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[PMID]:29248913
[Au] Autor:Pessoa B; Coelho J; Correia N; Ferreira N; Beirão M; Meireles A
[Ad] Endereço:Serviço de Oftalmologia, Centro Hospitalar do Porto, Hospital de Santo Antonio, Porto, Portugal.
[Ti] Título:Fluocinolone Acetonide Intravitreal Implant 190 µg (ILUVIEN®) in Vitrectomized versus Nonvitrectomized Eyes for the Treatment of Chronic Diabetic Macular Edema.
[So] Source:Ophthalmic Res;59(2):68-75, 2018.
[Is] ISSN:1423-0259
[Cp] País de publicação:Switzerland
[La] Idioma:eng
[Ab] Resumo:PURPOSE: To compare the functional and anatomical outcomes after a 0.2 µg/day fluocinolone acetonide (FAc) implant between vitrectomized and nonvitrectomized eyes with chronic diabetic macular edema (DME). METHODS: This is a retrospective, comparative analysis of 43 eyes with chronic DME. All eyes were treated with a single 0.2 µg/day FAc implant and followed up for a mean period of 8.5 months (median, 6.0 months; range, 1-21 months). The patients with a 0.2 µg/day FAc implant were divided into 2 groups: 24 eyes which had undergone pars plana vitrectomy prior to 0.2 µg/day FAc (group 1) and 19 eyes which had not been vitrectomized (group 2). Outcome measures included mean changes in best corrected visual acuity (BCVA) in Early Treatment Diabetic Retinopathy Study letters, central subfield foveal thickness (CSFT), and intraocular pressure (IOP), and were measured prior to administration of the 0.2 µg FAc implant, in the first week, at month 1, and quarterly thereafter. RESULTS: Following the 0.2 µg/day FAc implant, the mean change in BCVA at the last observation point, from baseline, was +16.9 ± 3.39 (mean ± SE) letters (p ≤ 0.001) in group 1 and +8.2 ± 4.62 letters (p = 0.092) in group 2. From baseline, a gain of ≥15 letters was achieved in 37.5 and 36.8% of the eyes in group 1 and group 2, respectively. Additionally, an improvement in vision ≥20/40 in 29.2% of group 1 and 15.8% of group 2 was observed. The mean change in CSFT was -217.7 ± 40.8 µm and -155.6 ± 43.4 µm in group 1 and group 2, respectively. The mean change in IOP was +1.6 ± 0.7 mm Hg in group 1 and +0.8 ± 1.3 mm Hg in group 2, relative to baseline. At the last observation point, there were no significant differences between groups 1 and 2 (p > 0.05) in terms of their changes in BCVA, CSFT, and IOP. CONCLUSION: The results from the real-life practice study demonstrate that the 0.2 µg/day FAc implant is effective and well tolerated in vitrectomized and nonvitrectomized eyes of patients with chronic DME. Our results support the use of a 0.2 µg/day FAc implant to obtain long-term functional and anatomical improvements (mean, 8.5 months; median, 6.0 months) in vitrectomized and nonvitrectomized eyes.
[Mh] Termos MeSH primário: Retinopatia Diabética/tratamento farmacológico
Fluocinolona Acetonida/administração & dosagem
Glucocorticoides/administração & dosagem
Edema Macular/tratamento farmacológico
Vitrectomia
[Mh] Termos MeSH secundário: Idoso
Doença Crônica
Retinopatia Diabética/cirurgia
Implantes de Medicamento
Feminino
Seres Humanos
Pressão Intraocular
Injeções Intravítreas
Edema Macular/cirurgia
Masculino
Meia-Idade
Estudos Retrospectivos
Acuidade Visual
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Drug Implants); 0 (Glucocorticoids); 0CD5FD6S2M (Fluocinolone Acetonide)
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180308
[Lr] Data última revisão:
180308
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171218
[St] Status:MEDLINE
[do] DOI:10.1159/000484091


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[PMID]:29486754
[Au] Autor:Fusi-Rubiano W; Mukherjee C; Lane M; Tsaloumas MD; Glover N; Kidess A; Denniston AK; Palmer HE; Manna A; Morjaria R
[Ad] Endereço:Ophthalmology Department, Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHSFT, Mindelsohn Way, Birmingham, B15 2TH, United Kingdom.
[Ti] Título:Treating Diabetic Macular Oedema (DMO): real world UK clinical outcomes for the 0.19mg Fluocinolone Acetonide intravitreal implant (Iluvien™) at 2 years.
[So] Source:BMC Ophthalmol;18(1):62, 2018 Feb 27.
