visit may create. Would a phone call be just as effective? This is a particularly knotty question when it comes to newborns. On one hand, office visits can be very disruptive to sleep and nursing schedules of sleep-deprived parents. However, I have seen too many situations in which a physician’s office has relied too heavily on the observations of inexperienced parents when an eyeball in the office or by a visiting nurse would have headed off disaster.

And who should make the call? Never underestimate the power of your voice, even if it’s just a message on an answering machine or smartphone. It leaves an impression. “You know my doctor calls me to check to see how I am?” I think whenever possible, the provider should make the first call. If you fail to connect, your staff can make subsequent attempts.

Finally, you may ask what is an “early” follow-up? The better descriptor would be “timely.” You won’t find this answer in a text book. This is another case in which art trumps medicine in the practice of medicine. The “when” of a timely follow-up depends on the patient’s illness, what is its usual course from your experience. How anxious is the patient? How anxious are you? The answer is that scheduling the follow-up should err on the early side. Another can always be scheduled if the situation is still fluid. At worst, it will demonstrate you are a caring physician.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

The number of Americans who die each year from alcohol, drugs, or suicide increased to an all-time high in 2017, and the increase was especially pronounced among young adults, according a June 13 report from two public health policy and advocacy organizations. A separate report found that rates of these “deaths of despair” vary widely by state.

Hailshadow/iStock/Getty Images

The report by Trust for America’s Health and Well Being Trust examined Centers for Disease Control and Prevention (CDC) data with a focus on adults aged 18-34 years. Between 2007 and 2017, alcohol-induced deaths increased by 69%, drug-related deaths by 108%, and suicide by 35% in this age group. These deaths increased in other age groups, too, but often to a lesser extent.

In 1999, there were 7 drug deaths per 100,000 people across age groups, which increased to 22.7 drug deaths per 100,000 people in 2017. Among adults aged 18-34, however, the rate was nearly 31 drug overdose deaths per 100,000 people. Opioid overdoses are largely responsible for the increase in drug-related deaths, and synthetic opioid death rates increased by 6,000% between 1999 and 2017, the report said.

Millennials, generally considered people born during 1981-1996, have faced “challenges unique to their generation ... including the opioid crisis, the skyrocketing costs of education and housing, and entering the job market during the great recession,” according to the report, which was funded with grants from Well Being Trust and the Robert Wood Johnson Foundation.

Screening, treatment, and addressing risk and protective factors are among the measures that the groups recommend to reduce “deaths of despair.”

On June 12, the Commonwealth Fund released a report that examines how drug, alcohol, and suicide death rates across age groups may vary widely by state.

“In Pennsylvania, Maryland, and Ohio, mortality rates from drug overdoses were at least five times higher than rates for alcohol-related deaths and about three times higher than suicide rates,” according to the Commonwealth Fund analysis. “In other states, deaths from suicide and alcohol dominate. In 2017, Montana, Nebraska, the Dakotas, Oregon, and Wyoming saw higher rates of death from suicide and alcohol than from drugs.”

Substance use disorders and suicide might be related, and researchers have suggested that many overdoses may be suicide attempts.

“We assumed that overdoses were accidental ... only to find that many users were actively suicidal, others were playing a version of Russian roulette, and others had passive suicidal ideation,” said Mark S. Gold, MD, adjunct professor of psychiatry at Washington University in St. Louis, in an interview. Opioid use disorders often are treated as “simply opioid deficiency syndromes,” and physicians may miss when patients have physical, sexual, or emotional trauma, anxiety disorders, or major depression, he said.

[email protected]

The number of Americans who die each year from alcohol, drugs, or suicide increased to an all-time high in 2017, and the increase was especially pronounced among young adults, according a June 13 report from two public health policy and advocacy organizations. A separate report found that rates of these “deaths of despair” vary widely by state.

Hailshadow/iStock/Getty Images

The report by Trust for America’s Health and Well Being Trust examined Centers for Disease Control and Prevention (CDC) data with a focus on adults aged 18-34 years. Between 2007 and 2017, alcohol-induced deaths increased by 69%, drug-related deaths by 108%, and suicide by 35% in this age group. These deaths increased in other age groups, too, but often to a lesser extent.

In 1999, there were 7 drug deaths per 100,000 people across age groups, which increased to 22.7 drug deaths per 100,000 people in 2017. Among adults aged 18-34, however, the rate was nearly 31 drug overdose deaths per 100,000 people. Opioid overdoses are largely responsible for the increase in drug-related deaths, and synthetic opioid death rates increased by 6,000% between 1999 and 2017, the report said.

Millennials, generally considered people born during 1981-1996, have faced “challenges unique to their generation ... including the opioid crisis, the skyrocketing costs of education and housing, and entering the job market during the great recession,” according to the report, which was funded with grants from Well Being Trust and the Robert Wood Johnson Foundation.

