¹University of Texas Southwestern Medical Center, Dallas, TX, USA

²The Ohio State University Medical Center, Columbus, OH, USA

³Harper Hospital School of Medicine, Detroit, MI, USA

⁴Bristol-Myers Squibb Pharmaceutical Research Institute, Princeton, NJ, USA

Correspondence to: Ravi Saini, Bristol-Myers Squibb Pharmaceutical Research Institute, Route 206 & Provinceline Road, Princeton, NJ 08543-4000, USA

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.

irbesartan; hydrochlorothiazide; angiotensin II receptor antagonist; diuretic; combination therapy