[Is] ISSN:1471-2415
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: To compare visual function and structural improvements in pseudophakic eyes with diabetic macular oedema (DMO) treated with the 0.19mg Fluocinolone Acetonide (FAc) intravitreal implant (Iluvien ) in a 'real world' setting. METHODS: A single centre retrospective evaluation of patients with DMO unresponsive to conventional treatment treated with the FAc implant according to UK guidelines. Primary efficacy endpoint was best corrected visual acuity (BCVA); secondary endpoints included optical coherence tomography evaluations of the macula (a) central retinal and (b) peak macular thickness collected at annual time points. Primary safety endpoint was new rise in IOP >27mmHg or glaucoma surgery. Patients with <1 year follow-up were excluded. RESULTS: Twenty-nine eyes were included, with mean(SD) follow up of 792(270) days. Improvement in BCVA and reduction in macular oedema was noted at all timepoints. Mean improvement in BCVA from baseline was 6 ETDRS letters at year 1(n=29), 6.5L at year 2(n=22) and 11L at year 3(n=6). Mean central retinal thickness at baseline was 451 microns, 337 microns at year 1, 342 microns at year 2 and 314 microns at year 3. Two eyes required IOP-lowering drops post implant. Supplementary treatment for persistence or recurrence of DMO was necessary in 18 eyes over the total study period of 3 years with mean time to supplementary treatment being 12 months. CONCLUSIONS: Our evaluation of the 0.19mg FAc implant delivered in a real-world setting, provides additional evidence that it is effective and safe in the treatment of patients with DMO, and can provide sustained benefit for patients with previously refractory disease.
[Mh] Termos MeSH primário: Retinopatia Diabética/tratamento farmacológico
Fluocinolona Acetonida/administração & dosagem
Glucocorticoides/administração & dosagem
Edema Macular/tratamento farmacológico
[Mh] Termos MeSH secundário: Adulto
Idoso
Idoso de 80 Anos ou mais
Retinopatia Diabética/patologia
Retinopatia Diabética/fisiopatologia
Implantes de Medicamento
Feminino
Seres Humanos
Injeções Intravítreas
Edema Macular/patologia
Edema Macular/fisiopatologia
Masculino
Meia-Idade
Retina/patologia
Estudos Retrospectivos
Reino Unido
Acuidade Visual/fisiologia
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Drug Implants); 0 (Glucocorticoids); 0CD5FD6S2M (Fluocinolone Acetonide)
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180306
[Lr] Data última revisão:
180306
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180301
[St] Status:MEDLINE
[do] DOI:10.1186/s12886-018-0726-1


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[PMID]:28836266
[Au] Autor:Onland W; Offringa M; van Kaam A
[Ad] Endereço:Department of Neonatology, Emma Children's Hospital AMC, University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands, 1105 AZ.
[Ti] Título:Late (≥ 7 days) inhalation corticosteroids to reduce bronchopulmonary dysplasia in preterm infants.
[So] Source:Cochrane Database Syst Rev;8:CD002311, 2017 08 24.
[Is] ISSN:1469-493X
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Bronchopulmonary dysplasia (BPD), defined as oxygen dependence at 36 weeks postmenstrual age (PMA), remains an important complication of prematurity. Pulmonary inflammation plays a central role in the pathogenesis of BPD. Attenuating pulmonary inflammation with postnatal systemic corticosteroids reduces the incidence of BPD in preterm infants but may be associated with an increased risk of adverse neurodevelopmental outcomes. Local administration of corticosteroids via inhalation might be an effective and safe alternative. OBJECTIVES: To determine if administration of inhalation corticosteroids after the first week of life until 36 weeks PMA to preterm infants at high risk of developing BPD is effective and safe in reducing the incidence of death and BPD as separate or combined outcomes. SEARCH METHODS: We used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL 2017, Issue 4), MEDLINE via PubMed (1966 to 19 May 2017), Embase (1980 to 19 May 2017), and CINAHL (1982 to 19 May 2017). We also searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials. SELECTION CRITERIA: We included randomised controlled trials comparing inhalation corticosteroids, started ≥ 7 days postnatal age (PNA) but before 36 weeks PMA, to placebo in ventilated and non-ventilated infants at risk of BPD. We excluded trials investigating systemic corticosteroids versus inhalation corticosteroids. DATA COLLECTION