Efficacy and safety of a fixed-dose combination of lercanidipine and enalapril in daily practice. A comparison of office, self-measured and ambulatory blood pressure

Abstract

Background: A fixed-dose combination (FDC) of enalapril and lercanidipine has been shown to be effective and safe in reducing blood pressure in randomized clinical trials. This study aims to determine effectiveness and safety in daily practice.

Methods: This was a prospective, open-label, uncontrolled multicenter study, with a 3-month follow-up at general practitioners and internists. Patients were treated with an FDC of 20 mg enalapril maleate and 10 mg lercanidipine hydrochloride, and blood pressure was determined in the office (OBPM) and by discretionary self- (SBPM) and ambulatory- (ABPM) measurements.

Results: Out of 622 patients (mean age 61.3 ± 13.3 years, 54.2% male): blood pressure was reduced by -29.2/-14.2 mmHg (OBPM) from baseline (164.4/95.2 mmHg). Pulse pressure was reduced by -15.0 ± 16.4 mmHg. Prevalence of microalbuminuria was reduced from 14.6% at baseline to 6.5% (p < 0.001). SBPM data were available for 71% of patients and ABPM for 12%. In the latter patients, blood pressure variability index was significantly reduced compared with baseline over 24 h (14.2 ± 4.2 vs 16.3 ± 4.0; p < 0.001) and with nighttime ABPM (13.7 ± 4.9 vs 15.2 ± 4.4; p = 0.022). Treatment was associated with a low incidence of adverse events (3.4%).

Conclusions: The FDC of 20 mg enalapril-maleate and 10 mg lercanidipine-hydrochloride seems to be effective and well tolerated in clinical practice. It improved vascular surrogate end points, including pulse pressure, blood pressure variability and microalbuminuria.

Keywords:

• ambulatory blood pressure
• blood pressure variability
• clinical practice
• enalapril
• lercanidipine
• microalbuminuria
• office blood pressure
• smoothness index

Acknowledgements

The authors are grateful to P Bosiljanoff, LC Rump and B Weiser for helpful comments regarding the design of this study. We thank the participating physicians, their assistants and all patients documented during the study. A special gratitude is given to the Clinical Research Organization Anfomed GmbH (responsible statistician Elmar Beck) for data processing and support in statistical analyses.

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