{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,8]],"date-time":"2026-01-08T20:14:58Z","timestamp":1767903298350,"version":"3.49.0"},"reference-count":32,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2012,3,27]],"date-time":"2012-03-27T00:00:00Z","timestamp":1332806400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["accpjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacotherapy"],"published-print":{"date-parts":[[2012,4]]},"abstract":"<jats:p>Generic antiepileptic drugs achieve blood concentrations similar to those of innovator drugs in healthy volunteers, but their comparative effectiveness has not been well evaluated. Thus, we assessed the efficacy, tolerability, and safety of innovator versus generic antiepileptic drugs. We searched the <jats:styled-content style=\"fixed-case\">MEDLINE<\/jats:styled-content> database, <jats:styled-content style=\"fixed-case\">C<\/jats:styled-content>ochrane <jats:styled-content style=\"fixed-case\">C<\/jats:styled-content>entral <jats:styled-content style=\"fixed-case\">R<\/jats:styled-content>egister of <jats:styled-content style=\"fixed-case\">C<\/jats:styled-content>ontrolled <jats:styled-content style=\"fixed-case\">T<\/jats:styled-content>rials, <jats:styled-content style=\"fixed-case\">C<\/jats:styled-content>ochrane <jats:styled-content style=\"fixed-case\">D<\/jats:styled-content>atabase of <jats:styled-content style=\"fixed-case\">S<\/jats:styled-content>ystematic <jats:styled-content style=\"fixed-case\">R<\/jats:styled-content>eviews, and <jats:styled-content style=\"fixed-case\">W<\/jats:styled-content>eb of <jats:styled-content style=\"fixed-case\">S<\/jats:styled-content>cience for studies that evaluated innovator and generic antiepileptic drugs in patients with epilepsy and reported data on prespecified outcomes. We extracted data on study design, interventions, quality criteria, study population, baseline characteristics, and outcomes. Compared with initiation of innovator antiepileptic drugs, initiation of generic antiepileptic drugs did not significantly alter seizure occurrence (relative risk [<jats:styled-content style=\"fixed-case\">RR<\/jats:styled-content>] 0.87, 95% confidence interval [<jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>] 0.64\u20131.18; strength of evidence: low) or frequency (standardized mean difference 0.03, 95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content> \u22120.08\u20130.14; strength of evidence: low), withdrawals due to lack of efficacy (<jats:styled-content style=\"fixed-case\">RR<\/jats:styled-content> 1.02, 95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content> 0.41\u20132.54; strength of evidence: low) or adverse events (<jats:styled-content style=\"fixed-case\">RR<\/jats:styled-content> 0.79, 95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content> 0.28\u20132.20; strength of evidence: low), pharmacokinetic concentrations (maximum, minimum, or area under the curve [strength of evidence: low]), or a myriad of adverse events (strength of evidence: low or insufficient) in clinical trials. In qualitatively evaluated observational studies, switching between forms of antiepileptic drug (innovator to generic, generic to generic) may increase the risk of hospitalization (strength of evidence: low), hospital stay duration (strength of evidence: low), and a composite end point of medical service utilization (strength of evidence: insufficient) but may not increase outpatient service utilization (strength of evidence: low). Data are limited predominantly to carbamazepine, phenytoin, and valproic acid. Clinical trials are limited by small sample size, short\u2010term nature, and lack of specification of A\u2010rated generic products (generics that the United States Food and Drug Administration has deemed bioequivalent to the innovator drug). Observational trials lack full accounting for confounders and have inherent limitations. With a low strength of evidence, it appears that initiating an innovator or generic antiepileptic drug will provide similar efficacy, tolerability, and safety but that switching from one form to the other may be associated with more hospitalizations and longer hospital stays.<\/jats:p>","DOI":"10.1002\/j.1875-9114.2012.01099.x","type":"journal-article","created":{"date-parts":[[2012,9,5]],"date-time":"2012-09-05T03:54:35Z","timestamp":1346817275000},"page":"314-322","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":27,"title":["Efficacy and Safety of Innovator versus Generic Drugs in Patients with Epilepsy: A Systematic Review"],"prefix":"10.1002","volume":"32","author":[{"given":"Ripple","family":"Talati","sequence":"first","affiliation":[{"name":"From the University of Connecticut\/Hartford Hospital Evidence\u2010Based Practice Center Hartford Connecticut"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jennifer M.","family":"Scholle","sequence":"additional","affiliation":[{"name":"From the University of Connecticut\/Hartford Hospital Evidence\u2010Based Practice Center Hartford Connecticut"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Olivia P.","family":"Phung","sequence":"additional","affiliation":[{"name":"From the University of Connecticut\/Hartford Hospital Evidence\u2010Based Practice Center Hartford Connecticut"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Erika L.","family":"Baker","sequence":"additional","affiliation":[{"name":"From the University of Connecticut\/Hartford Hospital Evidence\u2010Based Practice Center Hartford Connecticut"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"William L.","family":"Baker","sequence":"additional","affiliation":[{"name":"From the University of Connecticut\/Hartford Hospital Evidence\u2010Based Practice Center Hartford Connecticut"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ajibade","family":"Ashaye","sequence":"additional","affiliation":[{"name":"From the University of Connecticut\/Hartford Hospital Evidence\u2010Based Practice Center Hartford Connecticut"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jeffrey","family":"Kluger","sequence":"additional","affiliation":[{"name":"From the University of Connecticut\/Hartford Hospital Evidence\u2010Based Practice Center Hartford Connecticut"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Craig I.","family":"Coleman","sequence":"additional","affiliation":[{"name":"From the University of Connecticut\/Hartford Hospital Evidence\u2010Based Practice Center Hartford Connecticut"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"C. 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