AND ANALYSIS: We collected data on participant characteristics, trial methodology, and inhalation regimens. The primary outcome was death or BPD at 36 weeks PMA. Secondary outcomes were the combined outcome death or BPD at 28 days PNA, the seperate outcomes of death and BPD at both 28 days PNA, and at 36 weeks PMA, and short-term respiratory outcomes, such as failure to extubate; total days of mechanical ventilation and oxygen use; and the need for systemic corticosteroids. We contacted the original trialists to verify the validity of extracted data and to provide missing data. We analysed all data using Review Manager 5. When possible, we performed meta-analysis using typical risk ratio (RR) for dichotomous outcomes and weighted mean difference (WMD) for continuous outcomes along with their 95% confidence intervals (CI). We analysed ventilated and non-ventilated participants separately.We used the GRADE approach to assess the quality of the evidence. MAIN RESULTS: We included eight trials randomising 232 preterm infants in this review. Inhalation corticosteroids did not reduce the separate or combined outcomes of death or BPD. The meta-analyses of the studies showed a reduced risk in favor of inhalation steroids regarding failure to extubate at seven days (typical RR (TRR) 0.80, 95% CI 0.66 to 0.98; 5 studies, 79 infants) and at the latest reported time point after treatment onset (TRR 0.60, 95% CI 0.45 to 0.80; 6 studies, 90 infants). However, both analyses showed increased statistical heterogeneity (I statistic 73% and 86%, respectively). Furthermore, inhalation steroids did not impact total duration of mechanical ventilation or oxygen dependency. There was a trend toward a reduction in the use of systemic corticosteroids in infants receiving inhalation corticosteroids (TRR 0.51, 95% CI 0.26 to 1.00; 4 studies, 74 infants; very low-quality evidence). There was a paucity of data on short- and long-term adverse effects. Our results should be interpreted with caution because the total number of randomised participants is relatively small, and most trials differed considerably in participant characteristics, inhalation therapy, and outcome definitions. AUTHORS' CONCLUSIONS: Based on the results of the currently available evidence, inhalation corticosteroids initiated at ≥ 7 days of life for preterm infants at high risk of developing BPD cannot be recommended at this point in time. More and larger randomised, placebo-controlled trials are needed to establish the efficacy and safety of inhalation corticosteroids.
[Mh] Termos MeSH primário: Anti-Inflamatórios/administração & dosagem
Displasia Broncopulmonar/prevenção & controle
Glucocorticoides/administração & dosagem
Pneumonia/tratamento farmacológico
[Mh] Termos MeSH secundário: Administração por Inalação
Beclometasona/administração & dosagem
Displasia Broncopulmonar/etiologia
Budesonida/administração & dosagem
Dexametasona/administração & dosagem
Fluocinolona Acetonida/administração & dosagem
Fluocinolona Acetonida/análogos & derivados
Fluticasona/administração & dosagem
Seres Humanos
Recém-Nascido
Recém-Nascido Prematuro
Pneumonia/complicações
Ensaios Clínicos Controlados Aleatórios como Assunto
[Pt] Tipo de publicação:JOURNAL ARTICLE; META-ANALYSIS; RESEARCH SUPPORT, N.I.H., EXTRAMURAL; RESEARCH SUPPORT, NON-U.S. GOV'T; REVIEW
[Nm] Nome de substância:
0 (Anti-Inflammatory Agents); 0 (Glucocorticoids); 0CD5FD6S2M (Fluocinolone Acetonide); 51333-22-3 (Budesonide); 7S5I7G3JQL (Dexamethasone); CUT2W21N7U (Fluticasone); KGZ1SLC28Z (Beclomethasone); QK4DYS664X (flunisolide)
[Em] Mês de entrada:1709
[Cu] Atualização por classe:170920
[Lr] Data última revisão:
170920
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170825
[St] Status:MEDLINE
[do] DOI:10.1002/14651858.CD002311.pub4


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[PMID]:28624167
[Au] Autor:Sugar EA; Venugopal V; Thorne JE; Frick KD; Holland GN; Wang RC; Almanzor R; Jabs DA; Holbrook JT; Multicenter Uveitis Steroid Treatment (MUST) Trial Research Group
[Ad] Endereço:Department of Biostatistics, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland; Department of Epidemiology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland; Center for Clinical Trials, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Mar
[Ti] Título:Longitudinal Vision-Related Quality of Life for Patients with Noninfectious Uveitis Treated with Fluocinolone Acetonide Implant or Systemic Corticosteroid Therapy.
[So] Source:Ophthalmology;124(11):1662-1669, 2017 Nov.
