司普他前列素与拉坦前列素治疗原发性开角型青光眼或高眼压症患者的24小时疗效和安全性研究
A Study of 24-h Efficacy and Safety of Sepetaprost vs. Latanoprost in Patients with Primary Open-Angle Glaucoma or Ocular Hypertension.
作者信息
Konstas Anastasios-Georgios, Garhöfer Gerhard, Lübke Jan, Voykov Bogomil, Ropo Auli
机构信息
1st University Department of Ophthalmology, Aristotle University, Thessaloniki, Greece.
Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.
出版信息
Adv Ther. 2025 Jun 10. doi: 10.1007/s12325-025-03227-2.
INTRODUCTION
Understanding the 24-h efficacy and safety of a novel therapy option, sepetaprost ophthalmic solution 0.002% vs. latanoprost ophthalmic solution 0.005%, may delineate its future position in glaucoma treatment.
METHODS
In this exploratory study (EudraCT 2020-004836-93), adults with primary open-angle glaucoma (POAG) or ocular hypertension (OHT) were randomized to sepetaprost or latanoprost for 3 months following a ≤ 35-day screening period. The primary endpoint was mean 24-h intraocular pressure (IOP) at month 3 with sepetaprost vs. latanoprost. Safety outcomes included rate of adverse events (AEs).
RESULTS
Overall, 33 participants received treatment (sepetaprost, n = 17; latanoprost, n = 16). Mean 24-h IOP was numerically lower with sepetaprost vs. latanoprost at month 3 (- 0.88 mmHg; 95% confidence interval [CI] - 2.89, 1.14; not statistically significant at the 0.05 level [NS]). Mean change from baseline in IOP at month 3 ranged from - 5.63 to - 7.00 mmHg for sepetaprost and - 3.84 to - 6.66 mmHg for latanoprost. Lower nocturnal IOP was observed with sepetaprost vs. latanoprost at month 3 (- 1.61 mmHg difference; 95% CI - 4.05, 0.83; not statistically significant; however, the 90% CI was - 5.27, - 0.17 and therefore, nominal statistical significance was achieved at the 0.10 level). Mean difference between groups indicated similar, or numerically lower, IOP with sepetaprost at individual time points at week 6 and month 3. At 36 and 48 h following sepetaprost cessation, mean IOP was lower vs. baseline IOP at the same time points. AEs occurred in 13 (76.5%) vs. 11 (68.8%) participants treated with sepetaprost vs. latanoprost.
CONCLUSION
In participants with POAG or OHT, mean 24-h IOP and nocturnal IOP at month 3 were consistently numerically lower with sepetaprost vs. latanoprost. Safety profiles were similar between groups.
TRIAL REGISTRATION
EudraCT 2020-004836-93.
引言
了解新型治疗方案0.002%司铂前列素滴眼液与0.005%拉坦前列素滴眼液的24小时疗效和安全性，可能会明确其在青光眼治疗中的未来地位。
方法
在这项探索性研究（欧盟临床试验注册号：2020-004836-93）中，患有原发性开角型青光眼（POAG）或高眼压症（OHT）的成年人在≤35天的筛查期后，被随机分配接受司铂前列素或拉坦前列素治疗3个月。主要终点是第3个月时司铂前列素与拉坦前列素的平均24小时眼压（IOP）。安全性结果包括不良事件（AE）发生率。
结果
总体而言，33名参与者接受了治疗（司铂前列素组，n = 17；拉坦前列素组，n = 16）。第3个月时，司铂前列素组的平均24小时眼压在数值上低于拉坦前列素组（-0.88 mmHg；95%置信区间[CI]-2.89，1.14；在0.05水平无统计学意义[NS]）。第3个月时，司铂前列素组眼压相对于基线的平均变化范围为-5.63至-7.00 mmHg，拉坦前列素组为-3.84至-6.66 mmHg。第3个月时，司铂前列素组的夜间眼压低于拉坦前列素组（相差-1.61 mmHg；95% CI -4.05，0.83；无统计学意义；然而，90% CI为-5.27，-0.17，因此在0.10水平达到名义统计学意义）。组间平均差异表明，在第6周和第3个月的各个时间点，司铂前列素组的眼压相似或在数值上更低。在停用司铂前列素后36和48小时，相同时间点的平均眼压低于基线眼压。接受司铂前列素治疗的参与者中有13名（76.5%）发生不良事件，接受拉坦前列素治疗的参与者中有11名（68.8%）发生不良事件。
结论
在患有POAG或OHT的参与者中，第3个月时司铂前列素组的平均24小时眼压和夜间眼压在数值上始终低于拉坦前列素组。两组的安全性概况相似。
试验注册号
EudraCT 2020-004836-93。
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