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Efficacy and safety of branded vs generic lacosamide in epilepsy: a retrospective real-world study.

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Title: Efficacy and safety of branded vs generic lacosamide in epilepsy: a retrospective real-world study.
Authors: Salafica, Giuseppe (AUTHOR), Tilenni, Diana (AUTHOR), Vinaccia, Attilio (AUTHOR), Tripepi, Giovanni (AUTHOR), Martellino, Chiara (AUTHOR), Lima, Salvatore Maria (AUTHOR), Atanasio, Giorgia (AUTHOR), Lamanna, Fabio (AUTHOR), Pardeo, Orazio (AUTHOR), Panebianco, Mariangela (AUTHOR), Laganà, Angelina (AUTHOR), Labate, Angelo (AUTHOR)
Source: Neurological Sciences. Dec2025, Vol. 46 Issue 12, p6747-6753. 7p.
Subjects: Epilepsy, Generic drugs, Treatment effectiveness, Drug patents, Therapeutic equivalency in drugs, Safety, Vimpat, Field research
Geographic Terms: Italy
Abstract: Purpose: Lacosamide (LCS) is a third-generation antiseizure medication (ASM) approved for focal-onset seizures and generalized epilepsy. Although the branded formulation, Vimpat®, has shown efficacy and safety, the introduction of generic versions, such as Stutan®, raises concerns about clinical equivalence, especially considering the potential for therapeutic fluctuations that could result in breakthrough seizures or adverse events. This study aimed to compare the real-world efficacy, safety and tolerability of branded lacosamide (Vimpat®) versus its generic counterpart (Stutan®) in patients with focal or generalized epilepsy. Methods: A multicenter, retrospective, observational study was conducted at two epilepsy centers in Southern Italy. Sixty adult patients were included and divided into two groups: Group A (n = 30) received branded LCS and Group B (n = 30) received the generic formulation. Data were collected at treatment initiation (T0) and the first follow-up (T1), including seizure frequency, adverse events and dose adjustments. The primary outcome was the responder rate (≥ 50% reduction in seizure frequency), with secondary outcomes including seizure freedom, adverse events and dose changes. Results: Baseline characteristics were similar between groups. The average daily LCS dose was significantly higher in the Vimpat® group (275 ± 121 mg) compared to the Stutan® group (168 ± 89 mg, p < 0.001). Despite this, efficacy outcomes were comparable, with 60.0% of patients in Group A and 43.3% in Group B achieving a ≥ 50% seizure reduction (p = 0.08). Adverse events were mild or moderate. Conclusions: In this real-world setting, generic LCS (Stutan®) demonstrated comparable efficacy, safety and tolerability to Vimpat®, supporting its clinical use as a valid alternative in epilepsy management. [ABSTRACT FROM AUTHOR]
Copyright of Neurological Sciences is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Psychology and Behavioral Sciences Collection
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  Data: Efficacy and safety of branded vs generic lacosamide in epilepsy: a retrospective real-world study.
