Estacio R O, Jeffers B W, Hiatt W R, Biggerstaff S L, Gifford N, Schrier R W
Colorado Prevention Center, Division of General Internal Medicine, University of Colorado Health Sciences Center, Denver 80262, USA.
N Engl J Med. 1998 Mar 5;338(10):645-52. doi: 10.1056/NEJM199803053381003.
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.
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 (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.
Analysis of the 470 patients in the trial who had hypertension (base-line diastolic blood pressure, > or = 90 mm Hg) showed similar control of blood pressure, blood glucose and lipid concentrations, and smoking behavior in the nisoldipine group (237 patients) and the enalapril group (233 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 24) than enalapril (total, 4) (risk ratio, 9.5; 95 percent confidence interval, 2.7 to 33.8).
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.
最近有报道称，使用钙通道阻滞剂治疗高血压可能会增加心血管并发症的风险。由于这个问题仍存在争议，我们在一项更大规模研究的一部分中，对非胰岛素依赖型糖尿病合并高血压患者进行了研究，这些患者被随机分配接受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，我们研究了此类并发症的发生率。
糖尿病患者血压适当控制（ABCD）试验是一项前瞻性、随机、双盲试验，比较适度控制血压（目标舒张压80至89毫米汞柱）与强化控制血压（舒张压75毫米汞柱）对糖尿病并发症发生率和进展的影响。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延缓糖尿病并发症方面的效果。在当前研究中，我们分析了ABCD试验中患有高血压患者亚组的一个次要终点（心肌梗死发生率）的数据。
对试验中470例患有高血压（基线舒张压≥90毫米汞柱）的患者进行分析，结果显示，在整个五年的随访中，尼索地平组（237例患者）和依那普利组（233例患者）在血压、血糖和血脂浓度以及吸烟行为的控制方面相似。使用多因素逻辑回归模型并对心脏危险因素进行校正后，我们发现，与依那普利（总计4例）相比，尼索地平与致命和非致命心肌梗死的发生率更高（总计24例）相关（风险比为﹒5；95%置信区间为2﹒7至33﹒8）。
在这群糖尿病合并高血压患者中，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中，致命和非致命心肌梗死的发生率显著更高。由于我们的发现基于一个次要终点，因此需要进一步证实。
