CLINICAL STUDY
Efficacy and tolerability of eplerenone and losartan in hypertensive black and white patients
John M. Flack, MD, MPH*,*,
Suzanne Oparil, MD ,
J. Howard Pratt, MD ,
Barbara Roniker, MD ,
Susan Garthwaite, PhD,
Jay H. Kleiman, MD, MPA,
Yonghong Yang, PhD,
Scott L. Krause, BSN,
Diane Workman, PhD and
Elijah Saunders, MD||
* Department of Internal Medicine, Wayne State University, Detroit, Michigan, USA
Department of Medicine, University of Alabama, Birmingham, Alabama, USA
Department of Medicine, Indiana University School of Medicine and The Veterans Administration Medical Center, Indianapolis, Indiana, USA
Cardiovascular/Metabolic Diseases, Pharmacia Corporation, Skokie, Illinois, USA
|| Division of Hypertension, University of Maryland, Baltimore, Maryland, USA
Manuscript received April 30, 2002;
revised manuscript received October 17, 2002,
accepted November 19, 2002.
* Reprint requests and correspondence: Dr. John M. Flack, Department of Internal Medicine, Wayne State University School of Medicine, 4201 St. Antoine, Suite 2E, Detroit, Michigan 48201, USA.
JFlack{at}intmed.wayne.edu
OBJECTIVES: The purpose of this study was to evaluate the efficacy and tolerability of monotherapy with the selective aldosterone blocker eplerenone in both black and white patients with hypertension.
BACKGROUND: Essential hypertension and cardiovascular-renal-target organ damage is more prevalent in black than white adults in the U.S.
METHODS: Black (n = 348) and white (n = 203) patients with mild-to-moderate hypertension were randomized to double-blind treatment with eplerenone 50 mg, the angiotensin II receptor antagonist losartan 50 mg, or placebo once daily. Doses were increased if blood pressure remained uncontrolled. The primary end point was change in mean diastolic blood pressure (DBP) after 16 weeks of therapy.
RESULTS: Adjusted mean changes from baseline in DBP were –5.3 ± 0.7, –10.3 ± 0.7, and –6.9 ± 0.6 mm Hg in the placebo, eplerenone-treated, and losartan-treated groups, respectively (mean ± SE, p < 0.001 eplerenone vs. placebo, p < 0.001 eplerenone vs. losartan). In black patients, DBP decreased by –4.8 ± 1.0, –10.2 ± 0.9, and –6.0 ± 0.9 mm Hg for the placebo, eplerenone-treated, and losartan-treated groups, respectively (mean ± SE, p < 0.001 eplerenone vs. placebo, p < 0.001 eplerenone vs. losartan), whereas in white patients, DBP decreased by –6.4 ± 1.0, –11.1 ± 1.1, and –8.4 ± 1.0 mm Hg, respectively (p = 0.001 eplerenone vs. placebo, p = 0.068 for eplerenone vs. losartan). For reduction of systolic blood pressure (SBP), eplerenone was superior to placebo and losartan in all patients combined and in black patients, and was superior to placebo in white patients. Eplerenone was as effective as losartan in reducing SBP and DBP in the high renin patient, but more effective than losartan in the low renin patient. Similarly, eplerenone was at least as effective as losartan in patients with differing baseline levels of aldosterone. Both eplerenone and losartan were well tolerated.
CONCLUSIONS: The antihypertensive effect of eplerenone was equal in black and white patients and was superior to losartan in black patients.
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Abbreviations and Acronyms
| | ACE | = angiotensin-converting enzyme | | ANCOVA | = analysis of covariance | | BP | = blood pressure | | CI | = confidence interval | | DBP | = diastolic blood pressure | | HR | = heart rate | | SAB | = selective aldosterone blocker | | SBP | = systolic blood pressure | | UA/CR | = urinary albumin/creatinine ratio |
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