Screening, treatment, and addressing risk and protective factors are among the measures that the groups recommend to reduce “deaths of despair.”

On June 12, the Commonwealth Fund released a report that examines how drug, alcohol, and suicide death rates across age groups may vary widely by state.

“In Pennsylvania, Maryland, and Ohio, mortality rates from drug overdoses were at least five times higher than rates for alcohol-related deaths and about three times higher than suicide rates,” according to the Commonwealth Fund analysis. “In other states, deaths from suicide and alcohol dominate. In 2017, Montana, Nebraska, the Dakotas, Oregon, and Wyoming saw higher rates of death from suicide and alcohol than from drugs.”

Substance use disorders and suicide might be related, and researchers have suggested that many overdoses may be suicide attempts.

“We assumed that overdoses were accidental ... only to find that many users were actively suicidal, others were playing a version of Russian roulette, and others had passive suicidal ideation,” said Mark S. Gold, MD, adjunct professor of psychiatry at Washington University in St. Louis, in an interview. Opioid use disorders often are treated as “simply opioid deficiency syndromes,” and physicians may miss when patients have physical, sexual, or emotional trauma, anxiety disorders, or major depression, he said.

[email protected]

The number of Americans who die each year from alcohol, drugs, or suicide increased to an all-time high in 2017, and the increase was especially pronounced among young adults, according a June 13 report from two public health policy and advocacy organizations. A separate report found that rates of these “deaths of despair” vary widely by state.

Hailshadow/iStock/Getty Images

The report by Trust for America’s Health and Well Being Trust examined Centers for Disease Control and Prevention (CDC) data with a focus on adults aged 18-34 years. Between 2007 and 2017, alcohol-induced deaths increased by 69%, drug-related deaths by 108%, and suicide by 35% in this age group. These deaths increased in other age groups, too, but often to a lesser extent.

In 1999, there were 7 drug deaths per 100,000 people across age groups, which increased to 22.7 drug deaths per 100,000 people in 2017. Among adults aged 18-34, however, the rate was nearly 31 drug overdose deaths per 100,000 people. Opioid overdoses are largely responsible for the increase in drug-related deaths, and synthetic opioid death rates increased by 6,000% between 1999 and 2017, the report said.

Millennials, generally considered people born during 1981-1996, have faced “challenges unique to their generation ... including the opioid crisis, the skyrocketing costs of education and housing, and entering the job market during the great recession,” according to the report, which was funded with grants from Well Being Trust and the Robert Wood Johnson Foundation.

Screening, treatment, and addressing risk and protective factors are among the measures that the groups recommend to reduce “deaths of despair.”

On June 12, the Commonwealth Fund released a report that examines how drug, alcohol, and suicide death rates across age groups may vary widely by state.

“In Pennsylvania, Maryland, and Ohio, mortality rates from drug overdoses were at least five times higher than rates for alcohol-related deaths and about three times higher than suicide rates,” according to the Commonwealth Fund analysis. “In other states, deaths from suicide and alcohol dominate. In 2017, Montana, Nebraska, the Dakotas, Oregon, and Wyoming saw higher rates of death from suicide and alcohol than from drugs.”

Substance use disorders and suicide might be related, and researchers have suggested that many overdoses may be suicide attempts.

“We assumed that overdoses were accidental ... only to find that many users were actively suicidal, others were playing a version of Russian roulette, and others had passive suicidal ideation,” said Mark S. Gold, MD, adjunct professor of psychiatry at Washington University in St. Louis, in an interview. Opioid use disorders often are treated as “simply opioid deficiency syndromes,” and physicians may miss when patients have physical, sexual, or emotional trauma, anxiety disorders, or major depression, he said.

[email protected]

SAN FRANCISCO – Up to 21% of psychiatry residency programs provide no training or supervision for managing and treating chronic pain, and pain-related training and supervision by remaining programs is minimal, a new national survey shows.

Given the unique role of psychiatrists in helping chronic pain patients with coping strategies and managing comorbid psychiatric illness, this void is concerning, said Ali Ahsan Ali, MD, a resident psychiatrist at the Micah School of Medicine at Mount Sinai/Elmhurst Hospital Center in New York, in an interview at the annual meeting of the American Psychiatric Association.

In a video interview, Dr. Ali spoke with Ahmar M. Butt, MD, about how and why Dr. Ali and his colleagues conducted the survey of all 221 U.S. psychiatry residency programs in January 2019. They also discuss the implications of these trends for patients, particularly in light of the country’s opioid crisis.

Dr. Ali had no disclosures. Dr. Butt is board certified in general psychiatry, child and adolescent psychiatry, and preventive medicine, with a subspecialty in addiction medicine. Dr. Butt is interim program director of the psychiatry residency program at Broadlawns UnityPointe Health, Des Moines, Iowa. He had no disclosures.

