Endo 2015

SAN DIEGO – As prescriptions for less-regulated, custom-compounded menopausal hormones approach the number of prescriptions for FDA-approved hormones, Dr. JoAnn Pinkerton says that clinicians should educate patients on the differences between the hormones.

In an interview at the meeting of the Endocrine Society, Dr. Pinkerton, professor of obstetrics and gynecology at the University of Virginia Health System, Charlottesville, framed her remarks in light of findings from a recent survey of 483 pharmacists, which found that an estimated 26-33 million prescriptions for compounded, non–FDA-approved menopausal therapies are filled in the United States each year.

Dr. Pinkerton disclosed that she has received grants and research support (paid to the University of Virginia) from Pfizer, Inc., TherapeuticsMD, Noven, Shionogi, and TXMD.

SAN DIEGO – As prescriptions for less-regulated, custom-compounded menopausal hormones approach the number of prescriptions for FDA-approved hormones, Dr. JoAnn Pinkerton says that clinicians should educate patients on the differences between the hormones.

In an interview at the meeting of the Endocrine Society, Dr. Pinkerton, professor of obstetrics and gynecology at the University of Virginia Health System, Charlottesville, framed her remarks in light of findings from a recent survey of 483 pharmacists, which found that an estimated 26-33 million prescriptions for compounded, non–FDA-approved menopausal therapies are filled in the United States each year.

Dr. Pinkerton disclosed that she has received grants and research support (paid to the University of Virginia) from Pfizer, Inc., TherapeuticsMD, Noven, Shionogi, and TXMD.

SAN DIEGO – As prescriptions for less-regulated, custom-compounded menopausal hormones approach the number of prescriptions for FDA-approved hormones, Dr. JoAnn Pinkerton says that clinicians should educate patients on the differences between the hormones.

In an interview at the meeting of the Endocrine Society, Dr. Pinkerton, professor of obstetrics and gynecology at the University of Virginia Health System, Charlottesville, framed her remarks in light of findings from a recent survey of 483 pharmacists, which found that an estimated 26-33 million prescriptions for compounded, non–FDA-approved menopausal therapies are filled in the United States each year.

Dr. Pinkerton disclosed that she has received grants and research support (paid to the University of Virginia) from Pfizer, Inc., TherapeuticsMD, Noven, Shionogi, and TXMD.

SAN DIEGO – As prescriptions for less-regulated, custom-compounded menopausal hormones approach the number of prescriptions for FDA-approved hormones, Dr. JoAnn Pinkerton says that clinicians should educate patients on the differences between the hormones.

In an interview at the meeting of the Endocrine Society, Dr. Pinkerton, professor of obstetrics and gynecology at the University of Virginia Health System, Charlottesville, framed her remarks in light of findings from a recent survey of 483 pharmacists, which found that an estimated 26-33 million prescriptions for compounded, non–FDA-approved menopausal therapies are filled in the United States each year.

Dr. Pinkerton disclosed that she has received grants and research support (paid to the University of Virginia) from Pfizer, Inc., TherapeuticsMD, Noven, Shionogi, and TXMD.

dbrunk@frontlinemedcom.com

On Twitter @dougbrunk

SAN DIEGO – As prescriptions for less-regulated, custom-compounded menopausal hormones approach the number of prescriptions for FDA-approved hormones, Dr. JoAnn Pinkerton says that clinicians should educate patients on the differences between the hormones.

In an interview at the meeting of the Endocrine Society, Dr. Pinkerton, professor of obstetrics and gynecology at the University of Virginia Health System, Charlottesville, framed her remarks in light of findings from a recent survey of 483 pharmacists, which found that an estimated 26-33 million prescriptions for compounded, non–FDA-approved menopausal therapies are filled in the United States each year.

Dr. Pinkerton disclosed that she has received grants and research support (paid to the University of Virginia) from Pfizer, Inc., TherapeuticsMD, Noven, Shionogi, and TXMD.

dbrunk@frontlinemedcom.com

On Twitter @dougbrunk

SAN DIEGO – As prescriptions for less-regulated, custom-compounded menopausal hormones approach the number of prescriptions for FDA-approved hormones, Dr. JoAnn Pinkerton says that clinicians should educate patients on the differences between the hormones.

In an interview at the meeting of the Endocrine Society, Dr. Pinkerton, professor of obstetrics and gynecology at the University of Virginia Health System, Charlottesville, framed her remarks in light of findings from a recent survey of 483 pharmacists, which found that an estimated 26-33 million prescriptions for compounded, non–FDA-approved menopausal therapies are filled in the United States each year.

Dr. Pinkerton disclosed that she has received grants and research support (paid to the University of Virginia) from Pfizer, Inc., TherapeuticsMD, Noven, Shionogi, and TXMD.

dbrunk@frontlinemedcom.com

On Twitter @dougbrunk

SAN DIEGO – Breast cancer survivors face an increased risk of thyroid cancer, especially within 5 years of their breast cancer diagnosis, according to results from large retrospective analysis.

“The results of this study prompt a greater awareness of the increased risk for thyroid cancer among breast cancer survivors,” Dr. Jennifer H. Kuo said during a press briefing at the meeting of the Endocrine Society.

Doug Brunk/Frontline Medical News

Although the incidence of breast cancer has been stable in the last 2 decades, “it’s still a leading cause of cancer; it affects one in eight women in this country at some time in their lives,” said Dr. Kuo of the division of GI/endocrine surgery at Columbia University, New York. “With advancements for the treatment of breast cancer, however, survival after breast cancer has greatly improved, now reaching almost 90% at 5 years. What this means is the number of breast cancer survivors in this country is now increasing. These survivors have an 18%-30% risk of developing a second cancer. Most of these second cancers are hormonally mediated, such as ovarian and uterine cancers, but there are some studies that indicate thyroid cancer is also increased.”

To date, she said, the relationship between breast and thyroid cancer has been largely based on findings from single-center studies, which have suggested a possible increase in thyroid cancer incidence after breast cancer. To further explore this relationship, Dr. Kuo and her associates evaluated the National Cancer Institute’s Surveillance, Epidemiology, and End Results 9 (SEER 9) program to identify individuals diagnosed with breast cancer and/or thyroid cancer between 1973 and 2011. In all, they identified 704,402 patients with breast cancer only, 49,663 with thyroid cancer only, and 1,526 patients who developed thyroid cancer after breast cancer.

The 10-year risk of thyroid cancer in breast cancer survivors, compared with the general population, was highest among those aged 40 years and 50 years (16% and 12%, vs. 0.33% and 0.35%, respectively), and lowest among those 60 years and 70 years old (0.05% and 0.02% vs. 0.33% and 0.27%). Breast cancer survivors developed thyroid cancer a median of 5 years after their primary diagnosis.

Breast cancer survivors who developed thyroid cancer were younger compared with patients who had breast cancer only (a mean of 54 years vs. 61 years, respectively; P less than .001), had smaller breast cancers (a mean of 15 mm vs. 18 mm; P less than .001), a greater percentage of invasive ductal carcinoma (7.6% vs. 5.5%; P = .002), and were more likely to receive adjuvant radiation therapy (48% vs. 44%; P = .009). “This is probably reflective of the surgical treatment that these patients receive,” Dr. Kuo said.

No differences between the two cohorts were noted in terms of estrogen receptor/progesterone receptor positivity or lymph node involvement.

