A combined analysis of five observational studies evaluating the efficacy and tolerability of bimatoprost/timolol fixed combination in patients with primary open-angle glaucoma or ocular hypertension
Stefan Pfennigsdorf,1 Leo de Jong,2 Stefan Makk,3 Yvette Fournichot,4 Alain Bron,5 Robert J Morgan-Warren,6 John Maltman6 1Ophthalmology Practice, Polch, Germany; 2Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands; 3Ophthalmology Practice, Graz, Austria; 4Ophthalmology Practic...
Guardado en:
| Autores principales: | , , , , , , |
|---|---|
| Formato: | article |
| Lenguaje: | EN |
| Publicado: |
Dove Medical Press
2013
|
| Materias: | |
| Acceso en línea: | https://doaj.org/article/a22a4214c0ca42dd9a43a17c5e932af9 |
| Etiquetas: |
Agregar Etiqueta
Sin Etiquetas, Sea el primero en etiquetar este registro!
|
| id |
oai:doaj.org-article:a22a4214c0ca42dd9a43a17c5e932af9 |
|---|---|
| record_format |
dspace |
| spelling |
oai:doaj.org-article:a22a4214c0ca42dd9a43a17c5e932af92021-12-02T05:18:18ZA combined analysis of five observational studies evaluating the efficacy and tolerability of bimatoprost/timolol fixed combination in patients with primary open-angle glaucoma or ocular hypertension1177-54671177-5483https://doaj.org/article/a22a4214c0ca42dd9a43a17c5e932af92013-06-01T00:00:00Zhttp://www.dovepress.com/a-combined-analysis-of-five-observational-studies-evaluating-the-effic-a13431https://doaj.org/toc/1177-5467https://doaj.org/toc/1177-5483Stefan Pfennigsdorf,1 Leo de Jong,2 Stefan Makk,3 Yvette Fournichot,4 Alain Bron,5 Robert J Morgan-Warren,6 John Maltman6 1Ophthalmology Practice, Polch, Germany; 2Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands; 3Ophthalmology Practice, Graz, Austria; 4Ophthalmology Practice, Schlieren, Switzerland; 5Department of Ophthalmology, University Hospital, Dijon, France; 6Allergan Ltd, Marlow, UK Objective: The aim of this study was to evaluate the safety and efficacy of a fixed combination of bimatoprost 0.03% and timolol (BTFC) in a clinical setting, in a large sample of patients with primary open-angle glaucoma or ocular hypertension and insufficient intraocular pressure (IOP) lowering on prior therapy. Methods: Patient data were combined (n = 5556) from five multicenter, observational, non-controlled, open-label studies throughout Europe. Patients were identified from 830 sites in Austria, France, Germany, The Netherlands, and Switzerland. Assessments were made at baseline, 6 weeks (in Austrian, German and Swiss centers), and 12 weeks in all centers. Results: BTFC lowered mean IOP from baseline by 5.4 mmHg over the 12-week duration of the studies (P < 0.0001). At study entry, 92.9% of patients were receiving another ocular hypotensive medication. In patients with no previous treatment (n = 311), BTFC reduced IOP by -9.1 mmHg, corresponding to a reduction from baseline of 36.4% (P < 0.0001). In patients receiving prior therapy of a prostaglandin analog, a ß-blocker, or a fixed combination, BTFC reduced IOP by a further 24.5%, 25.9%, and 21.4%, respectively. The majority of patients (90.3%) reported no adverse events. The most common adverse events were conjunctival hyperemia (3.2%) and eye irritation (2.8%). BTFC was rated as "good" or "very good" by 92.5% of physicians and 88.0% of patients. Most patients (96.3%) were equally or more compliant with BTFC than with their previous treatment. Conclusion: In routine clinical practice, BTFC achieved consistent IOP lowering in both previously treated and untreated patients with primary open-angle glaucoma or ocular hypertension. BTFC was associated with significant IOP reductions, good tolerability, and good compliance. Keywords: bimatoprost 0.03%, intraocular pressure, ocular hypotensive medication, prostaglandin analog, ß-blockerPfennigsdorf Sde Jong LMakk SFournichot YBron AMorgan-Warren RJMaltman JDove Medical PressarticleOphthalmologyRE1-994ENClinical Ophthalmology, Vol 2013, Iss default, Pp 1219-1225 (2013) |