[Is] ISSN:1549-4713
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:PURPOSE: To evaluate longitudinal vision-related quality of life (VRQoL) in patients with noninfectious uveitis. DESIGN: Cohort study using randomized controlled trial data. PARTICIPANTS: Patients with active or recently active intermediate uveitis, posterior uveitis, or panuveitis enrolled in the Multicenter Steroid Treatment Trial and Follow-up Study. METHODS: Data from the 25-item National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) for the first 3 years after randomization were evaluated semiannually. Analyses were stratified by assigned treatment (129 implants vs. 126 systemic therapies) because of substantial differences in the trajectories of VRQoL. The impact of baseline measurements of visual function (visual acuity and visual field), demographics, and disease characteristics was assessed using generalized estimating equations. MAIN OUTCOME MEASURES: Primary outcome was the NEI-VFQ-25 composite score over 3 years after randomization. RESULTS: Individuals in both treatment groups showed similar improvement in NEI-VFQ-25 scores after 3 years of follow-up (implant: 11.9 points; 95% confidence interval [CI], 8.6-15.2; P < 0.001; systemic: 9.0 points; 95% CI, 5.6-12.3; P < 0.001; P = 0.21 for interaction). Individuals in the implant group showed a substantial improvement during the first 6 months followed by stable scores, whereas individuals in the systemic group showed a steady improvement over the course of follow-up. Worse initial visual acuity and visual fields were associated with lower initial NEI-VFQ-25 scores for both treatment groups. In the systemic group, these differences were maintained throughout follow-up. In the implant group, individuals with initial visual acuity worse than 20/40 showed additional improvement in NEI-VFQ-25 score to come within -7 points (95% CI, -15.0 to 0.9) of those with visual acuity 20/40 or better initially, a clinically meaningful but not statistically significant difference (P = 0.081). Results based on sensitivity analyses showed similar patterns. CONCLUSIONS: Both treatment groups demonstrated significant improvements in NEI-VFQ-25 scores; however, the improvement was immediate for the implant group as opposed to gradual for the systemic group. Poorer visual function was associated significantly with initial differences in NEI-VFQ-25 scores. However, only individuals in the implant group with poor visual acuity were able to overcome their initial deficits by the end of 3 years.
[Mh] Termos MeSH primário: Fluocinolona Acetonida/administração & dosagem
Glucocorticoides/administração & dosagem
Pan-Uveíte/tratamento farmacológico
Qualidade de Vida/psicologia
Uveíte Intermediária/tratamento farmacológico
Uveíte Posterior/tratamento farmacológico
[Mh] Termos MeSH secundário: Adulto
Idoso
Estudos de Coortes
Implantes de Medicamento
Feminino
Seguimentos
Nível de Saúde
Seres Humanos
Masculino
Meia-Idade
Pan-Uveíte/psicologia
Fatores de Risco
Perfil de Impacto da Doença
Inquéritos e Questionários
Uveíte Intermediária/psicologia
Uveíte Posterior/psicologia
Visão Ocular/fisiologia
Acuidade Visual/fisiologia
Campos Visuais/fisiologia
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Drug Implants); 0 (Glucocorticoids); 0CD5FD6S2M (Fluocinolone Acetonide)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171030
[Lr] Data última revisão:
171030
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170619
[St] Status:MEDLINE


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[PMID]:28477440
[Au] Autor:Kempen JH; Altaweel MM; Holbrook JT; Sugar EA; Thorne JE; Jabs DA; Writing Committee for the Multicenter Uveitis Steroid Treatment (MUST) Trial and Follow-up Study Research Group
[Ad] Endereço:Department of Ophthalmology, Massachusetts Eye and Ear, Boston3The Discovery Eye Center, MyungSung Christian Medical Center and MyungSung Medical School, Addis Ababa, Ethiopia.
[Ti] Título:Association Between Long-Lasting Intravitreous Fluocinolone Acetonide Implant vs Systemic Anti-inflammatory Therapy and Visual Acuity at 7 Years Among Patients With Intermediate, Posterior, or Panuveitis.
[So] Source:JAMA;317(19):1993-2005, 2017 May 16.
[Is] ISSN:1538-3598
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Importance: A randomized clinical trial comparing fluocinolone acetonide implant vs systemic corticosteroids and immunosuppression for treatment of severe noninfectious intermediate, posterior, and panuveitides did not result in a significant difference in visual acuity at 2 and 4.5 years; longer-term outcomes are not known. Objective: To compare the association between intravitreous fluocinolone acetonide implant vs systemic therapy and long-term visual and other outcomes in patients with uveitis. Design, Setting, and Participants: Nonprespecified 7-year observational follow-up of the Multicenter Uveitis Steroid Treatment (MUST) randomized clinical trial comparing the alternative treatments. Follow-up was conducted in tertiary uveitis subspecialty practices in the United States (21), the United Kingdom (1), and Australia (1). Of 255 patients 13 years or older with intermediate, posterior, or panuveitis (active within ≤60 days) enrolled in the MUST trial between December 6, 2005, and December 