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Systematic review and mixed treatment comparison of intravitreal aflibercept with other therapies for diabetic macular edema (DME)

BACKGROUND: This was an indirect comparison of the effectiveness of intravitreal aflibercept (IVT-AFL) 2 mg every 8 weeks after 5 initial monthly doses (or if different periods, after an initial monthly dosing period) (2q8) and other diabetic macular edema (DME) therapies at doses licensed outside t...

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Autores principales: Korobelnik, Jean-Francois, Kleijnen, Jos, Lang, Shona H, Birnie, Richard, Leadley, Regina M, Misso, Kate, Worthy, Gill, Muston, Dominic, Do, Diana V
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4467379/
https://www.ncbi.nlm.nih.gov/pubmed/25975823
http://dx.doi.org/10.1186/s12886-015-0035-x
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author Korobelnik, Jean-Francois
Kleijnen, Jos
Lang, Shona H
Birnie, Richard
Leadley, Regina M
Misso, Kate
Worthy, Gill
Muston, Dominic
Do, Diana V
author_facet Korobelnik, Jean-Francois
Kleijnen, Jos
Lang, Shona H
Birnie, Richard
Leadley, Regina M
Misso, Kate
Worthy, Gill
Muston, Dominic
Do, Diana V
author_sort Korobelnik, Jean-Francois
collection PubMed
description BACKGROUND: This was an indirect comparison of the effectiveness of intravitreal aflibercept (IVT-AFL) 2 mg every 8 weeks after 5 initial monthly doses (or if different periods, after an initial monthly dosing period) (2q8) and other diabetic macular edema (DME) therapies at doses licensed outside the USA. METHODS: A comprehensive search was undertaken to source relevant studies. Feasibility networks were prepared to identify viable comparisons of 12-month outcomes between IVT-AFL 2q8 and therapies licensed outside the USA, which were assessed for clinical and statistical homogeneity. Pooled effect sizes (mean difference [MD] and relative risk/risk ratio [RR]) were calculated using fixed- and random-effects models. Indirect comparisons were performed using Bucher analysis. If at least one ‘head-to-head’ study was found then a mixed treatment comparison (MTC) was performed using Bayesian methods. Two 12-month comparisons could be undertaken based on indirect analyses: IVT-AFL 2q8 versus intravitreal ranibizumab (IVR) 0.5 mg as needed (PRN) (10 studies) and IVT-AFL 2q8 versus dexamethasone 0.7 mg implants (three studies). RESULTS: There was an increase in mean best-corrected visual acuity (BCVA) with IVT-AFL 2q8 over IVR 0.5 mg PRN by 4.67 letters [95% credible interval (CrI): 2.45–6.87] in the fixed-effect MTC model (10 studies) and by 4.82 letters [95% confidence interval (CI): 2.52–7.11] in the Bucher indirect analysis (four studies). IVT-AFL 2q8 doubled the proportion of patients gaining ≥ 10 Early Treatment Diabetic Retinopathy Study letters at 12 months compared with dexamethasone 0.7 mg implants (RR = 2.10 [95% CI: 1.29–3.40]) in the fixed-effect model. There were no significant differences in safety outcomes between IVT-AFL 2q8 and IVR 0.5 mg PRN or dexamethasone 0.7 mg implants. CONCLUSIONS: Studies of IVT-AFL 2q8 showed improved 12-month visual acuity measures compared with studies of IVR 0.5 mg PRN and dexamethasone 0.7 mg implants based on indirect comparisons. These analyses are subject to a number of limitations which are inherent in indirect data comparisons. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12886-015-0035-x) contains supplementary material, which is available to authorized users.