[email protected]

SAN FRANCISCO – Up to 21% of psychiatry residency programs provide no training or supervision for managing and treating chronic pain, and pain-related training and supervision by remaining programs is minimal, a new national survey shows.

Given the unique role of psychiatrists in helping chronic pain patients with coping strategies and managing comorbid psychiatric illness, this void is concerning, said Ali Ahsan Ali, MD, a resident psychiatrist at the Micah School of Medicine at Mount Sinai/Elmhurst Hospital Center in New York, in an interview at the annual meeting of the American Psychiatric Association.

In a video interview, Dr. Ali spoke with Ahmar M. Butt, MD, about how and why Dr. Ali and his colleagues conducted the survey of all 221 U.S. psychiatry residency programs in January 2019. They also discuss the implications of these trends for patients, particularly in light of the country’s opioid crisis.

Dr. Ali had no disclosures. Dr. Butt is board certified in general psychiatry, child and adolescent psychiatry, and preventive medicine, with a subspecialty in addiction medicine. Dr. Butt is interim program director of the psychiatry residency program at Broadlawns UnityPointe Health, Des Moines, Iowa. He had no disclosures.

[email protected]

SAN FRANCISCO – Up to 21% of psychiatry residency programs provide no training or supervision for managing and treating chronic pain, and pain-related training and supervision by remaining programs is minimal, a new national survey shows.

Given the unique role of psychiatrists in helping chronic pain patients with coping strategies and managing comorbid psychiatric illness, this void is concerning, said Ali Ahsan Ali, MD, a resident psychiatrist at the Micah School of Medicine at Mount Sinai/Elmhurst Hospital Center in New York, in an interview at the annual meeting of the American Psychiatric Association.

In a video interview, Dr. Ali spoke with Ahmar M. Butt, MD, about how and why Dr. Ali and his colleagues conducted the survey of all 221 U.S. psychiatry residency programs in January 2019. They also discuss the implications of these trends for patients, particularly in light of the country’s opioid crisis.

Dr. Ali had no disclosures. Dr. Butt is board certified in general psychiatry, child and adolescent psychiatry, and preventive medicine, with a subspecialty in addiction medicine. Dr. Butt is interim program director of the psychiatry residency program at Broadlawns UnityPointe Health, Des Moines, Iowa. He had no disclosures.

[email protected]

Payment policy for physicians is now set at the federal level. The Centers for Medicare and Medicaid Services generates a yearly final rule and a fee schedule, and all the Medicare carriers, AND the Medicare Advantage plans AND the private insurers use the rule and fee schedule as a payment guide.

mathisworks

Sometimes these rules can be at odds with best practices for dermatology patients. That is why lobbying is so critically important for us and for our patients. Lobbying provides access to legislators and enables us to educate them about the impact of proposed changes in coverage.

Each year, SkinPAC contributes up to $5,000 a year to individual congressional races. The extent of contributions is based on an impartial scorecard that ranks congressional members by leadership position as well as the member’s understanding and history of support on our critical issues. I want to emphasize that the personal political leanings of the SkinPAC board members have no bearing on the level of support. We contribute to campaigns based on the congressional members’ positions on our issues, period. Full disclosure: I am the chair of SkinPAC for 2019-2021. This is an unpaid volunteer position.

To dermatologists who question the effectiveness of lobbying, I can attest that I have seen your political action committee contributions in action.

When Congress planned on tightening the Stark exceptions 5 years ago, our Washington office was able to gain access to key legislators. As a result of our good long-term relationships with these congress members and their staff, our lobbying group was able to explain the importance for dermatologists to be able to read their own slides and the value of global periods. Imagine the disasters of being unable to read our own dermatopathology slides, not performing diagnostic frozen sections before Mohs, and charging patients for suture removals. Lobbying efforts averted those potential catastrophes.

Unfortunately, the same issues are coming back. In the most recent Federal Register proposals, CMS again wanted to eliminate global periods and modifier 25, which allows you to bill for a procedure on the same day as an evaluation and management code. This action has been delayed for 2 years but will come back up for consideration next year.

Global periods are follow-up visits that are embedded in the destruction, excision, and repair codes that you currently use. For example, $42 of the $72 you get for destroying a premalignant lesion or a wart is a prepayment for the follow-up visit. Sure, if the global period is eliminated, you can bill the patient for the follow-up visit, but imagine the difficulty of collecting additional copays and deductibles. And imagine the impact of those additional costs on our patients.

This brings me to your 100,000 reasons to contribute to your PAC. In Medicare alone, elimination of global periods and modifier 25 will shift $1.4 billion dollars per year away from dermatology. Assuming you will be able to recoup some payment from follow-up visits and by rescheduling some procedures, you are still looking at $1 billion or so, per year, cut from about 10,000 dermatologists with the expense shifted to patients. That’s a $100,000 loss per dermatologist per year and a $1 billion per year additional responsibility for Medicare insureds.

