Abstract
To assess whether ACE inhibitors are superior to alternative agents for the prevention of cardiovascular events in patients with hypertension and type 2 diabetes. This study is a review and meta-analysis of randomized controlled trials that included patients with type 2 diabetes and hypertension who were randomized to an ACE inhibitor or an alternative drug, were followed for > or =2 years, and had adjudicated cardiovascular events. A total of 4 trials were eligible. The Appropriate Blood Pressure Control in Diabetes (ABCD) trial (n = 470) compared enalapril with nisoldipine, the Captopril Prevention Project (CAPPP) (n = 572) compared captopril with diuretics or beta-blockers, the Fosinopril Versus Amlodipine Cardiovascular Events Trial (FACET) (n = 380) compared fosinopril with amlodipine, and the U.K. Prospective Diabetes Study (UKPDS) (n = 758) compared captopril with atenolol. The cumulative results of the first 3 trials showed a significant benefit of ACE inhibitors compared with alternative treatments on the outcomes of acute myocardial infarction (63% reduction, P < 0.001), cardiovascular events (51% reduction, P < 0.001), and all-cause mortality (62% reduction, P = 0.010). These findings were not observed in the UKPDS. The ACE inhibitors did not appear to be superior to other agents for the outcome of stroke in any of the trials. None of the findings were explained by differences in blood pressure control. Compared with the alternative agents tested, ACE inhibitors may provide a special advantage in addition to blood pressure control. The question of whether atenolol is equivalent to captopril remains open. Conclusive evidence on the comparative effects of antihypertensive treatments will come from large prospective randomized trials.
Highlights
RESEARCH DESIGN AND METHODS — This study is a review and meta-analysis of randomized controlled trials that included patients with type 2 diabetes and hypertension who were randomized to an ACE inhibitor or an alternative drug, were followed for Ն2 years, and had adjudicated cardiovascular events
The cumulative results of the first 3 trials showed a significant benefit of ACE inhibitors compared with alternative treatments on the outcomes of acute myocardial infarction (63% reduction, P Ͻ 0.001), cardiovascular events (51% reduction, P Ͻ 0.001), and allcause mortality (62% reduction, P = 0.010)
In the ACE inhibitor group, the risk of acute myocardial infarction was significantly decreased in the Appropriate Blood Pressure Control in Diabetes (ABCD) trial and the Captopril Prevention Project (CAPPP), was nonsignificantly lower in the Fosinopril Versus Amlodipine Cardiovascular Events Trial (FACET), and was nonsignificantly higher in the U.K. Prospective Diabetes Study (UKPDS) compared with the alternative treatment
Summary
Data are means ± SEM, unless otherwise indicated. The following elements were abstracted: design, sample size, randomized treatments, follow-up time, average age, sex distribution, average BMI, proportion of participants with macroalbuminuria, duration of diabetes, baseline systolic and diastolic arterial pressures, and the number of events (including acute myocardial infarction, stroke, combined cardiovascular events, and all-cause mortality) occurring in each treatment group. 4 trials met all of the inclusion criteria Those trials were the Appropriate Blood Pressure Control in Diabetes (ABCD) trial (7), the diabetic group of the Captopril Prevention Project (CAPPP) (8), the Fosinopril Versus Amlodipine Cardiovascular Events Trial (FACET) (9), and the UKPDS (Table 1) (10). In the ABCD trial and the UKPDS, no significant differences were evident in blood pressure control among the randomized treatment groups. In the ACE inhibitor group, the risk of acute myocardial infarction was significantly decreased in the ABCD trial and the CAPPP, was nonsignificantly lower in the FACET, and was nonsignificantly higher in the UKPDS compared with the alternative treatment. For ACE inhibitors versus other treatments, the RRs (95% CIs) of acute myocardial infarction, stroke, cardiovascular events, and all-cause mortality
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