title: The combination of amlodipine/valsartan 5/160 mg produces less peripheral oedema than amlodipine 10 mg in hypertensive patients not adequately controlled with amlodipine 5 mg.
abstract: OBJECTIVE
  To demonstrate the benefit of the combination amlodipine/valsartan 5/160 mg over amlodipine 10 mg, in producing a lower incidence of peripheral oedema for a comparable mean sitting systolic blood pressure (MSSBP) reduction.
  
  
  METHODS
  After a 4-week amlodipine 5 mg run-in phase, inadequately controlled hypertension patients (aged > or = 55 years, MSSBP > or = 130 and < or = 160 mmHg) were randomised to receive amlodipine/valsartan 5/160 mg or amlodipine 10 mg for 8 weeks, followed by amlodipine/valsartan 5/160 mg for 4 weeks for all patients. Primary variables were MSSBP change from baseline to week 8 and incidence of peripheral oedema reported as an AE. Resolution of peripheral oedema was assessed 4 weeks after switching patients from amlodipine 10 mg to amlodipine/ valsartan 5/160 mg.
  
  
  RESULTS
  At week 8, MSSBP showed greater reduction with amlodipine/valsartan 5/160 mg than amlodipine 10 mg (least square mean: -8.01 vs.-5.95 mmHg, p < 0.001 for non-inferiority and p = 0.002 for superiority). Systolic control, overall BP control and systolic response rate at week 8 were significantly higher with combination than amlodipine 10 mg (34 vs. 26%; 57 vs. 50%; 36.57 vs. 27.77%, respectively). Incidence of peripheral oedema was significantly lower with the combination than amlodipine 10 mg (6.6 vs. 31.1%, p < 0.001). Peripheral oedema resolved in 56% patients who switched from amlodipine 10 mg to the combination, without the loss of effect on BP reduction.
  
  
  CONCLUSIONS
  In non-responders to amlodipine 5 mg, treatment with amlodipine/valsartan 5/160 mg induced significantly less peripheral oedema than amlodipine 10 mg for similar BP reduction. Peripheral oedema resolved in > 50% patients switching from amlodipine 10 mg to the combination.
authors.affiliation: St. Josef-Hospital, Cloppenburg, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Schrader
authors.forename: A
authors.initials: A
authors.lastname: Salvetti
authors.forename: C
authors.initials: C
authors.lastname: Calvo
authors.forename: E
authors.initials: E
authors.lastname: Akpinar
authors.forename: L
authors.initials: L
authors.lastname: Keeling
authors.forename: M
authors.initials: M
authors.lastname: Weisskopf
authors.forename: P
authors.initials: P
authors.lastname: Brunel
mesh_terms: D000368:Aged; D017311:Amlodipine / Q000008:administration & dosage / Q000009:adverse effects*; D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000009:adverse effects*; D004338:Drug Combinations; D004487:Edema / Q000139:chemically induced*; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D013777:Tetrazoles / Q000008:administration & dosage / Q000009:adverse effects*; D016896:Treatment Outcome; D014633:Valine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000068756:Valsartan
chemical_list: D000959:Antihypertensive Agents; D004338:Drug Combinations; D013777:Tetrazoles; D017311:Amlodipine; D000068756:Valsartan; D014633:Valine