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Abstract #27438 Published in IGR 12-4
Effectiveness of dorzolamide-timolol (COSOPT) in patients who were treatment naive for open-angle glaucoma or ocular hypertension: The COSOPT first-line study
Crichton ACS; Harasymowycz P; Hutnik CML; Behki R; Boucher S; Ibrahim F; Rifkind AW; Solomon L; Liao C; Bastien NRJournal of Ocular Pharmacology and Therapeutics 2010; 26: 503-511
Purpose: The aim of this study was to assess the effectiveness of dorzolamide-timolol (DT) in the management of open-angle glaucoma (OAG) and ocular hypertension. Methods: An open-label, 12-week, multicenter, Canadian study was conducted. Patients with untreated OAG or ocular hypertension received DT for 12 weeks to reduce intraocular pressure (IOP). If target IOP was not reached after the first 6-week treatment period, a prostaglandin (PG) (latanoprost) was added for the remaining 6 weeks. Primary outcome measures were changes in IOP from baseline to 6 and 12 weeks of treatment, and secondary outcome measures included the proportion of patients achieving target IOP and the proportion of patients achieving therapeutic response defined as a reduction of 5.0 mmHg or 20% in IOP from baseline. IOP values were the mean of 2 measures taken before and at least 2 h after patients administered the study medication. Results: A total of 164 patients were enrolled. Mean [standard deviation (SD)] population age was 63.0 (12.3) years and 53.0% of the patients were men. At week 6, the mean (SD) absolute and percent change in IOP for the total population was -11.1 (4.9) and -36.4% (13.9%), respectively, and 92.1% of the patients achieved a reduction in IOP of at least 5 mmHg. Therapeutic target was achieved by 136 (82.9%) patients (DT subgroup) at 6 weeks, whereas 28 (17.1%) patients were changed to a combination therapy of DT and latanoprost [DT plus PG (DT & PG) subgroup]. Between weeks 6 and 12, DT was effective in sustaining the IOP within therapeutic target, whereas addition of latanoprost reduced the IOP of the DT & PG subgroup by an additional 6.3 mmHg or 22.1% (20.1%). At week 12, patients in the DT subgroup experienced a clinically and statistically significant mean (SD) decrease in IOP from a baseline of 12.2 mmHg or 40.4% (11.9%) (P < 0.001), whereas these values corresponded to 13.4 mmHg and 39.7% (15.7%) (P < 0.001), respectively, in the DT & PG subgroup. The proportion of patients who achieved therapeutic response during the entire 12-week study period was over 82%. Treatment-related adverse events (AEs) were reported by 19 (14.0%) patients in the DT subgroup and by 6 (21.4%) patients in the combination subgroup. Eye disorders and nervous system disorders were among the most common treatment-related AEs in both subgroups. No serious AEs were reported during the study period. Conclusion: DT alone and DT in combination with a PG are effective in significantly reducing IOP in patients with untreated OAG or ocular hypertension. The treatment was safe and well tolerated with a low incidence of AEs. (copyright) Copyright 2010, Mary Ann Liebert, Inc.
J. S. Sampalis. JSS Medical Research, Inc., 4492 St. Catherine St. West, Westmount, QC H3Z 1R7, Canada. jsampalis@jssresearch.com
Classification:
11.13.2 Betablocker and carbon anhydrase inhibitor (Part of: 11 Medical treatment > 11.13 Combination therapy)
