Dose–response effect of the lercanidipine/enalapril combination: a pooled analysis

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 p p 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.