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I. Goldberg, X.–Y. Li, P. Selaru, D. Paggiarino, Long–Term Latanoprost Safety Study Group; Results of a Randomized, 5–Year Post Marketing Safety Study of Latanoprost Compared With Usual Care in Patients With Open–Angle Glaucoma or Ocular Hypertension . Invest. Ophthalmol. Vis. Sci. 2006;47(13):438.
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To investigate incidence of latanoprost–related adverse events on cornea, iris and retina and occurrence of local hyperpigmentation.
An open–label safety surveillance study was conducted in 406 centers in 14 countries. Patients on intraocular pressure (IOP)–reducing therapy other than latanoprost were eligible if they required a change in therapy. Eligible patients were randomly assigned (2:1) to latanoprost administered once daily or to usual care (UC). Patients randomized to latanoprost received it either as monotherapy or in combination with other medication(s). Patients randomized to UC, received any commercially available medications, excluding latanoprost. Investigators could modify the therapy in either randomization group if IOP was insufficiently controlled. Patients were examined at baseline and every 6 months thereafter for 5 years. Ocular examinations (slit lamp, IOP, ophthalmoscopy) were performed at each visit, and information recorded concerning specific ocular events, serious adverse drug reactions (SADRs), and changes in iris pigmentation or eyelashes. Iris photographs were taken before starting treatment with latanoprost.
A total of 5854 patients were randomized (latanoprost, 3936; UC, 1918). Of the patients who were initially randomized to latanoprost, 2707 (68.8%) completed the study, and 73.9% of them remained on latanoprost for the entire study. 4638 (79.2%) patients received at least 1 dose of latanoprost during the study. Baseline characteristics were similar between randomized groups. Estimates of the 5–year risks for new occurrences of corneal erosions, iritis/uveitis, or macular edema were ≤ 3.17% for each of the 3 events. SADRs were reported in 17 (0.43%) patients randomized to latanoprost and in 9 (0.47%) patients randomized to UC. Nine (0.19%) patients reported a total of 11 vision–related SADRs at the time of latanoprost treatment. A total of 14 patients (0.24%) discontinued latanoprost because of SADRs, including 3 patients who discontinued the study. 87.6% of patient ever treated with latanoprost had no increased iris pigmentation, 59.7% had no eyelash darkening, and 92.2% had no periorbital darkening. No SADRs were reported in patients with increased iris pigmentation.
This 5–year study suggests that latanoprost as prescribed in 14 countries was a safe long–term treatment for patients with glaucoma. The incidence of SADRs was low; no new safety concerns were raised.
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