Brand‐to‐generic levetiracetam switching: a 4‐year prospective observational real‐life study

Abstract

In our sample, brand-to-generic levetiracetam switching was effective and safe in both monotherapy and polytherapy regardless of the epilepsy syndrome.

Nocebo in Biosimilars and Generics in Neurology: A Systematic Review

“…At the same year, an Italian open-label observational study (Trimboli et al, 2018) of 125 out of 180 patients who switched to a generic LEV suggested no significant difference in terms of seizure frequency and AEs before and after switching and also compared to those who refused to switch. Notably, 10 out of 125 patients stopped treatment due to AEs, and two of them switched back (1.6%), during a long follow-up period.…”

“…Indicatively, age groups differed significantly in three studies, mainly young population in one of them (Kesselheim et al, 2016), and mainly elderly on the two others (Gagne et al, 2015; Lang et al, 2018). For studies on epilepsy, differences were observed among the studied type of epileptic syndromes (Privitera et al, 2016) (Fanella et al, 2017; Markoula et al, 2017; Trimboli et al, 2018), while in four studies based on database data (Duh et al, 2009; Gagne et al, 2015; Gollwitzer et al, 2016; Rahman et al, 2017), inaccuracies in coding of diagnosis could not been ruled out. Heterogeneity was observed also among studied populations regarding whether being on AED monotherapy or polytherapy, with studies mainly homogeneous (Bosak et al, 2017; Fanella et al, 2017; Trimboli et al, 2018) and others more heterogeneous (Bautista et al, 2011; Vari et al, 2016; Markoula et al, 2017).…”

“…Additionally, a selection bias could not be excluded in several studies for a variety of reasons. Firstly, due to study design, in open-label studies, patients’ attitudes toward generics may have influenced their results, as frequently patients who were negative about generics were excluded (Ngo et al, 2013; Bosnyak et al, 2014; Vari et al, 2016; Markoula et al, 2017; Reimers et al, 2017; Gha-Hyun and Dae, 2018; Trimboli et al, 2018). Nevertheless, two studies focused on generic brittle patients (Ting et al, 2015; Das et al, 2018); in one of them, however, the assessment of generic sensitivity was mainly based on patients’ opinions (Das et al, 2018) and, also in another study, generic brittle patients constituted only a minority among study’s population (Privitera et al, 2016).…”

“…Furthermore, several confounding factors that might have influenced studies’ results were identified by their authors. For example, several studies reported lack of information on variables that could have influenced seizure control, mainly because they were based on self-reported data (Mikati et al, 1992; Berg et al, 2008b; Bautista et al, 2011; Markoula et al, 2017; Gha-Hyun and Dae, 2018; Trimboli et al, 2018) or data extracted from databases (Gagne et al, 2015; Kesselheim et al, 2016). Indicatively, a limitation on adherence documentation was recognized in many studies (Mikati et al, 1992; Bautista et al, 2011; Trimboli et al, 2018).…”

“…For example, several studies reported lack of information on variables that could have influenced seizure control, mainly because they were based on self-reported data (Mikati et al, 1992; Berg et al, 2008b; Bautista et al, 2011; Markoula et al, 2017; Gha-Hyun and Dae, 2018; Trimboli et al, 2018) or data extracted from databases (Gagne et al, 2015; Kesselheim et al, 2016). Indicatively, a limitation on adherence documentation was recognized in many studies (Mikati et al, 1992; Bautista et al, 2011; Trimboli et al, 2018). However, one study included a strict protocol for adherence and seizure documentation (Privitera et al, 2016), while another one excluded from analysis possible confounders that could contribute to breakthrough seizures (Berg et al, 2008a), and finally, another one study used a widely adopted measure of adherence in population-based studies (Gollwitzer et al, 2016).…”