Journal
DIABETES CARE
Volume 33, Issue 7, Pages 1503-1508Publisher
AMER DIABETES ASSOC
DOI: 10.2337/dc09-2009
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Funding
- National Institutes of Health (National Cancer Institute
- National Heart, Lung, and Blood Institute
- National Institute on Aging
- National Eye Institute)
- Veteran's Affairs Cooperative Studies Program
- Pliva, Inc. (Zagreb, Croatia)
- VeroScience, LLC (Tiverton, RI)
- VeroScience, LLC
- Wyeth Pharmaceuticals
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OBJECTIVE - Quick-release bromocriptine (bromocriptine-QR), a D2 dopamine receptor agonist, is indicated as a treatment for type 2 diabetes. The Cycloset Safety Trial, a 52-week, randomized, double-blind, multicenter trial, evaluated the overall safety and cardiovascular safety of this novel therapy for type 2 diabetes. RESEARCH DESIGN AND METHODS - A total of 3,095 patients with type 2 diabetes were randomized 2:1 to bromocriptine-QR or placebo in conjunction with the patient's usual diabetes therapy (diet controlled only or up to two antidiabetes medications, including insulin). The all-cause safety end point was the occurrence of any serious adverse event (SAE), with a hazard ratio (HR) noninferiority margin of 1.5. In a prespecified analysis, the frequency of cardiovascular disease (CVD) events defined as a composite of myocardial infarction, stroke, coronary revascularization, and hospitalization for angina or congestive heart failure was evaluated using modified intent-to-treat analysis (clinicaltrials.gov, NCT00377676). RESULTS - In the bromocriptine-QR group, 176 (8.6%) people reported SAEs compared with 98(9.6%) in the placebo group (HR 1.02 [96% one-sided CI 1.27]). Fewer people reported a CVD end point in the bromocriptine-QR group versus the placebo group (37 [1.8%] vs. 32 [3.2%], respecively) (HR 0.60 195% two-sided CI 0.35-0.96]). Nausea was the most commonly reported adverse event in the bromocriptine-QR group. CONCLUSIONS - The frequency of SAEs was comparable between the treatment arms. Compared with patients in the placebo arm, fewer patients taking bromocriptine-QR experienced a cardiovascular end point.
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