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首页> 外文会议>International Symposium on Ocular Pharmacology and Therapeutics >Prior Prostaglandin Agonist Exposure and Conjunctival Hyperemia with Bimatoprost 0.03 Preservative-Free and Bimatoprost 0.03 Solutions in a Randomized, Multicenter Study
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Prior Prostaglandin Agonist Exposure and Conjunctival Hyperemia with Bimatoprost 0.03 Preservative-Free and Bimatoprost 0.03 Solutions in a Randomized, Multicenter Study

机译：先前前列腺素激动剂暴露和结膜充血与Bimatoprost 0.03％无保存和双咪替其前列素在随机的，多中心研究中的0.03％溶液

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Background: Preservative-free (PF) formulations of topical intraocular pressure (IOP)-lowering medications are being developed as alternatives for patients with sensitivity or allergies to preservatives. In a 12-week, double-masked, multicenter study, bimatoprost 0.03% PF showed equivalent IOP-lowering and similar safety to preserved bimatoprost 0.03% (Lumigan).Methods: Patients with glaucoma or ocular hypertension were randomized to receive either bimatoprost 0.03% PF or bimatoprost 0.03% ophthalmic solutions once daily. Prior to the baseline visit, those treated with topical IOP-lowering medications underwent a 4-week to 4-day washout period. Safety assessments included reports of treatment-related adverse events (AEs). In a post hoc analysis, the rate of conjunctival hyperemia was compared between patients who had prior prostaglandin analog washout and those who had not.Results: 596 patients were treated (301 bimatoprost PF, 295 preserved bimatoprost). Of the 363 patients who were washed out of prostaglandin agonists (PGA), over half being latanoprost, 18% were reported to have a hyperemia AE when receiving bimatoprost 0.03% PF, while 21% reported the same for the preserved formulation. Hyperemia was significantly lower in this subgroup than in the group of 233 patients not on prior PGAs; 34% in bimatoprost 0.03% PF (P=.002) and 33% in preserved bimatoprost 0.03% (P=.022).Conclusions: Patients with prior PGA exposure reported less frequent hyperemia after treatment with bimatoprost. The cause for this difference is unknown; caution should be exercised when comparing hyperemia rates across studies that do not include similar enrollment criteria.
机译：背景：无防腐剂（PF）局部眼压（IOP）的配方（IOP） - 潜力的药物正在作为敏感性或过敏性对防腐剂的患者的替代品开发。在12周，双掩盖，多中心的研究中，Bimatoprost 0.03％PF显示等效的IOP降低和类似的安全性，以保存的Bimatroprost 0.03％（Lumigan）。方法：青光眼或眼高血压的患者随机接受Bimatoprost 0.03％ PF或BimateProost每天每天0.3％眼科溶液。在基线访问之前，那些用局部IOP降低药物治疗的人在4周至4天的冲洗期。安全评估包括与治疗相关的不良事件（AES）的报告。在HOC分析中，在患有前列腺素模拟冲洗的患者之间比较结膜过度率，并且没有评论结果：治疗596名患者（301个Bimatoprost PF，295个保存的BimateChost）。在洗掉前列腺素激动剂（PGA）的363名患者中，超过一半的Latanoproprost，18％据报道，当接受Bimatoprost 0.03％PF时具有高血量AE，而21％报告的保存制剂也是相同的。该亚组中的高血量显着低于未见于前PGA的233名患者; Bimatoprost 0.03％pF（p = .002）中的34％和33％的保存双咪岛0.03％（p = .022）。结论：先前PGA暴露的患者报告了与双岛治疗后常急的高血量。这种差异的原因是未知的;在比较不包括类似注册标准的研究中的高血压率时，应注意谨慎。

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