Detail of "91524-16-2"

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Phase III long-term study and comparative clinical study of nipradilol ophthalmic solution in patients with primary open-angle glaucoma and ocular hypertension

All Rights Reserved. Phase III long-term study and comparative clinical study of nipradilol ophthalmic solution in patients with primary open-angle glaucoma and ocular hypertension. Kanno, Mikiko; Araie, Makoto; Masuda, Kanjiro; Takase, Masahiro; Kitazawa, Yoshiaki; Shiose, Yoshihiko; Azuma, Ikuo; Ogawa, Nobuya; Ohdo, Shigehiro (Department of Ophthalmology, School of Medicine, University of Tokyo, Japan). Arzneimittel Forschung, 56(11), 729-734 (English) 2006 Editio Cantor Verlag. CODEN: ARZNAD. ISSN: 0004-4172. DOCUMENT TYPE: Journal CA Section: 1 (Pharmacology) Section cross-reference(s): 63 Nipradilol (CAS 81486-22-8) is a non-selective b-blocker with a-1 blocking and nitroglycerin-like vasodilating activities. In the present communication, the long-term efficacy and safety of nipradilol were investigated and the efficacy, safety and utility of topical nipradilol and timolol (CAS 91524-16-2) were compared in patients with primary open-angle glaucoma or ocular hypertension. In the long-term study, nipradilol for 1 yr (52 wk) was performed by registration method. 67 Out of 68 patients were subjected to anal. and 57 patients (83.8%) completed 52-wk instillation. 0.25% Nipradilol was applied twice daily to patients. As a result, intraocular pressure (IOP) decreased significantly by 4.0 mmHg to 4.8 mmHg compared with the baseline without tachyphylaxis. The incidence of adverse events was 12.5% at 52 wk by anal. with Kaplan-Meier lifetable method. It showed no significant trend of increase after 3 mo. In the multi-centered double-masked comparative randomized study, 0.25% nipradilol was assigned to 96 patients and 0.5% timolol to 100 patients. Each patient was instilled nipradilol or timolol twice daily for 8 wk. IOP significantly decreased by 4.2 mmHg and by 4.7 mmHg at 8 wk and the incidence of adverse events was 10.5% and 12.1% in the nipradilol and timolol group, resp. No significant between-group difference in IOP redn. or incidence of adverse events was seen. Topical nipradilol showed long-term ocular hypotensive effects and clin. safety in a 52-wk study, and its efficacy and safety equiv.Except for chemicals metioned above, 26839-75-8 and 81486-22-8 are also used. to timolol was confirmed in a 8-wk comparative study. .