Ann Surg Treat Res.  2014 Apr;86(4):192-198. 10.4174/astr.2014.86.4.192.

A multicenter experience with generic mycophenolate mofetil conversion in stable liver transplant recipients

• Kim JM
• Kwon CH
• Yun IJ
• Lee KW
• Yu HC
• Suh KS
• Joh JW
• Cho BH

• KMID: 2167125
• DOI: http://doi.org/10.4174/astr.2014.86.4.192

Abstract

PURPOSE
Generic substitution of brand-name medications can lead to significant cost savings and is an accepted medical practice. This study evaluated clinical and safety outcomes among liver transplant recipients whose mycophenolate mofetil (MMF) was converted from the brand-name formulation (Cellcept) to a generic formulation (My-rept).
METHODS
Clinical data from multiple centers were prospectively collected for determination of complications, safety, and quality of life after in 154 clinically stable, adult liver transplant recipients whose MMF was converted to a generic formulation between April 2010 and September 2012. This protocol was approved by Institutional Review Boards of all involved sites.
RESULTS
In eight patients (5.19%), nine instances of drug-related complications occurred after medication conversion. Half of these complications were gastrointestinal disorders (n = 4), and most (7 of 9) were mild. No significant differences were noted in mean pre- and postconversion gastrointestinal symptoms via a rating system (8.9 vs. 10.4) or gastrointestinal quality-of-life index scores (125.6 vs. 123.1). More than 90% of patients reported a status of "about the same" when questioned about the brand-name and generic formulation using the Patient Overall Treatment Effect and Investigator Overall Treatment Effect measures. The incidence of serious adverse events was 5.8%. Acute rejection occurred in two patients, with no graft loss or death.
CONCLUSION
Clinical experience as well as research data showed that generic MMF was comparable in efficacy to the brand-name drug. Given the lack of adverse events and the safety findings, conversion from brand-name MMF to generic MMF should be encouraged.

Keyword

Drug-related side effects and adverse reactions; Generic drugs; Transplantation liver; Mycophenolate mofetil; Quality of life

MeSH Terms

Adult
Cost Savings
Drug Substitution
Drug-Related Side Effects and Adverse Reactions
Drugs, Generic
Ethics Committees, Research
Humans
Incidence
Liver*
Prospective Studies
Quality of Life
Research Personnel
Transplantation*
Transplants
Drugs, Generic

Figure

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  Fig. 1 Study population.

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  Fig. 2 Changes in GSRS (A) and GIQLI (B) scores between visit 1 (baseline) and visit 4. GSRS, Gastrointestinal Symptom Rating Scale; GIQLI, Gastrointestinal Quality-of-Life Index.

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  Fig. 3 Patient-reported and investigator-reported overall treatment effect on quality of life. P-OTE, patient overall treatment effect; I-OTE, investigator overall treatment effect.

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