The effect of nisoldipine as compared with enalapril on cardiovascular outcomes in patients with non-insulin-dependent diabetes and hypertension
The effect of nisoldipine as compared with enalapril on cardiovascular outcomes in patients with non-insulin-dependent diabetes and hypertension
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DOI：
10.1056/nejm199803053381003
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发表时间：
1998-03-05
影响因子：
158.5
通讯作者：
Schrier, RW
中科院分区：
文献类型：
--
作者：
Estacio, RO;Jeffers, BW;Schrier, RW
背景：最近有报道称，使用钙通道阻滞剂治疗高血压可能与心血管并发症的风险增加有关。由于这一问题仍然存在争议，我们研究了非胰岛素依赖型糖尿病和高血压患者的此类并发症的发生率，这些患者被随机分配到钙通道阻滞剂尼索地平或血管紧张素转换酶抑制剂依那普利治疗，作为一项大型研究的一部分。一项比较中度控制血压（目标舒张压，80 - 89 mm Hg）与强化控制血压（目标舒张压，75 mm Hg）对糖尿病并发症发生率和进展的影响的盲法试验。该研究还比较了尼索地平与依那普利作为一线抗高血压药物在预防和发展糖尿病并发症方面的作用。在目前的研究中，我们分析了次要终点的数据，结果分析ABCD试验中470例高血压患者的心肌梗死发生率（基线舒张压，大于或等于90 mm Hg）显示出对血压、血糖和脂质浓度的相似控制，尼索地平组（235例患者）和依那普利组（235例患者）在5年随访期间的吸烟行为。采用校正心脏危险因素的多元逻辑回归模型，我们发现尼索地平与致死性和非致死性心肌梗死的发生率较高相关（共25个）比依那普利（共5项）（风险比，9.5; 95%可信区间，2.3 ~ 21.4）。结论在糖尿病和高血压患者人群中，我们发现，与接受依那普利治疗的患者相比，接受钙通道阻滞剂尼索地平治疗的患者的致死性和非致死性心肌梗死的发生率显著更高。由于我们的发现是基于次要终点，因此需要确认。(C)1998年，马萨诸塞州医学会。
Background It has recently been reported that the use of calcium-channel blockers for hypertension may be associated with an increased risk of cardiovascular complications. Because this issue remains controversial, we studied the incidence of such complications in patients with non-insulin-dependent diabetes mellitus and hypertension who were randomly assigned to treatment with either the calcium-channel blocker nisoldipine or the angiotensin-converting-enzyme inhibitor enalapril as part of a larger study.Methods The Appropriate Blood Pressure Control in Diabetes (ABCD) Trial is a prospective, randomized, blinded trial comparing the effects of moderate control of blood pressure (target diastolic pressure, 80 to 89 mm Hg) with those of intensive control of blood pressure (target diastolic pressure, 75 mm Hg) on the incidence and progression of complications of diabetes. The study also compared nisoldipine with enalapril as a first-line antihypertensive agent in terms of the prevention and progression of complications of diabetes. In the current study, we analyzed data on a secondary end point (the incidence of myocardial infarction) in the subgroup of patients in the ABCD Trial who had hypertension.Results Analysis of the 470 patients in the trial who had hypertension (base-line diastolic blood pressure, greater than or equal to 90 mm Hg) showed similar control of blood pressure, blood glucose and lipid concentrations, and smoking behavior in the nisoldipine group (235 patients) and the enalapril group (235 patients) throughout five years of follow-up. Using a multiple logistic-regression model with adjustment for cardiac risk factors, we found that nisoldipine was associated with a higher incidence of fatal and nonfatal myocardial infarctions (a total of 25) than enalapril (total, 5) (risk ratio, 9.5; 95 percent confidence interval, 2.3 to 21.4).Conclusions In this population of patients with diabetes and hypertension, we found a significantly higher incidence of fatal and nonfatal myocardial infarction among those assigned to therapy with the calcium-channel blocker nisoldipine than among those assigned to receive enalapril. Since our findings are based on a secondary end point, they will require confirmation. (C) 1998, Massachusetts Medical Society.