Efficacy and safety of eplerenone in the management of mild to moderate arterial hypertension

Systematic review and meta-analysis

Francesco Pelliccia, Giuseppe Patti, Giuseppe Rosano, Cesare Greco, Carlo Gaudio

Research output: Contribution to journalArticle

17 Citations (Scopus)

Abstract

Methods We performed an electronic literature search of Medline, Pubmed, Scopus and Cochrane databases for studies published up to March 31, 2014. Randomized studies comparing eplerenone with placebo or other antihypertensive drugs for net reduction of systolic and diastolic blood pressures (SBP; DBP) from baseline and for incidence of adverse events were considered. Weighted mean differences (WMD) and odds ratios with 95% confidence interval were calculated for continuous and dichotomous data, respectively.

Background The role of eplerenone in arterial hypertension has been investigated only in small studies. To systematically assess the efficacy and tolerability of eplerenone in patients with mild to moderate arterial hypertension, we did a meta-analysis of controlled randomized trials.

Results A total of 11 trials and 3566 patients were overall included. Compared to placebo, eplerenone significantly reduced either SBP [WMD - 8.07, 95% CI - 8.17 to - 7.96 mm Hg, p <0.00001] and DBP [WMD - 4.08, - 4.15 to - 4.01 mm Hg, p <0.00001]. In the overall comparison, reduction of both SBP and DBP with eplerenone was greater than other antihypertensive agents (WMD for SBP - 1.50 mm Hg, p <0.0001; WMD for DBP - 0.54 mm Hg, p <0.00001); this was essentially driven by a greater anti-hypertensive action vs enalapril and losartan for SBP and vs losartan for DBP. Rates of any adverse event were significantly higher with eplerenone than placebo (odds ratio 1.37, 95% CI 1.1 to 1.71; p = 0.005), whereas the occurrence of serious adverse events and hyperkalemia was similar. There was no difference between eplerenone and other antihypertensives in the frequency of any or serious adverse events, whereas hyperkalemia was more common with eplerenone (odds ratio 2.36, 95% CI 1.00 to 5.57; p = 0.05).

Conclusion This study-level meta-analysis provides a robust evidence that eplerenone has a reassuring safety profile and is effective in lowering blood pressure in patients with mild-to-moderate hypertension; this effect is at least comparable to that of other anti-hypertensive agents (PROSPERO Registration No. CRD42014010071).

Original languageEnglish
Pages (from-to)219-228
Number of pages10
JournalInternational Journal of Cardiology
Volume177
Issue number1
DOIs
Publication statusPublished - Nov 15 2014

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Meta-Analysis
Hypertension
Safety
Antihypertensive Agents
Hyperkalemia
Losartan
Odds Ratio
Placebos
Blood Pressure
eplerenone
Enalapril
PubMed
Randomized Controlled Trials
Databases
Confidence Intervals
Incidence

Keywords

  • Aldosterone
  • Arterial hypertension
  • Blood pressure
  • Eplerenone
  • Mineralocorticoid receptor antagonist

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Medicine(all)

Cite this

Efficacy and safety of eplerenone in the management of mild to moderate arterial hypertension : Systematic review and meta-analysis. / Pelliccia, Francesco; Patti, Giuseppe; Rosano, Giuseppe; Greco, Cesare; Gaudio, Carlo.

In: International Journal of Cardiology, Vol. 177, No. 1, 15.11.2014, p. 219-228.

Research output: Contribution to journalArticle

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abstract = "Methods We performed an electronic literature search of Medline, Pubmed, Scopus and Cochrane databases for studies published up to March 31, 2014. Randomized studies comparing eplerenone with placebo or other antihypertensive drugs for net reduction of systolic and diastolic blood pressures (SBP; DBP) from baseline and for incidence of adverse events were considered. Weighted mean differences (WMD) and odds ratios with 95{\%} confidence interval were calculated for continuous and dichotomous data, respectively.Background The role of eplerenone in arterial hypertension has been investigated only in small studies. To systematically assess the efficacy and tolerability of eplerenone in patients with mild to moderate arterial hypertension, we did a meta-analysis of controlled randomized trials.Results A total of 11 trials and 3566 patients were overall included. Compared to placebo, eplerenone significantly reduced either SBP [WMD - 8.07, 95{\%} CI - 8.17 to - 7.96 mm Hg, p <0.00001] and DBP [WMD - 4.08, - 4.15 to - 4.01 mm Hg, p <0.00001]. In the overall comparison, reduction of both SBP and DBP with eplerenone was greater than other antihypertensive agents (WMD for SBP - 1.50 mm Hg, p <0.0001; WMD for DBP - 0.54 mm Hg, p <0.00001); this was essentially driven by a greater anti-hypertensive action vs enalapril and losartan for SBP and vs losartan for DBP. Rates of any adverse event were significantly higher with eplerenone than placebo (odds ratio 1.37, 95{\%} CI 1.1 to 1.71; p = 0.005), whereas the occurrence of serious adverse events and hyperkalemia was similar. There was no difference between eplerenone and other antihypertensives in the frequency of any or serious adverse events, whereas hyperkalemia was more common with eplerenone (odds ratio 2.36, 95{\%} CI 1.00 to 5.57; p = 0.05).Conclusion This study-level meta-analysis provides a robust evidence that eplerenone has a reassuring safety profile and is effective in lowering blood pressure in patients with mild-to-moderate hypertension; this effect is at least comparable to that of other anti-hypertensive agents (PROSPERO Registration No. CRD42014010071).",
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AU - Greco, Cesare

AU - Gaudio, Carlo

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N2 - Methods We performed an electronic literature search of Medline, Pubmed, Scopus and Cochrane databases for studies published up to March 31, 2014. Randomized studies comparing eplerenone with placebo or other antihypertensive drugs for net reduction of systolic and diastolic blood pressures (SBP; DBP) from baseline and for incidence of adverse events were considered. Weighted mean differences (WMD) and odds ratios with 95% confidence interval were calculated for continuous and dichotomous data, respectively.Background The role of eplerenone in arterial hypertension has been investigated only in small studies. To systematically assess the efficacy and tolerability of eplerenone in patients with mild to moderate arterial hypertension, we did a meta-analysis of controlled randomized trials.Results A total of 11 trials and 3566 patients were overall included. Compared to placebo, eplerenone significantly reduced either SBP [WMD - 8.07, 95% CI - 8.17 to - 7.96 mm Hg, p <0.00001] and DBP [WMD - 4.08, - 4.15 to - 4.01 mm Hg, p <0.00001]. In the overall comparison, reduction of both SBP and DBP with eplerenone was greater than other antihypertensive agents (WMD for SBP - 1.50 mm Hg, p <0.0001; WMD for DBP - 0.54 mm Hg, p <0.00001); this was essentially driven by a greater anti-hypertensive action vs enalapril and losartan for SBP and vs losartan for DBP. Rates of any adverse event were significantly higher with eplerenone than placebo (odds ratio 1.37, 95% CI 1.1 to 1.71; p = 0.005), whereas the occurrence of serious adverse events and hyperkalemia was similar. There was no difference between eplerenone and other antihypertensives in the frequency of any or serious adverse events, whereas hyperkalemia was more common with eplerenone (odds ratio 2.36, 95% CI 1.00 to 5.57; p = 0.05).Conclusion This study-level meta-analysis provides a robust evidence that eplerenone has a reassuring safety profile and is effective in lowering blood pressure in patients with mild-to-moderate hypertension; this effect is at least comparable to that of other anti-hypertensive agents (PROSPERO Registration No. CRD42014010071).

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