VALSARTAN, A NEW ANGIOTENSIN-II ANTAGONIST FOR THE TREATMENT OF ESSENTIAL-HYPERTENSION - EFFICACY AND SAFETY COMPARED WITH PLACEBO AND ENALAPRIL

Objective To compare the antihypertensive efficacy and systemic tolera bility of valsartan, a new angiotensin II receptor antagonist, with pl acebo and with an angiotensin converting enzyme (ACE) inhibitor, enala pril. Design A total of 348 adult outpatients with mild-to-moderate un complicated essential hypertension participated in this double-blind, parallel, study, Patients were allocated randomly in a ratio of 2:2:1 to receive 80 mg valsartan once a day, 20 mg enalapril once a day, or placebo for 8 weeks in general practice, Patients were assessed at 4 a nd 8 weeks of therapy. Main outcome measures The primary efficacy vari able was the change from baseline in mean sitting diastolic blood pres sure (SDBP) after 8 weeks of therapy, Secondary variables included the change in sitting systolic blood pressure (SSBP) and response rates a t 8 weeks. Results Valsartan and enalapril produced statistically sign ificant reductions in diastolic and systolic blood pressures compared with placebo, Similar falls were found in both of the active treatment groups with mean changes in SDBP at 8 weeks of -9.5 mmHg for valsarta n and -9.4 mmHg for enalapril (-4,5 mmHg for placebo), No significant differences between valsartan and enalapril were found for reductions in SDBP or SSBP. Response rates at 8 weeks were significantly greater for valsartan (54%) and enalapril (58%) than for placebo (20%), with n o significant difference between the two active treatments, Both valsa rtan and enalapril demonstrated a consistent antihypertensive effect o ver time, with 90% of patients with a response at 4 weeks responding a t 8 weeks, Both of the treatments were tolerated well. Although the in cidence of coughing was generally low in the study, more cases were re ported with enalapril (three) than with valsartan (one) or placebo (no ne). Conclusions The data show 80 mg valsartan once a day to be as eff ective as 20 mg enalapril once a day in the treatment of mild-to-moder ate hypertension, Valsartan is tolerated well and does not appear to b e associated with any increase in the incidence of coughing.