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NDT Advance Access originally published online on May 29, 2008
Nephrology Dialysis Transplantation 2008 23(11):3605-3612; doi:10.1093/ndt/gfn304
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© The Author [2008].
The online version of this article has been published under an open access model. Users are entitled to use, reproduce, disseminate, or display the open access version of this article for non-commercial purposes provided that: the original authorship is properly and fully attributed; the Journal and Oxford University Press are attributed as the original place of publication with the correct citation details given; if an article is subsequently reproduced or disseminated not in its entirety but only in part or as a derivative work this must be clearly indicated. For commercial re-use, please contact journals.permissions@oxfordjournals.org


Effect of amlodipine on cardiovascular events in hypertensive haemodialysis patients

Martin Tepel1, Werner Hopfenmueller2, Alexandra Scholze1, Alexandra Maier1 and Walter Zidek1

1 Medizinische Klinik Nephrologie 2 Medizinische Statistik und Biometrie, Charité Campus Benjamin Franklin, Berlin, Germany

Correspondence and offprint requests to: Martin Tepel, Medizinische Klinik Nephrologie, Charité Campus Benjamin Franklin, Hindenburgdamm 30, 12200 Berlin, Germany. Fax: +49-30-8445-4235; E-mail: martin.tepel{at}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 [ClinicalTrials.gov] ).

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.

Keywords: calcium channel blocker; cardiovascular risk; chronic kidney disease

Received for publication: 7. 2.08
Accepted in revised form: 6. 5.08


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