Effect of amlodipine on cardiovascular events in hypertensive haemodialysis patients

Abstract

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.

Figures

Fig. 1

The flowchart of the study trial.

Fig. 2

Kaplan–Meier curve of time to the primary endpoint. The primary endpoint was mortality from any cause.

Fig. 3

Kaplan–Meier curve of time to the secondary endpoint. The secondary endpoint was a composite variable consisting of mortality from any cause, cardiac event including myocardial infarction, need for coronary angioplasty or coronary bypass surgery, ischaemic stroke, peripheral vascular disease with the need for amputation or angioplasty.

Fig. 4

Systolic (upper panel) and diastolic (lower panel) blood pressure during the study in the placebo group and in the amlodipine group. Boxes show 25% percentile, median and 75% percentile; whiskers show minimum and maximum. Two-way ANOVA showed a significant reduction of systolic blood pressure by amlodipine during the study period (P < 0.01), whereas systolic blood pressure was unchanged in the placebo group. Diastolic blood pressure did not change during the study period in either group (P > 0.05).