October 10, 2003The Journal of Clinical Pharmacology
Can Renin Status Predict the Antihypertensive Efficacy of Eplerenone Add‐On Therapy?
Key result
Adding eplerenone to an ACE-I or ARB significantly reduced systolic and diastolic blood pressure by 5.9 and 2.4 mmHg (p<0.001 and p=0.006), but baseline renin or aldosterone did not predict response.
Why the study?
Does adding eplerenone to ACE-I or ARB reduce blood pressure in patients with uncontrolled hypertension, and can baseline renin or aldosterone levels predict this response?
Population
341 patients with a diastolic blood pressure > 95 mmHg on a fixed dose of ACE-I or ARB
Comparison
Eplerenone 50 mg once daily added to ACE-I or ARB vs Matching placebo added to ACE-I or ARB
Design
RCT, randomized, double-blind
Follow-up
8 weeks
Authors
Discussion
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Implication
Supports adding eplerenone to ACE-I/ARB for BP reduction in uncontrolled hypertension; confirms efficacy but challenges baseline renin or aldosterone as predictors.
Study Design
Type
RCT (n=341)
Blinding
Double-blind
Randomization
Randomized
Multicenter
Yes
Structured PICO
Does adding eplerenone to ACE-I or ARB reduce blood pressure in patients with uncontrolled hypertension, and can baseline renin or aldosterone levels predict this response?
P
Population
341 patients with a diastolic blood pressure > 95 mmHg on a fixed dose of ACE-I or ARB
I
Intervention
Eplerenone 50 mg once daily (increased to 100 mg once daily if blood pressure remained uncontrolled at 2, 4, or 6 weeks) added to ACE-I or ARB
C
Comparator
Matching placebo added to ACE-I or ARB
O
Outcome
Change in systolic and diastolic blood pressure, and prediction of blood pressure response by active plasma renin or serum aldosterone levelssurrogate
Main Result
Effect estimate: -5.9/-2.4 mmHg
p-value: p=<0.001 and 0.006
Adding eplerenone to ACE-I or ARB therapy effectively reduces blood pressure in patients with uncontrolled hypertension, but baseline renin or aldosterone levels cannot be used to predict the antihypertensive response.
Cite This Study
Prisant et al. (2003) conducted an RCT in Hypertension not controlled by ACE-I or ARB (n=341). Eplerenone vs. Placebo was evaluated on Placebo-adjusted change in systolic and diastolic blood pressure (-5.9/-2.4 mmHg, p=<0.001 and 0.006). Adding eplerenone to an ACE-I or ARB significantly reduced systolic and diastolic blood pressure by 5.9 and 2.4 mmHg (p<0.001 and p=0.006), but baseline renin or aldosterone did not predict response.