Does Cyclosporine work?
Yes, in large controlled trials. The key trial had 209 people.
The transplant use was established by randomized trials, including the Canadian Multicentre Transplant Study in the citations, which randomized 209 recipients of cadaveric kidneys and found one-year graft survival of 80% with cyclosporine against 64% with azathioprine and prednisone. Forty years of subsequent trials and registry data confirm it. 12
The Canadian Multicentre Transplant Study Group randomized 209 recipients of cadaveric kidneys. One group got cyclosporine plus prednisone. The other got the standard regimen of azathioprine plus prednisone. Predicted one-year graft survival was 80.4% with cyclosporine and 64.0% with standard therapy. One-year patient survival was 96.6% against 86.4%. Grafts did worse in the cyclosporine group when the kidney had been machine-perfused for over 24 hours. This was an early sign of the drug's kidney toxicity. 1
The labels summarize later controlled trials. These covered liver and heart transplantation, rheumatoid arthritis and severe psoriasis. For Restasis, two multicentre trials found a measurable rise in tear production at six months. More patients had it than with the vehicle alone. 234
Evidence checklist
- Randomised controlled trial Canadian Multicentre Transplant Study
- Human study over 100 people 209 kidney transplant recipients
- More than one research group Four decades of trials and registry data
- Clinical outcomes, not surrogate markers Graft survival 80% vs 64% at one year
- Human safety data beyond case reports Boxed warnings; decades of use and monitoring
Read the full Cyclosporine page
More on Cyclosporine
Citations
- Canadian Multicentre Transplant Study Group 1983, NEJM: randomised trial of cyclosporine in cadaveric renal transplantation doi.org
- Sandimmune (cyclosporine) prescribing information drugs.com
- Neoral (cyclosporine modified) prescribing information drugs.com
- Restasis (cyclosporine ophthalmic emulsion) prescribing information drugs.com
Reference information only, not medical advice. Drawn from the Cyclosporine article, fact-checked against the cited sources. No dosing anywhere on this site.