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The efficacy and safety of timolol maleate versus brinzolamide each given twice daily added to travoprost in patients with ocular hypertension or primary open-angle glaucoma
被引:30
作者:
Hollo, G.
Chiselita, D.
Petkova, N.
Cvenkel, B.
Liehneova, I.
Izgi, B.
Berta, A.
Szaflik, J.
Turacli, E.
Stewart, W. C.
机构:
[1] Pharmaceut Res Network LLC, Charleston, SC 29407 USA
[2] Univ S Carolina, Sch Med, Columbia, SC 29208 USA
[3] Ankara Univ, TR-06100 Ankara, Turkey
[4] Med Univ Warsaw, Dept Ophthalmol, Warsaw, Poland
[5] Univ Debrecen, Sch Med, Dept Ophthalmol, H-4012 Debrecen, Hungary
[6] Istanbul Univ, Istanbul Fac Med, Istanbul, Turkey
[7] Nemocnice Teplice, Teplice, Czech Republic
[8] Univ Eye Clin Ljubljana, Ljubljana, Slovenia
[9] Med Univ Eye Clin, Sofia, Bulgaria
[10] Clin Oftalmol 1, Iasi, Romania
[11] Semmelweis Univ, Dept Ophthalmol, H-1085 Budapest, Hungary
关键词:
timolol maleate;
brinzolamide;
travoprost;
ocular hypertension;
primary open-angle glaucoma;
D O I:
10.1177/112067210601600606
中图分类号:
R77 [眼科学];
学科分类号:
100212 ;
摘要:
PURPOSE. To compare the efficacy and safety of timolol maleate 0.5% versus brinzolamide 1% when added to travoprost 0.004% in patients with ocular hypertension or primary open-angle glaucoma. DESIGN. A prospective, double-masked, randomized, active-controlled, parallel comparison. METHODS. Qualified patients at Visit 1 were placed on travoprost dosed every evening for 4 weeks and then were randomized at baseline (Visit 2) to the addition of timolol maleate or brinzolamide each given twice daily. Patients returned to clinic at Week 4 (Visit 3) for a safety visit and Week 12 (Visit 4) for an efficacy visit. At Visits 2 and 4 the intraocular pressure (IOP) was measured at 08:00, 12:00, and 16:00 hours. RESULTS. Ninety-seven patients on brinzolamide had a baseline diurnal IOP of 21.5 +/- 2.2 mmHg and 95 on timolol maleate had 21.3 +/- 2.5 mmHg, each added to travoprost. The diurnal mean IOP at Week 12 was 18.1 +/- 2.7 mmHg for brinzolamide and 18.1 +/- 3.0 mmHg for timolol maleate (p=0.96). There was no statistical difference found between treatment groups in the absolute level of pressure, or in the reduction in IOP from baseline, at each time point or for the diurnal curve (p > 0.05). There was no significant difference for any adverse event between groups (p > 0.05), with the most common side effect being conjunctival hyperemia in 15197 (16%) brinzolamide and 6195 (6%) timolol treated patients (p=0.06). CONCLUSIONS. This study showed that brinzolamide provides similar safety and efficacy compared to timolol maleate when added to travoprost.
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页码:816 / 823
页数:8
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