PMID- 20874498 OWN - NLM STAT- MEDLINE DCOM- 20110328 LR - 20220309 IS - 1557-7732 (Electronic) IS - 1080-7683 (Linking) VI - 26 IP - 5 DP - 2010 Oct TI - Effectiveness of dorzolamide-timolol (COSOPT) in patients who were treatment naive for open-angle glaucoma or ocular hypertension: the COSOPT first-line study. PG - 503-11 LID - 10.1089/jop.2010.0032 [doi] AB - 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. FAU - Crichton, Andrew C S AU - Crichton AC AD - Faculty of Medicine, University of Calgary , Calgary, Canada. FAU - Harasymowycz, Paul AU - Harasymowycz P FAU - Hutnik, Cindy M L AU - Hutnik CM FAU - Behki, Rama AU - Behki R FAU - Boucher, Serge AU - Boucher S FAU - Ibrahim, Fahim AU - Ibrahim F FAU - Rifkind, Aaron W AU - Rifkind AW FAU - Solomon, Leon AU - Solomon L FAU - Liao, Chuanhong AU - Liao C FAU - Bastien, Natacha R AU - Bastien NR FAU - Sampalis, John S AU - Sampalis JS LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't PL - United States TA - J Ocul Pharmacol Ther JT - Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics JID - 9511091 RN - 0 (Drug Combinations) RN - 0 (Ophthalmic Solutions) RN - 0 (Prostaglandins F, Synthetic) RN - 0 (Sulfonamides) RN - 0 (Thiophenes) RN - 0 (dorzolamide-timolol combination) RN - 6Z5B6HVF6O (Latanoprost) RN - 817W3C6175 (Timolol) SB - IM MH - Aged MH - Drug Combinations MH - Eye/physiopathology MH - Female MH - Glaucoma/drug therapy MH - Glaucoma, Open-Angle/*drug therapy MH - Humans MH - Intraocular Pressure/drug effects MH - Latanoprost MH - Male MH - Middle Aged MH - Multicenter Studies as Topic MH - Ocular Hypertension/*drug therapy MH - Ophthalmic Solutions/administration & dosage/pharmacology MH - Prostaglandins F, Synthetic/administration & dosage/adverse effects/*pharmacology MH - Sulfonamides/adverse effects/*pharmacology MH - Thiophenes/adverse effects/*pharmacology MH - Timolol/adverse effects/*pharmacology MH - Tonometry, Ocular MH - Treatment Outcome EDAT- 2010/09/30 06:00 MHDA- 2011/03/29 06:00 CRDT- 2010/09/30 06:00 PHST- 2010/09/30 06:00 [entrez] PHST- 2010/09/30 06:00 [pubmed] PHST- 2011/03/29 06:00 [medline] AID - 10.1089/jop.2010.0032 [doi] PST - ppublish SO - J Ocul Pharmacol Ther. 2010 Oct;26(5):503-11. doi: 10.1089/jop.2010.0032.