Lercanidipine in general practice settings: safety and effectiveness. The LAPSE Study results

Objective: To determine the safety and effectiveness of a calcium antagonist (CA) lercanidipine in the general practice settings. Material and methods: 110 patients with essential arterial hypertension (AH) were included in the study (mean age 62,3±10,8 years; 51 men, 53 women; 38% with obesity (O) and body mass index, BMI, >30 kg/m2; 10 with diabetes mellitus, DM). In total, 104 patients completed the follow-up protocol. All patients were treated with lercanidipine (10 mg once daily in the morning). General clinical, biochemical and instrumental examination was performed at each visit: at baseline, at Days 45, 90, and 180. When blood pressure (BP) was not controlled, a second antihypertensive drug was added (typically, antiadrenergic agents, but not CA), with additional examination in 30 days. If BP was not controlled by combined antihypertensive therapy, the patients were excluded from the follow-up. Results: Significant reductions in both systolic BP, SBP (baseline 157,4±11,7 vs. 131,1±6,8 mm Hg; p<0,001) and diastolic BP, DBP (baseline 94,7±5,8 vs. 80,0±5,5 mm Hg; p<0,001) were achieved. At the end of the study, mean SBP and DBP reductions were 26,7 and 15,6 mm Hg, respectively. In 84,3% of the patients, both SBP and DBP were controlled (<140/90 mm Hg). Thirty patients needed a second antihypertensive medication to control BP at the first visit, compared to 26 at the study end. The overall incidence of adverse effects was 4,4% (n=6). Only 3 patients withdrew from the treatment due to adverse effects. Plasma cholesterol (CH) level decreased from 225,3±41,0 to 216,7±25,3 mg/dl (p=0,03), and concentration of urates decreased from 5,6±1,6 to 5,1±1,4 mg/ dl (p=0,03). Conclusions: In general practice settings, a CA lercanidipine demonstrated high antihypertensive effectiveness and minimal incidence of adverse effects. An important aspect of its therapeutic potential is metabolic neutrality, confirmed by beneficial effects on plasma levels of CH and urates.

1. Staessen JA, Wang JG, Thijs L. Calcium-channel blockade and cardiovascular prognosis: Recent evidence from clinical outcome trials. Am J Hypertens 2002; 15: 85S-93.

2. Messerli FM. Calcium antagonists in hypertension: From hemodynamics to outcomes. Am J Hypertens 2002; 94S-7.

3. Van Zwieten PA, Mancia G. Third generation calcium antagonists: further developments. Blood Press 1996; 5: 375-7.

4. Angelico P, Guarneri L Leonardi A, Testa R. Vascular-selective effect of lercanidipine and other 1,4-dihydoxipyridines in isolated rabbit tissues. J Pharm Pharmacol 1999; 51: 709-14.

5. Omboni S, Zanchetti A, on behalf of the Multicenter Study Investigators. Antihypertensive efficacy of lercanidipine 2,5, 5 and 10 mg in mild to moderate essential hypertensives assessed by clinic and ambulatory blood pressure. J Hypertens 1998; 16: 1831-8.

6. Circo A. Active dosis findings for lercanidipine in a double-blind placebocontrolled design in patients with mild to moderate hypertension. J Cardiovasc Pharmacol 1997; 29 (Suppl. 2): S22-6.

7. 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): S31-5.

8. DeGiorgio IA, Orlandini F, Malasorna P, Zappa A. Doubleblind, crossover study of lercanidipine versus amlodipine in the treatment of mild-to-moderate essential hypertension. Current Therapeutic Res 1999; 60: 511-20.

9. Ambrosioni E, Circo A. Activity of lercanidipine administered in single and repeated dosis once daily as monitores during 24 hours in patients with mild-tomoderate essential hypertension. J Cardiovasc Pharmacol 1997; 29 (Suppl. 2): S16-20.

10. Barrios V, Navarro A, Esteras A, Luque M, Romero J, Tamargo J, Prieto L, et al. Antihypertensive efficacy and tolerability of lercanidipine in daily clinical practice. The ELYPSE study. Blood Pres 2002; 11: 95-100.

11. Campo C, Castellanos C, Gil B, et al. Por el grupo CLUE. Control de la hipertensión arterial en las Unidades de Hipertensión. El estudio CLUE. Hipertensión 2001; 18 (abstracts): 108.

12. Coca A. Control de la hipertensión arterial en España. Resultado del estudio Controlpres 95. Hipertensión 1995; 12: 182-8.

13. Coca Payeras A. Evolución del Control de la Hipertensión arterial en España. Resultados del Estudio Controlpres 98. Hipertensión 1998; 15(8): 298-307.

14. Kaplan NM. Hipertensión Clínica. 2a Ed. Barcelona: Springer Verlag Ibérica, 1997. p. 280.

15. Corry DB, Tuck Ml. Insulin and glucorregulatory hormones: Implications for antihypertensive therapy. In Epstein M led: Calcium antagonists in clinical medicine, 2nd ed. Philadelphia: Hanley and Belfus 1998. pp. 217-41.

16. Messerli FH, Aepfelbacher FC. Cardiac effects of calcium antagonists in hypertension. In Messerli FH (ed): Cardiovasular Drug Therap, 2 ed. Philadelphia: WB Saunders, 1996. p. 908-15.

17. Ninci MA, Magliocca R, Malliani A. Efficacy and tolerability of lercanidipine in elderly patients with mild to moderate essential in a placebo-controlled, double blind study. J Cardiovasc Pharmacol 1997; 29 (Supl. 2): S31-5.

18. Zimmet P, Alberti KGMM, Shaw J. Global and societal implications of the diabetes epidemic. Nature 991; 414: 782-7.

19. Mark AL, Correia M, Morgan DA, et al. Obesity-induced hypertension. New concepts from the emerging biology of obesity. Hypertension 1999; 33: 537-41.