title: 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.
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: Department of Cardiology, Pulmonology, Hypertension & Nephrology, Ehime University Graduate School of Medicine, Ehime, Japan.
authors: Jitsuo
authors: J
authors: Higaki
authors: Department of Cardiovascular Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
authors: Issei
authors: I
authors: Komuro
authors: Medical Division, Nippon Boehringer Ingelheim Co. Ltd., Tokyo, Japan.
authors: Kosuke
authors: K
authors: Shiki
authors: Medical Division, Nippon Boehringer Ingelheim Co. Ltd., Tokyo, Japan.
authors: Hiroyuki
authors: H
authors: Ugai
authors: Medical Division, Nippon Boehringer Ingelheim Co. Ltd., Tokyo, Japan.
authors: Atsushi
authors: A
authors: Taniguchi
authors: Medical Division, Nippon Boehringer Ingelheim Co. Ltd., Tokyo, Japan.
authors: Hiroshi
authors: H
authors: Ikeda
authors: Medical Division, Nippon Boehringer Ingelheim Co. Ltd., Tokyo, Japan.
authors: Daisuke
authors: D
authors: Kuroki
authors: Medical Division, Nippon Boehringer Ingelheim Co. Ltd., Tokyo, Japan.
authors: Seiichiro
authors: S
authors: Nishimura
authors: Morinomiya University of Medical Sciences, Osaka, Japan.
authors: Toshio
authors: T
authors: Ogihara
mesh_terms: D000328:Adult; D000368:Aged; D017311:Amlodipine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D001562:Benzimidazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001565:Benzoates / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D000075222:Essential Hypertension; D005260:Female; D006801:Humans; D006852:Hydrochlorothiazide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006973:Hypertension / Q000188:drug therapy*; D007564:Japan; D008297:Male; D008875:Middle Aged; D000077333:Telmisartan; D016896:Treatment Outcome
chemical_list: D000959:Antihypertensive Agents; D001562:Benzimidazoles; D001565:Benzoates; D006852:Hydrochlorothiazide; D017311:Amlodipine; D000077333:Telmisartan