title: Valsartan 160 mg/Amlodipine 5 mg Combination Therapy versus Amlodipine 10 mg in Hypertensive Patients with Inadequate Response to Amlodipine 5 mg Monotherapy.
abstract: OBJECTIVE
  When monotherapy is inadequate for blood pressure control, the next step is either to continue monotherapy in increased doses or to add another antihypertensive agent. However, direct comparison of double-dose monotherapy versus combination therapy has rarely been done. The objective of this study is to compare 10 mg of amlodipine with an amlodipine/valsartan 5/160 mg combination in patients whose blood pressure control is inadequate with amlodipine 5 mg.
  
  
  METHODS
  This study was conducted as a multicenter, open-label, randomized controlled trial. Men and women aged 20-80 who were diagnosed as having hypertension, who had been on amlodipine 5 mg monotherapy for at least 4 weeks, and whose daytime mean systolic blood pressure (SBP) ≥135 mmHg or diastolic blood pressure (DBP) ≥85 mmHg on 24-hour ambulatory blood pressure monitoring (ABPM) were randomized to amlodipine (A) 10 mg or amlodipine/valsartan (AV) 5/160 mg group. Follow-up 24-hour ABPM was done at 8 weeks after randomization.
  
  
  RESULTS
  Baseline clinical characteristics did not differ between the 2 groups. Ambulatory blood pressure reduction was significantly greater in the AV group compared with the A group (daytime mean SBP change: -14±11 vs. -9±9 mmHg, p<0.001, 24-hour mean SBP change: -13±10 vs. -8±8 mmHg, p<0.0001). Drug-related adverse events also did not differ significantly (A:AV, 6.5 vs. 4.5 %, p=0.56).
  
  
  CONCLUSIONS
  Amlodipine/valsartan 5/160 mg combination was more efficacious than amlodipine 10 mg in hypertensive patients in whom monotherapy of amlodipine 5 mg had failed.
authors.affiliation: Division of Cardiology, Department of Medicine, Heart Vascular and Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: Jidong
authors.initials: J
authors.lastname: Sung
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon, Korea.
authors.forename: Jin-Ok
authors.initials: JO
authors.lastname: Jeong
authors.affiliation: Department of Internal Medicine, Vision 21 Cardiac and Vascular Center, Ilsan Paik Hospital, Inje University College of Medicine, Goyang, Korea.
authors.forename: Sung Uk
authors.initials: SU
authors.lastname: Kwon
authors.affiliation: Department of Cardiology, Cardiovascular Center, Seoul Medical Center, Seoul, Korea.
authors.forename: Kyung Heon
authors.initials: KH
authors.lastname: Won
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: Byung Jin
authors.initials: BJ
authors.lastname: Kim
authors.affiliation: Division of Interventional Cardiology, Department of Internal Medicine, Kangwon National University Hospital, Chooncheon, Korea.
authors.forename: Byung Ryul
authors.initials: BR
authors.lastname: Cho
authors.affiliation: Department of Cardiovascular Medicine, Kyung Hee University Medical Center, Seoul, Korea.
authors.forename: Myeong-Kon
authors.initials: MK
authors.lastname: Kim
authors.affiliation: Cardiology Division, Internal medicine, Eulji University Hospital, Daejeon, Korea.
authors.forename: Sahng
authors.initials: S
authors.lastname: Lee
authors.affiliation: Department of Cardiology, Center for Clinical Specialty, National Cancer Center, Goyang, Korea.
authors.forename: Hak Jin
authors.initials: HJ
authors.lastname: Kim
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Dankook University Hospital, Cheonan, Korea.
authors.forename: Seong-Hoon
authors.initials: SH
authors.lastname: Lim
authors.affiliation: Division of Cardiology, Department of Medicine, Heart Vascular and Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: Seung Woo
authors.initials: SW
authors.lastname: Park
authors.affiliation: Division of Cardiology, Department of Medicine, Heart Vascular and Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: Jeong Euy
authors.initials: JE
authors.lastname: Park
keywords: Amlodipine; Amlodipine-valsartan drug combination; Hypertension; Valsartan