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Three-year results of a randomized, double-blind, controlled trial of mycophenolate mofetil versus azathioprine in cardiac transplant recipients

Identifieur interne : 00A379 ( Main/Exploration ); précédent : 00A378; suivant : 00A380

Three-year results of a randomized, double-blind, controlled trial of mycophenolate mofetil versus azathioprine in cardiac transplant recipients

Auteurs : Howard J. Eisen [États-Unis] ; Jon Kobashigawa [États-Unis] ; Anne Keogh [Australie] ; Robert Bourge [États-Unis] ; Dale Renlund [États-Unis] ; Robert Mentzer [États-Unis] ; Edwin Alderman [États-Unis] ; Hannah Valantine [États-Unis] ; Georges Dureau [France] ; Donna Mancini [États-Unis] ; Richard Mamelok [États-Unis] ; Robert Gordon [États-Unis] ; Whedy Wang [États-Unis] ; Mandeep Mehra [États-Unis] ; Maria Rosa Constanzo [États-Unis] ; Manfred Hummel [Allemagne] ; Jay Johnson [États-Unis]

Source :

RBID : Pascal:05-0489642

Descripteurs français

English descriptors

Abstract

Background: This study reports the 36-month results of a randomized, double-blind, active-controlled trial of mycophenolate mofetil (MMF) vs azathioprine (AZA) in heart transplant patients. Methods: Patients were randomized at the time of transplant to receive MMF (1,500 mg twice a day, N = 327) or AZA (1.5 to 3 mg/kg in 4 daily doses, N = 323) in addition to cyclosporine and corticosteroids; 289 patients in each group received study drug. Data were analyzed in all randomized patients (enrolled) and in patients who received study medications (treated). Clinical and graft assessments continued for 36 months. Results: For the co-primary end-point, 53 of 289 (18.3%) AZA-treated patients either died or received another transplant compared with 34 of 289 (11.8%) MMF-treated patients (p < 0.01). Time to retransplantation or patient death was significantly shorter for AZA- than MMF-treated patients (p = 0.029). In patients undergoing intravascular ultrasound, the change in mean maximal intimal thickness was less for the MMF group than for the AZA group (0.06 ± 0.03 mm vs 0.13 ± 0.03 mm, respectively; p = 0.056). No significant differences between treatments were observed in quantitative coronary angiographic measurements of transplant coronary vasculopathy. Congestive heart failure, atrial arrhythmia and leukopenia were more common in the AZA group, whereas diarrhea, esophagitis, Herpes simplex, Herpes zoster and cytomegalovirus (CMV) tissue invasion were more common in MMF-treated patients. Conclusion: MMF reduces mortality and graft loss up to 36 months after transplantation.


