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Abstract #8483 Published in IGR 5-1
Dorzolamide/timolol combination versus concomitant administration of brimonidine and timolol: six-month comparison of efficacy and tolerability
Sall KN; Greff LJ; Johnson-Pratt LR; DeLucca PT; Polis AB; Kolodny AH; Fletcher CA; Cassel DA; Boyle DR; Skobieranda FOphthalmology 2003; 110: 615-624
PURPOSE: To compare the efficacy and tolerability of the 2% dorzolamide/0.5% timolol combination ophthalmic solution twice daily to the concomitant administration of 0.2% brimonidine ophthalmic solution twice daily and 0.5% timolol ophthalmic solution twice daily. DESIGN: Randomized, multicenter, observer-masked, parallel-group study. PARTICIPANTS: Two hundred and ninety-three patients with ocular hypertension or primary open-angle glaucoma participated. INTERVENTION: After an open-label three-week 0.5% timolol run-in period, patients with an hour-2 intraocular pressure (IOP) of ≥ 22 mmHg were randomly assigned to receive either the dorzolamide/timolol combination twice daily or the concomitant use of brimonidine twice daily and timolol twice daily (brimonidine + timolol) for six months. MAIN OUTCOME MEASURES: The IOP-lowering effects at hour 0 and hour 2 were collected at one, three, and six months. The authors hypothesized that both treatment regimens would have comparable hour-2 IOP-lowering effects at month 3. The treatments were considered comparable if the two-sided 95% confidence interval of the treatment difference was within ± 1.5 mmHg. Tolerability data were also collected at one, three, and six months. RESULTS: The primary efficacy analysis was based on the modified intent-to-treat population. At month 3, hour 2, the dorzolamide/timolol group had an adjusted mean (standard error) change in IOP of -5.04 (0.30) mmHg versus -5.41 (0.30) mmHg in the brimonidine + timolol group, with a treatment difference of 0.36 (0.40) mmHg (95% confidence interval (CI) of -0.42-1.14 mmHg). At month 3, hour 0, the dorzolamide/timolol group had a change in IOP of -3.66 (0.29) mmHg versus -4.15 (0.28) mmHg in the brimonidine + timolol group, with a treatment difference of 0.49 (0.39) mmHg (95% CI of -0.27-1.25 mmHg). Likewise, at all other observed time points, the 95% confidence interval of the treatment difference was within ± 1.5 mmHg. Ninety-three patients (64%) in the dorzolamide/timolol group and 88 patients (60%) in the brimonidine + timolol group had adverse experiences that were deemed drug related by the investigator, for which seven patients (5%) in the dorzolamide/timolol group and eight patients (5%) in the brimonidine + timolol group were discontinued from the study. CONCLUSIONS: The efficacy of the dorzolamide/timolol combination and the concomitant administration of brimonidine and timolol were comparable. The incidence of drug-related adverse experiences and the incidence of discontinuations caused by drug-related adverse experiences were similar between groups.
Dr. K.N. Sall, Sall Eye Surgery Medical Center Inc., Bellflower, CA, USA
Classification:
11.3.3 Apraclonidine, brimonidine (Part of: 11 Medical treatment > 11.3 Adrenergic drugs)
11.3.4 Betablocker (Part of: 11 Medical treatment > 11.3 Adrenergic drugs)
11.5.2 Topical (Part of: 11 Medical treatment > 11.5 Carbonic anhydrase inhibitors)
