Endo 2016

BOSTON – Prader-Willi syndrome patients lost more than 4% of their body weight over a 26-week period with the investigative antiobesity drug beloranib, compared with a similar gain in patients taking placebo, in the phase III bestPWS trial.

Hunger-related behavior was also reduced, along with total and LDL cholesterol levels and other cardiometabolic risk factors, lead investigator Dr. Merlin G. Butler reported at the annual meeting of the Endocrinology Society.

However, because of concerns over venous thromboembolic events in patients on beloranib, the trial was halted before all patients reached 26 weeks of treatment.

“bestPWS is the first phase III clinical trial to show statistically and clinically significant weight loss and improvement in hyperphagia-related behaviors in PWS [Prader-Willi syndrome] patients. The reduction in hyperphagia-related behaviors in the beloranib-treated groups represents a clinically meaningful benefit to patients,” Dr. Butler said.

Beloranib is a novel, first-in-class injectable molecule that works by inhibiting MetAP2, an enzyme that modulates the activity of cellular processes that are important in the control of metabolism. Its benefits in preclinical studies and a phase II trial in reducing body weight and decreasing hyperplasia fueled optimism regarding the therapeutic value in Prader-Willi syndrome, the most common genetic cause of morbid obesity. Although rare, Prader-Willi syndrome is life threatening and life limiting, with most of those affected dying before the age of 50.

“There are currently no treatment options for the intractable obesity and hyperphagia in Prader-Willi syndrome,” said Dr. Butler of the University of Kansas Medical Center, Kansas City, Kan.

In the bestPWS trial, 107 patients were randomized 2:1 to receive twice-weekly subcutaneous injections of beloranib or placebo for 26 weeks: 36 received 1.8 mg and 37 received 2.4 mg of beloranib, and 34 received placebo. Seventy-four patients completed the treatment. The coprimary efficacy endpoints were improvement in hyperphagia-related behaviors and reduction in body weight. Secondary endpoints included improvements in total body fat mass, lipids, and, as markers of cardiometabolic risk, total cholesterol and LDL cholesterol levels.

Baseline demographic and clinical characteristics were comparable in the three trial arms, with an average age of 20 years, average body mass index of 40 kg/m², average body weight of 100 kg, average fat mass of 51 kg, and average Hyperphagia Questionnaire for Clinical Trials (HQ-CT) total score of 16.9.

Patients in the placebo arm displayed an increase in body weight of about 4% over the 26-week trial. In contrast, patients treated with beloranib lost weight (4.1% and 5.3% in the 1.8-mg and 2.4-mg arms, respectively; both P less than .0001, compared with placebo). The weight loss in the two treatment arms did not differ significantly. Beloranib was also associated with improvements in body composition, total cholesterol, and LDL cholesterol, high-sensitivity C-reactive protein, leptin, and adiponectin, compared with placebo.

Both beloranib doses also appreciably reduced hunger-associated behaviors, with reductions of 6.7-7.4 points with beloranib, compared with a reduction of 0.4 with placebo.

Adverse events most commonly included injection-site bruising, aggression, and hyperphagia; they were generally mild and transient.

There were five serious adverse events. Those that occurred in the treatment arms were psychiatric disorders, which are common background comorbidities in Prader-Willi patients, and so are not necessarily treatment related. In the bestPWS trial, two deep vein thrombosis events and two fatal pulmonary embolism events occurred. After the first pulmonary embolism death, the trial was discontinued; at that point, 27 randomized patients had not completed the full 26-week course.

Overall, 11 venous thrombotic events, including pulmonary embolism, deep vein thrombosis, and superficial thrombophlebitis, have occurred in the roughly 400 patients who have so far received beloranib in the course of its development, including the adverse events in the bestPWS trial. None of these events has occurred in those receiving placebo.

Even in light of these sobering events, Dr. Butler said he remains optimistic. “In addition to the reduction in body weight and decrease in excessive eating behaviors previously reported from this study, [these data] demonstrate important reductions in cardiometabolic risk factors and further support a strong rationale for continued evaluation of beloranib as a potential treatment for Prader-Willi syndrome,” said Dr. Butler.

Beloranib is currently on clinical hold while the potential for a prothrombotic effect of beloranib and a heightened risk for Prader-Willi syndrome patients are assessed, Dr. Butler said.

Dr. Butler disclosed study funding by Zafgen, the manufacturer of Beloranib.

BOSTON – Prader-Willi syndrome patients lost more than 4% of their body weight over a 26-week period with the investigative antiobesity drug beloranib, compared with a similar gain in patients taking placebo, in the phase III bestPWS trial.

Hunger-related behavior was also reduced, along with total and LDL cholesterol levels and other cardiometabolic risk factors, lead investigator Dr. Merlin G. Butler reported at the annual meeting of the Endocrinology Society.

However, because of concerns over venous thromboembolic events in patients on beloranib, the trial was halted before all patients reached 26 weeks of treatment.

“bestPWS is the first phase III clinical trial to show statistically and clinically significant weight loss and improvement in hyperphagia-related behaviors in PWS [Prader-Willi syndrome] patients. The reduction in hyperphagia-related behaviors in the beloranib-treated groups represents a clinically meaningful benefit to patients,” Dr. Butler said.

Beloranib is a novel, first-in-class injectable molecule that works by inhibiting MetAP2, an enzyme that modulates the activity of cellular processes that are important in the control of metabolism. Its benefits in preclinical studies and a phase II trial in reducing body weight and decreasing hyperplasia fueled optimism regarding the therapeutic value in Prader-Willi syndrome, the most common genetic cause of morbid obesity. Although rare, Prader-Willi syndrome is life threatening and life limiting, with most of those affected dying before the age of 50.

“There are currently no treatment options for the intractable obesity and hyperphagia in Prader-Willi syndrome,” said Dr. Butler of the University of Kansas Medical Center, Kansas City, Kan.

In the bestPWS trial, 107 patients were randomized 2:1 to receive twice-weekly subcutaneous injections of beloranib or placebo for 26 weeks: 36 received 1.8 mg and 37 received 2.4 mg of beloranib, and 34 received placebo. Seventy-four patients completed the treatment. The coprimary efficacy endpoints were improvement in hyperphagia-related behaviors and reduction in body weight. Secondary endpoints included improvements in total body fat mass, lipids, and, as markers of cardiometabolic risk, total cholesterol and LDL cholesterol levels.

Baseline demographic and clinical characteristics were comparable in the three trial arms, with an average age of 20 years, average body mass index of 40 kg/m², average body weight of 100 kg, average fat mass of 51 kg, and average Hyperphagia Questionnaire for Clinical Trials (HQ-CT) total score of 16.9.

Patients in the placebo arm displayed an increase in body weight of about 4% over the 26-week trial. In contrast, patients treated with beloranib lost weight (4.1% and 5.3% in the 1.8-mg and 2.4-mg arms, respectively; both P less than .0001, compared with placebo). The weight loss in the two treatment arms did not differ significantly. Beloranib was also associated with improvements in body composition, total cholesterol, and LDL cholesterol, high-sensitivity C-reactive protein, leptin, and adiponectin, compared with placebo.

