AACE: Saroglitazar found safe, effective for management of diabetic dyslipidemia

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AACE: Saroglitazar found safe, effective for management of diabetic dyslipidemia

NASHVILLE – Saroglitazar, currently approved for use in India only, is effective and safe for treating diabetic dyslipidemia and has been shown to be a potent agent for managing levels of triglycerides, cholesterol, glucose, and hemoglobin A1c.

This is according to a postmarketing surveillance study presented by Dr. Shashank Joshi, whose endocrinology clinic in Mumbai was involved in a 9-month trial to test the safety and efficacy of once-daily 4-mg doses of Saroglitazar on a population with diabetic dyslipidemia. Saroglitazar, manufactured by Zydus, is the first dual-PPAR (peroxisome proliferator-activated receptor) alpha and gamma agonist available commercially anywhere in the world, and has been approved only in India and on the market in that country for 20 months.

“[Saroglitazar] is fundamentally not structurally similar to a glitazone, [nor] to a fibrate, and it’s also not structurally similar to other glitazars, which have been investigated,” explained Dr. Joshi, who added that all phase III studies of saroglitazar have been published. “We [also] know diabetic dyslipidemia is very prevalent in the Indian population, shown predominantly [by] low HDL, high triglycerides, and high LDL.”

A total of 787 diabetic dyslipidemia patients were included in the study, all of whom were evaluated for lipid and glycemic parameters at baseline. The mean age of subjects was 53 years, mean weight was 73.9 kg, and 507 subjects (64.4%) were male. All subjects underwent follow-ups at 3, 6, and 9 months after baseline.

Mean triglyceride, LDL cholesterol, non-HDL cholesterol, and total cholesterol levels all showed significant reductions: Triglycerides dropped 43.8% from 297.9 mg/dL to 156.1 mg/dL, LDL levels dropped 18.5% from 132.5 mg/dL to 100.5 mg/dL, non-HDL levels dropped 29.7% from 199 mg/dL to 131.9 mg/dL, and total cholesterol levels dropped 23.1% from 239.9 mg/dL to 176.6 mg/dL (P <.001 for all).

Significant reductions were also seen in HbA1clevels (8.5% to 7%), fasting glucose levels (171.6 mg/dL to 116.4 mg/dL), and postprandial glucose levels (244.6 mg/dL to 149.7 mg/dL) (P <.001 for all). Furthermore, HDL levels improved by 12.7%, over the 9-month period, going from 41 mg/dL to 44.5 mg/dL.

Seven hundred and twenty-two subjects (91.7%) were on an antidiabetic medication at baseline, the most common of which were metformin (73.7%), sulfonylureas (58.3%), dipeptidyl peptidase–4 inhibitors (26.2%), and insulin (17.4%). More than half of these patients (365; 50.6%) were on dual therapy, 195 (27%) were on triple therapy, 135 (18.7%) were on monotherapy, and 27 (3.7%) of these subjects were taking more than three drugs at baseline. Of the 787 in the total population, 395 (50.2%) were on statins, the most common of which was atorvastatin (71%).

“[Saroglitazar] was well tolerated over a long term of 9 months, with no weight gain and edema, and no serious adverse events reported,” said Dr. Joshi, who also acknowledged potential limitations of the trial because of its being an ongoing, prospective study.

Dr. Joshi disclosed relationships with Zydus, maker of saroglitazar, and numerous other pharmaceutical companies.

dchitnis@frontlinemedcom.com

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NASHVILLE – Saroglitazar, currently approved for use in India only, is effective and safe for treating diabetic dyslipidemia and has been shown to be a potent agent for managing levels of triglycerides, cholesterol, glucose, and hemoglobin A1c.

This is according to a postmarketing surveillance study presented by Dr. Shashank Joshi, whose endocrinology clinic in Mumbai was involved in a 9-month trial to test the safety and efficacy of once-daily 4-mg doses of Saroglitazar on a population with diabetic dyslipidemia. Saroglitazar, manufactured by Zydus, is the first dual-PPAR (peroxisome proliferator-activated receptor) alpha and gamma agonist available commercially anywhere in the world, and has been approved only in India and on the market in that country for 20 months.

“[Saroglitazar] is fundamentally not structurally similar to a glitazone, [nor] to a fibrate, and it’s also not structurally similar to other glitazars, which have been investigated,” explained Dr. Joshi, who added that all phase III studies of saroglitazar have been published. “We [also] know diabetic dyslipidemia is very prevalent in the Indian population, shown predominantly [by] low HDL, high triglycerides, and high LDL.”

A total of 787 diabetic dyslipidemia patients were included in the study, all of whom were evaluated for lipid and glycemic parameters at baseline. The mean age of subjects was 53 years, mean weight was 73.9 kg, and 507 subjects (64.4%) were male. All subjects underwent follow-ups at 3, 6, and 9 months after baseline.

Mean triglyceride, LDL cholesterol, non-HDL cholesterol, and total cholesterol levels all showed significant reductions: Triglycerides dropped 43.8% from 297.9 mg/dL to 156.1 mg/dL, LDL levels dropped 18.5% from 132.5 mg/dL to 100.5 mg/dL, non-HDL levels dropped 29.7% from 199 mg/dL to 131.9 mg/dL, and total cholesterol levels dropped 23.1% from 239.9 mg/dL to 176.6 mg/dL (P <.001 for all).

Significant reductions were also seen in HbA1clevels (8.5% to 7%), fasting glucose levels (171.6 mg/dL to 116.4 mg/dL), and postprandial glucose levels (244.6 mg/dL to 149.7 mg/dL) (P <.001 for all). Furthermore, HDL levels improved by 12.7%, over the 9-month period, going from 41 mg/dL to 44.5 mg/dL.

Seven hundred and twenty-two subjects (91.7%) were on an antidiabetic medication at baseline, the most common of which were metformin (73.7%), sulfonylureas (58.3%), dipeptidyl peptidase–4 inhibitors (26.2%), and insulin (17.4%). More than half of these patients (365; 50.6%) were on dual therapy, 195 (27%) were on triple therapy, 135 (18.7%) were on monotherapy, and 27 (3.7%) of these subjects were taking more than three drugs at baseline. Of the 787 in the total population, 395 (50.2%) were on statins, the most common of which was atorvastatin (71%).

“[Saroglitazar] was well tolerated over a long term of 9 months, with no weight gain and edema, and no serious adverse events reported,” said Dr. Joshi, who also acknowledged potential limitations of the trial because of its being an ongoing, prospective study.

Dr. Joshi disclosed relationships with Zydus, maker of saroglitazar, and numerous other pharmaceutical companies.

dchitnis@frontlinemedcom.com

NASHVILLE – Saroglitazar, currently approved for use in India only, is effective and safe for treating diabetic dyslipidemia and has been shown to be a potent agent for managing levels of triglycerides, cholesterol, glucose, and hemoglobin A1c.

This is according to a postmarketing surveillance study presented by Dr. Shashank Joshi, whose endocrinology clinic in Mumbai was involved in a 9-month trial to test the safety and efficacy of once-daily 4-mg doses of Saroglitazar on a population with diabetic dyslipidemia. Saroglitazar, manufactured by Zydus, is the first dual-PPAR (peroxisome proliferator-activated receptor) alpha and gamma agonist available commercially anywhere in the world, and has been approved only in India and on the market in that country for 20 months.

“[Saroglitazar] is fundamentally not structurally similar to a glitazone, [nor] to a fibrate, and it’s also not structurally similar to other glitazars, which have been investigated,” explained Dr. Joshi, who added that all phase III studies of saroglitazar have been published. “We [also] know diabetic dyslipidemia is very prevalent in the Indian population, shown predominantly [by] low HDL, high triglycerides, and high LDL.”

A total of 787 diabetic dyslipidemia patients were included in the study, all of whom were evaluated for lipid and glycemic parameters at baseline. The mean age of subjects was 53 years, mean weight was 73.9 kg, and 507 subjects (64.4%) were male. All subjects underwent follow-ups at 3, 6, and 9 months after baseline.

Mean triglyceride, LDL cholesterol, non-HDL cholesterol, and total cholesterol levels all showed significant reductions: Triglycerides dropped 43.8% from 297.9 mg/dL to 156.1 mg/dL, LDL levels dropped 18.5% from 132.5 mg/dL to 100.5 mg/dL, non-HDL levels dropped 29.7% from 199 mg/dL to 131.9 mg/dL, and total cholesterol levels dropped 23.1% from 239.9 mg/dL to 176.6 mg/dL (P <.001 for all).

Significant reductions were also seen in HbA1clevels (8.5% to 7%), fasting glucose levels (171.6 mg/dL to 116.4 mg/dL), and postprandial glucose levels (244.6 mg/dL to 149.7 mg/dL) (P <.001 for all). Furthermore, HDL levels improved by 12.7%, over the 9-month period, going from 41 mg/dL to 44.5 mg/dL.

Seven hundred and twenty-two subjects (91.7%) were on an antidiabetic medication at baseline, the most common of which were metformin (73.7%), sulfonylureas (58.3%), dipeptidyl peptidase–4 inhibitors (26.2%), and insulin (17.4%). More than half of these patients (365; 50.6%) were on dual therapy, 195 (27%) were on triple therapy, 135 (18.7%) were on monotherapy, and 27 (3.7%) of these subjects were taking more than three drugs at baseline. Of the 787 in the total population, 395 (50.2%) were on statins, the most common of which was atorvastatin (71%).

“[Saroglitazar] was well tolerated over a long term of 9 months, with no weight gain and edema, and no serious adverse events reported,” said Dr. Joshi, who also acknowledged potential limitations of the trial because of its being an ongoing, prospective study.

Dr. Joshi disclosed relationships with Zydus, maker of saroglitazar, and numerous other pharmaceutical companies.

dchitnis@frontlinemedcom.com

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AACE: Saroglitazar found safe, effective for management of diabetic dyslipidemia
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Key clinical point: Saroglitazar 4 mg is safe and effective for the treatment of diabetic dyslipidemia, specifically, for the management of glycemic and lipid parameters.

Major finding: At 9 months’ follow-up, subjects experienced a 43.8% drop in triglycerides, an 18.5% drop in LDL cholesterol levels, a 29.7% drop in non-HDL cholesterol levels, and a 23.1% drop in total cholesterol.

Data source: A multicenter observational phase IV study of 787 diabetic dyslipidemia patients in India over a 9-month period.

Disclosures: Dr. Joshi disclosed relationships with Zydus, maker of saroglitazar, and numerous other pharmaceutical companies.

AACE: Beware of hypoglycemia when ordering diabetics to fast for a test

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AACE: Beware of hypoglycemia when ordering diabetics to fast for a test

NASHVILLE, TENN. – When ordering a fasting blood test for patients with diabetes, it’s prudent to have them cut back on their insulin and oral hypoglycemic agents to avoid hypoglycemia.

Unless they take such protective actions, an estimated half or more will be hypoglycemic by the time their blood is drawn, according to a survey from Michigan State University.

Alex Otto/Frontline Medical News
Dr. Saleh Aldasouqi

Of the 74 study participants – mostly people with type 2 diabetes – who have enrolled so far in the ongoing project, 37 (50%) reported overnight fasting for lipid profiles or other tests in the previous year. Just three cut back on their medications, either on their own or on the advice of their doctors. Just over half the subjects were women, about three-quarters had type 2 diabetes, and the average age in the study was 53 years.

Twenty-three of the 37 patients (62%) reported at least one hypoglycemic event while fasting, with plasma glucose falling below 70 mg/dL. Some had up to seven events. Most told their doctors what had happened, but steps weren’t often taken to prevent future events.

“These interim results vividly confirm the occurrence of” fasting hypoglycemia “in clinical practice, and indicate a significant prevalence” among patients with diabetes. “This study serves as a means of increasing awareness about” the problem, “which clinicians appear to overlook,” concluded the investigators, led by Dr. Saleh Aldasouqi, associate professor of medicine and chief of endocrinology at Michigan State, East Lansing.

Dr. Aldasouqi first noticed the problem several years ago when practicing in Cape Girardeau, Mo. He fielded several calls there from nervous lab technicians reporting hypoglycemia in patients with diabetes who had fasted overnight. “We looked at the world literature on this at the time and found zero,” he said, except for a case report of a woman who collapsed and died while waiting for a lipid draw after fasting the night before. Her blood glucose was zero.