Because breast cancer doesn’t generally develop in younger women, breast cancer survivors in the SEER 9 database who then developed a subsequent thyroid cancer were older, compared with patients who had thyroid cancer only (a mean of 62 vs. 45 years, respectively; P less than .001). In addition, compared with patients who had thyroid cancer only, breast cancer survivors who developed thyroid cancer had smaller thyroid tumors (11 mm vs. 13 mm; P = .004) and less radioactive iodine positivity (46% vs. 37%; P less than .001). They also had a greater percentage of tall cell variant papillary thyroid cancer (.9% vs. .5%; P = .036), oxyphilic variant follicular thyroid cancer (4.3% vs. 2.6%; P less than .001), and anaplastic cancer 1.5% vs. 0.8%; P = .001).

Dr. Kuo plans to investigate if tamoxifen treatment plays a role in increasing the risk of thyroid cancer in breast cancer survivors. She reported having no relevant financial conflicts.

dbrunk@frontlinemedcom.com

On Twitter @dougbrunk

SAN DIEGO – Breast cancer survivors face an increased risk of thyroid cancer, especially within 5 years of their breast cancer diagnosis, according to results from large retrospective analysis.

“The results of this study prompt a greater awareness of the increased risk for thyroid cancer among breast cancer survivors,” Dr. Jennifer H. Kuo said during a press briefing at the meeting of the Endocrine Society.

Doug Brunk/Frontline Medical News

Although the incidence of breast cancer has been stable in the last 2 decades, “it’s still a leading cause of cancer; it affects one in eight women in this country at some time in their lives,” said Dr. Kuo of the division of GI/endocrine surgery at Columbia University, New York. “With advancements for the treatment of breast cancer, however, survival after breast cancer has greatly improved, now reaching almost 90% at 5 years. What this means is the number of breast cancer survivors in this country is now increasing. These survivors have an 18%-30% risk of developing a second cancer. Most of these second cancers are hormonally mediated, such as ovarian and uterine cancers, but there are some studies that indicate thyroid cancer is also increased.”

To date, she said, the relationship between breast and thyroid cancer has been largely based on findings from single-center studies, which have suggested a possible increase in thyroid cancer incidence after breast cancer. To further explore this relationship, Dr. Kuo and her associates evaluated the National Cancer Institute’s Surveillance, Epidemiology, and End Results 9 (SEER 9) program to identify individuals diagnosed with breast cancer and/or thyroid cancer between 1973 and 2011. In all, they identified 704,402 patients with breast cancer only, 49,663 with thyroid cancer only, and 1,526 patients who developed thyroid cancer after breast cancer.

The 10-year risk of thyroid cancer in breast cancer survivors, compared with the general population, was highest among those aged 40 years and 50 years (16% and 12%, vs. 0.33% and 0.35%, respectively), and lowest among those 60 years and 70 years old (0.05% and 0.02% vs. 0.33% and 0.27%). Breast cancer survivors developed thyroid cancer a median of 5 years after their primary diagnosis.

Breast cancer survivors who developed thyroid cancer were younger compared with patients who had breast cancer only (a mean of 54 years vs. 61 years, respectively; P less than .001), had smaller breast cancers (a mean of 15 mm vs. 18 mm; P less than .001), a greater percentage of invasive ductal carcinoma (7.6% vs. 5.5%; P = .002), and were more likely to receive adjuvant radiation therapy (48% vs. 44%; P = .009). “This is probably reflective of the surgical treatment that these patients receive,” Dr. Kuo said.

No differences between the two cohorts were noted in terms of estrogen receptor/progesterone receptor positivity or lymph node involvement.

Because breast cancer doesn’t generally develop in younger women, breast cancer survivors in the SEER 9 database who then developed a subsequent thyroid cancer were older, compared with patients who had thyroid cancer only (a mean of 62 vs. 45 years, respectively; P less than .001). In addition, compared with patients who had thyroid cancer only, breast cancer survivors who developed thyroid cancer had smaller thyroid tumors (11 mm vs. 13 mm; P = .004) and less radioactive iodine positivity (46% vs. 37%; P less than .001). They also had a greater percentage of tall cell variant papillary thyroid cancer (.9% vs. .5%; P = .036), oxyphilic variant follicular thyroid cancer (4.3% vs. 2.6%; P less than .001), and anaplastic cancer 1.5% vs. 0.8%; P = .001).

Dr. Kuo plans to investigate if tamoxifen treatment plays a role in increasing the risk of thyroid cancer in breast cancer survivors. She reported having no relevant financial conflicts.

dbrunk@frontlinemedcom.com

On Twitter @dougbrunk

SAN DIEGO – Breast cancer survivors face an increased risk of thyroid cancer, especially within 5 years of their breast cancer diagnosis, according to results from large retrospective analysis.

“The results of this study prompt a greater awareness of the increased risk for thyroid cancer among breast cancer survivors,” Dr. Jennifer H. Kuo said during a press briefing at the meeting of the Endocrine Society.

Doug Brunk/Frontline Medical News

Although the incidence of breast cancer has been stable in the last 2 decades, “it’s still a leading cause of cancer; it affects one in eight women in this country at some time in their lives,” said Dr. Kuo of the division of GI/endocrine surgery at Columbia University, New York. “With advancements for the treatment of breast cancer, however, survival after breast cancer has greatly improved, now reaching almost 90% at 5 years. What this means is the number of breast cancer survivors in this country is now increasing. These survivors have an 18%-30% risk of developing a second cancer. Most of these second cancers are hormonally mediated, such as ovarian and uterine cancers, but there are some studies that indicate thyroid cancer is also increased.”

To date, she said, the relationship between breast and thyroid cancer has been largely based on findings from single-center studies, which have suggested a possible increase in thyroid cancer incidence after breast cancer. To further explore this relationship, Dr. Kuo and her associates evaluated the National Cancer Institute’s Surveillance, Epidemiology, and End Results 9 (SEER 9) program to identify individuals diagnosed with breast cancer and/or thyroid cancer between 1973 and 2011. In all, they identified 704,402 patients with breast cancer only, 49,663 with thyroid cancer only, and 1,526 patients who developed thyroid cancer after breast cancer.

The 10-year risk of thyroid cancer in breast cancer survivors, compared with the general population, was highest among those aged 40 years and 50 years (16% and 12%, vs. 0.33% and 0.35%, respectively), and lowest among those 60 years and 70 years old (0.05% and 0.02% vs. 0.33% and 0.27%). Breast cancer survivors developed thyroid cancer a median of 5 years after their primary diagnosis.

Breast cancer survivors who developed thyroid cancer were younger compared with patients who had breast cancer only (a mean of 54 years vs. 61 years, respectively; P less than .001), had smaller breast cancers (a mean of 15 mm vs. 18 mm; P less than .001), a greater percentage of invasive ductal carcinoma (7.6% vs. 5.5%; P = .002), and were more likely to receive adjuvant radiation therapy (48% vs. 44%; P = .009). “This is probably reflective of the surgical treatment that these patients receive,” Dr. Kuo said.

No differences between the two cohorts were noted in terms of estrogen receptor/progesterone receptor positivity or lymph node involvement.

