The long-term antihypertensive activity and tolerability of irbesartan with hydrochlorothiazide

Abstract

The long-term safety, tolerability, and antihypertensive effects of irbesartan/hydrochlorothiazide (HCTZ) were assessed in hypertensive patients (seated diastolic blood pressure [SeDBP] 95–110 mm Hg). Patients (n = 1098) completing two randomised, double-blind trials of irbesartan alone, HCTZ alone, irbesartan/HCTZ combinations, or placebo, took 1 year of open-label therapy starting with irbesartan 75 mg/HCTZ 12.5 mg once daily. If target blood pressure (BP) (<140/<90 mm hg) was not achieved, the dose was titrated sequentially at 2- to 4-week intervals to irbesartan 150 mg/hctz 12.5 mg, then to irbesartan 300 mg/hctz 25 mg. if necessary, adjunctive therapies were added. mean changes in trough seated systolic bp/sedbp at months 2, 6, and 12 were −19.1/−14.2 mm hg (n = 941), −20.7/ −15.7 mm Hg (n = 948), and −20.6/−15.6 mm Hg (n = 898), respectively. From months 2 to 12, normalisation rates (trough SeDBP <90 mm hg) ranged from 75–85% and total responder rates (normalised or ⩾10 mm hg trough sedbp reduction) ranged from 81–91%, while target bp was achieved in 65–75% of patients. at all time-points, most patients (⩾87%) were receiving irbesartan/hctz alone. eighty-two patients (7.5%) discontinued the study due to adverse events, with half of these events considered unrelated to study medication. there were no reports of serious adverse events related to study medication. long-term therapy with irbesartan/hctz is safe, well tolerated, and maintains normalised bp in >80% of patients.