Yes, this will require a legislative fix. And unless it is fixed, the results will be viewed as price gouging by patients with disastrous implications for the physician-patient relationship. Imagine what your patient will say when you charge them to remove their sutures.

Your SkinPAC contribution should be viewed as a disaster insurance policy, just like any other insurance you buy. It covers the very real possibility of not a hurricane or a tornado, but a catastrophic blunder that will put you out of business as surely as any natural disaster. Support your SkinPAC! Support your patients and yourself.
 

Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Dr. Coldiron is the chair of SkinPAC for 2019-2021; this is an unpaid volunteer position. Write to him at [email protected].

Payment policy for physicians is now set at the federal level. The Centers for Medicare and Medicaid Services generates a yearly final rule and a fee schedule, and all the Medicare carriers, AND the Medicare Advantage plans AND the private insurers use the rule and fee schedule as a payment guide.

mathisworks

Sometimes these rules can be at odds with best practices for dermatology patients. That is why lobbying is so critically important for us and for our patients. Lobbying provides access to legislators and enables us to educate them about the impact of proposed changes in coverage.

Each year, SkinPAC contributes up to $5,000 a year to individual congressional races. The extent of contributions is based on an impartial scorecard that ranks congressional members by leadership position as well as the member’s understanding and history of support on our critical issues. I want to emphasize that the personal political leanings of the SkinPAC board members have no bearing on the level of support. We contribute to campaigns based on the congressional members’ positions on our issues, period. Full disclosure: I am the chair of SkinPAC for 2019-2021. This is an unpaid volunteer position.

To dermatologists who question the effectiveness of lobbying, I can attest that I have seen your political action committee contributions in action.

When Congress planned on tightening the Stark exceptions 5 years ago, our Washington office was able to gain access to key legislators. As a result of our good long-term relationships with these congress members and their staff, our lobbying group was able to explain the importance for dermatologists to be able to read their own slides and the value of global periods. Imagine the disasters of being unable to read our own dermatopathology slides, not performing diagnostic frozen sections before Mohs, and charging patients for suture removals. Lobbying efforts averted those potential catastrophes.

Unfortunately, the same issues are coming back. In the most recent Federal Register proposals, CMS again wanted to eliminate global periods and modifier 25, which allows you to bill for a procedure on the same day as an evaluation and management code. This action has been delayed for 2 years but will come back up for consideration next year.

Global periods are follow-up visits that are embedded in the destruction, excision, and repair codes that you currently use. For example, $42 of the $72 you get for destroying a premalignant lesion or a wart is a prepayment for the follow-up visit. Sure, if the global period is eliminated, you can bill the patient for the follow-up visit, but imagine the difficulty of collecting additional copays and deductibles. And imagine the impact of those additional costs on our patients.

This brings me to your 100,000 reasons to contribute to your PAC. In Medicare alone, elimination of global periods and modifier 25 will shift $1.4 billion dollars per year away from dermatology. Assuming you will be able to recoup some payment from follow-up visits and by rescheduling some procedures, you are still looking at $1 billion or so, per year, cut from about 10,000 dermatologists with the expense shifted to patients. That’s a $100,000 loss per dermatologist per year and a $1 billion per year additional responsibility for Medicare insureds.

Yes, this will require a legislative fix. And unless it is fixed, the results will be viewed as price gouging by patients with disastrous implications for the physician-patient relationship. Imagine what your patient will say when you charge them to remove their sutures.

Your SkinPAC contribution should be viewed as a disaster insurance policy, just like any other insurance you buy. It covers the very real possibility of not a hurricane or a tornado, but a catastrophic blunder that will put you out of business as surely as any natural disaster. Support your SkinPAC! Support your patients and yourself.
 

Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Dr. Coldiron is the chair of SkinPAC for 2019-2021; this is an unpaid volunteer position. Write to him at [email protected].

Payment policy for physicians is now set at the federal level. The Centers for Medicare and Medicaid Services generates a yearly final rule and a fee schedule, and all the Medicare carriers, AND the Medicare Advantage plans AND the private insurers use the rule and fee schedule as a payment guide.

mathisworks

Sometimes these rules can be at odds with best practices for dermatology patients. That is why lobbying is so critically important for us and for our patients. Lobbying provides access to legislators and enables us to educate them about the impact of proposed changes in coverage.

Each year, SkinPAC contributes up to $5,000 a year to individual congressional races. The extent of contributions is based on an impartial scorecard that ranks congressional members by leadership position as well as the member’s understanding and history of support on our critical issues. I want to emphasize that the personal political leanings of the SkinPAC board members have no bearing on the level of support. We contribute to campaigns based on the congressional members’ positions on our issues, period. Full disclosure: I am the chair of SkinPAC for 2019-2021. This is an unpaid volunteer position.

To dermatologists who question the effectiveness of lobbying, I can attest that I have seen your political action committee contributions in action.

