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Efficacy and tolerability of a single-pill combination of telmisartan/hydrochlorothiazide 80/25 mg in Chinese and Korean patients with moderate to severe hypertension: a subgroup analysis of a randomized, double-blind, active-controlled trial.
Chin Med J (Engl). 2013 Nov; 126(21):4072-7.CM

Abstract

BACKGROUND

Hypertension is an important issue in Asia, responsible for up to 66% of cardiovascular disease cases. This randomized controlled trial subgroup analysis compared telmisartan 80 mg (T80)/hydrochlorothiazide 25 mg (H25) singlepill combination with T80 monotherapy, specifically in Chinese and Korean patients.

METHODS

Patients with grade 2/3 hypertension were randomized to receive telmisartan 40 mg (T40)/hydrochlorothiazide 12.5 mg (H12.5) combination or T40 monotherapy for one week, before uptitrating the dose to T80/H25 or T80, respectively, for the remaining 6 weeks. The primary endpoint was systolic blood pressure (SBP) mean change from baseline. Secondary endpoints included mean diastolic blood pressure (DBP) change from baseline, and blood pressure (BP) goal achievement. Adverse events were recorded.

RESULTS

Of a total 888 patients who were treated, efficacy analyses for Chinese and Korean patients included 127 patients treated with T80/H25 and 54 patients treated with T80. At week 7, mean SBP reductions from baseline were -37.5 mmHg (1 mmHg = 0.133 kPa) and -26.9 mmHg in the T80/H25 and T80 groups (adjusted mean difference, -10.6 mmHg; 95% confidence interval (CI), -15.6 to -5.7). Mean DBP reductions were -19.0 and -14.1 mmHg in the T80/H25 and T80 groups (adjusted mean difference, -4.9 mmHg; 95% CI, -8.0 to -1.8). In total, 56.7% of patients receiving T80/H25 achieved BP goal (<140/90 mmHg) compared with 35.2% receiving T80. SBP goal attainment (<140 mmHg) and DBP goal attainment (<90 mmHg) were also higher in the T80/H25 group compared with the T80 group (SBP: 69.3% vs. 48.1%; DBP: 62.2% vs. 46.3%). A small number of treatment-related adverse events were observed in both T80/H25 (nine patients, 6.9%) and T80 monotherapy (two patients, 3.6%) groups.

CONCLUSIONS

In Chinese and Korean patients with moderate-to-severe hypertension, treatment with T80/H25 provided large reductions in mean SBP and DBP, and high BP goal attainment rates. This once-daily combination is effective and well tolerated in this patient group.

Authors+Show Affiliations

Shanghai Institute of Hypertension, Shanghai Ruijin Hospital, Shanghai 200025, China. Email: zhudingliang@sibs.ac.cn.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24229676

