Ophthalmology · 2004
Intraocular pressure-reducing effects and safety of latanoprost versus timolol in patients with chronic angle-closure glaucoma.
Клиническое исследованиеСравнительное исследованиеСтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Chew Paul T K, Aung Tin, Aquino M V, Rojanapongpun Prin, EXACT Study Group
Аннотация
OBJECTIVE: To demonstrate that the intraocular pressure (IOP)-reducing effect of latanoprost once daily is at least as good as that of timolol twice daily in patients with chronic angle-closure glaucoma (CACG).
DESIGN: Randomized, double-masked, multicenter 12-week study.
PARTICIPANTS: In all, 137 patients with unilateral or bilateral CACG were treated with latanoprost, and 138 were treated with timolol.
METHODS: Patients received either latanoprost (9 pm) and a placebo (9 am) or timolol (both 9 am and 9 pm). Intraocular pressure was measured at 9 am and 5 pm at baseline and weeks 2, 6, and 12.
MAIN OUTCOME MEASURES: The difference between groups in daily IOP (average of 9 am and 5 pm measures) reduction was the primary outcome. Secondary outcomes included differences between groups in IOP reductions at 9 am and 5 pm, and in proportions of patients reaching specified daily IOP levels.
RESULTS: Using repeated measures (analysis of covariance: intent to treat), mean changes from baseline in daily IOP levels during 12 weeks were -8.2 mmHg and -5.2 mmHg for latanoprost- and timolol-treated patients, respectively (difference: -3.0 mmHg [95% confidence interval: -4.0, -2.1], P<0.001). Greater reductions in IOP levels at both 9 am and 5 pm were found in latanoprost-treated patients (P<0.001 for both), and greater proportions of patients receiving latanoprost reached prespecified target daily IOP levels (P<0.001 for all 3 target levels tested). Both drugs were well tolerated.
CONCLUSION: Latanoprost administered once daily provides significantly greater IOP reduction in CACG patients than does timolol instilled twice daily.
DESIGN: Randomized, double-masked, multicenter 12-week study.
PARTICIPANTS: In all, 137 patients with unilateral or bilateral CACG were treated with latanoprost, and 138 were treated with timolol.
METHODS: Patients received either latanoprost (9 pm) and a placebo (9 am) or timolol (both 9 am and 9 pm). Intraocular pressure was measured at 9 am and 5 pm at baseline and weeks 2, 6, and 12.
MAIN OUTCOME MEASURES: The difference between groups in daily IOP (average of 9 am and 5 pm measures) reduction was the primary outcome. Secondary outcomes included differences between groups in IOP reductions at 9 am and 5 pm, and in proportions of patients reaching specified daily IOP levels.
RESULTS: Using repeated measures (analysis of covariance: intent to treat), mean changes from baseline in daily IOP levels during 12 weeks were -8.2 mmHg and -5.2 mmHg for latanoprost- and timolol-treated patients, respectively (difference: -3.0 mmHg [95% confidence interval: -4.0, -2.1], P<0.001). Greater reductions in IOP levels at both 9 am and 5 pm were found in latanoprost-treated patients (P<0.001 for both), and greater proportions of patients receiving latanoprost reached prespecified target daily IOP levels (P<0.001 for all 3 target levels tested). Both drugs were well tolerated.
CONCLUSION: Latanoprost administered once daily provides significantly greater IOP reduction in CACG patients than does timolol instilled twice daily.