Efficacy and safety of domestic Irbesartan in treating patients with mild and moderate primary hypertension

Objective: To evaluate the therapeutic effect and safety of domestic Irbesartan in treating mild and moderate primary hypertension patients.Methods:43 patients with mild or moderate primary hypertension (DBP:95～110 mmHg and SBP180 mmHg) were divided into two groups using random, double blind, and parallel comparative methods. After taking placebo for two weeks, only the patients with mean DBP 95～110 mmHg and SBP180 mmHg were selected for the trial. Each patient took 150 mg Irbesartan or 80 mg Valsartan per day for two weeks. If the therapeutic effect was not obvious,300 mg Irbesartan or 160 mg Valsartan was given per day for another two weeks.After 4 weeks, the same treatment for another 8 weeks was continued in Irbesartan group, then blood pressure was measured.Side-effects, including their degree and management were recorded,as well as the relationships between the side-effects and the drugs.Physical examinations,electrocardiogram,blood routine test,urine routine test and biochemistry were performed before and 4 week and 12 week after the treatment.Results: SBP and DBP in Irbesartan and Valsartan groups at 4-weeks and 12-weeks after treatment were statistically lower than that of before treatment (P0.01).The effective rate was 63.6% in Irbesartan group and 57.1% in Valsartan group, no significant difference was found(P0.05).To get the satisfied effects, 50% patients needed to take 300 mg in Irbesartan group, and 83.3% patients in Valsartan group had to use 160 mg, significant difference was found between the two groups(P0.01).No significant difference was found in blood routine, urine routine, biochemistry (liver and renal function, electrolyte, blood sugar, blood lipoid, uric acid) and ECG between pretherapy-and post treatment in these two groups. And the side-effects was no significant difference (P0.05). Conclusion: Domestic Irbesartan (150～300 mg each day) is safe and effective for treating mild and moderate primary hypertension patients.