PMID- 20469975
OWN - NLM
STAT- MEDLINE
DCOM- 20100928
LR  - 20221207
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 26
IP  - 7
DP  - 2010 Jul
TI  - Efficacy and safety of a single-pill combination of amlodipine/valsartan in Asian 
      hypertensive patients inadequately controlled with amlodipine monotherapy.
PG  - 1705-13
LID - 10.1185/03007995.2010.487391 [doi]
AB  - OBJECTIVE: The antihypertensive efficacy of amlodipine/valsartan combination has 
      not been evaluated in Asian patients as previous large-scale studies enrolled 
      very few patients. This multicentre, randomised, double-blind study assessed the 
      efficacy and safety of a single-pill combination of amlodipine/valsartan versus 
      amlodipine in Asian hypertensive patients. METHODS: After a 1-4-week washout 
      period, patients (mean sitting diastolic BP [msDBP]: >or=95-<110 mmHg) were 
      treated with amlodipine 5 mg for 4 weeks. Patients inadequately controlled on 
      amlodipine (msDBP >or=90 and <110 mmHg) were randomised to receive 
      amlodipine/valsartan 5/80 mg (n = 349) or amlodipine 5 mg (n = 349) for 8 weeks. 
      Efficacy variables were change in msDBP, mean sitting systolic BP (msSBP) from 
      baseline (at randomisation) to week 8 endpoint, and BP control rate (<140/90 
      mmHg) at week 8 endpoint. Safety assessments included monitoring and recording of 
      adverse events (AEs). RESULTS: Baseline characteristics were comparable between 
      the groups. Most patients were Chinese (86.4%), men (65.1%), with a baseline BP 
      139.5/94.5 mmHg. At week 8 endpoint, the least square mean reduction in BP was 
      significantly greater with amlodipine/valsartan combination than amlodipine 
      monotherapy (-11.4/-9.7 vs. -7.4/-7.1 mmHg; p < 0.0001) with a higher BP control 
      rate (69.2 vs. 57.6%; p = 0.0013). Ambulatory BP monitoring in a subgroup of 
      patients (n = 82), showed a significant 24-h mean BP reduction from baseline with 
      amlodipine/valsartan (-7.3/-6.3 mmHg; p < 0.0001), whereas the reduction was not 
      significant with amlodipine (-0.2/+0.3 mmHg; p > 0.05). The overall incidence of 
      AEs was similar in both groups. Peripheral oedema occurred only in the amlodipine 
      group n = 4 (1.1%) and not in the amlodipine/valsartan combination. Hypotension 
      was reported in only one patient in the amlodipine/valsartan combination. Six 
      patients (0.9%) experienced serious AEs, of which only one SAE, i.e. gastric 
      ulcer, was reported to be related to amlodipine treatment. CONCLUSION: The 
      single-pill combination of amlodipine/valsartan was efficacious and 
      well-tolerated in Asian hypertensive patients who were inadequately controlled on 
      amlodipine alone. As with all clinical trials, the entry criteria may limit the 
      extrapolation of these results to a broader population. ClinicalTrials.gov 
      Identifier: NCT00413049.
FAU - Ke, YuanNan
AU  - Ke Y
AD  - China-Japan Friendship Hospital, Beijing, China.
FAU - Zhu, DingLiang
AU  - Zhu D
FAU - Hong, HuaShan
AU  - Hong H
FAU - Zhu, JunRen
AU  - Zhu J
FAU - Wang, RuoNan
AU  - Wang R
FAU - Cardenas, Pamela
AU  - Cardenas P
FAU - Zhang, Ying
AU  - Zhang Y
LA  - eng
SI  - ClinicalTrials.gov/NCT00413049
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Antihypertensive Agents)
RN  - 0 (Drug Combinations)
RN  - 0 (Tablets)
RN  - 0 (Tetrazoles)
RN  - 1J444QC288 (Amlodipine)
RN  - 80M03YXJ7I (Valsartan)
RN  - HG18B9YRS7 (Valine)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Algorithms
MH  - Amlodipine/*administration & dosage/adverse effects
MH  - Antihypertensive Agents/administration & dosage/adverse effects
MH  - Asian People
MH  - Double-Blind Method
MH  - Drug Combinations
MH  - Drug Resistance/drug effects
MH  - Female
MH  - Humans
MH  - Hypertension/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Tablets
MH  - Tetrazoles/*administration & dosage
MH  - Treatment Outcome
MH  - Valine/administration & dosage/*analogs & derivatives
MH  - Valsartan
MH  - Young Adult
EDAT- 2010/05/18 06:00
MHDA- 2010/09/30 06:00
CRDT- 2010/05/18 06:00
PHST- 2010/05/18 06:00 [entrez]
PHST- 2010/05/18 06:00 [pubmed]
PHST- 2010/09/30 06:00 [medline]
AID - 10.1185/03007995.2010.487391 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2010 Jul;26(7):1705-13. doi: 10.1185/03007995.2010.487391.