Both beloranib doses also appreciably reduced hunger-associated behaviors, with reductions of 6.7-7.4 points with beloranib, compared with a reduction of 0.4 with placebo.

Adverse events most commonly included injection-site bruising, aggression, and hyperphagia; they were generally mild and transient.

There were five serious adverse events. Those that occurred in the treatment arms were psychiatric disorders, which are common background comorbidities in Prader-Willi patients, and so are not necessarily treatment related. In the bestPWS trial, two deep vein thrombosis events and two fatal pulmonary embolism events occurred. After the first pulmonary embolism death, the trial was discontinued; at that point, 27 randomized patients had not completed the full 26-week course.

Overall, 11 venous thrombotic events, including pulmonary embolism, deep vein thrombosis, and superficial thrombophlebitis, have occurred in the roughly 400 patients who have so far received beloranib in the course of its development, including the adverse events in the bestPWS trial. None of these events has occurred in those receiving placebo.

Even in light of these sobering events, Dr. Butler said he remains optimistic. “In addition to the reduction in body weight and decrease in excessive eating behaviors previously reported from this study, [these data] demonstrate important reductions in cardiometabolic risk factors and further support a strong rationale for continued evaluation of beloranib as a potential treatment for Prader-Willi syndrome,” said Dr. Butler.

Beloranib is currently on clinical hold while the potential for a prothrombotic effect of beloranib and a heightened risk for Prader-Willi syndrome patients are assessed, Dr. Butler said.

Dr. Butler disclosed study funding by Zafgen, the manufacturer of Beloranib.

BOSTON – Prader-Willi syndrome patients lost more than 4% of their body weight over a 26-week period with the investigative antiobesity drug beloranib, compared with a similar gain in patients taking placebo, in the phase III bestPWS trial.

Hunger-related behavior was also reduced, along with total and LDL cholesterol levels and other cardiometabolic risk factors, lead investigator Dr. Merlin G. Butler reported at the annual meeting of the Endocrinology Society.

However, because of concerns over venous thromboembolic events in patients on beloranib, the trial was halted before all patients reached 26 weeks of treatment.

“bestPWS is the first phase III clinical trial to show statistically and clinically significant weight loss and improvement in hyperphagia-related behaviors in PWS [Prader-Willi syndrome] patients. The reduction in hyperphagia-related behaviors in the beloranib-treated groups represents a clinically meaningful benefit to patients,” Dr. Butler said.

Beloranib is a novel, first-in-class injectable molecule that works by inhibiting MetAP2, an enzyme that modulates the activity of cellular processes that are important in the control of metabolism. Its benefits in preclinical studies and a phase II trial in reducing body weight and decreasing hyperplasia fueled optimism regarding the therapeutic value in Prader-Willi syndrome, the most common genetic cause of morbid obesity. Although rare, Prader-Willi syndrome is life threatening and life limiting, with most of those affected dying before the age of 50.

“There are currently no treatment options for the intractable obesity and hyperphagia in Prader-Willi syndrome,” said Dr. Butler of the University of Kansas Medical Center, Kansas City, Kan.

In the bestPWS trial, 107 patients were randomized 2:1 to receive twice-weekly subcutaneous injections of beloranib or placebo for 26 weeks: 36 received 1.8 mg and 37 received 2.4 mg of beloranib, and 34 received placebo. Seventy-four patients completed the treatment. The coprimary efficacy endpoints were improvement in hyperphagia-related behaviors and reduction in body weight. Secondary endpoints included improvements in total body fat mass, lipids, and, as markers of cardiometabolic risk, total cholesterol and LDL cholesterol levels.

Baseline demographic and clinical characteristics were comparable in the three trial arms, with an average age of 20 years, average body mass index of 40 kg/m², average body weight of 100 kg, average fat mass of 51 kg, and average Hyperphagia Questionnaire for Clinical Trials (HQ-CT) total score of 16.9.

Patients in the placebo arm displayed an increase in body weight of about 4% over the 26-week trial. In contrast, patients treated with beloranib lost weight (4.1% and 5.3% in the 1.8-mg and 2.4-mg arms, respectively; both P less than .0001, compared with placebo). The weight loss in the two treatment arms did not differ significantly. Beloranib was also associated with improvements in body composition, total cholesterol, and LDL cholesterol, high-sensitivity C-reactive protein, leptin, and adiponectin, compared with placebo.

Both beloranib doses also appreciably reduced hunger-associated behaviors, with reductions of 6.7-7.4 points with beloranib, compared with a reduction of 0.4 with placebo.

Adverse events most commonly included injection-site bruising, aggression, and hyperphagia; they were generally mild and transient.

There were five serious adverse events. Those that occurred in the treatment arms were psychiatric disorders, which are common background comorbidities in Prader-Willi patients, and so are not necessarily treatment related. In the bestPWS trial, two deep vein thrombosis events and two fatal pulmonary embolism events occurred. After the first pulmonary embolism death, the trial was discontinued; at that point, 27 randomized patients had not completed the full 26-week course.

Overall, 11 venous thrombotic events, including pulmonary embolism, deep vein thrombosis, and superficial thrombophlebitis, have occurred in the roughly 400 patients who have so far received beloranib in the course of its development, including the adverse events in the bestPWS trial. None of these events has occurred in those receiving placebo.

Even in light of these sobering events, Dr. Butler said he remains optimistic. “In addition to the reduction in body weight and decrease in excessive eating behaviors previously reported from this study, [these data] demonstrate important reductions in cardiometabolic risk factors and further support a strong rationale for continued evaluation of beloranib as a potential treatment for Prader-Willi syndrome,” said Dr. Butler.

Beloranib is currently on clinical hold while the potential for a prothrombotic effect of beloranib and a heightened risk for Prader-Willi syndrome patients are assessed, Dr. Butler said.

Dr. Butler disclosed study funding by Zafgen, the manufacturer of Beloranib.

BOSTON – Examination of weight-loss patterns in over 177,000 people has revealed that, regardless of the initial 6-month weight loss, after 2 years the majority of patients become “cyclers,” with periods of weight gain and loss rather than maintenance of the initial weight loss.

“One-third of American adults are obese. In 2010, the cost of obesity and obesity-related comorbidities in the United States was estimated to be $315.8 billion. Achieving and maintaining weight loss has proven to be difficult,” said Joanna Huang, PharmD, senior manager of health economics and outcomes research at Novo Nordisk, Plainsboro, N.J., and lead investigator of the study presented at the annual meeting of the Endocrine Society.

