Gandolfi S, Simmons S T, Sturm R, Chen K, VanDenburgh A M
University of Parma, Via Gramsci 14, Parma, 43100, Italy.
Adv Ther. 2001 May-Jun;18(3):110-21. doi: 10.1007/BF02850299.
A multicenter, randomized, investigator-masked, parallel-group trial compared bimatoprost and latanoprost for efficacy and safety in patients with glaucoma or ocular hypertension. Patients received bimatoprost 0.03% (n = 119) or latanoprost 0.005% (n = 113) once daily in the evening for 3 months. Visits were at prestudy, baseline (day 0), week 1, and months 1, 2, and 3. Primary outcome measures were mean IOP and the percentage of patients achieving IOP of 17 mm Hg or lower at 8:00 AM. Secondary outcome measures were diurnal IOP measurements (8:00 AM, 12 noon, 4:00 PM, 8:00 PM) at month 3 and safety measures including adverse events. Mean IOP was lower with bimatoprost than with latanoprost at all time points during the 3-month follow-up, although the between-group difference was not always statistically significant. At month 3 at 12 noon, mean IOP was as much as 1.0 mm Hg lower with bimatoprost (P = .021). Target pressures of < or = 17 mm Hg were reached more often with bimatoprost than with latanoprost at 8:00 AM (53% vs 43%; P = .029). Over all diurnal measurements at month 3, low target pressures of < or = 13, < or = 14, and < or = 15 mm Hg were achieved significantly more often with bimatoprost (P < or = .006). Both drugs were safe and well tolerated. Conjunctival hyperemia was more common with bimatoprost, while headache was more frequent with latanoprost. Bimatoprost provided lower mean pressures than latanoprost at every time point throughout the study and was statistically superior in achieving low target pressures. More patients reached low target pressures with bimatoprost.
一项多中心、随机、研究者设盲、平行组试验比较了比马前列素和拉坦前列素治疗青光眼或高眼压症患者的疗效和安全性。患者每晚接受一次0.03%比马前列素(n = 119)或0.005%拉坦前列素(n = 113)治疗,为期3个月。访视时间为研究前、基线(第0天)、第1周以及第1、2和3个月。主要结局指标为平均眼压以及上午8点时眼压降至17 mmHg或更低的患者百分比。次要结局指标为第3个月时的昼夜眼压测量值(上午8点、中午12点、下午4点、晚上8点)以及包括不良事件在内的安全性指标。在3个月的随访期间,比马前列素组的平均眼压在所有时间点均低于拉坦前列素组,尽管组间差异并非总是具有统计学意义。在第3个月中午12点时,比马前列素组的平均眼压比拉坦前列素组低达1.0 mmHg(P = 0.021)。上午8点时,比马前列素组达到目标眼压≤17 mmHg的情况比拉坦前列素组更常见(53%对43%;P = 0.029)。在第3个月的所有昼夜测量中,比马前列素组达到低目标眼压≤13、≤14和≤15 mmHg的情况明显更常见(P≤0.006)。两种药物均安全且耐受性良好。比马前列素组结膜充血更常见,而拉坦前列素组头痛更频繁。在整个研究过程中的每个时间点,比马前列素的平均眼压均低于拉坦前列素,且在实现低目标眼压方面具有统计学优势。更多患者使用比马前列素达到了低目标眼压。