That report prompted Dr. Aldasouqi and his colleagues in Cape Girardeau to study the issue. They found that hypoglycemia ranged from 69-30 mg/dL among 35 patients with diabetes who recalled fasting or possibly fasting for a blood test. None recalled adjusting their medications (Diabetes Care 2011;34:e52).

Dr. Aldasouqi dubbed the problem fasting-evoked en-route hypoglycemia in diabetes (FEEHD): “en-route” to invoke the possibility that patients with diabetes might crash if their blood sugar drops too low while driving in for a blood draw, he said at the annual meeting of the American Association of Clinical Endocrinologists.

The next step in Cape Girardeau was a prevention program to monitor blood glucose and adjust medications for patients with diabetes who were fasting for a test. It reduced the incidence of hypoglycemic events by 68%, with an even greater drop in the incidence of severe hypoglycemia below 50 mg/dL (Postgrad. Med. 2013;125:136-43).

“We’ve been trying to build a case” that FEEHD really is a problem, but there’s been some skepticism because “we are trying to change a deeply rooted tradition” and the notion that diabetics can fast just like anyone else. Even so, “people are coming around now that we have data,” Dr. Aldasouqi said. Currently at Michigan State, “my group is not ordering fasting” for lipid tests, although it remains routine in other clinics there. They opted for that approach, instead of reducing diabetes medications during fasts, because of the growing evidence that patients – whether they have diabetes or not – really don’t need to fast for lipid panels, he said (Circulation 2015;131:e471).

There was no external funding for the project. Dr. Aldasouqi is a speaker or adviser for Janssen, Sanofi, and Takeda.

aotto@frontlinemedcom.com

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NASHVILLE, TENN. – When ordering a fasting blood test for patients with diabetes, it’s prudent to have them cut back on their insulin and oral hypoglycemic agents to avoid hypoglycemia.

Unless they take such protective actions, an estimated half or more will be hypoglycemic by the time their blood is drawn, according to a survey from Michigan State University.

Alex Otto/Frontline Medical News
Dr. Saleh Aldasouqi

Of the 74 study participants – mostly people with type 2 diabetes – who have enrolled so far in the ongoing project, 37 (50%) reported overnight fasting for lipid profiles or other tests in the previous year. Just three cut back on their medications, either on their own or on the advice of their doctors. Just over half the subjects were women, about three-quarters had type 2 diabetes, and the average age in the study was 53 years.

Twenty-three of the 37 patients (62%) reported at least one hypoglycemic event while fasting, with plasma glucose falling below 70 mg/dL. Some had up to seven events. Most told their doctors what had happened, but steps weren’t often taken to prevent future events.

“These interim results vividly confirm the occurrence of” fasting hypoglycemia “in clinical practice, and indicate a significant prevalence” among patients with diabetes. “This study serves as a means of increasing awareness about” the problem, “which clinicians appear to overlook,” concluded the investigators, led by Dr. Saleh Aldasouqi, associate professor of medicine and chief of endocrinology at Michigan State, East Lansing.

Dr. Aldasouqi first noticed the problem several years ago when practicing in Cape Girardeau, Mo. He fielded several calls there from nervous lab technicians reporting hypoglycemia in patients with diabetes who had fasted overnight. “We looked at the world literature on this at the time and found zero,” he said, except for a case report of a woman who collapsed and died while waiting for a lipid draw after fasting the night before. Her blood glucose was zero.

That report prompted Dr. Aldasouqi and his colleagues in Cape Girardeau to study the issue. They found that hypoglycemia ranged from 69-30 mg/dL among 35 patients with diabetes who recalled fasting or possibly fasting for a blood test. None recalled adjusting their medications (Diabetes Care 2011;34:e52).

Dr. Aldasouqi dubbed the problem fasting-evoked en-route hypoglycemia in diabetes (FEEHD): “en-route” to invoke the possibility that patients with diabetes might crash if their blood sugar drops too low while driving in for a blood draw, he said at the annual meeting of the American Association of Clinical Endocrinologists.

The next step in Cape Girardeau was a prevention program to monitor blood glucose and adjust medications for patients with diabetes who were fasting for a test. It reduced the incidence of hypoglycemic events by 68%, with an even greater drop in the incidence of severe hypoglycemia below 50 mg/dL (Postgrad. Med. 2013;125:136-43).

“We’ve been trying to build a case” that FEEHD really is a problem, but there’s been some skepticism because “we are trying to change a deeply rooted tradition” and the notion that diabetics can fast just like anyone else. Even so, “people are coming around now that we have data,” Dr. Aldasouqi said. Currently at Michigan State, “my group is not ordering fasting” for lipid tests, although it remains routine in other clinics there. They opted for that approach, instead of reducing diabetes medications during fasts, because of the growing evidence that patients – whether they have diabetes or not – really don’t need to fast for lipid panels, he said (Circulation 2015;131:e471).

There was no external funding for the project. Dr. Aldasouqi is a speaker or adviser for Janssen, Sanofi, and Takeda.

aotto@frontlinemedcom.com

NASHVILLE, TENN. – When ordering a fasting blood test for patients with diabetes, it’s prudent to have them cut back on their insulin and oral hypoglycemic agents to avoid hypoglycemia.

Unless they take such protective actions, an estimated half or more will be hypoglycemic by the time their blood is drawn, according to a survey from Michigan State University.

Alex Otto/Frontline Medical News
Dr. Saleh Aldasouqi

Of the 74 study participants – mostly people with type 2 diabetes – who have enrolled so far in the ongoing project, 37 (50%) reported overnight fasting for lipid profiles or other tests in the previous year. Just three cut back on their medications, either on their own or on the advice of their doctors. Just over half the subjects were women, about three-quarters had type 2 diabetes, and the average age in the study was 53 years.

Twenty-three of the 37 patients (62%) reported at least one hypoglycemic event while fasting, with plasma glucose falling below 70 mg/dL. Some had up to seven events. Most told their doctors what had happened, but steps weren’t often taken to prevent future events.

“These interim results vividly confirm the occurrence of” fasting hypoglycemia “in clinical practice, and indicate a significant prevalence” among patients with diabetes. “This study serves as a means of increasing awareness about” the problem, “which clinicians appear to overlook,” concluded the investigators, led by Dr. Saleh Aldasouqi, associate professor of medicine and chief of endocrinology at Michigan State, East Lansing.

Dr. Aldasouqi first noticed the problem several years ago when practicing in Cape Girardeau, Mo. He fielded several calls there from nervous lab technicians reporting hypoglycemia in patients with diabetes who had fasted overnight. “We looked at the world literature on this at the time and found zero,” he said, except for a case report of a woman who collapsed and died while waiting for a lipid draw after fasting the night before. Her blood glucose was zero.

That report prompted Dr. Aldasouqi and his colleagues in Cape Girardeau to study the issue. They found that hypoglycemia ranged from 69-30 mg/dL among 35 patients with diabetes who recalled fasting or possibly fasting for a blood test. None recalled adjusting their medications (Diabetes Care 2011;34:e52).

Dr. Aldasouqi dubbed the problem fasting-evoked en-route hypoglycemia in diabetes (FEEHD): “en-route” to invoke the possibility that patients with diabetes might crash if their blood sugar drops too low while driving in for a blood draw, he said at the annual meeting of the American Association of Clinical Endocrinologists.

The next step in Cape Girardeau was a prevention program to monitor blood glucose and adjust medications for patients with diabetes who were fasting for a test. It reduced the incidence of hypoglycemic events by 68%, with an even greater drop in the incidence of severe hypoglycemia below 50 mg/dL (Postgrad. Med. 2013;125:136-43).

“We’ve been trying to build a case” that FEEHD really is a problem, but there’s been some skepticism because “we are trying to change a deeply rooted tradition” and the notion that diabetics can fast just like anyone else. Even so, “people are coming around now that we have data,” Dr. Aldasouqi said. Currently at Michigan State, “my group is not ordering fasting” for lipid tests, although it remains routine in other clinics there. They opted for that approach, instead of reducing diabetes medications during fasts, because of the growing evidence that patients – whether they have diabetes or not – really don’t need to fast for lipid panels, he said (Circulation 2015;131:e471).

There was no external funding for the project. Dr. Aldasouqi is a speaker or adviser for Janssen, Sanofi, and Takeda.

aotto@frontlinemedcom.com

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Key clinical point: Reduce insulin and oral hypoglycemics while diabetic patients fast for blood tests.

Major finding: Almost two-thirds of diabetics report plasma glucose falling below 70 mg/dL while fasting for a blood test.

Data source: Survey of 74 patients with diabetes.

Disclosures: There was no outside funding for the work. The lead investigator is a speaker or advisor for Janssen, Sanofi, and Takeda.

AACE: Neck circumference signals metabolic risk measures

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AACE: Neck circumference signals metabolic risk measures

NASHVILLE, TENN. – Neck circumferences at or above 36 cm in women and 39 cm in men might signal impending metabolic problems, according to researchers from the Medical University of Sofia, Bulgaria.

When patients have necks larger than that, “it is an argument to start more active preventative strategies because they will likely develop metabolic syndrome, if it’s not already present,” said investigator Dr. Zdravko Kamenov, an endocrinologist at the university.

Dr. Zdravko Kamenov

The conclusion is based on a study of waist and neck circumference in 168 obese, hospitalized patients to see which better correlated with metabolic lab values. All the patients had a body mass index above 30 kg/m2; the average BMI was 35. About 70% of the participants were women, and patients with known diabetes, cancer, or chronic kidney or liver disease were excluded from the study.

Waist circumference is well accepted as a marker for abdominal fat and metabolic risk, but it can be difficult to measure and unreliable in obese people, and there are different opinions about where to place the measuring tape. Over the past few years, neck circumference has emerged as an easier alternative and has been associated with metabolic syndrome, obstructive sleep apnea, and heart disease when large.

“At this point, it’s probably better to measure both to increase the predictive value of anthropomorphic measurements,” Dr. Kamenov said at the annual meeting of the American Association of Clinical Endocrinologists.

Measuring both seems best because, in the study, waist circumference correlated better with plasma glucose problems, while neck circumference correlated better with other metabolic issues. Neck circumference also seemed to work better in women than in men, probably because of differences in neck musculature.

For instance, a neck circumference above 35.75 cm was the better predictor of dyslipidemia in women (odds ratio, 4.7; 95% confidence interval, 1.9-12.1,;P = .001). Neck circumference above 34.5 cm in women (OR 5.4; 95% CI 1.80-16.0; P = .003) and 38.75 cm in men (OR 24.6, 95% CI 1.5-398.1, P = 0.024) better predicted metabolic syndrome.

On the other hand, waist circumference over 100.5 cm was more predictive of type 2 diabetes in women (OR 3.2; 95% CI 1.1-9.4; P = .029). Waist circumference above 96.5 cm in women (OR 3.2; 95% CI 1.1-9.5; P = .033) and 101 cm in men was the better predictor of insulin resistance, with a sensitivity of 93% and specificity of 75% in men.

Waist circumference was taken at the midpoint between the inferior costal margin and the superior border of the iliac crest on the mid-axillary line. Neck circumference was measured between the mid-cervical spine and mid-anterior neck just below the laryngeal prominence.

To some extent, neck and waist circumference measure different things. While waist circumference measures visceral fat and to a lesser extent subcutaneous fat, neck circumference is largely a measure of subcutaneous upper body fat, which is important for the generation of the free fatty acids associated with metabolic syndrome, Dr. Kamenov said.

Patients were, on average, 52 years old; 41% turned had type 2 diabetes; 42% had prediabetes; and 87% had metabolic syndrome.

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

aotto@frontlinemedcom.com

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NASHVILLE, TENN. – Neck circumferences at or above 36 cm in women and 39 cm in men might signal impending metabolic problems, according to researchers from the Medical University of Sofia, Bulgaria.

When patients have necks larger than that, “it is an argument to start more active preventative strategies because they will likely develop metabolic syndrome, if it’s not already present,” said investigator Dr. Zdravko Kamenov, an endocrinologist at the university.

