https://immattersacp.org/weekly/archives/2015/07/07/1.htm

Obese, nondiabetic patients lost weight with liraglutide injections

A manufacturer-funded double-blind trial examined 3,731 patients randomly assigned in a 2:1 ratio to receive 3.0 mg of liraglutide per day or placebo.


Obese patients without diabetes who took liraglutide for a year lost significantly more weight than similar patients who received placebo injections, a manufacturer-funded trial found.

The double-blind trial included 3,731 patients without diabetes (although 61% had prediabetes) who had a body mass index of at least 30 kg/m2 or 27 kg/m2 plus dyslipidemia or hypertension. They were randomized in a 2:1 ratio to daily subcutaneous injections of 3.0 mg of liraglutide or placebo. All patients received counseling on lifestyle modification. Results were published in the July 2 New England Journal of Medicine.

After 56 weeks of treatment, patients in the liraglutide group had lost a mean of 8.4 kg, compared to 2.8 kg in the placebo group (difference −5.6 kg; 95% CI, −6.0 to −5.1; P<0.001). The liraglutide patients were also more likely to lose at least 5% or 10% of their body weight (63.2% vs. 27.1% and 33.1% vs. 10.6%, respectively; P<0.001 for both comparisons). Liraglutide was also associated with improvements in metabolic control, the study authors noted. Patients in the active group had greater reductions in waist circumference, blood pressure, and fasting and postprandial glycemic measures, and they were less likely to develop diabetes during the study.

The most common adverse events with liraglutide were nausea (reported by 40.2%) and diarrhea (20.9%). Serious adverse events occurred in 6.2% of the liraglutide group and 5.0% of the placebo group. Gallbladder events and breast neoplasms were both more common with liraglutide than placebo, although they occurred mostly in patients with above-average weight loss, the study authors noted. No effect on calcitonin concentration or risk of medullary thyroid concentration was seen with the drug.

The study was limited by its use of last-observation-carried-forward imputation, in which missing data points are replaced by the last observed value of that variable, which may distort the study results, the authors noted. Patients in the liraglutide group were more likely to complete the 56 weeks of treatment (71.9% vs. 64.4%), although they were more likely to withdraw due to adverse events (9.9% vs. 3.8%). The study's findings are “welcome” and “reassuring,” an accompanying editorial said. “Still, liraglutide is no cure,” the editorialists wrote, calling for development of more practical weight-loss strategies and studies with longer follow-up.