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Improved Blood Pressure Control with Nifedipine GITS/Valsartan Combination Versus High-Dose Valsartan Monotherapy in Mild-to-Moderate Hypertensive Patients from Asia: Results from the ADVISE Study, a Randomized Trial.
MedLine Citation:
PMID:  23134522     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
Aims: ADVISE was a 12-week, multicenter, randomized, prospective, open-label, parallel-group study comparing combination therapy of nifedipine GITS 30 mg plus valsartan 80 mg (N + V) with high-dose valsartan (160 mg) monotherapy (V160) in Asian patients with hypertension. Methods: Patients with hypertension inadequately controlled with valsartan 80 mg for at least 4 weeks were randomized. The coprimary endpoints were the mean changes in clinic systolic and diastolic blood pressures (SBP and DBP, respectively) at Week 12. Other endpoints included blood pressure (BP) control rate, response rate, and adverse events. Results: The full analysis set (FAS) comprised 359 patients. Least squares (LS) mean changes in SBP were -18.3 mmHg (N + V; n = 177) and -16.5 mmHg (V160; n = 182) (difference: -1.9 mmHg; P = 0.0998). DBP LS mean changes were -9.8 mmHg (N + V) and -7.4 mmHg (V160) (difference: -2.4 mmHg; P = 0.0011). BP control rates were significantly higher in the N + V group (Week 4: 51.2% vs. 38.4%, P = 0.0138; Week 8: 68.3% vs. 50.3%, P = 0.0004; and Week 12: 71.2% vs. 55.5%, P = 0.0024). Similar findings were observed when patients were stratified according to smoking status, SBP baseline quartiles, and ESC/ESH guideline-defined added-risk category. The BP response rate was also higher in the N + V group compared with the V160 group. Rates of adverse drug reactions (all mild-to-moderate) were similar: 4.5% (N + V) and 4.4% (V160). Conclusions: Although one of the coprimary endpoints did not reach statistical significance, combination treatment with N + V provided a greater early and more consistent BP-lowering effect than monotherapy with V160, including superior reduction in DBP and BP control rates.
Authors:
Yuan-Nan Ke; Yu-Gang Dong; Shu-Ping Ma; Hong Yuan; Sang-Hyun Ihm; Sang Hong Baek
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Cardiovascular therapeutics     Volume:  30     ISSN:  1755-5922     ISO Abbreviation:  Cardiovasc Ther     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2012-11-08     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101319630     Medline TA:  Cardiovasc Ther     Country:  England    
Other Details:
Languages:  eng     Pagination:  326-32     Citation Subset:  IM    
Copyright Information:
© 2012 Blackwell Publishing Ltd.
Affiliation:
Cardiovascular Department, China-Japan Friendship Hospital, Beijing, China.
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