ACCOMPLISH
Trial question
Is benazepril plus amlodipine superior to benazepril plus hydrochlorothiazide in patients with hypertension who are at high-risk for cardiovascular events?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
39.0% female
61.0% male
N = 11506
11506 patients (4542 female, 6963 male)
Inclusion criteria: patients with hypertension who were at high risk for cardiovascular events
Key exclusion criteria: acute coronary syndromes, or coronary revascularizations within 1 month of the first visit; stroke or other ischemic cerebrovascular episodes within 3 months preceding study evaluation; or hypertension that is excessively severe, known to be refractory to treatment, or known to have a secondary cause
Interventions
N=5744 benazepril-amlodipine (20 mg benazepril and 5 mg amlodipine)
N=5762 benazepril-hydrochlorothiazide (20 mg benazepril and 12.5 mg hydrochlorothiazide)
Primary outcome
Rate of cardiovascular events and death from cardiovascular causes, at a mean follow-up of 36 months
9.6
11.8
11.8 %
8.9 %
5.9 %
3.0 %
0.0 %
Benazepril-amlodipine
Benazepril-hydrochlorothiazide
Significant decrease ▼
NNT = 45
Significant decrease in the rate of cardiovascular events and death from cardiovascular causes, at a mean follow-up of 36 months (9.6% vs. 11.8%; HR 0.8, 95% CI 0.72 to 0.9)
Secondary outcomes
Significant decrease in death from cardiovascular causes, nonfatal myocardial infarction, and nonfatal stroke (5% vs. 6.3%; HR 0.79, 95% CI 0.67 to 0.92)
Significant decrease in cardiovascular events (8.6% vs. 10.3%; HR 0.83, 95% CI 0.73 to 0.93)
Safety outcomes
No significant difference in dry cough (20.5% vs. 21.2%) and hyperkalemia (0.6% vs. 0.6%).
Significant differences in peripheral edema (31.2% vs. 13.4%), dizziness (20.7% vs. 25.4%), and hypotension (2.5% vs. 3.6%).
Conclusion
In patients with hypertension who were at high risk for cardiovascular events, benazepril-amlodipine was superior to benazepril-hydrochlorothiazide with respect to the rate of cardiovascular events and death from cardiovascular causes, at a mean follow-up of 36 months.
Reference
Jamerson K, Weber MA, Bakris GL et al. Benazepril plus amlodipine or hydrochlorothiazide for hypertension in high-risk patients. N Engl J Med. 2008 Dec 4;359(23):2417-28.
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