Tolerability of high doses of lercanidipine versus high doses of other dihydropyridines in daily clinical practice: the TOLERANCE Study

Abstract

Aim. The TOLERANCE study was aimed to compare the tolerability of high doses of lercanidipine (20 mg) with that of other frequently used dihydropyridines (amlodipine 10 mg/nifedipine GITS 60 mg) in the treatment of essential hypertension (EAH) in daily clinical practice. Material and methods. It was an observational, transversal, multicentre study performed in a Primary Care Setting. A total of 650 patients with EAH and age ≥18 years were included. They had been treated with high doses of lercanidipine (n=446) or amlodipine/nifedipine GITS (n=204) during at least 1 month and previously with low doses (10 mg, 5 mg, and 30 mg, respectively) of the same drugs. Results. The main objective was to compare the rates of vasodilation-related adverse events (AE) between both groups. Rates of signs and symptoms related to vasodilation were significantly higher (p<0,001) in the amlodipine/nifedipine GITS group (76,8%, CI 95% [70,7;82,9]) than in lercanidipine group (60,8%, [56,1;65,5]). Blood pressure control (<140/90 mm Hg or <130/80 for diabetics) and type of concomitant antihypertensive medications were similar in both groups. Treatment compliance was good (~93%) and fairly comparable in both groups. Most AE with lercanidipine were mild (74,5% vs. 64% in amlodipine/nifedipine GITS group, p=0,035) whereas severe AE rates did not differ significantly between groups (2,8% vs. 3,6%). Conclusion. In conclusion, treatment with lercanidipine at high doses is associated with a lower rate of AE related to vasodilation compared to high doses of amlodipine or nifedipine GITS in clinical practice.

Keywords

• adverse effects
• amlodipine
• antihypertensive drugs
• dihydropyridines
• hypertension
• lercanidipine
• nifedipine gits
• tolerability
• vasodilation