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OPHTHALMOLOGY

Effectiveness and Safety of Dorzolamide-Timolol Alone or Combined with Latanoprost in Open-Angle Glaucoma or Ocular Hypertension

Associate Clinical Professor and Director of Research, Department of Ophthalmology, University of Montreal, Montreal, Quebec, Canada

Theodoro Koulis, PhD

Director of Biostatistics, JSS Medical Research Inc., Westmount, Quebec

Fotini Sampalis, MD PhD

Medical Director, JSS Medical Research Inc., Westmount

John S Sampalis, MSc PhD

Associate Professor, Faculty of Medicine, McGill University, Montreal, Quebec, Canada; President, JSS Medical Research Inc., Westmount

Natacha R Bastien, PhD

Senior Manager of Clinical Research, Merck Frosst Canada Limited, Kirkland, Quebec; Principal Investigator, the EXACCT Study Group

Reprints: Dr. JS Sampalis, 4492 St. Catherine St. West, Westmount, Quebec H3Z 1R7, Canada, fax 514/934-9913, jsampalis{at}jssresearch.com

BACKGROUND: Treatment of glaucoma is aimed at reducing intraocular pressure (IOP) to prevent further damage to the optic nerve. For patients who do not respond to monotherapy, combination treatment may be effective in achieving therapeutic reduction or target IOP.

OBJECTIVE: To evaluate the effectiveness and safety of dorzolamide 2% with timolol 0.5% alone or combined with latanoprost in reducing IOP in a real-world setting.

METHODS: A prospective, open-label, multicenter, nonrandomized interventional study was designed. Three hundred fifty patients with primary open-angle glaucoma or ocular hypertension and uncontrolled IOP after latanoprost monotherapy for 4 or more weeks were treated with combination dorzolamide-timolol twice daily added to their existing latanoprost therapy (D/T-Add-On; n = 280) or dorzolamide-timolol twice daily monotherapy (D/T-Switch; n = 70). The primary effectiveness outcome measure was the change in IOP after 6 and 12 weeks of treatment.

RESULTS: Of the total population, 313 patients completed this trial (248 D/T-Add-On; 65 D/T-Switch). After 12 weeks, the mean ± SD IOP decrease was -6.3 ± 3.6 mm Hg (-28.1%) and -5.8 ± 4.9 mm Hg (-23.5%) in the D/T-Add-On and D/T-Switch groups, respectively (both p < 0.001). Therapeutic response rates (defined as IOP reduction >20%) after 12 weeks of treatment for the D/T-Add-On and the D/T-Switch groups were 66.4% (186/280) and 52.9% (37/70), respectively. There were 116 predominantly mild, nonserious adverse events attributed to the study drugs, reported by 86 (24.6%) patients. The most frequent adverse events were eye irritation (n = 42; 12.0%) and taste perversion (n = 15; 4.3%). No serious adverse events related to the study medications were reported.

CONCLUSIONS: In patients with primary open-angle glaucoma or ocular hypertension and elevated IOP while on monotherapy with latanoprost, switching to dorzolamide-timolol or combining dorzolamide-timolol with latanoprost are effective and safe treatment options for reducing IOP and achieving therapeutic response.

Key Words: dorzolamide-timolol, intraocular pressure, latanoprost, ocular hypertension, open-angle glaucoma

Published Online, March 25, 2008. www.theannals.com, DOI 10.1345/aph.1K565