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The efficacy and long-term safety of a triple combination of 80 mg telmisartan, 5 mg amlodipine and 12.5 mg hydrochlorothiazide in Japanese patients with essential hypertension: a randomized, double-blind study with open-label extension.
Hypertens Res. 2017 Jan; 40(1):51-60.HR

Abstract

The aim of this study was to compare 80 mg telmisartan/5 mg amlodipine/12.5 mg hydrochlorothiazide (T80/A5/H12.5) with 80 mg telmisartan/12.5 mg hydrochlorothiazide (T80/H12.5) to determine their relative blood pressure (BP) lowering effects in essential hypertensive patients with inadequate control and to evaluate the long-term safety of T80/A5/H12.5 in a 52-week extension period. Patients (n=132) were randomly assigned to receive double-blind treatment with T80/A5/H12.5 or T80/H12.5 for 8 weeks after a 6-week run-in-period of T80/H12.5. All 126 patients who completed the double-blind period entered the 52-week open-label extension and received T80/A5/H12.5. The adjusted mean changes from the reference baseline of the trough-seated systolic and diastolic BP (SBP/DBP) at week 8 were significantly larger in the T80/A5/H12.5 group (-10.6/-8.8 mm Hg) than in the T80/H12.5 group (-2.3/-1.3 mm Hg) (P<0.0001). The BP-lowering effect of T80/A5/H12.5 was maintained over the 52-week extension period. The adverse events (AEs) during both treatment periods were generally mild. Drug-related AEs were reported in one patient in each group in the double-blind period and in five patients exposed to T80/A5/H12.5 in the double-blind and/or open-label extension period. T80/A5/H12.5 therapy was clinically and statistically superior to T80/H12.5 therapy for the reduction of BP in patients with essential hypertension uncontrolled with T80/H12.5, and its BP-lowering effect was maintained in the long term. T80/A5/H12.5 was generally well-tolerated.

Authors+Show Affiliations

Department of Cardiology, Pulmonology, Hypertension & Nephrology, Ehime University Graduate School of Medicine, Ehime, Japan.Department of Cardiovascular Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.Medical Division, Nippon Boehringer Ingelheim Co. Ltd., Tokyo, Japan.Medical Division, Nippon Boehringer Ingelheim Co. Ltd., Tokyo, Japan.Medical Division, Nippon Boehringer Ingelheim Co. Ltd., Tokyo, Japan.Medical Division, Nippon Boehringer Ingelheim Co. Ltd., Tokyo, Japan.Medical Division, Nippon Boehringer Ingelheim Co. Ltd., Tokyo, Japan.Medical Division, Nippon Boehringer Ingelheim Co. Ltd., Tokyo, Japan.Morinomiya University of Medical Sciences, Osaka, Japan.

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

27581533

Citation

Higaki, Jitsuo, et al. "The Efficacy and Long-term Safety of a Triple Combination of 80 Mg Telmisartan, 5 Mg Amlodipine and 12.5 Mg Hydrochlorothiazide in Japanese Patients With Essential Hypertension: a Randomized, Double-blind Study With Open-label Extension." Hypertension Research : Official Journal of the Japanese Society of Hypertension, vol. 40, no. 1, 2017, pp. 51-60.
Higaki J, Komuro I, Shiki K, et al. The efficacy and long-term safety of a triple combination of 80 mg telmisartan, 5 mg amlodipine and 12.5 mg hydrochlorothiazide in Japanese patients with essential hypertension: a randomized, double-blind study with open-label extension. Hypertens Res. 2017;40(1):51-60.
Higaki, J., Komuro, I., Shiki, K., Ugai, H., Taniguchi, A., Ikeda, H., Kuroki, D., Nishimura, S., & Ogihara, T. (2017). The efficacy and long-term safety of a triple combination of 80 mg telmisartan, 5 mg amlodipine and 12.5 mg hydrochlorothiazide in Japanese patients with essential hypertension: a randomized, double-blind study with open-label extension. Hypertension Research : Official Journal of the Japanese Society of Hypertension, 40(1), 51-60. https://doi.org/10.1038/hr.2016.100
Higaki J, et al. The Efficacy and Long-term Safety of a Triple Combination of 80 Mg Telmisartan, 5 Mg Amlodipine and 12.5 Mg Hydrochlorothiazide in Japanese Patients With Essential Hypertension: a Randomized, Double-blind Study With Open-label Extension. Hypertens Res. 2017;40(1):51-60. PubMed PMID: 27581533.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The efficacy and long-term safety of a triple combination of 80 mg telmisartan, 5 mg amlodipine and 12.5 mg hydrochlorothiazide in Japanese patients with essential hypertension: a randomized, double-blind study with open-label extension. AU - Higaki,Jitsuo, AU - Komuro,Issei, AU - Shiki,Kosuke, AU - Ugai,Hiroyuki, AU - Taniguchi,Atsushi, AU - Ikeda,Hiroshi, AU - Kuroki,Daisuke, AU - Nishimura,Seiichiro, AU - Ogihara,Toshio, Y1 - 2016/09/01/ PY - 2016/04/21/received PY - 2016/06/07/revised PY - 2016/06/12/accepted PY - 2016/9/2/pubmed PY - 2017/8/11/medline PY - 2016/9/2/entrez SP - 51 EP - 60 JF - Hypertension research : official journal of the Japanese Society of Hypertension JO - Hypertens Res VL - 40 IS - 1 N2 - The aim of this study was to compare 80 mg telmisartan/5 mg amlodipine/12.5 mg hydrochlorothiazide (T80/A5/H12.5) with 80 mg telmisartan/12.5 mg hydrochlorothiazide (T80/H12.5) to determine their relative blood pressure (BP) lowering effects in essential hypertensive patients with inadequate control and to evaluate the long-term safety of T80/A5/H12.5 in a 52-week extension period. Patients (n=132) were randomly assigned to receive double-blind treatment with T80/A5/H12.5 or T80/H12.5 for 8 weeks after a 6-week run-in-period of T80/H12.5. All 126 patients who completed the double-blind period entered the 52-week open-label extension and received T80/A5/H12.5. The adjusted mean changes from the reference baseline of the trough-seated systolic and diastolic BP (SBP/DBP) at week 8 were significantly larger in the T80/A5/H12.5 group (-10.6/-8.8 mm Hg) than in the T80/H12.5 group (-2.3/-1.3 mm Hg) (P<0.0001). The BP-lowering effect of T80/A5/H12.5 was maintained over the 52-week extension period. The adverse events (AEs) during both treatment periods were generally mild. Drug-related AEs were reported in one patient in each group in the double-blind period and in five patients exposed to T80/A5/H12.5 in the double-blind and/or open-label extension period. T80/A5/H12.5 therapy was clinically and statistically superior to T80/H12.5 therapy for the reduction of BP in patients with essential hypertension uncontrolled with T80/H12.5, and its BP-lowering effect was maintained in the long term. T80/A5/H12.5 was generally well-tolerated. SN - 1348-4214 UR - https://www.unboundmedicine.com/medline/citation/27581533/The_efficacy_and_long_term_safety_of_a_triple_combination_of_80_mg_telmisartan_5_mg_amlodipine_and_12_5_mg_hydrochlorothiazide_in_Japanese_patients_with_essential_hypertension:_a_randomized_double_blind_study_with_open_label_extension_ L2 - https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/27581533/ DB - PRIME DP - Unbound Medicine ER -