A double-blind, randomized study comparing the antihypertensive effect of eplerenone and spironolactone in patients with hypertension and evidence of primary aldosteronism

Hari K. Parthasarathy, Joel Ménard, William B. White, William Francis Young, Gordon H. Williams, Bryan Williams, Luis Miguel Ruilope, Gordon T. McInnes, John M. Connell, Thomas M. MacDonald

Research output: Contribution to journalArticle

129 Citations (Scopus)

Abstract

Background: Eplerenone is claimed to be a more selective blocker of the mineralocorticoid receptor than spironolactone being associated with fewer antiandrogenic side-effects. We compared the efficacy, safety and tolerability of eplerenone versus spironolactone in patients with hypertension associated with primary aldosteronism. Methods: The study was multicentre, randomized, double-blind, active-controlled, and parallel group design. Following a single-blind, placebo run-in period, patients were randomized 1: 1 to a 16-week double-blind, treatment period of spironolactone (75-225 mg once daily) or eplerenone (100-300 mg once daily) using a titration-to-effect design. To be randomized, patients had to meet biochemical criteria for primary aldosteronism and have a seated DBP at least 90 mmHg and less than 120 mmHg and SBP less than 200 mmHg. The primary efficacy endpoint was the antihypertensive effect of eplerenone versus spironolactone to establish noninferiority of eplerenone in the mean change from baseline in seated DBP. Results: Changes from baseline in DBP were less on eplerenone (-5.6 ± 1.3 SE mmHg) than spironolactone (-12.5 ± 1.3 SE mmHg) [difference, -6.9 mmHg (-10.6, -3.3); P < 0.001]. Although there were no significant differences between eplerenone and spironolactone in the overall incidence of adverse events, more patients randomized to spironolactone developed male gynaecomastia (21.2 versus 4.5%; P = 0.033) and female mastodynia (21.1 versus 0.0%; P = 0.026). Conclusion: The antihypertensive effect of spironolactone was significantly greater than that of eplerenone in hypertension associated with primary aldosteronism.

Original languageEnglish (US)
Pages (from-to)980-990
Number of pages11
JournalJournal of Hypertension
Volume29
Issue number5
DOIs
StatePublished - May 2011

Fingerprint

Spironolactone
Hyperaldosteronism
Double-Blind Method
Antihypertensive Agents
Hypertension
Mastodynia
Mineralocorticoid Receptors
eplerenone
Multicenter Studies
Placebos
Safety
Incidence

Keywords

  • aldosteronism
  • eplerenone
  • hypertension
  • spironolactone
  • treatment

ASJC Scopus subject areas

  • Internal Medicine
  • Physiology
  • Cardiology and Cardiovascular Medicine

Cite this

A double-blind, randomized study comparing the antihypertensive effect of eplerenone and spironolactone in patients with hypertension and evidence of primary aldosteronism. / Parthasarathy, Hari K.; Ménard, Joel; White, William B.; Young, William Francis; Williams, Gordon H.; Williams, Bryan; Ruilope, Luis Miguel; McInnes, Gordon T.; Connell, John M.; MacDonald, Thomas M.

In: Journal of Hypertension, Vol. 29, No. 5, 05.2011, p. 980-990.

Research output: Contribution to journalArticle

Parthasarathy, Hari K. ; Ménard, Joel ; White, William B. ; Young, William Francis ; Williams, Gordon H. ; Williams, Bryan ; Ruilope, Luis Miguel ; McInnes, Gordon T. ; Connell, John M. ; MacDonald, Thomas M. / A double-blind, randomized study comparing the antihypertensive effect of eplerenone and spironolactone in patients with hypertension and evidence of primary aldosteronism. In: Journal of Hypertension. 2011 ; Vol. 29, No. 5. pp. 980-990.
@article{18f088e5c5b44cd6a2d49669701970ee,
title = "A double-blind, randomized study comparing the antihypertensive effect of eplerenone and spironolactone in patients with hypertension and evidence of primary aldosteronism",
abstract = "Background: Eplerenone is claimed to be a more selective blocker of the mineralocorticoid receptor than spironolactone being associated with fewer antiandrogenic side-effects. We compared the efficacy, safety and tolerability of eplerenone versus spironolactone in patients with hypertension associated with primary aldosteronism. Methods: The study was multicentre, randomized, double-blind, active-controlled, and parallel group design. Following a single-blind, placebo run-in period, patients were randomized 1: 1 to a 16-week double-blind, treatment period of spironolactone (75-225 mg once daily) or eplerenone (100-300 mg once daily) using a titration-to-effect design. To be randomized, patients had to meet biochemical criteria for primary aldosteronism and have a seated DBP at least 90 mmHg and less than 120 mmHg and SBP less than 200 mmHg. The primary efficacy endpoint was the antihypertensive effect of eplerenone versus spironolactone to establish noninferiority of eplerenone in the mean change from baseline in seated DBP. Results: Changes from baseline in DBP were less on eplerenone (-5.6 ± 1.3 SE mmHg) than spironolactone (-12.5 ± 1.3 SE mmHg) [difference, -6.9 mmHg (-10.6, -3.3); P < 0.001]. Although there were no significant differences between eplerenone and spironolactone in the overall incidence of adverse events, more patients randomized to spironolactone developed male gynaecomastia (21.2 versus 4.5{\%}; P = 0.033) and female mastodynia (21.1 versus 0.0{\%}; P = 0.026). Conclusion: The antihypertensive effect of spironolactone was significantly greater than that of eplerenone in hypertension associated with primary aldosteronism.",
keywords = "aldosteronism, eplerenone, hypertension, spironolactone, treatment",
author = "Parthasarathy, {Hari K.} and Joel M{\'e}nard and White, {William B.} and Young, {William Francis} and Williams, {Gordon H.} and Bryan Williams and Ruilope, {Luis Miguel} and McInnes, {Gordon T.} and Connell, {John M.} and MacDonald, {Thomas M.}",
year = "2011",
month = "5",
doi = "10.1097/HJH.0b013e3283455ca5",
language = "English (US)",
volume = "29",
pages = "980--990",
journal = "Journal of Hypertension",
issn = "0263-6352",
publisher = "Lippincott Williams and Wilkins",
number = "5",

