Feuerhake Cord, Buchholz Patricia, Kimmich Friedemann
Burgdorfer Strasse 19/21, Lehrte, Germany.
Curr Med Res Opin. 2009 Apr;25(4):1037-43. doi: 10.1185/03007990902816947.
To evaluate intraocular pressure (IOP)-lowering efficacy, tolerability, and safety of the fixed combination of bimatoprost 0.03% and timolol 0.5% (Ganfort) among German patients.
Multicenter, observational, open-label study of patients with primary open angle glaucoma or ocular hypertension (n = 606). As determined by participating physicians, patients had insufficient IOP control and required a medication change. They were switched to once-daily fixed-combination bimatoprost/timolol with no wash-out period. IOP was recorded at treated baseline, 4-6 weeks and 12 weeks after switching. Tolerability was measured using a 4-step scale (excellent, good, moderate, poor) and all adverse events were recorded.
A total of 405 patients switched from monotherapy, 97 switched from other fixed combinations, and 104 switched from non-fixed combinations. Among all patients, 32.5% had used prostaglandin analog (PGA) monotherapy, 8.7% had been using a fixed combination that included a PGA, and 6.9% had been using an adjunctive combination of a PGA and a beta-blocker. Mean treated baseline IOP (+/-SD) for all patients was 20.7 +/- 3.5 mmHg. Overall, changing medication to fixed-combination bimatoprost/timolol lowered IOP to 16.6 +/- 2.7 mmHg (p < 0.001 vs. baseline) after 4-6 weeks and to 16.1 +/- 2.6 mmHg (p < 0.001) after 12 weeks; reductions of 19.8% and 22.2%, respectively. Combined bimatoprost/timolol provided an additional IOP reduction versus baseline in most subgroups based on prior treatment. At week 12, patients who had previously used a beta-blocker achieved an additional 25.8% decrease from baseline and IOP was reduced by 22.6% in former PGA monotherapy patients. At week 12, 84.6% of all eyes reached a target pressure less than or equal to 18 mmHg. Tolerability of bimatoprost/timolol was rated excellent or good by the physicians for 98.7% of patients and by 96.7% of the patients themselves. Few adverse events occurred during the treatment period.
Although this study was limited by its observational design, our results show that the fixed combination of bimatoprost 0.03%/timolol 0.5% was effective, well tolerated, and safe in a broad patient population.
评估0.03%比马前列素与0.5%噻吗洛尔的固定复方制剂（Ganfort）在德国患者中的降眼压疗效、耐受性及安全性。
对原发性开角型青光眼或高眼压症患者（n = 606）进行多中心、观察性、开放标签研究。由参与研究的医生判定，患者眼压控制不佳且需要更换药物。他们直接换用每日一次的比马前列素/噻吗洛尔固定复方制剂，无需洗脱期。在换药后的治疗基线、4 - 6周及12周记录眼压。使用4级量表（优、良、中、差）评估耐受性，并记录所有不良事件。
共有405例患者从单药治疗换药，97例从其他固定复方制剂换药，104例从非固定复方制剂换药。在所有患者中，32.5%曾使用前列腺素类似物（PGA）单药治疗，8.7%曾使用含PGA的固定复方制剂，6.9%曾使用PGA与β受体阻滞剂的联合用药。所有患者治疗基线时的平均眼压（±标准差）为20.7±3.5 mmHg。总体而言，换用比马前列素/噻吗洛尔固定复方制剂后，4 - 6周时眼压降至16.6±2.7 mmHg（与基线相比，p < 0.001），12周时降至16.1±2.6 mmHg（p < 0.001）；分别降低了19.8%和22.2%。基于先前治疗情况，在大多数亚组中，比马前列素/噻吗洛尔复方制剂与基线相比进一步降低了眼压。在第12周时，先前使用β受体阻滞剂的患者眼压较基线额外降低了25.8%，先前使用PGA单药治疗的患者眼压降低了22.6%。在第12周时，84.6%的患眼眼压达到小于或等于18 mmHg的目标眼压。医生对98.7%的患者、患者自身对96.7%的患者的比马前列素/噻吗洛尔耐受性评价为优或良。治疗期间发生的不良事件很少。
尽管本研究受观察性设计的限制，但我们的结果表明，0.03%比马前列素/0.5%噻吗洛尔固定复方制剂在广泛的患者群体中有效、耐受性良好且安全。