Dr. Zdravko Kamenov

The conclusion is based on a study of waist and neck circumference in 168 obese, hospitalized patients to see which better correlated with metabolic lab values. All the patients had a body mass index above 30 kg/m2; the average BMI was 35. About 70% of the participants were women, and patients with known diabetes, cancer, or chronic kidney or liver disease were excluded from the study.

Waist circumference is well accepted as a marker for abdominal fat and metabolic risk, but it can be difficult to measure and unreliable in obese people, and there are different opinions about where to place the measuring tape. Over the past few years, neck circumference has emerged as an easier alternative and has been associated with metabolic syndrome, obstructive sleep apnea, and heart disease when large.

“At this point, it’s probably better to measure both to increase the predictive value of anthropomorphic measurements,” Dr. Kamenov said at the annual meeting of the American Association of Clinical Endocrinologists.

Measuring both seems best because, in the study, waist circumference correlated better with plasma glucose problems, while neck circumference correlated better with other metabolic issues. Neck circumference also seemed to work better in women than in men, probably because of differences in neck musculature.

For instance, a neck circumference above 35.75 cm was the better predictor of dyslipidemia in women (odds ratio, 4.7; 95% confidence interval, 1.9-12.1,;P = .001). Neck circumference above 34.5 cm in women (OR 5.4; 95% CI 1.80-16.0; P = .003) and 38.75 cm in men (OR 24.6, 95% CI 1.5-398.1, P = 0.024) better predicted metabolic syndrome.

On the other hand, waist circumference over 100.5 cm was more predictive of type 2 diabetes in women (OR 3.2; 95% CI 1.1-9.4; P = .029). Waist circumference above 96.5 cm in women (OR 3.2; 95% CI 1.1-9.5; P = .033) and 101 cm in men was the better predictor of insulin resistance, with a sensitivity of 93% and specificity of 75% in men.

Waist circumference was taken at the midpoint between the inferior costal margin and the superior border of the iliac crest on the mid-axillary line. Neck circumference was measured between the mid-cervical spine and mid-anterior neck just below the laryngeal prominence.

To some extent, neck and waist circumference measure different things. While waist circumference measures visceral fat and to a lesser extent subcutaneous fat, neck circumference is largely a measure of subcutaneous upper body fat, which is important for the generation of the free fatty acids associated with metabolic syndrome, Dr. Kamenov said.

Patients were, on average, 52 years old; 41% turned had type 2 diabetes; 42% had prediabetes; and 87% had metabolic syndrome.

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

aotto@frontlinemedcom.com

NASHVILLE, TENN. – Neck circumferences at or above 36 cm in women and 39 cm in men might signal impending metabolic problems, according to researchers from the Medical University of Sofia, Bulgaria.

When patients have necks larger than that, “it is an argument to start more active preventative strategies because they will likely develop metabolic syndrome, if it’s not already present,” said investigator Dr. Zdravko Kamenov, an endocrinologist at the university.

Dr. Zdravko Kamenov

The conclusion is based on a study of waist and neck circumference in 168 obese, hospitalized patients to see which better correlated with metabolic lab values. All the patients had a body mass index above 30 kg/m2; the average BMI was 35. About 70% of the participants were women, and patients with known diabetes, cancer, or chronic kidney or liver disease were excluded from the study.

Waist circumference is well accepted as a marker for abdominal fat and metabolic risk, but it can be difficult to measure and unreliable in obese people, and there are different opinions about where to place the measuring tape. Over the past few years, neck circumference has emerged as an easier alternative and has been associated with metabolic syndrome, obstructive sleep apnea, and heart disease when large.

“At this point, it’s probably better to measure both to increase the predictive value of anthropomorphic measurements,” Dr. Kamenov said at the annual meeting of the American Association of Clinical Endocrinologists.

Measuring both seems best because, in the study, waist circumference correlated better with plasma glucose problems, while neck circumference correlated better with other metabolic issues. Neck circumference also seemed to work better in women than in men, probably because of differences in neck musculature.

For instance, a neck circumference above 35.75 cm was the better predictor of dyslipidemia in women (odds ratio, 4.7; 95% confidence interval, 1.9-12.1,;P = .001). Neck circumference above 34.5 cm in women (OR 5.4; 95% CI 1.80-16.0; P = .003) and 38.75 cm in men (OR 24.6, 95% CI 1.5-398.1, P = 0.024) better predicted metabolic syndrome.

On the other hand, waist circumference over 100.5 cm was more predictive of type 2 diabetes in women (OR 3.2; 95% CI 1.1-9.4; P = .029). Waist circumference above 96.5 cm in women (OR 3.2; 95% CI 1.1-9.5; P = .033) and 101 cm in men was the better predictor of insulin resistance, with a sensitivity of 93% and specificity of 75% in men.

Waist circumference was taken at the midpoint between the inferior costal margin and the superior border of the iliac crest on the mid-axillary line. Neck circumference was measured between the mid-cervical spine and mid-anterior neck just below the laryngeal prominence.

To some extent, neck and waist circumference measure different things. While waist circumference measures visceral fat and to a lesser extent subcutaneous fat, neck circumference is largely a measure of subcutaneous upper body fat, which is important for the generation of the free fatty acids associated with metabolic syndrome, Dr. Kamenov said.

Patients were, on average, 52 years old; 41% turned had type 2 diabetes; 42% had prediabetes; and 87% had metabolic syndrome.

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

aotto@frontlinemedcom.com

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Key clinical point: To improve evaluation for metabolic syndrome, take a second to check the neck circumference of your patients.

Major finding: Neck circumference above 34.5 cm in women (OR 5.4, 95% CI 1.80-16.0, P = 0.003) and 38.75 cm in men (OR 24.6, 95% CI 1.5-398.1, P = 0.024) predicts metabolic syndrome better than does waist circumference.

Data source: Study of waist and neck circumference in 168 obese, hospitalized patients.

Disclosures: There was no outside funding for the work, and the lead investigator has no relevant disclosures.

AACE: How to safely skip radioactive iodine for low-grade thyroid cancer

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NASHVILLE, TENN. – Patients with stage I or II differentiated thyroid cancers do not need radioactive iodine treatment if their nonsuppressed thyroglobulin level is less than 2 ng/mL 2 weeks after surgery, according to Dr. Kathleen Hands.

When that’s the case, “I know the patient had an excellent surgery and will have an excellent prognosis with an extremely low likelihood of recurrence over the next 10 years without radioactive iodine. These patients can be managed safely and effectively without radioactive iodine in a community setting,” said Dr. Hands, a thyroidologist who practices in San Antonio.

Dr. Kathleen Hands

It’s common for patients in the United States to receive iodine-131 (I-131) after surgery for low-risk thyroid cancers “despite the abundance of evidence” showing that it does them no good and may cause harm and despite guidelines calling for conservative use of I-131, she said (World. J. Surg. 2002;26:879-85).

“It’s a habit,” a holdover from decades ago “when we didn’t actually have good surgical technique. We need to [heed recent data] and step away from what we did in the 60s, 70s, and 80s and get into the 21st century. We should stop using radioactive iodine in these low-risk patients,” Dr. Hands said at the American Association of Clinical Endocrinologists annual meeting.

Among radioactive iodine’s drawbacks are its expense and sometimes salivary and lacrimal problems associated with its use. Earlier in her career, “I personally had two of my cases” – 19 and 22 years old – “develop acute myelogenous leukemia [shortly] after I-131, one of whom succumbed. I took that very seriously. I’ve become very conservative in the use of this drug. Ablation should be restricted to patients with incomplete surgical excision or poor prognostic factors for recurrence or death,” she said.

This advice is backed up by findings from her review of 378 patients who underwent surgery for differentiated thyroid cancer, with MACIS (metastasis, age, completeness of resection, invasion, and size) scores below 7, meaning low-intermediate-risk disease. Patients ranged from 18 to 79 years old. The majority were women, and about a third had multifocal disease. Tumor sizes ranged from 0.8 mm to 4.0 cm. Twenty-one patients under 45 years old had lymph node metastases of less than 5 mm.

The patients had nonsuppressed thyroglobulin levels below 2 ng/mL 2 weeks after surgery. They opted against I-131, and were started on levothyroxine. There’s been no recurrence of disease in the group after 8 years’ follow-up; thyroglobulin was undetectable in 72% by 2 years. Those in whom thyroglobulin remained detectable had thyroglobulin velocities below 10% over a period of 5 years.

“Nonsuppressed thyroglobulin” means that the patients were not put on thyroxine right after surgery, so that Dr. Hands could get an idea if any tumor was left 2 weeks later. They also weren’t put on low-iodine diets in the interim, she said, because she had no intention of giving them I-131.

To get the most out of the approach, patients need excellent and complete surgeries. That means that endocrinologists should learn to perform preoperative neck ultrasounds – or refer to someone who can – to give surgeons a heads-up about tumor location, size, shape, and invasiveness, as well as lymph node involvement, calcifications, and other issues. “This is the kind of information your surgeon needs” to do a good job, Dr. Hands said.

She said she doesn’t worry about hypothyroidism when patients don’t get thyroxine right after surgery. Manipulation of the thyroid during surgery releases hormone into the system, and “I think that tides them over; It’s a long-acting hormone. Patients tolerate not having replacement immediately [after surgery],” Dr. Hands said.

There was no funding for the project, and Dr. Hands said she had no relevant financial disclosures.

aotto@frontlinemedcom.com

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NASHVILLE, TENN. – Patients with stage I or II differentiated thyroid cancers do not need radioactive iodine treatment if their nonsuppressed thyroglobulin level is less than 2 ng/mL 2 weeks after surgery, according to Dr. Kathleen Hands.

When that’s the case, “I know the patient had an excellent surgery and will have an excellent prognosis with an extremely low likelihood of recurrence over the next 10 years without radioactive iodine. These patients can be managed safely and effectively without radioactive iodine in a community setting,” said Dr. Hands, a thyroidologist who practices in San Antonio.

Dr. Kathleen Hands

It’s common for patients in the United States to receive iodine-131 (I-131) after surgery for low-risk thyroid cancers “despite the abundance of evidence” showing that it does them no good and may cause harm and despite guidelines calling for conservative use of I-131, she said (World. J. Surg. 2002;26:879-85).

“It’s a habit,” a holdover from decades ago “when we didn’t actually have good surgical technique. We need to [heed recent data] and step away from what we did in the 60s, 70s, and 80s and get into the 21st century. We should stop using radioactive iodine in these low-risk patients,” Dr. Hands said at the American Association of Clinical Endocrinologists annual meeting.

Among radioactive iodine’s drawbacks are its expense and sometimes salivary and lacrimal problems associated with its use. Earlier in her career, “I personally had two of my cases” – 19 and 22 years old – “develop acute myelogenous leukemia [shortly] after I-131, one of whom succumbed. I took that very seriously. I’ve become very conservative in the use of this drug. Ablation should be restricted to patients with incomplete surgical excision or poor prognostic factors for recurrence or death,” she said.

This advice is backed up by findings from her review of 378 patients who underwent surgery for differentiated thyroid cancer, with MACIS (metastasis, age, completeness of resection, invasion, and size) scores below 7, meaning low-intermediate-risk disease. Patients ranged from 18 to 79 years old. The majority were women, and about a third had multifocal disease. Tumor sizes ranged from 0.8 mm to 4.0 cm. Twenty-one patients under 45 years old had lymph node metastases of less than 5 mm.

The patients had nonsuppressed thyroglobulin levels below 2 ng/mL 2 weeks after surgery. They opted against I-131, and were started on levothyroxine. There’s been no recurrence of disease in the group after 8 years’ follow-up; thyroglobulin was undetectable in 72% by 2 years. Those in whom thyroglobulin remained detectable had thyroglobulin velocities below 10% over a period of 5 years.

“Nonsuppressed thyroglobulin” means that the patients were not put on thyroxine right after surgery, so that Dr. Hands could get an idea if any tumor was left 2 weeks later. They also weren’t put on low-iodine diets in the interim, she said, because she had no intention of giving them I-131.

To get the most out of the approach, patients need excellent and complete surgeries. That means that endocrinologists should learn to perform preoperative neck ultrasounds – or refer to someone who can – to give surgeons a heads-up about tumor location, size, shape, and invasiveness, as well as lymph node involvement, calcifications, and other issues. “This is the kind of information your surgeon needs” to do a good job, Dr. Hands said.

