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Clinical and research medicine: Hypertension
e0584 A study of Exforge on the treatment effects and CVE prevention in patients with mild to moderate essential hypertension
  1. Zhang Ying,
  2. Zhou Litao
  1. The Public Health Department of Zhejiang University

Abstract

Objective To compare the difference of the treatment effects and the incidence of CVE in further 10 years in the mild to moderate essential hypertensive population who used Exforge—a new fixed combination regimen, or Norvasc—a classic antihypertensive monotherapy, in order to provide more choices of regimens for them.

Designs and Methods This stage III clinical trial was 8-week and randomised. Patients received Exforge (Amlodipine 5 mg/Valsartan 80 mg) or Norvasc (Amlodipine 5 mg) once daily. The difference of blood pressure reductions between them were compared. The Chinese Multi-Provincial Cohort Study (CMCS) model, which is an adjusted model of Framingham model in China, was used to predict the incidence of CVE in further 10 years before and after taking the drug regimens in hypertensive patients with different levels of risk factors.

Results A total of 256 patients were randomised to the treatment groups (128 in Exforge group and 128 in Norvasc group), and the overall mean age was 54.4 years. (1) The treatment effects in Exforge group was better than that in Norvasc group, and the blood pressure lowering efficiency were 84.9% and 71.9% respectively. Meanwhile the risk difference was 13.0% (12.49%–13.51%), which was statistically different (χ2=6.692, p=0.010). (2) After taking the anti-hypertensive treatment, the incidence of CVE in further 10 years were smaller than those before therapy, and the reduction of incidence in Exforge group were more than those in Norvasc group. The preventive effects on stroke were more obvious than those on CHD. 1. Before taking the hypertensive treatment, the incidence of CHD in further 10 years was 17.40% at the baseline level of risk factors, and after the treatment, the incidence were 9.43% in Exforge group and 12.22% in Norvasc group, reducing 45.81% and 29.74% respectively. The reduction of incidence in Exforge group was 1.54 times than that in Norvasc group. Before taking the hypertensive treatment, the mean incidence of CHD in further 10 years was 27.63% at different levels of risk factors, and after the treatment, the mean incidence were 15.74% in Exforge group and 19.53% in Norvasc group, reducing 44.44% and 29.93% respectively. The reduction of incidence in Exforge group was 1.48 times than that in Norvasc group. 2. Before taking the hypertensive treatment, the incidence of stroke in further 10 years was 24.51% at the baseline level of risk factors, and after the treatment, the incidence were 8.31% in Exforge group and 15.22% in Norvasc group, reducing 66.82% and 37.91% respectively. The reduction of incidence in Exforge group was 1.76 times than that in Norvasc group. Before taking the hypertensive treatment, the mean incidence of stroke in further 10 years was 33.81% at different levels of risk factors, and after the treatment, the mean incidence were 12.71% in Exforge group and 22.34% in Norvasc group, reducing 63.02% and 34.60% respectively. The reduction of incidence in Exforge group was 1.82 times than that in Norvasc group.

Conclusions Compared to Norvasc, Exforge had better treatment effects in the patients with mild to moderate essential hypertension. The reductions of incidence of CVE in future 10 years in Exforge group were more than those in Norvasc group, and the preventive effects on stroke were more obvious than those on CHD. Exforge could be recommended to use in anti-hypertensive treatment and the CVE prevention.

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