Elias S. Siraj, M.D., FACP, FACE, director of the Diabetes Program at Temple University Hospital (TUH), and Kevin J. Williams, M.D., FACP, chief of endocrinology, diabetes and metabolism at TUH, co-authored an editorial piece published in the New England Journal of Medicine about a major weight loss study involving obese and overweight patients.
Siraj and Williams offered their take on the significance of the randomized, double-blind clinical trial that showed a daily injection of 3.0 mg of the drug liraglutide, when given as an adjunct to diet and exercise in non-diabetics with obesity or overweight, was associated with reduced body weight and improved metabolic control. The study, which was published on the same issue of the New England Journal of Medicine, was conducted at a large number of sites in various countries, and was led by researchers at the Obesity Research Center at Columbia University Medical Center in New York. Neither Siraj nor Williams participated in the research.
On the basis of this and similar studies, the FDA in December 2014 approved the use of liraglutide 3.0 mg daily for the treatment of obesity and selected overweight patients. "This is another approach in tackling the obesity epidemic in our country," explained Siraj. "The drug liraglutide at a lower dosage has been used for the treatment of diabetes for the last few years, and patients were noted to be losing weight while on the medication. This clinical study used a higher dosage of liraglutide in subjects without diabetes purely for weight loss purposes."
Participants in the trial did not have diabetes and were either obese or markedly overweight. Over 60 percent did have prediabetes at enrollment. Patients were either administered liraglutide or a placebo in conjunction with lifestyle counseling over the course of 56 weeks. More than 3700 participants from six continents took part in the study.
"At week 56, participants in the liraglutide group showed significant improvements," said Williams. "According to the study, participants in the liraglutide group lost a mean of 8.4 kg of body weight, as compared with a loss of 2.8 kg in the placebo group."
Siraj and Williams indicate the most common side effects in the liraglutide group were related to the gastrointestinal system and were mild. Both doctors say a slightly higher number of breast cancers were detected in the liraglutide group which will require continued attention, but they say that greater weight loss might have facilitated the detection of breast cancer.
Siraj and Williams conclude that, while the study has shown that the patients in the liraglutide group lost significant weight, liraglutide is no cure -- most obese patients who took the medication remained obese. Still, the benefits from modest weight loss can be considerable. "Fortunately, even modest weight loss of 5 percent to 10 percent makes nearly all medical issues more manageable. Modest weight loss may now be easier to achieve, but we need to await the results from studies with longer follow-up," said Siraj.