Liraglutide added to diet, exercise may help in weight loss

Last Updated: 2015-03-19

By Lorraine L. Janeczko

NEW YORK (Reuters Health) - Liraglutide may safely and effectively help overweight and obese adults lose weight when combined with increased physical activity and reduced calorie intake, new research suggests.

Patients in a clinical trial who received liraglutide, engaged in more physical activity, ate fewer calories, and were more than twice as likely to lose at least 5% of their body weight compared with those who made similar lifestyle changes but took placebo. In both the liraglutide and placebo groups, responders had greater glycemic, cardiometabolic and health-related quality-of-life improvements, the authors said.

The industry-sponsored study was presented March 7 at ENDO 2015, the annual meeting of the Endocrine Society, in San Diego.

"The U.S. Food and Drug Administration recently approved liraglutide for the treatment of obesity as an adjunct to diet and exercise," Dr. Patrick M. O'Neil, director of the Weight Management Center and professor in the Department of Psychiatry and Behavioral Sciences of the Medical University of South Carolina in Charleston, told Reuters Health by email.

"In the United States, 3.0 mg of liraglutide is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults who are overweight or obese and have at least one weight-related comorbidity," he said.

Dr. O'Neil and colleagues conducted a double-blind, placebo-controlled multicenter trial over 56 weeks. They randomized 2487 overweight or obese participants to treatment with 3.0 mg of subcutaneous liraglutide, and 1244 participants to placebo. All patients also reduced calorie intake and increased exercised. On average, they were 45 years old, weighed 106 kg/234 pounds, and had a BMI of 38 kg/m2, and 79% were female. Patients with prediabetes, hypertension, and dyslipidemia were included in the study, but those with diabetes were excluded.

After 56 weeks, 63.2% of participants on liraglutide lost at least 5% of their body weight and were considered responders, compared with 27.1% of those on placebo (p<0.0001).

Fasting plasma glucose decreased most among the responders in the liraglutide group followed by the non-responders in the liraglutide group. Waist circumference, systolic blood pressure, and 36-Item Short Form Health Survey (SF-36) decreased most among the responders in the liraglutide group followed by the responders in the placebo group.

Both groups had similar rates of adverse events, except liraglutide responders experienced gallbladder adverse events more commonly with than placebo responders. The most common adverse events were gastrointestinal, which were higher with liraglutide but similar in the responders and non-responders. Nausea, vomiting and dyspepsia were more prevalent in patients on liraglutide compared with patients on placebo.

The rates of serious adverse events were largely similar in responders compared with non-responders.

Dr. Dan Bessesen, professor of medicine at the University of Colorado School of Medicine in Denver, who was not involved in the study, told Reuters Health by email, "We now have a number of new medications that the FDA has approved for weight loss to help overweight and obese patients lose weight in conjunction with lifestyle changes. This is a sign of how the FDA and the medical profession in general are moving toward seeing obesity as a disease worth treating."

"Big questions are whether health care payors will reimburse for weight-loss medications, whether physicians will prescribe them, and whether patients want to and will take them," he wrote. "There currently does not seem to be a lot of enthusiasm among physicians for prescribing weight-loss medications. I think this is due to a lack of familiarity and a history of problems with medications in this therapeutic category."

Novo Nordisk funded the study and employs two of the authors.

SOURCE: http://bit.ly/1CwSFwk

ENDO 2015.