Literature DB >> 26722659

Twelve-month efficacy and safety of the conversion to everolimus in maintenance heart transplant recipients.

Nicolás Manito1, Juan F Delgado1, María G Crespo-Leiro1, José María Arizón1, Javier Segovia1, Francisco González-Vílchez1, Sònia Mirabet1, Ernesto Lage1, Domingo Pascual-Figal1, Beatriz Díaz1, Jesús Palomo1, Gregorio Rábago1, Marisa Sanz1, Teresa Blasco1, Eulàlia Roig1.   

Abstract

AIM: To determine the clinical reasons for conversion to everolimus (EVL) and long-term outcomes in heart transplant (HT) recipients.
METHODS: A retrospective 12-mo study has been carried out in 14 Spanish centres to assess the efficacy and safety of conversion to EVL in maintenance HT recipients.
RESULTS: Two hundred and twenty-two patients were included (mean age: 53 ± 10.5 years; mean time from HT: 8.1 ± 4.5 years). The most common reasons for conversion were nephrotoxicity (30%), chronic allograft vasculopathy (20%) and neoplasms (17%). The doses and mean levels of EVL at baseline (conversion to EVL) and after one year were 1.3 ± 0.3 and 1.2 ± 0.6 mg/d and 6.4 ± 3.4 and 5.6 ± 2.5 ng/mL, respectively. The percentage of patients receiving calcineurin inhibitors (CNIs) at baseline and on the final visit was 95% and 65%, respectively. The doses and mean levels of CNIs decreased between baseline and month 12 from 142.2 ± 51.6 to 98.0 ± 39.4 mg/d (P < 0.001) and from 126.1 ± 50.9 to 89.2 ± 47.7 ng/mL (P < 0.001), respectively, for cyclosporine, and from 2.9 ± 1.8 to 2.6 ± 1.9 mg/d and from 8.3 ± 4.0 to 6.5 ± 2.7 ng/mL (P = 0.011) for tacrolimus. In the subgroup of patients converted because of nephrotoxicity, creatinine clearance increased from 34.9 ± 10.1 to 40.4 ± 14.4 mL/min (P < 0.001). There were 37 episodes of acute rejection in 24 patients (11%). The most frequent adverse events were oedemas (12%), infections (9%) and gastrointestinal problems (6%). EVL was suspended in 44 patients (20%). Since the database was closed at the end of the study, no further follow-up data is available.
CONCLUSION: Conversion to EVL in maintenance HT recipients allowed minimisation or suspension of the CNIs, with improved kidney function in the patients with nephrotoxicity, after 12 mo.

Entities:  

Keywords:  Everolimus; Heart transplantation; Mammalian target of rapamycin inhibitors; Nephrotoxicity; Renal failure

Year:  2015        PMID: 26722659      PMCID: PMC4689942          DOI: 10.5500/wjt.v5.i4.310

Source DB:  PubMed          Journal:  World J Transplant        ISSN: 2220-3230


  38 in total

1.  Two-year outcomes in thoracic transplant recipients after conversion to everolimus with reduced calcineurin inhibitor within a multicenter, open-label, randomized trial.

Authors:  Lars Gullestad; Svend-Aage Mortensen; Hans Eiskjær; Gerdt C Riise; Lena Mared; Oystein Bjørtuft; Björn Ekmehag; Kjell Jansson; Svein Simonsen; Einar Gude; Bengt Rundqvist; Hans E Fagertun; Dag Solbu; Martin Iversen
Journal:  Transplantation       Date:  2010-12-27       Impact factor: 4.939

2.  Immunosuppressive drugs and the risk of cancer after organ transplantation.

Authors:  Jacques Dantal; Jean-Paul Soulillou
Journal:  N Engl J Med       Date:  2005-03-31       Impact factor: 91.245

3.  Use of mTOR inhibitors in chronic heart transplant recipients with renal failure: calcineurin-inhibitors conversion or minimization?

