Merck Sharp & Dohme Corp, Whitehouse Station, NJ, USA.
Cardiovasc Diabetol. 2013 Jan 3;12:3. doi: 10.1186/1475-2840-12-3.
To compare the incidence of cardiovascular events and mortality in patients with type 2 diabetes mellitus treated with sitagliptin or non-sitagliptin comparators.
A post hoc assessment of cardiovascular safety in 14,611 patients was performed by pooling data from 25 double-blind studies, which randomised patients at baseline to sitagliptin 100 mg/day or a non-sitagliptin comparator (i.e., non-exposed). Included studies were limited to those at least 12 weeks in duration (range: 12 to 104 weeks). Patient-level data were used in this analysis of major adverse cardiovascular events (MACE) including ischaemic events and cardiovascular deaths. Analyses were performed in three cohorts: the entire 25-study cohort, the cohort from placebo-controlled portions of studies (n=19), and the cohort from studies comparing sitagliptin to a sulphonylurea (n=3).
In the entire cohort analysis, 78 patients had at least 1 reported MACE-related event, with 40 in the sitagliptin group and 38 in the non-exposed group. The exposure-adjusted incidence rate was 0.65 per 100 patient-years in the sitagliptin group and 0.74 in the non-exposed group (incidence rate ratio = 0.83 [95% confidence interval (CI): 0.53, 1.30]). In the analysis comparing sitagliptin to placebo, the exposure-adjusted incidence rate was 0.80 per 100-patient-years with sitagliptin and 0.76 with placebo (incidence rate ratio = 1.01 [95% CI: 0.55, 1.86]). In the analysis comparing sitagliptin to sulphonylurea, the exposure-adjusted incidence rate was 0.00 per 100 patient-years with sitagliptin and 0.86 with sulphonylurea (incidence rate ratio = 0.00 [95% CI: 0.00, 0.31]).
A pooled analysis of 25 randomised clinical trials does not indicate that treatment with sitagliptin increases cardiovascular risk in patients with type 2 diabetes mellitus. In a subanalysis, a higher rate of cardiovascular-related events was associated with sulphonylurea relative to sitagliptin.
比较接受西他列汀或非西他列汀对照药物治疗的 2 型糖尿病患者的心血管事件和死亡率发生率。
对 25 项双盲研究的数据进行了事后评估，共纳入了 14611 名患者，这些患者在基线时随机接受西他列汀 100mg/天或非西他列汀对照药物（即未暴露）治疗。这些研究的持续时间至少为 12 周（范围：12-104 周）。本分析采用主要不良心血管事件（MACE）的患者水平数据，包括缺血性事件和心血管死亡。分析分为三个队列：整个 25 项研究队列、来自研究安慰剂对照部分的队列（n=19）和来自比较西他列汀与磺酰脲类药物的研究的队列（n=3）。
在整个队列分析中，78 名患者至少有 1 例报告的与 MACE 相关的事件，其中 40 例在西他列汀组，38 例在未暴露组。西他列汀组的暴露调整发生率为每 100 患者-年 0.65 例，未暴露组为 0.74 例（发生率比=0.83[95%置信区间（CI）：0.53，1.30]）。在比较西他列汀与安慰剂的分析中，西他列汀的暴露调整发生率为每 100 患者-年 0.80 例，安慰剂为 0.76 例（发生率比=1.01[95%CI：0.55，1.86]）。在比较西他列汀与磺酰脲类药物的分析中，西他列汀的暴露调整发生率为每 100 患者-年 0.00 例，磺酰脲类药物为 0.86 例（发生率比=0.00[95%CI：0.00，0.31]）。
25 项随机临床试验的汇总分析并未表明 2 型糖尿病患者接受西他列汀治疗会增加心血管风险。在一项亚分析中，磺酰脲类药物与西他列汀相比，与心血管相关事件的发生率更高。
