USVD Glaucoma Study Centre, University of Brescia, Brescia, Italy.
J Clin Pharmacol. 2012 Oct;52(10):1552-7. doi: 10.1177/0091270011420254. Epub 2011 Nov 22.
To investigate the circadian and blood pressure (BP) reduction obtained with timolol maleate 0.5% solution administered twice daily versus timolol 0.1% in gel-forming carbomer administered in the morning in patients with primary open-angle glaucoma (POAG).
This investigator-masked, crossover study prospectively enrolled naive POAG patients not receiving systemic cardiovascular medications. Following a baseline evaluation, they were randomized to receive a timolol 0.5% solution or timolol 0.1% hydrogel for 2 months and then switched to the alternative medication for a further 2 months. Intraocular pressure (IOP) phasing (sitting Goldmann tonometry at 10 am, 2 pm, 6 pm, and 10 pm and supine Perkins tonometry at 2 am and 6 am) and ambulatory home BP monitoring were measured at baseline and after each treatment period.
On the basis of a prospective sample size estimate, 28 patients were analyzed. Mean 24-hour IOP decreased from 23.1 ± 0.7 mm Hg at baseline to 18.9 ± 0.6 mm Hg after timolol 0.5% and 18.9 ± 0.8 mm Hg after timolol 0.1% hydrogel (P < .001); both formulations also significantly decreased diurnal, nocturnal, and individual time point IOP in a statistically similar manner. Systolic and diastolic BP remained generally unaffected. The calculated diastolic ocular perfusion pressure was either unaffected or tended to increase with either medication.
Both timolol formulations show similar and significant circadian efficacy and have minimal effects on BP and calculated diastolic ocular perfusion pressure.
研究马来酸噻吗洛尔 0.5%溶液每日两次给药与凝胶形成卡波姆中的 0.1%噻吗洛尔在原发性开角型青光眼(POAG)患者中的降眼压作用和昼夜节律。
本研究为前瞻性、双盲、交叉研究,纳入了未接受全身心血管药物治疗的初治 POAG 患者。在基线评估后,他们被随机分配接受马来酸噻吗洛尔 0.5%溶液或噻吗洛尔 0.1%水凝胶治疗 2 个月,然后再换用另一种药物治疗 2 个月。在基线和每个治疗期后,通过坐位 Goldmann 眼压计(上午 10 点、下午 2 点、下午 6 点和晚上 10 点以及仰卧位 Perkins 眼压计凌晨 2 点和早上 6 点)和动态家庭血压监测测量眼压相位(相位)。
根据前瞻性样本量估计,对 28 例患者进行了分析。24 小时平均眼压从基线时的 23.1 ± 0.7mmHg 下降至噻吗洛尔 0.5%治疗后时的 18.9 ± 0.6mmHg 和噻吗洛尔 0.1%水凝胶治疗后的 18.9 ± 0.8mmHg(P<.001);两种制剂在统计学上均以相似的方式显著降低了日间、夜间和个别时间点的眼压。收缩压和舒张压总体上无明显变化。计算得出的舒张期眼灌注压不受影响或倾向于随药物治疗而升高。
两种噻吗洛尔制剂均显示出相似且显著的昼夜节律疗效,对血压和计算得出的舒张期眼灌注压的影响最小。