Because breast cancer doesn’t generally develop in younger women, breast cancer survivors in the SEER 9 database who then developed a subsequent thyroid cancer were older, compared with patients who had thyroid cancer only (a mean of 62 vs. 45 years, respectively; P less than .001). In addition, compared with patients who had thyroid cancer only, breast cancer survivors who developed thyroid cancer had smaller thyroid tumors (11 mm vs. 13 mm; P = .004) and less radioactive iodine positivity (46% vs. 37%; P less than .001). They also had a greater percentage of tall cell variant papillary thyroid cancer (.9% vs. .5%; P = .036), oxyphilic variant follicular thyroid cancer (4.3% vs. 2.6%; P less than .001), and anaplastic cancer 1.5% vs. 0.8%; P = .001).

Dr. Kuo plans to investigate if tamoxifen treatment plays a role in increasing the risk of thyroid cancer in breast cancer survivors. She reported having no relevant financial conflicts.

dbrunk@frontlinemedcom.com

On Twitter @dougbrunk

SAN DIEGO – Conception is more likely if obese women lose weight and make other healthy lifestyle changes. What hasn’t been known until now is that the same holds true for their male partners, according to a prospective trial from the University of Sherbrooke, Quebec.

Forty-nine overweight women who were having a hard time conceiving worked with nutritionists, kinesiologists, and counselors there to improve their chances. When the investigators invited partners to join them, 25 men accepted the offer.

The men tended to be overweight and sedentary, too, compared with Canadian averages, and the program didn’t do much to change that. Even so, after about 1.5 years follow-up, couples were 33% more likely to conceive for each 1% of weight the men lost (odds ratio, 1.33; 95% confidence interval, 1.05-1.83, P = .013), with similar benefits for cutting back on soda, eating more fruits and vegetables, and other healthy diet changes.

Senior investigator Dr. Jean-Patrice Baillargeon, a professor of medicine at Sherbrooke, explained
the implications of those findings in an interview at the Endocrine Society's annual meeting.

aotto@frontlinemedcom.com

SAN DIEGO – Conception is more likely if obese women lose weight and make other healthy lifestyle changes. What hasn’t been known until now is that the same holds true for their male partners, according to a prospective trial from the University of Sherbrooke, Quebec.

Forty-nine overweight women who were having a hard time conceiving worked with nutritionists, kinesiologists, and counselors there to improve their chances. When the investigators invited partners to join them, 25 men accepted the offer.

The men tended to be overweight and sedentary, too, compared with Canadian averages, and the program didn’t do much to change that. Even so, after about 1.5 years follow-up, couples were 33% more likely to conceive for each 1% of weight the men lost (odds ratio, 1.33; 95% confidence interval, 1.05-1.83, P = .013), with similar benefits for cutting back on soda, eating more fruits and vegetables, and other healthy diet changes.

Senior investigator Dr. Jean-Patrice Baillargeon, a professor of medicine at Sherbrooke, explained
the implications of those findings in an interview at the Endocrine Society's annual meeting.

aotto@frontlinemedcom.com

SAN DIEGO – Conception is more likely if obese women lose weight and make other healthy lifestyle changes. What hasn’t been known until now is that the same holds true for their male partners, according to a prospective trial from the University of Sherbrooke, Quebec.

Forty-nine overweight women who were having a hard time conceiving worked with nutritionists, kinesiologists, and counselors there to improve their chances. When the investigators invited partners to join them, 25 men accepted the offer.

The men tended to be overweight and sedentary, too, compared with Canadian averages, and the program didn’t do much to change that. Even so, after about 1.5 years follow-up, couples were 33% more likely to conceive for each 1% of weight the men lost (odds ratio, 1.33; 95% confidence interval, 1.05-1.83, P = .013), with similar benefits for cutting back on soda, eating more fruits and vegetables, and other healthy diet changes.

Senior investigator Dr. Jean-Patrice Baillargeon, a professor of medicine at Sherbrooke, explained
the implications of those findings in an interview at the Endocrine Society's annual meeting.

aotto@frontlinemedcom.com

San Diego – Preemptive levothyroxine seems to help prevent hypothyroidism after radioactive iodine treatment for Graves’ disease, according to an interim analysis of an ongoing randomized, placebo-controlled trial at the Mayo Clinic in Rochester, Minn.

Following iodine treatment, the team is randomizing adult patients to levothyroxine 25 mcg/day or placebo at 4 weeks, then increasing the levothyroxine dose to 50 mcg/day at 6 weeks. The enrollment goal is 60 patients; the team presented results for the first 17 at the Endocrine Society annual meeting.

At 8 weeks, six of 11 (54.5%) levothyroxine patients – but four of the six (66.7%) placebo patients – had overt hypothyroidism.

Hyperthyroidism is the main concern with preemptive levothyroxine, but that hasn’t been a problem so far; in fact, the levothyroxine group has had lower rates of hyperthyroidism (18.2%) than the placebo group (33.3%). Quality of life indicators haven’t separated much; at 8 weeks, thyroid Specific Questionnaire scores were about 12 in both groups, and levothyroxine patients did slightly worse on the hypothyroid–Health Related Quality of Life survey (46 vs. 36).

Given the low numbers, you can’t put too much stock in the findings yet, but the prevention trends are moving in the right direction, said lead investigator Dr. Spyridoula Maraka, a Mayo endocrinology fellow.

“As expected, none of the analyses reached statistical significance given that the sample size is 25% of the planned population,” but “it is reassuring that initiating low-dose levothyroxine 4 weeks after [Graves’ treatment] appears safe, without an increased prevalence of hyperthyroidism. There is an encouraging trend for prevention of overt hypothyroidism .... Accordingly, we plan to continue the trial to completion,” she said.

The work is important because, in many places, the first follow-up visit after Graves’ treatment is at 2 or even 3 months. By then, the majority of patients are hypothyroid, and may even have new or worsened Graves’ orbitopathy. The hope is that pre-emptive levothyroxine will counter the problem.

The fact that more than half of the levothyroxine subjects developed hypothryroidism suggests that “maybe we need a higher dose,” Dr. Maraka said.

If nothing else, the findings argue for earlier follow-up after radioactive iodine treatment, when there’s still a chance of catching nascent hypothyroidism before symptoms set in. “Try to see your patients earlier than week 8.” Six weeks might be a good goal, Dr. Maraka said.

There were no significant baseline differences between the placebo and levothyroxine arms of the study. In both, patients were in their mid-50s, on average, with thyroids of about 30 grams; about two-thirds of patients in both arms were women.

There’s been one adverse event so far; a levothyroxine patient with a history of atrial fibrillation had heart palpitations after quitting her beta-blocker, and dropped out of the study.

Pre-emptive levothyroxine has been studied before, but only retrospectively.

Dr. Maraka has no disclosures, and there was no outside funding for the work.

aotto@frontlinemedcom.com

San Diego – Preemptive levothyroxine seems to help prevent hypothyroidism after radioactive iodine treatment for Graves’ disease, according to an interim analysis of an ongoing randomized, placebo-controlled trial at the Mayo Clinic in Rochester, Minn.

Following iodine treatment, the team is randomizing adult patients to levothyroxine 25 mcg/day or placebo at 4 weeks, then increasing the levothyroxine dose to 50 mcg/day at 6 weeks. The enrollment goal is 60 patients; the team presented results for the first 17 at the Endocrine Society annual meeting.

At 8 weeks, six of 11 (54.5%) levothyroxine patients – but four of the six (66.7%) placebo patients – had overt hypothyroidism.

Hyperthyroidism is the main concern with preemptive levothyroxine, but that hasn’t been a problem so far; in fact, the levothyroxine group has had lower rates of hyperthyroidism (18.2%) than the placebo group (33.3%). Quality of life indicators haven’t separated much; at 8 weeks, thyroid Specific Questionnaire scores were about 12 in both groups, and levothyroxine patients did slightly worse on the hypothyroid–Health Related Quality of Life survey (46 vs. 36).