She said she doesn’t worry about hypothyroidism when patients don’t get thyroxine right after surgery. Manipulation of the thyroid during surgery releases hormone into the system, and “I think that tides them over; It’s a long-acting hormone. Patients tolerate not having replacement immediately [after surgery],” Dr. Hands said.

There was no funding for the project, and Dr. Hands said she had no relevant financial disclosures.

aotto@frontlinemedcom.com

NASHVILLE, TENN. – Patients with stage I or II differentiated thyroid cancers do not need radioactive iodine treatment if their nonsuppressed thyroglobulin level is less than 2 ng/mL 2 weeks after surgery, according to Dr. Kathleen Hands.

When that’s the case, “I know the patient had an excellent surgery and will have an excellent prognosis with an extremely low likelihood of recurrence over the next 10 years without radioactive iodine. These patients can be managed safely and effectively without radioactive iodine in a community setting,” said Dr. Hands, a thyroidologist who practices in San Antonio.

Dr. Kathleen Hands

It’s common for patients in the United States to receive iodine-131 (I-131) after surgery for low-risk thyroid cancers “despite the abundance of evidence” showing that it does them no good and may cause harm and despite guidelines calling for conservative use of I-131, she said (World. J. Surg. 2002;26:879-85).

“It’s a habit,” a holdover from decades ago “when we didn’t actually have good surgical technique. We need to [heed recent data] and step away from what we did in the 60s, 70s, and 80s and get into the 21st century. We should stop using radioactive iodine in these low-risk patients,” Dr. Hands said at the American Association of Clinical Endocrinologists annual meeting.

Among radioactive iodine’s drawbacks are its expense and sometimes salivary and lacrimal problems associated with its use. Earlier in her career, “I personally had two of my cases” – 19 and 22 years old – “develop acute myelogenous leukemia [shortly] after I-131, one of whom succumbed. I took that very seriously. I’ve become very conservative in the use of this drug. Ablation should be restricted to patients with incomplete surgical excision or poor prognostic factors for recurrence or death,” she said.

This advice is backed up by findings from her review of 378 patients who underwent surgery for differentiated thyroid cancer, with MACIS (metastasis, age, completeness of resection, invasion, and size) scores below 7, meaning low-intermediate-risk disease. Patients ranged from 18 to 79 years old. The majority were women, and about a third had multifocal disease. Tumor sizes ranged from 0.8 mm to 4.0 cm. Twenty-one patients under 45 years old had lymph node metastases of less than 5 mm.

The patients had nonsuppressed thyroglobulin levels below 2 ng/mL 2 weeks after surgery. They opted against I-131, and were started on levothyroxine. There’s been no recurrence of disease in the group after 8 years’ follow-up; thyroglobulin was undetectable in 72% by 2 years. Those in whom thyroglobulin remained detectable had thyroglobulin velocities below 10% over a period of 5 years.

“Nonsuppressed thyroglobulin” means that the patients were not put on thyroxine right after surgery, so that Dr. Hands could get an idea if any tumor was left 2 weeks later. They also weren’t put on low-iodine diets in the interim, she said, because she had no intention of giving them I-131.

To get the most out of the approach, patients need excellent and complete surgeries. That means that endocrinologists should learn to perform preoperative neck ultrasounds – or refer to someone who can – to give surgeons a heads-up about tumor location, size, shape, and invasiveness, as well as lymph node involvement, calcifications, and other issues. “This is the kind of information your surgeon needs” to do a good job, Dr. Hands said.

She said she doesn’t worry about hypothyroidism when patients don’t get thyroxine right after surgery. Manipulation of the thyroid during surgery releases hormone into the system, and “I think that tides them over; It’s a long-acting hormone. Patients tolerate not having replacement immediately [after surgery],” Dr. Hands said.

There was no funding for the project, and Dr. Hands said she had no relevant financial disclosures.

aotto@frontlinemedcom.com

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Key clinical point: Thyroid cancer patients do not need radioactive iodine treatment if their nonsuppressed thyroglobulin is less than 2 ng/mL 2 weeks after surgery.

Major finding: Among 378 patients whose nonsuppressed thyroglobulin levels were below 2 ng/mL 2 weeks after removal of low-risk differentiated thyroid cancers, there were zero recurrences over 8 years of follow-up.

Data source: A single-center, retrospective study.

Disclosures: The investigator said she had no relevant financial disclosures and no outside funding.

AACE: Try medical management before surgery for hyperinsulinemic hypoglycemia after gastric bypass

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AACE: Try medical management before surgery for hyperinsulinemic hypoglycemia after gastric bypass

NASHVILLE, TENN. – Postprandial hyperinsulinemic hypoglycemia after gastric bypass surgery can be managed or even corrected by medical management with calcium channel blockers or acarbose.

First described in 2005, it is a rare complication distinct from dumping syndrome, which is common after bypass. For unknown reasons, the pancreas starts to oversecrete insulin in response to even small meals a few months to a few decades after gastric bypass surgery. Until now, treatment has often meant partial or even total pancreatectomy (N. Engl. J. Med. 2005;353:249-54).

Dr. John Mordes

“The message from me is very simple: There’s a medical alternative to surgery. Before you take these people to surgery, try medical management,” said Dr. John Mordes, an endocrinologist and professor of medicine at the University of Massachusetts Medical School in Worcester.

The study involved five patients, who were seen there after suddenly developing severe, sometimes daily, postprandial hypoglycemic attacks from 1 to 26 years after Roux-en-Y bypass; several had passed out after meals. On 75-g fasting-glucose challenges, their insulin levels were at or above 17 microU/mL, despite glucose concentrations at or below 54 mg/dL. None of the patients had evidence of insulinomas, and none was on exogenous insulin or diabetes drugs. Their hemoglobin A1c levels were below 6% (Endocr. Pract. 2015;21:237-46).

The first patient refused surgery, “so we researched the literature” and found that nifedipine helped infants with congenital nesidioblastosis in a study from India. The drug worked at a dose of 30 mg extended release once daily; 30 mg t.i.d. worked in the second patient. Calcium channel blockers blunt insulin secretion, which probably explains why nifedipine helped, Dr. Mordes said at the annual meeting of the American Association of Clinical Endocrinologists.

Both patients stopped taking the pills on their own after about 3 years; their symptoms hadn’t returned after a year or more of follow-up.

The third and fourth patients couldn’t tolerate nifedipine, so Dr. Mordes tried acarbose to slow absorption of glucose from the gut; it also worked. One patient has had only two mild attacks on 50 mg t.i.d for 15 months; the fourth was symptom free while on 25 mg t.i.d for 2 months. That patient stopped the drug at that point, and remained symptom free for 9 more months, but since then has had about one attack a month. The fifth patient has been symptom free for about 6 months on a combination of nifedipine 20 mg t.i.d. and acarbose 50 mg t.i.d, and has no intention of stopping either.

The subjects gained from a few to almost 50 pounds while on the drugs, which might also have contributed to their recovery. Overall, they “are fine now. None of them have needed surgery,” and they’re happy to have avoided it, Dr. Mordes said.

All that’s needed to diagnose the problem is a history of exclusively postprandial symptoms of hypoglycemia with no vasomotor or bowel symptoms suggestive of dumping, plus confirmatory blood work. Invasive tests aren’t necessary, he said.

A sixth patient didn’t respond to nifedipine, acarbose, or the insulinoma drug diazoxide, but she was atypical in that she had a decades-long history of nocturnal hypoglycemic events following a gastric bypass in Mexico at age 13 years for pyloric stenosis. “Something is very different about her,” Dr. Mordes said.

He said he had no relevant financial disclosures, and no outside funding for his work.

aotto@frontlinemedcom.com


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NASHVILLE, TENN. – Postprandial hyperinsulinemic hypoglycemia after gastric bypass surgery can be managed or even corrected by medical management with calcium channel blockers or acarbose.

First described in 2005, it is a rare complication distinct from dumping syndrome, which is common after bypass. For unknown reasons, the pancreas starts to oversecrete insulin in response to even small meals a few months to a few decades after gastric bypass surgery. Until now, treatment has often meant partial or even total pancreatectomy (N. Engl. J. Med. 2005;353:249-54).

Dr. John Mordes

“The message from me is very simple: There’s a medical alternative to surgery. Before you take these people to surgery, try medical management,” said Dr. John Mordes, an endocrinologist and professor of medicine at the University of Massachusetts Medical School in Worcester.

The study involved five patients, who were seen there after suddenly developing severe, sometimes daily, postprandial hypoglycemic attacks from 1 to 26 years after Roux-en-Y bypass; several had passed out after meals. On 75-g fasting-glucose challenges, their insulin levels were at or above 17 microU/mL, despite glucose concentrations at or below 54 mg/dL. None of the patients had evidence of insulinomas, and none was on exogenous insulin or diabetes drugs. Their hemoglobin A1c levels were below 6% (Endocr. Pract. 2015;21:237-46).

The first patient refused surgery, “so we researched the literature” and found that nifedipine helped infants with congenital nesidioblastosis in a study from India. The drug worked at a dose of 30 mg extended release once daily; 30 mg t.i.d. worked in the second patient. Calcium channel blockers blunt insulin secretion, which probably explains why nifedipine helped, Dr. Mordes said at the annual meeting of the American Association of Clinical Endocrinologists.

Both patients stopped taking the pills on their own after about 3 years; their symptoms hadn’t returned after a year or more of follow-up.

The third and fourth patients couldn’t tolerate nifedipine, so Dr. Mordes tried acarbose to slow absorption of glucose from the gut; it also worked. One patient has had only two mild attacks on 50 mg t.i.d for 15 months; the fourth was symptom free while on 25 mg t.i.d for 2 months. That patient stopped the drug at that point, and remained symptom free for 9 more months, but since then has had about one attack a month. The fifth patient has been symptom free for about 6 months on a combination of nifedipine 20 mg t.i.d. and acarbose 50 mg t.i.d, and has no intention of stopping either.

The subjects gained from a few to almost 50 pounds while on the drugs, which might also have contributed to their recovery. Overall, they “are fine now. None of them have needed surgery,” and they’re happy to have avoided it, Dr. Mordes said.

All that’s needed to diagnose the problem is a history of exclusively postprandial symptoms of hypoglycemia with no vasomotor or bowel symptoms suggestive of dumping, plus confirmatory blood work. Invasive tests aren’t necessary, he said.

A sixth patient didn’t respond to nifedipine, acarbose, or the insulinoma drug diazoxide, but she was atypical in that she had a decades-long history of nocturnal hypoglycemic events following a gastric bypass in Mexico at age 13 years for pyloric stenosis. “Something is very different about her,” Dr. Mordes said.

He said he had no relevant financial disclosures, and no outside funding for his work.

aotto@frontlinemedcom.com


NASHVILLE, TENN. – Postprandial hyperinsulinemic hypoglycemia after gastric bypass surgery can be managed or even corrected by medical management with calcium channel blockers or acarbose.

First described in 2005, it is a rare complication distinct from dumping syndrome, which is common after bypass. For unknown reasons, the pancreas starts to oversecrete insulin in response to even small meals a few months to a few decades after gastric bypass surgery. Until now, treatment has often meant partial or even total pancreatectomy (N. Engl. J. Med. 2005;353:249-54).

Dr. John Mordes

“The message from me is very simple: There’s a medical alternative to surgery. Before you take these people to surgery, try medical management,” said Dr. John Mordes, an endocrinologist and professor of medicine at the University of Massachusetts Medical School in Worcester.

The study involved five patients, who were seen there after suddenly developing severe, sometimes daily, postprandial hypoglycemic attacks from 1 to 26 years after Roux-en-Y bypass; several had passed out after meals. On 75-g fasting-glucose challenges, their insulin levels were at or above 17 microU/mL, despite glucose concentrations at or below 54 mg/dL. None of the patients had evidence of insulinomas, and none was on exogenous insulin or diabetes drugs. Their hemoglobin A1c levels were below 6% (Endocr. Pract. 2015;21:237-46).

