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
Yuan-Nan Ke, Yu-Gang Dong, Shu-Ping Ma, Hong Yuan, Sang-Hyun Ihm, Sang Hong Baek, ADVISE study group, Yuqing Zhang, Ping-Jin Gao, Tianlun Yang, Jun Huang, Biao Xu, Kook-Jin Chun, Jin-Ok Jeong, Youngkeun Ahn, Young-Guk Ko, Yong-Jin Kim, Yuan-Nan Ke, Sang Hong Baek, Yuan-Nan Ke, Yu-Gang Dong, Shu-Ping Ma, Hong Yuan, Sang-Hyun Ihm, Sang Hong Baek, ADVISE study group, Yuqing Zhang, Ping-Jin Gao, Tianlun Yang, Jun Huang, Biao Xu, Kook-Jin Chun, Jin-Ok Jeong, Youngkeun Ahn, Young-Guk Ko, Yong-Jin Kim, Yuan-Nan Ke, Sang Hong Baek
Abstract
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.
Trial registration: ClinicalTrials.gov NCT00993109.
© 2012 Blackwell Publishing Ltd.
Source: PubMed