}

TY - JOUR

T1 - A double-blind, randomized study comparing the antihypertensive effect of eplerenone and spironolactone in patients with hypertension and evidence of primary aldosteronism

AU - Parthasarathy, Hari K.

AU - Ménard, Joel

AU - White, William B.

AU - Young, William Francis

AU - Williams, Gordon H.

AU - Williams, Bryan

AU - Ruilope, Luis Miguel

AU - McInnes, Gordon T.

AU - Connell, John M.

AU - MacDonald, Thomas M.

PY - 2011/5

Y1 - 2011/5

N2 - Background: Eplerenone is claimed to be a more selective blocker of the mineralocorticoid receptor than spironolactone being associated with fewer antiandrogenic side-effects. We compared the efficacy, safety and tolerability of eplerenone versus spironolactone in patients with hypertension associated with primary aldosteronism. Methods: The study was multicentre, randomized, double-blind, active-controlled, and parallel group design. Following a single-blind, placebo run-in period, patients were randomized 1: 1 to a 16-week double-blind, treatment period of spironolactone (75-225 mg once daily) or eplerenone (100-300 mg once daily) using a titration-to-effect design. To be randomized, patients had to meet biochemical criteria for primary aldosteronism and have a seated DBP at least 90 mmHg and less than 120 mmHg and SBP less than 200 mmHg. The primary efficacy endpoint was the antihypertensive effect of eplerenone versus spironolactone to establish noninferiority of eplerenone in the mean change from baseline in seated DBP. Results: Changes from baseline in DBP were less on eplerenone (-5.6 ± 1.3 SE mmHg) than spironolactone (-12.5 ± 1.3 SE mmHg) [difference, -6.9 mmHg (-10.6, -3.3); P < 0.001]. Although there were no significant differences between eplerenone and spironolactone in the overall incidence of adverse events, more patients randomized to spironolactone developed male gynaecomastia (21.2 versus 4.5%; P = 0.033) and female mastodynia (21.1 versus 0.0%; P = 0.026). Conclusion: The antihypertensive effect of spironolactone was significantly greater than that of eplerenone in hypertension associated with primary aldosteronism.

AB - Background: Eplerenone is claimed to be a more selective blocker of the mineralocorticoid receptor than spironolactone being associated with fewer antiandrogenic side-effects. We compared the efficacy, safety and tolerability of eplerenone versus spironolactone in patients with hypertension associated with primary aldosteronism. Methods: The study was multicentre, randomized, double-blind, active-controlled, and parallel group design. Following a single-blind, placebo run-in period, patients were randomized 1: 1 to a 16-week double-blind, treatment period of spironolactone (75-225 mg once daily) or eplerenone (100-300 mg once daily) using a titration-to-effect design. To be randomized, patients had to meet biochemical criteria for primary aldosteronism and have a seated DBP at least 90 mmHg and less than 120 mmHg and SBP less than 200 mmHg. The primary efficacy endpoint was the antihypertensive effect of eplerenone versus spironolactone to establish noninferiority of eplerenone in the mean change from baseline in seated DBP. Results: Changes from baseline in DBP were less on eplerenone (-5.6 ± 1.3 SE mmHg) than spironolactone (-12.5 ± 1.3 SE mmHg) [difference, -6.9 mmHg (-10.6, -3.3); P < 0.001]. Although there were no significant differences between eplerenone and spironolactone in the overall incidence of adverse events, more patients randomized to spironolactone developed male gynaecomastia (21.2 versus 4.5%; P = 0.033) and female mastodynia (21.1 versus 0.0%; P = 0.026). Conclusion: The antihypertensive effect of spironolactone was significantly greater than that of eplerenone in hypertension associated with primary aldosteronism.

KW - aldosteronism

KW - eplerenone

KW - hypertension

KW - spironolactone

KW - treatment

UR - http://www.scopus.com/inward/record.url?scp=79954692757&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=79954692757&partnerID=8YFLogxK

U2 - 10.1097/HJH.0b013e3283455ca5

DO - 10.1097/HJH.0b013e3283455ca5

M3 - Article

C2 - 21451421

AN - SCOPUS:79954692757

VL - 29

SP - 980

EP - 990

JO - Journal of Hypertension

JF - Journal of Hypertension

SN - 0263-6352

IS - 5

ER -