曲伏前列素 0.004%/噻吗洛尔 0.5% 固定联合制剂在从固定或不固定浓度的贝美前列素 0.03%/噻吗洛尔 0.5% 转换过来的患者中的应用。

Travoprost 0.004%/timolol 0.5% fixed combination in patients transitioning from fixed or unfixed bimatoprost 0.03%/timolol 0.5%.

机构信息

Marktplatz, Regenstauf, Germany.

出版信息

Adv Ther. 2011 Aug;28(8):661-70. doi: 10.1007/s12325-011-0043-z. Epub 2011 Jul 15.

DOI:10.1007/s12325-011-0043-z

PMID:21773673

Abstract

INTRODUCTION

Patients with glaucoma or ocular hypertension who do not achieve target intraocular pressure (IOP) using one hypotensive agent are often transitioned to combination therapy. Travoprost 0.004%/timolol 0.5% fixed combination (TTFC) has shown efficacy in patients whose IOP is not controlled with other therapies. The goal of this study was to assess the efficacy and safety of transitioning to TTFC in patients whose IOP was uncontrolled on bimatoprost 0.03%/timolol 0.5%, administered concomitantly or as a fixed combination.

METHODS

This was a prospective, open-label, multicenter study of patients with open-angle glaucoma or ocular hypertension who transitioned to TTFC from fixed or unfixed bimatoprost/timolol. Patients self-administered TTFC once daily for 8 weeks, and efficacy and safety were assessed at baseline, Week 4, and Week 8. A symptom survey was administered at baseline and Week 8. Both patients and investigators reported their medication preference at Week 8.

RESULTS

A total of 105 patients were enrolled in the study. Mean IOP decreased by 16.5% from baseline after 8 weeks of TTFC therapy in the total population, 15.0% in patients transitioning from fixed-combination therapy, and 20.8% in patients transitioning from unfixed therapy (P<0.001 for all groups). The percentage of patients reaching target IOP (≤18 mmHg) after treatment with TTFC was 69.2% (P<0.001). Patients judged stinging/burning to be less severe with TTFC than with prior therapy (P=0.029); all other symptom frequencies and severities were similar for both treatments. Patients preferred TTFC over bimatoprost/timolol (fixed and unfixed) at a ratio of more than 4:1 (81.4% vs. 18.6%; P<0.001), and investigators reported a nearly five-fold preference for TTFC (83.3% vs. 16.7%; P<0.001). No unexpected safety concerns with TTFC were observed.

CONCLUSION

Travoprost 0.004%/timolol 0.5% fixed combination produced a significant reduction in IOP, with favorable safety and tolerability profiles. Both patients and investigators strongly preferred TTFC to prior bimatoprost 0.03%/timolol 0.5% therapy.

摘要

简介

对于那些使用单一降眼压药物未能达到目标眼压（IOP）的青光眼或高眼压症患者，通常会转为联合治疗。曲伏前列素 0.004%/噻吗洛尔 0.5%固定联合制剂（TTFC）在其他治疗方法未能控制眼压的患者中已显示出疗效。本研究的目的是评估 TTFC 在那些同时使用或不使用固定联合制剂的患者中，从贝美前列素 0.03%/噻吗洛尔 0.5%控制不佳的患者转为 TTFC 的疗效和安全性。

方法

这是一项前瞻性、开放标签、多中心研究，纳入了从固定或非固定贝美前列素/噻吗洛尔转为 TTFC 的开角型青光眼或高眼压症患者。患者自行每日使用 TTFC 一次，持续 8 周，在基线、第 4 周和第 8 周评估疗效和安全性。在基线和第 8 周进行症状调查。患者和研究者在第 8 周报告他们对药物的偏好。

结果

共有 105 例患者入组本研究。在总人群中，TTFC 治疗 8 周后，平均 IOP 从基线下降 16.5%，固定联合治疗组下降 15.0%，非固定治疗组下降 20.8%（各组均 P<0.001）。治疗后达到目标 IOP（≤18mmHg）的患者比例为 69.2%（P<0.001）。与先前的治疗相比，患者认为 TTFC 引起的刺痛/烧灼感更轻微（P=0.029）；两种治疗的其他症状频率和严重程度相似。患者对 TTFC 的偏好明显超过贝美前列素/噻吗洛尔（固定和非固定），比例超过 4:1（81.4% vs. 18.6%；P<0.001），而研究者报告 TTFC 的偏好几乎是贝美前列素/噻吗洛尔的五倍（83.3% vs. 16.7%；P<0.001）。未观察到 TTFC 有任何意外的安全性问题。