Efficacy and safety of travoprost 0.004%/timolol 0.5% fixed combination as transition therapy in patients previously on prostaglandin analog monotherapy

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dc.contributor.authorCosta, Vital Paulino
dc.contributor.authorMoreira, Hamilton
dc.contributor.authorPaolera, Mauricio Della
dc.contributor.authorSilva, Maria Rosa Bet de Moraes [UNESP]
dc.contributor.institutionUniversidade Estadual de Campinas (UNICAMP)
dc.contributor.institutionUniversidade Federal do Paraná (UFPR)
dc.contributor.institutionSanta Casa de Misericórdia de São Paulo
dc.contributor.institutionUniversidade Estadual Paulista (Unesp)
dc.date.accessioned2014-05-27T11:26:30Z
dc.date.available2014-05-27T11:26:30Z
dc.date.issued2012-05-05
dc.description.abstractPurpose: To assess the safety and efficacy of transitioning patients whose intraocular pressure (IOP) had been insufficiently controlled on prostaglandin analog (PGA) monotherapy to treatment with travoprost 0.004%/timolol 0.5% fixed combination with benzalkonium chloride (TTFC). Methods: This prospective, multicenter, open-label, historical controlled, single-arm study transitioned patients who had primary open-angle glaucoma, pigment dispersion glaucoma, or ocular hypertension and who required further IOP reduction from PGA monotherapy to oncedaily treatment with TTFC for 12 weeks. IOP and safety (adverse events, corrected distance visual acuity, and slit-lamp biomicroscopy) were assessed at baseline, week 4, and week 12. A solicited ocular symptom survey was administered at baseline and at week 12. Patients and investigators reported their medication preference at week 12. Results: Of 65 patients enrolled, 43 had received prior travoprost therapy and 22 had received prior nontravoprost therapy (n = 18, bimatoprost; n = 4, latanoprost). In the total population, mean IOP was significantly reduced from baseline (P = 0.000009), showing a 16.8% reduction after 12 weeks of TTFC therapy. In the study subgroups, mean IOP was significantly reduced from baseline to week 12 (P = 0.0001) in the prior travoprost cohort (19.0% reduction) and in the prior nontravoprost cohort (13.1% reduction). Seven mild, ocular, treatment-related adverse events were reported. Of the ten ocular symptom questions, eight had numerically lower percentages with TTFC compared with prior PGA monotherapy and two had numerically higher percentages with TTFC (dry eye symptoms and ocular stinging/burning). At week 12, TTFC was preferred over prior therapy for 84.2% of patients (48 of 57) by the patients themselves, and for 94.7% of patients (54 of 57) by their physicians. Conclusion: When TTFC replaced PGA monotherapy in patients whose IOP had been uncontrolled, the outcome was a significant reduction in IOP and an acceptable safety and tolerability profile. Most patients and investigators preferred TTFC to prior PGA monotherapy. © 2012 Costa et al, publisher and licensee Dove Medical Press Ltd.en
dc.description.affiliationUniversidade Estadual de Campinas - UNICAMP, Rua Mato Grosso, 306, Higienopolis, 01239-040 São Paulo
dc.description.affiliationUniversidade Federal do Paraná, Curitiba
dc.description.affiliationSanta Casa de Misericórdia de São Paulo, São Paulo
dc.description.affiliationFaculdade de Medicina de Botucatu UNESP
dc.description.affiliationUnespFaculdade de Medicina de Botucatu UNESP
dc.format.extent699-706
dc.identifierhttp://dx.doi.org/10.2147/OPTH.S30717
dc.identifier.citationClinical Ophthalmology, v. 6, n. 1, p. 699-706, 2012.
dc.identifier.doi10.2147/OPTH.S30717
dc.identifier.file2-s2.0-84863433622.pdf
dc.identifier.issn1177-5467
dc.identifier.issn1177-5483
dc.identifier.lattes5988776856320701
dc.identifier.scopus2-s2.0-84863433622
dc.identifier.urihttp://hdl.handle.net/11449/73318
dc.language.isoeng
dc.relation.ispartofClinical Ophthalmology
dc.relation.ispartofsjr1,035
dc.relation.ispartofsjr1,035
dc.rights.accessRightsAcesso aberto
dc.sourceScopus
dc.subjectFixed combination
dc.subjectGlaucoma
dc.subjectIntraocular pressure
dc.subjectProstaglandin analog
dc.subjectTimolol
dc.subjectTravoprost
dc.subjectbenzalkonium chloride
dc.subjectbimatoprost
dc.subjecteye drops
dc.subjectlatanoprost
dc.subjectprostaglandin derivative
dc.subjecttimolol plus travoprost
dc.subjecttravoprost
dc.subjectabnormal sensation
dc.subjectadult
dc.subjectadverse outcome
dc.subjectaged
dc.subjectblepharitis
dc.subjectclinical assessment
dc.subjectclinical effectiveness
dc.subjectcontrolled clinical trial
dc.subjectcontrolled study
dc.subjectdisease control
dc.subjectdose response
dc.subjectdrug efficacy
dc.subjectdrug hypersensitivity
dc.subjectdrug safety
dc.subjectdrug tolerability
dc.subjectdrug withdrawal
dc.subjectdry eye
dc.subjectevening dosage
dc.subjecteye burning
dc.subjecteye disease
dc.subjecteye redness
dc.subjectfemale
dc.subjecthuman
dc.subjectintraocular hypertension
dc.subjectintraocular pressure abnormality
dc.subjectmajor clinical study
dc.subjectmale
dc.subjectmonotherapy
dc.subjectmulticenter study
dc.subjectocular pruritus
dc.subjectopen angle glaucoma
dc.subjectopen study
dc.subjectoutcome assessment
dc.subjectslit lamp
dc.subjecttreatment duration
dc.subjectvisual acuity
dc.titleEfficacy and safety of travoprost 0.004%/timolol 0.5% fixed combination as transition therapy in patients previously on prostaglandin analog monotherapyen
dc.typeArtigo
dcterms.licensehttp://www.dovepress.com/why_publish_with_dove.php?folder_id=204
unesp.author.lattes5988776856320701
unesp.campusUniversidade Estadual Paulista (Unesp), Faculdade de Medicina, Botucatupt

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