Abstract
This randomised, double-blind, double-dummy, parallel group, multicentre study compared the efficacy and tolerability of lercanidipine with lacidipine. Elderly patients with isolated systolic hypertension (supine blood pressure ⩾160/<95 mmHg) were enrolled and underwent a placebo run-in period of 14–27 days before random allocation to lercanidipine tablets 10 mg once daily (n=111) or lacidipine tablets 2 mg once daily (n=111) for the assessment period (112–160 days). Titration to lercanidipine 20 mg once daily (two 10 mg tablets) or lacidipine 4 mg once daily (two 2 mg tablets) was allowed after 8 weeks, if required. Both treatments decreased supine and standing systolic and diastolic blood pressure between the end of the run-in period and the end of the assessment period (P<0.0001). At the end of the assessment period, the estimated mean treatment difference (95% confidence intervals) in supine systolic blood pressure was −0.81 (−4.45, 2.84) mmHg. These confidence intervals were within the limits specified for equivalence, that is, (−5, 5) mmHg. Ambulatory blood pressure monitoring showed that the antihypertensive effects of both drugs lasted for the full 24-h dosing period and followed a circadian pattern. Both treatments were well tolerated with a low incidence of adverse drug reactions and a low withdrawal rate. Significantly fewer patients withdrew from treatment with lercanidipine (P=0.015). Neither treatment had any clinically significant effect on pulse rate or cardiac conduction. In conclusion, both treatments were equally effective in controlling supine systolic blood pressure in patients with isolated systolic hypertension.
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References
Ramsay LE et al. Guidelines for management of hypertension: report of the third working party of the British Hypertension Society. J Hum Hypertens 1999; 13: 569–592.
Staessen JA et al. for the Systolic Hypertension in Europe (Syst-Eur) Trial Investigators. Randomised double-blind comparison of placebo and active treatment for older patients with isolated systolic hypertension. Lancet 1997; 350: 757–764.
SHEP Cooperative Research Group . Prevention of stroke by antihypertensive drug treatment in older persons with isolated systolic hypertension: final results of the Systolic Hypertension in the Elderly Program (SHEP). JAMA 1991; 265: 3255–3264.
Herbette LG, Vecchiarelli M, Leonardi A . Lercanidipine: short plasma half-life, long duration of action: a molecular model to rationalize its pharmacokinetic properties. J Cardiovasc Pharmacol 1997; 29(Suppl 1): S19–S24.
Ambrosioni E, Circo A . Activity of lercanidipine administered in single and repeated doses once daily as monitored over 24 hours in patients with mild to moderate essential hypertension. J Cardiovasc Pharmacol 1997; 29(Suppl 2): S16–S20.
Barchielli M et al. Clinical pharmacokinetics of lercanidipine. J Cardiovasc Pharmacol 1997; 29(Suppl 2): S1–S15.
Circo A . Active dose findings for lercanidipine in a double-blind, placebo-controlled design in patients with mild to moderate hypertension. J Cardiovasc Pharmacol 1997; 29(Suppl 2): S21–S25.
Morisco C, Trimarco B . Efficacy and tolerability of lercanidipine in comparison to and in combination with atenolol in patients with mild to moderate hypertension in a double-blind controlled study. J Cardiovasc Pharmacol 1997; 29(Suppl 2): S26–S30.
Notarbartolo A, Rengo F, Scafidi V, Acanfora D . Long-term effects of lercanidipine on the lipoprotein and apolipoprotein profile of patients with mild-to-moderate essential hypertension. Curr Ther Res Clin Exp 1999; 60: 228–236.
Barbagallo Sangiorgi G, Putignano E, Calcara L, Barbagallo M . Efficacy and tolerability of lercanidipine vs. captopril in patients with mild to moderate hypertension in a double-blind controlled study. J Cardiovasc Pharmacol 1997; 29(Suppl 2): S36–S39.
Policicchio D, Magliocca R, Malliani A . Efficacy and tolerability of lercanidipine in patients with mild to moderate essential hypertension: a comparative study with slow-release nifedipine. J Cardiovasc Pharmacol 1997; 29(Suppl 2): S31–S35.
Barbagallo M, Barbagallo Sangiorgi G . Efficacy and tolerability of lercanidipine in monotherapy in elderly patients with isolated systolic hypertension. Aging Clin Exp Res 2000; 12: 375–379.
Chiariello M, for the Southern Italy Lacidipine Study Group. A double-blind comparison of the efficacy and safety of lacidipine and hydrochlorothiazide in essential hypertension. J Cardiovasc Pharmacol 1991; 17(Suppl 4): S35–S37.
The United Kingdom Lacidipine Study Group. A double-blind comparison of the efficacy and safety of lacidipine with atenolol in the treatment of essential hypertension. J Cardiovasc Pharmacol 1991; 17(Suppl 4): S27–S30.
Leonetti G, on behalf of The Northern Italian Study Group of Lacidipine in Hypertension. Comparative study of lacidipine and nifedipine SR in the treatment of hypertension: an Italian multicenter study. J Cardiovasc Pharmacol 1991; 17(Suppl 4): S31–S34.
Zanchetti A . Evaluating the benefits of an antihypertensive agent using trials based on event and organ damage: the Systolic Hypertension in the Elderly Long-term Lacidipine (SHELL) trial and the European Lacidipine Study on Atherosclerosis (ELSA). J Hypertens 1995; 13(Suppl 4): S35–S39.
Liu L et al, for the Systolic Hypertension in China (Syst-China) Collaborative Group. J Hypertens 1998; 16: 1823–1829.
Parati G et al. The smoothness index: a new, reproducible and clinically relevant measure of the homogeneity of the blood pressure reduction with treatment for hypertension. J Hypertens 1998; 16: 1685–1691.
Cafiero M, Giasi M . Long-term (12-month) treatment with lercanidipine in patients with mild to moderate hypertension. J Cardiovasc Pharmacol 1997; 29(Suppl 2): S45–S49.
Macchiarulo C, Pieri R, Mitolo DC, Pirrelli A . Antihypertensive effects of six calcium antagonists: evidence from Fourier analysis of 24-hour ambulatory blood pressure recordings. Curr Ther Res Clin Exp 2001; 62: 236–253.
Brown MJ et al. Morbidity and mortality in patients randomised to double-blind treatment with a long-acting calcium channel blocker or diuretic in the International Nifedipine GITS study: Intervention as a Goal in Hypertension Treatment (INSIGHT). Lancet 2000; 356: 366–372.
Borghi C et al. The use of lercanidipine can improve the individual tolerability to dihydropiridine calcium blockers in hypertensive patients [abstract]. J Hypertens 2000; 18(Suppl 2): S155.
Leonetti G et al. Tolerability of long-term treatment with lercanidipine versus amlodipine and lacidipine in elderly hypertensives. Am J Hypertens 2002; 15: 932–940.
Acknowledgements
This study was sponsored by Napp Pharmaceuticals Limited. We acknowledge the work of the other investigators in this study and the help of Dr Joanna Dietrich in preparing this manuscript.
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Millar-Craig, M., Shaffu, B., Greenough, A. et al. Lercanidipine vs lacidipine in isolated systolic hypertension. J Hum Hypertens 17, 799–806 (2003). https://doi.org/10.1038/sj.jhh.1001614
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DOI: https://doi.org/10.1038/sj.jhh.1001614