Saxenda is indicated for treatment of overweight in people with a BMI >30 or a BMI between 27 and 30 with at least one weight-related complication as an adjunct to a reduced-calorie diet and physical activity. Saxenda contains liraglutide, a long-acting glucagon-like peptide-1 (GLP-1 analogue) and is administered subcutaneously once daily. The dose is escalated over a period of four weeks to the daily maintenance dose of 3 mg liraglutide.
Saxenda's exact mechanism of action in weight loss is not entirely clear. Overall, treatment with Saxenda produces a placebo-adjusted weight loss of 5.2%. The weight loss achieved was statistically significantly greater in women compared to men. Saxenda treatment gave a continuous decrease in weight during the first 40 weeks of treatment, after which the weight loss achieved was maintained. No efficacy data for Saxenda beyond a two-year period have been published. The efficacy of Saxenda is expected to be present during periods of use only.
The most common adverse reactions in Saxenda treatment are gastrointestinal effects. Liraglutide increases the heart rate, and it is still unclear whether there is a possible link between treatment with GLP-1 analogues and pancreatitis as well as medullary thyroid carcinoma.
It is IRF’s overall assessment that Saxenda has no place in the treatment regimen of obesity and overweight, given the relatively small percentage weight reduction, the high incidence of gastrointestinal adverse reactions as well as the considerable price of treatment. There is presently no evidence available on Saxenda's efficacy on hard endpoints such as mortality.