The Evaluation of the Safety and Tolerability of Two Formulations of Cyclosporine: Neoral and Sandimmune

Shah, Malay B.; Martin, Jill E.; Schroeder, T. J.; First, M R

doi:10.1097/00007890-199906150-00004

Cited by 53 publications

(20 citation statements)

References 16 publications

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“…In previous studies of Neoral and prednisolone vs. Sandimmune and prednisolone treatment after renal transplantation a reduction of rejection episodes in the Neoral group has been reported. This has been explained by the more stable and effective immunosuppression of Neoral because of better resorption (22–24). In these studies CMV infections have not been considered in great detail.…”

Section: Discussionmentioning

confidence: 99%

Effects of changing immunosuppressive regimen on the incidence, duration, and viral load of cytomegalovirus infection in renal transplantation: a single center report

Maar

Verschuuren

Heide

et al. 2002

Transplant Infectious Dis

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Background. In this retrospective single center study we have evaluated the relation between the immunosuppressive regimen and the incidence and characteristics of cytomegalovirus (CMV) infection in the setting without CMV prophylaxis from 1989 through 1998. Methods. All (470) first cadaveric renal transplantations in nonsensitized (PRA < 60%) patients were analyzed. Immunosuppression consisted of cyclosporine A (Sandimmune) and prednisolone from 1989 through 2-1993 (S; 189 patients), of cyclosporine microemulsion (Neoral) and prednisolone from 3-1993 through 5-1997 (N; 200 patients) and of mycophenolate mofetil, Neoral and prednisolone from 5-1997 until 1998 (M; 81 patients). The CMV pp65-antigenemia was measured routinely at least once weekly from day 10 till 12 weeks after transplantation or until pp65-antigenemia became negative. No CMV-prophylaxis was given. Results. By changing from Sandimmune to Neoral and by adding mycophenolate mofetil, respectively, we observed a higher frequency of especially secondary CMV infections (S vs. N vs. M, respectively, 28 vs. 50 vs. 63%, P = 0.026; S vs. N, P = 0.027; S vs. M, P = 0.015; and N vs. M, n.s). The CMV infections lasted longer (median duration antigenemia S vs. N vs. M, respectively, 3 vs. 5 vs. 7 weeks, P = 0.0003; S vs. N, P < 0.002; S vs. M, P < 0.001; and N vs. M, P < 0.05). Viral load was higher in M (median maximal pp65-antigenemia S vs. N vs. M, respectively, 19 vs. 14.5 vs. 73, P < 0.01; S vs. N, n.s.; S vs. M, P < 0.001 and N vs. M, P < 0.01). Conclusions. The use of Neoral and the addition of mycophenolate mofetil caused significant changes in the incidence, duration and viral load of CMV infections.

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Section: Discussionmentioning

confidence: 99%

Effects of changing immunosuppressive regimen on the incidence, duration, and viral load of cytomegalovirus infection in renal transplantation: a single center report

Maar

Verschuuren

Heide

et al. 2002

Transplant Infectious Dis

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“…The microemulsion was developed to provide greater and more consistent exposure to cyclosporine than the older, oil-based Sandimmune formulation (9). This facilitated the individual tailoring and monitoring of cyclosporine therapy, which translated into a reduced incidence of acute rejection episodes and an improved graft survival, without increasing adverse effects related to cyclosporine toxicity, not only in kidney transplantation (10,11) but also in other clinical settings such as heart (12) and liver (13) transplantation. As a result of the better risk/benefit profile, Neoral soon became the preferred form of cyclosporine in many centers (9,11,14).…”

mentioning

confidence: 99%

Mycophenolate Mofetil versus Azathioprine for Prevention of Chronic Allograft Dysfunction in Renal Transplantation

Remuzzi¹,

Cravedi²,

Costantini³

et al. 2007

Journal of the American Society of Nephrology

102

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The Mycophenolate Steroids Sparing (MYSS) study found that in renal transplant recipients who were on immunosuppressive therapy with the cyclosporine microemulsion Neoral, mycophenolate mofetil (MMF) was not better than azathioprine in preventing acute rejection at 21 mo after transplantation and was 15 times more expensive ; P ‫؍‬ 0.53), and adverse events were similar on azathioprine (n ‫؍‬ 124) and MMF (n ‫؍‬ 124), respectively. Outcomes in the two groups were comparable also among patients with or without steroid therapy, considered separately. In kidney transplantation, the long-term risk/benefit profile of MMF and azathioprine therapy in combination with cyclosporine Neoral is similar. In view of the cost, standard immunosuppression regimens for kidney transplantation should perhaps include azathioprine rather than MMF.

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“…Problems with variable absorption of the Sandimmune ®1 brand of cyclosporine have been diminished with the introduction of a microemulsion formulation marketed as Neoral ® (Novartis). [6][7][8] Generic forms of cyclosporine are under development.…”

Section: Calcineurin Inhibitorsmentioning

confidence: 99%

Prevention and Treatment of Severe Hemodynamic Compromise in Pediatric Heart Transplant Patients

Costello

Pahl

2002

Pediatric Drugs

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Allograft rejection is a leading cause of severe hemodynamic compromise in pediatric heart transplant patients. A triple-drug immunosuppression regimen, which includes a calcineurin inhibitor, antiproliferative agent, and corticosteroid, suppresses the immune system at multiple different levels for optimal graft protection while minimizing the adverse effects of any one particular agent. Some pediatric centers also use induction therapy with anti-T cell antibodies immediately following transplantation as additional rejection prophylaxis. These antibodies augment immunosuppression by either depleting the T cell pool or blocking interleukin-2 receptors on activated T cells. Despite the aggressive preventive measures outlined above, some pediatric heart transplant patients will develop severe hemodynamic compromise, most commonly due to fulminant rejection. Such patients require attention to, and optimization of, the four determinants of cardiac output (heart rate, preload, contractility and afterload) to stabilize the circulation until the rejection can be reversed. Careful administration of volume, diuretics, inotropes, and afterload-reducing agents will meet this goal. Patients with allograft rejection require augmentation of immune suppression to facilitate myocardial recovery. Corticosteroids form the cornerstone of treatment for both cellular and vascular rejection. In patients with refractory cellular rejection, conversion to mycophenolate mofetil or tacrolimus may be appropriate if these agents are not already being used for maintenance immunosuppression. Critically ill patients may additionally benefit from muromonab-CD3 (OKT3) to augment lympholysis. Treatment employed specifically for humoral rejection is prescribed with the intention of suppressing new antibody formation, removing circulating antibody, and improving coronary blood flow. In addition to corticosteroids, cyclophosphamide and antithymocyte globulin or muromonab-CD3, along with plasmapheresis, may improve survival. Systemic heparinization should be considered to minimize coronary thrombosis in patients with humoral rejection. In the future, novel immunosuppressive agents may further assist in the prevention as well as treatment of severe hemodynamic compromise due to rejection in pediatric heart transplant recipients.

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The Evaluation of the Safety and Tolerability of Two Formulations of Cyclosporine: Neoral and Sandimmune

Cited by 53 publications

References 16 publications

Effects of changing immunosuppressive regimen on the incidence, duration, and viral load of cytomegalovirus infection in renal transplantation: a single center report

Effects of changing immunosuppressive regimen on the incidence, duration, and viral load of cytomegalovirus infection in renal transplantation: a single center report

Mycophenolate Mofetil versus Azathioprine for Prevention of Chronic Allograft Dysfunction in Renal Transplantation

Prevention and Treatment of Severe Hemodynamic Compromise in Pediatric Heart Transplant Patients

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