The study examined the electronic records of about 178,000 obese patients whose weight loss had been by deliberate intent and not due to illness. The subjects were allocated into four groups based on the extent of weight loss in terms of body mass index (BMI) over 6 months: Those who remained stable and lost less than 5% (n = 151,902), those who lost 5%-10% (modest loss; n = 16,637), those who lost 10%-15% (moderate loss; n = 4,035), and those who lost in excess of 15% (high loss; n = 5,945).

The subjects who were at least 18 years of age at baseline (mean age 54-58 years), had at least one BMI measurement that was indicative of obesity (greater than or equal to 30 kg/m²), with at least four BMI determinations done over at least 5 years. Subjects were mostly white (about 66% in all four groups) and mostly from the southern United States.

Regardless of the amount that the participants lost in the first 6 months, regain of 50% of more of body weight was common in the modest weight-loss group (40%) and moderate weight-loss group (36%), while only 19% of those in the high weight-loss group cycled back up in weight, reported study presenter Maral DerSarkissian, PhD, of the Analysis Group in Boston.

More than 73% and about 70% of those in the moderate and modest weight-loss group, respectively, experienced weight cycling within 2 years. In the stable and high weight-loss groups, the situation was somewhat more optimistic, with about 60% of participants cycling in weight within 2 years. Total regain of lost weight occurred in about 23%, 16%, and 7% of the modest, moderate, and high weight-loss group, respectively.

“Weight loss maintenance, even in the moderate and high weight-loss groups, is very difficult to achieve,” said Dr. Huang.

Interventions that seek to maintain the weight conventionally are directed at dietary changes. But, according to Dr. DerSarkissian, “these modifications alone might not be enough to achieve and maintain weight loss.”

Pharmacotherapy is another weight-loss option. The data indicated that only 2% of the participants were receiving weight-loss pharmacotherapy. Whether this figure is accurate is an open question, according to Dr. Huang, since a lot of the data were compiled from physicians’ notes. Since clinicians may not record weight-loss advice offered to their patients, the data base may well not reflect lifestyle interventions, including pharmacotherapy.

In addition, since the data captured only primary outpatient care, whether or not a patient ever had bariatric surgery was unknown. Other unrecorded factors that can influence weight over time included comorbidities, use of medications, diet changes, and changes in physical activity.

The data points to a multifactor approach to weight loss that includes counseling, positive reinforcement, dietary advice, pharmacotherapy where appropriate, and, in some cases, bariatric surgery.

“Successful and sustained clinically meaningful weight loss requires chronic and effective weight management strategies,” said Dr. Huang.

Dr. Huang is an employee of Novo Nordisk and Dr. DerSarkissian is a researcher for Novo Nordisk.

BOSTON – Examination of weight-loss patterns in over 177,000 people has revealed that, regardless of the initial 6-month weight loss, after 2 years the majority of patients become “cyclers,” with periods of weight gain and loss rather than maintenance of the initial weight loss.

“One-third of American adults are obese. In 2010, the cost of obesity and obesity-related comorbidities in the United States was estimated to be $315.8 billion. Achieving and maintaining weight loss has proven to be difficult,” said Joanna Huang, PharmD, senior manager of health economics and outcomes research at Novo Nordisk, Plainsboro, N.J., and lead investigator of the study presented at the annual meeting of the Endocrine Society.

The study examined the electronic records of about 178,000 obese patients whose weight loss had been by deliberate intent and not due to illness. The subjects were allocated into four groups based on the extent of weight loss in terms of body mass index (BMI) over 6 months: Those who remained stable and lost less than 5% (n = 151,902), those who lost 5%-10% (modest loss; n = 16,637), those who lost 10%-15% (moderate loss; n = 4,035), and those who lost in excess of 15% (high loss; n = 5,945).

The subjects who were at least 18 years of age at baseline (mean age 54-58 years), had at least one BMI measurement that was indicative of obesity (greater than or equal to 30 kg/m²), with at least four BMI determinations done over at least 5 years. Subjects were mostly white (about 66% in all four groups) and mostly from the southern United States.

Regardless of the amount that the participants lost in the first 6 months, regain of 50% of more of body weight was common in the modest weight-loss group (40%) and moderate weight-loss group (36%), while only 19% of those in the high weight-loss group cycled back up in weight, reported study presenter Maral DerSarkissian, PhD, of the Analysis Group in Boston.

More than 73% and about 70% of those in the moderate and modest weight-loss group, respectively, experienced weight cycling within 2 years. In the stable and high weight-loss groups, the situation was somewhat more optimistic, with about 60% of participants cycling in weight within 2 years. Total regain of lost weight occurred in about 23%, 16%, and 7% of the modest, moderate, and high weight-loss group, respectively.

“Weight loss maintenance, even in the moderate and high weight-loss groups, is very difficult to achieve,” said Dr. Huang.

Interventions that seek to maintain the weight conventionally are directed at dietary changes. But, according to Dr. DerSarkissian, “these modifications alone might not be enough to achieve and maintain weight loss.”

Pharmacotherapy is another weight-loss option. The data indicated that only 2% of the participants were receiving weight-loss pharmacotherapy. Whether this figure is accurate is an open question, according to Dr. Huang, since a lot of the data were compiled from physicians’ notes. Since clinicians may not record weight-loss advice offered to their patients, the data base may well not reflect lifestyle interventions, including pharmacotherapy.

In addition, since the data captured only primary outpatient care, whether or not a patient ever had bariatric surgery was unknown. Other unrecorded factors that can influence weight over time included comorbidities, use of medications, diet changes, and changes in physical activity.

The data points to a multifactor approach to weight loss that includes counseling, positive reinforcement, dietary advice, pharmacotherapy where appropriate, and, in some cases, bariatric surgery.

“Successful and sustained clinically meaningful weight loss requires chronic and effective weight management strategies,” said Dr. Huang.

Dr. Huang is an employee of Novo Nordisk and Dr. DerSarkissian is a researcher for Novo Nordisk.

BOSTON – Examination of weight-loss patterns in over 177,000 people has revealed that, regardless of the initial 6-month weight loss, after 2 years the majority of patients become “cyclers,” with periods of weight gain and loss rather than maintenance of the initial weight loss.

“One-third of American adults are obese. In 2010, the cost of obesity and obesity-related comorbidities in the United States was estimated to be $315.8 billion. Achieving and maintaining weight loss has proven to be difficult,” said Joanna Huang, PharmD, senior manager of health economics and outcomes research at Novo Nordisk, Plainsboro, N.J., and lead investigator of the study presented at the annual meeting of the Endocrine Society.

The study examined the electronic records of about 178,000 obese patients whose weight loss had been by deliberate intent and not due to illness. The subjects were allocated into four groups based on the extent of weight loss in terms of body mass index (BMI) over 6 months: Those who remained stable and lost less than 5% (n = 151,902), those who lost 5%-10% (modest loss; n = 16,637), those who lost 10%-15% (moderate loss; n = 4,035), and those who lost in excess of 15% (high loss; n = 5,945).