Authors:  F Gonzalez-Vilchez; J A Vazquez de Prada; M J Paniagua; M Gomez-Bueno; J M Arizon; L Almenar; E Roig; J Delgado; J L Lambert; F Perez-Villa; M L Sanz-Julve; M Crespo-Leiro; J Segovia; A Lopez-Granados; L Martinez-Dolz; S Mirabet; P Escribano; B Diaz-Molina; M Farrero; T Blasco
Journal:  Int J Cardiol       Date:  2013-11-23       Impact factor: 4.164

4.  Everolimus versus mycophenolate mofetil in heart transplantation: a randomized, multicenter trial.

Authors:  H J Eisen; J Kobashigawa; R C Starling; D F Pauly; A Kfoury; H Ross; S-S Wang; B Cantin; A Van Bakel; G Ewald; S Hirt; H Lehmkuhl; A Keogh; M Rinaldi; L Potena; A Zuckermann; G Dong; C Cornu-Artis; P Lopez
Journal:  Am J Transplant       Date:  2013-02-22       Impact factor: 8.086

5.  The Effect of Everolimus Initiation and Calcineurin Inhibitor Elimination on Cardiac Allograft Vasculopathy in De Novo Recipients: One-Year Results of a Scandinavian Randomized Trial.

Authors:  S Arora; A K Andreassen; B Andersson; F Gustafsson; H Eiskjaer; H E Bøtker; G Rådegran; E Gude; D Ioanes; D Solbu; V Sigurdardottir; G Dellgren; I Erikstad; O G Solberg; T Ueland; P Aukrust; L Gullestad
Journal:  Am J Transplant       Date:  2015-03-17       Impact factor: 8.086

6.  SDZ RAD, a new rapamycin derivative: pharmacological properties in vitro and in vivo.

Authors:  W Schuler; R Sedrani; S Cottens; B Häberlin; M Schulz; H J Schuurman; G Zenke; H G Zerwes; M H Schreier
Journal:  Transplantation       Date:  1997-07-15       Impact factor: 4.939

7.  Prospective study of everolimus with calcineurin inhibitor-free immunosuppression in maintenance heart transplant patients: results at 2 years.

Authors:  Markus A Engelen; Susanne Amler; Henryk Welp; Christian Vahlhaus; Stefan Gunia; Juergen R Sindermann; Markus Rothenburger; Joerg Stypmann
Journal:  Transplantation       Date:  2011-05-27       Impact factor: 4.939

8.  Cyclosporine-associated chronic nephropathy.

Authors:  B D Myers; J Ross; L Newton; J Luetscher; M Perlroth
Journal:  N Engl J Med       Date:  1984-09-13       Impact factor: 91.245

9.  Mycophenolate and sirolimus as calcineurin inhibitor-free immunosuppression improves renal function better than calcineurin inhibitor-reduction in late cardiac transplant recipients with chronic renal failure.

Authors:  Jan Groetzner; Ingo Kaczmarek; Uwe Schulz; Emilia Stegemann; Kristina Kaiser; Thorsten Wittwer; Johannes Schirmer; Meinolf Voss; Justus Strauch; Thorsten Wahlers; Hae-Young Sohn; Florian Wagner; Gero Tenderich; Hans-Ulrich Stempfle; Jochen Mueller-Ehmsen; Christof Schmid; Michael Vogeser; Karrl Christian Koch; Hermann Reichenspurner; Sabine Daebritz; Bruno Meiser; Bruno Reichart
Journal:  Transplantation       Date:  2009-03-15       Impact factor: 4.939

10.  Tolerance profile of the proliferation signal inhibitors everolimus and sirolimus in heart transplantation.

Authors:  J A Moro; L Almenar; L Martínez-Dolz; I Sánchez-Lázaro; J Agüero; A Salvador
Journal:  Transplant Proc       Date:  2008-11       Impact factor: 1.066

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  2 in total

1.  Association of Whole Blood Tacrolimus Concentrations with Kidney Injury in Heart Transplantation Patients.

Authors:  Maaike A Sikma; Claudine C Hunault; Johannes H Kirkels; Marianne C Verhaar; Jozef Kesecioglu; Dylan W de Lange
Journal:  Eur J Drug Metab Pharmacokinet       Date:  2018-06       Impact factor: 2.441

2.  Everolimus Use for Intolerance or Failure of Baseline Immunosuppression in Adult Heart and Lung Transplantation.

Authors:  Shelby E Kelsh; Reda Girgis; Michael Dickinson; Jennifer K McDermott
Journal:  Ann Transplant       Date:  2018-10-23       Impact factor: 1.530

  2 in total

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