Key result
Single-pill telmisartan/HCTZ improves BP control vs telmisartan alone in both men and women.
Why the study?
Does a single-pill combination of telmisartan 80 mg and hydrochlorothiazide 25 mg improve systolic blood pressure reduction compared to telmisartan 80 mg monotherapy in patients with moderate-severe hypertension?
RCT
Double-blind
Randomized
Yes
Does a single-pill combination of telmisartan 80 mg and hydrochlorothiazide 25 mg improve systolic blood pressure reduction compared to telmisartan 80 mg monotherapy in patients with moderate-severe hypertension?
The combination of telmisartan 80 mg and hydrochlorothiazide 25 mg is more effective than telmisartan 80 mg alone for blood pressure control in moderate-severe hypertension across various demographic and clinical subgroups.
Supports telmisartan-HCTZ single-pill combination for BP control in moderate-severe hypertension; extends RCT evidence across demographic subgroups.
BACKGROUND: The purpose of this work was to describe the efficacy and safety of a telmisartan 80 mg + hydrochlorothiazide 25 mg (T80/H25) single-pill combination therapy in patients with moderate-severe hypertension (mean seated trough cuff systolic blood pressure [BP] ≥ 160 mmHg and diastolic BP ≥ 100 mmHg) in specific patient subpopulations. METHODS: This was a planned analysis of a double-blind, multicenter, parallel-group trial that demonstrated the superiority of a single-pill combination of T80/H25 versus T80 monotherapy in terms of systolic BP change from baseline to week 7. Subpopulations included older (aged ≥ 65 years) versus younger, gender, race, hypertension severity, and prior antihypertensive therapy. Endpoints were change from baseline in mean seated trough cuff systolic and diastolic BP, proportion of patients achieving their BP goal (systolic/diastolic BP < 140/90 mmHg), and proportion of patients attaining systolic BP reductions of >30 mmHg and >40 mmHg. RESULTS: Across all subgroups, the T80/H25 single-pill combination provided consistently greater systolic and diastolic BP reductions than T80 and more patients had systolic BP reductions of >30 mmHg. In the T80 and T80/H25 groups, BP control was achieved in 34.1% and 48.8% of men, 35.5% and 62.7% of women, 34.5% and 56.6% of Asians, 22.6% and 38.6% of blacks, 36.7% and 57.8% of whites, 36.9% and 57.5% of patients < 65 years, 29.3% and 49.3% ≥65 years, 44.2% and 66.2% of those with grade 2 hypertension, 20.4% and 39.4% of those with grade 3 hypertension, 38.9% and 53.2% of previously untreated patients, 38.1% and 62.5% of patients previously treated with one antihypertensive, and 29.7% and 48.9% of patients previously treated with two or more antihypertensive agents respectively. Treatment was generally well tolerated across the patient subgroups. CONCLUSION: The T80/H25 single-pill combination provides consistent BP reductions and higher goal attainment rates versus T80 across a range of hypertensive patient subgroups, which are likely to have a positive impact on patients' cardiovascular risk.
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Zhu et al. (2013) conducted an RCT in Moderate-severe hypertension. Telmisartan and hydrochlorothiazide single-pill combination vs. Telmisartan 80 mg monotherapy was evaluated on Systolic BP change from baseline to week 7. A single-pill combination of telmisartan 80 mg and hydrochlorothiazide 25 mg improved BP control compared to telmisartan 80 mg across subgroups, including women (62.7% vs 35.5%) and men (48.8% vs 34.1%).
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