HEART

H.B. Lehmkuhl¹, C. Bara², A. Karpov³, H. Schwende⁴, A. Zuckermann⁵, G. Junge^6
1, Deutsches Herzzentrum Berlin, Berlin/GERMANY, ²Heart Transplant Surgery, Medical School Hannover, Hannover/GERMANY, ³, Novartis Pharmaceuticals, Basel/SWITZERLAND, ⁴Iid, Novartis Pharmaceuticals, Basel/SWITZERLAND, ⁵Cardiothoracic Surgery, Medical University of Vienna, Vienna/AUSTRIA, ⁶, Novartis Pharma AG, Basel/SWITZERLAND

Body: Introduction: Hyperlipidemia is a well known risk factor for cardiovascular events in the general population. However, there is limited data evaluating the impact of immunosuppression-related hyperlipidemia in heart transplant recipients (HTxR). We retrospectively evaluated the impact of 6 different immunosuppressive regimens (ISR) on lipid patterns, also accounting for the use of lipid modifying agents (LMA). Methods: HTxR (safety population, n=1007) from 3 randomized, multicenter trials were exposed to one of the following ISR: SD-CsA/AZA (n=214); SD-CsA/MMF (n=83); SD-CsA/h-EVR (n=211); SD-CsA/l-EVR (n=209); SD-CsA/TDM-EVR (n=100); RD-CsA/TDM-EVR (pooled from 2 studies; n=190) [SD=standard dose; RD=reduced dose; h-EVR=fixed dose 3.0 mg/d; l-EVR= fixed dose 1.5 mg/d; TDM-EVR=C0 3-8 ng/mL]. Lipid panels (TC, TG, LDL, HDL, TC/HDL ratio), use of LMA and specific risk factors were followed and analyzed for 6 and 12 months post HTx. Results: Demographic and Tx specific baseline(BL) characteristics were comparable across groups. Percentage of patients taking LMA at BL ranged from 27.3 to 37.3% and increased to >70% in all groups at M6. Retrospective categorical analysis showed highest percentage of HTxR in the TC>240mg/dL category for SD-CsA/h-EVR (40.8%) and l-EVR (38.1%) compared to AZA (21.7%), MMF (11.1%), SD-CsA/TDM-EVR (26.6%), and RD-CsA/TDM-EVR (33.8%). Similar pattern were seen for categorical TG>200mg/dL and LDL>130mg/dL: h-EVR(60.9%; 41.3%), l-EVR(57.4%; 31.5%) compared to AZA (29.5%; 27.1%), MMF(19%; 27%) and SD-CsA/TDM-EVR(40.7%; 39.3%), and RD-CsA/TDM-EVR (43%; 39.7%); For categorical HDL>60mg/dL and TC/HDL<4, different distributions were observed (Table). Full categorical analysis and risk factors will be presented. Conclusion: Hyperlipidemia is a known side-effect of mTOR based immunosuppression. High exposure EVR in combination with SD-CsA showed the highest incidence of patients with increased lipid values. Consequently, reduction of both, EVR- and CsA-exposure, facilitated by TDM-EVR, markedly improved the lipid pattern in EVR-treated HTxR. Finally, TDM-EVR based immunosuppression showed better TC/HDL profiles comparing to fixed dose EVR in combination with SD-CsA.

Disclosure: All authors have declared no conflicts of interest.