The subjects who were at least 18 years of age at baseline (mean age 54-58 years), had at least one BMI measurement that was indicative of obesity (greater than or equal to 30 kg/m²), with at least four BMI determinations done over at least 5 years. Subjects were mostly white (about 66% in all four groups) and mostly from the southern United States.

Regardless of the amount that the participants lost in the first 6 months, regain of 50% of more of body weight was common in the modest weight-loss group (40%) and moderate weight-loss group (36%), while only 19% of those in the high weight-loss group cycled back up in weight, reported study presenter Maral DerSarkissian, PhD, of the Analysis Group in Boston.

More than 73% and about 70% of those in the moderate and modest weight-loss group, respectively, experienced weight cycling within 2 years. In the stable and high weight-loss groups, the situation was somewhat more optimistic, with about 60% of participants cycling in weight within 2 years. Total regain of lost weight occurred in about 23%, 16%, and 7% of the modest, moderate, and high weight-loss group, respectively.

“Weight loss maintenance, even in the moderate and high weight-loss groups, is very difficult to achieve,” said Dr. Huang.

Interventions that seek to maintain the weight conventionally are directed at dietary changes. But, according to Dr. DerSarkissian, “these modifications alone might not be enough to achieve and maintain weight loss.”

Pharmacotherapy is another weight-loss option. The data indicated that only 2% of the participants were receiving weight-loss pharmacotherapy. Whether this figure is accurate is an open question, according to Dr. Huang, since a lot of the data were compiled from physicians’ notes. Since clinicians may not record weight-loss advice offered to their patients, the data base may well not reflect lifestyle interventions, including pharmacotherapy.

In addition, since the data captured only primary outpatient care, whether or not a patient ever had bariatric surgery was unknown. Other unrecorded factors that can influence weight over time included comorbidities, use of medications, diet changes, and changes in physical activity.

The data points to a multifactor approach to weight loss that includes counseling, positive reinforcement, dietary advice, pharmacotherapy where appropriate, and, in some cases, bariatric surgery.

“Successful and sustained clinically meaningful weight loss requires chronic and effective weight management strategies,” said Dr. Huang.

Dr. Huang is an employee of Novo Nordisk and Dr. DerSarkissian is a researcher for Novo Nordisk.

BOSTON – Infants above the 85th percentile for body mass index at 6 months are up to nine times more likely to be severely obese by the age of 6, according to a Cincinnati Children’s Hospital investigation.

The finding means that pediatricians should routinely plot and follow body mass index (BMI) from an early age, just like height, weight, and head circumference, said investigator Dr. Allison Smego, an endocrinology fellow.

She and her colleagues reviewed the charts from birth to age 6 of 783 lean children and 480 children above the 99th BMI percentile. BMI started differentiating when children were as young as 4 months old, about a year and half before the onset of clinical obesity. The predictive value of the 85th percentile threshold held at 6, 12, and 18 months. The finding was subsequently validated in over 2,600 children.

In an interview at the annual meeting of the Endocrine Society, Dr. Smego explained how to use the findings.

BOSTON – Infants above the 85th percentile for body mass index at 6 months are up to nine times more likely to be severely obese by the age of 6, according to a Cincinnati Children’s Hospital investigation.

The finding means that pediatricians should routinely plot and follow body mass index (BMI) from an early age, just like height, weight, and head circumference, said investigator Dr. Allison Smego, an endocrinology fellow.

She and her colleagues reviewed the charts from birth to age 6 of 783 lean children and 480 children above the 99th BMI percentile. BMI started differentiating when children were as young as 4 months old, about a year and half before the onset of clinical obesity. The predictive value of the 85th percentile threshold held at 6, 12, and 18 months. The finding was subsequently validated in over 2,600 children.

In an interview at the annual meeting of the Endocrine Society, Dr. Smego explained how to use the findings.

BOSTON – Infants above the 85th percentile for body mass index at 6 months are up to nine times more likely to be severely obese by the age of 6, according to a Cincinnati Children’s Hospital investigation.

The finding means that pediatricians should routinely plot and follow body mass index (BMI) from an early age, just like height, weight, and head circumference, said investigator Dr. Allison Smego, an endocrinology fellow.

She and her colleagues reviewed the charts from birth to age 6 of 783 lean children and 480 children above the 99th BMI percentile. BMI started differentiating when children were as young as 4 months old, about a year and half before the onset of clinical obesity. The predictive value of the 85th percentile threshold held at 6, 12, and 18 months. The finding was subsequently validated in over 2,600 children.

In an interview at the annual meeting of the Endocrine Society, Dr. Smego explained how to use the findings.

BOSTON – Infants above the 85th percentile for body mass index at 6 months are up to nine times more likely to be severely obese by the age of 6, according to a Cincinnati Children’s Hospital investigation.

The finding means that pediatricians should routinely plot and follow body mass index (BMI) from an early age, just like height, weight, and head circumference, said investigator Dr. Allison Smego, an endocrinology fellow.

She and her colleagues reviewed the charts from birth to age 6 of 783 lean children and 480 children above the 99th BMI percentile. BMI started differentiating when children were as young as 4 months old, about a year and half before the onset of clinical obesity. The predictive value of the 85th percentile threshold held at 6, 12, and 18 months. The finding was subsequently validated in over 2,600 children.

In an interview at the annual meeting of the Endocrine Society, Dr. Smego explained how to use the findings.

aotto@frontlinemedcom.com

BOSTON – Infants above the 85th percentile for body mass index at 6 months are up to nine times more likely to be severely obese by the age of 6, according to a Cincinnati Children’s Hospital investigation.

The finding means that pediatricians should routinely plot and follow body mass index (BMI) from an early age, just like height, weight, and head circumference, said investigator Dr. Allison Smego, an endocrinology fellow.

She and her colleagues reviewed the charts from birth to age 6 of 783 lean children and 480 children above the 99th BMI percentile. BMI started differentiating when children were as young as 4 months old, about a year and half before the onset of clinical obesity. The predictive value of the 85th percentile threshold held at 6, 12, and 18 months. The finding was subsequently validated in over 2,600 children.

In an interview at the annual meeting of the Endocrine Society, Dr. Smego explained how to use the findings.

aotto@frontlinemedcom.com

BOSTON – Infants above the 85th percentile for body mass index at 6 months are up to nine times more likely to be severely obese by the age of 6, according to a Cincinnati Children’s Hospital investigation.

The finding means that pediatricians should routinely plot and follow body mass index (BMI) from an early age, just like height, weight, and head circumference, said investigator Dr. Allison Smego, an endocrinology fellow.

She and her colleagues reviewed the charts from birth to age 6 of 783 lean children and 480 children above the 99th BMI percentile. BMI started differentiating when children were as young as 4 months old, about a year and half before the onset of clinical obesity. The predictive value of the 85th percentile threshold held at 6, 12, and 18 months. The finding was subsequently validated in over 2,600 children.