| institution |
DOAJ |
| collection |
DOAJ |
| language |
EN |
| topic |
Ophthalmology RE1-994 |
| spellingShingle |
Ophthalmology RE1-994 Pfennigsdorf S de Jong L Makk S Fournichot Y Bron A Morgan-Warren RJ Maltman J A combined analysis of five observational studies evaluating the efficacy and tolerability of bimatoprost/timolol fixed combination in patients with primary open-angle glaucoma or ocular hypertension |
| description |
Stefan Pfennigsdorf,1 Leo de Jong,2 Stefan Makk,3 Yvette Fournichot,4 Alain Bron,5 Robert J Morgan-Warren,6 John Maltman6 1Ophthalmology Practice, Polch, Germany; 2Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands; 3Ophthalmology Practice, Graz, Austria; 4Ophthalmology Practice, Schlieren, Switzerland; 5Department of Ophthalmology, University Hospital, Dijon, France; 6Allergan Ltd, Marlow, UK Objective: The aim of this study was to evaluate the safety and efficacy of a fixed combination of bimatoprost 0.03% and timolol (BTFC) in a clinical setting, in a large sample of patients with primary open-angle glaucoma or ocular hypertension and insufficient intraocular pressure (IOP) lowering on prior therapy. Methods: Patient data were combined (n = 5556) from five multicenter, observational, non-controlled, open-label studies throughout Europe. Patients were identified from 830 sites in Austria, France, Germany, The Netherlands, and Switzerland. Assessments were made at baseline, 6 weeks (in Austrian, German and Swiss centers), and 12 weeks in all centers. Results: BTFC lowered mean IOP from baseline by 5.4 mmHg over the 12-week duration of the studies (P < 0.0001). At study entry, 92.9% of patients were receiving another ocular hypotensive medication. In patients with no previous treatment (n = 311), BTFC reduced IOP by -9.1 mmHg, corresponding to a reduction from baseline of 36.4% (P < 0.0001). In patients receiving prior therapy of a prostaglandin analog, a ß-blocker, or a fixed combination, BTFC reduced IOP by a further 24.5%, 25.9%, and 21.4%, respectively. The majority of patients (90.3%) reported no adverse events. The most common adverse events were conjunctival hyperemia (3.2%) and eye irritation (2.8%). BTFC was rated as "good" or "very good" by 92.5% of physicians and 88.0% of patients. Most patients (96.3%) were equally or more compliant with BTFC than with their previous treatment. Conclusion: In routine clinical practice, BTFC achieved consistent IOP lowering in both previously treated and untreated patients with primary open-angle glaucoma or ocular hypertension. BTFC was associated with significant IOP reductions, good tolerability, and good compliance. Keywords: bimatoprost 0.03%, intraocular pressure, ocular hypotensive medication, prostaglandin analog, ß-blocker |
| format |
article |
| author |
Pfennigsdorf S de Jong L Makk S Fournichot Y Bron A Morgan-Warren RJ Maltman J |
| author_facet |
Pfennigsdorf S de Jong L Makk S Fournichot Y Bron A Morgan-Warren RJ Maltman J |
| author_sort |
Pfennigsdorf S |
| title |
A combined analysis of five observational studies evaluating the efficacy and tolerability of bimatoprost/timolol fixed combination in patients with primary open-angle glaucoma or ocular hypertension |
| title_short |
A combined analysis of five observational studies evaluating the efficacy and tolerability of bimatoprost/timolol fixed combination in patients with primary open-angle glaucoma or ocular hypertension |
