Cyclosporine Lowering With Everolimus or Mycophenolate to Preserve Renal Function in Heart Recipients: A Randomized Study

Potena, Luciano; Bianchi, Isidoro Giorgio; Magnani, Gaia; Masetti, M.; Coccolo, Fabio; Fallani, Francesco; Russo, Antonio; Grigioni, Francesco; Branzi, Angelo; Ponticelli, Claudio

doi:10.1097/tp.0b013e3181c42b95

Cited by 30 publications

(28 citation statements)

References 22 publications

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“…2,6 -11 In an earlier randomized study we found a similar efficacy for cyclosporine lowering when administered in combination with either mycophenolate mofetil (MMF) or everolimus, with evaluation done after 12 months. 15 In the current study we aimed to determine whether any differences could be observed at 3 years.…”

mentioning

confidence: 97%

Cyclosporine lowering with everolimus versus mycophenolate mofetil in heart transplant recipients: Long-term follow-up of the SHIRAKISS randomized, prospective study

Potena

Prestinenzi

Bianchi

et al. 2012

The Journal of Heart and Lung Transplantation

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confidence: 97%

Cyclosporine lowering with everolimus versus mycophenolate mofetil in heart transplant recipients: Long-term follow-up of the SHIRAKISS randomized, prospective study

Potena

Prestinenzi

Bianchi

et al. 2012

The Journal of Heart and Lung Transplantation

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“…[10][11][12][13] In contrast, trials in maintenance patients have been restricted to patients who have already developed renal dysfunction. [14][15][16] The kidney-sparing effect of these various everolimus-based regimens has been mixed (Table 1). Of note, however, the only two trials to use measured GFR instead of eGFR or other secondary markers both found a significant advantage for everolimus.…”

Section: Preservation Of Renal Functionmentioning

confidence: 98%

“…25 Studies in which everolimus is introduced more than 12 months after heart transplantation generally do not report CMV rates due to the very low rate of such lateonset cases. [14][15][16] Cardiac allograft vasculopathy CAV is a leading cause of death in heart transplant patients. 26 It has a complex etiology, with multiple risk factors 27 including CMV infection 28 and rejection.…”

Section: Cytomegalovirus Infectionmentioning

confidence: 99%

The MANDELA study: A multicenter, randomized, open-label, parallel group trial to refine the use of everolimus after heart transplantation

Deuse¹,

Bara

Barten³

et al. 2015

Contemporary Clinical Trials

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“…EVRL was associated with twice as many pneumonias in the first year and 1.8 fold increases in risk of rejection after 2 years. Proteinuria was not reported.To complicate the picture, the small, randomized SHIRAKISS study, showed that late addition of MMF or EVRL while reducing CNI levels by 30% and 70% respectively, resulted in better renal function on MMF after 3 years [46,47]. This outcome was dependent on baseline proteinuria only with EVRL.…”

mentioning

confidence: 99%

“…Kidney function at the time of introduction of the drugs should be moderately decreased to see the most benefit and although patients with GFR below 30mL/ min can benefit many of the above studies showed that more patients with poor baseline GFR will progress despite PSI therapy due to advanced, irreversible CNI kidney toxicity [56]. The presence of baseline proteinuria is cause for concern as is the presence of diabetes and might negate any benefit of PSI use [34,37,46,47,54]. The use of ACE inhibitors and angiotensin receptor blockers might mitigate the adverse effect of PSI induced proteinuria on worsening renal function but this is not based on large number of patients [34,37,57].…”

mentioning

confidence: 99%

Cardiac Troponin I Level in STEMI and Clinical Correlation with Left Ventricular Dysfunction in Indian Population

Sharma¹,

Sharma²

2013

J Cardiovasc Dis Diagn

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Calcium Channel Blockers (CCBs): CNIs cause vasoconstriction as noted above. CCBs, specifically vasodilating dihydropyridines, have been shown to improve renal plasma flow and GFR [9,16]. A small prospective study comparing amlodipine to placebo showed a slower decline in GFR at one year [13]. There was no effect on LV mass and only a modest decrease in proteinuria. Diltiazem did not appear to offer the same protection [14]. RAAS Inhibitors:The use of RAAS inhibitors is beneficial in most patients with CKD; however, this has not been shown in OHT patients. A systematic review of randomized studies in CSA-treated kidney AbstractBackground: The use of calcineurin inhibitors revolutionized transplantation by prolonging patients' survival. However, their utility is limited by the development of significant chronic kidney disease. Methods:We reviewed the English literature looking for recent publications regarding the management of chronic kidney disease in cardiac transplant patients. We chose relevant papers based on design, number of patients and clinical utility.Results: Most publications on the subject involve small populations with few prospective, randomized studies. Early use of tacrolimus appears to be associated with better kidney function after one year compared to cyclosporine. Once chronic kidney disease is established, successful strategies include reduction or elimination of calcineurin inhibitors while relying on mycophenolate mofetil, proliferation signal inhibitors or anti-CD 25 antibodies to prevent rejection. There is no follow up longer than two years with these approaches. Kidney transplantation might offer improved long-term survival compared to dialysis in end-stage disease. Conclusions:Prospective studies with long-term follow-up are needed to decide about the timing and to confirm the utility of replacing calcineurin inhibitors with other agents in cardiac transplant patients with chronic kidney disease. transplant patients show, after a median of 27 months, a reduction in GFR (around 5.8 cc/min) with a reduction of proteinuria (decrease of 470 mg/day) [17]. It is uncertain if the reduction in proteinuria would translate into better outcomes in the long run. In fact, Opelz et al. showed, in a retrospective study of 1,744 OHT patients, that the use of RAAS inhibitors did not improve patient survival after 6 years [18]. The same study looked at 17,209 kidney transplant patients and showed no difference in graft or patient survival [18]. The use of spironolactone in rat models prevented the decline in GFR and the histologic changes seen with CSA [19]. There are no data in patients. Management of Calcineurin Modification of immunosuppressive drugsTransplant centers have tried multiple immunosuppressive strategies in OHT patient with CKD to prevent progression of renal dysfunction. Most of the data come from small studies, limiting the strength of recommendations that can be made. Larger studies come usually from kidney transplantation literature. Tacrolimus:In small studies, Tacrolimus (TAC) do...

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Cyclosporine Lowering With Everolimus or Mycophenolate to Preserve Renal Function in Heart Recipients: A Randomized Study

Cited by 30 publications

References 22 publications

Cyclosporine lowering with everolimus versus mycophenolate mofetil in heart transplant recipients: Long-term follow-up of the SHIRAKISS randomized, prospective study

Cyclosporine lowering with everolimus versus mycophenolate mofetil in heart transplant recipients: Long-term follow-up of the SHIRAKISS randomized, prospective study

The MANDELA study: A multicenter, randomized, open-label, parallel group trial to refine the use of everolimus after heart transplantation

Cardiac Troponin I Level in STEMI and Clinical Correlation with Left Ventricular Dysfunction in Indian Population

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