Given the low numbers, you can’t put too much stock in the findings yet, but the prevention trends are moving in the right direction, said lead investigator Dr. Spyridoula Maraka, a Mayo endocrinology fellow.

“As expected, none of the analyses reached statistical significance given that the sample size is 25% of the planned population,” but “it is reassuring that initiating low-dose levothyroxine 4 weeks after [Graves’ treatment] appears safe, without an increased prevalence of hyperthyroidism. There is an encouraging trend for prevention of overt hypothyroidism .... Accordingly, we plan to continue the trial to completion,” she said.

The work is important because, in many places, the first follow-up visit after Graves’ treatment is at 2 or even 3 months. By then, the majority of patients are hypothyroid, and may even have new or worsened Graves’ orbitopathy. The hope is that pre-emptive levothyroxine will counter the problem.

The fact that more than half of the levothyroxine subjects developed hypothryroidism suggests that “maybe we need a higher dose,” Dr. Maraka said.

If nothing else, the findings argue for earlier follow-up after radioactive iodine treatment, when there’s still a chance of catching nascent hypothyroidism before symptoms set in. “Try to see your patients earlier than week 8.” Six weeks might be a good goal, Dr. Maraka said.

There were no significant baseline differences between the placebo and levothyroxine arms of the study. In both, patients were in their mid-50s, on average, with thyroids of about 30 grams; about two-thirds of patients in both arms were women.

There’s been one adverse event so far; a levothyroxine patient with a history of atrial fibrillation had heart palpitations after quitting her beta-blocker, and dropped out of the study.

Pre-emptive levothyroxine has been studied before, but only retrospectively.

Dr. Maraka has no disclosures, and there was no outside funding for the work.

aotto@frontlinemedcom.com

San Diego – Preemptive levothyroxine seems to help prevent hypothyroidism after radioactive iodine treatment for Graves’ disease, according to an interim analysis of an ongoing randomized, placebo-controlled trial at the Mayo Clinic in Rochester, Minn.

Following iodine treatment, the team is randomizing adult patients to levothyroxine 25 mcg/day or placebo at 4 weeks, then increasing the levothyroxine dose to 50 mcg/day at 6 weeks. The enrollment goal is 60 patients; the team presented results for the first 17 at the Endocrine Society annual meeting.

At 8 weeks, six of 11 (54.5%) levothyroxine patients – but four of the six (66.7%) placebo patients – had overt hypothyroidism.

Hyperthyroidism is the main concern with preemptive levothyroxine, but that hasn’t been a problem so far; in fact, the levothyroxine group has had lower rates of hyperthyroidism (18.2%) than the placebo group (33.3%). Quality of life indicators haven’t separated much; at 8 weeks, thyroid Specific Questionnaire scores were about 12 in both groups, and levothyroxine patients did slightly worse on the hypothyroid–Health Related Quality of Life survey (46 vs. 36).

Given the low numbers, you can’t put too much stock in the findings yet, but the prevention trends are moving in the right direction, said lead investigator Dr. Spyridoula Maraka, a Mayo endocrinology fellow.

“As expected, none of the analyses reached statistical significance given that the sample size is 25% of the planned population,” but “it is reassuring that initiating low-dose levothyroxine 4 weeks after [Graves’ treatment] appears safe, without an increased prevalence of hyperthyroidism. There is an encouraging trend for prevention of overt hypothyroidism .... Accordingly, we plan to continue the trial to completion,” she said.

The work is important because, in many places, the first follow-up visit after Graves’ treatment is at 2 or even 3 months. By then, the majority of patients are hypothyroid, and may even have new or worsened Graves’ orbitopathy. The hope is that pre-emptive levothyroxine will counter the problem.

The fact that more than half of the levothyroxine subjects developed hypothryroidism suggests that “maybe we need a higher dose,” Dr. Maraka said.

If nothing else, the findings argue for earlier follow-up after radioactive iodine treatment, when there’s still a chance of catching nascent hypothyroidism before symptoms set in. “Try to see your patients earlier than week 8.” Six weeks might be a good goal, Dr. Maraka said.

There were no significant baseline differences between the placebo and levothyroxine arms of the study. In both, patients were in their mid-50s, on average, with thyroids of about 30 grams; about two-thirds of patients in both arms were women.

There’s been one adverse event so far; a levothyroxine patient with a history of atrial fibrillation had heart palpitations after quitting her beta-blocker, and dropped out of the study.

Pre-emptive levothyroxine has been studied before, but only retrospectively.

Dr. Maraka has no disclosures, and there was no outside funding for the work.

aotto@frontlinemedcom.com

SAN DIEGO – More than half of adult males referred for borderline testosterone levels have depression or depressive symptoms, judging from results from a single-center study.

“Men diagnosed with depressive symptoms should be referred to a mental health professional for formal evaluation and treatment,” Dr. Michael S. Irwig said during a press briefing at the 2015 annual meeting of the Endocrine Society. “We as clinicians should consider managing common comorbidities in this sample population such as obesity and sedentary lifestyle. For example, there’s practically no risk to getting men to lose weight, which would have a lot of health benefits, but there are potential risks to testosterone therapy. I’ll tell men that if they lose weight, that will increase their body’s production of testosterone.”

In the wake of multi-million dollar pharmaceutical advertising campaigns geared to educate the public about low testosterone, Dr. Irwig and his associates set out to describe the population of men referred for borderline testosterone levels and to assess comorbidities. They hypothesized that men referred for borderline testosterone levels would have higher rates of depression and depressive symptoms than the general population.

“There’s been a dramatic increase in testing for testosterone levels,” said Dr. Irwig, director of the Center for Andrology in the division of endocrinology at George Washington University, Washington. “There are many men who wind up having borderline testosterone levels that are closer to the lower end of the reference range. Nobody really knows what a low testosterone level is; there’s no clear agreement on this. There are virtually no published studies looking at this group of men who seek medical care for borderline testosterone levels.”

The researchers recruited 200 men aged 20-77 years who were referred for management of borderline-to-low testosterone levels. They defined borderline testosterone levels as between 200 ng/dL and 350 ng/dL (which corresponds to 6.9-12 nmol/L) and assessed depressive symptoms with the validated Patient Health Questionnaire 9 (PHQ-9), with scores 10 or greater considered positive. They also collected data on demographics, medical history, what medications they were taking, and any signs and symptoms of hypogonadism.

Dr. Irwig reported that 56% of men had either depressive symptoms based on the PHQ-9, a known diagnosis of depression, and/or they were already on an antidepressant. By comparison, previous studies of PHQ-9 scores have demonstrated that the rate of depression in the general population is 15%-20% among ethnically diverse primary care patients and 5.6% of overweight and obese adults who participated in the National Health and Nutrition Examination Survey. “So clearly, this population [of men referred for borderline testosterone levels] has a much higher rate of depression and depressive symptoms,” he said.

When the study participants were asked if they engaged in exercise other than walking, 51% reported that they weren’t doing any exercise, 27% were exercising 1-3 times per week, and 22% were exercising 4 times per week or more. Only 16% of the study participants were normal weight based on their body mass index, while 39% were overweight, 43% were obese, and 2% were underweight.

As for symptoms that prompted the men to get their testosterone levels checked in the first place, most reported erectile dysfunction (89%), followed by low libido (69%), fewer morning erections (58%), low energy (52%), sleep disturbances (42%), and decreased concentration (27%).