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Le document en format XML

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<title xml:lang="en" level="a">Three-year results of a randomized, double-blind, controlled trial of mycophenolate mofetil versus azathioprine in cardiac transplant recipients</title>
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<name sortKey="Constanzo, Maria Rosa" sort="Constanzo, Maria Rosa" uniqKey="Constanzo M" first="Maria Rosa" last="Constanzo">Maria Rosa Constanzo</name>
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<name sortKey="Hummel, Manfred" sort="Hummel, Manfred" uniqKey="Hummel M" first="Manfred" last="Hummel">Manfred Hummel</name>
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<name sortKey="Johnson, Jay" sort="Johnson, Jay" uniqKey="Johnson J" first="Jay" last="Johnson">Jay Johnson</name>
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<s1>University of California at Los Angeles</s1>
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<series>
<title level="j" type="main">The Journal of heart and lung transplantation</title>
<title level="j" type="abbreviated">J. heart lung transplant.</title>
<idno type="ISSN">1053-2498</idno>
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<date when="2005">2005</date>
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</biblStruct>
</sourceDesc>
<seriesStmt>
<title level="j" type="main">The Journal of heart and lung transplantation</title>
<title level="j" type="abbreviated">J. heart lung transplant.</title>
<idno type="ISSN">1053-2498</idno>
</seriesStmt>
</fileDesc>
<profileDesc>
<textClass>
<keywords scheme="KwdEn" xml:lang="en">
<term>Antibiotic</term>
<term>Antiviral</term>
<term>Azathioprine</term>
<term>Cardiovascular disease</term>
<term>Comparative study</term>
<term>Double blind study</term>
<term>Heart</term>
<term>Homotransplantation</term>
<term>Immunosuppressive agent</term>
<term>Long term</term>
<term>Mofetil</term>
<term>Mycophenolate mofetil</term>
<term>Mycophenolic acid</term>
<term>Prognosis</term>
<term>Randomization</term>
<term>Respiratory disease</term>
<term>Surgery</term>
<term>Treatment</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr">
<term>Appareil circulatoire pathologie</term>
<term>Appareil respiratoire pathologie</term>
<term>Mycophenolate mofetil</term>
<term>Acide mycophénolique</term>
<term>Mofétil</term>
<term>Long terme</term>
<term>Pronostic</term>
<term>Randomisation</term>
<term>Etude double insu</term>
<term>Immunodépresseur</term>
<term>Etude comparative</term>
<term>Azathioprine</term>
<term>Coeur</term>
<term>Homotransplantation</term>
<term>Chirurgie</term>
<term>Antiviral</term>
<term>Antibiotique</term>
<term>Traitement</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr">
<term>Chirurgie</term>
<term>Antibiotique</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front>
<div type="abstract" xml:lang="en">Background: This study reports the 36-month results of a randomized, double-blind, active-controlled trial of mycophenolate mofetil (MMF) vs azathioprine (AZA) in heart transplant patients. Methods: Patients were randomized at the time of transplant to receive MMF (1,500 mg twice a day, N = 327) or AZA (1.5 to 3 mg/kg in 4 daily doses, N = 323) in addition to cyclosporine and corticosteroids; 289 patients in each group received study drug. Data were analyzed in all randomized patients (enrolled) and in patients who received study medications (treated). Clinical and graft assessments continued for 36 months. Results: For the co-primary end-point, 53 of 289 (18.3%) AZA-treated patients either died or received another transplant compared with 34 of 289 (11.8%) MMF-treated patients (p < 0.01). Time to retransplantation or patient death was significantly shorter for AZA- than MMF-treated patients (p = 0.029). In patients undergoing intravascular ultrasound, the change in mean maximal intimal thickness was less for the MMF group than for the AZA group (0.06 ± 0.03 mm vs 0.13 ± 0.03 mm, respectively; p = 0.056). No significant differences between treatments were observed in quantitative coronary angiographic measurements of transplant coronary vasculopathy. Congestive heart failure, atrial arrhythmia and leukopenia were more common in the AZA group, whereas diarrhea, esophagitis, Herpes simplex, Herpes zoster and cytomegalovirus (CMV) tissue invasion were more common in MMF-treated patients. Conclusion: MMF reduces mortality and graft loss up to 36 months after transplantation.</div>
</front>
</TEI>
<affiliations>
<list>
<country>
<li>Allemagne</li>
<li>Australie</li>
<li>France</li>
<li>États-Unis</li>
</country>
<region>
<li>Alabama</li>
<li>Auvergne-Rhône-Alpes</li>
<li>Berlin</li>
<li>Californie</li>
<li>Illinois</li>
<li>Louisiane</li>
<li>New Jersey</li>
<li>Pennsylvanie</li>
<li>Rhône-Alpes</li>
<li>Utah</li>
<li>Wisconsin</li>
<li>État de New York</li>
</region>
<settlement>
<li>Berlin</li>
<li>Lyon</li>
</settlement>
</list>
<tree>
<country name="États-Unis">
<region name="Pennsylvanie">
<name sortKey="Eisen, Howard J" sort="Eisen, Howard J" uniqKey="Eisen H" first="Howard J." last="Eisen">Howard J. Eisen</name>
</region>
<name sortKey="Alderman, Edwin" sort="Alderman, Edwin" uniqKey="Alderman E" first="Edwin" last="Alderman">Edwin Alderman</name>
<name sortKey="Bourge, Robert" sort="Bourge, Robert" uniqKey="Bourge R" first="Robert" last="Bourge">Robert Bourge</name>
<name sortKey="Constanzo, Maria Rosa" sort="Constanzo, Maria Rosa" uniqKey="Constanzo M" first="Maria Rosa" last="Constanzo">Maria Rosa Constanzo</name>
<name sortKey="Gordon, Robert" sort="Gordon, Robert" uniqKey="Gordon R" first="Robert" last="Gordon">Robert Gordon</name>
<name sortKey="Johnson, Jay" sort="Johnson, Jay" uniqKey="Johnson J" first="Jay" last="Johnson">Jay Johnson</name>
<name sortKey="Kobashigawa, Jon" sort="Kobashigawa, Jon" uniqKey="Kobashigawa J" first="Jon" last="Kobashigawa">Jon Kobashigawa</name>
<name sortKey="Mamelok, Richard" sort="Mamelok, Richard" uniqKey="Mamelok R" first="Richard" last="Mamelok">Richard Mamelok</name>
<name sortKey="Mancini, Donna" sort="Mancini, Donna" uniqKey="Mancini D" first="Donna" last="Mancini">Donna Mancini</name>
<name sortKey="Mehra, Mandeep" sort="Mehra, Mandeep" uniqKey="Mehra M" first="Mandeep" last="Mehra">Mandeep Mehra</name>
<name sortKey="Mentzer, Robert" sort="Mentzer, Robert" uniqKey="Mentzer R" first="Robert" last="Mentzer">Robert Mentzer</name>
<name sortKey="Renlund, Dale" sort="Renlund, Dale" uniqKey="Renlund D" first="Dale" last="Renlund">Dale Renlund</name>
<name sortKey="Valantine, Hannah" sort="Valantine, Hannah" uniqKey="Valantine H" first="Hannah" last="Valantine">Hannah Valantine</name>
<name sortKey="Wang, Whedy" sort="Wang, Whedy" uniqKey="Wang W" first="Whedy" last="Wang">Whedy Wang</name>
</country>
<country name="Australie">
<noRegion>
<name sortKey="Keogh, Anne" sort="Keogh, Anne" uniqKey="Keogh A" first="Anne" last="Keogh">Anne Keogh</name>
</noRegion>
</country>
<country name="France">
<region name="Auvergne-Rhône-Alpes">
<name sortKey="Dureau, Georges" sort="Dureau, Georges" uniqKey="Dureau G" first="Georges" last="Dureau">Georges Dureau</name>
</region>
</country>
<country name="Allemagne">
<region name="Berlin">
<name sortKey="Hummel, Manfred" sort="Hummel, Manfred" uniqKey="Hummel M" first="Manfred" last="Hummel">Manfred Hummel</name>
</region>
</country>
</tree>
</affiliations>
</record>

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