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P. Lanzetta, G. Burian, A. Weichselberger, Y. Hashad; Safety Profiles of Diabetic versus Non-Diabetic AMD Patients in Randomized Controlled Clinical Studies With Ranibizumab. Invest. Ophthalmol. Vis. Sci. 2010;51(13):91.
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The safety of ranibizumab in patients with age-related macular degeneration (AMD) was demonstrated in the multicenter randomized controlled clinical studies ANCHOR, MARINA, PIER, SAILOR, EXCITE, and EXTEND I. This analysis compares the safety profiles of diabetic (Db) and non-diabetic (nDb) patients from these AMD trials to identify potential signals of increased safety risk in ranibizumab-treated AMD patients with diabetes.
A meta-analysis was performed using pooled 1-year incidence rates of potential risks of ranibizumab in diabetic (Db, n=523) and non-diabetic (nDb, n=3213) AMD patients treated monthly with 0.5 mg ranibizumab in ANCHOR, MARINA, PIER, SAILOR, EXCITE, and EXTEND I. Safety risks comprised ocular and non-ocular adverse events (AEs) and serious AEs (SAEs). Multiple occurrences of the same event in a patient were counted only once.
The two patient groups were balanced for baseline demographics and ocular characteristics with a mean duration of 8.9±8.8 years since diagnosis of diabetes in the Db group. There was no indication of an increased risk of ocular and non-ocular AEs for diabetic patients and no differences between diabetic and non-diabetic patients for ocular and non-ocular SAEs (low incidence rates). A numerical difference was observed for AEs/SAEs in cardiac disorders (AEs/SAEs: 9.6/6.7% in Db, 6.8/3.2% in nDb), infections and infestations (AEs/SAEs: 26.6/4.4% in Db, 22.8/2.7% in nDb), and metabolism and nutrition disorders (AEs/SAEs: 13.0/1.5% in Db, 6.4/0.3% in nDb). As suggested by epidemiological assessments in the general diabetic population, these numerically higher risks in the Db group may be attributed to the underlying disease.
The comparison of the safety profiles between diabetic and non-diabetic patients revealed no apparent signal towards an increased ocular safety risk in ranibizumab-treated diabetic patients with AMD.
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