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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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The flowchart of the study trial.
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Figure 1: The flowchart of the study trial.

Mentions: We investigated the effects of amlodipine on mortality and cardiovascular events in hypertensive patients with chronic kidney disease stage 5 on haemodialysis treatment in an investigator-designed, prospective, randomized, double-blind, placebo-controlled, multicentre trial. Figure 1 shows the flowchart of the study. The study was conducted using 251 patients with chronic kidney disease stage 5 on haemodialysis treatment [159 males, 92 females; median age, 61 years (25% percentile − 75% percentile, 47–69 years); systolic blood pressure 140 mmHg (130–160 mmHg) and diastolic blood pressure 80 mmHg (70–82 mmHg)] who had been undergoing maintenance haemodialysis for a minimum of 3 months three times weekly in ambulatory centres. The median duration of haemodialysis at the study entry was 27 months (12–46 months). The cause of chronic kidney disease stage 5 was diabetic nephropathy in 45 cases (18%), nephrosclerosis in 43 cases (17%), chronic glomerulonephritis in 77 cases (31%), polycystic kidney disease and interstitial nephritis in 50 cases (20%), and other/unknown in 36 cases (14%). Forty-one patients (13%) underwent kidney transplantation during the follow-up and were censored on the day of transplantation. One hundred twenty-three patients were randomly assigned to receive amlodipine (10 mg once daily) and 128 patients were randomly assigned to receive placebo. All patients commenced study medication and all received their intended treatment.


Effect of amlodipine on cardiovascular events in hypertensive haemodialysis patients.

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

The flowchart of the study trial.
© Copyright Policy - creative-commons
Related In: Results  -  Collection

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

Figure 1: The flowchart of the study trial.
Mentions: We investigated the effects of amlodipine on mortality and cardiovascular events in hypertensive patients with chronic kidney disease stage 5 on haemodialysis treatment in an investigator-designed, prospective, randomized, double-blind, placebo-controlled, multicentre trial. Figure 1 shows the flowchart of the study. The study was conducted using 251 patients with chronic kidney disease stage 5 on haemodialysis treatment [159 males, 92 females; median age, 61 years (25% percentile − 75% percentile, 47–69 years); systolic blood pressure 140 mmHg (130–160 mmHg) and diastolic blood pressure 80 mmHg (70–82 mmHg)] who had been undergoing maintenance haemodialysis for a minimum of 3 months three times weekly in ambulatory centres. The median duration of haemodialysis at the study entry was 27 months (12–46 months). The cause of chronic kidney disease stage 5 was diabetic nephropathy in 45 cases (18%), nephrosclerosis in 43 cases (17%), chronic glomerulonephritis in 77 cases (31%), polycystic kidney disease and interstitial nephritis in 50 cases (20%), and other/unknown in 36 cases (14%). Forty-one patients (13%) underwent kidney transplantation during the follow-up and were censored on the day of transplantation. One hundred twenty-three patients were randomly assigned to receive amlodipine (10 mg once daily) and 128 patients were randomly assigned to receive placebo. All patients commenced study medication and all received their intended treatment.

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