Dr. Irwig emphasized that the study participants “are a select sample, because they probably had some symptom that prompted them to get [their testosterone level] tested,” he said. “Therefore, our findings cannot be generalized to men with borderline testosterone levels who do not seek medical care.”

Dr. Irwig reported having no relevant financial conflicts.

SAN DIEGO – More than half of adult males referred for borderline testosterone levels have depression or depressive symptoms, judging from results from a single-center study.

“Men diagnosed with depressive symptoms should be referred to a mental health professional for formal evaluation and treatment,” Dr. Michael S. Irwig said during a press briefing at the 2015 annual meeting of the Endocrine Society. “We as clinicians should consider managing common comorbidities in this sample population such as obesity and sedentary lifestyle. For example, there’s practically no risk to getting men to lose weight, which would have a lot of health benefits, but there are potential risks to testosterone therapy. I’ll tell men that if they lose weight, that will increase their body’s production of testosterone.”

In the wake of multi-million dollar pharmaceutical advertising campaigns geared to educate the public about low testosterone, Dr. Irwig and his associates set out to describe the population of men referred for borderline testosterone levels and to assess comorbidities. They hypothesized that men referred for borderline testosterone levels would have higher rates of depression and depressive symptoms than the general population.

“There’s been a dramatic increase in testing for testosterone levels,” said Dr. Irwig, director of the Center for Andrology in the division of endocrinology at George Washington University, Washington. “There are many men who wind up having borderline testosterone levels that are closer to the lower end of the reference range. Nobody really knows what a low testosterone level is; there’s no clear agreement on this. There are virtually no published studies looking at this group of men who seek medical care for borderline testosterone levels.”

The researchers recruited 200 men aged 20-77 years who were referred for management of borderline-to-low testosterone levels. They defined borderline testosterone levels as between 200 ng/dL and 350 ng/dL (which corresponds to 6.9-12 nmol/L) and assessed depressive symptoms with the validated Patient Health Questionnaire 9 (PHQ-9), with scores 10 or greater considered positive. They also collected data on demographics, medical history, what medications they were taking, and any signs and symptoms of hypogonadism.

Dr. Irwig reported that 56% of men had either depressive symptoms based on the PHQ-9, a known diagnosis of depression, and/or they were already on an antidepressant. By comparison, previous studies of PHQ-9 scores have demonstrated that the rate of depression in the general population is 15%-20% among ethnically diverse primary care patients and 5.6% of overweight and obese adults who participated in the National Health and Nutrition Examination Survey. “So clearly, this population [of men referred for borderline testosterone levels] has a much higher rate of depression and depressive symptoms,” he said.

When the study participants were asked if they engaged in exercise other than walking, 51% reported that they weren’t doing any exercise, 27% were exercising 1-3 times per week, and 22% were exercising 4 times per week or more. Only 16% of the study participants were normal weight based on their body mass index, while 39% were overweight, 43% were obese, and 2% were underweight.

As for symptoms that prompted the men to get their testosterone levels checked in the first place, most reported erectile dysfunction (89%), followed by low libido (69%), fewer morning erections (58%), low energy (52%), sleep disturbances (42%), and decreased concentration (27%).

Dr. Irwig emphasized that the study participants “are a select sample, because they probably had some symptom that prompted them to get [their testosterone level] tested,” he said. “Therefore, our findings cannot be generalized to men with borderline testosterone levels who do not seek medical care.”

Dr. Irwig reported having no relevant financial conflicts.

SAN DIEGO – More than half of adult males referred for borderline testosterone levels have depression or depressive symptoms, judging from results from a single-center study.

“Men diagnosed with depressive symptoms should be referred to a mental health professional for formal evaluation and treatment,” Dr. Michael S. Irwig said during a press briefing at the 2015 annual meeting of the Endocrine Society. “We as clinicians should consider managing common comorbidities in this sample population such as obesity and sedentary lifestyle. For example, there’s practically no risk to getting men to lose weight, which would have a lot of health benefits, but there are potential risks to testosterone therapy. I’ll tell men that if they lose weight, that will increase their body’s production of testosterone.”

In the wake of multi-million dollar pharmaceutical advertising campaigns geared to educate the public about low testosterone, Dr. Irwig and his associates set out to describe the population of men referred for borderline testosterone levels and to assess comorbidities. They hypothesized that men referred for borderline testosterone levels would have higher rates of depression and depressive symptoms than the general population.

“There’s been a dramatic increase in testing for testosterone levels,” said Dr. Irwig, director of the Center for Andrology in the division of endocrinology at George Washington University, Washington. “There are many men who wind up having borderline testosterone levels that are closer to the lower end of the reference range. Nobody really knows what a low testosterone level is; there’s no clear agreement on this. There are virtually no published studies looking at this group of men who seek medical care for borderline testosterone levels.”

The researchers recruited 200 men aged 20-77 years who were referred for management of borderline-to-low testosterone levels. They defined borderline testosterone levels as between 200 ng/dL and 350 ng/dL (which corresponds to 6.9-12 nmol/L) and assessed depressive symptoms with the validated Patient Health Questionnaire 9 (PHQ-9), with scores 10 or greater considered positive. They also collected data on demographics, medical history, what medications they were taking, and any signs and symptoms of hypogonadism.

Dr. Irwig reported that 56% of men had either depressive symptoms based on the PHQ-9, a known diagnosis of depression, and/or they were already on an antidepressant. By comparison, previous studies of PHQ-9 scores have demonstrated that the rate of depression in the general population is 15%-20% among ethnically diverse primary care patients and 5.6% of overweight and obese adults who participated in the National Health and Nutrition Examination Survey. “So clearly, this population [of men referred for borderline testosterone levels] has a much higher rate of depression and depressive symptoms,” he said.

When the study participants were asked if they engaged in exercise other than walking, 51% reported that they weren’t doing any exercise, 27% were exercising 1-3 times per week, and 22% were exercising 4 times per week or more. Only 16% of the study participants were normal weight based on their body mass index, while 39% were overweight, 43% were obese, and 2% were underweight.

As for symptoms that prompted the men to get their testosterone levels checked in the first place, most reported erectile dysfunction (89%), followed by low libido (69%), fewer morning erections (58%), low energy (52%), sleep disturbances (42%), and decreased concentration (27%).

Dr. Irwig emphasized that the study participants “are a select sample, because they probably had some symptom that prompted them to get [their testosterone level] tested,” he said. “Therefore, our findings cannot be generalized to men with borderline testosterone levels who do not seek medical care.”

Dr. Irwig reported having no relevant financial conflicts.

SAN DIEGO – More than half of adult males referred for borderline testosterone levels have depression or depressive symptoms, judging from results from a single-center study.

“Men diagnosed with depressive symptoms should be referred to a mental health professional for formal evaluation and treatment,” Dr. Michael S. Irwig said during a press briefing at the 2015 annual meeting of the Endocrine Society. “We as clinicians should consider managing common comorbidities in this sample population such as obesity and sedentary lifestyle. For example, there’s practically no risk to getting men to lose weight, which would have a lot of health benefits, but there are potential risks to testosterone therapy. I’ll tell men that if they lose weight, that will increase their body’s production of testosterone.”

