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Dr. Lee's Research Grant Proposal

Young H. Lee, MD
Pennsylvania State University College of Medicine, Department of Dermatology
2014 Research Grant Recipient


Research Grant Proposal

A Meta-Analysis of Laboratory Monitoring During Treatment with Isotretinoin

Severe nodulocystic acne is often treated with isotretinoin, which dramatically improves inflammatory acne within months.  Though it is extremely effective, isotretinoin has been reported to be associated with several adverse effects of concern, including teratogenicity, hyperlipidemia and associated pancreatitis, leukopenia, thrombocytopenia, and transaminitis with hepatotoxicity.  Monitoring of pregnancy during therapy is mandated via the iPLEDGE program.  However, laboratory monitoring of serum lipids, liver function tests, and blood counts are done at the discretion of the clinician, and wide variability exists in the type and frequency of monitoring that is done.

The package insert currently recommends baseline fasting lipids and liver function tests with repeated testing at weekly or biweekly intervals until “the response has been established”.  There is no mention of monitoring of blood counts.  Beyond that, there are no established evidence-based guidelines for both the type and frequency of monitoring.  In order for the testing to be worthwhile, it should presumably identify clinically significant changes in laboratory values that affect the course of isotretinoin therapy.  In this era of healthcare reform, it would be prudent to examine the existing data to determine if and when clinically meaningful abnormalities are detected so that testing can be used with greater efficiency.

The aim of this study is to determine the frequency of laboratory abnormalities detected by routine monitoring during isotretinoin therapy by using existing trials and cohort studies.  Using this data, a more targeted schedule for laboratory monitoring can be proposed.  A secondary aim is to determine the potential cost-savings for targeted and purposeful laboratory monitoring with isotretinoin.


Publications

Lee Y, Scharnitz T, et al. Laboratory monitoring during isotretinoin therapy of acne: A systematic review and meta-analysis. Atlantic Dermatology Meeting. Philadelphia, PA. Apr 2015.
View Atlantic Dermatology Meeting poster presentation.

Lee Y, Scharnitz T, et al. Laboratory monitoring during isotretinoin therapy of acne: A systematic review and meta-analysis. Society for Investigative Dermatology Meeting. Atlanta, GA. May 2015.
View Society for Investigative Dermatology poster presentation.

Straight C, Lee Y, Liu G, Kirby J. Duration of oral antibiotic therapy for the treatment of adult acne: A retrospective analysis investigating adherence to guideline recommendations and opportunities for cost-savings. May 2015. Journal of the American Academy of Dermatology. Submitted for Publication.
View Dr. Lee's submitted abstract.