Evaluating Therapeutic Equivalence of Generic and Original Levetiracetam in Patients with Epilepsy: A Retrospective Study
The brand interchangeability of antiepileptic drugs (AEDs) is a topic of debate, especially regarding their therapeutic equivalence. This study evaluates the efficacy and tolerability of generic levetiracetam compared to the brand-name equivalent in a routine clinical setting. We conducted a retrosp...
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MDPI AG
2022-03-01
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| Series: | Neurology International |
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| Online Access: | https://www.mdpi.com/2035-8377/14/1/22 |
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| author | Jannapas Tharavichitkun Tinonkorn Yadee Poomchai Angkaow Thanarat Suansanae |
| author_facet | Jannapas Tharavichitkun Tinonkorn Yadee Poomchai Angkaow Thanarat Suansanae |
| author_sort | Jannapas Tharavichitkun |
| collection | DOAJ |
| description | The brand interchangeability of antiepileptic drugs (AEDs) is a topic of debate, especially regarding their therapeutic equivalence. This study evaluates the efficacy and tolerability of generic levetiracetam compared to the brand-name equivalent in a routine clinical setting. We conducted a retrospective study, examining patients with stable seizure frequency who received generic levetiracetam after the brand-name drug. During the six-month substitution period, changes in seizure frequency, hospitalization due to seizure exacerbation, adverse events, composite outcomes related to adjusting the AED dosage, and switching back to original levetiracetam were analyzed. Seventy-five patients were enrolled; the majority (85.3%) had focal onset seizures, and almost half (49.3%) had refractory epilepsy. Six months after the substitution, the mean seizure frequency per month was not significantly different (3.15 ± 14.47 vs. 2.77 ± 11.41; <i>p</i> = 0.970). In patients with controlled seizures before the change, the seizure frequency increased significantly (0.56 ± 1.83 vs. 0.03 ± 0.16; <i>p</i> = 0.012). Adverse events occurred in six patients. We have observed recurrent seizures or adverse events from 14 days after the transition. The original drug return rates due to recurrent seizures and adverse events were 5.3% and 1.3%, respectively. Generic levetiracetam might not show therapeutic equivalence to the original molecule, especially in patients adequately controlled by the brand-name drug. |
| first_indexed | 2024-03-09T13:06:55Z |
| format | Article |
| id | doaj.art-a2321e6fb87d4cd68385a4adfe3438d1 |
| institution | Directory Open Access Journal |
| issn | 2035-8377 |
| language | English |
| last_indexed | 2024-03-09T13:06:55Z |
| publishDate | 2022-03-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Neurology International |
| spelling | doaj.art-a2321e6fb87d4cd68385a4adfe3438d12023-11-30T21:47:44ZengMDPI AGNeurology International2035-83772022-03-0114127128310.3390/neurolint14010022Evaluating Therapeutic Equivalence of Generic and Original Levetiracetam in Patients with Epilepsy: A Retrospective StudyJannapas Tharavichitkun0Tinonkorn Yadee1Poomchai Angkaow2Thanarat Suansanae3Department of Pharmacy, Faculty of Pharmacy, Mahidol University, Bangkok 10400, ThailandDepartment of Neurology, Neurological Institute of Thailand, Bangkok 10400, ThailandDepartment of Pharmacy, Neurological Institute of Thailand, Bangkok 10400, ThailandDepartment of Pharmacy, Faculty of Pharmacy, Mahidol University, Bangkok 10400, ThailandThe brand interchangeability of antiepileptic drugs (AEDs) is a topic of debate, especially regarding their therapeutic equivalence. This study evaluates the efficacy and tolerability of generic levetiracetam compared to the brand-name equivalent in a routine clinical setting. We conducted a retrospective study, examining patients with stable seizure frequency who received generic levetiracetam after the brand-name drug. During the six-month substitution period, changes in seizure frequency, hospitalization due to seizure exacerbation, adverse events, composite outcomes related to adjusting the AED dosage, and switching back to original levetiracetam were analyzed. Seventy-five patients were enrolled; the majority (85.3%) had focal onset seizures, and almost half (49.3%) had refractory epilepsy. Six months after the substitution, the mean seizure frequency per month was not significantly different (3.15 ± 14.47 vs. 2.77 ± 11.41; <i>p</i> = 0.970). In patients with controlled seizures before the change, the seizure frequency increased significantly (0.56 ± 1.83 vs. 0.03 ± 0.16; <i>p</i> = 0.012). Adverse events occurred in six patients. We have observed recurrent seizures or adverse events from 14 days after the transition. The original drug return rates due to recurrent seizures and adverse events were 5.3% and 1.3%, respectively. Generic levetiracetam might not show therapeutic equivalence to the original molecule, especially in patients adequately controlled by the brand-name drug.https://www.mdpi.com/2035-8377/14/1/22epilepsyseizuretherapeutic equivalencegeneric substitutionlevetiracetam |
| spellingShingle | Jannapas Tharavichitkun Tinonkorn Yadee Poomchai Angkaow Thanarat Suansanae Evaluating Therapeutic Equivalence of Generic and Original Levetiracetam in Patients with Epilepsy: A Retrospective Study Neurology International epilepsy seizure therapeutic equivalence generic substitution levetiracetam |
| title | Evaluating Therapeutic Equivalence of Generic and Original Levetiracetam in Patients with Epilepsy: A Retrospective Study |
| title_full | Evaluating Therapeutic Equivalence of Generic and Original Levetiracetam in Patients with Epilepsy: A Retrospective Study |
| title_fullStr | Evaluating Therapeutic Equivalence of Generic and Original Levetiracetam in Patients with Epilepsy: A Retrospective Study |
| title_full_unstemmed | Evaluating Therapeutic Equivalence of Generic and Original Levetiracetam in Patients with Epilepsy: A Retrospective Study |
| title_short | Evaluating Therapeutic Equivalence of Generic and Original Levetiracetam in Patients with Epilepsy: A Retrospective Study |
| title_sort | evaluating therapeutic equivalence of generic and original levetiracetam in patients with epilepsy a retrospective study |
| topic | epilepsy seizure therapeutic equivalence generic substitution levetiracetam |
| url | https://www.mdpi.com/2035-8377/14/1/22 |
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