In an interview at the annual meeting of the Endocrine Society, Dr. Smego explained how to use the findings.

aotto@frontlinemedcom.com

BOSTON – Switching from sitagliptin to liraglutide, in combination with metformin, improved control of hypoglycemia and resulted in greater weight loss in patients with type 2 diabetes, reported Dr. Maximo Maislos at the annual meeting of the Endocrine Society.

Results of a randomized, double-blind, double-dummy, active-controlled 26-week trial have indicated that liraglutide can be used as an add-on to metformin for patients with type 2 diabetes who have remained hyperglycemic.

“Switching from sitagliptin to liraglutide resulted in superior [glycated hemoglobin] and body weight reductions, compared with continued sitagliptin treatment,” said Dr. Maximo Maislos of Ben-Gurion University, Beer-Sheva, Israel.

The LIRA-SWITCH trial (Efficacy and Safety of Switching From Sitagliptin to Liraglutide in Subjects With Type 2 Diabetes Not Achieving Adequate Glycaemic Control on Sitagliptin and Metformin) involved 407 patients. The majority (60%) were male; mean age was 56 years and mean body mass index was 32 kg/m². The subjects had all been treated with sitagliptin (100 mg/day) and metformin (greater than or equal to 1,500 mg/day or a maximum tolerated dose greater than or equal to 1,000 mg/day) for at least 90 days. Hyperglycemia had not been well controlled, with a mean hemoglobin A_1C (HbA_IC) level of 8.3% (67 mmol/mol). The mean duration of type 2 diabetes was 8 years.

Subjects were randomized to continued sitagliptin along with metformin (n = 204) or liraglutide (1.8 mg daily) along with metformin (n = 203).

After 26 weeks of treatment, reduction in HbA_IC was significantly greater in the liraglutide arm than in the sitagliptin arm (1.14% vs. 0.54%; estimated treatment difference [ETD], –0.61%; 95% confidence interval, –0.82 to –0.40; P less than .0001). Those receiving liraglutide had statistically significantly greater weight loss, compared with those who continued on sitagliptin.

The less than 7% and less than or equal to 6.5% target levels of HbA_IC were achieved by 50.6% and 29.5%, respectively, of patients in the liraglutide arm. These percentages were significantly higher than the respective 26.9% and 9.9% of patients in the sitagliptin arm (P less than .0001 for both). Fasting plasma glucose levels were significantly reduced with liraglutide treatment while decreases in systolic and diastolic blood pressure were similar in the two study arms.

Adverse events (AEs) occurred more often in the liraglutide group than in the sitagliptin group (68.8% vs. 56.9%). Thirteen patients receiving liraglutide discontinued treatment, compared with five in the sitagliptin arm. The most common AEs in the liraglutide group were gastrointestinal disorders, principally nausea (21.8% with liraglutide vs. 7.8% with sitagliptin) and diarrhea (16.3% with liraglutide vs. 9.3% with sitagliptin), followed by decreased appetite (8.9% vs. 3.4%, respectively). These AEs tended to subside within the first few weeks of treatment.

Serious AEs occurred in eight patients in both arms. Rescue medication was needed for 30 patients receiving sitagliptin and 11 patients receiving liraglutide. No cases of pancreatitis were reported. In the sitagliptin group, one subject each developed bladder cancer and squamous cell carcinoma. Nocturnal hypoglycemia did not develop in either trial arm.

Funding was provided by liraglutide maker Novo Nordisk. Dr. Maislos had no disclosures.

BOSTON – Switching from sitagliptin to liraglutide, in combination with metformin, improved control of hypoglycemia and resulted in greater weight loss in patients with type 2 diabetes, reported Dr. Maximo Maislos at the annual meeting of the Endocrine Society.

Results of a randomized, double-blind, double-dummy, active-controlled 26-week trial have indicated that liraglutide can be used as an add-on to metformin for patients with type 2 diabetes who have remained hyperglycemic.

“Switching from sitagliptin to liraglutide resulted in superior [glycated hemoglobin] and body weight reductions, compared with continued sitagliptin treatment,” said Dr. Maximo Maislos of Ben-Gurion University, Beer-Sheva, Israel.

The LIRA-SWITCH trial (Efficacy and Safety of Switching From Sitagliptin to Liraglutide in Subjects With Type 2 Diabetes Not Achieving Adequate Glycaemic Control on Sitagliptin and Metformin) involved 407 patients. The majority (60%) were male; mean age was 56 years and mean body mass index was 32 kg/m². The subjects had all been treated with sitagliptin (100 mg/day) and metformin (greater than or equal to 1,500 mg/day or a maximum tolerated dose greater than or equal to 1,000 mg/day) for at least 90 days. Hyperglycemia had not been well controlled, with a mean hemoglobin A_1C (HbA_IC) level of 8.3% (67 mmol/mol). The mean duration of type 2 diabetes was 8 years.

Subjects were randomized to continued sitagliptin along with metformin (n = 204) or liraglutide (1.8 mg daily) along with metformin (n = 203).

After 26 weeks of treatment, reduction in HbA_IC was significantly greater in the liraglutide arm than in the sitagliptin arm (1.14% vs. 0.54%; estimated treatment difference [ETD], –0.61%; 95% confidence interval, –0.82 to –0.40; P less than .0001). Those receiving liraglutide had statistically significantly greater weight loss, compared with those who continued on sitagliptin.

The less than 7% and less than or equal to 6.5% target levels of HbA_IC were achieved by 50.6% and 29.5%, respectively, of patients in the liraglutide arm. These percentages were significantly higher than the respective 26.9% and 9.9% of patients in the sitagliptin arm (P less than .0001 for both). Fasting plasma glucose levels were significantly reduced with liraglutide treatment while decreases in systolic and diastolic blood pressure were similar in the two study arms.

Adverse events (AEs) occurred more often in the liraglutide group than in the sitagliptin group (68.8% vs. 56.9%). Thirteen patients receiving liraglutide discontinued treatment, compared with five in the sitagliptin arm. The most common AEs in the liraglutide group were gastrointestinal disorders, principally nausea (21.8% with liraglutide vs. 7.8% with sitagliptin) and diarrhea (16.3% with liraglutide vs. 9.3% with sitagliptin), followed by decreased appetite (8.9% vs. 3.4%, respectively). These AEs tended to subside within the first few weeks of treatment.

Serious AEs occurred in eight patients in both arms. Rescue medication was needed for 30 patients receiving sitagliptin and 11 patients receiving liraglutide. No cases of pancreatitis were reported. In the sitagliptin group, one subject each developed bladder cancer and squamous cell carcinoma. Nocturnal hypoglycemia did not develop in either trial arm.

Funding was provided by liraglutide maker Novo Nordisk. Dr. Maislos had no disclosures.

BOSTON – Switching from sitagliptin to liraglutide, in combination with metformin, improved control of hypoglycemia and resulted in greater weight loss in patients with type 2 diabetes, reported Dr. Maximo Maislos at the annual meeting of the Endocrine Society.