In the wake of multi-million dollar pharmaceutical advertising campaigns geared to educate the public about low testosterone, Dr. Irwig and his associates set out to describe the population of men referred for borderline testosterone levels and to assess comorbidities. They hypothesized that men referred for borderline testosterone levels would have higher rates of depression and depressive symptoms than the general population.

“There’s been a dramatic increase in testing for testosterone levels,” said Dr. Irwig, director of the Center for Andrology in the division of endocrinology at George Washington University, Washington. “There are many men who wind up having borderline testosterone levels that are closer to the lower end of the reference range. Nobody really knows what a low testosterone level is; there’s no clear agreement on this. There are virtually no published studies looking at this group of men who seek medical care for borderline testosterone levels.”

The researchers recruited 200 men aged 20-77 years who were referred for management of borderline-to-low testosterone levels. They defined borderline testosterone levels as between 200 ng/dL and 350 ng/dL (which corresponds to 6.9-12 nmol/L) and assessed depressive symptoms with the validated Patient Health Questionnaire 9 (PHQ-9), with scores 10 or greater considered positive. They also collected data on demographics, medical history, what medications they were taking, and any signs and symptoms of hypogonadism.

Dr. Irwig reported that 56% of men had either depressive symptoms based on the PHQ-9, a known diagnosis of depression, and/or they were already on an antidepressant. By comparison, previous studies of PHQ-9 scores have demonstrated that the rate of depression in the general population is 15%-20% among ethnically diverse primary care patients and 5.6% of overweight and obese adults who participated in the National Health and Nutrition Examination Survey. “So clearly, this population [of men referred for borderline testosterone levels] has a much higher rate of depression and depressive symptoms,” he said.

When the study participants were asked if they engaged in exercise other than walking, 51% reported that they weren’t doing any exercise, 27% were exercising 1-3 times per week, and 22% were exercising 4 times per week or more. Only 16% of the study participants were normal weight based on their body mass index, while 39% were overweight, 43% were obese, and 2% were underweight.

As for symptoms that prompted the men to get their testosterone levels checked in the first place, most reported erectile dysfunction (89%), followed by low libido (69%), fewer morning erections (58%), low energy (52%), sleep disturbances (42%), and decreased concentration (27%).

Dr. Irwig emphasized that the study participants “are a select sample, because they probably had some symptom that prompted them to get [their testosterone level] tested,” he said. “Therefore, our findings cannot be generalized to men with borderline testosterone levels who do not seek medical care.”

Dr. Irwig reported having no relevant financial conflicts.

dbrunk@frontlinemedcom.com

On Twitter @dougbrunk

SAN DIEGO – More than half of adult males referred for borderline testosterone levels have depression or depressive symptoms, judging from results from a single-center study.

“Men diagnosed with depressive symptoms should be referred to a mental health professional for formal evaluation and treatment,” Dr. Michael S. Irwig said during a press briefing at the 2015 annual meeting of the Endocrine Society. “We as clinicians should consider managing common comorbidities in this sample population such as obesity and sedentary lifestyle. For example, there’s practically no risk to getting men to lose weight, which would have a lot of health benefits, but there are potential risks to testosterone therapy. I’ll tell men that if they lose weight, that will increase their body’s production of testosterone.”

In the wake of multi-million dollar pharmaceutical advertising campaigns geared to educate the public about low testosterone, Dr. Irwig and his associates set out to describe the population of men referred for borderline testosterone levels and to assess comorbidities. They hypothesized that men referred for borderline testosterone levels would have higher rates of depression and depressive symptoms than the general population.

“There’s been a dramatic increase in testing for testosterone levels,” said Dr. Irwig, director of the Center for Andrology in the division of endocrinology at George Washington University, Washington. “There are many men who wind up having borderline testosterone levels that are closer to the lower end of the reference range. Nobody really knows what a low testosterone level is; there’s no clear agreement on this. There are virtually no published studies looking at this group of men who seek medical care for borderline testosterone levels.”

The researchers recruited 200 men aged 20-77 years who were referred for management of borderline-to-low testosterone levels. They defined borderline testosterone levels as between 200 ng/dL and 350 ng/dL (which corresponds to 6.9-12 nmol/L) and assessed depressive symptoms with the validated Patient Health Questionnaire 9 (PHQ-9), with scores 10 or greater considered positive. They also collected data on demographics, medical history, what medications they were taking, and any signs and symptoms of hypogonadism.

Dr. Irwig reported that 56% of men had either depressive symptoms based on the PHQ-9, a known diagnosis of depression, and/or they were already on an antidepressant. By comparison, previous studies of PHQ-9 scores have demonstrated that the rate of depression in the general population is 15%-20% among ethnically diverse primary care patients and 5.6% of overweight and obese adults who participated in the National Health and Nutrition Examination Survey. “So clearly, this population [of men referred for borderline testosterone levels] has a much higher rate of depression and depressive symptoms,” he said.

When the study participants were asked if they engaged in exercise other than walking, 51% reported that they weren’t doing any exercise, 27% were exercising 1-3 times per week, and 22% were exercising 4 times per week or more. Only 16% of the study participants were normal weight based on their body mass index, while 39% were overweight, 43% were obese, and 2% were underweight.

As for symptoms that prompted the men to get their testosterone levels checked in the first place, most reported erectile dysfunction (89%), followed by low libido (69%), fewer morning erections (58%), low energy (52%), sleep disturbances (42%), and decreased concentration (27%).

Dr. Irwig emphasized that the study participants “are a select sample, because they probably had some symptom that prompted them to get [their testosterone level] tested,” he said. “Therefore, our findings cannot be generalized to men with borderline testosterone levels who do not seek medical care.”

Dr. Irwig reported having no relevant financial conflicts.

dbrunk@frontlinemedcom.com

On Twitter @dougbrunk

SAN DIEGO – More than half of adult males referred for borderline testosterone levels have depression or depressive symptoms, judging from results from a single-center study.

“Men diagnosed with depressive symptoms should be referred to a mental health professional for formal evaluation and treatment,” Dr. Michael S. Irwig said during a press briefing at the 2015 annual meeting of the Endocrine Society. “We as clinicians should consider managing common comorbidities in this sample population such as obesity and sedentary lifestyle. For example, there’s practically no risk to getting men to lose weight, which would have a lot of health benefits, but there are potential risks to testosterone therapy. I’ll tell men that if they lose weight, that will increase their body’s production of testosterone.”

In the wake of multi-million dollar pharmaceutical advertising campaigns geared to educate the public about low testosterone, Dr. Irwig and his associates set out to describe the population of men referred for borderline testosterone levels and to assess comorbidities. They hypothesized that men referred for borderline testosterone levels would have higher rates of depression and depressive symptoms than the general population.

“There’s been a dramatic increase in testing for testosterone levels,” said Dr. Irwig, director of the Center for Andrology in the division of endocrinology at George Washington University, Washington. “There are many men who wind up having borderline testosterone levels that are closer to the lower end of the reference range. Nobody really knows what a low testosterone level is; there’s no clear agreement on this. There are virtually no published studies looking at this group of men who seek medical care for borderline testosterone levels.”

The researchers recruited 200 men aged 20-77 years who were referred for management of borderline-to-low testosterone levels. They defined borderline testosterone levels as between 200 ng/dL and 350 ng/dL (which corresponds to 6.9-12 nmol/L) and assessed depressive symptoms with the validated Patient Health Questionnaire 9 (PHQ-9), with scores 10 or greater considered positive. They also collected data on demographics, medical history, what medications they were taking, and any signs and symptoms of hypogonadism.