9, 2008, 215 consented to ongoing follow-up through at least 7 years postrandomization (last visit, February 10, 2016). Interventions: Participants had been randomized to receive a surgically placed intravitreous fluocinolone acetonide implant or systemic corticosteroids supplemented by immunosuppression. When both eyes required treatment, both eyes were treated. Main Outcomes and Measures: Primary outcome was change from baseline in best-corrected visual acuity in uveitic eyes (5 letters = 1 visual acuity chart line; potential range of change in letters read, -121 to +101; minimal clinically important difference, 7 letters), analyzed by treatment assignment accounting for nonindependence of eyes when patients had 2 uveitic eyes. Secondary outcomes included potential systemic toxicities of corticosteroid and immunosuppressive therapy and death. Results: Seven-year data were obtained for 161 uveitic eyes (70% of 90 patients assigned to implant) and 167 uveitic eyes (71% of 90 patients assigned to systemic therapy) (77% female; median age at enrollment, 48 [interquartile range, 36-56] years). Change in mean visual acuity from baseline (implant, 61.7; systemic therapy, 65.0) through 7 years (implant, 55.8; systemic therapy, 66.2) favored systemic therapy by 7.2 (95% CI, 2.1-12) letters. Among protocol-specified, prospectively collected systemic adverse outcomes, the cumulative 7-year incidence in the implant and systemic therapy groups, respectively, was less than 10%, with the exceptions of hyperlipidemia (6.1% vs 11.2%), hypertension (9.8% vs 18.4%), osteopenia (41.5% vs 43.1%), fractures (11.3% vs 18.6%), hospitalization (47.6% vs 42.3%), and antibiotic-treated infection (57.4% vs 72.3%). Conclusions and Relevance: In 7-year extended follow-up of a randomized trial of patients with severe intermediate, posterior, or panuveitis, those randomized to receive systemic therapy had better visual acuity than those randomized to receive intravitreous fluocinolone acetonide implants. Study interpretation is limited by loss to follow-up. Trial Registration: clinicaltrials.gov Identifier: NCT00132691.
[Mh] Termos MeSH primário: Anti-Inflamatórios/administração & dosagem
Fluocinolona Acetonida/administração & dosagem
Uveíte/tratamento farmacológico
Acuidade Visual/efeitos dos fármacos
[Mh] Termos MeSH secundário: Adulto
Anti-Inflamatórios/efeitos adversos
Austrália
Implantes de Medicamento
Feminino
Fluocinolona Acetonida/efeitos adversos
Seguimentos
Seres Humanos
Imunossupressão/efeitos adversos
Injeções Intravítreas
Masculino
Meia-Idade
Pan-Uveíte/tratamento farmacológico
Qualidade de Vida
Fatores de Tempo
Resultado do Tratamento
Reino Unido
Estados Unidos
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE; MULTICENTER STUDY; OBSERVATIONAL STUDY; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Anti-Inflammatory Agents); 0 (Drug Implants); 0CD5FD6S2M (Fluocinolone Acetonide)
[Em] Mês de entrada:1708
[Cu] Atualização por classe:170807
[Lr] Data última revisão:
170807
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170507
[St] Status:MEDLINE
[do] DOI:10.1001/jama.2017.5103


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[PMID]:28376510
[Au] Autor:Wykoff CC
[Ad] Endereço:Retina Consultants of Houston, Blanton Eye Institute, Houston Methodist Hospital, Greater Houston Retina Research Foundation, Weill Cornell Medical College, Houston, Texas, USA.
[Ti] Título:Impact of intravitreal pharmacotherapies including antivascular endothelial growth factor and corticosteroid agents on diabetic retinopathy.
[So] Source:Curr Opin Ophthalmol;28(3):213-218, 2017 May.
[Is] ISSN:1531-7021
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:PURPOSE OF REVIEW: Diabetic retinopathy is common and increasing in prevalence. Pharmacologic management of diabetic macular edema (DME) has improved tremendously over the last decade with the use of two families of intravitreally administered medications: antivascular endothelial growth factor-specific agents and corticosteroids. Clinical evaluation of these pharmaceuticals has demonstrated that they can have a substantial impact on diabetic retinopathy severity levels and the underlying retinal vasculature itself. RECENT FINDINGS: Phase 3 trials employing ranibizumab, aflibercept, and fluocinolone acetonide enrolling eyes with center-involving DME causing visual acuity loss have demonstrated impressive alteration of the natural history of progressive diabetic retinopathy worsening over time through blunted progression to proliferative diabetic retinopathy, improving diabetic retinopathy severity levels, and slowing progressive retinal nonperfusion, the underlying disease process central to diabetic retinopathy itself. SUMMARY: Accumulating data indicate that the threshold to initiate ocular-specific pharmacologic treatment for diabetic retinopathy, previously predominately limited to eyes with visual loss because of center-involved DME or proliferative diabetic retinopathy, is being lowered to earlier stages of diabetic retinopathy. Ongoing clinical trials and secondary analyses continue to further explore the impact and durability of vascular endothelial growth factor blockade and corticosteroids on modification of diabetic retinopathy and the underlying retinal vasculature itself.