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  Data: &lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22Salafica%2C+Giuseppe%22&quot;&gt;Salafica, Giuseppe&lt;/searchLink&gt; (AUTHOR)&lt;br /&gt;&lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22Tilenni%2C+Diana%22&quot;&gt;Tilenni, Diana&lt;/searchLink&gt; (AUTHOR)&lt;br /&gt;&lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22Vinaccia%2C+Attilio%22&quot;&gt;Vinaccia, Attilio&lt;/searchLink&gt; (AUTHOR)&lt;br /&gt;&lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22Tripepi%2C+Giovanni%22&quot;&gt;Tripepi, Giovanni&lt;/searchLink&gt; (AUTHOR)&lt;br /&gt;&lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22Martellino%2C+Chiara%22&quot;&gt;Martellino, Chiara&lt;/searchLink&gt; (AUTHOR)&lt;br /&gt;&lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22Lima%2C+Salvatore+Maria%22&quot;&gt;Lima, Salvatore Maria&lt;/searchLink&gt; (AUTHOR)&lt;br /&gt;&lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22Atanasio%2C+Giorgia%22&quot;&gt;Atanasio, Giorgia&lt;/searchLink&gt; (AUTHOR)&lt;br /&gt;&lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22Lamanna%2C+Fabio%22&quot;&gt;Lamanna, Fabio&lt;/searchLink&gt; (AUTHOR)&lt;br /&gt;&lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22Pardeo%2C+Orazio%22&quot;&gt;Pardeo, Orazio&lt;/searchLink&gt; (AUTHOR)&lt;br /&gt;&lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22Panebianco%2C+Mariangela%22&quot;&gt;Panebianco, Mariangela&lt;/searchLink&gt; (AUTHOR)&lt;br /&gt;&lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22Lagan&#224;%2C+Angelina%22&quot;&gt;Lagan&#224;, Angelina&lt;/searchLink&gt; (AUTHOR)&lt;br /&gt;&lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22Labate%2C+Angelo%22&quot;&gt;Labate, Angelo&lt;/searchLink&gt; (AUTHOR)
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  Data: &lt;searchLink fieldCode=&quot;JN&quot; term=&quot;%22Neurological+Sciences%22&quot;&gt;Neurological Sciences&lt;/searchLink&gt;. Dec2025, Vol. 46 Issue 12, p6747-6753. 7p.
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  Data: &lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Epilepsy%22&quot;&gt;Epilepsy&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Generic+drugs%22&quot;&gt;Generic drugs&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Treatment+effectiveness%22&quot;&gt;Treatment effectiveness&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Drug+patents%22&quot;&gt;Drug patents&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Therapeutic+equivalency+in+drugs%22&quot;&gt;Therapeutic equivalency in drugs&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Safety%22&quot;&gt;Safety&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Vimpat%22&quot;&gt;Vimpat&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Field+research%22&quot;&gt;Field research&lt;/searchLink&gt;
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  Data: &lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Italy%22&quot;&gt;Italy&lt;/searchLink&gt;
– Name: Abstract
  Label: Abstract
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  Data: Purpose: Lacosamide (LCS) is a third-generation antiseizure medication (ASM) approved for focal-onset seizures and generalized epilepsy. Although the branded formulation, Vimpat&#174;, has shown efficacy and safety, the introduction of generic versions, such as Stutan&#174;, raises concerns about clinical equivalence, especially considering the potential for therapeutic fluctuations that could result in breakthrough seizures or adverse events. This study aimed to compare the real-world efficacy, safety and tolerability of branded lacosamide (Vimpat&#174;) versus its generic counterpart (Stutan&#174;) in patients with focal or generalized epilepsy. Methods: A multicenter, retrospective, observational study was conducted at two epilepsy centers in Southern Italy. Sixty adult patients were included and divided into two groups: Group A (n = 30) received branded LCS and Group B (n = 30) received the generic formulation. Data were collected at treatment initiation (T0) and the first follow-up (T1), including seizure frequency, adverse events and dose adjustments. The primary outcome was the responder rate (≥ 50% reduction in seizure frequency), with secondary outcomes including seizure freedom, adverse events and dose changes. Results: Baseline characteristics were similar between groups. The average daily LCS dose was significantly higher in the Vimpat&#174; group (275 &#177; 121 mg) compared to the Stutan&#174; group (168 &#177; 89 mg, p &lt; 0.001). Despite this, efficacy outcomes were comparable, with 60.0% of patients in Group A and 43.3% in Group B achieving a ≥ 50% seizure reduction (p = 0.08). Adverse events were mild or moderate. Conclusions: In this real-world setting, generic LCS (Stutan&#174;) demonstrated comparable efficacy, safety and tolerability to Vimpat&#174;, supporting its clinical use as a valid alternative in epilepsy management. [ABSTRACT FROM AUTHOR]
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  Data: &lt;i&gt;Copyright of Neurological Sciences is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder&#39;s express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.&lt;/i&gt; (Copyright applies to all Abstracts.)
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        Value: 10.1007/s10072-025-08563-3
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        Text: English
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      – SubjectFull: Epilepsy
        Type: general
      – SubjectFull: Generic drugs
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      – SubjectFull: Treatment effectiveness
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      – SubjectFull: Drug patents
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              M: 12
              Text: Dec2025
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