Long-term efficacy, safety, and tolerability of valsartan and hydrochlorothiazide in patients with essential hypertension

Abstract

The long-term safety data on angiotensin II receptor blockers in combination with thiazide diuretics are limited. The present study reports on the long-term efficacy, safety, and tolerability data from a third-year extension trial in patients receiving valsartan 80 mg in combination with hydrochlorothiazide (HCTZ) 12.5 or 25 mg for at least 2 years. Seventy-three patients (age range, 30 to 77 years) with essential hypertension who had participated in a 6-week, double-masked core trial followed by a 2-year, open-label extension phase entered the 3-year, open-label extension trial. They received valsartan 80 mg/HCTZ 12.5 mg (n = 18), valsartan 80 mg/HCTZ 25 mg (n = 52), or valsartan 80 mg with HCTZ that varied between 12.5 mg and 25 mg (n = 3) during the third year. For all patients, mean reductions from baseline (core trial) in trough mean sitting diastolic blood pressure (DBP) and systolic blood pressure (SBP) during the third-year extension phase remained stable over time and comparable to mean reductions at the end of the second-year extension phase. Comparable mean reductions in both SBP and DBP were observed for patients treated with valsartan 80 mg/HCTZ 12.5 mg (SBP, 11.7 to 17.1 mm Hg; DBP, 12.3 to 13.8 mm Hg) and those treated with valsartan 80 mg/HCTZ 25 mg (SBP, 15.0 to 16.4 mm Hg; DBP, 11.9 to 12.6 mm Hg). When the third-year extension results for blood pressure were compared with results at the end of the original 6-week core trial, further mean reductions in blood pressure were observed at all time points. No relevant differences in antihypertensive effect were seen in younger (<65 years) or older (⩾65 years) patients or in male or female patients. Both combinations were well tolerated, and none of the patients discontinued therapy because of treatment-related adverse events. Based on these results, we concluded that long-term use of valsartan 80 mg in combination with HCTZ 12.5 or 25 mg is effective, safe, and well tolerated. There was no evidence of long-term safety or tolerability issues.