[Mh] Termos MeSH primário: Inibidores da Angiogênese/uso terapêutico
Retinopatia Diabética/tratamento farmacológico
Glucocorticoides/uso terapêutico
Fator A de Crescimento do Endotélio Vascular/antagonistas & inibidores
[Mh] Termos MeSH secundário: Fluocinolona Acetonida/uso terapêutico
Seres Humanos
Injeções Intravítreas
Ranibizumab/uso terapêutico
Receptores de Fatores de Crescimento do Endotélio Vascular/uso terapêutico
Proteínas Recombinantes de Fusão/uso terapêutico
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Angiogenesis Inhibitors); 0 (Glucocorticoids); 0 (Recombinant Fusion Proteins); 0 (VEGFA protein, human); 0 (Vascular Endothelial Growth Factor A); 0CD5FD6S2M (Fluocinolone Acetonide); 15C2VL427D (aflibercept); EC 2.7.10.1 (Receptors, Vascular Endothelial Growth Factor); ZL1R02VT79 (Ranibizumab)
[Em] Mês de entrada:1704
[Cu] Atualização por classe:170418
[Lr] Data última revisão:
170418
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170405
[St] Status:MEDLINE
[do] DOI:10.1097/ICU.0000000000000364


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[PMID]:28283896
[Au] Autor:Syed YY
[Ad] Endereço:Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand. demail@springer.com.
[Ti] Título:Fluocinolone Acetonide Intravitreal Implant 0.19 mg (ILUVIEN ): A Review in Diabetic Macular Edema.
[So] Source:Drugs;77(5):575-583, 2017 Apr.
[Is] ISSN:1179-1950
[Cp] País de publicação:New Zealand
[La] Idioma:eng
[Ab] Resumo:Fluocinolone acetonide intravitreal implant 0.19 mg (ILUVIEN ) is a nonbiodegradable, injectable, corticosteroid implant that is approved in several countries, including the USA, for the treatment of diabetic macular edema (DME). ILUVIEN releases fluocinolone acetonide at an initial rate of 0.25 µg/day (average rate 0.2 µg/day) and lasts 36 months. In the two pooled pivotal FAME trials in patients with DME previously treated with macular laser photocoagulation, fluocinolone acetonide intravitreal implant 0.2 µg/day was significantly more effective than sham injection with respect to the proportion of patients with an improvement from baseline in best-corrected visual acuity of ≥15 letters at 24 months (primary endpoint). This therapeutic effect was maintained at 36 months. The implant also significantly decreased foveal thickness at 24 months. FAME study results are broadly supported by real-world studies in patients with chronic DME considered insufficiently responsive to available therapies. Consistent with corticosteroid class-specific adverse events, cataract and elevated intraocular pressure (IOP) were the most common adverse events with the fluocinolone acetonide intravitreal implant. Raised IOP was treated with medications in most patients, with <5% requiring incisional IOP-lowering surgery. In the USA, fluocinolone acetonide intravitreal implant should be used only in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant increase in IOP. Available data indicate that fluocinolone acetonide intravitreal implant 0.19 mg is a useful option for the treatment of DME in these patients.
[Mh] Termos MeSH primário: Retinopatia Diabética/complicações
Retinopatia Diabética/tratamento farmacológico
Fluocinolona Acetonida/administração & dosagem
Fluocinolona Acetonida/uso terapêutico
Edema Macular/complicações
Edema Macular/tratamento farmacológico
[Mh] Termos MeSH secundário: Relação Dose-Resposta a Droga
Fluocinolona Acetonida/química
Seres Humanos
Próteses e Implantes
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0CD5FD6S2M (Fluocinolone Acetonide)
[Em] Mês de entrada:1705
[Cu] Atualização por classe:171114
[Lr] Data última revisão:
171114
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170312
[St] Status:MEDLINE
[do] DOI:10.1007/s40265-017-0722-4


  8 / 1141 MEDLINE  
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[PMID]:28178701
[Au] Autor:Figueira J; Henriques J; Amaro M; Rosas V; Alves D; Cunha-Vaz J
[Ad] Endereço:AIBILI - Association for Innovation and Biomedical Research on Light and Image, Coimbra, Portugal.
[Ti] Título:A Nonrandomized, Open-Label, Multicenter, Phase 4 Pilot Study on the Effect and Safety of ILUVIEN® in Chronic Diabetic Macular Edema Patients Considered Insufficiently Responsive to Available Therapies (RESPOND).
[So] Source:Ophthalmic Res;57(3):166-172, 2017.
