In a double-blind (DB), multicenter, clinical trial, 355 patients with mild-to-moderate essential hypertension, characterized by a diastoiic blood pressure (DBP) of 95-115 mm Hg, received either timoiol (T) 10-30 mg twice-a-day, or placebo (P). After 12 weeks of treatment, the mean supine BP for the T group was 145/94 mm Hg (baseline [BL] = 154/103), and for the P group, 155/102 (BL = 156/103). Fifty-seven percent (74/129) of the patients receiving T and 13% (15/114) of the patients receiving P

more »

... had a reduction in supine DBP (SDBP) to 90 mm Hg or less or had a reduction greater than 10 mm Hg but not to 90 mm Hg. The reduction in SDBP for the T group was significantly greater than the reduction for the P group. After Week 12, patients responding to T continued to receive T (T/T group), while patients receiving P who did not respond were then treated with T (P/T group). Results obtained after 24 weeks of timoiol treatment for the T/T group and after 12 weeks of timoiol treatment for the P/T group were similar to those observed for the T group at 12 weeks. During the 12-week DB study, the incidence of adverse experiences was not significantly different between the T and P groups. Safety evaluations, including complete ophthalmologic exams, have not revealed any toxic effects for T. Withdrawal of timoiol for 2 weeks after 24 weeks of treatment for the T/T group and after 12 weeks of treatment for the P/T group was not associated with any rebound phenomena. (Hypertension 2: 643-648, 1980)