title: Efficacy of fimasartan/hydrochlorothiazide combination in hypertensive patients inadequately controlled by fimasartan monotherapy.
abstract: BACKGROUND
  The study reported here compared the blood pressure (BP)-lowering efficacy of fimasartan alone with that of fimasartan/hydrochlorothiazide (HCTZ) combination in patients whose BP goal was not achieved after 4 weeks of treatment with once-daily fimasartan 60 mg.
  
  
  METHODS
  Patients with sitting diastolic blood pressure (siDBP) ≥90 mmHg with 4 weeks of once-daily fimasartan 60 mg were randomly assigned to receive either once-daily fimasartan 60 mg/HCTZ 12.5 mg or fimasartan 60 mg for 4 weeks. After 4 weeks, the dose was increased from fimasartan 60 mg/HCTZ 12.5 mg to fimasartan 120 mg/HCTZ 12.5 mg or from fimasartan 60 mg to fimasartan 120 mg if siDBP was ≥90 mmHg.
  
  
  RESULTS
  Of the 263 randomized patients, 256 patients who had available efficacy data were analyzed. The fimasartan/HCTZ treatment group showed a greater reduction of siDBP compared to the fimasartan treatment group at Week 4 (6.88±8.10 mmHg vs 3.38±7.33, P=0.0008), and the effect persisted at Week 8 (8.67±9.39 mmHg vs 5.02±8.27 mmHg, P=0.0023). Reduction of sitting systolic BP in the fimasartan/HCTZ treatment group was also greater than that in the fimasartan treatment group (at Week 4, 10.50±13.76 mmHg vs 5.75±12.18 mmHg, P=0.0069 and, at Week 8, 13.45±15.15 mmHg vs 6.84±13.57 mmHg, P=0.0007). The proportion of patients who achieved a reduction of siDBP ≥10 mmHg from baseline and/or a mean siDBP <90 mmHg after 4 weeks of treatment was higher in the fimasartan/HCTZ treatment group than in the fimasartan treatment group (53.6% vs 39.8%, P=0.0359). The overall incidence of adverse drug reaction was 11.79% with no significant difference between the treatment groups.
  
  
  CONCLUSIONS
  The combination treatment of fimasartan and HCTZ achieved better BP control than fimasartan monotherapy, and had comparable safety and tolerance to fimasartan monotherapy.
authors.affiliation: Cardiovascular Center, Dongguk University Ilsan Hospital, Goyang, Republic of Korea.
authors.forename: Moo-Yong
authors.initials: MY
authors.lastname: Rhee
authors.affiliation: Catholic University of Korea, Seoul St Mary's Hospital, Seoul, Republic of Korea.
authors.forename: Sang Hong
authors.initials: SH
authors.lastname: Baek
authors.affiliation: Cardiovascular Department of Internal Medicine, Kyung Hee University Medical Center, Seoul, Republic of Korea.
authors.forename: Weon
authors.initials: W
authors.lastname: Kim
authors.affiliation: Division of Cardiology, Guro Hospital, Korea University College of Medicine, Seoul, Republic of Korea.
authors.forename: Chang Gyu
authors.initials: CG
authors.lastname: Park
authors.affiliation: Division of Cardiology, Samsung Medical Center, Seoul, Republic of Korea.
authors.forename: Seung Woo
authors.initials: SW
authors.lastname: Park
authors.affiliation: Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
authors.forename: Byung-Hee
authors.initials: BH
authors.lastname: Oh
authors.affiliation: Division of Cardiology, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, Republic of Korea.
authors.forename: Sang-Hyun
authors.initials: SH
authors.lastname: Kim
authors.affiliation: Division of Cardiology, Asan Medical Center, Seoul, Republic of Korea.
authors.forename: Jae-Joong
authors.initials: JJ
authors.lastname: Kim
authors.affiliation: Division of Cardiology, Ajou University Hospital, Suwon, Republic of Korea.
authors.forename: Joon-Han
authors.initials: JH
authors.lastname: Shin
authors.affiliation: Division of Cardiology, Wonju Severance Christian Hospital, Wonju, Republic of Korea.
authors.forename: Byung-Su
authors.initials: BS
authors.lastname: Yoo
authors.affiliation: Division of Cardiology, GangNam Severance Hospital, Seoul, Republic of Korea.
authors.forename: Se-Joong
authors.initials: SJ
authors.lastname: Rim
authors.affiliation: Division of Cardiology, Severance Hospital, Seoul, Republic of Korea.
authors.forename: Jong-Won
authors.initials: JW
authors.lastname: Ha
authors.affiliation: Division of Cardiology, Inje University Ilsan Hospital, Goyang, Republic of Korea.
authors.forename: Joon Hyung
authors.initials: JH
authors.lastname: Doh
authors.affiliation: Department of Cardiology, Chonnam National University Hospital, Gwangju, Republic of Korea.
authors.forename: Youngkeun
authors.initials: Y
authors.lastname: Ahn
authors.affiliation: Chonbuk National University Hospital, Jeonju, Republic of Korea.
authors.forename: Jei Keon
authors.initials: JK
authors.lastname: Chae
authors.affiliation: Department of Cardiology, Cheil General Hospital, Dankook University College of Medicine, Seoul, Republic of Korea.
authors.forename: Jeong Bae
authors.initials: JB
authors.lastname: Park
authors.affiliation: Department of Cardiology, Hanyang University Guri Hospital, Guri, Republic of Korea.
authors.forename: Soon-Kil
authors.initials: SK
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
authors.forename: Cheol Ho
authors.initials: CH
authors.lastname: Kim
mesh_terms: D000959:Antihypertensive Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D001713:Biphenyl Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D006852:Hydrochlorothiazide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006973:Hypertension / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011743:Pyrimidines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013777:Tetrazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000959:Antihypertensive Agents; D001713:Biphenyl Compounds; D004338:Drug Combinations; D011743:Pyrimidines; D013777:Tetrazoles; D006852:Hydrochlorothiazide; C558933:fimasartan
keywords: angiotensin II type 1 receptor; angiotensin-converting enzyme inhibitor; angiotensin-receptor blocker; antihypertensive; blood pressure; renin–angiotensin–aldosterone system inhibitor