University Hospital Uppsala, Uppsala, Sweden †Pfizer Inc, New York, New York, USA.
J Glaucoma. 2011 Apr-May;20(4):215-22. doi: 10.1097/IJG.0b013e3181e08121.
To evaluate the safety of fixed-combination latanoprost/timolol (Xalacom) in patients requiring additional intraocular pressure (IOP) reduction over 5 years.
This phase 3b, open-label, multicenter study included prostaglandin-naive participants with open-angle glaucoma or ocular hypertension insufficiently responsive to β-blockers and requiring additional IOP reduction. Participants were evaluated at eleven 6-month visits. A masked assessor evaluated iris/eyelash changes at baseline and 12, 36, and 60 months. Increased iris pigmentation incidence was compared with a historic control from a similarly designed study evaluating latanoprost. Ocular and systemic adverse events were recorded.
Among 828/974 treated participants with assessable iris photographs, 233 (28.1%) developed increased iris pigmentation versus 127/380 (33.4%) in the historic controls. Participants with mixed eye colors exhibited greater susceptibility to overall increased iris pigmentation (85.8% in both studies). In this study, most participants (80.3%) with increased iris pigmentation developed only a weak increase. Eyelash changes were seen in 58.1% of participants and darkening of the eyelids in 5-6%; 14.1% experienced a serious adverse event. Adverse events resulted in treatment withdrawal in 133 (13.7%) participants. Most were nonserious ocular adverse events, about half of them ocular irritation. Only 3 of 13 serious systemic adverse events were considered to be drug related by the investigator. Mean IOP reductions were stable over 5 years.
After 5 years, more than 70% of participants treated with fixed-combination latanoprost/timolol had no increased iris pigmentation. The fixed combination is safe and well tolerated for long-term treatment in patients with open-angle glaucoma or ocular hypertension.
评估固定配比拉坦前列素/噻吗洛尔（Xalacom）在需要 5 年以上降低眼内压（IOP）的患者中的安全性。
这是一项 3b 期、开放性、多中心研究，纳入了对前列腺素无反应的开角型青光眼或眼压升高患者，他们对β受体阻滞剂反应不足，需要进一步降低 IOP。参与者在 11 次 6 个月的访视中接受评估。一名经盲法评估的评估员在基线时和 12、36 和 60 个月时评估虹膜/睫毛变化。与评估拉坦前列素的类似设计研究的历史对照相比，比较了虹膜色素沉着发生率的增加。记录眼部和全身不良反应事件。
在 828/974 名可评估虹膜照片的治疗参与者中，233 名（28.1%）出现虹膜色素沉着增加，而历史对照中为 127/380 名（33.4%）。混合眼色的参与者对整体虹膜色素沉着增加的易感性更大（两项研究中均为 85.8%）。在这项研究中，大多数（80.3%）有虹膜色素沉着增加的患者只有轻微增加。58.1%的参与者出现睫毛变化，5-6%的参与者出现眼睑变暗；14.1%发生严重不良事件。133 名（13.7%）参与者因不良事件退出治疗。大多数是轻微的眼部不良反应，其中一半是眼部刺激。只有 3 例严重全身性不良反应被研究者认为与药物有关。5 年来，平均 IOP 降低稳定。
固定配比拉坦前列素/噻吗洛尔治疗 5 年后，70%以上的患者没有出现虹膜色素沉着增加。对于开角型青光眼或眼压升高的患者，固定组合是安全且耐受良好的长期治疗方法。
