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Editor's Correspondence
September 18, 2006

It Is Time to Stop Comparing Blood Pressure–Lowering Drugs With Placebo

Arch Intern Med. 2006;166(16):1786. doi:10.1001/archinte.166.16.1786-a

In the March 27 issue of the ARCHIVES, the Perindopril and Remodeling in Elderly with Acute Myocardial Infarction (PREAMI) investigators showed that the use of an angiotensin-converting enzyme (ACE) inhibitor in patients who recovered from an acute myocardial infarction, with mildly depressed or preserved ejection fraction (≥40%), lowered the incidence of left ventricular remodeling.1 The internal validity of this double-blind trial, with meticulous evaluation of outcome, is undisputable. The conception of this trial, however, particularly with the choosing of a placebo control arm, casts doubt about its external validity. The absence of effect on hard outcomes was expected, in view of the small sample size, but even the effect on cardiac remodeling can be attributed to the blood pressure–lowering effect of perindopril. The magnitude of this effect, despite being statistically significant, cannot be fully captured by occasional office blood pressure measurement, as it was shown in the Heart Outcomes Prevention Evaluation (HOPE) trial.2 The expectations about the putative antiatherosclerotic and myocardial effects of antagonists of the renin-angiotensin system may be down in face of the results of trials comparing them with active treatments,3,4 and the use of ACE inhibitors has been recommended for any patient recovering from an acute myocardial infarction, even if blood pressure is within the prehypertensive levels.5 The blood pressure–lowering effect of the several classes of antihypertensive drugs explains most, if not all, of their clinical efficacy, and it is surely time to stop comparing them with placebo to prevent cardiovascular outcomes.