OBJECTIVE: The long-acting glucagon-like peptide 1 receptor agonist liraglutide is linked to progressive and sustained weight loss in obese people with diabetes. However, its efficacy and safety in women with polycystic ovary syndrome (PCOS) has not yet been addressed. DESIGN:Thirty-two obese women (aged 27.6±7.2 years, BMI 39.5±6.2 kg/m(2)) with newly diagnosed PCOS were randomized to receive either liraglutide 1.2 mg QD sc (n=17) or metformin 1000 mg BID po (n=15) for 12 weeks; 28 patients completed the study (14 onliraglutide and 14 on metformin). The main outcome was change in body weight. RESULTS: Intention-to-treat analysis showed significant BMI (-0.98 kg/m(2); p<0.001), body weight (-2.52 kg; p<0.001), waist circumference (-3.38 cm; p<0.001) and whole-body fat mass (-1.26%; p<0.001) reduction in both treatment arms without significant differences between therapeutic groups. However, in a subgroup of patients (n=9) with insulin resistance (HOMA(IR) >2), severe obesity and higher odds ratio for the metabolic syndrome (OR=3.9), the patients fared much better with liraglutide than with metformin (mean BMI decreased 2.13 kg/m(2) vs. 0.62 kg/m(2), respectively). CONCLUSIONS: Short-term liraglutide treatment was associated with significant weight loss in a subset of obese patients with newly diagnosed PCOS and a higher metabolic risk profile.
RCT Entities:
OBJECTIVE: The long-acting glucagon-like peptide 1 receptor agonist liraglutide is linked to progressive and sustained weight loss in obese people with diabetes. However, its efficacy and safety in women with polycystic ovary syndrome (PCOS) has not yet been addressed. DESIGN: Thirty-two obesewomen (aged 27.6±7.2 years, BMI 39.5±6.2 kg/m(2)) with newly diagnosed PCOS were randomized to receive either liraglutide 1.2 mg QD sc (n=17) or metformin 1000 mg BID po (n=15) for 12 weeks; 28 patients completed the study (14 on liraglutide and 14 on metformin). The main outcome was change in body weight. RESULTS: Intention-to-treat analysis showed significant BMI (-0.98 kg/m(2); p<0.001), body weight (-2.52 kg; p<0.001), waist circumference (-3.38 cm; p<0.001) and whole-body fat mass (-1.26%; p<0.001) reduction in both treatment arms without significant differences between therapeutic groups. However, in a subgroup of patients (n=9) with insulin resistance (HOMA(IR) >2), severe obesity and higher odds ratio for the metabolic syndrome (OR=3.9), the patients fared much better with liraglutide than with metformin (mean BMI decreased 2.13 kg/m(2) vs. 0.62 kg/m(2), respectively). CONCLUSIONS: Short-term liraglutide treatment was associated with significant weight loss in a subset of obesepatients with newly diagnosed PCOS and a higher metabolic risk profile.