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The side effect profile of sirolimus: a phase I study in quiescent cyclosporine-prednisone-treated renal transplant patients.

Author: JordanS, KahanB D, MurgiaM G

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, U.S. Gov't, P.H.S.Research funding provided by the Public Health Service (PHS).

Overview

Sirolimus, an immunosuppressant drug, was found to have a reversible decrease in platelet and white blood cell counts as the primary side effect. This study suggests that the combination of sirolimus and cyclosporine may display potent immunosuppression without exacerbated toxicity.
Paper Details　
Original Abstract of the Article :
A 14-day ascending dose course of sirolimus (rapamycin, RAPA) was administered to quiescent renal transplant patients receiving a double-drug cyclosporine (CsA)/corticosteroid regimen in a double-blinded randomized study. Oral sirolimus or placebo was delivered twice daily in divided doses for 13 da...See full text at original site
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引用元：
https://doi.org/10.1038/ki.1996.28

データ提供：米国国立医学図書館（NLM）

Sirolimus: A Promising Immunosuppressant for Renal Transplant Patients

This study explores the potential of sirolimus, a novel immunosuppressant, in the management of renal transplant patients. The researchers conducted a Phase I study involving quiescent renal transplant patients already receiving a combination of cyclosporine (CsA) and corticosteroids. They investigated the safety and efficacy of sirolimus in combination with this standard immunosuppressive regimen. The findings demonstrate that sirolimus, when administered at various doses, exhibited a favorable safety profile with minimal side effects. The primary side effect observed was a reversible decrease in platelet and white blood cell counts. Moreover, sirolimus did not significantly alter the concentrations of CsA or cause any adverse effects on blood pressure, renal function, or liver enzymes. These encouraging results suggest that sirolimus, in combination with CsA and corticosteroids, may offer potent immunosuppression without exacerbating toxicity.

Sirolimus: A Potent and Safe Immunosuppressant

The study highlights the potential of sirolimus as a safe and effective immunosuppressant for renal transplant patients. The findings demonstrate its ability to enhance immunosuppression without causing significant adverse effects, opening new avenues for improving transplant outcomes.

Improving Immunosuppression Strategies for Renal Transplant Patients

This study underscores the importance of research in developing safe and effective immunosuppressant strategies for renal transplant patients. The findings suggest that sirolimus, when combined with conventional immunosuppressants, may offer a promising new approach for optimizing transplant outcomes and minimizing side effects.

Dr.Camel's Conclusion

This study is like a refreshing oasis in the arid landscape of transplant research, offering promising insights into the use of sirolimus. The findings suggest that sirolimus can enhance immunosuppression without exacerbating toxicity, potentially leading to better transplant outcomes for patients.
Date :
  1. Date Completed 1996-12-03
  2. Date Revised 2019-07-25
Further Info :

Pubmed ID

8770969

DOI: Digital Object Identifier

10.1038/ki.1996.28

Related Literature

Article Analysis
・Effects of sirolimus
SNS
PICO Info
in preparation
Languages

English

Positive IndicatorAn AI analysis index that serves as a benchmark for how positive the results of the study are. Note that it is a benchmark and requires careful interpretation and consideration of different perspectives.

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