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A randomised, double-blind, double-dummy comparison of the efficacy and tolerability of lercanidipine tablets and losartan tablets in patients with mild to moderate essential hypertension

Abstract

A double-blind, double-dummy, randomised, multicentre study to compare the efficacy and tolerability of lercanidipine with losartan. Patients with mild to moderate hypertension (supine diastolic blood pressure (DBP) 95–115 mm Hg) were enrolled and underwent a placebo run-in period of 14–30 days before random allocation to lercanidipine tablets 10 mg once-daily (n = 234) or losartan tablets 50 mg once-daily (n = 231) during the assessment period (approximately 16 weeks). Titration to lercanidipine 20 mg once-daily (two 10 mg tablets) or losartan 100 mg once-daily (two 50 mg tablets) was allowed after 8 weeks, if necessary. At the end of the study, 71% of patients who received lercanidipine tablets had achieved normalised DBP (ie, 90 mm Hg) and 81% had responded to treatment (ie, DBP 90 mm Hg or a decrease in DBP 10 mm Hg). The corresponding numbers in the losartan tablets group were 65% and 78%, respectively. In those patients who required dose titration, there was evidence of a greater response with lercanidipine tablets than with losartan tablets. Both treatments were well tolerated with a low incidence of adverse drug reactions and a low withdrawal rate. In conclusion, the antihypertensive effects of lercanidipine tablets were comparable with those of losartan tablets; both treatments gave a high response rate for an antihypertensive monotherapy and were very well tolerated.

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Acknowledgements

This study was sponsored by Napp Pharmaceuticals Limited. The authors would like to acknowledge the work of the other investigators in this study and the help of Mrs T Roberts, Mrs C O'Brien, Dr C McDonald, and Dr A Greenough for their help in preparing this manuscript.

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Correspondence to I G V James.

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James, I., Jones, A. & Davies, P. A randomised, double-blind, double-dummy comparison of the efficacy and tolerability of lercanidipine tablets and losartan tablets in patients with mild to moderate essential hypertension. J Hum Hypertens 16, 605–610 (2002). https://doi.org/10.1038/sj.jhh.1001430

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