Usefulness of combination therapy in hypertensive patients who do not respond to an angiotensin type 1 receptor antagonist alone

Objective To compare the antihypertensive effects and tolerability of a tel misartan 80 mg + hydrochlorothiazide 12.5 mg fixed-dose combination and tel misartan 80 mg monotherapy in patients with mild-to-moderate essential hype rtension that is inadequately controlled by telmisartan alone. Methods After 8 weeks of telmisartan 40-80 mg monotherapy, 491 patients (me an age 55.3 years; 62.9% men) whose seated diastolic blood pressure (DBP) w as at least 90 mmHg were allocated randomly to groups to receive once-daily fixed-dose telmisartan 80 mg + hydrochlorothiazide 12.5 mg (n = 246) or te lmisartan 80 mg (n = 245). Trough cuff blood pressure (24 h after administr ation of drug) was measured after 4 and 8 weeks of treatment. Results Telmisartan 80 mg + hydrochlorothiazide 12.5 mg produced additional reductions over telmisartan 80 mg of 5.7 mmHg in seated systolic blood pre ssure (SBP) and 3.1 mmHg in seated DBP (P < 0.01). Most of the additional e ffect occurred during the first 4 weeks of treatment. Blood pressure was no rmalized (SBP less than 140 mmHg and DBP less than 90 mmHg) in a significan tly greater proportion of patients receiving the comibination therapy than among those receiving the monotherapy (41.5% compared with 26.1%; P < 0.05) . Both treatments were well tolerated, and the incidence of adverse events during the double-blind period was similar in the two treatment groups (36. 2% for combination therapy and 39.6% for monotherapy). Conclusions A fixed-dose combination of telmisartan 80 mg + hydrochlorothia zide 12.5 mg confers clinically significant additional blood pressure reduc tions in patients whose hypertension is inadequately controlled by telmisar tan alone. (C) 2001 Lippincott Williams & Wilkins.