Results of a randomized, double-blind, double-dummy, active-controlled 26-week trial have indicated that liraglutide can be used as an add-on to metformin for patients with type 2 diabetes who have remained hyperglycemic.

“Switching from sitagliptin to liraglutide resulted in superior [glycated hemoglobin] and body weight reductions, compared with continued sitagliptin treatment,” said Dr. Maximo Maislos of Ben-Gurion University, Beer-Sheva, Israel.

The LIRA-SWITCH trial (Efficacy and Safety of Switching From Sitagliptin to Liraglutide in Subjects With Type 2 Diabetes Not Achieving Adequate Glycaemic Control on Sitagliptin and Metformin) involved 407 patients. The majority (60%) were male; mean age was 56 years and mean body mass index was 32 kg/m². The subjects had all been treated with sitagliptin (100 mg/day) and metformin (greater than or equal to 1,500 mg/day or a maximum tolerated dose greater than or equal to 1,000 mg/day) for at least 90 days. Hyperglycemia had not been well controlled, with a mean hemoglobin A_1C (HbA_IC) level of 8.3% (67 mmol/mol). The mean duration of type 2 diabetes was 8 years.

Subjects were randomized to continued sitagliptin along with metformin (n = 204) or liraglutide (1.8 mg daily) along with metformin (n = 203).

After 26 weeks of treatment, reduction in HbA_IC was significantly greater in the liraglutide arm than in the sitagliptin arm (1.14% vs. 0.54%; estimated treatment difference [ETD], –0.61%; 95% confidence interval, –0.82 to –0.40; P less than .0001). Those receiving liraglutide had statistically significantly greater weight loss, compared with those who continued on sitagliptin.

The less than 7% and less than or equal to 6.5% target levels of HbA_IC were achieved by 50.6% and 29.5%, respectively, of patients in the liraglutide arm. These percentages were significantly higher than the respective 26.9% and 9.9% of patients in the sitagliptin arm (P less than .0001 for both). Fasting plasma glucose levels were significantly reduced with liraglutide treatment while decreases in systolic and diastolic blood pressure were similar in the two study arms.

Adverse events (AEs) occurred more often in the liraglutide group than in the sitagliptin group (68.8% vs. 56.9%). Thirteen patients receiving liraglutide discontinued treatment, compared with five in the sitagliptin arm. The most common AEs in the liraglutide group were gastrointestinal disorders, principally nausea (21.8% with liraglutide vs. 7.8% with sitagliptin) and diarrhea (16.3% with liraglutide vs. 9.3% with sitagliptin), followed by decreased appetite (8.9% vs. 3.4%, respectively). These AEs tended to subside within the first few weeks of treatment.

Serious AEs occurred in eight patients in both arms. Rescue medication was needed for 30 patients receiving sitagliptin and 11 patients receiving liraglutide. No cases of pancreatitis were reported. In the sitagliptin group, one subject each developed bladder cancer and squamous cell carcinoma. Nocturnal hypoglycemia did not develop in either trial arm.

Funding was provided by liraglutide maker Novo Nordisk. Dr. Maislos had no disclosures.

BOSTON – Switching from sitagliptin to liraglutide, in combination with metformin, improved control of hypoglycemia and resulted in greater weight loss in patients with type 2 diabetes, reported Dr. Maximo Maislos at the annual meeting of the Endocrine Society.

Results of a randomized, double-blind, double-dummy, active-controlled 26-week trial have indicated that liraglutide can be used as an add-on to metformin for patients with type 2 diabetes who have remained hyperglycemic.

“Switching from sitagliptin to liraglutide resulted in superior [glycated hemoglobin] and body weight reductions, compared with continued sitagliptin treatment,” said Dr. Maximo Maislos of Ben-Gurion University, Beer-Sheva, Israel.

The LIRA-SWITCH trial (Efficacy and Safety of Switching From Sitagliptin to Liraglutide in Subjects With Type 2 Diabetes Not Achieving Adequate Glycaemic Control on Sitagliptin and Metformin) involved 407 patients. The majority (60%) were male; mean age was 56 years and mean body mass index was 32 kg/m². The subjects had all been treated with sitagliptin (100 mg/day) and metformin (greater than or equal to 1,500 mg/day or a maximum tolerated dose greater than or equal to 1,000 mg/day) for at least 90 days. Hyperglycemia had not been well controlled, with a mean hemoglobin A_1C (HbA_IC) level of 8.3% (67 mmol/mol). The mean duration of type 2 diabetes was 8 years.

Subjects were randomized to continued sitagliptin along with metformin (n = 204) or liraglutide (1.8 mg daily) along with metformin (n = 203).

After 26 weeks of treatment, reduction in HbA_IC was significantly greater in the liraglutide arm than in the sitagliptin arm (1.14% vs. 0.54%; estimated treatment difference [ETD], –0.61%; 95% confidence interval, –0.82 to –0.40; P less than .0001). Those receiving liraglutide had statistically significantly greater weight loss, compared with those who continued on sitagliptin.

The less than 7% and less than or equal to 6.5% target levels of HbA_IC were achieved by 50.6% and 29.5%, respectively, of patients in the liraglutide arm. These percentages were significantly higher than the respective 26.9% and 9.9% of patients in the sitagliptin arm (P less than .0001 for both). Fasting plasma glucose levels were significantly reduced with liraglutide treatment while decreases in systolic and diastolic blood pressure were similar in the two study arms.

Adverse events (AEs) occurred more often in the liraglutide group than in the sitagliptin group (68.8% vs. 56.9%). Thirteen patients receiving liraglutide discontinued treatment, compared with five in the sitagliptin arm. The most common AEs in the liraglutide group were gastrointestinal disorders, principally nausea (21.8% with liraglutide vs. 7.8% with sitagliptin) and diarrhea (16.3% with liraglutide vs. 9.3% with sitagliptin), followed by decreased appetite (8.9% vs. 3.4%, respectively). These AEs tended to subside within the first few weeks of treatment.

Serious AEs occurred in eight patients in both arms. Rescue medication was needed for 30 patients receiving sitagliptin and 11 patients receiving liraglutide. No cases of pancreatitis were reported. In the sitagliptin group, one subject each developed bladder cancer and squamous cell carcinoma. Nocturnal hypoglycemia did not develop in either trial arm.

Funding was provided by liraglutide maker Novo Nordisk. Dr. Maislos had no disclosures.

BOSTON – Switching from sitagliptin to liraglutide, in combination with metformin, improved control of hypoglycemia and resulted in greater weight loss in patients with type 2 diabetes, reported Dr. Maximo Maislos at the annual meeting of the Endocrine Society.

Results of a randomized, double-blind, double-dummy, active-controlled 26-week trial have indicated that liraglutide can be used as an add-on to metformin for patients with type 2 diabetes who have remained hyperglycemic.

“Switching from sitagliptin to liraglutide resulted in superior [glycated hemoglobin] and body weight reductions, compared with continued sitagliptin treatment,” said Dr. Maximo Maislos of Ben-Gurion University, Beer-Sheva, Israel.

