Abstract
This double-blind, placebo-controlled, four-way balanced design crossover study included hypertensive patients aged 60–85 years with mean office-measured sitting systolic blood pressure (SBP) 160–179 mm Hg and daytime SBP ⩾135 mm Hg. After a 2-week run-in period, during which previous medications were discontinued, each patient received the following four treatments in randomized order for 4 weeks each: lercanidipine 10 mg (L), enalapril 20 mg (E), lercanidipine 10 mg plus enalapril 20 mg (L/E) and placebo (P). At the end of each treatment period, office trough blood pressure (BP) was measured and a 24-h Ambulatory Blood Pressure Monitoring (ABPM) was performed. Seventy-five patients (mean age 66 years, office BP 168/92 mm Hg, daytime SBP 151 mm Hg) were randomized and 62 completed the study with four valid post-baseline ABPMs. The administration of P, L, E and L/E was associated with a mean 24-h SBP of 144, 137, 133 and 127 mm Hg, respectively. All active treatments significantly reduced the mean 24-h SBP in comparison with placebo, but L/E was significantly more effective than L and E alone. Similarly, office SBP was significantly more reduced with L/E (−16.9 mm Hg) than with L (−5.0 mm Hg) or E (−5.9 mm Hg). A BP <140/90 mm Hg was recorded in 18% of patients with L, 19% with E and 45% with L/E. Two patients on P and two on L/E were withdrawn from the study due to adverse events. In conclusion, combination therapy with L/E has additive antihypertensive effects on both ambulatory and office BP in elderly patients and is well tolerated.
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Acknowledgements
We acknowledge the contribution of the primary care Attending Physicians of Grupo MAPA-MADRID who referred patients to La Paz University Hospital for this study. The study was supported by a grant from Recordati S.p.A., Milan, Italy.
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The study was presented in abstract form at the XVI European Meeting on Hypertension (J Hyperten 2006; 24(Suppl 4): S420).
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Puig, J., Calvo, C., Luurila, O. et al. Lercanidipine, enalapril and their combination in the treatment of elderly hypertensive patients: placebo-controlled, randomized, crossover study with four ABPM. J Hum Hypertens 21, 917–924 (2007). https://doi.org/10.1038/sj.jhh.1002248
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DOI: https://doi.org/10.1038/sj.jhh.1002248
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