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Efficacy and tolerability of initial therapy with single-pill combination telmisartan/hydrochlorothiazide 80/25 mg in patients with grade 2 or 3 hypertension: a multinational, randomized, double-blind, active-controlled trial.
Clin Ther. 2012 Jul; 34(7):1613-24.CT

Abstract

BACKGROUND

Patients with grade 2 or 3 hypertension may require high-dose combination therapy to achieve blood pressure (BP) targets in a timely manner.

OBJECTIVES

This study compared the effectiveness and tolerability of a single-pill combination (SPC) of telmisartan/hydrochlorothiazide 80/25 mg (T80/H25) with T80 monotherapy.

METHODS

In a Phase IV, multinational, randomized, double-blind, double-dummy, active-controlled, parallel-group trial, 894 patients with mean seated trough cuff systolic BP [SBP] ≥160 mm Hg and diastolic BP [DBP] ≥100 mm Hg were randomly assigned in a 2:1 ratio to receive T40/H12.5 SPC or telmisartan 40 mg monotherapy for 1 week before the dose was uptitrated to T80/H25 SPC or T80, respectively, administered for 6 weeks. The primary efficacy measure was the change from baseline in mean seated cuff trough SBP. Adverse events (AEs) were recorded.

RESULTS

A total of 888 patients received treatment (294 and 594 patients in the T80/H25 and T80 groups, respectively) (mean age, 57.0 years; age ≥65 years, 25.7%; male, 53.8%; white, 68.0%); 61 patients prematurely discontinued. Mean baseline SBP/DBP values were 172.3/104.3 mm Hg (T80/H25) and 173.3/104.5 mm Hg (T80). After 7 weeks, SBP was changed by -37.0 and -28.5 mm Hg in the T80/H25 and T80 groups (P < 0.0001); DBP was changed by -18.6 and -15.4 mm Hg respectively (P < 0.0001). These differences were significant after 2 weeks at the higher dosage (P < 0.0001). BP target (SBP/DBP <140/<90 mm Hg) was achieved in 55.5% and 34.7% of patients in the T80/H25 and T80 groups (P < 0.0001). T80/H25 SPC and T80 had a similar frequency of overall AEs (16.0% vs 17.0%). The prevalences of treatment-related AEs with T80/H25 SPC and T80 were low (4.6% and 2.8%), as were the rates of AEs that led to discontinuation (1.0% and 2.8%).

CONCLUSIONS

In these patients with grade 2 or 3 hypertension, initial therapy with T80/H25 was associated with a significantly greater reduction in mean seated cuff trough SBP compared with T80 alone, as well as with improved hypertension goal attainment rates. Both treatments appeared to be well tolerated.

Authors+Show Affiliations

Shanghai Ruijin Hospital, Shanghai Institute of Hypertension, 197 Ruijin 2nd Road, Shanghai, China. zhudingliang@sibs.ac.cnNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase IV
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22717420

