Clinical efficacy and safety of domestic produced amlodipine in the treatment of chronic renal insufficiency with hypertension / 中国基层医药

ABSTRACT

Objective To evaluate the antihypertensive effect and safety of domestic produced amlodipine(Lan Di) in the treatment of chronic renal insufficiency with mild-mnderate hypertension and to compare with the effect of imported amledipine.Methods Sixty-onc patients with chronic renal insufficiency(Scr265～442 μmol/L,seated DBP 90 ～105mmHg and seated SBP≤170mmHg) were enrolled in this study.Patients were randomly assigned to receive Lan Di 5mg or novasc 5mg once daily for 4 weeks.Doses were titrating to 10mg/d for another 4 weeks in patients hating seated DBP≥80mmHg or SBP≥130mmHg at the end of 4 weeks.Blood pressure,heart rate,laboratory examinations were performed at baseline and the end of the trial,and side effects were assessed pre and post Lan Di or novasc treatment.Results Lan Di group(31 cases) and novasc group(30 cases) finished a 8 week clinical trial.At the end of 4,8 weeks,seated SBP and DBP were significantly lowered compared with those at baseline(P＜0.01 ).There was no significant difference in the reduction of seated DBP or SBP between the two groups at the end of 4,8 weeks(P＞0.05).At the end of 8 weeks ,the response rate was 87% in Lan Di group and 90% in novasc group.If the target value of blood pressure is below 130/80mmHg,the response rate was 36% in Lan Di group and 30% in novasc group.At the end of 8 weeks,no difference was found in laboratory findings compared with those at baseline in two groups(P＞0.05).Side effects were comparable during the period of treatment.Condusion Domestic produced amlodipine 5mg or 10mg daily is as effective and safe as imported amolodipine in chronic renal insufficiency patients with mild to moderate hypertension.