| title_full |
A combined analysis of five observational studies evaluating the efficacy and tolerability of bimatoprost/timolol fixed combination in patients with primary open-angle glaucoma or ocular hypertension |
| title_fullStr |
A combined analysis of five observational studies evaluating the efficacy and tolerability of bimatoprost/timolol fixed combination in patients with primary open-angle glaucoma or ocular hypertension |
| title_full_unstemmed |
A combined analysis of five observational studies evaluating the efficacy and tolerability of bimatoprost/timolol fixed combination in patients with primary open-angle glaucoma or ocular hypertension |
| title_sort |
combined analysis of five observational studies evaluating the efficacy and tolerability of bimatoprost/timolol fixed combination in patients with primary open-angle glaucoma or ocular hypertension |
| publisher |
Dove Medical Press |
| publishDate |
2013 |
| url |
https://doaj.org/article/a22a4214c0ca42dd9a43a17c5e932af9 |
| work_keys_str_mv |
AT pfennigsdorfs acombinedanalysisoffiveobservationalstudiesevaluatingtheefficacyandtolerabilityofbimatoprosttimololfixedcombinationinpatientswithprimaryopenangleglaucomaorocularhypertension AT dejongl acombinedanalysisoffiveobservationalstudiesevaluatingtheefficacyandtolerabilityofbimatoprosttimololfixedcombinationinpatientswithprimaryopenangleglaucomaorocularhypertension AT makks acombinedanalysisoffiveobservationalstudiesevaluatingtheefficacyandtolerabilityofbimatoprosttimololfixedcombinationinpatientswithprimaryopenangleglaucomaorocularhypertension AT fournichoty acombinedanalysisoffiveobservationalstudiesevaluatingtheefficacyandtolerabilityofbimatoprosttimololfixedcombinationinpatientswithprimaryopenangleglaucomaorocularhypertension AT brona acombinedanalysisoffiveobservationalstudiesevaluatingtheefficacyandtolerabilityofbimatoprosttimololfixedcombinationinpatientswithprimaryopenangleglaucomaorocularhypertension AT morganwarrenrj acombinedanalysisoffiveobservationalstudiesevaluatingtheefficacyandtolerabilityofbimatoprosttimololfixedcombinationinpatientswithprimaryopenangleglaucomaorocularhypertension AT maltmanj acombinedanalysisoffiveobservationalstudiesevaluatingtheefficacyandtolerabilityofbimatoprosttimololfixedcombinationinpatientswithprimaryopenangleglaucomaorocularhypertension AT pfennigsdorfs combinedanalysisoffiveobservationalstudiesevaluatingtheefficacyandtolerabilityofbimatoprosttimololfixedcombinationinpatientswithprimaryopenangleglaucomaorocularhypertension AT dejongl combinedanalysisoffiveobservationalstudiesevaluatingtheefficacyandtolerabilityofbimatoprosttimololfixedcombinationinpatientswithprimaryopenangleglaucomaorocularhypertension AT makks combinedanalysisoffiveobservationalstudiesevaluatingtheefficacyandtolerabilityofbimatoprosttimololfixedcombinationinpatientswithprimaryopenangleglaucomaorocularhypertension AT fournichoty combinedanalysisoffiveobservationalstudiesevaluatingtheefficacyandtolerabilityofbimatoprosttimololfixedcombinationinpatientswithprimaryopenangleglaucomaorocularhypertension AT brona combinedanalysisoffiveobservationalstudiesevaluatingtheefficacyandtolerabilityofbimatoprosttimololfixedcombinationinpatientswithprimaryopenangleglaucomaorocularhypertension AT morganwarrenrj combinedanalysisoffiveobservationalstudiesevaluatingtheefficacyandtolerabilityofbimatoprosttimololfixedcombinationinpatientswithprimaryopenangleglaucomaorocularhypertension AT maltmanj combinedanalysisoffiveobservationalstudiesevaluatingtheefficacyandtolerabilityofbimatoprosttimololfixedcombinationinpatientswithprimaryopenangleglaucomaorocularhypertension |
| _version_ |
1718400487965851648 |