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Comparative effectiveness of generic versus brand-name antiepileptic medications
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from Jules: There are examples where generic products have not achieved the same therapeutic effect: antiepileptic drugs, thyroid supplements, immunosuppressants for organ transplant.
Comparative effectiveness of generic versus brand-name antiepileptic medications
Epilepsy & Behavior 2015
Joshua J. Gagne a, Aaron S. Kesselheim a, Niteesh K. Choudhry a, Jennifer M. Polinski b, David Hutchins b,
Olga S. Matlin b, Troyen A. Brennan b, Jerry Avorn a, William H. Shrank b
a Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA
b CVS Health, Woonsocket, RI, USA
Objective: The objective of this study was to compare treatment persistence and rates of seizure-related events in patients who initiate antiepileptic drug (AED) therapy with a generic versus a brand-name product.
Methods: We used linked electronic medical and pharmacy claims data to identify Medicare beneficiaries who initiated one of five AEDs (clonazepam, gabapentin, oxcarbazepine, phenytoin, zonisamide). We matched initiators of generic versus brand-name versions of these drugs using a propensity score that accounted for demographic, clinical, and health service utilization variables. We used a Cox proportional hazards model to compare rates of seizure-related emergency room (ER) visit or hospitalization (primary outcome) and ER visit for bone fracture or head injury (secondary outcome) between the matched generic and brand-name initiators. We also compared treatment persistence,measured as time to first 14-day treatment gap, between generic and brand-name initiators.
Results: We identified 19,760 AED initiators who met study eligibility criteria; 18,306 (93%) initiated a generic AED. In the matched cohort, we observed 47 seizure-related hospitalizations and ER visits among brand-name initiators and 31 events among generic initiators, corresponding to a hazard ratio of 0.53 (95% confidence interval, 0.30 to 0.96). Similar results were observed for the secondary clinical endpoint and across sensitivity analyses. Mean time to first treatment gap was 124.2 days (standard deviation [sd], 125.8) for brand-name initiators and 137.9 (sd, 148.6) for generic initiators.
Significance: Patients who initiated generic AEDs had fewer adverse seizure-related clinical outcomes and longer continuous treatment periods before experiencing a gap than those who initiated brand-name versions.
Bioequivalence in Italy
On July 12, 2012, a diagnosis of acute cystitis was performed and a 7 days treatment with ciprofloxacin (Ciproxin, Bayer® 750 mg once daily) was prescribed; on 13 July microbiological evaluation of urine samples revealed the presence of Escherichia coli (2 x 105 colony forming units [CFU]/mL), with a good sensibility to both ciprofloxacin (Minimum inhibitory concentrations [MIC]: 4.9 mcg/mL; range: 0.06-8) and amoxycillin-clavulanate (3.96 mcg/mL; range: 1-16).
During the follow-up performed on 20 July, the persistence of cystitis induced a new microbiological evaluation that revealed, 3 days later, an infection sustained from E. coli (5 x 105 CFU/mL) still ciprofloxacin-sensitive (MIC: 4.9 mcg/mL; range: 0.06-8). Pharmacological evaluation revealed that the patient took the generic ciprofloxacin (Mylan Generics® 750 mg once daily) instead of the prescribed drug; therefore, the brand formulation of ciprofloxacin (Ciproxin, Bayer®; 750 mg once daily) was prescribed with an improvement of clinical symptoms and laboratory values [Table 1] and without the development of side-effects.
Difference in excipients
Previous study suggested that a possible explanation in clinical difference between brand formulation and a generic one might be represented by the difference in excipients.[33]

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