Pfennigsdorf Stefan, Ramez Osman, von Kistowski Gerrit, Mäder Birgit, Eschstruth Peter, Froböse Michael, Thelen Ulrich, Spraul Christoph, Schnober Dietmar, Cooper Hazel, Laube Thomas
Polch Ophthalmology Practice, Polch.
Clin Ophthalmol. 2012;6:739-46. doi: 10.2147/OPTH.S31330. Epub 2012 May 11.
Bimatoprost 0.01% was developed for improved tolerability over bimatoprost 0.03%, while maintaining efficacy in lowering intraocular pressure (IOP). This multicenter, prospective, open-label, observational study was designed to investigate the efficacy and tolerability of bimatoprost 0.01% in routine clinical practice.
Data were collected from 10,337 patients with primary open-angle glaucoma or ocular hypertension attending 1334 centers in Germany. The primary efficacy outcome was mean change in IOP in each eye from baseline to 10-14 weeks after initiation of bimatoprost 0.01%. Target IOP, prior therapies, additional treatments, and adverse events were also assessed. All treatment decisions were at the physicians' discretion.
Bimatoprost 0.01% significantly lowered mean IOP from baseline by -4.1 mmHg (P < 0.0001) in all patients after a mean of 10.45 weeks. In patients without previous treatment, bimatoprost 0.01% reduced mean IOP from baseline by -6.5 mmHg (P < 0.0001). Bimatoprost 0.01% also significantly reduced IOP in patients previously treated with monotherapy of β-blockers, prostaglandin analogs, carbonic anhydrase inhibitors or bimatoprost 0.03%. No adverse events were reported by 93.9% of patients during treatment with bimatoprost 0.01%; the most commonly reported adverse events were eye irritation (2.0%), ocular hyperemia (1.4%), and conjunctival hyperemia (1.2%). Physicians and patients rated tolerability and adherence as high, and most patients said they would continue with bimatoprost 0.01% treatment.
Bimatoprost 0.01% can produce additional IOP-lowering effects when used in routine clinical practice in patients who have received prior therapy, in addition to lowering IOP in previously untreated patients. A high rate of continuation of therapy with bimatoprost 0.01% was observed in patients who switched from a variety of different medications. The results suggest that bimatoprost 0.01% is a suitable first-choice therapy in patients with primary open-angle glaucoma or ocular hypertension.
0.01%的比马前列素在研发时旨在提高耐受性，相比0.03%的比马前列素，同时保持降低眼压（IOP）的疗效。这项多中心、前瞻性、开放标签的观察性研究旨在调查0.01%比马前列素在常规临床实践中的疗效和耐受性。
收集了来自德国1334个中心的10337例原发性开角型青光眼或高眼压症患者的数据。主要疗效指标是每只眼睛从基线到开始使用0.01%比马前列素后10 - 14周眼压的平均变化。还评估了目标眼压、先前的治疗、额外的治疗以及不良事件。所有治疗决策由医生自行决定。
在平均10.45周后，0.01%比马前列素使所有患者的平均眼压从基线显著降低了 -4.1 mmHg（P < 0.0001）。在未接受过治疗的患者中，0.01%比马前列素使平均眼压从基线降低了 -6.5 mmHg（P < 0.0001）。0.01%比马前列素在先前接受过β受体阻滞剂、前列腺素类似物、碳酸酐酶抑制剂或0.03%比马前列素单一疗法治疗的患者中也显著降低了眼压。93.9%的患者在使用0.01%比马前列素治疗期间未报告不良事件；最常报告的不良事件是眼部刺激（2.0%）、眼部充血（1.4%）和结膜充血（1.2%）。医生和患者对耐受性和依从性的评价很高，大多数患者表示他们会继续使用0.01%比马前列素治疗。
0.01%比马前列素在常规临床实践中，对于先前接受过治疗的患者除了能降低眼压外，还能产生额外的降眼压效果。从各种不同药物转换而来的患者中观察到0.01%比马前列素的治疗延续率很高。结果表明，0.01%比马前列素是原发性开角型青光眼或高眼压症患者合适的首选治疗方法。