Dr. Irwig reported that 56% of men had either depressive symptoms based on the PHQ-9, a known diagnosis of depression, and/or they were already on an antidepressant. By comparison, previous studies of PHQ-9 scores have demonstrated that the rate of depression in the general population is 15%-20% among ethnically diverse primary care patients and 5.6% of overweight and obese adults who participated in the National Health and Nutrition Examination Survey. “So clearly, this population [of men referred for borderline testosterone levels] has a much higher rate of depression and depressive symptoms,” he said.

When the study participants were asked if they engaged in exercise other than walking, 51% reported that they weren’t doing any exercise, 27% were exercising 1-3 times per week, and 22% were exercising 4 times per week or more. Only 16% of the study participants were normal weight based on their body mass index, while 39% were overweight, 43% were obese, and 2% were underweight.

As for symptoms that prompted the men to get their testosterone levels checked in the first place, most reported erectile dysfunction (89%), followed by low libido (69%), fewer morning erections (58%), low energy (52%), sleep disturbances (42%), and decreased concentration (27%).

Dr. Irwig emphasized that the study participants “are a select sample, because they probably had some symptom that prompted them to get [their testosterone level] tested,” he said. “Therefore, our findings cannot be generalized to men with borderline testosterone levels who do not seek medical care.”

Dr. Irwig reported having no relevant financial conflicts.

dbrunk@frontlinemedcom.com

On Twitter @dougbrunk

SAN DIEGO – An estimated 26-33 million prescriptions for compounded, non–FDA-approved menopausal hormone therapy are filled in the United States each year, with annual sales reaching $1.3-$1.7 billion, results from a national pharmacist survey suggest.

What’s more, 69% of pharmacists expect their custom-compounded hormone therapy business to grow over the next 2 years.

“This is key, because if you expect that there’s nearly equivalent prescribing of compounded hormone therapy and menopausal hormone therapy, then it behooves us as care providers to make sure that [consumers] understand the difference between something that’s FDA approved, monitored, and regulated, and something that’s compounded, less well-regulated, and that is not FDA monitored or tested in rigorous clinical trials,” lead study author JoAnn Pinkerton said during a press briefing at the annual meeting of the Endocrine Society. “There are concerns about overdosing and under-dosing, sterility issues, the issue of batch-to-batch stability, and also the fact that if you get an FDA-approved product, you get a ‘black box’ warning of everything that’s been reported for HT [hormone therapy]. If you get a compounded product, they’re not required to give you any information about the risks. Many women are using these products. They’re being prescribed and we want people to be educated about the differences.”

Following the release of Women’s Health Initiative (WHI) data linking menopausal hormone therapy (MHT) to certain health risks, FDA-approved MHT users decreased from about 17.9 million in 2002 to about 3.7 million in 2013, said Dr. Pinkerton, a professor of obstetrics and gynecology at the University of Virginia Health System, Charlottesville. “This resulted in a marked increase in the compounded ‘bioidentical’ hormone therapy market primarily, we believe, because of a lot of hype that they might be safer, more effective, and that estriol might prevent breast cancer,” Dr. Pinkerton said. Specifically, the compounded ‘bioidentical’ hormone therapy (CHT) market has grown “from almost a negligible amount to about 2.5 million women, which is about 2% of U.S. women based on consumer surveys and U.S Census data. In earlier consumer surveys, most women who use these products were not aware that they are not FDA approved. There’s a knowledge gap for providers and women to learn about.”

For the study, Dr. Pinkerton and her associates evaluated results from an online national survey that was e-mailed to 12,250 independent community pharmacies and independent compounding pharmacies in the fall of 2014. Respondents “had to be knowledgeable of the annual revenue and the volume of compounded and noncompounded [prescriptions] at the pharmacy locations,” Dr. Pinkerton said. “We asked questions including the percentage of nonsterile compounding volume that is CHT, the percentage of monthly prescriptions for each type of CHT, and the likelihood of MHT prescribing over the next 2 years.”

Based on complete responses from 483 pharmacists, the researchers found that an estimated 26-33 million CHT prescriptions are filled each year, which is similar to the number of FDA-approved MHT prescriptions filled each year. In addition, based on an average compounded price of $50, the estimated sales of CHT currently range from $1.3 to $1.7 billion. More than half of compounding pharmacies (69%) expected demand for CHT to grow by 5%-25%. “Very few expected that the market would ‘explode,’ and very few thought that it would decrease,” Dr. Pinkerton said.

Dr. Pinkerton disclosed that she has received grants and research support (paid to the University of Virginia) from Pfizer, Inc., TherapeuticsMD, Noven, Shionogi, and TXMD.

dbrunk@frontlinemedcom.com

On Twitter @dougbrunk

SAN DIEGO – An estimated 26-33 million prescriptions for compounded, non–FDA-approved menopausal hormone therapy are filled in the United States each year, with annual sales reaching $1.3-$1.7 billion, results from a national pharmacist survey suggest.

What’s more, 69% of pharmacists expect their custom-compounded hormone therapy business to grow over the next 2 years.

“This is key, because if you expect that there’s nearly equivalent prescribing of compounded hormone therapy and menopausal hormone therapy, then it behooves us as care providers to make sure that [consumers] understand the difference between something that’s FDA approved, monitored, and regulated, and something that’s compounded, less well-regulated, and that is not FDA monitored or tested in rigorous clinical trials,” lead study author JoAnn Pinkerton said during a press briefing at the annual meeting of the Endocrine Society. “There are concerns about overdosing and under-dosing, sterility issues, the issue of batch-to-batch stability, and also the fact that if you get an FDA-approved product, you get a ‘black box’ warning of everything that’s been reported for HT [hormone therapy]. If you get a compounded product, they’re not required to give you any information about the risks. Many women are using these products. They’re being prescribed and we want people to be educated about the differences.”

Following the release of Women’s Health Initiative (WHI) data linking menopausal hormone therapy (MHT) to certain health risks, FDA-approved MHT users decreased from about 17.9 million in 2002 to about 3.7 million in 2013, said Dr. Pinkerton, a professor of obstetrics and gynecology at the University of Virginia Health System, Charlottesville. “This resulted in a marked increase in the compounded ‘bioidentical’ hormone therapy market primarily, we believe, because of a lot of hype that they might be safer, more effective, and that estriol might prevent breast cancer,” Dr. Pinkerton said. Specifically, the compounded ‘bioidentical’ hormone therapy (CHT) market has grown “from almost a negligible amount to about 2.5 million women, which is about 2% of U.S. women based on consumer surveys and U.S Census data. In earlier consumer surveys, most women who use these products were not aware that they are not FDA approved. There’s a knowledge gap for providers and women to learn about.”

For the study, Dr. Pinkerton and her associates evaluated results from an online national survey that was e-mailed to 12,250 independent community pharmacies and independent compounding pharmacies in the fall of 2014. Respondents “had to be knowledgeable of the annual revenue and the volume of compounded and noncompounded [prescriptions] at the pharmacy locations,” Dr. Pinkerton said. “We asked questions including the percentage of nonsterile compounding volume that is CHT, the percentage of monthly prescriptions for each type of CHT, and the likelihood of MHT prescribing over the next 2 years.”

Based on complete responses from 483 pharmacists, the researchers found that an estimated 26-33 million CHT prescriptions are filled each year, which is similar to the number of FDA-approved MHT prescriptions filled each year. In addition, based on an average compounded price of $50, the estimated sales of CHT currently range from $1.3 to $1.7 billion. More than half of compounding pharmacies (69%) expected demand for CHT to grow by 5%-25%. “Very few expected that the market would ‘explode,’ and very few thought that it would decrease,” Dr. Pinkerton said.

