SAN DIEGO — Overweight and obese patients treated with liraglutide 3.0 mg were more than twice as likely to achieve weight loss of at least 5% when compared with those treated with placebo, new data presented at ENDO 2015 suggest.
This weight loss resulted in significant improvements in glycemic, cardiometabolic and quality-of-life outcomes in a considerable number of patients. Specifically, patients on liraglutide experienced greater improvements in blood glucose control and blood pressure (BP).
Liraglutide 3.0 mg was recently approved by the U.S. Food and Drug Administration (FDA) as an adjunct to diet and exercise for treatment of obesity, noted lead study author Patrick O’Neil, PhD, who is director of the Weight Management Center and professor in the department of psychiatry and behavioral sciences of the Medical University of South Carolina in Charleston.
However, he and his colleagues wanted to further investigate the safety and efficacy of liraglutide for weight management as well as the drug’s effect on other outcomes.
Dr. O’Neil and colleagues conducted the double blind, placebo-controlled multinational SCALE Obesity and Prediabetes trial over 56 weeks. In this study, 2,487 overweight or obese participants were randomly assigned to treatment with liraglutide 3.0 mg and 1,244 to placebo, both in combination with diet and exercise. Mean age was 45 years, 79% were women and participants had comorbidities such as prediabetes, hypertension and dyslipidemia. However, those with diabetes were excluded from the trial.
Those individuals who lost 5% or more of their body weight after 56 weeks were classified as responders. After 56 weeks, 63.2% of participants on liraglutide were considered responders compared with 27.1% of those on placebo (P<.0001). The responders in both the drug and placebo groups also achieved clinically meaningful improvements in other health outcomes.
Fasting plasma glucose decreased most among the responders in the liraglutide group followed by the non-responders in the liraglutide group. Waist circumference, systolic BP and 36-Item Short Form Health Survey (SF-36) scores decreased most among the responders in the liraglutide group followed by the responders in the placebo group.
The study showed that serious adverse events were equivalent in responders (liraglutide, 6.7% vs. placebo. 5.7%) compared with non-responders (liraglutide, 5.2% vs. placebo, 4.8%).
Many people with obesity are unaware of its severity and its implications for their health. However, losing 5% to 10% of their weight can yield significant health benefits, including improvements in blood glucose levels, BP, cholesterol levels and obstructive sleep apnea, according to Dr. O’Neil.
“Those who met the criterion had greater improvements in many of these variables vs. those who did not meet it. This was true for patients on liraglutide 3.0 mg and for those on placebo. However, patients on liraglutide 3.0 mg were more than twice as likely to achieve weight loss of at least 5%,” Dr. O’Neil told Endocrinology Advisor.
“Among the responders, the patients on liraglutide 3.0 mg had numerically better improvement on measures of blood glucose and systolic blood pressure.”
- O’Neil P et al. Abstract SAT-572. Presented at: The Endocrine Society’s 97th Annual Meeting & Expo (ENDO 2015); March 5-8, 2015; San Diego.