0.1%和0.15%的酒石酸溴莫尼定的安全性和耐受性：两项3期研究的荟萃分析。

Safety and tolerability of brimonidine purite 0.1% and brimonidine purite 0.15%: a meta-analysis of two phase 3 studies.

作者信息

Cantor Louis B, Liu Ching-Chi, Batoosingh Amy L, Hollander David A

机构信息

Glaucoma Service, Eugene and Marilyn Glick Eye Institute, Indiana University School of Medicine, Department of Ophthalmology, Indianapolis, IN 46202, USA.

出版信息

Curr Med Res Opin. 2009 Jul;25(7):1615-20. doi: 10.1185/03007990902997655.

DOI:10.1185/03007990902997655

PMID:19469697

Abstract

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, multicenter, 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 < or = 0.014). In the meta-analysis of study 1 and study 2, the overall incidence of treatment-related 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.

摘要

目的

比较两种布林佐胺滴眼液制剂（0.1%普瑞明（P）布林佐胺和0.15% P布林佐胺）在降低青光眼或高眼压症（OHT）患者眼压方面的安全性和耐受性。

研究设计与方法

对两项先前报道的前瞻性、随机、为期12个月、双盲、多中心、平行组临床研究的安全性和耐受性结果进行荟萃分析，这两项研究具有相似的纳入标准和方案。在研究1（两项临床试验）中，在停用先前药物后，青光眼或OHT患者被随机分为每日三次接受0.15% P布林佐胺治疗（n = 381）、0.2% P布林佐胺治疗（n = 383）或0.2%布林佐胺治疗（n = 383）。在研究2（一项临床试验）中，治疗组为每日三次接受0.1% P布林佐胺治疗（n = 215）和0.2%布林佐胺治疗（n = 218）。

主要观察指标

治疗相关不良事件（AE）以及因AE导致的停药情况。

结果

在研究1中，与0.2%布林佐胺相比，0.15% P布林佐胺显著减少了治疗相关AE（p < 0.001）。在研究2中，与0.2%布林佐胺相比，0.1% P布林佐胺显著减少了治疗相关AE以及因AE导致的停药情况（p ≤ 0.014）。在对研究1和研究2的荟萃分析中，0.1% P布林佐胺治疗相关AE的总体发生率低于0.15% P布林佐胺（41.4%对49.7%；p = 0.050）。尽管0.1%和0.15% P布林佐胺治疗相关眼部AE的发生率相似（p = 0.461），但0.1% P布林佐胺治疗相关全身AE的发生率低于0.15% P布林佐胺（4.7%对14.2%；p < 0.001），并且因全身AE导致停药的情况，0.1% P布林佐胺比0.15% P布林佐胺更少（p = 0.025）。