Allergan Inc., Irvine, CA 92612-1599, USA.
Curr Med Res Opin. 2013 Sep;29(9):1201-9. doi: 10.1185/03007995.2013.815160. Epub 2013 Jul 19.
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.
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.
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-naïve and elderly (≥65 years) patients.
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.
比较新型贝美前列素 0.01%（具有与贝美前列素 0.03%相当的降眼压疗效和更好的耐受性）与原贝美前列素 0.03%制剂在患者用药依从性和持久性方面的差异。
分析了一项超过 1.15 亿患者处方和医疗索赔的纵向数据库中的药房索赔数据。2011 年 4 月至 6 月期间，首次（索引）处方贝美前列素 0.01%或 0.03%，且在之前 18 个月内没有眼部前列腺素或前列腺酰胺类似物用药记录的患者被纳入研究。治疗依从性表示为索引处方后 365 天内研究药物的覆盖天数（PDC）比例。采用 Kaplan-Meier 分析评估索引处方后 12 个月内的治疗持久性，假设处方续方有 30 天的宽限期。索引后 12 个月内每月确定治疗状态（是否用药）。
共评估了 6150 例患者的治疗依从性和 7660 例患者的持久性。与贝美前列素 0.03%相比，贝美前列素 0.01%的用药依从性显著更好（平均 PDC 0.540 比 0.438；p<0.001）。与贝美前列素 0.03%相比，更多患者具有较高的用药依从性（PDC>0.80），贝美前列素 0.01%为 29.1%（95%置信区间 [CI]：28.3%，30.8%），贝美前列素 0.03%为 17.3%（95% CI：16.8%，19.9%）（p<0.001）。贝美前列素 0.01%的治疗持久性也显著更好，12 个月时，29.5%（95%CI：28.3%，30.8%）的患者持续接受连续治疗，18.3%（95%CI：16.8%，19.9%）的患者持续接受连续治疗（p<0.001）。12 个月时，与贝美前列素 0.03%相比，更多患者（继续/重新开始治疗）使用贝美前列素 0.01%（48.8%比 33.9%；p<0.001）。敏感性分析显示，在眼压低治疗初治和老年（≥65 岁）患者队列中也观察到了类似的结果。
与贝美前列素 0.03%相比，新型贝美前列素 0.01%在需要眼部降压治疗的患者中具有更好的用药依从性和持久性。研究存在一定局限性，包括观察性设计、患者特征失衡的控制不足，以及假设处方续方与药物使用相同。
