title: Efficacy and tolerability of amlodipine camsylate/losartan 5/100-mg versus losartan/hydrochlorothiazide 100/12.5-mg fixed-dose combination in hypertensive patients nonresponsive to losartan 100-mg monotherapy.
abstract: OBJECTIVE
  The aim of this study was to determine whether the efficacy and tolerability of amlodipine camsylate/losartan 5/100 mg/d (AML/LOS) are noninferior to those of losartan/hydrochlorothiazide 100/12.5 mg/d (LOS/HCTZ) fixed-dose combination in hypertensive patients unresponsive to losartan 100-mg/d monotherapy.
  
  
  METHODS
  Male and female patients aged ≥ 18 years with hypertension despite 4-week, stable treatment with losartan 100-mg/d monotherapy were eligible for inclusion in this multicenter, randomized, double-blind study. Patients were randomly assigned to receive AML/LOS or LOS/HCTZ once daily for 8 weeks. The primary end point was the change from baseline to week 8 in sitting diastolic blood pressure (ΔsiDBP), and the secondary end points were the changes from baseline to 4 weeks in siDBP and sitting systolic BP (ΔsiSBP) and changes from baseline to 4 and 8 weeks in BP response rate. Tolerability was evaluated by physical examination, including vital sign measurement; laboratory analysis; and ECG.
  
  
  RESULTS
  Of 275 patients screened at 9 cardiovascular centers, 199 were enrolled (AML/LOS, n = 101; LOS/HCTZ, n = 98), and 183 completed the study. The demographic characteristics were similar between the 2 groups (mean age, 51.56 [9.97] years; men, 70.53%). At 8 weeks, the mean ΔsiDBP values were -11.54 (7.89) and -9.05 (6.57) mm Hg in the AML/LOS and LOS/HCTZ groups, respectively (both, P < 0.0001 vs baseline). The mean difference between the 2 groups was -2.57 mm Hg, a nonsignificant difference, meaning that AML/LOS was noninferior to LOS/HCTZ with regard to the primary end point. At 8 weeks, the mean uric acid level was changed significantly from baseline in the LOS/HCTZ group (+0.41 [0.80] mg/dL; P < 0.0001) but not in the AML/LOS group (-0.12 [0.82] mg/dL), representing a significant intergroup difference (P < 0.0001). Nineteen patients each in the AML/LOS (18.81%) and LOS/HCTZ (20.00%) groups experienced ≥ 1 adverse event, with 4 (3.96%) and 3 (3.16%) patients, respectively, experiencing 1 or more events considered by the investigators to have been treatment related.
  
  
  CONCLUSIONS
  The efficacy and tolerability of AML/LOS 5/100 mg/d was found to have been noninferior to those of LOS/HCTZ 100/12.5 mg/d in these hypertensive patients nonresponsive to losartan 100-mg/d monotherapy.
authors.affiliation: Gachon University Gil Hospital, Incheon, Republic of Korea.
authors.forename: Soon Yong
authors.initials: SY
authors.lastname: Suh
authors.affiliation: Gachon University Gil Hospital, Incheon, Republic of Korea. Electronic address: encore@gilhospital.com.
authors.forename: Taehoon
authors.initials: T
authors.lastname: Ahn
authors.affiliation: Konyang University Hospital, Daejeon, Republic of Korea.
authors.forename: Jang-Ho
authors.initials: JH
authors.lastname: Bae
authors.affiliation: Korea University Anam Hospital, Seoul, Republic of Korea.
authors.forename: Do-Sun
authors.initials: DS
authors.lastname: Lim
authors.affiliation: Kwangju Christian Hospital, Kwangju, Republic of Korea.
authors.forename: Seoung Uk
authors.initials: SU
authors.lastname: Lee
authors.affiliation: Dongguk University Ilsan Hospital, Ilsan, Republic of Korea.
authors.forename: Young Kwon
authors.initials: YK
authors.lastname: Kim
authors.affiliation: Soonchunhyang University Hospital, Seoul, Republic of Korea.
authors.forename: Min Su
authors.initials: MS
authors.lastname: Hyon
authors.affiliation: Chungbuk National University Hospital, Jeonju, Republic of Korea.
authors.forename: Won Ho
authors.initials: WH
authors.lastname: Kim
authors.affiliation: Hallym University Kangdong Sacred Heart Hospital, Seoul, Republic of Korea.
authors.forename: Kyoo Rok
authors.initials: KR
authors.lastname: Han
authors.affiliation: VHS Medical Center, Seoul, Republic of Korea.
authors.forename: Hoon Ki
authors.initials: HK
authors.lastname: Park
mesh_terms: D000328:Adult; D017311:Amlodipine / 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; 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* / Q000503:physiopathology; D019808:Losartan / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D000959:Antihypertensive Agents; D004338:Drug Combinations; D006852:Hydrochlorothiazide; D017311:Amlodipine; D019808:Losartan
keywords: amlodipine; hypertension; losartan