Liraglutide treatment led to greater reduction in body weight than placebo, orlistat

Treatment with liraglutide resulted in greater weight loss, improvement in blood pressure and reduction in prediabetes incidence compared with placebo or orlistat in a new study published online in The Lancet.

Researchers conducted the double-blind, placebo-controlled, 20-week trial (n=564) at 19 sites in Europe. They randomly assigned participants, who had a BMI of 30 to 40, to once-daily subcutaneous liraglutide (Victoza, Novo Nordisk) 1.2 mg, 1.8 mg, 2.4 mg or 3 mg (n=90-95), once-daily subcutaneous placebo (n=98) or to three times daily oral orlistat (Xenical, Roche; Alli, GlaxoSmithKline) 120 mg (n=95). Participants also underwent a 500 kcal per day energy-deficit diet and increased physical activity.

Compared with placebo, those assigned to 1.2 mg liraglutide daily lost more weight (P=.003), as did those assigned to liraglutide 1.8 mg to 3.0 mg (P<.0001). Those assigned to placebo lost a mean 2.8 kg and those assigned to orlistat lost a mean 4.1 kg. In comparison, participants assigned to liraglutide lost a mean 4.8 kg with the 1.2-mg dose, 5.5 kg with the 1.8-mg dose, 6.3 kg with the 2.4-mg dose and 7.2 kg with the 3-mg dose.

Sixty-one percent of participants assigned to liraglutide lost 5% of their body weight from baseline. Specifically, 76% of those assigned to the 3.0-mg dose of liraglutide lost more than 5% of their weight compared with 30% of those assigned placebo and 44% of those assigned to orlistat.

The researchers also reported reductions in blood pressure at all doses of liraglutide and an 84% to 96% reduction in the incidence of prediabetes with the 1.8-mg to 3-mg doses of liraglutide. Results also demonstrated a 60% reduction in the proportion of participants with metabolic syndrome who were assigned to liraglutide 2.4 mg or 3 mg compared with a 38% reduction in the placebo group and a 13% reduction in the orlistat group. Participants assigned to all doses of liraglutide had a greater probability of having a normal glucose tolerance at week 20 compared with those assigned to placebo or orlistat (P<.01).

Participants assigned to liraglutide more often reported nausea and vomiting compared with those assigned to placebo, but the researchers wrote that adverse events were transient and rarely led to participants discontinuing treatment.

Astrup A. Lancet. 2009;doi:10.1016/S0140-6736(09)61375-1.