Early Weight Loss With Saxenda Predicts More - MedPage Today

Action Points

• Early weight loss in patients taking the newly approved injectable obesity drug liraglutide 3 mg (Saxenda, Novo Nordisk) predicts sustained weight loss with the drug.
• Note that more than 90% of patients in both trials experienced adverse events on the drug, with gastrointestinal side effects occurring in 56% to 76% of diabetic- and 65% to 69% of nondiabetic patients.

Early weight loss in patients taking the newly approved injectable obesity drug liraglutide 3 mg (Saxenda, Novo Nordisk) predicts sustained weight loss with the drug, according to findings from a post hoc analysis of two large randomized trials.
More than half (55%) of nondiabetic study participants who lost at least 5% of their total body weight after 4 months on liraglutide (early responders) had a 10% or more weight loss after 56 weeks on the drug, compared to fewer than one in 10 (8%) patients who did achieve this early weight loss.
Early responders, with and without type 2 diabetes, achieved a mean weight loss at week 56 of 9.3% and 11.5%, respectively, according to researcher John Wilding, FRCP, of the University of Liverpool, U.K., and colleagues.
Wilding presented findings from the post hoc analysis of the SCALE Obesity and Prediabetes and Diabetes trials Dec. 2 at the International Diabetes Federation World Diabetes Congress in Vancouver, Canada.
FDA Approved Liraglutide Last December
A glucagon-like peptide-1 (GLP-1) receptor agonist, liraglutide 3 mg, was approved by FDA for weight loss last December. The once-a-day injectable drug is also approved at a lower dose (1.2 or 1.8 mg/day) as Victoza for lowering blood sugar in patients with type 2 diabetes.
With a treatment cost of around $1,000 a month, liraglutide 3 mg is among the most expensive of the new crop of weight-loss drugs now available in the U.S.
In a telephone interview with MedPage Today, Wilding said the analysis gives clinicians prescribing the drug a metric for determining if their patients should stay on it or not.
"Patients who don't achieve at least 5% weight loss after 16 weeks are not likely to do well on this drug," he said. "If a patient loses 5% or more of their total weight during this early period it might be worth the investment."
Canadian Diabetes Association chief science officer Jan Hux, MD, said the analysis provides important information for both clinicians and patients. Hux commented on the study findings for MedPage Today.
"Defining a stopping point beyond which we can say that taking this drug isn't worth it is important in terms of efficient use of health care resources and efficient investment of patient optimism," she said. "Patients who struggle with their weight really do struggle and they are looking for reasons to be optimistic."
Weight Loss Continued for Most Early Responders
The analysis included a total of 2,910 patients randomized to liraglutide 3.0 mg/day along with diet and exercise, including 2,487 who did not have type 2 diabetes. The mean baseline BMI was 38 kg/m² and 37 kg/m² for nondiabetics and diabetics, respectively. In all, 2,152 participants without diabetes and 365 with diabetes completed 16 weeks of treatment.
A total of 68% of patients without diabetes who remained on the drug were early responders, with a mean weight loss of 11.5% at 56 weeks.
The analysis revealed that:

• Most early responders (88%) had lost at least 5% of their total body weight at 1 year, and around a quarter (24%) lost more than 15% of their total body weight.
• Among nonresponders without diabetes who failed to lose 5% of their body weight after 16 weeks on the drug, 37% reached this goal by 56 weeks, but just 8% and 2%, respectively lost more than 10% and 15% of their total body weight.
• Half of patients with diabetes who completed 16 weeks on the drug were early responders, and these patients had a mean weight loss at 56 weeks of 9.3%. Four out of 5 diabetic early responders had lost at least 5% of their total body weight at 56 weeks and 12% lost more than 15%.
• Early nonresponders with diabetes had a mean weight loss at 56 weeks of just 3.6%, and just 1% lost more than 15% of their total body weight.

More than 90% of patients in both trials experienced adverse events on the drug, with gastrointestinal side effects occurring in 56% to 76% of diabetic- and 65% to 69% of nondiabetic patients. Between 5% and 10% of patients experienced adverse events that were considered serious.

The SCALE randomized trials were funded by Novo Nordisk.
Wilding reported receiving consulting fees from Novo Nordisk.

• Reviewed by Robert Jasmer, MD Associate Clinical Professor of Medicine, University of California, San Francisco