Effects of Fenofibric Acid on Diabetic Macular Edema: The MacuFen study
Rattachement africain : fr, gb, mx, ch. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
PURPOSE: Fenofibrate reduced progression of diabetic retinopathy in two large randomized studies. The effect of 135 mg fenofibric acid on diabetic macular edema (DME) was evaluated in subjects with existing DME. METHODS: In this double-blind, randomized, placebo-controlled study, 110 subjects with DME not requiring immediate photocoagulation or intraocular treatment with adequate diabetes and blood pressure control received either fenofibric acid or placebo once daily for 1 year. Total macula volume (TMV) and thickness were measured in the worse eye and all eligible eyes with time-domain optical coherence tomography at baseline and quarterly thereafter. RESULTS: TMV decreased by -0.35 mm(3) (within-group difference) after fenofibric acid treatment and by -0.11 mm(3) after placebo. The between-group comparison of the change was -0.25 mm(3) (95% confidence interval, CI, -0.645-0.155; p = 0.227, worse eye analysis). Weighted inner zone thickness and volume decreased by -18.7 µm and -0.13 mm(3), respectively, for within group difference after fenofibric acid and by -3.1 µm and -0.02 mm(3), respectively, after placebo. Considering all eligible eyes, thicknesses at central zone, mean inner zone, and entire retina decreased by -21.3 µm, -19.8 µm, and -20.4 µm, respectively, after fenofibric acid. No between-group difference in changes of these measurements was observed. Triglycerides decreased by 23% after fenofibric acid (vs 4% after placebo, p = 0.001) and high-density lipoprotein cholesterol increased by 8% (vs 0.3%, p = 0.014). No safety concern was identified. CONCLUSION: Subjects treated with fenofibric acid had a modest improvement in TMV, although the study was probably underpowered to detect a benefit over placebo after 1 year.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Effects of Fenofibric Acid on Diabetic Macular Edema: The MacuFen study
- Date Crossref
- 18/08/2014
- Éditeur
- Informa UK Limited
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Hôpital Lariboisière pays non établi dans la noticeÉtablissement de santé
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Moorfields Eye Hospital NHS Foundation Trust pays non établi dans la noticeÉtablissement de santé
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Institute of Ophthalmology pays non établi dans la noticeOrganisation à but non lucratif
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University College London pays non établi dans la noticeUniversité ou école supérieure
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Abbott (Switzerland) pays non établi dans la noticeEntreprise
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Clinsciences pays non établi dans la noticeInstitution
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Strategic Medical Affairs pays non établi dans la noticeInstitution
Hôpital Lariboisière, Moorfields Eye Hospital NHS Foundation Trust et Institute of Ophthalmology, avec 4 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.