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 Menard, William B. White, William F. Young, Gordon H. Williams, Bryan Williams, Luis Miguel Ruilope, Gordon T. McInnes, John M. Connell, Thomas M. MacDonald

    Research output: Contribution to journalArticle

    123 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 +/- 1.3SE mmHg) than spironolactone (-12.5 +/- 1.3SE 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. J Hypertens 29: 980-990 (C) 2011 Wolters Kluwer Health vertical bar Lippincott Williams & Wilkins.

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

    Keywords

    • aldosteronism
    • eplerenone
    • hypertension
    • spironolactone
    • treatment
    • TO-MODERATE HYPERTENSION
    • MYOCARDIAL-INFARCTION
    • BLOCKER EPLERENONE
    • HEART-FAILURE
    • PLASMA-RENIN
    • EFFICACY
    • AGENTS
    • ANTAGONISTS
    • DIAGNOSIS
    • OUTCOMES

    Cite this

    Parthasarathy, Hari K. ; Menard, Joel ; White, William B. ; Young, William F. ; Williams, Gordon H. ; Williams, Bryan ; Miguel Ruilope, Luis ; 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.
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    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 +/- 1.3SE mmHg) than spironolactone (-12.5 +/- 1.3SE 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. J Hypertens 29: 980-990 (C) 2011 Wolters Kluwer Health vertical bar Lippincott Williams & Wilkins.",
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    author = "Parthasarathy, {Hari K.} and Joel Menard and White, {William B.} and Young, {William F.} and Williams, {Gordon H.} and Bryan Williams and {Miguel Ruilope}, Luis and McInnes, {Gordon T.} and Connell, {John M.} and MacDonald, {Thomas M.}",
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    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.; Menard, Joel; White, William B.; Young, William F.; Williams, Gordon H.; Williams, Bryan; Miguel Ruilope, Luis; 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

    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 - Menard, Joel

    AU - White, William B.

    AU - Young, William F.

    AU - Williams, Gordon H.

    AU - Williams, Bryan

    AU - Miguel Ruilope, Luis

    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 +/- 1.3SE mmHg) than spironolactone (-12.5 +/- 1.3SE 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. J Hypertens 29: 980-990 (C) 2011 Wolters Kluwer Health vertical bar Lippincott Williams & Wilkins.

    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 +/- 1.3SE mmHg) than spironolactone (-12.5 +/- 1.3SE 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. J Hypertens 29: 980-990 (C) 2011 Wolters Kluwer Health vertical bar Lippincott Williams & Wilkins.

    KW - aldosteronism

    KW - eplerenone

    KW - hypertension

    KW - spironolactone

    KW - treatment

    KW - TO-MODERATE HYPERTENSION

    KW - MYOCARDIAL-INFARCTION

    KW - BLOCKER EPLERENONE

    KW - HEART-FAILURE

    KW - PLASMA-RENIN

    KW - EFFICACY

    KW - AGENTS

    KW - ANTAGONISTS

    KW - DIAGNOSIS

    KW - OUTCOMES

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    U2 - 10.1097/HJH.0b013e3283455ca5

    DO - 10.1097/HJH.0b013e3283455ca5

    M3 - Article

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    SP - 980

    EP - 990

    JO - Journal of Hypertension

    JF - Journal of Hypertension

    SN - 0263-6352

    IS - 5

    ER -