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Abstract

It has been speculated that choice of open-label step-up drugs in ALLHAT may have influenced intent-to-treat results for major clinical outcomes. We have previously shown that the excess of heart failure in the doxazosin versus chlorthalidone group was not materially changed after adjustment for step-up drugs or blood pressure (BP) differences (Ann Intern Med 2002).

To compare coronary (CHD) and cardiovascular (CVD) outcomes for patients randomized to and taking single study drugs at one year [monotherapy groups]—amlodipine (A, n=4485), doxazosin (D, n=3775), lisinopril (L, n=3810), each versus those taking chlorthalidone (C, n=7701).

Monotherapy groups were compared for baseline characteristics, follow-up BP's, and, using proportional hazard methods, the primary (fatal CHD/ nonfatal MI) and major secondary CVD outcomes post 1 year for up to 7 years.

Baseline differences for monotherapy groups were small, and few were significant: C used less aspirin than A, D, and L patients; smaller % of D and L than C were Black; D had higher serum potassium (K+) than C; smaller % of L were women or had prior BP drugs than C, while % with coronary revascularization and mean serum K+ were higher, and HDLc lower. For each group at almost all years, diastolic BP changes from baseline were <1 mmHg different from those with C. At year 1 and 2, systolic (S)BP changes were 2 mmHg less in A than C, but similar thereafter. Through year 4, SBP changes were 3 mmHg less in D than C. Except at year 5, all SBP changes were within 1 mmHg for L vs. C. Relative risks versus C for CHD were 1.13 (p=.07), 1.02 (p=.87), and 0.94 (p=.43) for A, D, and L, respectively. Relative risks for combined CVD (CHD, stroke, coronary revascularization, treated heart failure (HF) or angina or peripheral arterial disease) were, compared with C, 1.11 (p=.006) for A, 1.15 for D (p<.01), and 1.04 for L (p=.30). These differences were largely driven by HF results: A vs. C, 1.41 (p<.001); D vs. C, 1.79 (p<.001); L vs. C, 1.14, (p=.16).

Analyses using monotherapy groups were similar to those of intent-to-treat analyses, suggesting that step-up drugs had little influence on the main ALLHAT finding of the superiority of chlorthalidone for prevention of major CV events, particularly HF.

Am J Hypertens (2004) 17, 30A–31A; doi: 10.1016/j.amjhyper.2004.03.070

Antihypertensive Monotherapy, Cardiovascular Events, ALLHAT
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© American Journal of Hypertension, Ltd. 2004
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