PMID- 27720505 OWN - NLM STAT- MEDLINE DCOM- 20170928 LR - 20190318 IS - 1879-114X (Electronic) IS - 0149-2918 (Linking) VI - 38 IP - 10 DP - 2016 Oct TI - Comparison of the Efficacy and Safety of Fixed-dose S-Amlodipine/Telmisartan and Telmisartan in Hypertensive Patients Inadequately Controlled with Telmisartan: A Randomized, Double-blind, Multicenter Study. PG - 2185-2194 LID - S0149-2918(16)30728-7 [pii] LID - 10.1016/j.clinthera.2016.09.006 [doi] AB - PURPOSE: The objective of this study was to evaluate the efficacy and safety of the fixed-dose combination S-amlodipine plus telmisartan (S-AM/TEL) compared with TEL monotherapy in patients with hypertension inadequately controlled by TEL monotherapy. METHODS: this study was a randomized, multicenter, double-blind, parallel group, Phase III, 8-week clinical trial to compare the superiority of the S-AM/TEL 2.5/40-mg and S-AM/TEL 5/40-mg combinations with TEL 80-mg mono-therapy. The primary end point was the change in the mean sitting diastolic blood pressure from baseline (week 0) after 8 weeks of therapy between treatment groups. FINDINGS: Of 325 patients screened, 183 were randomly assigned to 3 groups (61 in the S-AM/TEL 2.5/40-mg group, 60 in the S-AM/TEL 5/40-mg group, and 62 in the TEL 80-mg group). Mean (SD) age was 53.9 (7.5) years, and male patients comprised 87%. No significant differences were found among the 3 groups in baseline characteristics. The primary end points, the changes of mean (SD) diastolic blood pressure at week 8 from the baseline were -10.56 (7.23) mm Hg in the S-AM/TEL 2.5/40-mg group, -12.32 (9.23) mm Hg in the S-AM/TEL 5/40-mg group, and -2.44 (7.92) mm Hg in the TEL 80-mg group. Both the S-AM/TEL 2.5/40-mg group and the S-AM/TEL 5/40-mg group had a statistically superior hypotensive effect compared with the TEL 80-mg group (P < 0.0001 for both). For evaluation of the safety profile, the frequencies of adverse events (AEs) among the groups were also not significantly different (S-AM/TEL 2.5/40-mg group, 18.6%; S-AM/TEL 5/40-mg group, 20%; and TEL 80-mg group, 22.6%), and the incidences of AEs were not different among the groups. The most common AEs were respiratory disorders, followed by headache, dizziness, and peripheral edema. IMPLICATIONS: Treatment with S-AM/TEL 2.5/40 mg and S-AM/TEL 5/40 mg was superior to increasing the TEL dose in terms of hypotensive effect in patients with hypertension inadequately controlled by TEL monotherapy. S-AM/TEL fixed-dose combinations are an effective and tolerable option for patients inadequately responding to TEL monotherapy and also a good option for improving patients' medication adherence. ClinicalTrials.gov identifier: NCT011426100. CI - Copyright (c) 2016. Published by Elsevier Inc. FAU - Park, Chang Gyu AU - Park CG AD - Cardiology Division, Korea University Guro Hospital, Seoul, Korea. Electronic address: parkcg@kumc.or.kr. FAU - Ahn, Tae Hun AU - Ahn TH AD - Gachon University Gil Medical Center, Seoul, Korea. FAU - Cho, Eun Ju AU - Cho EJ AD - The Catholic University of Korea, St. Paul's Hospital, Seoul, Korea. FAU - Kim, Won AU - Kim W AD - KyungHee University Medical Center, Seoul, Korea. FAU - Kim, Hyung Seob AU - Kim HS AD - Keimyung University Dongsan Medical Center, Daegu, Korea. FAU - Yang, Ju Yeong AU - Yang JY AD - National Health Insurance Service Ilsan Hospital, Ilsan, Korea. FAU - Ryu, Jae Geun AU - Ryu JG AD - Daegu Catholic University Medical Center, Daegul, Korea. FAU - Kim, Cheol Ho AU - Kim CH AD - Seoul National University Bundang Hospital, Bundang, Korea. FAU - Hyeon, Min Soo AU - Hyeon MS AD - Soon Chun Hyang University Hospital, Seoul, Korea. FAU - Tak, Seung Je AU - Tak SJ AD - Ajou University Hospital, Suwon, Korea. FAU - Im, Se Jung AU - Im SJ AD - Yonsei University, Seoul, Korea. FAU - Ha, Jong Won AU - Ha JW AD - Yonsei University, Seoul, Korea. FAU - Pyeon, Wook Beom AU - Pyeon WB AD - Ewha Womans University, Seoul, Korea. FAU - Jae, Je Geon AU - Jae JG AD - Chonbuk National University, Jeonju, Korea. FAU - Han, Gyu Rok AU - Han GR AD - Hallym University, Kangdong Sacred Heart Hospital, Seoul, Korea. FAU - Doh, Jun Hyung AU - Doh JH AD - Inje University, Ilsan Paik Hospital, Gyeonggi-do, South Korea. FAU - Im, Sang Wook AU - Im SW AD - CHA University Bundang Medical Center, Bundang, Korea. FAU - Lee, Myeong Muk AU - Lee MM AD - Sejong Hospital, Bucheon, Korea. LA - eng PT - Clinical Trial, Phase III PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20161006 PL - United States TA - Clin Ther JT - Clinical therapeutics JID - 7706726 RN - 0 (Antihypertensive Agents) RN - 0 (Benzimidazoles) RN - 0 (Benzoates) RN - 0 (Drug Combinations) RN - 0 (telmisartan amlodipine combination) RN - 1J444QC288 (Amlodipine) RN - U5SYW473RQ (Telmisartan) SB - IM MH - Amlodipine/*administration & dosage MH - Antihypertensive Agents/*administration & dosage MH - Benzimidazoles/*administration & dosage MH - Benzoates/*administration & dosage MH - Blood Pressure/drug effects MH - Double-Blind Method MH - Drug Combinations MH - Female MH - Humans MH - Hypertension/*drug therapy MH - Male MH - Middle Aged MH - Telmisartan OTO - NOTNLM OT - *S-amlodipine OT - *blood pressure OT - *fixed-dose combinations OT - *hypertension OT - *single-pill combination OT - *telmisartan EDAT- 2016/10/11 06:00 MHDA- 2017/09/29 06:00 CRDT- 2016/10/11 06:00 PHST- 2016/06/21 00:00 [received] PHST- 2016/09/12 00:00 [revised] PHST- 2016/09/20 00:00 [accepted] PHST- 2016/10/11 06:00 [pubmed] PHST- 2017/09/29 06:00 [medline] PHST- 2016/10/11 06:00 [entrez] AID - S0149-2918(16)30728-7 [pii] AID - 10.1016/j.clinthera.2016.09.006 [doi] PST - ppublish SO - Clin Ther. 2016 Oct;38(10):2185-2194. doi: 10.1016/j.clinthera.2016.09.006. Epub 2016 Oct 6.