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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...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2015
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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. |
format | Online Article Text |
id | pubmed-4467379 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
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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