| pubmed-article:15575918 | rdf:type | pubmed:Citation | lld:pubmed |
| pubmed-article:15575918 | lifeskim:mentions | umls-concept:C0376387 | lld:lifeskim |
| pubmed-article:15575918 | lifeskim:mentions | umls-concept:C0018823 | lld:lifeskim |
| pubmed-article:15575918 | lifeskim:mentions | umls-concept:C1720825 | lld:lifeskim |
| pubmed-article:15575918 | lifeskim:mentions | umls-concept:C0541315 | lld:lifeskim |
| pubmed-article:15575918 | lifeskim:mentions | umls-concept:C0870071 | lld:lifeskim |
| pubmed-article:15575918 | lifeskim:mentions | umls-concept:C1705938 | lld:lifeskim |
| pubmed-article:15575918 | lifeskim:mentions | umls-concept:C1527178 | lld:lifeskim |
| pubmed-article:15575918 | pubmed:issue | 12 | lld:pubmed |
| pubmed-article:15575918 | pubmed:dateCreated | 2004-12-3 | lld:pubmed |
| pubmed-article:15575918 | pubmed:abstractText | Everolimus, a proliferation signal inhibitor, is an immunosuppressant that targets the primary causes of progressive allograft dysfunction, thus improving the long-term outcome after heart transplantation. The present study investigated whether therapeutic drug monitoring (TDM) of everolimus would benefit heart transplant patients. Data from a twelve-month phase III trial comparing everolimus (1.5 or 3 mg daily) with azathioprine were used to evaluate everolimus pharmacokinetics, exposure-efficacy/safety and TDM prognostic simulations. Everolimus trough levels were stable in the first year post-transplant and averaged 5.2 +/- 3.8 and 9.4 +/- 6.3 ng/mL in patients treated with 1.5 and 3 mg/day, respectively. Cyclosporine trough levels were similar in all treatment groups. Biopsy-proven acute rejection (BPAR) was reduced with everolimus trough levels > or =3 ng/mL. Intravascular ultrasound (IVUS) analysis showed evidence of reduced vasculopathy at 12 months with increasing everolimus exposure. Unlike cyclosporine, increasing everolimus exposure was not related to a higher rate of renal dysfunction. The TDM simulation, which was based on two everolimus dose adjustments and an initial starting dose of 1.5 mg/day, showed that the simulated BPAR rate (with TDM) was 21% versus 26% in the group with fixed dosing. Therefore, TDM in heart transplantation could optimize immunosuppressive efficacy and reduce treatment-related toxicity. | lld:pubmed |
| pubmed-article:15575918 | pubmed:commentsCorrections | http://linkedlifedata.com/r... | lld:pubmed |
| pubmed-article:15575918 | pubmed:language | eng | lld:pubmed |
| pubmed-article:15575918 | pubmed:journal | http://linkedlifedata.com/r... | lld:pubmed |
| pubmed-article:15575918 | pubmed:citationSubset | IM | lld:pubmed |
| pubmed-article:15575918 | pubmed:chemical | http://linkedlifedata.com/r... | lld:pubmed |
| pubmed-article:15575918 | pubmed:chemical | http://linkedlifedata.com/r... | lld:pubmed |
| pubmed-article:15575918 | pubmed:chemical | http://linkedlifedata.com/r... | lld:pubmed |
| pubmed-article:15575918 | pubmed:chemical | http://linkedlifedata.com/r... | lld:pubmed |
| pubmed-article:15575918 | pubmed:status | MEDLINE | lld:pubmed |
| pubmed-article:15575918 | pubmed:month | Dec | lld:pubmed |
| pubmed-article:15575918 | pubmed:issn | 1600-6135 | lld:pubmed |
| pubmed-article:15575918 | pubmed:author | pubmed-author:StarlingRanda... | lld:pubmed |
| pubmed-article:15575918 | pubmed:author | pubmed-author:KovarikJohn... | lld:pubmed |
| pubmed-article:15575918 | pubmed:author | pubmed-author:HareJoshua... | lld:pubmed |
| pubmed-article:15575918 | pubmed:author | pubmed-author:SchmidliHeinz... | lld:pubmed |
| pubmed-article:15575918 | pubmed:author | pubmed-author:McCurryKennet... | lld:pubmed |
| pubmed-article:15575918 | pubmed:author | pubmed-author:HauptmanPaulP | lld:pubmed |
| pubmed-article:15575918 | pubmed:author | pubmed-author:MayerHartmut... | lld:pubmed |
| pubmed-article:15575918 | pubmed:issnType | Print | lld:pubmed |
| pubmed-article:15575918 | pubmed:volume | 4 | lld:pubmed |
| pubmed-article:15575918 | pubmed:owner | NLM | lld:pubmed |
| pubmed-article:15575918 | pubmed:authorsComplete | Y | lld:pubmed |
| pubmed-article:15575918 | pubmed:pagination | 2126-31 | lld:pubmed |
| pubmed-article:15575918 | pubmed:dateRevised | 2007-2-14 | lld:pubmed |
| pubmed-article:15575918 | pubmed:meshHeading | pubmed-meshheading:15575918... | lld:pubmed |
| pubmed-article:15575918 | pubmed:meshHeading | pubmed-meshheading:15575918... | lld:pubmed |
| pubmed-article:15575918 | pubmed:meshHeading | pubmed-meshheading:15575918... | lld:pubmed |
| pubmed-article:15575918 | pubmed:meshHeading | pubmed-meshheading:15575918... | lld:pubmed |
| pubmed-article:15575918 | pubmed:meshHeading | pubmed-meshheading:15575918... | lld:pubmed |
| pubmed-article:15575918 | pubmed:meshHeading | pubmed-meshheading:15575918... | lld:pubmed |
| pubmed-article:15575918 | pubmed:meshHeading | pubmed-meshheading:15575918... | lld:pubmed |
| pubmed-article:15575918 | pubmed:meshHeading | pubmed-meshheading:15575918... | lld:pubmed |
| pubmed-article:15575918 | pubmed:meshHeading | pubmed-meshheading:15575918... | lld:pubmed |
| pubmed-article:15575918 | pubmed:year | 2004 | lld:pubmed |
| pubmed-article:15575918 | pubmed:articleTitle | Therapeutic drug monitoring for everolimus in heart transplant recipients based on exposure-effect modeling. | lld:pubmed |
| pubmed-article:15575918 | pubmed:affiliation | Department of Cardiovascular Medicine, Kaufman Center for Heart Failure, Cleveland, OH, USA. starlir@ccf.org | lld:pubmed |
| pubmed-article:15575918 | pubmed:publicationType | Journal Article | lld:pubmed |
| pubmed-article:15575918 | pubmed:publicationType | Clinical Trial | lld:pubmed |
| pubmed-article:15575918 | pubmed:publicationType | Comparative Study | lld:pubmed |
| pubmed-article:15575918 | pubmed:publicationType | Randomized Controlled Trial | lld:pubmed |
| pubmed-article:15575918 | pubmed:publicationType | Research Support, Non-U.S. Gov't | lld:pubmed |
| pubmed-article:15575918 | pubmed:publicationType | Multicenter Study | lld:pubmed |
| pubmed-article:15575918 | pubmed:publicationType | Clinical Trial, Phase III | lld:pubmed |
| http://linkedlifedata.com/r... | pubmed:referesTo | pubmed-article:15575918 | lld:pubmed |
