Health Problem: Polycystic ovary syndrome (PCOS) is a common endocrine disorder affecting 6% to 20% of women of reproductive age. It is characterized by oligoovulation (menstrual irregularity), hyperandrogenism (increased testosterone levels), and polycystic ovaries. Obesity is a common feature of PCOS, affecting approximately 40% to 80% of women diagnosed with the syndrome. Weight loss is a central component of treatment for women with PCOS who are overweight or obese. Weight reduction can decrease androgen effects, increase ovulation, and improve insulin sensitivity.

Technology Description: Glucagon-like Peptide-1(GLP-1) receptor agonists are a class of drugs that mimic the effects of the naturally occurring gut hormone GLP-1. The GLP-1 hormone, which is released in the gastrointestinal tract after a meal, stimulates insulin secretion, inhibits glucagon release, delays gastric emptying, reduces food intake, and normalizes fasting and postprandial insulin secretion. GLP-1 receptor agonists have similar, but more enduring, effects to the naturally occurring hormone.

Controversy: Prescribing information for Saxenda (liraglutide) and Byetta (exenatide) states that these drugs must be used in conjunction with a reduced-calorie diet and exercise. However, the randomized controlled trials evaluated in this report did not implement diet and exercise programs in conjunction with GLP-1 receptor agonists. Further, use of GLP-1 receptor agonists could potentially cause serious adverse events (AEs). While the most frequently occurring AEs associated with GLP-1 receptor agonists include mild to moderate gastrointestinal discomfort (e.g., nausea, diarrhea, and vomiting), the FDA has issued a black box warning for Saxenda (liraglutide) concerning the potential risk of thyroid C-cell tumors. The FDA also warns that Saxenda is contraindicated in patients with a personal or family history of medullary thyroid carcinoma and in patients with multiple endocrine neoplasia syndrome type 2.

Key Questions:

  • Are GLP-1 receptor agonists effective in treating obesity in adult women with PCOS?

  • How do GLP-1 receptor agonists compare with placebo or other active drug therapies?

  • Are GLP-1 receptor agonists safe?

  • Have definitive patient selection criteria been identified for GLP-1 receptor agonists?

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