The first patient refused surgery, “so we researched the literature” and found that nifedipine helped infants with congenital nesidioblastosis in a study from India. The drug worked at a dose of 30 mg extended release once daily; 30 mg t.i.d. worked in the second patient. Calcium channel blockers blunt insulin secretion, which probably explains why nifedipine helped, Dr. Mordes said at the annual meeting of the American Association of Clinical Endocrinologists.

Both patients stopped taking the pills on their own after about 3 years; their symptoms hadn’t returned after a year or more of follow-up.

The third and fourth patients couldn’t tolerate nifedipine, so Dr. Mordes tried acarbose to slow absorption of glucose from the gut; it also worked. One patient has had only two mild attacks on 50 mg t.i.d for 15 months; the fourth was symptom free while on 25 mg t.i.d for 2 months. That patient stopped the drug at that point, and remained symptom free for 9 more months, but since then has had about one attack a month. The fifth patient has been symptom free for about 6 months on a combination of nifedipine 20 mg t.i.d. and acarbose 50 mg t.i.d, and has no intention of stopping either.

The subjects gained from a few to almost 50 pounds while on the drugs, which might also have contributed to their recovery. Overall, they “are fine now. None of them have needed surgery,” and they’re happy to have avoided it, Dr. Mordes said.

All that’s needed to diagnose the problem is a history of exclusively postprandial symptoms of hypoglycemia with no vasomotor or bowel symptoms suggestive of dumping, plus confirmatory blood work. Invasive tests aren’t necessary, he said.

A sixth patient didn’t respond to nifedipine, acarbose, or the insulinoma drug diazoxide, but she was atypical in that she had a decades-long history of nocturnal hypoglycemic events following a gastric bypass in Mexico at age 13 years for pyloric stenosis. “Something is very different about her,” Dr. Mordes said.

He said he had no relevant financial disclosures, and no outside funding for his work.

aotto@frontlinemedcom.com


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Key clinical point: Hyperinsulinemic hypoglycemia after gastric bypass doesn’t require surgery.

Major finding: Hypoglycemic attacks were reduced or eliminated by nifedipine, acarbose, or both in five patients with hyperinsulinemic hypoglycemia after gastric bypass.

Data source: A case series at the University of Massachusetts Medical School.

Disclosures: The investigator said he had no relevant financial disclosures, and no outside funding for his work.

AACE: Endocrine treatment of childhood cancer survivors needs improvement

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NASHVILLE – Endocrinologists dealing with adult patients who survived cancer during childhood should ensure that they have an adequate understanding of the elevated risk that such patients are at for various endocrine conditions, such as hypogonadism, hypopituitarism, and ovarian failure.

This is according to the findings of a survey study presented at the annual meeting of the American Association of Clinical Endocrinologists by Dr. Sripriya Raman of Children’s Mercy Hospital and Clinics in Kansas City, Missouri.

“Incidences of childhood cancer have crept up from 1975 to 1995, but mortality has gone down, thanks to advancements in cancer therapy,” explained Dr. Raman. “Even among ethnic groups – whites, Hispanics, African Americans, and Asians – cancer incidence rates have either stabilized or increased slightly, which means we’re seeing more and more of these types of patients at our clinics.”

Dr. Raman and coinvestigators developed a survey of 19 questions: 10 questions on provider characteristics, 5 on demographic data, and 4 questions derived from two clinical vignettes. This survey was then sent to 294 endocrinologists belonging to either the Pediatric Endocrine Society (PES) or the AACE between October and December 2014; 274 surveys were returned either complete or near complete. Of those, 231 (84%) were from pediatric endocrinologists (PE) and 43 (16%) were from adult endocrinologists (AE).

None of the AE clinics reported having a focus clinic for childhood cancer survivors in their practices, compared with 54% of PE practices that reported having such a focus clinic (P < .001). Furthermore, 84% of practices that reported a general lack of adequate training, confidence, and general awareness of the long-term follow-up guidelines for treating childhood cancer survivors were AE, compared with 16% PE (P < .001).

Overall, 53% of practices reported receiving cancer treatment summaries for their patients on a consistent basis. Regarding the training they’ve received on how to treat childhood cancer survivors, 65% reported receiving “somewhat adequate training” but 22% reported receiving either very little or no training all. While 67% of practices reported feeling “somewhat confident” in their ability to properly treat childhood cancer survivors, 10% reported feeling either very little or no confidence. Infertility and growth hormone deficiency were the most commonly cited conditions reported by AE clinics that responded to the survey.

Of PE practices, 64% reported following at least six patients who were childhood cancer survivors, while only 19% of AE practices reported the same (P < .001). Regarding the clinical vignettes, PE practices scored higher than their AE counterparts on identifying childhood cancer survivors’ susceptibility to cranial radiation (76% vs. 50%; P = .001) and ovarian failure (28% vs. 13%; P = .048), but there was “no significant difference” in scores on the topics of hypopituitarism and hypogonadism.

Nearly 1 out of every 640 young adults in the United States are childhood cancer survivors, and roughly 40% of those will experience at least one endocrine disorder at some point in their adult life. To solve the issue of insufficient experience or preparation regarding treatment of these patients, Dr. Raman suggested that practices create personalized management plans with specific protocols derived from clinical guidelines and expert opinions. These protocols could either be cancer center based, community based, or a hybrid of the two, which would involve care at a community site along with “close collaboration with [a] cancer center.”

“There are no treatment guidelines specifically for endocrinologists,” said Dr. Raman. “There are screening guidelines, which are more guided towards oncologists [and] family practitioners who would be seeing these patients with the idea that they would be referred to endocrinologists once they identify a problem.”

Dr. Raman did not report any relevant financial disclosures.

dchitnis@frontlinemedcom.com

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NASHVILLE – Endocrinologists dealing with adult patients who survived cancer during childhood should ensure that they have an adequate understanding of the elevated risk that such patients are at for various endocrine conditions, such as hypogonadism, hypopituitarism, and ovarian failure.

This is according to the findings of a survey study presented at the annual meeting of the American Association of Clinical Endocrinologists by Dr. Sripriya Raman of Children’s Mercy Hospital and Clinics in Kansas City, Missouri.

“Incidences of childhood cancer have crept up from 1975 to 1995, but mortality has gone down, thanks to advancements in cancer therapy,” explained Dr. Raman. “Even among ethnic groups – whites, Hispanics, African Americans, and Asians – cancer incidence rates have either stabilized or increased slightly, which means we’re seeing more and more of these types of patients at our clinics.”

Dr. Raman and coinvestigators developed a survey of 19 questions: 10 questions on provider characteristics, 5 on demographic data, and 4 questions derived from two clinical vignettes. This survey was then sent to 294 endocrinologists belonging to either the Pediatric Endocrine Society (PES) or the AACE between October and December 2014; 274 surveys were returned either complete or near complete. Of those, 231 (84%) were from pediatric endocrinologists (PE) and 43 (16%) were from adult endocrinologists (AE).

None of the AE clinics reported having a focus clinic for childhood cancer survivors in their practices, compared with 54% of PE practices that reported having such a focus clinic (P < .001). Furthermore, 84% of practices that reported a general lack of adequate training, confidence, and general awareness of the long-term follow-up guidelines for treating childhood cancer survivors were AE, compared with 16% PE (P < .001).

Overall, 53% of practices reported receiving cancer treatment summaries for their patients on a consistent basis. Regarding the training they’ve received on how to treat childhood cancer survivors, 65% reported receiving “somewhat adequate training” but 22% reported receiving either very little or no training all. While 67% of practices reported feeling “somewhat confident” in their ability to properly treat childhood cancer survivors, 10% reported feeling either very little or no confidence. Infertility and growth hormone deficiency were the most commonly cited conditions reported by AE clinics that responded to the survey.

Of PE practices, 64% reported following at least six patients who were childhood cancer survivors, while only 19% of AE practices reported the same (P < .001). Regarding the clinical vignettes, PE practices scored higher than their AE counterparts on identifying childhood cancer survivors’ susceptibility to cranial radiation (76% vs. 50%; P = .001) and ovarian failure (28% vs. 13%; P = .048), but there was “no significant difference” in scores on the topics of hypopituitarism and hypogonadism.

Nearly 1 out of every 640 young adults in the United States are childhood cancer survivors, and roughly 40% of those will experience at least one endocrine disorder at some point in their adult life. To solve the issue of insufficient experience or preparation regarding treatment of these patients, Dr. Raman suggested that practices create personalized management plans with specific protocols derived from clinical guidelines and expert opinions. These protocols could either be cancer center based, community based, or a hybrid of the two, which would involve care at a community site along with “close collaboration with [a] cancer center.”

“There are no treatment guidelines specifically for endocrinologists,” said Dr. Raman. “There are screening guidelines, which are more guided towards oncologists [and] family practitioners who would be seeing these patients with the idea that they would be referred to endocrinologists once they identify a problem.”

Dr. Raman did not report any relevant financial disclosures.

dchitnis@frontlinemedcom.com

NASHVILLE – Endocrinologists dealing with adult patients who survived cancer during childhood should ensure that they have an adequate understanding of the elevated risk that such patients are at for various endocrine conditions, such as hypogonadism, hypopituitarism, and ovarian failure.

This is according to the findings of a survey study presented at the annual meeting of the American Association of Clinical Endocrinologists by Dr. Sripriya Raman of Children’s Mercy Hospital and Clinics in Kansas City, Missouri.

“Incidences of childhood cancer have crept up from 1975 to 1995, but mortality has gone down, thanks to advancements in cancer therapy,” explained Dr. Raman. “Even among ethnic groups – whites, Hispanics, African Americans, and Asians – cancer incidence rates have either stabilized or increased slightly, which means we’re seeing more and more of these types of patients at our clinics.”

Dr. Raman and coinvestigators developed a survey of 19 questions: 10 questions on provider characteristics, 5 on demographic data, and 4 questions derived from two clinical vignettes. This survey was then sent to 294 endocrinologists belonging to either the Pediatric Endocrine Society (PES) or the AACE between October and December 2014; 274 surveys were returned either complete or near complete. Of those, 231 (84%) were from pediatric endocrinologists (PE) and 43 (16%) were from adult endocrinologists (AE).

None of the AE clinics reported having a focus clinic for childhood cancer survivors in their practices, compared with 54% of PE practices that reported having such a focus clinic (P < .001). Furthermore, 84% of practices that reported a general lack of adequate training, confidence, and general awareness of the long-term follow-up guidelines for treating childhood cancer survivors were AE, compared with 16% PE (P < .001).

Overall, 53% of practices reported receiving cancer treatment summaries for their patients on a consistent basis. Regarding the training they’ve received on how to treat childhood cancer survivors, 65% reported receiving “somewhat adequate training” but 22% reported receiving either very little or no training all. While 67% of practices reported feeling “somewhat confident” in their ability to properly treat childhood cancer survivors, 10% reported feeling either very little or no confidence. Infertility and growth hormone deficiency were the most commonly cited conditions reported by AE clinics that responded to the survey.

Of PE practices, 64% reported following at least six patients who were childhood cancer survivors, while only 19% of AE practices reported the same (P < .001). Regarding the clinical vignettes, PE practices scored higher than their AE counterparts on identifying childhood cancer survivors’ susceptibility to cranial radiation (76% vs. 50%; P = .001) and ovarian failure (28% vs. 13%; P = .048), but there was “no significant difference” in scores on the topics of hypopituitarism and hypogonadism.

Nearly 1 out of every 640 young adults in the United States are childhood cancer survivors, and roughly 40% of those will experience at least one endocrine disorder at some point in their adult life. To solve the issue of insufficient experience or preparation regarding treatment of these patients, Dr. Raman suggested that practices create personalized management plans with specific protocols derived from clinical guidelines and expert opinions. These protocols could either be cancer center based, community based, or a hybrid of the two, which would involve care at a community site along with “close collaboration with [a] cancer center.”

“There are no treatment guidelines specifically for endocrinologists,” said Dr. Raman. “There are screening guidelines, which are more guided towards oncologists [and] family practitioners who would be seeing these patients with the idea that they would be referred to endocrinologists once they identify a problem.”

Dr. Raman did not report any relevant financial disclosures.

dchitnis@frontlinemedcom.com

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Key clinical point: Endocrinologists treating adult patients who are childhood cancer survivors often do not adequately address these patients’ elevated risk for various endocrine conditions.