Citation

Zhu, Dingliang L., et al. "Efficacy and Tolerability of Initial Therapy With Single-pill Combination Telmisartan/hydrochlorothiazide 80/25 Mg in Patients With Grade 2 or 3 Hypertension: a Multinational, Randomized, Double-blind, Active-controlled Trial." Clinical Therapeutics, vol. 34, no. 7, 2012, pp. 1613-24.
Zhu DL, Bays H, Gao P, et al. Efficacy and tolerability of initial therapy with single-pill combination telmisartan/hydrochlorothiazide 80/25 mg in patients with grade 2 or 3 hypertension: a multinational, randomized, double-blind, active-controlled trial. Clin Ther. 2012;34(7):1613-24.
Zhu, D. L., Bays, H., Gao, P., Mattheus, M., Voelker, B., & Ruilope, L. M. (2012). Efficacy and tolerability of initial therapy with single-pill combination telmisartan/hydrochlorothiazide 80/25 mg in patients with grade 2 or 3 hypertension: a multinational, randomized, double-blind, active-controlled trial. Clinical Therapeutics, 34(7), 1613-24. https://doi.org/10.1016/j.clinthera.2012.05.007
Zhu DL, et al. Efficacy and Tolerability of Initial Therapy With Single-pill Combination Telmisartan/hydrochlorothiazide 80/25 Mg in Patients With Grade 2 or 3 Hypertension: a Multinational, Randomized, Double-blind, Active-controlled Trial. Clin Ther. 2012;34(7):1613-24. PubMed PMID: 22717420.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and tolerability of initial therapy with single-pill combination telmisartan/hydrochlorothiazide 80/25 mg in patients with grade 2 or 3 hypertension: a multinational, randomized, double-blind, active-controlled trial. AU - Zhu,Dingliang L, AU - Bays,Harold, AU - Gao,Pingjin, AU - Mattheus,Michaela, AU - Voelker,Birgit, AU - Ruilope,Luis M, Y1 - 2012/06/19/ PY - 2011/11/15/received PY - 2012/05/23/revised PY - 2012/05/23/accepted PY - 2012/6/22/entrez PY - 2012/6/22/pubmed PY - 2012/12/22/medline SP - 1613 EP - 24 JF - Clinical therapeutics JO - Clin Ther VL - 34 IS - 7 N2 - BACKGROUND: Patients with grade 2 or 3 hypertension may require high-dose combination therapy to achieve blood pressure (BP) targets in a timely manner. OBJECTIVES: This study compared the effectiveness and tolerability of a single-pill combination (SPC) of telmisartan/hydrochlorothiazide 80/25 mg (T80/H25) with T80 monotherapy. METHODS: In a Phase IV, multinational, randomized, double-blind, double-dummy, active-controlled, parallel-group trial, 894 patients with mean seated trough cuff systolic BP [SBP] ≥160 mm Hg and diastolic BP [DBP] ≥100 mm Hg were randomly assigned in a 2:1 ratio to receive T40/H12.5 SPC or telmisartan 40 mg monotherapy for 1 week before the dose was uptitrated to T80/H25 SPC or T80, respectively, administered for 6 weeks. The primary efficacy measure was the change from baseline in mean seated cuff trough SBP. Adverse events (AEs) were recorded. RESULTS: A total of 888 patients received treatment (294 and 594 patients in the T80/H25 and T80 groups, respectively) (mean age, 57.0 years; age ≥65 years, 25.7%; male, 53.8%; white, 68.0%); 61 patients prematurely discontinued. Mean baseline SBP/DBP values were 172.3/104.3 mm Hg (T80/H25) and 173.3/104.5 mm Hg (T80). After 7 weeks, SBP was changed by -37.0 and -28.5 mm Hg in the T80/H25 and T80 groups (P < 0.0001); DBP was changed by -18.6 and -15.4 mm Hg respectively (P < 0.0001). These differences were significant after 2 weeks at the higher dosage (P < 0.0001). BP target (SBP/DBP <140/<90 mm Hg) was achieved in 55.5% and 34.7% of patients in the T80/H25 and T80 groups (P < 0.0001). T80/H25 SPC and T80 had a similar frequency of overall AEs (16.0% vs 17.0%). The prevalences of treatment-related AEs with T80/H25 SPC and T80 were low (4.6% and 2.8%), as were the rates of AEs that led to discontinuation (1.0% and 2.8%). CONCLUSIONS: In these patients with grade 2 or 3 hypertension, initial therapy with T80/H25 was associated with a significantly greater reduction in mean seated cuff trough SBP compared with T80 alone, as well as with improved hypertension goal attainment rates. Both treatments appeared to be well tolerated. SN - 1879-114X UR - https://www.unboundmedicine.com/medline/citation/22717420/Efficacy_and_tolerability_of_initial_therapy_with_single_pill_combination_telmisartan/hydrochlorothiazide_80/25_mg_in_patients_with_grade_2_or_3_hypertension:_a_multinational_randomized_double_blind_active_controlled_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0149-2918(12)00325-6 DB - PRIME DP - Unbound Medicine ER -