IngentaConnect Tolerability of High Doses of Lercanidipine versus High Doses of ...

Authors: Barrios, Vivencio¹; Escobar, Carlos¹; de la Figuera, Mariano²; Llisterri, Jose Luis³; Honorato, Jesus⁴; Segura, Julián⁵; Calderón, Alberto⁶

Source: Cardiovascular Drug Reviews, Volume 26, Number 1, Spring 2008 , pp. 2-9(8)

Publisher: Blackwell Publishing

Abstract:

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 in daily clinical practice. It was an observational, transversal, multicentre study performed in a Primary Care Setting. A total of 650 evaluable patients with essential hypertension 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. The main objective was to compare the rates of vasodilation-related adverse events 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 mmHg or <130/80 for diabetics) and type of concomitant antihypertensive medications were similar in both groups. Treatment compliance was good (around 93%) and fairly comparable in both groups. Most adverse events with lercanidipine were mild (74.5% vs. 64% in amlodipine/nifedipine GITS group, P= 0.035) whereas severe adverse event rates did not differ significantly between groups (2.8% vs. 3.6%). In conclusion, treatment with lercanidipine at high doses is associated with a lower rate of adverse events related to vasodilation compared to high doses of amlodipine or nifedipine GITS in clinical practice.

Keywords: Adverse effects; Amlodipine; Antihypertensive drugs; Dihydropyridines; Hypertension; Lercanipine; Nifedipine GITS; Tolerability; Vasodilation

Document Type: Research article

DOI: 10.1111/j.1527-3466.2007.00035.x

Affiliations: 1: Hospital Ramón y Cajal, Madrid 2: CAP La Mina, San Adrían del Besós-Barcelona 3: CS Joaquín Benlloch, Valencia 4: Clínica Universitaria de Navarra 5: Hospital 12 de Octubre 6: CS Rosa de Luxemburgo, SS de los Reyes-Madrid, Spain

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Tolerability of High Doses of Lercanidipine versus High Doses of Other Dihydropyridines in Daily Clinical Practice: The TOLERANCE Study