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Preservative-free bimatoprost 0.03% in patients with primary open-angle glaucoma or ocular hypertension in clinical practice

机译:原发性开角型青光眼或高眼压症患者的无防腐剂比马前列素0.03%临床实践

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Background: Intraocular pressure (IOP)-lowering medications for primary open-angle glaucoma and ocular hypertension commonly contain preservatives that can cause ocular surface damage in many patients. The purpose of this study was to evaluate the efficacy and tolerability of, and compliance to, preservative-free (PF) bimatoprost 0.03% in patients with primary open-angle glaucoma or ocular hypertension (IOP ≥18?mmHg) in a clinical practice setting. Methods: This open-label study observed patients who were switched to PF bimatoprost 0.03% for medical reasons. IOP was measured at baseline and ~12?weeks later at the final visit, and the change in IOP was calculated. Tolerability and continuation of therapy were assessed at two follow-up visits. Results: A total of 1,830 patients were included in the study, and complete IOP data were available for 1,543 patients. Mean IOP was reduced by 23% from 21.64?mmHg to 16.59?mmHg ( P <0.0001). In subgroup analyses, the mean IOP was significantly reduced compared with baseline, regardless of prior therapy, including those previously treated with PF monotherapy. A total of 85.7% of physicians reported the IOP-lowering efficacy of PF bimatoprost 0.03% to be as expected or better than expected. Adverse events (AEs) were experienced by 5.7% of patients, and there were no serious AEs reported. The most common AEs were eye irritation (1.7%) and hyperemia (1.4%). Physician-reported treatment compliance was reported as better than (48.7%) or equal to (43.6%) prior treatment in most patients. Most patients (82%) were expected to continue PF bimatoprost 0.03% after the end of the study. Conclusion: This observational study showed that, in clinical practice, switching to PF bimatoprost 0.03% was associated with a significant IOP reduction from baseline. There was a low AE rate. PF bimatoprost 0.03% may, therefore, be an effective treatment option for patients who are intolerant of preservatives or have an inadequate response to prior IOP-lowering treatments.
机译:背景:用于原发性开角型青光眼和高眼压症的降低眼内压(IOP)的药物通常含有防腐剂,这些防腐剂可能导致许多患者的眼表受损。这项研究的目的是在临床实践中评估无防腐剂(PF)比马前列素0.03%在原发性开角型青光眼或高眼压症(IOP≥18?mmHg)患者中的疗效,耐受性和依从性。方法:这项开放标签研究观察了由于医学原因而改用PF bimatoprost 0.03%的患者。在基线期和约12周后的最终访视时测量IOP,并计算IOP的变化。在两次随访中评估了耐受性和治疗的持续性。结果:总共1,830名患者被纳入研究,并且完整的IOP数据可用于1,543名患者。平均IOP从21.64?mmHg降低到16.59?mmHg(23%)(P <0.0001)。在亚组分析中,与先前的治疗方法(包括先前接受PF单药治疗的患者)无关,平均IOP与基线相比明显降低。共有85.7%的医生报告说PF bimatoprost的IOP降低功效为0.03%达到预期或优于预期。 5.7%的患者经历了不良事件(AEs),并且没有严重的AEs报告。最常见的不良事件是眼睛刺激(1.7%)和充血(1.4%)。在大多数患者中,医师报告的治疗依从性优于(48.7%)或等于(43.6%)。研究结束后,预计大多数患者(82%)将继续使用PF比马前列素0.03%。结论:这项观察性研究表明,在临床实践中,切换至PF比马前列素0.03%与从基线开始显着降低IOP有关。 AE率较低。因此,对于不耐受防腐剂或对先前降低眼压的治疗反应不充分的患者,PF比马前列素0.03%可能是一种有效的治疗选择。

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