达塞曲匹降低冠心病患者新发糖尿病的风险。
Dalcetrapib Reduces Risk of New-Onset Diabetes in Patients With Coronary Heart Disease.
机构信息
Cardiology Section, Veterans Affairs Medical Center, and University of Colorado School of Medicine, Aurora, CO
Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, Canada.
出版信息
Diabetes Care. 2020 May;43(5):1077-1084. doi: 10.2337/dc19-2204. Epub 2020 Mar 6.
OBJECTIVE
Incident type 2 diabetes is common among patients with recent acute coronary syndrome and is associated with an adverse prognosis. Some data suggest that cholesteryl ester transfer protein (CETP) inhibitors reduce incident type 2 diabetes. We compared the effect of treatment with the CETP inhibitor dalcetrapib or placebo on incident diabetes in patients with recent acute coronary syndrome.
RESEARCH DESIGN AND METHODS
In the dal-OUTCOMES trial, 15,871 patients were randomly assigned to treatment with dalcetrapib 600 mg daily or placebo, beginning 4-12 weeks after an acute coronary syndrome. Absence of diabetes at baseline was based on medical history, no use of antihyperglycemic medication, and hemoglobin A and serum glucose levels below diagnostic thresholds. Among these patients, incident diabetes after randomization was defined by any diabetes-related adverse event, new use of antihyperglycemic medication, hemoglobin A ≥6.5%, or a combination of at least two measurements of serum glucose ≥7.0 mmol/L (fasting) or ≥11.1 mmol/L (random).
RESULTS
At baseline, 10,645 patients (67% of the trial cohort) did not have diabetes. During a median follow-up of 30 months, incident diabetes was identified in 403 of 5,326 patients (7.6%) assigned to dalcetrapib and in 516 of 5,319 (9.7%) assigned to placebo, corresponding to absolute risk reduction of 2.1%, hazard ratio of 0.77 (95% CI 0.68-0.88; < 0.001), and a need to treat 40 patients for 3 years to prevent 1 incident case of diabetes. Considering only those with prediabetes at baseline, the number needed to treat for 3 years to prevent 1 incident case of diabetes was 25. Dalcetrapib also decreased the number of patients who progressed from normoglycemia to prediabetes and increased the number who regressed from diabetes to no diabetes.
CONCLUSIONS
In patients with a recent acute coronary syndrome, incident diabetes is common and is reduced substantially by treatment with dalcetrapib.
目的
近期发生急性冠脉综合征的患者中，2 型糖尿病的发病率较高，且与不良预后相关。一些数据表明，胆固醇酯转移蛋白（CETP）抑制剂可降低 2 型糖尿病的发病率。我们比较了近期发生急性冠脉综合征的患者中，CETP 抑制剂 dalcetrapib 与安慰剂治疗对新发糖尿病的影响。
研究设计和方法
在 dal-OUTCOMES 试验中，15871 例患者随机分为 dalcetrapib 每日 600mg 治疗组或安慰剂组，起始时间为急性冠脉综合征后 4-12 周。基线时无糖尿病的定义为：无糖尿病病史、未使用降糖药物以及血红蛋白 A 和血清葡萄糖水平低于诊断阈值。在这些患者中，随机分组后新发糖尿病的定义为：任何与糖尿病相关的不良事件、新使用降糖药物、血红蛋白 A≥6.5%或至少两次测量的血清葡萄糖值≥7.0mmol/L（空腹）或≥11.1mmol/L（随机）。
结果
基线时，10645 例患者（试验队列的 67%）无糖尿病。中位随访 30 个月期间，5326 例 dalcetrapib 治疗患者中有 403 例（7.6%）和 5319 例安慰剂治疗患者中有 516 例（9.7%）发生新发糖尿病，绝对风险降低 2.1%，风险比为 0.77（95%CI 0.68-0.88；<0.001），每治疗 40 例患者 3 年可预防 1 例新发糖尿病。仅考虑基线时存在糖尿病前期的患者，每治疗 3 年预防 1 例新发糖尿病的患者数为 25 例。daletrapib 还降低了从血糖正常进展到糖尿病前期的患者数量，并增加了从糖尿病恢复到无糖尿病的患者数量。
结论
近期发生急性冠脉综合征的患者中，新发糖尿病很常见，dalcetrapib 治疗可显著降低其发病率。
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