January 1, 2001Open Access

Combination treatment with telmisartan and hydrochlorothiazide in black patients with mild to moderate hypertension

Q: What is the clinical evidence from this study?

Study design: RCT. Population: mild to moderate hypertension (n=222). Intervention: telmisartan and hydrochlorothiazide (HCTZ) vs. monotherapies and placebo. Primary outcome: supine trough diastolic blood pressure (DBP) (p=< 0.01).

Key Result

Telmisartan 80 mg combined with HCTZ 12.5 mg reduced supine trough diastolic blood pressure by 13.3 mmHg, providing greater antihypertensive activity than corresponding monotherapies (p<0.01).

Study Design

Type

RCT (n=222)

Blinding

Double-blind

Randomization

randomized

PICO

Population

mild to moderate hypertension (n=222)

Intervention / Comparator

telmisartan and hydrochlorothiazide (HCTZ) vs monotherapies and placebo (telmisartan (0, 20, 40, 80, 160 mg) and HCTZ (0, 6.25, 12.5, 25 mg))

Primary Outcome

supine trough diastolic blood pressure (DBP), p=< 0.01

Main Result

p-value: p=< 0.01

Abstract

BACKGROUND: Hydrochlorothiazide (HCTZ) is commonly used to treat black patients with hypertension. To avoid the metabolic disturbances associated with high-dose HCTZ, blood pressure control may be achieved by combining low doses with another antihypertensive. HYPOTHESIS: The study was undertaken to assess the tolerability and antihypertensive dose-response efficacy of telmisartan and HCTZ and their combination in black patients with mild to moderate hypertension (mean supine blood pressure 140/95-200/114 mmHg). METHODS: Following a 4-week, single-blind, placebo run-in period, 222 black patients were randomized to once-daily treatment with one of 20 different double-blind combinations of telmisartan (0, 20, 40, 80, 160 mg) and HCTZ (0, 6.25, 12.5, 25 mg) for 8 weeks. Blood pressure was measured at baseline and after 2, 4, and 8 weeks. RESULTS: Telmisartan 80 mg/HCTZ 12.5 mg reduced supine trough diastolic blood pressure (DBP)--primary efficacy parameter--by 13.3 mmHg, and supine trough systolic blood pressure (SBP) by 21.5 mmHg. These reductions represented benefits of 13.7/8.7 mmHg over telmisartan 80 mg and 12.3/8.1 mmHg over HCTZ 12.5 mg (p < 0.01). Telmisartan 40 mg/HCTZ 12.5 mg reduced supine trough SBP/DBP by 14.3/10.0 mmHg, amounting to 12.3/3.3 mmHg more than telmisartan 40 mg and 5.1/4.8 mmHg more than HCTZ 12.5 mg. This reached significance for the comparisons with telmisartan 40 mg for SBP and HCTZ 12.5 mg for DBP (p<0.05). A response surface analysis and therapeutic response rates confirmed the additive antihypertensive effects of telmisartan and HCTZ. All treatments were well tolerated, with side-effect profiles comparable with placebo. Adverse events were mainly transient and of mild to moderate severity. CONCLUSIONS: Telmisartan 80 mg combined with HCTZ 12.5 mg is effective and well tolerated in black patients with mild to moderate hypertension, providing greater antihypertensive activity than the corresponding monotherapies.