LONG-TERM EFFICACY, SAFETY, AND TOLERABILITY OF VALSARTAN AND HYDROCHLOROTHIAZIDE IN PATIENTS WITH ESSENTIAL-HYPERTENSION

The long-term safety data on angiotensin II receptor blockers in combi nation 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 combinat ion with hydrochlorothiazide (HCTZ) 12.5 or 25 mg for at least 2 years . Seventy-three patients (age range, 30 to 77 years) with essential hy pertension who had participated in a 6-week, double-masked core trial followed by a 2-year, open-label extension phase entered the S-year, o pen-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 y ear. For all patients, mean reductions from baseline (core trial) in t rough mean sitting diastolic blood pressure (DBP) and systolic blood p ressure (SBP) during the third-year extension phase remained stable ov er time and comparable to mean reductions at the end of the second-yea r extension phase. Comparable mean reductions in both SEP 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 v alsartan 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 g-week core trial, fu rther mean reductions in blood pressure were observed at all time poin ts. No relevant differences In antihypertensive effect were seen in yo unger (<65 years) or older (greater than or equal to 65 years) patient s or in male or female patients. Both combinations were well tolerated , and none of the patients discontinued therapy because of treatment-r elated 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-ter m safety or tolerability issues.