When Congress planned on tightening the Stark exceptions 5 years ago, our Washington office was able to gain access to key legislators. As a result of our good long-term relationships with these congress members and their staff, our lobbying group was able to explain the importance for dermatologists to be able to read their own slides and the value of global periods. Imagine the disasters of being unable to read our own dermatopathology slides, not performing diagnostic frozen sections before Mohs, and charging patients for suture removals. Lobbying efforts averted those potential catastrophes.

Unfortunately, the same issues are coming back. In the most recent Federal Register proposals, CMS again wanted to eliminate global periods and modifier 25, which allows you to bill for a procedure on the same day as an evaluation and management code. This action has been delayed for 2 years but will come back up for consideration next year.

Global periods are follow-up visits that are embedded in the destruction, excision, and repair codes that you currently use. For example, $42 of the $72 you get for destroying a premalignant lesion or a wart is a prepayment for the follow-up visit. Sure, if the global period is eliminated, you can bill the patient for the follow-up visit, but imagine the difficulty of collecting additional copays and deductibles. And imagine the impact of those additional costs on our patients.

This brings me to your 100,000 reasons to contribute to your PAC. In Medicare alone, elimination of global periods and modifier 25 will shift $1.4 billion dollars per year away from dermatology. Assuming you will be able to recoup some payment from follow-up visits and by rescheduling some procedures, you are still looking at $1 billion or so, per year, cut from about 10,000 dermatologists with the expense shifted to patients. That’s a $100,000 loss per dermatologist per year and a $1 billion per year additional responsibility for Medicare insureds.

Yes, this will require a legislative fix. And unless it is fixed, the results will be viewed as price gouging by patients with disastrous implications for the physician-patient relationship. Imagine what your patient will say when you charge them to remove their sutures.

Your SkinPAC contribution should be viewed as a disaster insurance policy, just like any other insurance you buy. It covers the very real possibility of not a hurricane or a tornado, but a catastrophic blunder that will put you out of business as surely as any natural disaster. Support your SkinPAC! Support your patients and yourself.
 

Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Dr. Coldiron is the chair of SkinPAC for 2019-2021; this is an unpaid volunteer position. Write to him at [email protected].

SAN FRANCISCO – Rheumatologists take note: Women with systemic lupus erythematosus (SLE) are at increased risk of falling behind in their screening for cervical cancer, Ann Igoe, MD, said at an international congress on systemic lupus erythematosus.

Bruce Jancin/MDedge News

Why is this of relevance to rheumatologists?

“The rheumatologist is probably the main physician that lupus patients see. They may see their rheumatologist every couple of months. The question is, how often do rheumatologists say, ‘Hey, you need your Pap smear!’ I don’t think many of them address it,” said Dr. Igoe, a rheumatology fellow at Case Western Reserve University in Cleveland.

She presented a retrospective, cross-sectional, single-center study utilizing the EHRs of 604 women with SLE and 3,337 female controls who had asthma but not SLE. Sixty percent of the SLE patients were overdue for a Pap smear, compared with 51% of controls.

“We also looked at race,” Dr. Igoe said in an interview. “We were able to show that, at our institution, racial disparities do exist, that the black lupus patients had a much higher rate of HPV [human papillomavirus] positivity, compared to the white lupus patients, and they also were more behind on their Pap screening.”

Indeed, 56% of the black lupus patients were overdue for a Pap test, compared with 43% of the white SLE patients, and 46% of black women without SLE. Among the subgroup composed of black HPV-positive SLE patients, the overdue status rate soared to 70%, versus 30% in white HPV-positive SLE patients.

Dr. Igoe noted that in October 2018, the Food and Drug Administration approved an expanded indication for the quadrivalent HPV vaccine known as Gardasil 9 for women through 45 years of age. The prior upper age limit was age 26. This is an especially important development for unvaccinated women with SLE. Women with SLE have been shown to have higher rates of cervical neoplasia than in the general population, and being on potent immunosuppressive agents such as mycophenolate mofetil, azathioprine, and methotrexate further boosts that risk.

“We and others have shown that women with lupus who receive the vaccine mount a good response. So regardless of whether you’ve had HPV in the past, that doesn’t preclude you from getting the vaccine,” she noted.

The Advisory Committee on Immunization Practices and Centers for Disease Control and Prevention have yet to adopt the expanded age limit recommendation. That needs to happen, Dr. Igoe stressed.

“I’d like to see this study as a little stepping stone towards having women get their Pap screen addressed and making the Gardasil vaccine available to women who are not vaccinated,” she said.

She reported having no financial conflicts regarding her study, conducted free of commercial support.

[email protected]

SAN FRANCISCO – Rheumatologists take note: Women with systemic lupus erythematosus (SLE) are at increased risk of falling behind in their screening for cervical cancer, Ann Igoe, MD, said at an international congress on systemic lupus erythematosus.

Bruce Jancin/MDedge News

Why is this of relevance to rheumatologists?

