Massachusetts Veterans Epidemiology Research and Information Center/VA Cooperative Studies Programs, VA Boston Healthcare System, Boston, Massachusetts, USA.
Diabetes Care. 2010 Jul;33(7):1503-8. doi: 10.2337/dc09-2009. Epub 2010 Mar 23.
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.
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).
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 [95% two-sided CI 0.35-0.96]). Nausea was the most commonly reported adverse event in the bromocriptine-QR group.
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.
快速释放溴隐亭（bromocriptine-QR）是一种 D2 多巴胺受体激动剂，用于治疗 2 型糖尿病。Cycloset 安全性试验是一项为期 52 周、随机、双盲、多中心试验，评估了这种新型 2 型糖尿病治疗药物的整体安全性和心血管安全性。
共有 3095 名 2 型糖尿病患者被随机分为 2:1 组，分别接受溴隐亭-QR 或安慰剂治疗，同时接受患者的常规糖尿病治疗（仅饮食控制或两种抗糖尿病药物，包括胰岛素）。主要安全性终点是任何严重不良事件（SAE）的发生，非劣效性边界为 1.5。在一项预设分析中，使用修改后的意向治疗分析（clinicaltrials.gov，NCT00377676）评估了定义为心肌梗死、中风、冠状动脉血运重建以及心绞痛或充血性心力衰竭住院的心血管疾病（CVD）事件的发生率。
在溴隐亭-QR 组中，有 176 人（8.6%）报告了 SAE，而安慰剂组有 98 人（9.6%）（HR 1.02 [96%单侧 CI 1.27]）。与安慰剂组相比，溴隐亭-QR 组报告心血管终点的人数较少（37 [1.8%] vs. 32 [3.2%]）（HR 0.60 [95%双侧 CI 0.35-0.96]）。溴隐亭-QR 组最常见的不良反应是恶心。
治疗组 SAE 的发生频率相当。与安慰剂组相比，接受溴隐亭-QR 治疗的患者发生心血管终点事件的频率较低。