Major finding: Of 274 surveys completed by members of PES and AACE, 84% of adult endocrinologists vs. 16% of pediatric endocrinologists reported a lack of awareness of long-term follow-up guidelines.

Data source: Survey of 274 members of PES and AACE sent between October and December 2014.

Disclosures: Dr. Raman did not report any relevant financial disclosures.

AACE: Bisphosphonates do not prevent fractures in adults with osteogenesis imperfecta

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AACE: Bisphosphonates do not prevent fractures in adults with osteogenesis imperfecta

NASHVILLE, TENN. – Bisphosphonates help prevent fractures in some children with osteogenesis imperfecta, but they don't do the same for adults with the condition, according to a review from Johns Hopkins University and the Kennedy Krieger Institute.

Even so, bisphosphonates are used widely for adult osteogenesis imperfecta (OI) “because people have nothing else to hang their hat on, and the average physician doesn’t understand that osteogenesis imperfecta is not the same as age-related osteoporosis,” said senior investigator Dr. Jay R. Shapiro, director of Kennedy Krieger’s osteogenesis imperfecta program in Baltimore.

Dr. Jay R. Shapiro

“We see adults with OI all the time who have been on bisphosphonates for 10 years, 12 years. It’s not doing anything for them, and sooner or later they come to realize that.” Meanwhile, “I think people are getting a little bit of a queasy feeling about not fully understanding the effectiveness and side effects of long-term treatment with bisphosphonates,” said Dr. Shapiro, also professor in the department of physical medicine and rehabilitation at Johns Hopkins University, Baltimore.

Adults with OI “also don’t respond to Forteo [teriparatide]. I do not recommend treatment with bisphosphonates or Forteo in” adults, he said at the annual meeting of the American Association of Clinical Endocrinologists.

Dr. Shapiro shared his thoughts during an interview regarding his latest study, an analysis of five children with OI under 18 years of age who responded to pamidronate (Aredia) and 11 who did not, meaning that they had two or more fractures per year while on the drug.

His team also compared fracture outcomes in 34 adults with OI treated with oral or intravenous bisphosphonates with 12 untreated adults. The adults were, on average, 52 years old.

The goal was to see if common bone markers predicted who would respond to bisphosphonates, but they did not. Vitamin D, phosphorus, alkaline phosphatase, C-telopeptide, and other measures were the same in children regardless of their response to pamidronate, and the same in adults with OI whether or not they were on bisphosphonates.

“We have not yet defined what the difference is between responders and nonresponders. If you take a crack at the simple things, they don’t help,” Dr. Shapiro said.

Children who responded had a mean of 4.8 fractures over an average of 42.6 months of treatment. Nonresponders had a mean of 15.6 fractures over an average of 72.7 months of treatment.

“For a period of time, you can expect about two-thirds of kids to respond. I would look to see a decrease in fracture rates within 2 years of treatment. If they haven’t decreased their fracture rate [by then], I would be very cautious about continuing,” he said, adding that the optimal duration of treatment in children is unknown.

In adults, the team found no difference in fracture rates at 5 and 10 years. Treated adults had an average of 1.71 fractures over 10 years, versus 1.23 in untreated adults (P = 0.109).

The numbers in the study were too small for meaningful subgroup analysis by OI type.

The findings parallel recent meta-analyses; some have found that bisphosphonates help OI children, but none has found benefits for adults (J. Bone. Miner. Res. 2015;30:929-33). “To date, there is no evidence indicating that bisphosphonates have a positive effect on fracture rates in adults,” Dr. Shapiro said.

Bone turnover declines after puberty, which may explain why the drugs lose their effectiveness after age 18 or so. “What happens in OI anyway is that, after puberty, the fracture rates normally go way down,” Dr. Shapiro said.

Dr. Shapiro said that he had no relevant disclosures, and that there was no outside funding for the work.

aotto@frontlinemedcom.com

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NASHVILLE, TENN. – Bisphosphonates help prevent fractures in some children with osteogenesis imperfecta, but they don't do the same for adults with the condition, according to a review from Johns Hopkins University and the Kennedy Krieger Institute.

Even so, bisphosphonates are used widely for adult osteogenesis imperfecta (OI) “because people have nothing else to hang their hat on, and the average physician doesn’t understand that osteogenesis imperfecta is not the same as age-related osteoporosis,” said senior investigator Dr. Jay R. Shapiro, director of Kennedy Krieger’s osteogenesis imperfecta program in Baltimore.

Dr. Jay R. Shapiro

“We see adults with OI all the time who have been on bisphosphonates for 10 years, 12 years. It’s not doing anything for them, and sooner or later they come to realize that.” Meanwhile, “I think people are getting a little bit of a queasy feeling about not fully understanding the effectiveness and side effects of long-term treatment with bisphosphonates,” said Dr. Shapiro, also professor in the department of physical medicine and rehabilitation at Johns Hopkins University, Baltimore.

Adults with OI “also don’t respond to Forteo [teriparatide]. I do not recommend treatment with bisphosphonates or Forteo in” adults, he said at the annual meeting of the American Association of Clinical Endocrinologists.

Dr. Shapiro shared his thoughts during an interview regarding his latest study, an analysis of five children with OI under 18 years of age who responded to pamidronate (Aredia) and 11 who did not, meaning that they had two or more fractures per year while on the drug.

His team also compared fracture outcomes in 34 adults with OI treated with oral or intravenous bisphosphonates with 12 untreated adults. The adults were, on average, 52 years old.

The goal was to see if common bone markers predicted who would respond to bisphosphonates, but they did not. Vitamin D, phosphorus, alkaline phosphatase, C-telopeptide, and other measures were the same in children regardless of their response to pamidronate, and the same in adults with OI whether or not they were on bisphosphonates.

“We have not yet defined what the difference is between responders and nonresponders. If you take a crack at the simple things, they don’t help,” Dr. Shapiro said.

Children who responded had a mean of 4.8 fractures over an average of 42.6 months of treatment. Nonresponders had a mean of 15.6 fractures over an average of 72.7 months of treatment.

“For a period of time, you can expect about two-thirds of kids to respond. I would look to see a decrease in fracture rates within 2 years of treatment. If they haven’t decreased their fracture rate [by then], I would be very cautious about continuing,” he said, adding that the optimal duration of treatment in children is unknown.

In adults, the team found no difference in fracture rates at 5 and 10 years. Treated adults had an average of 1.71 fractures over 10 years, versus 1.23 in untreated adults (P = 0.109).

The numbers in the study were too small for meaningful subgroup analysis by OI type.

The findings parallel recent meta-analyses; some have found that bisphosphonates help OI children, but none has found benefits for adults (J. Bone. Miner. Res. 2015;30:929-33). “To date, there is no evidence indicating that bisphosphonates have a positive effect on fracture rates in adults,” Dr. Shapiro said.

Bone turnover declines after puberty, which may explain why the drugs lose their effectiveness after age 18 or so. “What happens in OI anyway is that, after puberty, the fracture rates normally go way down,” Dr. Shapiro said.

Dr. Shapiro said that he had no relevant disclosures, and that there was no outside funding for the work.

aotto@frontlinemedcom.com

NASHVILLE, TENN. – Bisphosphonates help prevent fractures in some children with osteogenesis imperfecta, but they don't do the same for adults with the condition, according to a review from Johns Hopkins University and the Kennedy Krieger Institute.

Even so, bisphosphonates are used widely for adult osteogenesis imperfecta (OI) “because people have nothing else to hang their hat on, and the average physician doesn’t understand that osteogenesis imperfecta is not the same as age-related osteoporosis,” said senior investigator Dr. Jay R. Shapiro, director of Kennedy Krieger’s osteogenesis imperfecta program in Baltimore.

Dr. Jay R. Shapiro

“We see adults with OI all the time who have been on bisphosphonates for 10 years, 12 years. It’s not doing anything for them, and sooner or later they come to realize that.” Meanwhile, “I think people are getting a little bit of a queasy feeling about not fully understanding the effectiveness and side effects of long-term treatment with bisphosphonates,” said Dr. Shapiro, also professor in the department of physical medicine and rehabilitation at Johns Hopkins University, Baltimore.

Adults with OI “also don’t respond to Forteo [teriparatide]. I do not recommend treatment with bisphosphonates or Forteo in” adults, he said at the annual meeting of the American Association of Clinical Endocrinologists.

Dr. Shapiro shared his thoughts during an interview regarding his latest study, an analysis of five children with OI under 18 years of age who responded to pamidronate (Aredia) and 11 who did not, meaning that they had two or more fractures per year while on the drug.

His team also compared fracture outcomes in 34 adults with OI treated with oral or intravenous bisphosphonates with 12 untreated adults. The adults were, on average, 52 years old.

The goal was to see if common bone markers predicted who would respond to bisphosphonates, but they did not. Vitamin D, phosphorus, alkaline phosphatase, C-telopeptide, and other measures were the same in children regardless of their response to pamidronate, and the same in adults with OI whether or not they were on bisphosphonates.

“We have not yet defined what the difference is between responders and nonresponders. If you take a crack at the simple things, they don’t help,” Dr. Shapiro said.

Children who responded had a mean of 4.8 fractures over an average of 42.6 months of treatment. Nonresponders had a mean of 15.6 fractures over an average of 72.7 months of treatment.

“For a period of time, you can expect about two-thirds of kids to respond. I would look to see a decrease in fracture rates within 2 years of treatment. If they haven’t decreased their fracture rate [by then], I would be very cautious about continuing,” he said, adding that the optimal duration of treatment in children is unknown.

In adults, the team found no difference in fracture rates at 5 and 10 years. Treated adults had an average of 1.71 fractures over 10 years, versus 1.23 in untreated adults (P = 0.109).

The numbers in the study were too small for meaningful subgroup analysis by OI type.

The findings parallel recent meta-analyses; some have found that bisphosphonates help OI children, but none has found benefits for adults (J. Bone. Miner. Res. 2015;30:929-33). “To date, there is no evidence indicating that bisphosphonates have a positive effect on fracture rates in adults,” Dr. Shapiro said.

Bone turnover declines after puberty, which may explain why the drugs lose their effectiveness after age 18 or so. “What happens in OI anyway is that, after puberty, the fracture rates normally go way down,” Dr. Shapiro said.

Dr. Shapiro said that he had no relevant disclosures, and that there was no outside funding for the work.

aotto@frontlinemedcom.com

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Key clinical point: Adult osteogenesis imperfecta patients don’t need bisphosphonates.

Major finding: Treated adults had an average of 1.71 fractures over 10 years; untreated adults had an average of 1.23 (P = 0.109).

Data source: Retrospective study of 16 pediatric and 46 adult OI patients.

Disclosures: There was no outside funding for the work, and the senior investigator had no relevant disclosures.

AACE: Artificial sweeteners tentatively linked to Hashimoto’s thyroiditis

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AACE: Artificial sweeteners tentatively linked to Hashimoto’s thyroiditis

NASHVILLE, TENN.– You might want to discourage your patients with Hashimoto’s thyroiditis from using artificial sweeteners, according to investigators from Mount Sinai Hospital in New York.

They found that of 100 patients with antibody-confirmed Hashimoto’s thyroiditis (HT), 53 reported using the equivalent of 3.5 packets of artificial sweetener per day – mostly aspartame (Equal, NutraSweet) or sucralose (Splenda) – as estimated from a questionnaire about their daily intake of sugar-free foods. The investigators also found a weak but significant correlation between daily consumption of sugar substitutes and elevated levels of TSH (r = 0.23, P = 0.05).

Alex Otto/Frontline Medical News
Dr. Issac Sachmechi

They checked those results against 125 controls who were referred for Hashimoto’s work up but turned out to be antibody negative; 15 (12%) regularly used artificial sweeteners, 110 (88%) did not.

Perhaps artificial sweeteners, which are widely used in diet soda, yogurt, gum, ice cream, and other products, somehow amp up the immune system to attack the thyroid in some people. “I think there is something to this,” said lead investigator Dr. Issac Sachmechi, an associate professor of medicine, endocrinology, diabetes, and bone disease at Mount Sinai.

“When patients come to me for Hashimoto’s and I diagnose them, I ask them if they use artificial sweeteners. If they do, I mention this study and highly suggest they stop using them,” he said at the annual meeting of the American Association of Clinical Endocrinologists.

