title: Comparison of the efficacy and safety of fixed-dose amlodipine/losartan and losartan in hypertensive patients inadequately controlled with losartan: a randomized, double-blind, multicenter study.
abstract: BACKGROUND
  Fixed-dose combination drugs may enhance blood pressure (BP) goal attainment through complementary effects and reduced side effects, which leads to better compliance.
  
  
  OBJECTIVE
  This study aimed to evaluate the efficacy and safety profiles of once-daily combination amlodipine/losartan versus losartan.
  
  
  METHODS
  This was an 8-week, double-blind, multicenter, randomized phase III study conducted in outpatient hospital clinics. Korean patients with essential hypertension inadequately controlled on losartan 100 mg were administered amlodipine/losartan 5 mg/100 mg combination versus losartan 100 mg. The main outcome measures were changes in sitting diastolic blood pressure (DBP) and sitting systolic blood pressure (SBP) and BP response rate from baseline values, which were assessed after 4 and 8 weeks of treatment. Safety and tolerability were also assessed.
  
  
  RESULTS
  At week 8, both groups achieved significant reductions from baseline in DBP (11.7 ± 7.0 and 3.2 ± 7.9 mmHg), which was significantly greater in the amlodipine/losartan 5 mg/100 mg combination (n = 70) group (p < 0.0001). Additionally, the amlodipine/losartan 5 mg/100 mg combination group achieved significantly greater reductions in SBP at week 8 and in SBP and DBP at week 4 compared with the losartan 100 mg (n = 72) group (all p < 0.0001). Response rates were significantly higher in the amlodipine/losartan 5 mg/100 mg group versus the losartan 100 mg group (81.4% vs 63.9% at week 4, p < 0.0192; 90.0% vs 66.7% at week 8, p < 0.001). Both treatments were generally well tolerated.
  
  
  CONCLUSIONS
  Switching to a fixed-dose combination therapy of amlodipine/losartan 5 mg/100 mg was associated with significantly greater reductions in BP and superior achievement of BP goals compared with a maintenance dose of losartan 100 mg in Korean patients with essential hypertension inadequately controlled on losartan 100 mg.
  
  
  BACKGROUND
  Registered at Clinicaltrials.gov as NCT00940680.
authors.affiliation: Heart Center, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Bum-Kee
authors.initials: BK
authors.lastname: Hong
authors.forename: Chang Gyu
authors.initials: CG
authors.lastname: Park
authors.forename: Ki Sik
authors.initials: KS
authors.lastname: Kim
authors.forename: Myeong Ho
authors.initials: MH
authors.lastname: Yoon
authors.forename: Ho Joong
authors.initials: HJ
authors.lastname: Yoon
authors.forename: Jeong Han
authors.initials: JH
authors.lastname: Yoon
authors.forename: Joo Young
authors.initials: JY
authors.lastname: Yang
authors.forename: Young Jin
authors.initials: YJ
authors.lastname: Choi
authors.forename: Seung Yun
authors.initials: SY
authors.lastname: Cho
mesh_terms: D000328:Adult; D017311:Amlodipine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D047228:Angiotensin II Type 1 Receptor Blockers / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects; D002121:Calcium Channel Blockers / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000503:physiopathology; D019808:Losartan / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D056910:Republic of Korea; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D047228:Angiotensin II Type 1 Receptor Blockers; D000959:Antihypertensive Agents; D002121:Calcium Channel Blockers; D004338:Drug Combinations; D017311:Amlodipine; D019808:Losartan