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MS Dirks, L Johnson-Pratt, A Polis, P DeLucca, A Kolodny, C Fletcher, D Cassel, D Boyle, F Skobieranda; A Comparison of Efficacy, Tolerability, and Patient-Reported Measures Between Cosopt® and the Concomitant Administration of Alphagan® and Timolol . Invest. Ophthalmol. Vis. Sci. 2002;43(13):1063.
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© ARVO (1962-2015); The Authors (2016-present)
Purpose: To compare peak and trough intraocular pressure (IOP) lowering effects, tolerability, and patient-reported measures between Cosopt® b.i.d. and the concomitant administration of Alphagan® b.i.d. + timolol b.i.d. after 6 months. Methods: This was a randomized, multicenter, observer-masked, parallel-group study of patients with ocular hypertension or primary open-angle glaucoma. Following a 3-week timolol run-in period, 293 patients with a peak IOP of ≷ 22 mmHg were randomized to receive either Cosopt or Alphagan+timolol, each b.i.d., for 6 months. Adjusted mean changes from randomization in peak and trough IOP were compared at 6 months. Equivalence was defined as a difference in IOP lowering effects of less than 1.5 mmHg between treatments. Tolerability data were gathered by standard adverse event reporting. A patient-reported convenience and satisfaction questionnaire was also administered. Results: At 6 months, the Cosopt (C) group had a change in peak IOP of -4.59 (SE 0.29) mmHg vs. -5.07 (0.29) in the Alphagan+timolol (A+t) group, for a treatment difference of 0.48 (0.39) mmHg; (95% CI -0.29 to 1.25). At trough, the C group had a change in IOP of -3.12 (0.28) mmHg vs. -3.82 (0.27) in the A+t group, for a treatment difference of 0.70 (0.37) mmHg; (95% CI -0.04 to 1.43). Drug-related adverse experiences were reported in 64% of patients in the C group and 60% of patients in the A+t group (p=0.411). Drug-related adverse experiences that resulted in discontinuations occurred in 5% of both the C group and the A+t group (p=0.823). 90% and 78% of the C group and A+t group, respectively, rated their medication regimen as convenient (p=0.018). 92% and 79% of the C group and A+t group, respectively, were satisfied with their treatment regimen (p=0.005). Conclusion: Peak and trough IOP lowering effects of Cosopt and the concomitant administration of Alphagan+timolol were comparable at 6 months. The incidence of drug-related adverse experiences and the rate of discontinuations due to drug-related adverse experiences were similar between treatment groups. Patient-reported convenience and satisfaction measures were greater for Cosopt than the Alphagan+timolol regimen.
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