The LIRA-SWITCH trial (Efficacy and Safety of Switching From Sitagliptin to Liraglutide in Subjects With Type 2 Diabetes Not Achieving Adequate Glycaemic Control on Sitagliptin and Metformin) involved 407 patients. The majority (60%) were male; mean age was 56 years and mean body mass index was 32 kg/m². The subjects had all been treated with sitagliptin (100 mg/day) and metformin (greater than or equal to 1,500 mg/day or a maximum tolerated dose greater than or equal to 1,000 mg/day) for at least 90 days. Hyperglycemia had not been well controlled, with a mean hemoglobin A_1C (HbA_IC) level of 8.3% (67 mmol/mol). The mean duration of type 2 diabetes was 8 years.

Subjects were randomized to continued sitagliptin along with metformin (n = 204) or liraglutide (1.8 mg daily) along with metformin (n = 203).

After 26 weeks of treatment, reduction in HbA_IC was significantly greater in the liraglutide arm than in the sitagliptin arm (1.14% vs. 0.54%; estimated treatment difference [ETD], –0.61%; 95% confidence interval, –0.82 to –0.40; P less than .0001). Those receiving liraglutide had statistically significantly greater weight loss, compared with those who continued on sitagliptin.

The less than 7% and less than or equal to 6.5% target levels of HbA_IC were achieved by 50.6% and 29.5%, respectively, of patients in the liraglutide arm. These percentages were significantly higher than the respective 26.9% and 9.9% of patients in the sitagliptin arm (P less than .0001 for both). Fasting plasma glucose levels were significantly reduced with liraglutide treatment while decreases in systolic and diastolic blood pressure were similar in the two study arms.

Adverse events (AEs) occurred more often in the liraglutide group than in the sitagliptin group (68.8% vs. 56.9%). Thirteen patients receiving liraglutide discontinued treatment, compared with five in the sitagliptin arm. The most common AEs in the liraglutide group were gastrointestinal disorders, principally nausea (21.8% with liraglutide vs. 7.8% with sitagliptin) and diarrhea (16.3% with liraglutide vs. 9.3% with sitagliptin), followed by decreased appetite (8.9% vs. 3.4%, respectively). These AEs tended to subside within the first few weeks of treatment.

Serious AEs occurred in eight patients in both arms. Rescue medication was needed for 30 patients receiving sitagliptin and 11 patients receiving liraglutide. No cases of pancreatitis were reported. In the sitagliptin group, one subject each developed bladder cancer and squamous cell carcinoma. Nocturnal hypoglycemia did not develop in either trial arm.

Funding was provided by liraglutide maker Novo Nordisk. Dr. Maislos had no disclosures.

BOSTON – Switching from sitagliptin to liraglutide, in combination with metformin, improved control of hypoglycemia and resulted in greater weight loss in patients with type 2 diabetes, reported Dr. Maximo Maislos at the annual meeting of the Endocrine Society.

Results of a randomized, double-blind, double-dummy, active-controlled 26-week trial have indicated that liraglutide can be used as an add-on to metformin for patients with type 2 diabetes who have remained hyperglycemic.

“Switching from sitagliptin to liraglutide resulted in superior [glycated hemoglobin] and body weight reductions, compared with continued sitagliptin treatment,” said Dr. Maximo Maislos of Ben-Gurion University, Beer-Sheva, Israel.

The LIRA-SWITCH trial (Efficacy and Safety of Switching From Sitagliptin to Liraglutide in Subjects With Type 2 Diabetes Not Achieving Adequate Glycaemic Control on Sitagliptin and Metformin) involved 407 patients. The majority (60%) were male; mean age was 56 years and mean body mass index was 32 kg/m². The subjects had all been treated with sitagliptin (100 mg/day) and metformin (greater than or equal to 1,500 mg/day or a maximum tolerated dose greater than or equal to 1,000 mg/day) for at least 90 days. Hyperglycemia had not been well controlled, with a mean hemoglobin A_1C (HbA_IC) level of 8.3% (67 mmol/mol). The mean duration of type 2 diabetes was 8 years.

Subjects were randomized to continued sitagliptin along with metformin (n = 204) or liraglutide (1.8 mg daily) along with metformin (n = 203).

After 26 weeks of treatment, reduction in HbA_IC was significantly greater in the liraglutide arm than in the sitagliptin arm (1.14% vs. 0.54%; estimated treatment difference [ETD], –0.61%; 95% confidence interval, –0.82 to –0.40; P less than .0001). Those receiving liraglutide had statistically significantly greater weight loss, compared with those who continued on sitagliptin.

The less than 7% and less than or equal to 6.5% target levels of HbA_IC were achieved by 50.6% and 29.5%, respectively, of patients in the liraglutide arm. These percentages were significantly higher than the respective 26.9% and 9.9% of patients in the sitagliptin arm (P less than .0001 for both). Fasting plasma glucose levels were significantly reduced with liraglutide treatment while decreases in systolic and diastolic blood pressure were similar in the two study arms.

Adverse events (AEs) occurred more often in the liraglutide group than in the sitagliptin group (68.8% vs. 56.9%). Thirteen patients receiving liraglutide discontinued treatment, compared with five in the sitagliptin arm. The most common AEs in the liraglutide group were gastrointestinal disorders, principally nausea (21.8% with liraglutide vs. 7.8% with sitagliptin) and diarrhea (16.3% with liraglutide vs. 9.3% with sitagliptin), followed by decreased appetite (8.9% vs. 3.4%, respectively). These AEs tended to subside within the first few weeks of treatment.

Serious AEs occurred in eight patients in both arms. Rescue medication was needed for 30 patients receiving sitagliptin and 11 patients receiving liraglutide. No cases of pancreatitis were reported. In the sitagliptin group, one subject each developed bladder cancer and squamous cell carcinoma. Nocturnal hypoglycemia did not develop in either trial arm.

Funding was provided by liraglutide maker Novo Nordisk. Dr. Maislos had no disclosures.

BOSTON – A prospective cohort study of women with polycystic ovarian syndrome who developed gestational diabetes mellitus during pregnancy has implicated fasting blood glucose, non–high density lipoprotein, and sex hormone–binding globulin as significant predictive factors for the development of GDM.

“Polycystic ovarian syndrome [PCOS] is the most common reproductive disorder in women of reproductive age and is commonly associated with metabolic disorders including diabetes and obesity. In women with GDM, a history of PCOS is associated with higher incidence of complications and postpregnancy glucose intolerance. Risk factors during early pregnancy in women with PCOS for development of GDM have not been well characterized,” said Dr. Wenyu Huang of Northwestern University, Chicago.

