Effect of amlodipine on cardiovascular events in hypertensive haemodialysis patients.
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].


CONCLUSIONS
Amlodipine safely reduces systolic blood pressure and it may have a beneficial effect on cardiovascular outcomes in hypertensive haemodialysis patients.
Medizinische Klinik Nephrologie, Charité Campus Benjamin Franklin, Berlin, Germany. martin.tepel@charite.de
Martin
M
Tepel
Werner
W
Hopfenmueller
Alexandra
A
Scholze
Alexandra
A
Maier
Walter
W
Zidek
D000368:Aged; D017311:Amlodipine / Q000494:pharmacology / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects / Q000502:physiology; D002121:Calcium Channel Blockers / Q000494:pharmacology / Q000627:therapeutic use*; D002318:Cardiovascular Diseases / Q000453:epidemiology / Q000517:prevention & control*; D002908:Chronic Disease; D004311:Double-Blind Method; D023381:Endpoint Determination; D005260:Female; D005858:Germany; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000503:physiopathology; D007674:Kidney Diseases / Q000150:complications* / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D006435:Renal Dialysis; D012307:Risk Factors
D002121:Calcium Channel Blockers; D017311:Amlodipine