Abstract | BACKGROUND AND OBJECTIVES: DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: This was a randomized controlled trial of prevalent patients receiving hemodialysis at five Canadian centers. Participants were randomly allocated to 13 weeks of eplerenone titrated to 50 mg daily (n=77) or a matching placebo (n=77). The primary outcome was permanent discontinuation of the drug because of hyperkalemia or hypotension. Secondary outcomes included hyperkalemia, hypotension, and cardiovascular events. RESULTS: Seventy-five eplerenone-treated patients and 71 placebo-treated patients were included in the per protocol population. The primary outcome occurred in three patients (4.0%) in the eplerenone group and two (2.8%) in the placebo group, for an absolute risk difference of 1.2 percentage points (95% confidence interval, -4.7 to 7.1 percentage points). Eplerenone was interpreted as noninferior to placebo with respect to the primary outcome (i.e., a discontinuation rate for these reasons >10% was excluded). In the eplerenone group, nine patients (11.7%) developed hyperkalemia ( potassium level >6.5 mEq/L), compared with two patients (2.6%) in the placebo group (relative risk, 4.5; 95% confidence interval, 1.0 to 20.2). There was no significant effect on predialysis or postdialysis BP. CONCLUSION:
Eplerenone increased the risk of hyperkalemia but did not result in an excess need to permanently discontinue the drug. Further trials are required to determine whether mineralocorticoid receptor antagonism improves cardiovascular outcomes in patients receiving long-term dialysis.
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Authors | Michael Walsh, Braden Manns, Amit X Garg, Joe Bueti, Christian Rabbat, Andrew Smyth, Jessica Tyrwhitt, Jackie Bosch, Peggy Gao, P J Devereaux, Ron Wald |
Journal | Clinical journal of the American Society of Nephrology : CJASN
(Clin J Am Soc Nephrol)
Vol. 10
Issue 9
Pg. 1602-8
(Sep 04 2015)
ISSN: 1555-905X [Electronic] United States |
PMID | 26138259
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2015 by the American Society of Nephrology. |
Chemical References |
- Mineralocorticoid Receptor Antagonists
- Spironolactone
- Eplerenone
- Potassium
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Topics |
- Aged
- Blood Pressure
- Dose-Response Relationship, Drug
- Double-Blind Method
- Eplerenone
- Female
- Humans
- Hyperkalemia
(blood, chemically induced)
- Hypotension
(chemically induced, physiopathology)
- Kidney Failure, Chronic
(therapy)
- Male
- Middle Aged
- Mineralocorticoid Receptor Antagonists
(administration & dosage, adverse effects)
- Pilot Projects
- Potassium
(blood)
- Renal Dialysis
- Spironolactone
(administration & dosage, adverse effects, analogs & derivatives)
- Withholding Treatment
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