ALLHAT (angiotensin-converting enzyme inhibitor)
Trial question
Is lisinopril superior to chlorthalidone in high-risk patients with hypertension?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
47.0% female
53.0% male
N = 24309
24309 patients (11358 female, 12951 male).
Inclusion criteria: patients ≥ 55 years of age with hypertension and at least 1 other coronary artery disease risk factor.
Key exclusion criteria: history of hospitalized or treated symptomatic HF and/or known LVEF < 35%.
Interventions
N=9054 lisinopril (a dose of 10-40 mg/day).
N=15255 chlorthalidone (a dose of 12.5-25 mg/day).
Primary outcome
Rate of fatal coronary artery disease or nonfatal MI within 6 years
11.4%
11.5%
11.5 %
8.6 %
5.8 %
2.9 %
0.0 %
Lisinopril
Chlorthalidone
No significant
difference ↔
No significant difference in the rate of fatal coronary artery disease or nonfatal MI within 6 years (11.4% vs. 11.5%; RR 0.99, 99% CI 0.91 to 1.08).
Secondary outcomes
No significant difference in the rate of all-cause mortality within 6 years (17.2% vs. 17.3%; RR 1, 95% CI 0.94 to 1.08).
No significant difference in the rate of coronary artery disease within 6 years (20.8% vs. 19.9%; RR 1.05, 95% CI 0.98 to 1.11).
Significant increase in the rate of stroke within 6 years (6.3% vs. 5.6%; RR 1.15, 95% CI 1.02 to 1.3).
Safety outcomes
No significant difference in hospitalization for gastrointestinal bleeding.
Conclusion
In patients ≥ 55 years of age with hypertension and at least 1 other coronary artery disease risk factor, lisinopril was not superior to chlorthalidone with respect to the rate of fatal coronary artery disease or nonfatal MI within 6 years.
Reference
ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial. Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). JAMA. 2002 Dec 18;288(23):2981-97.
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