Excellent efficacy with concentration-controlled everolimus in preventing biopsy-proven acute rejection following cardiac transplantation

Lehmkuhl, HB; Dengler, Thomas J.; Junge, G.; Scheidl, Stefan; Hetzer, R.

doi:10.1055/s-0029-1247080

Cited by 1 publication

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“…More recently, another randomized trial in de novo heart transplant patients has compared everolimus with reduced‐exposure CsA versus mycophenolate mofetil (MMF) with standard‐exposure CsA in 176 recipients [12]. Efficacy was similar in both treatment arms; indeed, there were fewer patients with recurrent biopsy‐proven acute rejection (BPAR) in the everolimus/reduced‐CsA cohort [13], indicating that reduced CsA exposure in everolimus‐treated de novo heart transplant patients does not compromise efficacy. Creatinine clearance at month 12, and the change in creatinine clearance over the first year post‐transplant, did not differ significantly between the two treatment groups [12].…”

Section: Introductionmentioning

confidence: 99%

Reduction of cyclosporine following the introduction of everolimus in maintenance heart transplant recipients: a pilot study

Ross

Pflugfelder

Haddad

et al. 2010

Transplant International

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Summary Data are scarce concerning the calcineurin inhibitor dose reduction required following introduction of everolimus in maintenance heart transplant recipients to maintain stable renal function. In a 48‐week, multicenter, single‐arm pilot study in heart transplant patients >12 months post‐transplant, everolimus was started at 1.5 mg/day (subsequently adjusted to target C0 5–10 ng/ml). Mycophenolate mofetil or azathioprine was discontinued on the same day and cyclosporine (CsA) dose was reduced by 25%, with a further 25% reduction each time calculated glomerular filtration rate (cGFR) decreased to <75% of baseline. Of 36 patients enrolled, 25 were receiving everolimus at week 48. From baseline to week 48, there was a mean decrease of 44.5%, 50.9% and 44.6% in CsA dose, C0 and C2, respectively. Mean cGFR was 68.9 ± 14.5 ml/min at baseline and 61.6 ± 11.5 ml/min at week 48 (P = 0.018). The prespecified criterion for stable renal function was met, i.e. a mean decrease ≤25% of cGFR from baseline. Two patients experienced biopsy‐proven acute rejection Grade 3A (5.6%). Between baseline and week 48, there were significant increases in total cholesterol, LDL‐cholesterol and triglycerides, and small but significant elevations in liver enzymes. This 1‐year pilot study suggests that CsA dose reduction of ca. 40% after initiation of everolimus was associated with a decrease in cGFR, however, based on the prespecified criteria stable renal function was attained.

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Section: Introductionmentioning

confidence: 99%