So far, three have taken his advice. Two had a complete reversal of disease, going from antibody positive to antibody negative and no longer needing thyroid replacements. Quitting artificial sweeteners had no effect on the third person. Her mother also had autoimmune thyroiditis, so perhaps there was a genetic component that went beyond any possible impact of artificial sweeteners, Dr. Sachmechi said.

The link, however, is far from proven; spontaneous remission has been reported before in the medical literature. Dr. Sachmechi said he plans to continue looking into the issue.

There is, however, biological plausibility for a connection. Aspartame, for instance, is metabolized to formaldehyde, which has been associated with type 4 delayed hypersensitivity reactions. There’s also been suggestions that sucralose may have negative effects on the thymus and spleen, and possible associations with autoimmune disorders, Dr. Sachmechi said.

The idea to look into the issue came “about 3 years ago, when I got a consult from a neurologist about a young woman with paresthesia. He looked at her thyroid function, and her TSH was elevated, so he sent her to me. I put her on Synthroid, 125 mcg. During her follow up, I saw that her requirement for Synthroid was going down, and eventually I had to stop it. I asked her if she was doing anything differently, and she told me she had read that artificial sweeteners may actually cause weight gain, so she stopped them to lose weight.” That was the only change, Dr. Sachmechi said.

There was no outside funding for the work and Dr. Sachmechi had no relevant disclosures.

aotto@frontlinemedcom.com

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NASHVILLE, TENN.– You might want to discourage your patients with Hashimoto’s thyroiditis from using artificial sweeteners, according to investigators from Mount Sinai Hospital in New York.

They found that of 100 patients with antibody-confirmed Hashimoto’s thyroiditis (HT), 53 reported using the equivalent of 3.5 packets of artificial sweetener per day – mostly aspartame (Equal, NutraSweet) or sucralose (Splenda) – as estimated from a questionnaire about their daily intake of sugar-free foods. The investigators also found a weak but significant correlation between daily consumption of sugar substitutes and elevated levels of TSH (r = 0.23, P = 0.05).

Alex Otto/Frontline Medical News
Dr. Issac Sachmechi

They checked those results against 125 controls who were referred for Hashimoto’s work up but turned out to be antibody negative; 15 (12%) regularly used artificial sweeteners, 110 (88%) did not.

Perhaps artificial sweeteners, which are widely used in diet soda, yogurt, gum, ice cream, and other products, somehow amp up the immune system to attack the thyroid in some people. “I think there is something to this,” said lead investigator Dr. Issac Sachmechi, an associate professor of medicine, endocrinology, diabetes, and bone disease at Mount Sinai.

“When patients come to me for Hashimoto’s and I diagnose them, I ask them if they use artificial sweeteners. If they do, I mention this study and highly suggest they stop using them,” he said at the annual meeting of the American Association of Clinical Endocrinologists.

So far, three have taken his advice. Two had a complete reversal of disease, going from antibody positive to antibody negative and no longer needing thyroid replacements. Quitting artificial sweeteners had no effect on the third person. Her mother also had autoimmune thyroiditis, so perhaps there was a genetic component that went beyond any possible impact of artificial sweeteners, Dr. Sachmechi said.

The link, however, is far from proven; spontaneous remission has been reported before in the medical literature. Dr. Sachmechi said he plans to continue looking into the issue.

There is, however, biological plausibility for a connection. Aspartame, for instance, is metabolized to formaldehyde, which has been associated with type 4 delayed hypersensitivity reactions. There’s also been suggestions that sucralose may have negative effects on the thymus and spleen, and possible associations with autoimmune disorders, Dr. Sachmechi said.

The idea to look into the issue came “about 3 years ago, when I got a consult from a neurologist about a young woman with paresthesia. He looked at her thyroid function, and her TSH was elevated, so he sent her to me. I put her on Synthroid, 125 mcg. During her follow up, I saw that her requirement for Synthroid was going down, and eventually I had to stop it. I asked her if she was doing anything differently, and she told me she had read that artificial sweeteners may actually cause weight gain, so she stopped them to lose weight.” That was the only change, Dr. Sachmechi said.

There was no outside funding for the work and Dr. Sachmechi had no relevant disclosures.

aotto@frontlinemedcom.com

NASHVILLE, TENN.– You might want to discourage your patients with Hashimoto’s thyroiditis from using artificial sweeteners, according to investigators from Mount Sinai Hospital in New York.

They found that of 100 patients with antibody-confirmed Hashimoto’s thyroiditis (HT), 53 reported using the equivalent of 3.5 packets of artificial sweetener per day – mostly aspartame (Equal, NutraSweet) or sucralose (Splenda) – as estimated from a questionnaire about their daily intake of sugar-free foods. The investigators also found a weak but significant correlation between daily consumption of sugar substitutes and elevated levels of TSH (r = 0.23, P = 0.05).

Alex Otto/Frontline Medical News
Dr. Issac Sachmechi

They checked those results against 125 controls who were referred for Hashimoto’s work up but turned out to be antibody negative; 15 (12%) regularly used artificial sweeteners, 110 (88%) did not.

Perhaps artificial sweeteners, which are widely used in diet soda, yogurt, gum, ice cream, and other products, somehow amp up the immune system to attack the thyroid in some people. “I think there is something to this,” said lead investigator Dr. Issac Sachmechi, an associate professor of medicine, endocrinology, diabetes, and bone disease at Mount Sinai.

“When patients come to me for Hashimoto’s and I diagnose them, I ask them if they use artificial sweeteners. If they do, I mention this study and highly suggest they stop using them,” he said at the annual meeting of the American Association of Clinical Endocrinologists.

So far, three have taken his advice. Two had a complete reversal of disease, going from antibody positive to antibody negative and no longer needing thyroid replacements. Quitting artificial sweeteners had no effect on the third person. Her mother also had autoimmune thyroiditis, so perhaps there was a genetic component that went beyond any possible impact of artificial sweeteners, Dr. Sachmechi said.

The link, however, is far from proven; spontaneous remission has been reported before in the medical literature. Dr. Sachmechi said he plans to continue looking into the issue.

There is, however, biological plausibility for a connection. Aspartame, for instance, is metabolized to formaldehyde, which has been associated with type 4 delayed hypersensitivity reactions. There’s also been suggestions that sucralose may have negative effects on the thymus and spleen, and possible associations with autoimmune disorders, Dr. Sachmechi said.

The idea to look into the issue came “about 3 years ago, when I got a consult from a neurologist about a young woman with paresthesia. He looked at her thyroid function, and her TSH was elevated, so he sent her to me. I put her on Synthroid, 125 mcg. During her follow up, I saw that her requirement for Synthroid was going down, and eventually I had to stop it. I asked her if she was doing anything differently, and she told me she had read that artificial sweeteners may actually cause weight gain, so she stopped them to lose weight.” That was the only change, Dr. Sachmechi said.

There was no outside funding for the work and Dr. Sachmechi had no relevant disclosures.

aotto@frontlinemedcom.com

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Key clinical point: Discourage Hashimoto’s patients from using sugar substitutes.

Major finding: In 100 patients with the disease, daily consumption of artificial sweeteners correlated with elevated levels of TSH (r = 0.23, P = 0.05).

Data source: Observational study of 225 patients.

Disclosures: There was no outside funding for the work, and the lead investigator has no relevant disclosures.

Consider laser ablation therapy for treatment of benign thyroid nodules

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Consider laser ablation therapy for treatment of benign thyroid nodules

NASHVILLE – Ultrasound-guided laser ablation therapy was found to be a clinically safe, effective, and well-tolerated option for the treatment of benign thyroid nodules, both solid and mixed, in a retrospective, multicenter study presented at the annual meeting of the American Association of Clinical Endocrinologists.

“We know that image-guided laser ablation of solid thyroid nodules has demonstrated favorable results in several prospective randomized trials,” said Dr. Enrico Papini of Regina Apostolorum Hospital in Rome. “However, these results were obtained in selected patients, with single treatments and fixed modalities of treatment; so the question is, what happens in a real. clinical practice?”

Dr. Papini explained that the aim of the study was to assess clinical efficacy and side effects of laser ablation therapy (LAT) in a large series of unselected benign thyroid nodules of variable structure and size, using data from centers who use LAT as a standard operating technique. Patients with solid or mixed nodules with up to 40% fluid composition, benign cytological findings, and normal thyroid function were included.

Clinical records of 1,534 thyroid nodules in 1,531 patients, all of whom were treated in the last 10 years, was collected from eight Italian thyroid referral centers. A total of 1,837 LAT procedures were performed on these nodules, of which 1,280 (83% of 1,534) were treated in a single session. All nodules were treated in no more than three consecutive sessions, with a fixed output power of 3 watts. According to Dr. Papini, the laser is only fired for up to 10 minutes.

Mean nodule volume significantly decreased following LAT from 27 ± 24 mL at baseline to 8 ± 8 mL at 12 months after treatment (P < .001), and mean nodule volume reduction was 72% ± 11%, with an overall range of 48%-100%. Mixed nodules experienced significantly larger decreases than solid ones. On average, mixed nodule volume decreased 79% ± 7%, versus 72% ± 11% for solid nodules (P < .001) because of fluid components being drained prior to LAT.

Symptoms decreased from 49% at baseline to 10% at 12 months post-treatment. Similarly robust reductions were also seen in cosmetic signs, which decreased 86% to 8% over 12 months. Only 17 patients experienced a complication, including 8 with a “major” complication of dysphonia, which resolved within 2-84 days, and 9 with “minor” complications, such as skin burn and hematoma.

“Laser ablation was performed in outpatient setting, with no hospital admission after treatment,” said Dr. Papini. “It was well-tolerated, and severe pain – requiring more than 3 days of analgesics – occurred in less than 2% of patients.”

Dr. Papini did not report any relevant financial disclosures.

dchitnis@frontlinemedcom.com

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NASHVILLE – Ultrasound-guided laser ablation therapy was found to be a clinically safe, effective, and well-tolerated option for the treatment of benign thyroid nodules, both solid and mixed, in a retrospective, multicenter study presented at the annual meeting of the American Association of Clinical Endocrinologists.

“We know that image-guided laser ablation of solid thyroid nodules has demonstrated favorable results in several prospective randomized trials,” said Dr. Enrico Papini of Regina Apostolorum Hospital in Rome. “However, these results were obtained in selected patients, with single treatments and fixed modalities of treatment; so the question is, what happens in a real. clinical practice?”

Dr. Papini explained that the aim of the study was to assess clinical efficacy and side effects of laser ablation therapy (LAT) in a large series of unselected benign thyroid nodules of variable structure and size, using data from centers who use LAT as a standard operating technique. Patients with solid or mixed nodules with up to 40% fluid composition, benign cytological findings, and normal thyroid function were included.

Clinical records of 1,534 thyroid nodules in 1,531 patients, all of whom were treated in the last 10 years, was collected from eight Italian thyroid referral centers. A total of 1,837 LAT procedures were performed on these nodules, of which 1,280 (83% of 1,534) were treated in a single session. All nodules were treated in no more than three consecutive sessions, with a fixed output power of 3 watts. According to Dr. Papini, the laser is only fired for up to 10 minutes.

Mean nodule volume significantly decreased following LAT from 27 ± 24 mL at baseline to 8 ± 8 mL at 12 months after treatment (P < .001), and mean nodule volume reduction was 72% ± 11%, with an overall range of 48%-100%. Mixed nodules experienced significantly larger decreases than solid ones. On average, mixed nodule volume decreased 79% ± 7%, versus 72% ± 11% for solid nodules (P < .001) because of fluid components being drained prior to LAT.

Symptoms decreased from 49% at baseline to 10% at 12 months post-treatment. Similarly robust reductions were also seen in cosmetic signs, which decreased 86% to 8% over 12 months. Only 17 patients experienced a complication, including 8 with a “major” complication of dysphonia, which resolved within 2-84 days, and 9 with “minor” complications, such as skin burn and hematoma.

“Laser ablation was performed in outpatient setting, with no hospital admission after treatment,” said Dr. Papini. “It was well-tolerated, and severe pain – requiring more than 3 days of analgesics – occurred in less than 2% of patients.”

