Long-term safety and antihypertensive efficacy of irbesartan: pooled results of five open-label studies.

Author(s): Littlejohn T 3rd, Saini R, Kassler-Taub K, Chrysant SG, Marbury T

Affiliation(s): Piedmont Medical Research Associates, Winston-Salem, NC, USA.

Publication date & source: 1999-11, Clin Exp Hypertens., 21(8):1273-95.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

An analysis of 5 multicenter, open-label studies was conducted to evaluate the long-term safety and efficacy of irbesartan in 1,006 patients with seated diastolic blood pressure (SeDBP) 95-110 mm Hg. Irbesartan monotherapy was started at 75 mg and titrated to 300 mg at 2- to 4-week intervals to achieve normalized blood pressure (SeDBP <90 mm Hg). If normalized BP was not attained with irbesartan 300 mg alone, adjunctive medications could be added. At 12 months of therapy, the mean reduction in seated systolic blood pressure/SeDBP was 21.0/15.8 mm Hg, and 83% (684/821) of patients were normalized. Of those normalized, 64% were receiving irbesartan monotherapy and 86% were receiving irbesartan or irbesartan/hydrochlorothiazide only. No evidence of tachyphylaxis to the antihypertensive effect of irbesartan was noted. Thus, long-term irbesartan therapy, with or without other antihypertensives, achieved and maintained normalized BP in the majority of patients and was well tolerated.