Clinical considerations in hypertensive black patients: the role of angiotensin II receptor blockers in combination with a diuretic

Objective To evaluate the dose-response efficacy and tolerability of telmisartan, HCT, and their combination in black patients with mild-to-moderate hypertension (mean supine blood pressure 140/95-200/114 mmHg). Methods A 4-week, single-blind, placebo run-in period was followed by a 4 x 5 factorial, double-blind, 8-week treatment period. During the double-blind phase, 222 black patients (supine blood pressure 140/95-200/114 mmHg) were allocated randomly to groups to receive once-daily treatment with a combination of telmisartan (0, 20, 40, 80, or 160 mg) and HCT (0, 6.25, 12.5, or 25 mg). Blood pressure was measured at baseline and after 2, 4, and 8 weeks. Results Telmisartan 80 mg + HCT 12.5 mg reduced supine trough systolic blood pressure (SBP) by 21.5 mmHg and supine trough diastolic blood pressure (DBP; primary efficacy parameter) by 13.3 mmHg, which were 13.7/8.7 mmHg greater reductions than were produced by telmisartan 80 mg alone and 12.3/8.1 mmHg greater reductions than those produced by HCT 12.5 mg alone (P <0.01). Telmisartan 40 mg + HCT 12.5 mg reduced supine trough SBP/DBP by 14.3/10.0 mmHg, 12.3/3.3 mmHg and 5.1/4.8 mmHg more than was achieved with the respective monotherapies. These effects attained statistical significance for tine comparisons with telmisartan 40 mg for SBP and HCT 12.5 mg for DBP (P less than or equal to0.05). A response surface analysis and therapeutic response rates confirmed the additive antihypertensive effects of telmisartan and HCT. All treatments were well tolerated, with side-effect profiles comparable to those of placebo. Conclusions Telmisartan 80 mg and HCT 12.5 mg combination therapy is effective and well tolerated in black patients with hypertension, improving anti hypertensive activity beyond that achieved with the corresponding monotherapies. (C) 2001 Lippincott Williams & Wilkins.