title: Valsartan/amlodipine compared to nifedipine GITS in patients with hypertension inadequately controlled by monotherapy.
abstract: BACKGROUND
  Current hypertension guidelines recommend single-pill combinations because they not only improve convenience and compliance to therapy and thus blood pressure (BP) control, but also reduce health-care costs. This study compared the efficacy and safety of valsartan/amlodipine single-pill combination with nifedipine gastrointestinal therapeutic system (GITS) in Chinese patients with hypertension who were inadequately controlled with monotherapy.
  
  
  METHODS
  In this multicenter, open-label, active-controlled, parallel-group study, 564 patients with hypertension not adequately controlled by prior monotherapy were randomized to receive valsartan/amlodipine 80/5 mg or nifedipine GITS 30 mg once daily for 12 weeks.
  
  
  RESULTS
  In the intention-to-treat analysis (n = 540), valsartan/amlodipine (n = 272) showed a least-square mean reduction of -16.6 versus -10.8 mmHg by nifedipine GITS (n = 268; mean between-treatment difference: -5.8 mmHg; P < 0.0001) from baseline to week 12. The corresponding results for mean sitting diastolic BP were -8.6 and -4.6 mmHg, respectively (difference: -4.0 mmHg; P < 0.0001). The percentage of patients achieving the BP target (<140/90 or <130/80 mmHg in the absence or presence of diabetes mellitus, respectively) was significantly higher with valsartan/amlodipine (79.0%) versus nifedipine GITS (57.4%; P < 0.0001). The overall incidence rate of adverse events was lower with valsartan/amlodipine (19.2%) than with nifedipine GITS (29.4%; P = 0.004).
  
  
  CONCLUSIONS
  The valsartan/amlodipine 80/5 mg single-pill combination is well tolerated and more effective than nifedipine GITS 30 mg for BP control in Chinese patients with hypertension.
authors: Centre for Epidemiological Studies and Clinical Trials, Shanghai Key Lab of Hypertension, The Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China, jiguangw@gmail.com.
authors: Ji-Guang
authors: JG
authors: Wang
authors: Wei-Fang
authors: WF
authors: Zeng
authors: Yu-Song
authors: YS
authors: He
authors: Liang-Long
authors: LL
authors: Chen
authors: Meng
authors: M
authors: Wei
authors: Zhao-Ping
authors: ZP
authors: Li
authors: Bao-Wei
authors: BW
authors: Zhang
authors: Yan
authors: Y
authors: Li
mesh_terms: D000328:Adult; D017311:Amlodipine / Q000627:therapeutic use*; D000068838:Amlodipine, Valsartan Drug Combination; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D044466:Asian People; D003692:Delayed-Action Preparations; D004338:Drug Combinations; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009543:Nifedipine / Q000627:therapeutic use*; D013777:Tetrazoles / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000068838:Amlodipine, Valsartan Drug Combination; D000959:Antihypertensive Agents; D003692:Delayed-Action Preparations; D004338:Drug Combinations; D013777:Tetrazoles; D017311:Amlodipine; D009543:Nifedipine