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Abstract #24259 Published in IGR 11-3
Safety and tolerability of brimonidine purite 0.1% and brimonidine purite 0.15%: A meta-analysis of two phase 3 studies
Cantor LB; Liu C-C; Batoosingh AL; Hollander DACurrent Medical Research and Opinion 2009; 25: 1615-1620
OBJECTIVE: To compare the safety and tolerability of two formulations of brimonidine ophthalmic solution, brimonidine Purite*(P) 0.1% and brimonidine P 0.15%, for reducing intraocular pressure in patients with glaucoma or ocular hypertension (OHT). Study design and methods: Meta-analysis of safety and tolerability results from two previously reported prospective, randomized, 12-month, double-masked, multi-center, parallel-group clinical studies with similar entry criteria and protocols. In study 1 (two clinical trials), after washout of previous medications, patients with glaucoma or OHT were randomized to thrice-daily treatment with brimonidine P 0.15% (n = 381), brimonidine P 0.2% (n = 383), or brimonidine 0.2% (n = 383). In study 2 (one clinical trial), the treatment arms were thrice-daily brimonidine P 0.1% (n = 215) and brimonidine 0.2% (n = 218). Main outcome measure: Treatment-related adverse events (AEs) and discontinuations due to AEs. RESULTS: Treatment-related AEs were significantly reduced with brimonidine P 0.15% compared with brimonidine 0.2% in study 1 (p<0.001). Treatment-related AEs and discontinuations due to AEs were significantly reduced with brimonidine P 0.1% compared with brimonidine 0.2% in study 2 (p ≤ 0.014). In the meta-analysis of study 1 and study 2, the overall incidence of treatmentrelated Aes was lower with brimonidine P 0.1% than with brimonidine P 0.15% (41.4 vs. 49.7%; p = 0.050). Although the incidence of treatment-related ocular Aes was similar with brimonidine P 0.1% and 0.15% (p = 0.461), treatment-related systemic Aes were less frequent with brimonidine P 0.1% than with brimonidine P 0.15% (4.7 vs. 14.2%; p<0.001), and there were fewer discontinuations due to systemic Aes with brimonidine P 0.1% than with brimonidine P 0.15% (p = 0.025). CONCLUSIONS: Brimonidine P 0.1% has improved systemic safety and tolerability compared with brimonidine P 0.15%. The ocular safety and tolerability of the formulations are similar. The present meta-analysis is based on only two clinical studies, and additional studies further evaluating the safety and tolerability of these medications are warranted.
Dr. L.B. Cantor, Eugene and Marilyn Glick Eye Institute, Indiana University School of Medicine, Department of Ophthalmology, 702 Rotary Circle, Indianapolis, IN 46202, USA. lcantor@iupui.edu
Classification:
11.3.3 Apraclonidine, brimonidine (Part of: 11 Medical treatment > 11.3 Adrenergic drugs)
