VALSARTAN, A NEW ANGIOTENSIN-II ANTAGONIST FOR THE TREATMENT OF ESSENTIAL-HYPERTENSION - EFFICACY AND SAFETY COMPARED TO HYDROCHLOROTHIAZIDE

Objective. To compare the antihypertensive efficacy of a new angiotens in II antagonist, valsartan, with a reference therapy, hydrochlorothia zide (HCTZ). Methods: In this double-blind study, 167 adult outpatient s with mild-to-moderate essential hypertension were randomly allocated in equal number to receive valsartan 80 mg or HCTZ 25 mg for 12 weeks . In patients whose blood pressure (BP) remained uncontrolled after 8 weeks of monotherapy, atenolol 50 mg was added to the initial treatmen t. Patients were assessed at 4, s and 12 weeks. The primary efficacy v ariable was change from baseline in mean sitting diastolic BP (SDBP) a t 8 weeks. Secondary variables included change in sitting systolic BP (SSBP) and responder rates (percentage of patients with SDBP <90 mmHg or drop greater than or equal to 10 mmHg compared to baseline) at 8 we eks. Results: Valsartan and HCTZ were both effective at lowering diast olic and systolic blood pressure at all time points. Similar falls wer e seen in both groups with no significant differences between treatmen ts. For the primary variable (decrease in SDBP) there was no significa nt difference between treatments. For SSBP there was also no significa nt difference observed. Responder rates at 8 weeks were 74% for valsar tan and 62% for HCTZ (P = 0.10). Both treatments were well tolerated, both as monotherapy, and when combined with atenolol 50 mg per day. Co nclusion: The data show valsartan 80 mg to be as effective as HCTZ in the treatment of mild-to-moderate hypertension. The results also show valsartan to be well tolerated when taken alone or in combination with atenolol.