PMID- 27581533 OWN - NLM STAT- MEDLINE DCOM- 20170810 LR - 20190221 IS - 1348-4214 (Electronic) IS - 0916-9636 (Print) IS - 0916-9636 (Linking) VI - 40 IP - 1 DP - 2017 Jan TI - 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. PG - 51-60 LID - 10.1038/hr.2016.100 [doi] AB - 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. FAU - Higaki, Jitsuo AU - Higaki J AD - Department of Cardiology, Pulmonology, Hypertension & Nephrology, Ehime University Graduate School of Medicine, Ehime, Japan. FAU - Komuro, Issei AU - Komuro I AD - Department of Cardiovascular Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan. FAU - Shiki, Kosuke AU - Shiki K AD - Medical Division, Nippon Boehringer Ingelheim Co. Ltd., Tokyo, Japan. FAU - Ugai, Hiroyuki AU - Ugai H AD - Medical Division, Nippon Boehringer Ingelheim Co. Ltd., Tokyo, Japan. FAU - Taniguchi, Atsushi AU - Taniguchi A AD - Medical Division, Nippon Boehringer Ingelheim Co. Ltd., Tokyo, Japan. FAU - Ikeda, Hiroshi AU - Ikeda H AD - Medical Division, Nippon Boehringer Ingelheim Co. Ltd., Tokyo, Japan. FAU - Kuroki, Daisuke AU - Kuroki D AD - Medical Division, Nippon Boehringer Ingelheim Co. Ltd., Tokyo, Japan. FAU - Nishimura, Seiichiro AU - Nishimura S AD - Medical Division, Nippon Boehringer Ingelheim Co. Ltd., Tokyo, Japan. FAU - Ogihara, Toshio AU - Ogihara T AD - Morinomiya University of Medical Sciences, Osaka, Japan. LA - eng PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20160901 PL - England TA - Hypertens Res JT - Hypertension research : official journal of the Japanese Society of Hypertension JID - 9307690 RN - 0 (Antihypertensive Agents) RN - 0 (Benzimidazoles) RN - 0 (Benzoates) RN - 0J48LPH2TH (Hydrochlorothiazide) RN - 1J444QC288 (Amlodipine) RN - U5SYW473RQ (Telmisartan) SB - IM CIN - Hypertens Res. 2017 Apr;40(4):346-347. PMID: 27881849 MH - Adult MH - Aged MH - Amlodipine/administration & dosage/adverse effects/*therapeutic use MH - Antihypertensive Agents/administration & dosage/adverse effects/therapeutic use MH - Benzimidazoles/administration & dosage/adverse effects/*therapeutic use MH - Benzoates/administration & dosage/adverse effects/*therapeutic use MH - Blood Pressure/*drug effects MH - Double-Blind Method MH - Drug Therapy, Combination MH - Essential Hypertension MH - Female MH - Humans MH - Hydrochlorothiazide/administration & dosage/adverse effects/*therapeutic use MH - Hypertension/*drug therapy MH - Japan MH - Male MH - Middle Aged MH - Telmisartan MH - Treatment Outcome PMC - PMC5222993 COIS- JH has received consulting and lecture fees and/or research funding from Astellas Pharm, Nippon Boehringer Ingelheim, Mochida Pharm, Daiichi Sankyo, Sumitomo Dainippon Pharma, MSD K.K., Novartis Pharma K.K., Teijin Pharma Limited and Takeda Pharmaceutical. IK has received lecture fees, research funding and/or scholarship grants from Daiichi Sankyo, Sumitomo Dainippon Pharma, Takeda Pharmaceutical, Mitsubishi Tanabe Pharma, Nippon Boehringer Ingelheim, Ono Pharmaceutical, Astellas Pharma, Teijin Pharma Limited, Sanofi K.K., Kowa Company, Bayel Yakuhin, TOA EIYO and Takeda Pharmaceutical. The remaining authors declare no conflict of interest. JH and IK were the medical experts and TO was the coordinating investigator of this study. KS, HU, AT, HI, DK and SN are employees of Nippon Boehringer Ingelheim. EDAT- 2016/09/02 06:00 MHDA- 2017/08/11 06:00 PMCR- 2017/01/10 CRDT- 2016/09/02 06:00 PHST- 2016/04/21 00:00 [received] PHST- 2016/06/07 00:00 [revised] PHST- 2016/06/12 00:00 [accepted] PHST- 2016/09/02 06:00 [pubmed] PHST- 2017/08/11 06:00 [medline] PHST- 2016/09/02 06:00 [entrez] PHST- 2017/01/10 00:00 [pmc-release] AID - hr2016100 [pii] AID - 10.1038/hr.2016.100 [doi] PST - ppublish SO - Hypertens Res. 2017 Jan;40(1):51-60. doi: 10.1038/hr.2016.100. Epub 2016 Sep 1.