Efficacy and safety of valsartan in hypertensive Taiwanese patients: post-marketing surveillance study.

OBJECTIVE: To evaluate the efficacy and safety of valsartan in Taiwanese patients with essential hypertension.

METHODS: This 12-week multi-center, open-label, observational, post-marketing surveillance study enrolled 2046 hypertensive patients who were prescribed valsartan 80 or 160 mg as monotherapy or in combination with other antihypertensives based on clinical judgment. The primary endpoint was the incidence rate of dizziness with valsartan 160 mg monotherapy or combination therapy at Week 4. Secondary endpoints included the blood-pressure-lowering efficacy and the overall safety and tolerability of valsartan at Weeks 4 and 12.

RESULTS: The monotherapy and combination groups had comparable baseline characteristics. At Week 4, monotherapy was found non-inferior to combination for incidence rate of dizziness (monotherapy, 9.25%; combination, 10%; difference in incidence of dizziness, 0.75%; 95% CI - 0.61% to 2.12%; non-inferiority margin, -1.33%;WaldTest approach). Greater blood pressure (BP) reduction was noted atWeek 12 than atWeek 4.The antihypertensive effect was greater with combination therapy and the 160-mg dose. BP control (systolic <140 mmHg or diastolic <90 mmHg) was achieved in 80-90% patients.Valsartan was well tolerated; most commonly reported adverse events included dizziness, headache, constipation and cough.

CONCLUSION: Valsartan is an effective treatment option for essential hypertension in Taiwanese patients.