University of Montreal, Montreal, Canada.
Bellevue Ophthalmology Clinics and Montreal Glaucoma Institute, Montreal, Canada.
Adv Ther. 2021 Jun;38(6):3019-3031. doi: 10.1007/s12325-021-01731-9. Epub 2021 Apr 23.
To compare the tolerability and efficacy of a preservative-containing latanoprost (PCL) to a preservative-free formulation of latanoprost (PFL) in patients with open-angle glaucoma or ocular hypertension.
A pooled analysis was performed of data from five published studies. The primary outcome was tolerability as evaluated by the severity of hyperemia. The secondary objectives were patient tolerance based on a composite ocular surface disease (OSD) score arising from ocular signs and symptoms, patient and investigator satisfaction, and a comparison of IOP-lowering efficacy.
There were three randomized controlled trials and two observational studies included in the analysis. Conjunctival hyperemia improved significantly in 25.6% (388) of patients switched to the PFL group versus 11.7% (117) of patients switched to the PCL group (p < 0.001). PFL was two times superior to PCL in reducing ocular hyperemia (odds ratio = 1.96; p < 0.001). The mean OSD composite score decreased by 32.2% in patients switched to the PFL group and 14.1% in the PCL group (p < 0.001). At 3 months, the mean IOP was similar between groups (p = 0.312).
This post hoc pooled analysis confirmed the findings of the individual studies that PFL is as efficacious at reducing IOP as PCL but better tolerated. After switching to PFL, there was twice the improvement in the OSD composite score. PFL was twice as effective at reducing ocular hyperemia and other ocular signs. These findings suggest that PFL has features that may improve patient compliance, thereby potentially improving the IOP-lowering efficacy on a long-term basis.
比较含防腐剂的拉坦前列素（PCL）和不含防腐剂的拉坦前列素（PFL）在开角型青光眼或高眼压症患者中的耐受性和疗效。
对五项已发表研究的数据进行了汇总分析。主要结局是通过充血严重程度评估的耐受性。次要目标是根据眼部体征和症状引起的综合眼表面疾病（OSD）评分评估的患者耐受性、患者和研究者满意度，以及比较眼压降低疗效。
分析中包括三项随机对照试验和两项观察性研究。与转换到 PCL 组的 11.7%（117 例）患者相比，转换到 PFL 组的 25.6%（388 例）患者的结膜充血明显改善（p<0.001）。PFL 降低眼部充血的效果是 PCL 的两倍（优势比=1.96；p<0.001）。转换到 PFL 组的患者的平均 OSD 综合评分下降了 32.2%，而 PCL 组的患者下降了 14.1%（p<0.001）。在 3 个月时，两组之间的平均眼压相似（p=0.312）。
这项事后汇总分析证实了个别研究的发现，即 PFL 降低眼压的疗效与 PCL 相当，但耐受性更好。转换到 PFL 后，OSD 综合评分改善了两倍。PFL 降低眼部充血和其他眼部体征的效果是 PCL 的两倍。这些发现表明，PFL 具有可能提高患者依从性的特征，从而有可能在长期基础上提高眼压降低疗效。
