title: 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.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Cardiology Division, Korea University Guro Hospital, Seoul, Korea. Electronic address: parkcg@kumc.or.kr.
authors.forename: Chang Gyu
authors.initials: CG
authors.lastname: Park
authors.affiliation: Gachon University Gil Medical Center, Seoul, Korea.
authors.forename: Tae Hun
authors.initials: TH
authors.lastname: Ahn
authors.affiliation: The Catholic University of Korea, St. Paul's Hospital, Seoul, Korea.
authors.forename: Eun Ju
authors.initials: EJ
authors.lastname: Cho
authors.affiliation: KyungHee University Medical Center, Seoul, Korea.
authors.forename: Won
authors.initials: W
authors.lastname: Kim
authors.affiliation: Keimyung University Dongsan Medical Center, Daegu, Korea.
authors.forename: Hyung Seob
authors.initials: HS
authors.lastname: Kim
authors.affiliation: National Health Insurance Service Ilsan Hospital, Ilsan, Korea.
authors.forename: Ju Yeong
authors.initials: JY
authors.lastname: Yang
authors.affiliation: Daegu Catholic University Medical Center, Daegul, Korea.
authors.forename: Jae Geun
authors.initials: JG
authors.lastname: Ryu
authors.affiliation: Seoul National University Bundang Hospital, Bundang, Korea.
authors.forename: Cheol Ho
authors.initials: CH
authors.lastname: Kim
authors.affiliation: Soon Chun Hyang University Hospital, Seoul, Korea.
authors.forename: Min Soo
authors.initials: MS
authors.lastname: Hyeon
authors.affiliation: Ajou University Hospital, Suwon, Korea.
authors.forename: Seung Je
authors.initials: SJ
authors.lastname: Tak
authors.affiliation: Yonsei University, Seoul, Korea.
authors.forename: Se Jung
authors.initials: SJ
authors.lastname: Im
authors.affiliation: Yonsei University, Seoul, Korea.
authors.forename: Jong Won
authors.initials: JW
authors.lastname: Ha
authors.affiliation: Ewha Womans University, Seoul, Korea.
authors.forename: Wook Beom
authors.initials: WB
authors.lastname: Pyeon
authors.affiliation: Chonbuk National University, Jeonju, Korea.
authors.forename: Je Geon
authors.initials: JG
authors.lastname: Jae
authors.affiliation: Hallym University, Kangdong Sacred Heart Hospital, Seoul, Korea.
authors.forename: Gyu Rok
authors.initials: GR
authors.lastname: Han
authors.affiliation: Inje University, Ilsan Paik Hospital, Gyeonggi-do, South Korea.
authors.forename: Jun Hyung
authors.initials: JH
authors.lastname: Doh
authors.affiliation: CHA University Bundang Medical Center, Bundang, Korea.
authors.forename: Sang Wook
authors.initials: SW
authors.lastname: Im
authors.affiliation: Sejong Hospital, Bucheon, Korea.
authors.forename: Myeong Muk
authors.initials: MM
authors.lastname: Lee
mesh_terms: D017311:Amlodipine / Q000008:administration & dosage*; D000959:Antihypertensive Agents / Q000008:administration & dosage*; D001562:Benzimidazoles / Q000008:administration & dosage*; D001565:Benzoates / Q000008:administration & dosage*; D001794:Blood Pressure / Q000187:drug effects; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D000077333:Telmisartan
chemical_list: D000959:Antihypertensive Agents; D001562:Benzimidazoles; D001565:Benzoates; D004338:Drug Combinations; C548840:telmisartan amlodipine combination; D017311:Amlodipine; D000077333:Telmisartan
keywords: S-amlodipine; blood pressure; fixed-dose combinations; hypertension; single-pill combination; telmisartan