Dr. Papini did not report any relevant financial disclosures.

dchitnis@frontlinemedcom.com

NASHVILLE – Ultrasound-guided laser ablation therapy was found to be a clinically safe, effective, and well-tolerated option for the treatment of benign thyroid nodules, both solid and mixed, in a retrospective, multicenter study presented at the annual meeting of the American Association of Clinical Endocrinologists.

“We know that image-guided laser ablation of solid thyroid nodules has demonstrated favorable results in several prospective randomized trials,” said Dr. Enrico Papini of Regina Apostolorum Hospital in Rome. “However, these results were obtained in selected patients, with single treatments and fixed modalities of treatment; so the question is, what happens in a real. clinical practice?”

Dr. Papini explained that the aim of the study was to assess clinical efficacy and side effects of laser ablation therapy (LAT) in a large series of unselected benign thyroid nodules of variable structure and size, using data from centers who use LAT as a standard operating technique. Patients with solid or mixed nodules with up to 40% fluid composition, benign cytological findings, and normal thyroid function were included.

Clinical records of 1,534 thyroid nodules in 1,531 patients, all of whom were treated in the last 10 years, was collected from eight Italian thyroid referral centers. A total of 1,837 LAT procedures were performed on these nodules, of which 1,280 (83% of 1,534) were treated in a single session. All nodules were treated in no more than three consecutive sessions, with a fixed output power of 3 watts. According to Dr. Papini, the laser is only fired for up to 10 minutes.

Mean nodule volume significantly decreased following LAT from 27 ± 24 mL at baseline to 8 ± 8 mL at 12 months after treatment (P < .001), and mean nodule volume reduction was 72% ± 11%, with an overall range of 48%-100%. Mixed nodules experienced significantly larger decreases than solid ones. On average, mixed nodule volume decreased 79% ± 7%, versus 72% ± 11% for solid nodules (P < .001) because of fluid components being drained prior to LAT.

Symptoms decreased from 49% at baseline to 10% at 12 months post-treatment. Similarly robust reductions were also seen in cosmetic signs, which decreased 86% to 8% over 12 months. Only 17 patients experienced a complication, including 8 with a “major” complication of dysphonia, which resolved within 2-84 days, and 9 with “minor” complications, such as skin burn and hematoma.

“Laser ablation was performed in outpatient setting, with no hospital admission after treatment,” said Dr. Papini. “It was well-tolerated, and severe pain – requiring more than 3 days of analgesics – occurred in less than 2% of patients.”

Dr. Papini did not report any relevant financial disclosures.

dchitnis@frontlinemedcom.com

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Key clinical point: Ultrasound-guided laser ablation therapy is a clinically effective and well-tolerated tool for treating benign solid and mixed thyroid nodules.

Major finding: In 1,837 treatments for 1,534 nodules, mean nodule volume decreased from 27 ± 24 mL at baseline to 8 ± 8 mL at 12 months after treatment (P < .001), and mean nodule volume reduction was 72% ± 11% (range 48%-100%).

Data source: Retrospective, multicenter study of 1,534 benign solid and mixed thyroid nodules.

Disclosures: Dr. Papini did not report any relevant financial disclosures.

AACE: Free testosterone, prolactin levels signal MRI need in men with secondary hypogonadism

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AACE: Free testosterone, prolactin levels signal MRI need in men with secondary hypogonadism

NASHVILLE, TENN.– Checking free testosterone and prolactin levels can help identify which men with secondary hypogonadism should get brain MRIs.

If the levels are normal, it’s unlikely that hypothalamic-pituitary imaging will reveal a medically significant pituitary abnormality. “However, MRI is warranted in men with high prolactin or very low free testosterone [because] both are associated with pituitary structural abnormalities,” said lead investigator and medical resident Dr. Cong Santoso of Wright-Patterson Air Force Base Medical Center in Dayton, Ohio.

M. Alexander Otto/Frontline Medical News
Dr. Cong Santoso

Dr. Santoso and her associate, Dr. Thomas Koroscil of Wright State University, Dayton, reviewed the charts of 88 men with secondary hypogonadism, all of whom had gotten an MRI, which in many places was once a routine investigation for the problem. Men with known pituitary lesions, pituitary apoplexy, infiltrative diseases, infections, or glucocorticoid use were among those excluded from the study.

A total of 16 men (18%) had abnormal MRIs. Adenomas were found in nine (10%) and empty sellas in seven (8%). Men with pituitary adenomas had significantly lower free testosterone (FT), compared with those who had normal MRIs (18.7 pg/mL vs. 36.4 pg/mL). Men with empty sella syndrome had significantly higher prolactin (PRL), compared with men who had normal MRIs (21.4 ng/mL vs. 11.2 ng/mL), Dr. Santoso reported.

There was no difference in levels of follicle-stimulating hormone or luteinizing hormone. There was a trend towards lower total testosterone in men with structural abnormalities, but it was not significant, probably because of the low numbers in the study, Dr. Santoso said at the annual meeting of the American Association of Clinical Endocrinologists.

At 16%, the incidence of pituitary imaging abnormalities was not greater than the prevalence of abnormalities in the general population, “indicating that there is little value to routinely obtain MRI in the evaluation of men with secondary hypogonadism” when FT and PRL are normal, she said.

Endocrine Society guidelines for secondary hypogonadism in men note that “the diagnostic yield of pituitary imaging to exclude pituitary and/or hypothalamic tumor can be improved by performing [MRIs] in men with serum testosterone less than 150 ng/dL, panhypopituitarism, persistent hyperprolactinemia, or symptoms of tumor mass effect.”

The findings from Dr. Santoso’s study add to that advice by suggesting a role for FT and by pinning high PRL and low FT to particular structural abnormalities. “We are adding to the guidelines to make them” stronger, she said.

About 70 men (80%) had type 2 diabetes or metabolic syndrome, both of which are associated with secondary hypogonadism, but they had no endocrinologic differences, compared with the other men.

Endocrinologists at Dr. Santoso’s institutions have moved away from routine MRIs in men with secondary hypogonadism and are relying more on lab values to indicate when MRIs are needed, she said.

There was no outside funding for the work, and Dr. Santoso had no disclosures.

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NASHVILLE, TENN.– Checking free testosterone and prolactin levels can help identify which men with secondary hypogonadism should get brain MRIs.

If the levels are normal, it’s unlikely that hypothalamic-pituitary imaging will reveal a medically significant pituitary abnormality. “However, MRI is warranted in men with high prolactin or very low free testosterone [because] both are associated with pituitary structural abnormalities,” said lead investigator and medical resident Dr. Cong Santoso of Wright-Patterson Air Force Base Medical Center in Dayton, Ohio.

M. Alexander Otto/Frontline Medical News
Dr. Cong Santoso

Dr. Santoso and her associate, Dr. Thomas Koroscil of Wright State University, Dayton, reviewed the charts of 88 men with secondary hypogonadism, all of whom had gotten an MRI, which in many places was once a routine investigation for the problem. Men with known pituitary lesions, pituitary apoplexy, infiltrative diseases, infections, or glucocorticoid use were among those excluded from the study.

A total of 16 men (18%) had abnormal MRIs. Adenomas were found in nine (10%) and empty sellas in seven (8%). Men with pituitary adenomas had significantly lower free testosterone (FT), compared with those who had normal MRIs (18.7 pg/mL vs. 36.4 pg/mL). Men with empty sella syndrome had significantly higher prolactin (PRL), compared with men who had normal MRIs (21.4 ng/mL vs. 11.2 ng/mL), Dr. Santoso reported.

There was no difference in levels of follicle-stimulating hormone or luteinizing hormone. There was a trend towards lower total testosterone in men with structural abnormalities, but it was not significant, probably because of the low numbers in the study, Dr. Santoso said at the annual meeting of the American Association of Clinical Endocrinologists.

At 16%, the incidence of pituitary imaging abnormalities was not greater than the prevalence of abnormalities in the general population, “indicating that there is little value to routinely obtain MRI in the evaluation of men with secondary hypogonadism” when FT and PRL are normal, she said.

Endocrine Society guidelines for secondary hypogonadism in men note that “the diagnostic yield of pituitary imaging to exclude pituitary and/or hypothalamic tumor can be improved by performing [MRIs] in men with serum testosterone less than 150 ng/dL, panhypopituitarism, persistent hyperprolactinemia, or symptoms of tumor mass effect.”

The findings from Dr. Santoso’s study add to that advice by suggesting a role for FT and by pinning high PRL and low FT to particular structural abnormalities. “We are adding to the guidelines to make them” stronger, she said.

About 70 men (80%) had type 2 diabetes or metabolic syndrome, both of which are associated with secondary hypogonadism, but they had no endocrinologic differences, compared with the other men.

Endocrinologists at Dr. Santoso’s institutions have moved away from routine MRIs in men with secondary hypogonadism and are relying more on lab values to indicate when MRIs are needed, she said.

There was no outside funding for the work, and Dr. Santoso had no disclosures.

NASHVILLE, TENN.– Checking free testosterone and prolactin levels can help identify which men with secondary hypogonadism should get brain MRIs.

If the levels are normal, it’s unlikely that hypothalamic-pituitary imaging will reveal a medically significant pituitary abnormality. “However, MRI is warranted in men with high prolactin or very low free testosterone [because] both are associated with pituitary structural abnormalities,” said lead investigator and medical resident Dr. Cong Santoso of Wright-Patterson Air Force Base Medical Center in Dayton, Ohio.

M. Alexander Otto/Frontline Medical News
Dr. Cong Santoso

Dr. Santoso and her associate, Dr. Thomas Koroscil of Wright State University, Dayton, reviewed the charts of 88 men with secondary hypogonadism, all of whom had gotten an MRI, which in many places was once a routine investigation for the problem. Men with known pituitary lesions, pituitary apoplexy, infiltrative diseases, infections, or glucocorticoid use were among those excluded from the study.

A total of 16 men (18%) had abnormal MRIs. Adenomas were found in nine (10%) and empty sellas in seven (8%). Men with pituitary adenomas had significantly lower free testosterone (FT), compared with those who had normal MRIs (18.7 pg/mL vs. 36.4 pg/mL). Men with empty sella syndrome had significantly higher prolactin (PRL), compared with men who had normal MRIs (21.4 ng/mL vs. 11.2 ng/mL), Dr. Santoso reported.

There was no difference in levels of follicle-stimulating hormone or luteinizing hormone. There was a trend towards lower total testosterone in men with structural abnormalities, but it was not significant, probably because of the low numbers in the study, Dr. Santoso said at the annual meeting of the American Association of Clinical Endocrinologists.

At 16%, the incidence of pituitary imaging abnormalities was not greater than the prevalence of abnormalities in the general population, “indicating that there is little value to routinely obtain MRI in the evaluation of men with secondary hypogonadism” when FT and PRL are normal, she said.

Endocrine Society guidelines for secondary hypogonadism in men note that “the diagnostic yield of pituitary imaging to exclude pituitary and/or hypothalamic tumor can be improved by performing [MRIs] in men with serum testosterone less than 150 ng/dL, panhypopituitarism, persistent hyperprolactinemia, or symptoms of tumor mass effect.”

The findings from Dr. Santoso’s study add to that advice by suggesting a role for FT and by pinning high PRL and low FT to particular structural abnormalities. “We are adding to the guidelines to make them” stronger, she said.

About 70 men (80%) had type 2 diabetes or metabolic syndrome, both of which are associated with secondary hypogonadism, but they had no endocrinologic differences, compared with the other men.

Endocrinologists at Dr. Santoso’s institutions have moved away from routine MRIs in men with secondary hypogonadism and are relying more on lab values to indicate when MRIs are needed, she said.

There was no outside funding for the work, and Dr. Santoso had no disclosures.

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Key clinical point: Lab values can guide imaging decisions in men with pituitary adenomas.

Major finding: Men with pituitary adenomas had significantly lower free testosterone, compared with those who had normal MRIs (18.7 pg/mL vs. 36.4 pg/mL). Men with empty sella syndrome had significantly higher prolactin, compared with men who had normal MRIs (21.4 ng/mL vs. 11.2 ng/mL).

Data source: Review of<b/>88 men with secondary hypogonadism.

Disclosures: There was no outside funding for the work, and the lead investigator had no disclosures.