[Is] ISSN:1423-0259
[Cp] País de publicação:Switzerland
[La] Idioma:eng
[Ab] Resumo:PURPOSE: The aim of this study was to assess the effectiveness and safety of ILUVIEN® in patients with chronic diabetic macular edema (DME) who were insufficiently responsive to prior therapies. METHODS: This is a prospective, nonrandomized, multicenter, open-label, phase 4 pilot study assessing the effectiveness and safety of ILUVIEN® involving 12 patients insufficiently responsive to available therapies. Assessments were performed at screening, baseline, week 1, and months 1, 3, 6, 9, and 12. Demographics, medical/ophthalmic history, prior laser, anti-VEGF, and steroid treatments, and lab tests were recorded at screening. A complete ophthalmic examination and SD-OCT were performed at screening and at all follow-up visits. RESULTS: The patients showed improvements in best-corrected visual acuity (+3.7 letters), with greater improvement among pseudophakic patients (+6.8 letters) compared with phakic patients (-2.5 letters) 12 months after ILUVIEN®. The mean central subfield thickness decrease from baseline to month 12 was statistically significant, with a rapid reduction in the first week. Regarding safety, only 2 patients showed an intraocular pressure (IOP) increase over 25 mm Hg during the study, and the rise in IOP was well managed with eye drops only. CONCLUSIONS: This prospective and pilot study suggests that ILUVIEN® is safe and may be considered effective for chronic DME patients insufficiently responsive to other available therapies as it showed a rapid and sustained improvement of macular edema obtained after treatment with ILUVIEN®.
[Mh] Termos MeSH primário: Inibidores da Angiogênese/uso terapêutico
Retinopatia Diabética/tratamento farmacológico
Fluocinolona Acetonida/uso terapêutico
Edema Macular/tratamento farmacológico
[Mh] Termos MeSH secundário: Idoso
Inibidores da Angiogênese/administração & dosagem
Inibidores da Angiogênese/efeitos adversos
Doença Crônica
Preparações de Ação Retardada/administração & dosagem
Retinopatia Diabética/fisiopatologia
Implantes de Medicamento
Feminino
Fluocinolona Acetonida/administração & dosagem
Fluocinolona Acetonida/efeitos adversos
Seres Humanos
Injeções Intravítreas
Edema Macular/fisiopatologia
Masculino
Meia-Idade
Projetos Piloto
Estudos Prospectivos
Acuidade Visual
[Pt] Tipo de publicação:CLINICAL TRIAL, PHASE IV; JOURNAL ARTICLE; MULTICENTER STUDY
[Nm] Nome de substância:
0 (Angiogenesis Inhibitors); 0 (Delayed-Action Preparations); 0 (Drug Implants); 0CD5FD6S2M (Fluocinolone Acetonide)
[Em] Mês de entrada:1704
[Cu] Atualização por classe:170420
[Lr] Data última revisão:
170420
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170209
[St] Status:MEDLINE
[do] DOI:10.1159/000455235


  9 / 1141 MEDLINE  
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[PMID]:28165610
[Au] Autor:El-Ghrably I; Steel DHW; Habib M; Vaideanu-Collins D; Manvikar S; Hillier RJ
[Ad] Endereço:Ophthalmology Department, James Cook University Hospital, Middlesbrough - UK.
[Ti] Título:Diabetic macular edema outcomes in eyes treated with fluocinolone acetonide 0.2 µg/d intravitreal implant: real-world UK experience.
[So] Source:Eur J Ophthalmol;27(3):357-362, 2017 May 11.
[Is] ISSN:1724-6016
[Cp] País de publicação:Italy
[La] Idioma:eng
[Ab] Resumo:PURPOSE: To conduct an observational, multicenter study to evaluate real-world clinical efficacy and safety of the 0.2 µg/day fluocinolone acetonide (FAc) implant in the treatment of patients with chronic diabetic macular edema (DME) in 3 large hospital ophthalmology departments in the United Kingdom. METHODS: Fluocinolone acetonide implants were inserted into the study eyes following a suitable washout period; phakic eyes received FAc implant following cataract surgery. Follow-up visits took place 2-4 weeks postinjection and then at 3, 6, and 12 months; change in central macular thickness (CMT) from baseline was measured by optical coherence tomography and best-corrected visual acuity (BCVA) was also assessed. Adverse events and changes in intraocular pressure (IOP) were recorded in order to evaluate the safety profile for the FAc implant. RESULTS: Improvements in BCVA and CMT were observed from 3 months and sustained for the duration of observation. At 12 months, the overall mean change from baseline CMT was -126 µm and mean increase in BCVA from baseline was 5.1 letters. Increases in IOP following FAc implant were easily managed with IOP-lowering medication. Implant migration into the anterior chamber occurred in 2 eyes where prior vitrectomy had resulted in a posterior capsule defect; this was rectified and resolved. CONCLUSIONS: The results of this study provide further efficacy and safety profile data for FAc implant treatment of chronic DME in a real-world clinical setting; the FAc implant appears to be a valuable therapeutic approach for patients with chronic DME who have suboptimal response to other treatment options.
