A 5-year, randomized, open-label safety study of latanoprost and usual care in patients with open-angle glaucoma or ocular hypertension.
OBJECTIVE
To investigate the incidence of latanoprost-related adverse events of the cornea, iris, and retina and the occurrence of hyperpigmentation.


METHODS
An open-label safety surveillance study was conducted in 14 countries. Patients on intraocular pressure (IOP)-reducing therapy other than latanoprost were eligible if they required a change in therapy. Patients were randomly assigned (2:1) to latanoprost administered once daily or to usual care (any other commercially available medication). Patients were examined at baseline and every 6 months for 5 years.


RESULTS
In all, 5854 patients were included (latanoprost, 3936; usual care, 1918). Of those initially randomized to latanoprost, 2707 (68.8%) completed the study, and 4638 (79.2%) patients received at least one dose of latanoprost. Five-year risks were < or = 3.17% for new occurrences of corneal erosions, iritis/uveitis, or macular edema in both randomization groups. Serious adverse drug reactions were reported in 17/3936 (0.43%) latanoprost and 9/1918 (0.47%) usual care patients. In all, 87.6% of patients ever treated with latanoprost had no increased iris pigmentation; no serious adverse drug reactions were reported in patients with increased iris pigmentation.


CONCLUSIONS
This 5-year study suggests that latanoprost as prescribed in 14 countries is a safe long-term treatment for patients with glaucoma and ocular hypertension.
Goldberg
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Eye Associates, Glaucoma Services, Sydney Eye Hospital, University of Sydney - Australia. eyegoldberg@gmail.com
Li
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Selaru
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Paggiarino
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D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000959:Antihypertensive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D005500:Follow-Up Studies; D005902:Glaucoma, Open-Angle / Q000188:drug therapy*; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects*; D000077338:Latanoprost; D008297:Male; D008875:Middle Aged; D009798:Ocular Hypertension / Q000188:drug therapy; D011358:Product Surveillance, Postmarketing; D011461:Prostaglandins F, Synthetic / Q000009:adverse effects / Q000627:therapeutic use*; D055815:Young Adult
D000959:Antihypertensive Agents; D011461:Prostaglandins F, Synthetic; D000077338:Latanoprost