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Adverse Events (AEs) Associated with Everolimus (EVR) or Mycophenolate Mofetil (MMF) in De Novo Heart Transplant (HTx) Recipients: Results from the North American (NA) Subpopulation of Study A2310
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Adverse Events (AEs) Associated with Everolimus (EVR) or Mycophenolate Mofetil (MMF) in De Novo Heart Transplant (HTx) Recipients: Results from the North American (NA) Subpopulation of Study A2310

H. Eisen, H. Ross, D. Pauly, A. Kfoury, A. Van Bakel, R. Starling, D. Patel, A. Wiland, P. Lopez, A. Balfour, …
The Journal of heart and lung transplantation, v 32(4), pp S200-S201
Apr 2013
DOI: https://doi.org/10.1016/j.healun.2013.01.495

Abstract

Patients (pts) enrolled from NA in study A2310 had a different pattern of induction therapy use; no induction therapy (~50% vs 15% ex-NA); thymoglobulin (17% vs 46% ex-NA). Since this may impact complications post-transplant, we report safety results for NA pts. A 24-month (M), randomized, open-label study of EVR 1.5 or 3mg/d (C0: 3-8 or 6-12ng/mL)+reduced-dose cyclosporine (CsA) vs MMF 3g/d+standard-dose CsA in de novo HTx recipients. All pts received steroids ± induction. The EVR 3mg arm was prematurely terminated due to higher mortality. Compared to the overall population, mortality rates in NA for both EVR (7.7% vs 10.6%) & MMF (7.6% vs 9.2%) were low. The incidence of AEs for NA (EVR/MMF) vs overall was also low: neutropenia (5.3%/8.3% vs 17.9%/40.3%); hyperlipidemia (11.8%/5.8% vs 37.3%/26.9%); peripheral edema (48.7%/47.4% vs 57.7%/57.1%) & CMV infection (5.3%/16.0% vs 7.2%/21.6%). For NA, AE rates were similar at 12 & 24M in EVR & MMF groups (Table). EVR 1.5mg or MMF was better tolerated in NA pts vs the overall population, perhaps due to differences in induction therapy use. Relevant AEs in NA ptsAE, n (%) at month 12/month 24EVR 1.5mg (n=152)MMF (n=156)Thrombocytopenia15 (9.9)/15 (9.9)18 (11.5)/19 (12.2)Leukopenia18 (11.8)/21 (13.8)38 (24.4)/43 (27.6)Neutropenia8 (5.3)/8 (5.3)12 (7.7)/13 (8.3)Hyperlipidemia11 (7.2)/18 (11.8)10 (6.4)/9 (5.8)Diabetes mellitus17 (11.2)/17 (11.2)13 (8.3)/15 (9.6)Any wound event58 (38.2)/65 (42.8)44 (28.2)/47 (30.1)Pericardial effusion67 (44.1)/71 (46.7)40 (25.6)/43 (27.6)Pleural effusion50 (32.9)/52 (34.2)36 (23.1)/39 (25.0)Peripheral edema68 (44.7)/74 (48.7)59 (37.8)/74 (47.4)Proteinuria6 (3.9)/6 (3.9)2 (1.3)/2 (1.3)Any infection98 (64.5)/107 (70.4)96 (61.5)/103 (66.0)Viral infection14 (9.2)/17 (11.2)34 (21.8)/41 (26.3)CMV infection8 (5.3)/8 (5.3)21 (13.5)/25 (16.0)

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Web of Science research areas
Cardiac & Cardiovascular Systems
Respiratory System
Surgery
Transplantation
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