“The rheumatologist is probably the main physician that lupus patients see. They may see their rheumatologist every couple of months. The question is, how often do rheumatologists say, ‘Hey, you need your Pap smear!’ I don’t think many of them address it,” said Dr. Igoe, a rheumatology fellow at Case Western Reserve University in Cleveland.

She presented a retrospective, cross-sectional, single-center study utilizing the EHRs of 604 women with SLE and 3,337 female controls who had asthma but not SLE. Sixty percent of the SLE patients were overdue for a Pap smear, compared with 51% of controls.

“We also looked at race,” Dr. Igoe said in an interview. “We were able to show that, at our institution, racial disparities do exist, that the black lupus patients had a much higher rate of HPV [human papillomavirus] positivity, compared to the white lupus patients, and they also were more behind on their Pap screening.”

Indeed, 56% of the black lupus patients were overdue for a Pap test, compared with 43% of the white SLE patients, and 46% of black women without SLE. Among the subgroup composed of black HPV-positive SLE patients, the overdue status rate soared to 70%, versus 30% in white HPV-positive SLE patients.

Dr. Igoe noted that in October 2018, the Food and Drug Administration approved an expanded indication for the quadrivalent HPV vaccine known as Gardasil 9 for women through 45 years of age. The prior upper age limit was age 26. This is an especially important development for unvaccinated women with SLE. Women with SLE have been shown to have higher rates of cervical neoplasia than in the general population, and being on potent immunosuppressive agents such as mycophenolate mofetil, azathioprine, and methotrexate further boosts that risk.

“We and others have shown that women with lupus who receive the vaccine mount a good response. So regardless of whether you’ve had HPV in the past, that doesn’t preclude you from getting the vaccine,” she noted.

The Advisory Committee on Immunization Practices and Centers for Disease Control and Prevention have yet to adopt the expanded age limit recommendation. That needs to happen, Dr. Igoe stressed.

“I’d like to see this study as a little stepping stone towards having women get their Pap screen addressed and making the Gardasil vaccine available to women who are not vaccinated,” she said.

She reported having no financial conflicts regarding her study, conducted free of commercial support.

[email protected]

SAN FRANCISCO – Rheumatologists take note: Women with systemic lupus erythematosus (SLE) are at increased risk of falling behind in their screening for cervical cancer, Ann Igoe, MD, said at an international congress on systemic lupus erythematosus.

Bruce Jancin/MDedge News

Why is this of relevance to rheumatologists?

“The rheumatologist is probably the main physician that lupus patients see. They may see their rheumatologist every couple of months. The question is, how often do rheumatologists say, ‘Hey, you need your Pap smear!’ I don’t think many of them address it,” said Dr. Igoe, a rheumatology fellow at Case Western Reserve University in Cleveland.

She presented a retrospective, cross-sectional, single-center study utilizing the EHRs of 604 women with SLE and 3,337 female controls who had asthma but not SLE. Sixty percent of the SLE patients were overdue for a Pap smear, compared with 51% of controls.

“We also looked at race,” Dr. Igoe said in an interview. “We were able to show that, at our institution, racial disparities do exist, that the black lupus patients had a much higher rate of HPV [human papillomavirus] positivity, compared to the white lupus patients, and they also were more behind on their Pap screening.”

Indeed, 56% of the black lupus patients were overdue for a Pap test, compared with 43% of the white SLE patients, and 46% of black women without SLE. Among the subgroup composed of black HPV-positive SLE patients, the overdue status rate soared to 70%, versus 30% in white HPV-positive SLE patients.

Dr. Igoe noted that in October 2018, the Food and Drug Administration approved an expanded indication for the quadrivalent HPV vaccine known as Gardasil 9 for women through 45 years of age. The prior upper age limit was age 26. This is an especially important development for unvaccinated women with SLE. Women with SLE have been shown to have higher rates of cervical neoplasia than in the general population, and being on potent immunosuppressive agents such as mycophenolate mofetil, azathioprine, and methotrexate further boosts that risk.

“We and others have shown that women with lupus who receive the vaccine mount a good response. So regardless of whether you’ve had HPV in the past, that doesn’t preclude you from getting the vaccine,” she noted.

The Advisory Committee on Immunization Practices and Centers for Disease Control and Prevention have yet to adopt the expanded age limit recommendation. That needs to happen, Dr. Igoe stressed.

“I’d like to see this study as a little stepping stone towards having women get their Pap screen addressed and making the Gardasil vaccine available to women who are not vaccinated,” she said.

She reported having no financial conflicts regarding her study, conducted free of commercial support.

[email protected]

SAN FRANCISCO – SGLT2 inhibitors did a better job than GLP-1 receptor agonists at preventing heart failure hospitalizations in elderly patients with type 2 diabetes, but at the cost of more strokes, myocardial infarctions, and deaths among those without preexisting cardiovascular disease, according to Harvard University investigators.