[Mh] Termos MeSH primário: Retinopatia Diabética/tratamento farmacológico
Fluocinolona Acetonida/administração & dosagem
Edema Macular/tratamento farmacológico
Acuidade Visual
[Mh] Termos MeSH secundário: Adulto
Idoso
Idoso de 80 Anos ou mais
Retinopatia Diabética/complicações
Retinopatia Diabética/diagnóstico
Relação Dose-Resposta a Droga
Implantes de Medicamento
Feminino
Glucocorticoides/administração & dosagem
Seres Humanos
Injeções Intravítreas
Edema Macular/diagnóstico
Edema Macular/etiologia
Masculino
Meia-Idade
Tomografia de Coerência Óptica
Reino Unido
[Pt] Tipo de publicação:JOURNAL ARTICLE; MULTICENTER STUDY; OBSERVATIONAL STUDY
[Nm] Nome de substância:
0 (Drug Implants); 0 (Glucocorticoids); 0CD5FD6S2M (Fluocinolone Acetonide)
[Em] Mês de entrada:1705
[Cu] Atualização por classe:170531
[Lr] Data última revisão:
170531
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170207
[St] Status:MEDLINE
[do] DOI:10.5301/ejo.5000929


  10 / 1141 MEDLINE  
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[PMID]:28084022
[Au] Autor:Alniemi DT; Wetter DA; Bridges AG; El-Azhary RA; Davis MD; Camilleri MJ; McEvoy MT
[Ad] Endereço:Mayo Medical School, Mayo Clinic College of Medicine, Rochester, MN, USA.
[Ti] Título:Acute generalized exanthematous pustulosis: clinical characteristics, etiologic associations, treatments, and outcomes in a series of 28 patients at Mayo Clinic, 1996-2013.
[So] Source:Int J Dermatol;56(4):405-414, 2017 Apr.
[Is] ISSN:1365-4632
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Acute generalized exanthematous pustulosis (AGEP) is a rare skin condition typically caused by medications. The objective of this study was to examine the clinical features, causes, and outcomes of AGEP at a sole tertiary care center. METHODS: A retrospective review of patients with AGEP (European Study of Severe Cutaneous Adverse Reactions score of ≥ 5) seen at Mayo Clinic (Rochester, MN, USA) between January 1, 1996, and December 31, 2013, was conducted. RESULTS: Of 28 patients (mean age at onset: 56 years), 17 (61%) were women. The development of AGEP was attributed to medications in 25 patients (89%), with clindamycin the most common culprit (six patients). Three patients (11%) had mucous membrane involvement, and 21 (75%) showed systemic involvement. Ten patients (36%) received systemic corticosteroids for treatment of AGEP. Skin findings resolved within 15 days in 26 patients (93%) (mean time to resolution: 7.6 days). In three patients (11%), generalized skin eruptions or dermatitis developed weeks to months after the resolution of AGEP. Twenty-four patients (86%) had a personal history of drug reactions before the development of AGEP. CONCLUSIONS: A previous history of drug reactions and clindamycin causation were more common in the present cohort than in prior reports. A small subset of patients experienced new-onset non-AGEP skin eruptions within a few months of the resolution of AGEP.
[Mh] Termos MeSH primário: Pustulose Exantematosa Aguda Generalizada/tratamento farmacológico
Pustulose Exantematosa Aguda Generalizada/etiologia
Antibacterianos/efeitos adversos
Anti-Inflamatórios/uso terapêutico
[Mh] Termos MeSH secundário: Pustulose Exantematosa Aguda Generalizada/patologia
Administração Cutânea
Administração Oral
Adulto
Idoso
Idoso de 80 Anos ou mais
Anti-Inflamatórios/administração & dosagem
Clindamicina/efeitos adversos
Dermatite/etiologia
Quimioterapia Combinada
Feminino
Fluocinolona Acetonida/análogos & derivados
Fluocinolona Acetonida/uso terapêutico
Fluocinonida/uso terapêutico
Seres Humanos
Hidrocortisona/uso terapêutico
Masculino
Meia-Idade
Membrana Mucosa
Prednisona/uso terapêutico
Estudos Retrospectivos
Índice de Gravidade de Doença
Resultado do Tratamento
Triancinolona/uso terapêutico
Adulto Jovem
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Anti-Bacterial Agents); 0 (Anti-Inflammatory Agents); 0CD5FD6S2M (Fluocinolone Acetonide); 1ZK20VI6TY (Triamcinolone); 2W4A77YPAN (Fluocinonide); 3U02EL437C (Clindamycin); CT1IX58L9S (fluocinolone); VB0R961HZT (Prednisone); WI4X0X7BPJ (Hydrocortisone)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171017
[Lr] Data última revisão:
171017
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170114
[St] Status:MEDLINE
[do] DOI:10.1111/ijd.13434



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