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A randomized trial of everolimus-based quadruple therapy vs standard triple therapy early after lung transplantation.
Gottlieb, Jens; Neurohr, Claus; Müller-Quernheim, Joachim; Wirtz, Hubert; Sill, Bjoern; Wilkens, Heinrike; Bessa, Vasiliki; Knosalla, Christoph; Porstner, Martina; Capusan, Carmen; Strüber, Martin.
Afiliação
  • Gottlieb J; Department of Respiratory Medicine, Hannover Medical School, Hannover, Germany.
  • Neurohr C; Biomedical Research in Endstage and Obstructive Lung Disease Hannover (BREATH), Member of the German Center for Lung Research (DZL), Hannover, Germany.
  • Müller-Quernheim J; Grosshadern Medical Clinic and Policlinic V, LMU Munich University Hospital, Munich, Germany.
  • Wirtz H; Pulmonology Medical Clinic, Freiburg University Hospital, Freiburg, Germany.
  • Sill B; Internal Medicine/Department of Pneumology, Leipzig University Hospital, Leipzig, Germany.
  • Wilkens H; Department of Cardiovascular Surgery, Hamburg-Eppendorf University Hospital, Hamburg, Germany.
  • Bessa V; Internal Medicine V, University Hospital of Saarland, Homburg Saar, Germany.
  • Knosalla C; Department of Pneumology, Ruhrlandklinik, West German Center for Lung Transplantation, University Hospital Essen, University Duisburg-Essen, Essen, Germany.
  • Porstner M; Department of Cardiothoracic and Vascular Surgery, German Heart Institute Berlin, DZHK (German Center for Cardiovascular Research), Berlin, Germany.
  • Capusan C; Novartis Pharma GmbH, Nuremberg, Germany.
  • Strüber M; Novartis Pharma GmbH, Nuremberg, Germany.
Am J Transplant ; 19(6): 1759-1769, 2019 06.
Article em En | MEDLINE | ID: mdl-30615259
ABSTRACT
Calcineurin inhibitor (CNI) therapy after lung transplantation increases risk of kidney failure. Early everolimus-based quadruple low CNI immunosuppression may improve renal function without compromising efficacy or safety. A prospective, randomized, open-label, 12-month multicenter trial was conducted at 8 German sites. Patients 3-18 months after lung transplantation were randomized (11), stratified by baseline estimated glomerular filtration rate (eGFR). In the quadruple low CNI regimen, patients received everolimus (target trough level 3-5 ng/mL) with reduced CNI (tacrolimus 3-5 ng/mL or cyclosporine 25-75 ng/mL) and a cell cycle inhibitor plus prednisone. In the standard triple CNI regimen, patients received tacrolimus (target trough level >5 ng/mL) or cyclosporine (>100 ng/mL) and a cell cycle inhibitor plus prednisone. Of the 180 patients screened, 130 were randomized 67 in the quadruple low CNI group and 63 in the standard triple CNI group. The primary endpoint (eGFR after 12 months) demonstrated superiority of the quadruple low CNI regimen 64.5 mL/min vs 54.6 mL/min for the standard triple group (least squares mean, analysis of covariance; P < .001). Key efficacy parameters (biopsy-proven acute rejection, chronic lung allograft dysfunction, and death) and safety endpoints were similar between both groups. Quadruple low CNI immunosuppression early after lung transplantation was demonstrated to be efficacious and safe. Clinical trials registry ClinicalTrials.gov NCT01404325.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Transplante de Pulmão / Everolimo / Imunossupressores Tipo de estudo: Clinical_trials / Observational_studies / Risk_factors_studies Limite: Female / Humans / Male / Middle aged País como assunto: Europa Idioma: En Ano de publicação: 2019 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Transplante de Pulmão / Everolimo / Imunossupressores Tipo de estudo: Clinical_trials / Observational_studies / Risk_factors_studies Limite: Female / Humans / Male / Middle aged País como assunto: Europa Idioma: En Ano de publicação: 2019 Tipo de documento: Article