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Effect of amlodipine on cardiovascular events in hypertensive haemodialysis patients.

Tepel M, Hopfenmueller W, Scholze A, Maier A, Zidek W - Nephrol. Dial. Transplant. (2008)

Bottom Line: This study was undertaken to ascertain whether the calcium channel blocker amlodipine reduces mortality and cardiovascular events in these high-risk patients.Analysis was by intention-to-treat.Amlodipine safely reduces systolic blood pressure and it may have a beneficial effect on cardiovascular outcomes in hypertensive haemodialysis patients.

View Article: PubMed Central - PubMed

Affiliation: Medizinische Klinik Nephrologie, Charité Campus Benjamin Franklin, Berlin, Germany. martin.tepel@charite.de

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.

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Kaplan–Meier curve of time to the primary endpoint. The primary endpoint was mortality from any cause.
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Figure 2: Kaplan–Meier curve of time to the primary endpoint. The primary endpoint was mortality from any cause.

Mentions: During the follow-up (median, 19 months; 8–30 months) the primary endpoint, i.e. mortality of all causes, was reached in 37 out of 251 patients (15%). Causes of death were classified as cardiovascular including sudden death (26 patients; 70%), infection (7 patients; 19%) and cancer (4 patients; 11%). A total of 15 (12%) of the 123 haemodialysis patients assigned to amlodipine, and 22 (17%) of the 128 haemodialysis patients assigned to placebo had a primary endpoint. Figure 2 shows Kaplan–Meier estimates of the proportion of patients reaching the primary endpoint. Fewer patients in the amlodipine group than in the placebo group reached the primary endpoint, though this finding was not significant [hazard ratio 0.65 (95% CI 0.34–1.23); P = 0.19].


Effect of amlodipine on cardiovascular events in hypertensive haemodialysis patients.

Tepel M, Hopfenmueller W, Scholze A, Maier A, Zidek W - Nephrol. Dial. Transplant. (2008)

Kaplan–Meier curve of time to the primary endpoint. The primary endpoint was mortality from any cause.
© Copyright Policy - creative-commons
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2568006&req=5

Figure 2: Kaplan–Meier curve of time to the primary endpoint. The primary endpoint was mortality from any cause.
Mentions: During the follow-up (median, 19 months; 8–30 months) the primary endpoint, i.e. mortality of all causes, was reached in 37 out of 251 patients (15%). Causes of death were classified as cardiovascular including sudden death (26 patients; 70%), infection (7 patients; 19%) and cancer (4 patients; 11%). A total of 15 (12%) of the 123 haemodialysis patients assigned to amlodipine, and 22 (17%) of the 128 haemodialysis patients assigned to placebo had a primary endpoint. Figure 2 shows Kaplan–Meier estimates of the proportion of patients reaching the primary endpoint. Fewer patients in the amlodipine group than in the placebo group reached the primary endpoint, though this finding was not significant [hazard ratio 0.65 (95% CI 0.34–1.23); P = 0.19].

Bottom Line: This study was undertaken to ascertain whether the calcium channel blocker amlodipine reduces mortality and cardiovascular events in these high-risk patients.Analysis was by intention-to-treat.Amlodipine safely reduces systolic blood pressure and it may have a beneficial effect on cardiovascular outcomes in hypertensive haemodialysis patients.

View Article: PubMed Central - PubMed

Affiliation: Medizinische Klinik Nephrologie, Charité Campus Benjamin Franklin, Berlin, Germany. martin.tepel@charite.de

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.

Show MeSH