Safety and efficacy of changing to the travoprost/timolol maleate fixed combination (DuoTrav) from prior mono- or adjunctive therapy
Norbert Pfeiffer1, Maria-Luise Scherzer2, Hubert Maier3, Sonja Schoelzel4, Mark C Jasek5, Jeanette A Stewart6, William C Stewart6 On behalf of the DuoTravMED study group1Johannes Gutenberg-Universität Mainz, Mainz, Germany; 2Regenstauf, Germany; 3Gerolzhofen, Germany; 4Institutes of Mol...
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Dove Medical Press
2010
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oai:doaj.org-article:5f3342e3d4c646aeae3e9f5eab6063f82021-12-02T03:42:25ZSafety and efficacy of changing to the travoprost/timolol maleate fixed combination (DuoTrav) from prior mono- or adjunctive therapy1177-54671177-5483https://doaj.org/article/5f3342e3d4c646aeae3e9f5eab6063f82010-05-01T00:00:00Zhttp://www.dovepress.com/safety-and-efficacy-of-changing-to-the-travoprosttimolol-maleate-fixed-a4379https://doaj.org/toc/1177-5467https://doaj.org/toc/1177-5483Norbert Pfeiffer1, Maria-Luise Scherzer2, Hubert Maier3, Sonja Schoelzel4, Mark C Jasek5, Jeanette A Stewart6, William C Stewart6 On behalf of the DuoTravMED study group1Johannes Gutenberg-Universität Mainz, Mainz, Germany; 2Regenstauf, Germany; 3Gerolzhofen, Germany; 4Institutes of Molecular Medicine, University of Freiburg, Department of Surgery, Freiburg, Germany; 5Alcon Laboratories, Inc., Fort Worth, TX, USA; 6PRN Pharmaceutical Research Network, LLC, Charleston, SC, USAPurpose: To assess the safety and efficacy of changing to the travoprost/timolol fixed combination (TTFC) from other mono- or adjunctive therapies.Patients and methods: A prospective, open-label, observational cohort of primary open-angle glaucoma and ocular hypertensive patients whose intraocular pressure (IOP) was uncontrolled on prior therapy or was not on target. Patients were changed from prior mono- or adjunctive treatment at Day 0 to TTFC dosed every evening and underwent active treatment efficacy and safety evaluations at Week 12.Results: In 474/522 (91%) patients who completed this trial an IOP (mm Hg) of 21.9 ± 2.0 on prior treatment was reduced by TTFC at Month 3: from all prior treatments 5.6 ± 2.6; from monotherapy 5.9 ± 2.3; from adjunctive treatments 4.5 ± 2.9; and from several of the most frequent individual treatments: timolol 5.7 ± 2.2; latanoprost 6.3 ± 2.6; and latanoprost/timolol fixed combination 4.4 ± 1.9. Ocular hyperemia was the most frequent adverse effect (n = 21, 4%). Both patients and physicians preferred TTFC compared to all prior and common individual treatments. The solicited symptom survey showed, following a modified Bonferroni correction (α/5), a reduced incidence with TTFC of ocular pain (P = 0.01) while the prior medicine had a lower incidence of burning on instillation (P < 0.001).Conclusions: Changing patients from prior mono- or adjunctive therapy to TTFC can provide on average a further reduction in IOP while demonstrating a favorable safety profile and a high patient preference.Keywords: travoprost/timolol fixed combination, primary open-angle glaucoma, ocular hypertension, safety, efficacy, intraocular pressure Norbert PfeifferMaria-Luise ScherzerHubert Maieret alDove Medical PressarticleOphthalmologyRE1-994ENClinical Ophthalmology, Vol 2010, Iss default, Pp 459-466 (2010) |
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Ophthalmology RE1-994 |
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Ophthalmology RE1-994 Norbert Pfeiffer Maria-Luise Scherzer Hubert Maier et al Safety and efficacy of changing to the travoprost/timolol maleate fixed combination (DuoTrav) from prior mono- or adjunctive therapy |
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Norbert Pfeiffer1, Maria-Luise Scherzer2, Hubert Maier3, Sonja Schoelzel4, Mark C Jasek5, Jeanette A Stewart6, William C Stewart6 On behalf of the DuoTravMED study group1Johannes Gutenberg-Universität Mainz, Mainz, Germany; 2Regenstauf, Germany; 3Gerolzhofen, Germany; 4Institutes of Molecular Medicine, University of Freiburg, Department of Surgery, Freiburg, Germany; 5Alcon Laboratories, Inc., Fort Worth, TX, USA; 6PRN Pharmaceutical Research Network, LLC, Charleston, SC, USAPurpose: To assess the safety and efficacy of changing to the travoprost/timolol fixed combination (TTFC) from other mono- or adjunctive therapies.Patients and methods: A prospective, open-label, observational cohort of primary open-angle glaucoma and ocular hypertensive patients whose intraocular pressure (IOP) was uncontrolled on prior therapy or was not on target. Patients were changed from prior mono- or adjunctive treatment at Day 0 to TTFC dosed every evening and underwent active treatment efficacy and safety evaluations at Week 12.Results: In 474/522 (91%) patients who completed this trial an IOP (mm Hg) of 21.9 ± 2.0 on prior treatment was reduced by TTFC at Month 3: from all prior treatments 5.6 ± 2.6; from monotherapy 5.9 ± 2.3; from adjunctive treatments 4.5 ± 2.9; and from several of the most frequent individual treatments: timolol 5.7 ± 2.2; latanoprost 6.3 ± 2.6; and latanoprost/timolol fixed combination 4.4 ± 1.9. Ocular hyperemia was the most frequent adverse effect (n = 21, 4%). Both patients and physicians preferred TTFC compared to all prior and common individual treatments. The solicited symptom survey showed, following a modified Bonferroni correction (α/5), a reduced incidence with TTFC of ocular pain (P = 0.01) while the prior medicine had a lower incidence of burning on instillation (P < 0.001).Conclusions: Changing patients from prior mono- or adjunctive therapy to TTFC can provide on average a further reduction in IOP while demonstrating a favorable safety profile and a high patient preference.Keywords: travoprost/timolol fixed combination, primary open-angle glaucoma, ocular hypertension, safety, efficacy, intraocular pressure |
| format |
article |
| author |
Norbert Pfeiffer Maria-Luise Scherzer Hubert Maier et al |
| author_facet |
Norbert Pfeiffer Maria-Luise Scherzer Hubert Maier et al |
| author_sort |
Norbert Pfeiffer |
| title |
Safety and efficacy of changing to the travoprost/timolol maleate fixed combination (DuoTrav) from prior mono- or adjunctive therapy |
| title_short |
Safety and efficacy of changing to the travoprost/timolol maleate fixed combination (DuoTrav) from prior mono- or adjunctive therapy |
| title_full |
Safety and efficacy of changing to the travoprost/timolol maleate fixed combination (DuoTrav) from prior mono- or adjunctive therapy |
| title_fullStr |
Safety and efficacy of changing to the travoprost/timolol maleate fixed combination (DuoTrav) from prior mono- or adjunctive therapy |
| title_full_unstemmed |
Safety and efficacy of changing to the travoprost/timolol maleate fixed combination (DuoTrav) from prior mono- or adjunctive therapy |
| title_sort |
safety and efficacy of changing to the travoprost/timolol maleate fixed combination (duotrav) from prior mono- or adjunctive therapy |
| publisher |
Dove Medical Press |
| publishDate |
2010 |
| url |
https://doaj.org/article/5f3342e3d4c646aeae3e9f5eab6063f8 |
| work_keys_str_mv |
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