Efficacy of a preservative-free formulation of fixed-combination bimatoprost and timolol (Ganfort PF) in treatment-naive patients vs previously treated patients
| Autor: | M Francesca Cordeiro, Rhett M. Schiffman, Ivan Goldberg, Paula Bernstein, Marina Bejanian |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2015 |
| Předmět: |
medicine.medical_specialty
Intraocular pressure genetic structures Timolol Glaucoma Ocular hypertension Subgroup analysis CONTROLLED-TRIAL EYE benzalkonium chloride THERAPY INDIVIDUAL COMPONENTS 0.03-PERCENT/TIMOLOL 0.5-PERCENT Ophthalmology medicine METAANALYSIS Original Research Science & Technology Bimatoprost business.industry Clinical Ophthalmology medicine.disease timolol Confidence interval eye diseases 1113 Opthalmology and Optometry glaucoma OCULAR HYPERTENSION sense organs 1-YEAR OPEN-ANGLE GLAUCOMA business Previously treated bimatoprost Life Sciences & Biomedicine medicine.drug intraocular pressure |
| Zdroj: | Clinical Ophthalmology (Auckland, N.Z.) |
| Popis: | M Francesca Cordeiro,1 Ivan Goldberg,2 Rhett Schiffman,3 Paula Bernstein,3 Marina Bejanian31Western Eye Hospital, Imperial College Healthcare NHS Trust, London, UK; 2Discipline of Ophthalmology, University of Sydney, Sydney, NSW, Australia; 3Allergan, Inc., Irvine, CA, USAPurpose: To evaluate, using subgroup analysis, the effect of treatment status on the intraocular pressure (IOP)-lowering efficacy of a preservative-free formulation of fixed-combination bimatoprost 0.03%/timolol 0.5% (FCBT PF).Methods: A primary, multicenter, randomized, double-masked, 12-week study compared the efficacy and safety of FCBT PF with preserved FCBT (Ganfort®) in 561 patients diagnosed with glaucoma or ocular hypertension. For this analysis, eligible patients were treatment-naïve or had inadequate IOP lowering and underwent a washout of previous treatment. IOP (8 am, 10 am, and 4 pm) was measured at baseline and weeks 2, 6, and 12. Subgroup analysis of the FCBT PF arm assessed changes in average eye IOP from baseline in treatment-naïve vs previously treated patients. To evaluate the effect of treatment status at baseline (treatment-naïve vs previously treated) on IOP reduction in the FCBT PF treatment group, an analysis of covariance model was used with treatment status and investigator as fixed effects, and baseline average eye IOP, age, glaucoma diagnosis, and baseline average eye corneal thickness as covariates. P-values and the 95% confidence intervals were determined using the model.Results: In the FCBT PF arm, IOP mean changes from baseline ranged from -8.7mmHg to -9.8mmHg in treatment-naïve patients (N=50), compared with -7.3mmHg to -8.5mmHg in previously treated patients (N=228). Baseline IOP, age, glaucoma diagnosis, and corneal thickness significantly affected IOP reduction in the FCBT PF group. Adjusting for these covariates, FCBT PF had a greater IOP-lowering effect (0.8–1.7mmHg) in treatment-naïve patients than previously treated patients, which was statistically significant (P≤0.05) at seven of nine time points.Conclusion: In this subgroup analysis, FCBT PF reduced IOP more effectively in treatment-naïve than in previously treated patients possibly due, in part, to altered responsiveness or tachyphylaxis that has been associated with prior ocular hypotensive agent treatment.Keywords: glaucoma, ocular hypertension, intraocular pressure, bimatoprost, timolol, benzalkonium chloride |
| Databáze: | OpenAIRE |
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