HOMEPRODUCTSCOMPANYCONTACTFAQResearchDictionaryPharmaSign Up FREE or Login

The Safety of Eplerenone in Hemodialysis Patients: A Noninferiority Randomized Controlled Trial.

AbstractBACKGROUND AND OBJECTIVES:
Mineralocorticoid receptor antagonism reduces morbidity and mortality in patients with heart failure, but the safety of these drugs in patients receiving dialysis is unclear. This study evaluated whether hyperkalemia and/or hypotension limited the use of eplerenone, a selective mineralocorticoid receptor antagonist, in hemodialysis patients.
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.
AuthorsMichael Walsh, Braden Manns, Amit X Garg, Joe Bueti, Christian Rabbat, Andrew Smyth, Jessica Tyrwhitt, Jackie Bosch, Peggy Gao, P J Devereaux, Ron Wald
JournalClinical 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
PMID26138259 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
CopyrightCopyright © 2015 by the American Society of Nephrology.
Chemical References
  • Mineralocorticoid Receptor Antagonists
  • Spironolactone
  • Eplerenone
  • Potassium
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

Join CureHunter, for free Research Interface BASIC access!

Take advantage of free CureHunter research engine access to explore the best drug and treatment options for any disease. Find out why thousands of doctors, pharma researchers and patient activists around the world use CureHunter every day.
Realize the full power of the drug-disease research graph!


Choose Username:
Email:
Password:
Verify Password:
Enter Code Shown: