Exploring generic brittleness and the demographic factors for its susceptibility in patients with epilepsy

Das, Sharmila; Xia, Pu; Jiang, Xiaohui; Jiang, Wenlei; Tung, Renee; Ting, Tricia Y.; Polli, James E.

doi:10.1016/j.yebeh.2018.11.039

Cited by 8 publications

(5 citation statements)

References 21 publications

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“…In 2018, Das et al, (2019) found that generic brittle patients constituted the 40.5% of the study population, with almost all of them having a negative opinion on generics. Factors associated with generic brittleness were being currently on a “problem” AED and taking at least six medications (not only AEDs).…”

Section: Resultsmentioning

confidence: 99%

“…Overall, nine studies (Crawford et al, 1996; Guberman and Corman, 2000; Wilner, 2002; Berg et al, 2008a; Berg et al, 2008b; Ngo et al, 2013; Gollwitzer et al, 2016; Roth et al, 2016; Das et al, 2019) were found, investigating patient’s, physician’s, and pharmacist’s attitutes toward generics of AEDs.…”

Section: Resultsmentioning

confidence: 99%

“…From the patients’ side, several studies investigating their attitudes toward generics use in neurological diseases were found (Crawford et al, 1996; Guberman and Corman, 2000; Berg et al, 2008a; Ngo et al, 2013; Piguet et al, 2015; Gollwitzer et al, 2016; Das et al, 2019). Patients were often unaware of the process of generic substitution (Guberman and Corman, 2000; Berg et al, 2008a; Ngo et al, 2013), while in another study, the majority of them reported that they had discussed the switch with the pharmacist (Piguet et al, 2015).…”

Section: Discussionmentioning

confidence: 99%

“…Furthermore, patients frequently expressed their concerns about generics efficacy and safety (Berg et al, 2008a; Ngo et al, 2013; Piguet et al, 2015), while several studies investigated the factors associated with increased switchbacks, with emphasis to patient’s characteristics, and found that a probable nocebo effect might be implicated. More specifically, patients taking more frequently close interest to drug therapy (Crawford et al, 1996), as well as patients with negative opinion of generics, currently on a problem AED and on polypharmacy (Das et al, 2019), reported higher switchback rates, with the authors suggesting an underlying nocebo effect. Similarly, better adherence was reported by patients on branded compared to generic AED (Gollwitzer et al, 2016).…”

Section: Discussionmentioning

confidence: 99%

“…Several authors stated, as a limitation of their study, the limited number of patients included (Mikati et al, 1992; Guberman and Corman, 2000; Bautista et al, 2011; Abolfazli et al, 2012; Ngo et al, 2013; Fehse et al, 2015; Piguet et al, 2015; Ting et al, 2015; Faasse et al, 2016; Privitera et al, 2016; Vari et al, 2016; Bosak et al, 2017; Fanella et al, 2017; Markoula et al, 2017; Gha-Hyun and Dae, 2018; Saposnik et al, 2018), while two large population-based studies (Gollwitzer et al, 2016; Kesselheim et al, 2016) were included. Moreover, in five studies, patients’ recruitment was made from a tertiary epilepsy clinic (Guberman and Corman, 2000; Bautista et al, 2011; Bosak et al, 2017; Das et al, 2019; Gha-Hyun and Dae, 2018), thus making the generalization of their results difficult. On the contrary, Gollwitzer et al, (2016) and Lang et al, (2018) stated as a limitation missing data from patients being treated in outpatient departments of hospitals, and also, Kesselheim et al, (2016) reported that patients who experienced seizures that did not require hospital visits or medical care were not included to their results.…”

Section: Discussionmentioning

confidence: 99%

See 4 more Smart Citations

Nocebo in Biosimilars and Generics in Neurology: A Systematic Review

Spanou¹,

Mavridis²,

Mitsikostas³

2019

Front. Pharmacol.

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Background: Nocebo refers to adverse events related to patients’ negative expectations and previous experiences, mediated by several neurobiological pathways within the brain. It is common among neurological patients and affects adherence and treatment outcomes, representing a real clinical challenge. Methods: We conducted a systematic search based on the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines in MEDLINE database, using several keywords for studies that can be processed to investigate the magnitude of nocebo in generics and biosimilars used in the most common neurological diseases. The aim was to estimate its size and suggest strategies to minimize its prevalence in clinical trials and practice. Results: Of a total of 2,606 identified articles, after criteria-based selection, 35 studies were included for analysis. Overall, there was vast heterogeneity across the studies concerning population, study design, and outcomes. Nocebo response could be estimated only in one double-blind randomized trial of generic glatiramer acetate in relapsing remitting multiple sclerosis that included a placebo arm. In this trial, no significant differences observed between the three arms (innovator, bioequivalent, and placebo) in favorable and unfavorable outcomes. In the open-label phase of the trial, an increased withdrawal rate was recorded in patients switched from placebo to bioequivalent (8.4%) that may be related to nocebo. In other open-label and real-world studies evaluating biosimilars or generics for brain disorders, a similar indirect nocebo effect is assuming by several investigators. Also, knowledge gaps between health-care providers and patients exist towards generics and biosimilars. Conclusions: Despite its presence, the true burden of the nocebo response and effect cannot be accurately estimated in existing studies with generics and biosimilars in neurological diseases. Targeted strategies for clinical trials’ design are needed in order to measure the exact nocebo’s size.

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Section: Resultsmentioning

confidence: 99%