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A Lower Incidence of Cytomegalovirus Infection in De Novo Heart Transplant Recipients Randomized to Everolimus.

Author(s): Hill JA, Hummel M, Starling RC, Kobashigawa JA, Perrone SV, Arizon JM, Simonsen S, Abeywickrama KH, Bara C

Affiliation(s): 1 Medical Director Heart Failure/Transplantation, Shands Hospital at the University of Florida, Gainesville, FL. 2 Deutsches Herzzentrum, Berlin, Germany. 3 Department of Cardiovascular Medicine, The Cleveland Clinic Foundation, Cleveland, OH. 4 Heart Transplant Program, University of California at Los Angeles School of Medicine, Los Angeles, CA. 5 Intrathoracic Transplant & Heart Failure Division, FLENI Institute, Buenos Aires, Argentina. 6 Servicio de Cardiologia, Hospital Universitario Reina Sofia, Cordoba, Spain. 7 Rikshospitalet - Radiumhospitalet, Oslo, Norway. 8 Novartis Pharma, Basel, Switzerland. 9 Department of Thoracic and Cardiovascular Surgery, Hannover Medical School, Hannover, Germany.

Publication date & source: 2007-12-15, Transplantation., 84(11):1436-1442.

BACKGROUND.: Cytomegalovirus (CMV) infection in recipients of cardiac transplants is associated with higher rates of morbidity. A recent phase III trial showed highly significantly (P<0.001) lower CMV rates with the proliferation signal inhibitor everolimus compared to azathioprine (AZA). To better define this association, data on CMV risk factors were collected retrospectively and analyzed. METHODS.: Data on CMV risk factors from a multicenter phase III trial on de novo heart transplant recipients (n=634) receiving a triple immunosuppressive regimen randomized to everolimus 1.5 mg/day (group 1), everolimus 3 mg/day (group 2), or AZA (group 3) were merged with prospectively collected CMV-related outcome data and analyzed. RESULTS.: CMV-positive donors (D+) and CMV-negative recipients (R-) were evenly distributed across groups 1-3 at 36/209 (17.2%), 48/211 (22.7%), and 38/214 (17.8%), respectively. CMV prophylaxis had been given for a mean (SD) of 175 (127.8), 183 (137.1), and 177 (132.9) days, respectively. In the high-risk D+/R- subgroup with prophylaxis, the proportions of patients with CMV infection compared with group 3 (12/29 [41.4%]) were 3/25 (12.0%) in group 1 (P=0.031) and 6/36 (16.7%) in group 2 (P=0.049). In D+/R+ subgroups either with or without prophylaxis, the everolimus groups had less CMV disease (P<0.001). The incidence of CMV syndrome, organ involvement, and laboratory evidence was lower with everolimus use compared to AZA. CONCLUSIONS.: Everolimus is associated with lower rates of CMV infection, syndrome, or organ involvement, suggesting an additional advantage from the use of everolimus in cardiac transplant recipients.

Page last updated: 2008-01-02

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