The long-term retention of pregabalin in a large cohort of patients with epilepsy at a tertiary referral centre

Yuen, Alan W.C.; Singh, Rinki; Bell, Gail S.; Bhattacharjee, Anupam; Neligan, Aidan; Heaney, Dominic; Duncan, John S.; Sander, Josemir W.

doi:10.1016/j.eplepsyres.2009.08.001

Cited by 25 publications

(18 citation statements)

References 12 publications

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“…The type of SAEs and TEAEs leading to discontinuation during this trial were similar to those observed in previous double‐blind, placebo‐controlled trials with lacosamide. The rate of discontinuation due to TEAEs (10.7%) was comparable to or lower than that reported for some other AEDs following long‐term treatment with concomitant AEDs in patients with POS (Datta & Crawford, 2000; Bootsma et al., 2008; Brandt et al., 2009; Cho et al., 2009; Yuen et al., 2009; Zaccara & Specchio, 2009). It should be noted that a direct comparison of TEAEs in this trial to those observed in previous double‐blind studies is difficult due to differences in trial design and duration.…”

Section: Discussionsupporting

confidence: 58%

Long‐term safety and efficacy in patients with uncontrolled partial‐onset seizures treated with adjunctive lacosamide: Results from a phase III open‐label extension trial

et al. 2012

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and xUCB Pharma, Raleigh, North Carolina, U.S.A. SUMMARYPurpose: To evaluate the long-term (up to 5 years exposure) safety and efficacy of lacosamide as adjunctive therapy in patients with uncontrolled partial-onset seizures taking one to three concomitant antiepileptic drugs (AEDs) in open-label extension trial SP756 (NCT00522275). Methods: Patients who completed the double-blind trial SP754 (NCT00136019) were eligible to participate in this open-label extension trial (SP756). At the conclusion of trial SP754, patients had transitioned to lacosamide 200 mg/day. Subsequent dosage adjustments of lacosamide (100-800 mg/day) and/or concomitant AEDs were allowed to optimize tolerability and seizure reduction. Treatment-emergent adverse events (TEAEs), vital signs, body weight, clinical laboratory data, electrocardiography studies, and seizure frequency were evaluated. Key Findings: A total of 308 patients received open-label lacosamide and 138 patients (44.8%) completed the longterm trial. The median modal dose (defined as the daily lacosamide dose a patient received for the longest duration during the treatment period) was 500 mg/day. The percentages of patients with lacosamide exposure >1, >2, >3, or >4 years were 75%, 63%, 54%, and 29%, respectively. Primary reasons for discontinuation were lack of efficacy (26%) and adverse events (11%). Common TEAEs ( ‡15%) were dizziness, headache, contusion, nausea, convulsion, nasopharyngitis, fall, vomiting, and diplopia. TEAEs that led to discontinuation in ‡1.0% of patients were dizziness (1.6%) and convulsion (1.0%). The median percent reductions from baseline of trial SP754 in 28-day seizure frequency were 53.4%, 55.2%, 58.1%, and 62.5%, respectively, for 1-, 2-, 3-, and 4-year completers. The ‡50% responder rates were 52.8%, 56.5%, 58.7%, and 62.5% for 1-, 2-, 3-, and 4-year completers, respectively. Seven of eight patients on lacosamide monotherapy for ‡12 months were deemed 50% responders. Of patients exposed to lacosamide ‡2 years, 3.1% remained seizure-free for a period ‡2 years. Significance: Long-term (up to 5 years) lacosamide treatment was generally well tolerated. The safety profile of lacosamide observed in this trial is consistent with that established in previous double-blind, placebo-controlled trials. Although the open-label trial design limits the analysis of efficacy, long-term reduction in seizure frequency and maintenance of efficacy was observed.

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Section: Discussionsupporting

confidence: 58%

Long‐term safety and efficacy in patients with uncontrolled partial‐onset seizures treated with adjunctive lacosamide: Results from a phase III open‐label extension trial

et al. 2012

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“…One study with a large cohort from a tertiary epilepsy center reported a three year retention rate of 30% [27]. Here, the drug was fairly well tolerated, with only 30% of the subjects discontinuing therapy due to adverse events, in line with an earlier study [24].…”

Section: Discussionsupporting

confidence: 57%

Comparative effectiveness of eight antiepileptic drugs in adults with focal refractory epilepsy: the influence of age, gender, and the sequence in which drugs were introduced onto the market

et al. 2017

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Objectives: The first objective was to determine the long-term retention rate of eight antiepileptic drugs (AEDs) commonly used as adjunctive therapy in adults with focal refractory epilepsy. Secondly, we assessed the effects of age and gender on retention rates. Thirdly, we examined if the retention rate could be influenced by the sequence in which the AEDs had entered the market. Materials and methods: Patients with focal refractory epilepsy treated with any of the eight AEDs in Tampere UniversityHospital were identified retrospectively (N=507). Retention rates were evaluated with the Kaplan-Meier method. Followup started at the first date of treatment and each individual was followed a maximum of 36 months. Results:We calculated the following three-year retention rates; lacosamide, 77.1% (N=137); lamotrigine, 68.3% (N=177); levetiracetam 66.7% (N=319), clobazam, 65.6% (N=130); topiramate, 61.6% (N=178); zonisamide, 60.4% (N=103); pregabalin, 54.6% (N=127); gabapentin, 40.2% (N=66). Lacosamide, levetiracetam and clobazam were the most effective AEDs in the elderly. The retention rate for pregabalin was higher in males (65%) than females (51%) whereas females had higher retention rates for both topiramate (72% vs. 58%) and zonisamide (67% vs. 57%). The retention rate was influenced by the sequence in which these AEDs entered the market. Conclusion:We provide important information about practical aspects of these eight AEDs, revealing that there are differences in their effectiveness as adjunctive treatment for focal refractory epilepsy. Most importantly, the retention rate appears to be influenced by the sequence in which these AEDs were introduced onto the market.

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“…These rates were not dissimilar to those from other clinical audits where the drug was discontinued by 40-60% of patients over 1-2.5 years (9,(11)(12)(13). These rates were not dissimilar to those from other clinical audits where the drug was discontinued by 40-60% of patients over 1-2.5 years (9,(11)(12)(13).…”

Section: Discussionmentioning

confidence: 40%

“…Eight patients discontinued PGB because of worsening seizure control or a change in semiology, a previously reported phenomenon (12,13). Of these, 6 (four with learning disabilities) experienced a worsening in partial seizure frequency and one developing status epilepticus.…”

Section: Discussionmentioning

confidence: 97%

Adjunctive pregabalin for uncontrolled partial-onset seizures: findings from a prospective audit

Stephen

Parker

Kelly

et al. 2011

Acta Neurologica Scandinavica

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The long-term retention of pregabalin in a large cohort of patients with epilepsy at a tertiary referral centre

Cited by 25 publications

References 12 publications

Long‐term safety and efficacy in patients with uncontrolled partial‐onset seizures treated with adjunctive lacosamide: Results from a phase III open‐label extension trial

Long‐term safety and efficacy in patients with uncontrolled partial‐onset seizures treated with adjunctive lacosamide: Results from a phase III open‐label extension trial

Comparative effectiveness of eight antiepileptic drugs in adults with focal refractory epilepsy: the influence of age, gender, and the sequence in which drugs were introduced onto the market

Adjunctive pregabalin for uncontrolled partial-onset seizures: findings from a prospective audit

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