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spelling pubmed-44673792015-06-16 Systematic review and mixed treatment comparison of intravitreal aflibercept with other therapies for diabetic macular edema (DME) Korobelnik, Jean-Francois Kleijnen, Jos Lang, Shona H Birnie, Richard Leadley, Regina M Misso, Kate Worthy, Gill Muston, Dominic Do, Diana V BMC Ophthalmol Research Article BACKGROUND: This was an indirect comparison of the effectiveness of intravitreal aflibercept (IVT-AFL) 2 mg every 8 weeks after 5 initial monthly doses (or if different periods, after an initial monthly dosing period) (2q8) and other diabetic macular edema (DME) therapies at doses licensed outside the USA. METHODS: A comprehensive search was undertaken to source relevant studies. Feasibility networks were prepared to identify viable comparisons of 12-month outcomes between IVT-AFL 2q8 and therapies licensed outside the USA, which were assessed for clinical and statistical homogeneity. Pooled effect sizes (mean difference [MD] and relative risk/risk ratio [RR]) were calculated using fixed- and random-effects models. Indirect comparisons were performed using Bucher analysis. If at least one ‘head-to-head’ study was found then a mixed treatment comparison (MTC) was performed using Bayesian methods. Two 12-month comparisons could be undertaken based on indirect analyses: IVT-AFL 2q8 versus intravitreal ranibizumab (IVR) 0.5 mg as needed (PRN) (10 studies) and IVT-AFL 2q8 versus dexamethasone 0.7 mg implants (three studies). RESULTS: There was an increase in mean best-corrected visual acuity (BCVA) with IVT-AFL 2q8 over IVR 0.5 mg PRN by 4.67 letters [95% credible interval (CrI): 2.45–6.87] in the fixed-effect MTC model (10 studies) and by 4.82 letters [95% confidence interval (CI): 2.52–7.11] in the Bucher indirect analysis (four studies). IVT-AFL 2q8 doubled the proportion of patients gaining ≥ 10 Early Treatment Diabetic Retinopathy Study letters at 12 months compared with dexamethasone 0.7 mg implants (RR = 2.10 [95% CI: 1.29–3.40]) in the fixed-effect model. There were no significant differences in safety outcomes between IVT-AFL 2q8 and IVR 0.5 mg PRN or dexamethasone 0.7 mg implants. CONCLUSIONS: Studies of IVT-AFL 2q8 showed improved 12-month visual acuity measures compared with studies of IVR 0.5 mg PRN and dexamethasone 0.7 mg implants based on indirect comparisons. These analyses are subject to a number of limitations which are inherent in indirect data comparisons. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12886-015-0035-x) contains supplementary material, which is available to authorized users. BioMed Central 2015-05-15 /pmc/articles/PMC4467379/ /pubmed/25975823 http://dx.doi.org/10.1186/s12886-015-0035-x Text en © Korobelnik et al. 2015 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research Article
Korobelnik, Jean-Francois
Kleijnen, Jos
Lang, Shona H
Birnie, Richard
Leadley, Regina M
Misso, Kate
Worthy, Gill
Muston, Dominic
Do, Diana V
Systematic review and mixed treatment comparison of intravitreal aflibercept with other therapies for diabetic macular edema (DME)
title Systematic review and mixed treatment comparison of intravitreal aflibercept with other therapies for diabetic macular edema (DME)
title_full Systematic review and mixed treatment comparison of intravitreal aflibercept with other therapies for diabetic macular edema (DME)
title_fullStr Systematic review and mixed treatment comparison of intravitreal aflibercept with other therapies for diabetic macular edema (DME)
title_full_unstemmed Systematic review and mixed treatment comparison of intravitreal aflibercept with other therapies for diabetic macular edema (DME)
title_short Systematic review and mixed treatment comparison of intravitreal aflibercept with other therapies for diabetic macular edema (DME)
title_sort systematic review and mixed treatment comparison of intravitreal aflibercept with other therapies for diabetic macular edema (dme)
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4467379/
https://www.ncbi.nlm.nih.gov/pubmed/25975823
http://dx.doi.org/10.1186/s12886-015-0035-x
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