To provide some clarity, Dr. Huang and his colleagues conducted a prospective cohort study. Inclusion criteria were age 18-45 years, diagnosis of PCOS prior to conception, singlet pregnancy, and enrollment during the first trimester. Preexisting chronic disease including diabetes, hypertension, and thyroid, kidney, or cardiovascular disease was grounds for exclusion. The findings were presented at the annual meeting of the Endocrine Society.

The 248 women with PCOS enrolled from 2011 to 2013 from a screened population of 25,000 pregnant women were followed from their first prenatal visit (before week 18) to delivery. Blood was collected at the first visit for analysis of metabolic hormones. A 75-g oral glucose tolerance test (OGTT) was carried out at week 24-28 and diagnosis of GDM was according to 2013 American Diabetes Association OGTT criteria.

Of the 248 women, 75 (30.2%) developed GDM, and 173 (69.8%) women had normal OGTT results. Examination over the same time period early in pregnancy revealed a higher incidence of GDM in women with PCOS.

In a univariate analysis, PCOS patients who developed GDM had higher fasting blood glucose (FBG), Homeostasis Model Assessment-Insulin resistance (HOMA-IR) score, total cholesterol, low-density lipoprotein cholesterol, non-HDL cholesterol, systolic and diastolic blood pressures, and free testosterone index. These patients also had lower levels of sex hormone–binding globulin (SHBG) and higher likelihood of family history of diabetes and earlier delivery.

Multiple logistic regression revealed associations between increased incidence of GDM and FBG greater than or equal to 4.86 mmol/L, non-HDL cholesterol greater than or equal to 2.84 mmol/L, and SHBG greater than or equal to 222 nmol/L. The predictive power of the three factors for the development of GDM in PCOS was relatively strong.

Future studies could aim to validate the prediction model and clarify the pathogenic basis of GDM in PCOS women, according to the researchers .

The study was funded by the Beijing Science Committee. Dr. Huang had no disclosures.

BOSTON – A prospective cohort study of women with polycystic ovarian syndrome who developed gestational diabetes mellitus during pregnancy has implicated fasting blood glucose, non–high density lipoprotein, and sex hormone–binding globulin as significant predictive factors for the development of GDM.

“Polycystic ovarian syndrome [PCOS] is the most common reproductive disorder in women of reproductive age and is commonly associated with metabolic disorders including diabetes and obesity. In women with GDM, a history of PCOS is associated with higher incidence of complications and postpregnancy glucose intolerance. Risk factors during early pregnancy in women with PCOS for development of GDM have not been well characterized,” said Dr. Wenyu Huang of Northwestern University, Chicago.

To provide some clarity, Dr. Huang and his colleagues conducted a prospective cohort study. Inclusion criteria were age 18-45 years, diagnosis of PCOS prior to conception, singlet pregnancy, and enrollment during the first trimester. Preexisting chronic disease including diabetes, hypertension, and thyroid, kidney, or cardiovascular disease was grounds for exclusion. The findings were presented at the annual meeting of the Endocrine Society.

The 248 women with PCOS enrolled from 2011 to 2013 from a screened population of 25,000 pregnant women were followed from their first prenatal visit (before week 18) to delivery. Blood was collected at the first visit for analysis of metabolic hormones. A 75-g oral glucose tolerance test (OGTT) was carried out at week 24-28 and diagnosis of GDM was according to 2013 American Diabetes Association OGTT criteria.

Of the 248 women, 75 (30.2%) developed GDM, and 173 (69.8%) women had normal OGTT results. Examination over the same time period early in pregnancy revealed a higher incidence of GDM in women with PCOS.

In a univariate analysis, PCOS patients who developed GDM had higher fasting blood glucose (FBG), Homeostasis Model Assessment-Insulin resistance (HOMA-IR) score, total cholesterol, low-density lipoprotein cholesterol, non-HDL cholesterol, systolic and diastolic blood pressures, and free testosterone index. These patients also had lower levels of sex hormone–binding globulin (SHBG) and higher likelihood of family history of diabetes and earlier delivery.

Multiple logistic regression revealed associations between increased incidence of GDM and FBG greater than or equal to 4.86 mmol/L, non-HDL cholesterol greater than or equal to 2.84 mmol/L, and SHBG greater than or equal to 222 nmol/L. The predictive power of the three factors for the development of GDM in PCOS was relatively strong.

Future studies could aim to validate the prediction model and clarify the pathogenic basis of GDM in PCOS women, according to the researchers .

The study was funded by the Beijing Science Committee. Dr. Huang had no disclosures.

BOSTON – A prospective cohort study of women with polycystic ovarian syndrome who developed gestational diabetes mellitus during pregnancy has implicated fasting blood glucose, non–high density lipoprotein, and sex hormone–binding globulin as significant predictive factors for the development of GDM.

“Polycystic ovarian syndrome [PCOS] is the most common reproductive disorder in women of reproductive age and is commonly associated with metabolic disorders including diabetes and obesity. In women with GDM, a history of PCOS is associated with higher incidence of complications and postpregnancy glucose intolerance. Risk factors during early pregnancy in women with PCOS for development of GDM have not been well characterized,” said Dr. Wenyu Huang of Northwestern University, Chicago.

To provide some clarity, Dr. Huang and his colleagues conducted a prospective cohort study. Inclusion criteria were age 18-45 years, diagnosis of PCOS prior to conception, singlet pregnancy, and enrollment during the first trimester. Preexisting chronic disease including diabetes, hypertension, and thyroid, kidney, or cardiovascular disease was grounds for exclusion. The findings were presented at the annual meeting of the Endocrine Society.

The 248 women with PCOS enrolled from 2011 to 2013 from a screened population of 25,000 pregnant women were followed from their first prenatal visit (before week 18) to delivery. Blood was collected at the first visit for analysis of metabolic hormones. A 75-g oral glucose tolerance test (OGTT) was carried out at week 24-28 and diagnosis of GDM was according to 2013 American Diabetes Association OGTT criteria.

Of the 248 women, 75 (30.2%) developed GDM, and 173 (69.8%) women had normal OGTT results. Examination over the same time period early in pregnancy revealed a higher incidence of GDM in women with PCOS.

In a univariate analysis, PCOS patients who developed GDM had higher fasting blood glucose (FBG), Homeostasis Model Assessment-Insulin resistance (HOMA-IR) score, total cholesterol, low-density lipoprotein cholesterol, non-HDL cholesterol, systolic and diastolic blood pressures, and free testosterone index. These patients also had lower levels of sex hormone–binding globulin (SHBG) and higher likelihood of family history of diabetes and earlier delivery.

Multiple logistic regression revealed associations between increased incidence of GDM and FBG greater than or equal to 4.86 mmol/L, non-HDL cholesterol greater than or equal to 2.84 mmol/L, and SHBG greater than or equal to 222 nmol/L. The predictive power of the three factors for the development of GDM in PCOS was relatively strong.

Future studies could aim to validate the prediction model and clarify the pathogenic basis of GDM in PCOS women, according to the researchers .

The study was funded by the Beijing Science Committee. Dr. Huang had no disclosures.