Indian Journal of Urology Users online:2720  
IJU
Home Current Issue Ahead of print Editorial Board Archives Symposia Guidelines Subscriptions Login 
Print this page  Email this page Small font sizeDefault font sizeIncrease font size
ORIGINAL ARTICLE
Year : 2007  |  Volume : 23  |  Issue : 2  |  Page : 130-132

Clinical evaluation of efficacy and safety of cyclosporine (Imusporin) in renal transplant patients with stable graft function maintained on neoral or bioral


1 Department of Urology and Renal Transplantation, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, UP, India
2 Department of Nephrology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, UP, India

Correspondence Address:
Aneesh Srivastava
Department of Urology and Renal Transplantation, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow - 226 014, UP
India
Login to access the Email id

Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0970-1591.32062

Rights and Permissions

Objective: Previous pharmacokinetic studies have demonstrated bioequivalence of Imusporin (microemulsion preparation of cyclosporine, Cipla) to the innovator product Neoral (Novartis, Switzerland). This study was done to evaluate the clinical efficacy and safety of Imusporin in patients who have already undergone renal transplant and have stable graft function maintained on cyclosporine preparation other than Imusporin. Materials and Methods: Twenty-two renal allograft recipients (mean age of 31.77 years, range 18-53 years), with stable graft function, previously on Neoral or Bioral were switched over to Imusporin after recording their relevant baseline clinical and biochemical parameters. These were repeated on 1, 4, 7, 15, 30 and 90 days after the start of therapy. Change in dosage required to maintain C2 levels at each visit were analyzed by paired sample t -test. Safety of the drug was assessed by the type and severity of adverse events developed during the therapy. Cost analysis was done assuming an average maintenance immunosuppression dose of 150 mg/day of cyclosporine. Results: Twenty-one patients completed the study. One patient was lost to follow-up. Mean C2 value before switchover was 894 208 ng/ml, which was not significantly different from the mean values of C2 after switchover therapy ( P >0.30). Change in dosage required to maintain C2 levels was not significantly different from the baseline dose of 2.34 mg/ kg body weight ( P >0.1). No patient developed graft rejection after switchover therapy at a median follow-up of 16 months (14-18 months). Mean baseline SCr was similar to SCr at day 90 (1.38 vs. 1.37 mg/dl, P =0.930). No severe adverse events were reported. Mild side-effects included headache (4), somnolence (2), dry mouth (5) and generalized fatigue (6). Use of Imusporin (Cipla, India) results in an annual savings of Rs. 19892 over Neoral (Novartis, Switzerland) and Rs. 2263 over Bioral (Panacea Biotech, India). Conclusions: Imusporin is clinically as safe and efficacious as other cyclosporine preparations available while significantly reducing the cost of treatment.


[FULL TEXT] [PDF]*
Print this article     Email this article
 Next article
 Previous article
 Table of Contents

 Similar in PUBMED
   Search Pubmed for
   Search in Google Scholar for
 Related articles
 Citation Manager
 Access Statistics
 Reader Comments
 Email Alert *
 Add to My List *
 * Requires registration (Free)
 

 Article Access Statistics
    Viewed4448    
    Printed92    
    Emailed0    
    PDF Downloaded364    
    Comments [Add]    
    Cited by others 2    

Recommend this journal

 

HEALTHWARE INDIA