Citation

Zhu, Ding-Liang, et al. "Efficacy and Tolerability of a Single-pill Combination of Telmisartan/hydrochlorothiazide 80/25 Mg in Chinese and Korean Patients With Moderate to Severe Hypertension: a Subgroup Analysis of a Randomized, Double-blind, Active-controlled Trial." Chinese Medical Journal, vol. 126, no. 21, 2013, pp. 4072-7.
Zhu DL, Gao PJ, Liu SW, et al. Efficacy and tolerability of a single-pill combination of telmisartan/hydrochlorothiazide 80/25 mg in Chinese and Korean patients with moderate to severe hypertension: a subgroup analysis of a randomized, double-blind, active-controlled trial. Chin Med J (Engl). 2013;126(21):4072-7.
Zhu, D. L., Gao, P. J., Liu, S. W., Jeong, M. H., Mattheus, M., & Birgit, V. (2013). Efficacy and tolerability of a single-pill combination of telmisartan/hydrochlorothiazide 80/25 mg in Chinese and Korean patients with moderate to severe hypertension: a subgroup analysis of a randomized, double-blind, active-controlled trial. Chinese Medical Journal, 126(21), 4072-7.
Zhu DL, et al. Efficacy and Tolerability of a Single-pill Combination of Telmisartan/hydrochlorothiazide 80/25 Mg in Chinese and Korean Patients With Moderate to Severe Hypertension: a Subgroup Analysis of a Randomized, Double-blind, Active-controlled Trial. Chin Med J (Engl). 2013;126(21):4072-7. PubMed PMID: 24229676.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and tolerability of a single-pill combination of telmisartan/hydrochlorothiazide 80/25 mg in Chinese and Korean patients with moderate to severe hypertension: a subgroup analysis of a randomized, double-blind, active-controlled trial. AU - Zhu,Ding-Liang, AU - Gao,Ping-Jin, AU - Liu,Shao-Wen, AU - Jeong,Myung Ho, AU - Mattheus,Michaela, AU - Birgit,Voelker, PY - 2013/11/16/entrez PY - 2013/11/16/pubmed PY - 2014/5/16/medline SP - 4072 EP - 7 JF - Chinese medical journal JO - Chin Med J (Engl) VL - 126 IS - 21 N2 - BACKGROUND: Hypertension is an important issue in Asia, responsible for up to 66% of cardiovascular disease cases. This randomized controlled trial subgroup analysis compared telmisartan 80 mg (T80)/hydrochlorothiazide 25 mg (H25) singlepill combination with T80 monotherapy, specifically in Chinese and Korean patients. METHODS: Patients with grade 2/3 hypertension were randomized to receive telmisartan 40 mg (T40)/hydrochlorothiazide 12.5 mg (H12.5) combination or T40 monotherapy for one week, before uptitrating the dose to T80/H25 or T80, respectively, for the remaining 6 weeks. The primary endpoint was systolic blood pressure (SBP) mean change from baseline. Secondary endpoints included mean diastolic blood pressure (DBP) change from baseline, and blood pressure (BP) goal achievement. Adverse events were recorded. RESULTS: Of a total 888 patients who were treated, efficacy analyses for Chinese and Korean patients included 127 patients treated with T80/H25 and 54 patients treated with T80. At week 7, mean SBP reductions from baseline were -37.5 mmHg (1 mmHg = 0.133 kPa) and -26.9 mmHg in the T80/H25 and T80 groups (adjusted mean difference, -10.6 mmHg; 95% confidence interval (CI), -15.6 to -5.7). Mean DBP reductions were -19.0 and -14.1 mmHg in the T80/H25 and T80 groups (adjusted mean difference, -4.9 mmHg; 95% CI, -8.0 to -1.8). In total, 56.7% of patients receiving T80/H25 achieved BP goal (<140/90 mmHg) compared with 35.2% receiving T80. SBP goal attainment (<140 mmHg) and DBP goal attainment (<90 mmHg) were also higher in the T80/H25 group compared with the T80 group (SBP: 69.3% vs. 48.1%; DBP: 62.2% vs. 46.3%). A small number of treatment-related adverse events were observed in both T80/H25 (nine patients, 6.9%) and T80 monotherapy (two patients, 3.6%) groups. CONCLUSIONS: In Chinese and Korean patients with moderate-to-severe hypertension, treatment with T80/H25 provided large reductions in mean SBP and DBP, and high BP goal attainment rates. This once-daily combination is effective and well tolerated in this patient group. SN - 2542-5641 UR - https://www.unboundmedicine.com/medline/citation/24229676/Efficacy_and_tolerability_of_a_single_pill_combination_of_telmisartan/hydrochlorothiazide_80/25_mg_in_Chinese_and_Korean_patients_with_moderate_to_severe_hypertension:_a_subgroup_analysis_of_a_randomized_double_blind_active_controlled_trial_ L2 - https://Insights.ovid.com/pubmed?pmid=24229676 DB - PRIME DP - Unbound Medicine ER -