advertisement
Abstract #10111 Published in IGR 6-1
Efficacy of bunazosin hydrochloride 0.01% as adjunctive therapy of latanoprost or timolol
Kobayashi H; Kobayashi K; Okinami SJournal of Glaucoma 2004; 13: 73-80
PURPOSE: To evaluate the ocular hypotensive response of bunazosin hydrochloride 0.01% administered as adjunctive therapy in patients with glaucoma who were already receiving latanoprost 0.005% or timolol 0.5%. METHODS: Patients with primary open angle glaucoma who had received latanoprost (n = 60) or timolol (n = 60) for six months or longer were enrolled and prospectively randomized to receive additional administration of bunazosin or placebo. Thus, 120 eyes of 120 patients were divided into four subgroups of 30 patients each. Bunazosin was administered twice daily, and timolol or latanoprost was administered per label. The patients were followed up for three months. Responders were defined as having a reduction in intraocular pressure (IOP) of more than 2 mmHg from baseline. RESULTS: Mean baseline IOP was 22.3 ± 3.0 mmHg in the bunazosin subgroup and 22.3 ± 3.1 mmHg in the placebo subgroup of the latanoprost arm, and 22.5 ± 3.5 mmHg in the bunazosin subgroup and 22.3 ± 3.0 mmHg in the placebo subgroup of the timolol arm. In the bunazosin subgroups of both arms, IOP was significantly reduced compared with baseline measurements (p < 0.05) with mean IOP measurement reductions of 2.1 ± 2.4 and 2.8 ± 2.1 mmHg in the latanoprost arm and 2.6 ± 2.1 and 2.8 ± 2.1 mmHg in the timolol arm at six and 12 weeks after the start of the follow-up, respectively. In the latanoprost group, bunazosin provided a further reduction in IOP pressure (7.7%) at 12 weeks from that initially obtained at two weeks (p = 0.0377). In the placebo subgroups of the latanoprost and timolol arms, no significant change was found between at baseline and at any visit after the start of the follow-up. In the latanoprost and timolol arms, there was a significant difference in IOP and its change between the bunazosin subgroup and placebo subgroup at any visit after four weeks from the start of the follow-up (p < 0.01). CONCLUSIONS: Bunazosin hydrochloride 0.01% may provide an additional IOP reduction in patients already receiving latanoprost or timolol. Since adding bunazosin to eyes treated with latanoprost caused a relatively small hypotensive response at two weeks and provided a further reduction from two to 12 weeks, longer than four weeks may be required to evaluate a clinically meaningful response to treatment. Further investigation on more cases and longer follow-up are needed.
Dr. H. Kobayashi, Department of Ophthalmology, Saga Medical School, Japan. kobayas3@post.saga-med.ac.jp
Classification:
11.14 Investigational drugs; pharmacological experiments (Part of: 11 Medical treatment)