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Comparison of adherence and persistence with bimatoprost 0.01% versus bimatoprost 0.03% topical ophthalmic solutions

机译:0.01%比马前列素与0.03%比马前列素局部滴眼液的依从性和持久性比较

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Objective: To compare patient adherence and persistence with bimatoprost 0.01%, a new formulation that offers equivalent intraocular pressure-lowering efficacy to bimatoprost 0.03% and improved tolerability, with that of the original bimatoprost 0.03% formulation. Methods: Pharmacy claims from a longitudinal database of prescription and medical claims for >115 million patients were analyzed. Patients with an initial (index) prescription for bimatoprost 0.01% or 0.03% between April and June 2011, and with no claim for ophthalmic prostaglandin or prostamide analogs during the preceding 18 months, were identified. Treatment adherence was expressed as the proportion of days covered (PDC) with study medication over the first 365 days after the index prescription. Treatment persistence over the first 12 months following the index prescription was assessed using Kaplan-Meier analyses, assuming a 30 day grace period for prescription refill. Treatment status (on/off study medication) was determined monthly for 12 months post-index. Results: In total, 6150 patients were assessed for treatment adherence and 7660 for persistence. Adherence was significantly better with bimatoprost 0.01% than bimatoprost 0.03% (mean PDC 0.540 vs. 0.438; p < 0.001). Significantly more patients had high adherence (PDC > 0.80) with bimatoprost 0.01% than 0.03% (29.1% vs. 17.3%; p < 0.001). Persistence was also significantly better with bimatoprost 0.01%, with 29.5% (95% confidence interval [CI]: 28.3%, 30.8%) versus 18.3% (95% CI: 16.8%, 19.9%) of patients remaining on continuous treatment for 12 months (p < 0.001). At 12 months, significantly more patients were 'on treatment' (continuing/restarting treatment) with bimatoprost 0.01% than 0.03% (48.8% vs. 33.9%; p < 0.001). Sensitivity analyses demonstrated similar findings in cohorts of ocular hypotensive treatment-na?ve and elderly (≥65 years) patients. Conclusions: Bimatoprost 0.01% offers adherence and persistency advantages over bimatoprost 0.03% in patients requiring ocular hypotensive therapy. Study limitations included the observational design, lack of control for imbalances in patient characteristics, and assumption that prescription refill is synonymous with medication use.
机译:目的:比较比马前列素0.01%与新的比马前列素0.03%具有相同的降眼压功效和改善的耐受性的新制剂比马前列素0.01%对患者的依从性和持久性。方法:分析处方的纵向数据库中的药房索赔和超过1.15亿患者的医疗索赔。鉴定出在2011年4月至2011年6月间接受比马前列素0.01%或0.03%的初始(索引)处方,并且在前18个月内未要求眼用前列腺素或前列腺酰胺类似物的患者。治疗依从性表示为指数处方后头365天内研究药物覆盖的天数(PDC)。假设处方有30天的宽限期,使用Kaplan-Meier分析评估指数处方后前12个月的治疗持续性。在索引后的12个月中每月确定治疗状态(开/关研究用药)。结果:总共对6150例患者进行了治疗依从性评估,对7660例患者进行了持续性评估。比马前列素0.01%的粘附力明显优于比马前列素0.03%的粘附力(平均PDC为0.540对0.438; p <0.001)。具有比马前列素0.01%的高依从性(PDC> 0.80)的患者明显多于0.03%(29.1%对17.3%; p <0.001)。比马前列素0.01%的持久性也显着提高,其中29.5%(95%置信区间[CI]:28.3%,30.8%)与18.3%(95%CI:16.8%,19.9%)的患者连续治疗12年月(p <0.001)。在12个月时,比马前列素0.01%的“接受治疗”(继续/重新开始治疗)的患者明显多于0.03%(48.8%对33.9%; p <0.001)。敏感性分析显示,在初次和低龄(≥65岁)的低眼压治疗人群中,发现了相似的结果。结论:对于需要降压治疗的患者,比马前列素0.01%比比马前列素0.03%具有坚持和持久性优势。研究的局限性包括观察设计,缺乏对患者特征失衡的控制以及假设处方补充与药物使用同义。

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