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 receivedlatanoprost (n = 60) ortimolol (n = 60) for 6 months or longer were enrolled and prospectively randomized to receive additional administration of bunazosin or placebo. One hundred twenty eyes of 120 patients were thus divided into 4 subgroups of 30 patients each. Bunazosin was administered twice daily, and timolol or latanoprost was administered per label. The patients were followed up for 3 months. Responders were defined as having a reduction in intraocular pressure of greater than 2 mm Hg from baseline. RESULTS:Mean baseline intraocular pressure was 22.3 +/- 3.0 mm Hg in the bunazosin subgroup and 22.3 +/- 3.1 mm Hg in the placebo subgroup of the latanoprost arm, and 22.5 +/- 3.5 mm Hg in the bunazosin subgroup and 22.3 +/- 3.0 mm Hg in the placebo subgroup of the timolol arm. In the bunazosin subgroups of both arms, intraocular pressure was significantly reduced compared with baseline measurements (P < 0.05) with mean intraocular pressure measurement reductions of 2.1 +/- 2.4 mm Hg and 2.8 +/- 2.1 mm Hg in the latanoprost arm and 2.6 +/- 2.1 mm Hg and 2.8 +/- 2.1 mm Hg in the timolol arm at 6 and 12 weeks after the start of the follow-up, respectively. In the latanoprost group, bunazosin provided a further reduction of intraocular pressure (7.7%) at 12 weeks from that initially obtained at 2 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 intraocular pressure and its change between the bunazosin subgroup and placebo subgroup at any visit after 4 weeks from the start of the follow-up (P < 0.01). CONCLUSION:Bunazosin hydrochloride 0.01% may provide an additional intraocular pressure reduction in patients already receiving latanoprost or timolol. Since adding bunazosin to eyes treated with latanoprost caused a relatively small hypotensive response at 2 weeks and provided a further reduction from 2 weeks to 12 weeks, longer than 4 weeks may be required to evaluate a clinically meaningful response to treatment. Further investigation on more cases and longer follow-up are needed.
RCT Entities:
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 6 months or longer were enrolled and prospectively randomized to receive additional administration of bunazosin or placebo. One hundred twenty eyes of 120 patients were thus divided into 4 subgroups of 30 patients each. Bunazosin was administered twice daily, and timolol or latanoprost was administered per label. The patients were followed up for 3 months. Responders were defined as having a reduction in intraocular pressure of greater than 2 mm Hg from baseline. RESULTS: Mean baseline intraocular pressure was 22.3 +/- 3.0 mm Hg in the bunazosin subgroup and 22.3 +/- 3.1 mm Hg in the placebo subgroup of the latanoprost arm, and 22.5 +/- 3.5 mm Hg in the bunazosin subgroup and 22.3 +/- 3.0 mm Hg in the placebo subgroup of the timolol arm. In the bunazosin subgroups of both arms, intraocular pressure was significantly reduced compared with baseline measurements (P < 0.05) with mean intraocular pressure measurement reductions of 2.1 +/- 2.4 mm Hg and 2.8 +/- 2.1 mm Hg in the latanoprost arm and 2.6 +/- 2.1 mm Hg and 2.8 +/- 2.1 mm Hg in the timolol arm at 6 and 12 weeks after the start of the follow-up, respectively. In the latanoprost group, bunazosin provided a further reduction of intraocular pressure (7.7%) at 12 weeks from that initially obtained at 2 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 intraocular pressure and its change between the bunazosin subgroup and placebo subgroup at any visit after 4 weeks from the start of the follow-up (P < 0.01). CONCLUSION:Bunazosin hydrochloride 0.01% may provide an additional intraocular pressure reduction in patients already receiving latanoprost or timolol. Since adding bunazosin to eyes treated with latanoprost caused a relatively small hypotensive response at 2 weeks and provided a further reduction from 2 weeks to 12 weeks, longer than 4 weeks may be required to evaluate a clinically meaningful response to treatment. Further investigation on more cases and longer follow-up are needed.