Using Medicare claims data and propensity scoring, they matched 43,609 elderly patients who started a sodium-glucose cotransporter 2 (SGLT2) inhibitor for type 2 diabetes, 77% of whom were taking canagliflozin (Invokana), to 43,609 who started a glucagonlike peptide–1 (GLP-1)–receptor agonist, 60% of whom were taking liraglutide (Victoza).

Patients were paired by age, comorbidities, diabetes severity, and dozens of other variables, more than 120 in all. The data window ran from April 2013 through December 2016.

The idea was to compare the drugs directly in order to help clinicians decide which class to choose for older patients as second-line therapy, an important consideration at a time when there’s not much guidance specifically for the elderly, and manufacturers are issuing dueling placebo-controlled trials.

Both classes have shown cardiovascular benefits, but studies were mostly in younger people with preexisting cardiovascular disease (CVD). “The comparative impact of these agents in the older population has not yet been established,” lead investigator Elisabetta Patorno, MD, DrPH, of Harvard University, Boston, said at the annual scientific sessions of the American Diabetes Association.

General themes are emerging from Dr. Patorno’s work; it seems that deciding between the two classes has a lot to do with whether the main concern is heart failure or cardiovascular events. Even so, she said, it’s too early to incorporate the observations into guidelines. The analysis is ongoing, and there are plans to compare impacts on renal disease and other problems.

In the meantime, she and her colleagues found that initiating an SGLT2 inhibitor versus a GLP-1 receptor agonist in the elderly was associated with a 34% decreased risk of heart failure hospitalization (2.5 fewer hospitalizations per 1,000 patient years), with an even larger drop among people who had preexisting CVD.

There was, however, a 41% increased risk of lower limb amputations (0.8 more events per 1,000 patient years) and a 62% increase in diabetic ketoacidosis (DKA, 1 more event), problems previously associated with the class.

Results were comparable – fewer heart failure hospitalizations but more amputations and DKA – when SGLT2 initiation was compared to initiation with dipeptidyl peptidase-4 (DPP-4) inhibitors, another second-line option for type 2 diabetes that includes sitagliptin (Januvia), among others.

There was a 25% increased relative risk of the composite primary outcome of myocardial infarction, stroke, and all-cause mortality when patients without baseline CVD were started on an SGLT2 inhibitor instead of a GLP-1 receptor agonist (3.7 more events per 1,000 patient years). There was no increased risk among patients who already had CVD.

SGLT2 initiation actually had a protective effect, compared with dipeptidyl peptidase-4 inhibitors, with a 23% decreased risk of the composite outcome (6.5 fewer events) among patients both with and without baseline CVD. The findings were all statistically significant.

The average age in the study was 71.5 years; 45% of the subjects were men; 40% had a history of cardiovascular disease; and 60% were on metformin and 24% on insulin at study entry.

The work was funded by the National Institutes of Health. Dr. Patorno disclosed research grants form Boehringer Ingelheim and GlaxoSmithKline. Other investigators reported relationships with numerous pharmaceutical companies.

[email protected]

SAN FRANCISCO – SGLT2 inhibitors did a better job than GLP-1 receptor agonists at preventing heart failure hospitalizations in elderly patients with type 2 diabetes, but at the cost of more strokes, myocardial infarctions, and deaths among those without preexisting cardiovascular disease, according to Harvard University investigators.

Using Medicare claims data and propensity scoring, they matched 43,609 elderly patients who started a sodium-glucose cotransporter 2 (SGLT2) inhibitor for type 2 diabetes, 77% of whom were taking canagliflozin (Invokana), to 43,609 who started a glucagonlike peptide–1 (GLP-1)–receptor agonist, 60% of whom were taking liraglutide (Victoza).

Patients were paired by age, comorbidities, diabetes severity, and dozens of other variables, more than 120 in all. The data window ran from April 2013 through December 2016.

The idea was to compare the drugs directly in order to help clinicians decide which class to choose for older patients as second-line therapy, an important consideration at a time when there’s not much guidance specifically for the elderly, and manufacturers are issuing dueling placebo-controlled trials.

Both classes have shown cardiovascular benefits, but studies were mostly in younger people with preexisting cardiovascular disease (CVD). “The comparative impact of these agents in the older population has not yet been established,” lead investigator Elisabetta Patorno, MD, DrPH, of Harvard University, Boston, said at the annual scientific sessions of the American Diabetes Association.

General themes are emerging from Dr. Patorno’s work; it seems that deciding between the two classes has a lot to do with whether the main concern is heart failure or cardiovascular events. Even so, she said, it’s too early to incorporate the observations into guidelines. The analysis is ongoing, and there are plans to compare impacts on renal disease and other problems.