Dr. Pinkerton disclosed that she has received grants and research support (paid to the University of Virginia) from Pfizer, Inc., TherapeuticsMD, Noven, Shionogi, and TXMD.

dbrunk@frontlinemedcom.com

On Twitter @dougbrunk

SAN DIEGO – An estimated 26-33 million prescriptions for compounded, non–FDA-approved menopausal hormone therapy are filled in the United States each year, with annual sales reaching $1.3-$1.7 billion, results from a national pharmacist survey suggest.

What’s more, 69% of pharmacists expect their custom-compounded hormone therapy business to grow over the next 2 years.

“This is key, because if you expect that there’s nearly equivalent prescribing of compounded hormone therapy and menopausal hormone therapy, then it behooves us as care providers to make sure that [consumers] understand the difference between something that’s FDA approved, monitored, and regulated, and something that’s compounded, less well-regulated, and that is not FDA monitored or tested in rigorous clinical trials,” lead study author JoAnn Pinkerton said during a press briefing at the annual meeting of the Endocrine Society. “There are concerns about overdosing and under-dosing, sterility issues, the issue of batch-to-batch stability, and also the fact that if you get an FDA-approved product, you get a ‘black box’ warning of everything that’s been reported for HT [hormone therapy]. If you get a compounded product, they’re not required to give you any information about the risks. Many women are using these products. They’re being prescribed and we want people to be educated about the differences.”

Following the release of Women’s Health Initiative (WHI) data linking menopausal hormone therapy (MHT) to certain health risks, FDA-approved MHT users decreased from about 17.9 million in 2002 to about 3.7 million in 2013, said Dr. Pinkerton, a professor of obstetrics and gynecology at the University of Virginia Health System, Charlottesville. “This resulted in a marked increase in the compounded ‘bioidentical’ hormone therapy market primarily, we believe, because of a lot of hype that they might be safer, more effective, and that estriol might prevent breast cancer,” Dr. Pinkerton said. Specifically, the compounded ‘bioidentical’ hormone therapy (CHT) market has grown “from almost a negligible amount to about 2.5 million women, which is about 2% of U.S. women based on consumer surveys and U.S Census data. In earlier consumer surveys, most women who use these products were not aware that they are not FDA approved. There’s a knowledge gap for providers and women to learn about.”

For the study, Dr. Pinkerton and her associates evaluated results from an online national survey that was e-mailed to 12,250 independent community pharmacies and independent compounding pharmacies in the fall of 2014. Respondents “had to be knowledgeable of the annual revenue and the volume of compounded and noncompounded [prescriptions] at the pharmacy locations,” Dr. Pinkerton said. “We asked questions including the percentage of nonsterile compounding volume that is CHT, the percentage of monthly prescriptions for each type of CHT, and the likelihood of MHT prescribing over the next 2 years.”

Based on complete responses from 483 pharmacists, the researchers found that an estimated 26-33 million CHT prescriptions are filled each year, which is similar to the number of FDA-approved MHT prescriptions filled each year. In addition, based on an average compounded price of $50, the estimated sales of CHT currently range from $1.3 to $1.7 billion. More than half of compounding pharmacies (69%) expected demand for CHT to grow by 5%-25%. “Very few expected that the market would ‘explode,’ and very few thought that it would decrease,” Dr. Pinkerton said.

Dr. Pinkerton disclosed that she has received grants and research support (paid to the University of Virginia) from Pfizer, Inc., TherapeuticsMD, Noven, Shionogi, and TXMD.

dbrunk@frontlinemedcom.com

On Twitter @dougbrunk

SAN DIEGO – Encourage teens with metabolic syndrome to snack on nuts; it just might improve their health.

Investigators from the University of Texas Southwestern Medical Center, in Dallas, found that children who ate 12.9 g of nuts per day – the equivalent of a small handful of peanuts, almonds, walnuts, and the like 3 times a week – had less than half the risk of metabolic syndrome, compared with those who did not, when age, sex, race, household income, and daily intake of sugar, fruits, and vegetables were controlled for (odds ratio, 0.43; 95% confidence interval, 0.20-0.92). The benefit persisted up to about 50 g/day, then tapered off, perhaps because the extra calories offset the metabolic benefit.

Adolescents who ate nuts a few times a week also had lower body mass index z scores, smaller waists, lower systolic blood pressure, and higher HDL cholesterol levels. Similar benefits have been found in adults.

The data come from the 2003-2010 National Health and Nutrition Examination Survey (NHANES) of 2,233 12- to 19-year-olds; nut consumption was self-reported.

Pediatrician and lead investigator Dr. Roy Kim stressed that the correlations don’t prove cause and effect. Still, he said he now encourages his patients to eat nuts. He explained why in an interview at a meeting of the Endocrine Society.

aotto@frontlinemedcom.com

SAN DIEGO – Encourage teens with metabolic syndrome to snack on nuts; it just might improve their health.

Investigators from the University of Texas Southwestern Medical Center, in Dallas, found that children who ate 12.9 g of nuts per day – the equivalent of a small handful of peanuts, almonds, walnuts, and the like 3 times a week – had less than half the risk of metabolic syndrome, compared with those who did not, when age, sex, race, household income, and daily intake of sugar, fruits, and vegetables were controlled for (odds ratio, 0.43; 95% confidence interval, 0.20-0.92). The benefit persisted up to about 50 g/day, then tapered off, perhaps because the extra calories offset the metabolic benefit.

Adolescents who ate nuts a few times a week also had lower body mass index z scores, smaller waists, lower systolic blood pressure, and higher HDL cholesterol levels. Similar benefits have been found in adults.

The data come from the 2003-2010 National Health and Nutrition Examination Survey (NHANES) of 2,233 12- to 19-year-olds; nut consumption was self-reported.

Pediatrician and lead investigator Dr. Roy Kim stressed that the correlations don’t prove cause and effect. Still, he said he now encourages his patients to eat nuts. He explained why in an interview at a meeting of the Endocrine Society.

aotto@frontlinemedcom.com

SAN DIEGO – Encourage teens with metabolic syndrome to snack on nuts; it just might improve their health.

Investigators from the University of Texas Southwestern Medical Center, in Dallas, found that children who ate 12.9 g of nuts per day – the equivalent of a small handful of peanuts, almonds, walnuts, and the like 3 times a week – had less than half the risk of metabolic syndrome, compared with those who did not, when age, sex, race, household income, and daily intake of sugar, fruits, and vegetables were controlled for (odds ratio, 0.43; 95% confidence interval, 0.20-0.92). The benefit persisted up to about 50 g/day, then tapered off, perhaps because the extra calories offset the metabolic benefit.

Adolescents who ate nuts a few times a week also had lower body mass index z scores, smaller waists, lower systolic blood pressure, and higher HDL cholesterol levels. Similar benefits have been found in adults.

The data come from the 2003-2010 National Health and Nutrition Examination Survey (NHANES) of 2,233 12- to 19-year-olds; nut consumption was self-reported.

Pediatrician and lead investigator Dr. Roy Kim stressed that the correlations don’t prove cause and effect. Still, he said he now encourages his patients to eat nuts. He explained why in an interview at a meeting of the Endocrine Society.

aotto@frontlinemedcom.com