DOSE-RESPONSE AND ANTIHYPERTENSIVE EFFICACY OF THE AT(1) RECEPTOR ANTAGONIST TELMISARTAN IN PATIENTS WITH MILD-TO-MODERATE HYPERTENSION

This multicenter, randomized, double-blind, double-dummy, placebo-cont rolled trial assessed the dose response, pharmacokinetics, and safety of telmisartan compared with placebo in the treatment of mild to moder ate hypertension. After a 4-week placebo run-in period, patients with supine diastolic blood pressure (DBP) of 100 to 114 mm Hg were randomi zed to receive either placebo or telmisartan (20, 40, 80, 120, or 160 mg) once daily for 4 weeks of double-blind treatment. Blood pressure w as measured weekly. A clinically relevant and statistically significan t reduction in blood pressure was seen at week 1. All doses of telmisa rtan significantly lowered trough (24 hours postdose) blood pressure c ompared with placebo after 4 weeks. Mean reductions from baseline rang ed from 6.9 to 10.5 mm Hg for DBP and 3.3 to 11.7 mm Hg for systolic b lood pressure (SBP). Trough-to-peak ratios for supine DBP at the end o f week 4 approached 100% for all doses of telmisartan. For supine SEP, telmisartan 20 mg had a trough-to-peak ratio of 49%; all other doses produced ratios of 66% or greater. No additional blood pressure-loweri ng benefit was seen with doses beyond 80 mg. The side-effect profile o f telmisartan was similar to placebo, with no evidence of rebound hype rtension and no first-dose orthostatic effect. Telmisartan was effecti ve across a wide dosage range, producing sustained 24-hour antihyperte nsive effects with once-daily administration.