Amlodipine did not significantly reduce all-cause mortality compared to placebo in hypertensive hemodialysis patients (12% vs 17%; HR 0.65; 95% CI 0.34-1.23; P=0.19).
RCT (n=251)
double-blind
randomized
Yes
Does amlodipine reduce mortality from any cause in hypertensive haemodialysis patients?
In hypertensive hemodialysis patients, amlodipine did not significantly reduce all-cause mortality but did reduce the composite of mortality or cardiovascular events.
Effect estimate: HR 0.65 (95% CI 0.34-1.23)
Absolute Event Rate: 12% vs 17%
p-value: p=0.19
BACKGROUND: Hypertensive haemodialysis patients may be at a high risk for cardiovascular events. This study was undertaken to ascertain whether the calcium channel blocker amlodipine reduces mortality and cardiovascular events in these high-risk patients. METHODS: We evaluated the effects of amlodipine on cardiovascular events in 251 hypertensive haemodialysis patients in an investigator-designed, prospective, randomized, double-blind, placebo-controlled, multicenter trial. One hundred and twenty-three patients were randomly assigned to amlodipine (10 mg once daily) and 128 to placebo. The primary endpoint was mortality from any cause. The secondary endpoint was a composite variable consisting of mortality from any cause or cardiovascular event. Analysis was by intention-to-treat. The trial was registered with ClinicalTrials.gov (number NCT00124969). RESULTS: The median age of patients was 61 years (25% percentile - 75% percentile, 47-69), and the median follow-up was 19 months (8-30). Fifteen (12%) of the 123 patients assigned to amlodipine and 22 (17%) of the 128 patients assigned to placebo had a primary endpoint hazard ratio 0.65 (95% CI 0.34-1.23); P = 0.19. Nineteen (15%) of the 123 haemodialysis patients assigned to amlodipine and 32 (25%) of the 128 haemodialysis patients assigned to placebo reached the secondary composite endpoint hazard ratio 0.53 (95% CI 0.31-0.93); P = 0.03. CONCLUSION: Amlodipine safely reduces systolic blood pressure and it may have a beneficial effect on cardiovascular outcomes in hypertensive haemodialysis patients.
Tepel et al. (Fri,) conducted a rct in hypertensive haemodialysis (n=251). amlodipine vs. placebo was evaluated on mortality from any cause (HR 0.65, 95% CI 0.34-1.23, p=0.19). Amlodipine did not significantly reduce all-cause mortality compared to placebo in hypertensive hemodialysis patients (12% vs 17%; HR 0.65; 95% CI 0.34-1.23; P=0.19).
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