Key result
Fixed-dose combinations of lercanidipine and enalapril were superior to placebo in reducing sitting diastolic blood pressure, with the 20 mg/20 mg dose achieving the greatest reduction (-15.3 mmHg; p<0.05).
Why the study?
Do fixed-dose combinations of lercanidipine and enalapril reduce blood pressure in a dose-dependent manner in patients with mild-to-moderate hypertension?
Meta-Analysis (n=2,340)
Do fixed-dose combinations of lercanidipine and enalapril reduce blood pressure in a dose-dependent manner in patients with mild-to-moderate hypertension?
p-value: p=<0.05
Fixed-dose combinations of lercanidipine and enalapril demonstrate a dose-response effect in reducing blood pressure in patients with mild-to-moderate hypertension, with the 20/20 mg dose being the most effective.
Supports titration to lercanidipine 20 mg/enalapril 20 mg for greater BP reduction in mild-to-moderate hypertension; confirms dose-response efficacy of this FDC.
OBJECTIVE: The dose-effect relationship of fixed-dose combinations of anti-hypertensive drugs has been only poorly explored. This pooled analysis investigates the dose-response relationship of fixed-dose lercanidipine + enalapril in patients with mild-to-moderate hypertension. RESEARCH DESIGN AND METHODS: This was an individual patient data analysis of four randomized studies (n = 2340). MAIN OUTCOME MEASURES: The primary efficacy variable was the change from baseline in sitting diastolic blood pressure (SDBP). Secondary variables were change from baseline in sitting systolic BP (SSBP), proportion of responder patients, and safety. RESULTS: All fixed-dose combinations were superior to placebo in the reduction of SDBP. The greatest effect was observed with the market-available combination lercanidipine 20 mg/enalapril 20 mg (-15.3 mmHg vs. baseline; p < 0.05). The reduction in SDBP associated with the other two marketed fixed combinations of lercanidipine/enalapril were -10.7 mmHg for the 10 mg/20 mg combination and -9.8 mmHg for the 10 mg/10 mg combination (p < .05 for both comparisons). Similar findings were reported for SSBP reduction: the greatest effect was observed with lercanidipine 20 mg/enalapril 20 mg (-19.2 mmHg). The reduction in SSBP was -12.5 mmHg for the 10 mg/20 mg combination and -11.1 mmHg for the 10 mg/10 mg combination (p < .05 for all comparisons). The highest responder rate was reported with lercanidipine 20 mg/enalapril 20 mg (75.0%); this figure was 56.1% with the 10 mg/20 mg and 53.0% with the 10/10 mg combination. No safety concerns were reported. CONCLUSION: This pooled analysis of four randomized studies shows evidence of a dose-response effect in BP reduction with different fixed combinations of lercanidipine + enalapril. To our knowledge, this is the first analysis investigating the dose-response effect of a specific fixed-dose combination of anti-hypertensive agents. Further studies on this intriguing topic are however necessary.
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Damiano Rizzoni (2016) conducted a meta-analysis in mild-to-moderate hypertension (n=2,340). lercanidipine/enalapril combination vs. placebo was evaluated on change from baseline in sitting diastolic blood pressure (SDBP) (p=<0.05). Fixed-dose combinations of lercanidipine and enalapril were superior to placebo in reducing sitting diastolic blood pressure, with the 20 mg/20 mg dose achieving the greatest reduction (-15.3 mmHg; p<0.05).
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