A scoping review and network meta-analysis for efficacy and safety of glaucoma medication in Japanese patients.

Abstract

To investigate the efficacy and safety of glaucoma medication in Japanese patients, network meta-analysis (NMA) of an intraocular pressure(IOP) reduction, adverse reaction rates and conjunctival congestion rates of major glaucoma drugs used in clinical practice in Japan were conducted using the new drug application (NDA) data. Scoping network meta-analysis. Out of all clinical trials in the interview forms of major glaucoma drugs approved in Japan as of July 2015, active-control clinical trials with Japanese patients were identified through screening with specific criteria. The details of IOP reduction, adverse reaction rates and conjunctival hyperemia rates of the trials were collected from published articles, package inserts, interview forms and Summary basis of approval made by Japan Pharmaceutical and Medical Devices Agency (PMDA). The mean difference in IOP reduction, adverse reaction rates, and conjunctival hyperemia rates of eligible trials were assessed using NMA as referenced to those of timolol maleate 0.5%. Eleven multicenter trials of ten medications in total, (five prostaglandin (PG) analogs, three β-blockers, one α-1 blocker, and one α-2 stimulator) were selected. The mean difference in IOP reduction in mmHg with 95% confidence intervals were as follows: bimatoprost -3.00 (-3.71; -2.29), tafluprost -2.45 (-3.65; -1.25), travoprost -2.35 (-3.41; -1.29), and latanoprost -2.05 (-2.72; -1.38). The highest IOP reduction was achieved by PG analogs. Adverse reaction rates and conjunctival hyperemia rates were significantly larger with PG analogs than with other medications. The efficacy and safety of glaucoma medications were assessed by NMA as reference to those of timolol maleate 0.5% in Japanese patients. PG analogs were the most efficacious in reducing IOP. However, PG analogs were also associated with higher rates of adverse reactions and conjunctival hyperemia.