PMID- 20716145
OWN - NLM
STAT- MEDLINE
DCOM- 20111123
LR  - 20151119
IS  - 1742-1241 (Electronic)
IS  - 1368-5031 (Linking)
VI  - 64
IP  - 10
DP  - 2010 Sep
TI  - Combination therapy with amlodipine/valsartan in essential hypertension: a 
      52-week, randomised, open-label, extension study.
PG  - 1367-74
LID - 10.1111/j.1742-1241.2010.02480.x [doi]
AB  - BACKGROUND: A majority of hypertensive patients require > or = 2 agents to 
      achieve target blood pressure (BP). METHODS: This 52-week, multicentre, 
      open-label, randomised extension trial to a previously reported double-blind, 
      placebo-controlled study evaluated the safety and efficacy of 
      amlodipine/valsartan (Aml/Val) combination. Patients who successfully completed 
      the core study without serious drug-related adverse events (AEs) and mean sitting 
      systolic BP (MSSBP)/mean sitting diastolic BP (MSDBP) < or = 150/95 mmHg were 
      eligible to enter the extension and be treated with Aml/Val 2.5/80 or 5/80 mg. 
      After 4 weeks of treatment, patients underwent force-titration to receive 5/160 
      mg (low dose) or 10/160 mg (high dose) for 48 weeks. Addition of 
      hydrochlorothiazide (HCTZ) 12.5 mg was permitted if BP was > or = 140/90 mmHg at 
      Week 8 or later. Patients could be down-titrated to the prior lower combination 
      dose with or without HCTZ if an intolerable AE occurred. Safety evaluations 
      included monitoring of AEs. Efficacy variables were change from baseline in MSDBP 
      (primary) and MSSBP (secondary). RESULTS: Of 1246 patients randomised, 1075 
      (86.3%) completed the extension study. At week 52 end-point, change in 
      MSSBP/MSDBP from core study baseline was -22.1/-17.2 mmHg for low-dose regimen 
      and -22.8/-18.1 mmHg for high-dose regimen. For both regimens, reductions in BP 
      were sustained over 52 weeks and mean BP maintained below approximately 135/85 
      mmHg at all visits. Frequent AEs in the low- and high-dose regimens were 
      peripheral oedema (9.7% and 17.1% respectively), nasopharyngitis (8.1% and 7.2%), 
      and dizziness (5.2% and 7.0%). Incidence of serious AEs was 3.7% with low dose 
      and 4.1% with high dose. CONCLUSION: The combination of Aml/Val with the optional 
      addition of HCTZ produced clinically significant and persistent reductions in BP 
      over 52 weeks with a favourable tolerability profile.
FAU - Smith, T R
AU  - Smith TR
AD  - Mercy Health Research, Washington University School of Medicine, St Louis, MO, 
      USA. timothy.smith@mercy.net
FAU - Glazer, R D
AU  - Glazer RD
FAU - Koren, M J
AU  - Koren MJ
FAU - Wernsing, M
AU  - Wernsing M
FAU - Zhang, Y
AU  - Zhang Y
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - India
TA  - Int J Clin Pract
JT  - International journal of clinical practice
JID - 9712381
RN  - 0 (Amlodipine, Valsartan Drug Combination)
RN  - 0 (Antihypertensive Agents)
RN  - 0 (Drug Combinations)
RN  - 0 (Tetrazoles)
RN  - 1J444QC288 (Amlodipine)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Amlodipine/*administration & dosage/adverse effects
MH  - Amlodipine, Valsartan Drug Combination
MH  - Antihypertensive Agents/*administration & dosage/adverse effects
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Combinations
MH  - Female
MH  - Humans
MH  - Hypertension/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Tetrazoles/*administration & dosage/adverse effects
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2010/08/19 06:00
MHDA- 2011/12/13 00:00
CRDT- 2010/08/19 06:00
PHST- 2010/08/19 06:00 [entrez]
PHST- 2010/08/19 06:00 [pubmed]
PHST- 2011/12/13 00:00 [medline]
AID - IJCP2480 [pii]
AID - 10.1111/j.1742-1241.2010.02480.x [doi]
PST - ppublish
SO  - Int J Clin Pract. 2010 Sep;64(10):1367-74. doi: 10.1111/j.1742-1241.2010.02480.x.