Twenty-four-hour efficacy of the brimonidine/timolol fixed combination versus therapy with the unfixed components

Abstract

Purpose To evaluate the 24-h intraocular pressure (IOP) control of brimonidine/timolol fixed combination (BTFC) versus the unfixed combination of its individual components, each dosed twice daily, in patients with primary open-angle glaucoma or ocular hypertension. Methods An observer-masked, randomized, crossover, active-controlled, two-centre comparison. Following a 6-week medicine-free period, patients were randomized to BTFC or to the unfixed combination of brimonidine and timolol for 3 months. Patients then were crossed over to the opposite treatment for another 3 months. At the end of the medicinefree period, and each treatment period, patients underwent 24-h IOP measurements at 0600, 1000, 1400, 1800, 2200, and 0200 hours. Results Twenty-eight patients completed this study. Both BTFC and the unfixed components showed a significant IOP reduction from untreated baseline (Po0.0001), and were statistically equal when compared directly, for each individual time point and for the 24-h IOP curve (P40.05). The mean 24-h IOP was 24.671.9 for baseline, 19.271.9 for BTFC, and 19.271.6 mmHg for the unfixed components (P ¼ 1.0). Four patients were discontinued due to side effects. The most common ocular adverse event was ocular hyperaemia (n ¼ 3 with BTFC and n ¼ 5 with the unfixed components, P ¼ 0.7) and systemic adverse events were rare. Conclusion This study suggests that both BTFC and the unfixed components of brimonidine and timolol provide a significant 24-h IOP reduction from untreated baseline, and statistically equal control when compared directly, at each time point and for the 24-h pressure curve.

Twenty-four hour efficacy with the dorzolamide/timolol-fixed combination compared with the brimonidine/timolol-fixed combination in primary open-angle glaucoma

“…Nevertheless, the mean IOP reduction over 24 h (22%) observed with BTFC was less than anticipated. 17 Although this range of pressure reduction is consistent with the evidence obtained from the regulatory trials for BTFC, 18,19 the extent of the 24-h IOP reduction is less than that observed with DTFC. 20 Specifically, with DTFC, reported daytime IOP reduction ranges from 27 to 33% [21][22][23][24] and the 24-h IOP reduction ranges between 26 and 28% [25][26][27] in published studies.…”

“…The results herein may explain for the first time why the 24-h IOP reduction provided by BTFC may be less than might be anticipated. Considering the previously documented 24-h efficacy of brimonidine and BTFC, 17,33,35 it is conceivable that the reason for the reduced efficacy with BTFC may be the shorter duration of action of brimonidine, when instilled twice daily, whereas dorzolamide may have a longer duration of action and better night-time efficacy. 20,37 We observed the mean IOP, when six time-points over 24-h are averaged, to be significantly better with DTFC than with BTFC.…”

Efficacy of antiglaucoma fixed combination therapy versus unfixed components in reducing intraocular pressure: a systematic review

“…The number of patients reported to discontinue from the study due to intolerance or adverse events was found to be higher in the fixed combination groups in five versus two studies (table 5). However, the number of patients involved was extremely small in relation to the study population sizes (1–6%) with the exception of Konstas et al 13 (12.5%).…”

“…They incorporated four of the five glaucoma fixed combinations on the current market: Cosopt ,12 15 Combigan ,10 13 Duotrav 11 14 and Xalacom 9. The only study for Ganfort 20 was excluded due to its short duration.…”

Comparison of Dorzolamide/Timolol Versus Brimonidine/Timolol Fixed Combination Therapy in the Management of Steroid-Induced Ocular Hypertension

“…FCBT and FCDT are more efficacious than either of both their components administered as monotherapy 30,31 and equally efficacious compared with concomitant administration of their active components. 32,33 We demonstrated that after 4 and 12 weeks of treatment, both FCDT and FCBT led to significant reductions in mean IOP from their corresponding postinjection IOP values (Table 3). However, FCBT was associated with significantly greater reductions in mean IOP at both the 4th-and 12th-week visits compared with FCDT (Table 4).…”