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Abstract #17186 Published in IGR 9-1
Phase III long-term study and comparative clinical study of nipradilol ophthalmic solution in patients with primary open-angle glaucoma and ocular hypertension: Part 1
Kanno M; Araie M; Masuda K; Takase M; Kitazawa Y; Shiose Y; Azuma I; Ogawa N; Ohdo SArzneimittel-Forschung/Drug Research 2006; 56: 729-734
Nipradilol (CAS 81486-22-8) is a non-selective (β)-blocker with α-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 year (52 weeks) was performed by registration method. Sixty-seven out of 68 patients were subjected to analysis and 57 patients (83.8%) completed 52-week 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 weeks by analysis with Kaplan-Meier life-table method. It showed no significant trend of increase after 3 months. 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 weeks. IOP significantly decreased by 4.2 mmHg and by 4.7 mmHg at 8 weeks and the incidence of adverse events was 10.5% and 12.1% in the nipradilol and timolol group, respectively. No significant between-group difference in IOP reduction or incidence of adverse events was seen. Topical nipradilol showed long-term ocular hypotensive effects and clinical safety in a 52-week study, and its efficacy and safety equivalent to timolol was confirmed in a 8-week comparative study.
Dr. M. Araie, Department of Ophthalmology, University of Tokyo, School of Medicine, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113, Japan. araie-tky@umin.ac.jp
Classification:
11.3.4 Betablocker (Part of: 11 Medical treatment > 11.3 Adrenergic drugs)
