Sabrina Giometto1, Laura Baglietto2, Marco Conte3, Alfredo Vannacci4, Marco Tuccori5, Alessandro Mugelli6, Rosa Gini7, Ersilia Lucenteforte8. 1. Department of Clinical and Experimental Medicine, University of Pisa, 56126 Pisa, Italy. Electronic address: sabrina.giometto@med.unipi.it. 2. Department of Clinical and Experimental Medicine, University of Pisa, 56126 Pisa, Italy. Electronic address: laura.baglietto@unipi.it. 3. Department of Clinical and Experimental Medicine, University of Pisa, 56126 Pisa, Italy. 4. Department of Neurosciences, Psychology, Drug Research and Child Health (NEUROFARBA), University of Florence, Florence, Italy. Electronic address: alfredo.vannacci@unifi.it. 5. Unit of Pharmacology and Pharmacovigilance, Department of Clinical and Experimental Medicine, University Hospital of Pisa, Pisa, Italy. 6. Department of Neurosciences, Psychology, Drug Research and Child Health (NEUROFARBA), University of Florence, Florence, Italy. Electronic address: alessandro.mugelli@unifi.it. 7. Agenzia regionale di sanità della Toscana, Florence, Italy. Electronic address: rosa.gini@ars.toscana.it. 8. Department of Clinical and Experimental Medicine, University of Pisa, 56126 Pisa, Italy. Electronic address: ersilia.lucenteforte@unipi.it.
Abstract
PURPOSE: To assess patterns of use of antiseizure medications (ASMs) and to compare the safety of generic versus branded formulations in terms of admission to hospital or to emergency department (ED). METHODS: We conducted a drug utilization study with a propensity score-matched design using the administrative databases of the Italian Tuscany region. New users of ASMs during 2015 with no history of neoplasia were considered and their first prescription was classified as: available only as branded (only-B-ASM); branded with generic available (B-ASM); and generic (G-ASM). Patients with G-ASM first prescription were matched with four patients with B-ASM prescription. Participants were followed up for one year or until the date of death or diagnosis of neoplasia. Cox regression models were fitted to estimate the risk of admission to hospital or ED. RESULTS: We identified 36,601 ASM new-users, including 2094 (6.4%) with only-B-ASM as first prescription, 24,588 (74.9%) with B-ASM, and 5788 (17.6%) with G-ASM. We found no differences in the risk of admission to hospital or ED (Hazard Ratio (HR), 0.92; 95% Confidence Interval (CI), 0.85-1.02) among users of generic ASMs compared to those using branded ASMs. CONCLUSIONS: In our study population, generic ASMs were used less than branded ones. The similarity in the safety of branded and generic formulations suggests that generic ASMs could be the preferred formulation in current clinical practice resulting in a substantial decrease in the cost of treatment.
PURPOSE: To assess patterns of use of antiseizure medications (ASMs) and to compare the safety of generic versus branded formulations in terms of admission to hospital or to emergency department (ED). METHODS: We conducted a drug utilization study with a propensity score-matched design using the administrative databases of the Italian Tuscany region. New users of ASMs during 2015 with no history of neoplasia were considered and their first prescription was classified as: available only as branded (only-B-ASM); branded with generic available (B-ASM); and generic (G-ASM). Patients with G-ASM first prescription were matched with four patients with B-ASM prescription. Participants were followed up for one year or until the date of death or diagnosis of neoplasia. Cox regression models were fitted to estimate the risk of admission to hospital or ED. RESULTS: We identified 36,601 ASM new-users, including 2094 (6.4%) with only-B-ASM as first prescription, 24,588 (74.9%) with B-ASM, and 5788 (17.6%) with G-ASM. We found no differences in the risk of admission to hospital or ED (Hazard Ratio (HR), 0.92; 95% Confidence Interval (CI), 0.85-1.02) among users of generic ASMs compared to those using branded ASMs. CONCLUSIONS: In our study population, generic ASMs were used less than branded ones. The similarity in the safety of branded and generic formulations suggests that generic ASMs could be the preferred formulation in current clinical practice resulting in a substantial decrease in the cost of treatment.
Authors: Ippazio Cosimo Antonazzo; Carla Fornari; Sandy Maumus-Robert; Eleonora Cei; Olga Paoletti; Sara Conti; Paolo Angelo Cortesi; Lorenzo Giovanni Mantovani; Rosa Gini; Giampiero Mazzaglia Journal: Int J Environ Res Public Health Date: 2021-12-16 Impact factor: 3.390