MedicalResearch.com Interview with:
Dr. Michael Privitera MD
Professor of the Department of Neurology and director of the Epilepsy Center
University of Cincinnati Neuroscience Institute
Medical Research: What is the background for this study? What are the main findings?
Dr. Privitera: Generic substitution of medications has saved the American health care system billions of dollars per year. However, based on a series of uncontrolled studies, patients and clinicians share concerns that generic substitution of antiepileptic drugs may lead to loss of efficacy or emergence of adverse effects. To answer this question we undertook a prospective, randomized study that tested bioequivalence of two generic products of the antiepileptic drug lamotrigine. Lamotrigine was identified in several publications as a possible source of problems after generic switches. FDA studies test a single generic versus the brand name product in a single dose study in normal volunteers. We designed a study that would be most likely to show a difference between generics if one existed. We compared the two generic lamotrigine products showing the most difference in prior testing in patients with epilepsy taking the drug daily using rigorous pharmacokinetic methods. Each patient took each of the two generics for 2 four week periods. Our study showed the two generics were essentially indistinguishable and easily met bioequivalence standards. No patient had loss of seizure control or unexpected adverse effects.
Medical Research: What should clinicians and patients take away from your report?
Dr. Privitera: The findings of this study should increase the confidence of clinicians and people with epilepsy that current regulations governing generic antiepileptic drugs provide bioequivalent generic products that can be safely substituted. Because lamotrigine has many drug-drug interactions, and epilepsy appears to be a sensitive model for therapeutic differences, the findings of this study are likely applicable to many other therapeutic areas.
Medical Research: What recommendations do you have for future research as a result of this study?
Dr. Privitera: Recent studies have shown that changes in the color of medications can be associated with lapses in medication adherence. Future studies should examine this possibility or possibly doing rigorous pharmacokinetic sampling in patients who believe they have had adverse experiences when undergoing generic switches.
Medical Research: Is there anything else you would like to add?
Dr. Privitera: This study was a model for public-private partnerships because it was funded by a combination of FDA, American Epilepsy Society and Epilepsy Foundation funds, and all three organizations had members on the study design team.
Generic-to-generic lamotrigine switches in people with epilepsy: the randomised controlled EQUIGEN trial
Privitera, Michael D et al.
The Lancet Neurology , Volume 0 , Issue 0 ,
Dr. Michael Privitera (2016). Two Generic Lamotrigine Medications Demonstrate Bioequivalence in Epilepsy