Document Detail


Improved systemic safety and risk-benefit ratio of topical 0.1% timolol hydrogel compared with 0.5% timolol aqueous solution in the treatment of glaucoma.
MedLine Citation:
PMID:  16628416     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
PURPOSE: The purpose of the study was to compare the systemic safety and risk-benefit ratio of 0.1% timolol hydrogel and 0.5% aqueous timolol eye drops in the treatment of glaucoma. METHODS: An 8-week randomised, double-blind, cross-over, multicentre study. A total of 25 patients with primary open-angle glaucoma, exfoliation glaucoma, or ocular hypertension was enrolled. After completing a wash-out period, patients were randomly chosen to receive either 0.1% timolol hydrogel once daily or 0.5% aqueous timolol eye drops twice daily. Intraocular pressure and heart rate during rest and exercise, head-up tilt test results, spirometry readings, and plasma concentrations of timolol were recorded. The risk-benefit ratio was determined by calculating the ratio between several heart rate endpoints and the change in intraocular pressure (IOP). RESULTS: The mean drug-induced change in the peak heart rate during exercise was -13.5 beats/min (SD 7.6) in the 0.5% aqueous timolol group and -5.1 beats/min (SD 6.7) in the 0.1% timolol hydrogel group (P<0.001; 95% CI 4.06-12.18). There was no significant difference in the IOP-reducing efficacy between these compounds. The risk-benefit ratio was significantly improved when 0.1% timolol hydrogel was used, compared with 0.5% aqueous timolol in the exercise test. In the head-up tilt test the risk-benefit ratio was significantly improved at rest (P<0.05), at 1 min (P<0.05) and at 5 min (P<0.001) after patients had received 0.1% timolol hydrogel. There were, however, no differences in spirometry readings. After patients had been treated with 0.1% timolol hydrogel, plasma concentrations of timolol were 1/6 (at peak) and 1/50 (at trough) of those of 0.5% aqueous timolol. CONCLUSIONS: Drug-induced changes in the peak heart rate, and head-up tilt test results as well as plasma concentrations of timolol, were significantly more pronounced after treatment with 0.5% aqueous timolol than with 0.1% timolol hydrogel. Because of the statistically similar IOP-reducing efficacy of these formulations the risk-benefit ratio was significantly improved when patients used 0.1% timolol hydrogel instead of 0.5% aqueous timolol.
Authors:
Hannu Uusitalo; Mika Kähönen; Auli Ropo; Jukka Mäenpää; Gunilla Bjärnhall; Hans Hedenström; Väinö Turjanmaa
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2006-04-21
Journal Detail:
Title:  Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv für klinische und experimentelle Ophthalmologie     Volume:  244     ISSN:  0721-832X     ISO Abbreviation:  Graefes Arch. Clin. Exp. Ophthalmol.     Publication Date:  2006 Nov 
Date Detail:
Created Date:  2006-11-09     Completed Date:  2007-08-20     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8205248     Medline TA:  Graefes Arch Clin Exp Ophthalmol     Country:  Germany    
Other Details:
Languages:  eng     Pagination:  1491-6     Citation Subset:  IM    
Affiliation:
Department of Ophthalmology, University of Kuopio and Kuopio University Hospital, P.O. Box 1777, 70211 Kuopio, Finland. hannu.uusitalo@uku.fi
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MeSH Terms
Descriptor/Qualifier:
Administration, Topical
Antihypertensive Agents / adverse effects,  pharmacokinetics,  therapeutic use*
Biological Availability
Cross-Over Studies
Double-Blind Method
Exercise Test
Female
Glaucoma, Open-Angle / drug therapy*
Heart Rate / drug effects
Humans
Hydrogel / adverse effects,  pharmacokinetics,  therapeutic use*
Intraocular Pressure / drug effects
Male
Middle Aged
Ocular Hypertension / drug therapy
Ophthalmic Solutions / adverse effects,  pharmacokinetics,  therapeutic use
Risk Assessment
Spirometry
Tilt-Table Test
Timolol / adverse effects,  pharmacokinetics,  therapeutic use*
Visual Acuity / drug effects
Chemical
Reg. No./Substance:
0/Antihypertensive Agents; 0/Ophthalmic Solutions; 25852-47-5/Hydrogel; 26839-75-8/Timolol

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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