Suchergebnisse

Adnan Tufail,1 Sue Lightman,1 Ahmed Kamal,2 Uwe Pleyer,3 Nuria María Gajate Paniagua,4 Corrine Dot,5,6 Xiao-Yan Li,7 Jenny Jiao,7 Jean Lou,7 Yehia Hashad7 For the CONSTANCE Study Group 1Moorfields Eye Hospital, London, UK; 2Aintree University Hospital, Liverpool, UK; 3University Eye Hospital, Uveitis Center, Charité – Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt University Berlin, and Berlin Institute of Health, Berlin, Germany; 4University Hospital of Burgos, Burgos, Spain; 5Department of Ophthalmology, Desgenettes Military Hospital, Lyon, France; 6French Military Health Service Academy, Val de Grâce, Paris, France; 7Allergan Plc, Irvine, CA, USA Purpose: To evaluate the long-term safety of dexamethasone intravitreal implant (DEX) in patients treated for macular edema associated with retinal vein occlusion (RVO) or noninfectious posterior segment uveitis (NIPSU) in clinical practice.Patients and methods: Multicenter (102 sites in France, Germany, Spain, UK), prospective, observational, post-authorization safety study in adult patients treated with DEX. Data collected up to 2 years after enrollment included serious adverse events (SAEs) and adverse events of special interest (AESIs; adverse drug reactions that are considered important risks associated with DEX and listed in the European Union Ozurdex Risk Management Plan).Results: Overall, 803 patients (652 RVO, 151 NIPSU) received on-study DEX treatment, and 73.1% completed 24 months of follow-up; 72.6% were DEX-naïve. Median number of on-study injections per treated eye was 2 (range, 1–7); median reinjection interval was 27.1 weeks. Nonocular SAEs affected 9.5% of patients; none were considered DEX-related. Ocular SAEs (most common: cataract progression) occurred in 3.2% of treated eyes. SAEs were similar in eyes stratified by previous DEX use and number of on-study DEX injections (≤2 or >2), in both RVO and NIPSU. The most common AESIs were cataract formation and progression (20.0% and 19.2% of treated phakic eyes, n=551), increased intraocular pressure (19.0% of treated eyes), and vitreous hemorrhage (3.3% of treated eyes). Cataract progression was more frequent in baseline phakic eyes that were previously treated with DEX or received >2 on-study DEX injections.Conclusion: The long-term safety profile of DEX was acceptable. No new safety concerns were identified. Keywords: corticosteroid, dexamethasone, drug delivery device, retinal vein occlusion, safety profile, uveitis

Diese Leitlinie richtet sich an Dermatologen, Ophthalmologen, HNO‐Ärzte, Pädiater, Neurologen, Virologen sowie Infektiologen, Anästhesisten und Allgemeinmediziner in Klinik und Praxis und dient zur Information für andere medizinische Fachrichtungen, die an der Behandlung des Zoster beteiligt sind. Darüber hinaus soll die Leitlinie Kostenträgern und politischen Entscheidungsträgern zur Orientierung dienen. Die Leitlinie wurde im formellen Konsensusverfahren (S2k) von Dermatologen, Virologen/Infektiologen, Ophthalmologen, HNO‐Ärzten, Neurologen, Pädiatern und Anästhesisten/Schmerzmedizinern erstellt. Die Leitlinie stellt einen Überblick über die klinische und molekulare Diagnostik sowie den Antigennachweis, die Antikörperkultur und Viruskultur dar. Diagnostisch besondere Situationen und komplizierte Verläufe der Erkrankung finden ebenfalls Berücksichtigung. Die antivirale Therapie des Zoster und der Postzosterneuralgie wird im Allgemeinen und für besondere Situationen dargelegt. Detaillierte Angaben zur Schmerzbehandlung finden Erwähnung und sind in einer Übersicht dargestellt. Ebenso werden die lokaltherapeutischen Maßnahmen thematisiert.