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The Effect of Latanoprost on Intraocular Pressure During 2 Years of Treatment
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Neuroscience, Ophthalmology.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Neuroscience, Ophthalmology.
2002 (English)In: Survey of ophthalmology, ISSN 0039-6257, E-ISSN 1879-3304, Vol. 47, no S1, 65-76 p.Article in journal (Refereed) Published
Abstract [en]

Our objective was to study the intraocular pressure (IOP) in open-angle glaucoma or ocular hypertensive patients during long-term treatment with latanoprost. A total of 532 patients treated with 0.005% latanoprost were enrolled, including 493 and 113 patients treated for 6 and 24 months, respectively. Mean IOP was analyzed with the analysis of variance technique. The risk of treatment failure was analyzed with survival analysis technique. After 2 weeks of latanoprost treatment, the mean IOP was reduced 8.2 (32%) and 8.9 (34%) mm Hg in the subgroups of patients treated for 6 and 24 months, respectively. The change in mean IOP during 2 years of latanoprost treatment was not statistically significant (p = 0.15). Patients with primary open-angle glaucoma or ocular hypertension showed an 86% and 97% chance of receiving a sufficient IOP reduction with latanoprost (p < 0.01), repectively. The initial mean IOP reduction was maintained throughout the 2 years of treatment.

Place, publisher, year, edition, pages
2002. Vol. 47, no S1, 65-76 p.
National Category
Medical and Health Sciences
Identifiers
URN: urn:nbn:se:uu:diva-90324DOI: 10.1016/S0039-6257(02)00301-6PubMedID: 12204702OAI: oai:DiVA.org:uu-90324DiVA: diva2:162636
Available from: 2003-04-07 Created: 2003-04-07 Last updated: 2013-03-21Bibliographically approved
In thesis
1. Pooling Data from Similar Randomized Clinical Trials Comparing Latanoprost with Timolol; Medical Results and Statistical Aspects
Open this publication in new window or tab >>Pooling Data from Similar Randomized Clinical Trials Comparing Latanoprost with Timolol; Medical Results and Statistical Aspects
2003 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Two different principles were studied. 1st - statistical analysis techniques were used to obtain medical results from a patient population. 2nd - the patient population was used to study the statistical analysis techniques.

Medical conclusions: latanoprost and timolol treatment showed a statistically significant and clinically useful mean IOP-reduction in a typical worldwide clinical trial population. Latanoprost reduced the IOP 1.6 mm Hg more than timolol. The IOP-reduction was maintained with timolol and slightly enforced with latanoprost up to 6 months of treatment. The mean IOP-reduction was maintained during 2 years of latanoprost treatment. The overall risk of withdrawal due to insufficient IOP-reduction with latanoprost was 8%.

The statistical methodological issues are of a general and reoccurring character in trial design of the IOP-reduction: should the statistical hypothesis testing be based on the mean intraocular pressure (IOP) or the proportion of patients who reach a specific IOP level, should the estimate of the IOP or IOP-reduction be based on single eyes, mean of bilaterally eligible and identically treated eyes or the difference between an eye with active treatment and a placebo treated contralateral eye, and is mean of replicated recordings useful? Statistical methodological conclusions: the most effective response variable varies with the selected patient population. Therefore, the trial design process should include a comparison of the variability, test power and required sample size for the possible response variables in a sample of the target population. At minimum a statistical consideration should be done.

Place, publisher, year, edition, pages
Uppsala: Acta Universitatis Upsaliensis, 2003. 54 p.
Series
Comprehensive Summaries of Uppsala Dissertations from the Faculty of Medicine, ISSN 0282-7476 ; 1235
Keyword
Ophtalmology, mean intraocular pressure, target intraocular pressure, latanoprost, timolol, open-angle glaucoma, ocular hypertension, trial design, Oftalmiatrik
National Category
Ophthalmology
Research subject
Ophtalmology
Identifiers
urn:nbn:se:uu:diva-3392 (URN)91-554-5570-0 (ISBN)
Public defence
2003-05-03, Grönwallsalen, Uppsala University Hospital, entrance 70, Uppsala, 13:15
Opponent
Supervisors
Available from: 2003-04-07 Created: 2003-04-07Bibliographically approved

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