In the meantime, she and her colleagues found that initiating an SGLT2 inhibitor versus a GLP-1 receptor agonist in the elderly was associated with a 34% decreased risk of heart failure hospitalization (2.5 fewer hospitalizations per 1,000 patient years), with an even larger drop among people who had preexisting CVD.

There was, however, a 41% increased risk of lower limb amputations (0.8 more events per 1,000 patient years) and a 62% increase in diabetic ketoacidosis (DKA, 1 more event), problems previously associated with the class.

Results were comparable – fewer heart failure hospitalizations but more amputations and DKA – when SGLT2 initiation was compared to initiation with dipeptidyl peptidase-4 (DPP-4) inhibitors, another second-line option for type 2 diabetes that includes sitagliptin (Januvia), among others.

There was a 25% increased relative risk of the composite primary outcome of myocardial infarction, stroke, and all-cause mortality when patients without baseline CVD were started on an SGLT2 inhibitor instead of a GLP-1 receptor agonist (3.7 more events per 1,000 patient years). There was no increased risk among patients who already had CVD.

SGLT2 initiation actually had a protective effect, compared with dipeptidyl peptidase-4 inhibitors, with a 23% decreased risk of the composite outcome (6.5 fewer events) among patients both with and without baseline CVD. The findings were all statistically significant.

The average age in the study was 71.5 years; 45% of the subjects were men; 40% had a history of cardiovascular disease; and 60% were on metformin and 24% on insulin at study entry.

The work was funded by the National Institutes of Health. Dr. Patorno disclosed research grants form Boehringer Ingelheim and GlaxoSmithKline. Other investigators reported relationships with numerous pharmaceutical companies.

[email protected]

SAN FRANCISCO – SGLT2 inhibitors did a better job than GLP-1 receptor agonists at preventing heart failure hospitalizations in elderly patients with type 2 diabetes, but at the cost of more strokes, myocardial infarctions, and deaths among those without preexisting cardiovascular disease, according to Harvard University investigators.

Using Medicare claims data and propensity scoring, they matched 43,609 elderly patients who started a sodium-glucose cotransporter 2 (SGLT2) inhibitor for type 2 diabetes, 77% of whom were taking canagliflozin (Invokana), to 43,609 who started a glucagonlike peptide–1 (GLP-1)–receptor agonist, 60% of whom were taking liraglutide (Victoza).

Patients were paired by age, comorbidities, diabetes severity, and dozens of other variables, more than 120 in all. The data window ran from April 2013 through December 2016.

The idea was to compare the drugs directly in order to help clinicians decide which class to choose for older patients as second-line therapy, an important consideration at a time when there’s not much guidance specifically for the elderly, and manufacturers are issuing dueling placebo-controlled trials.

Both classes have shown cardiovascular benefits, but studies were mostly in younger people with preexisting cardiovascular disease (CVD). “The comparative impact of these agents in the older population has not yet been established,” lead investigator Elisabetta Patorno, MD, DrPH, of Harvard University, Boston, said at the annual scientific sessions of the American Diabetes Association.

General themes are emerging from Dr. Patorno’s work; it seems that deciding between the two classes has a lot to do with whether the main concern is heart failure or cardiovascular events. Even so, she said, it’s too early to incorporate the observations into guidelines. The analysis is ongoing, and there are plans to compare impacts on renal disease and other problems.

In the meantime, she and her colleagues found that initiating an SGLT2 inhibitor versus a GLP-1 receptor agonist in the elderly was associated with a 34% decreased risk of heart failure hospitalization (2.5 fewer hospitalizations per 1,000 patient years), with an even larger drop among people who had preexisting CVD.

There was, however, a 41% increased risk of lower limb amputations (0.8 more events per 1,000 patient years) and a 62% increase in diabetic ketoacidosis (DKA, 1 more event), problems previously associated with the class.

Results were comparable – fewer heart failure hospitalizations but more amputations and DKA – when SGLT2 initiation was compared to initiation with dipeptidyl peptidase-4 (DPP-4) inhibitors, another second-line option for type 2 diabetes that includes sitagliptin (Januvia), among others.

There was a 25% increased relative risk of the composite primary outcome of myocardial infarction, stroke, and all-cause mortality when patients without baseline CVD were started on an SGLT2 inhibitor instead of a GLP-1 receptor agonist (3.7 more events per 1,000 patient years). There was no increased risk among patients who already had CVD.

SGLT2 initiation actually had a protective effect, compared with dipeptidyl peptidase-4 inhibitors, with a 23% decreased risk of the composite outcome (6.5 fewer events) among patients both with and without baseline CVD. The findings were all statistically significant.

The average age in the study was 71.5 years; 45% of the subjects were men; 40% had a history of cardiovascular disease; and 60% were on metformin and 24% on insulin at study entry.

The work was funded by the National Institutes of Health. Dr. Patorno disclosed research grants form Boehringer Ingelheim and GlaxoSmithKline. Other investigators reported relationships with numerous pharmaceutical companies.

[email protected]