Safety and efficacy of adjunctive lacosamide among patients with partial-onset seizures in a long-term open-label extension trial of up to 8 years

Rosenfeld, William E.; Fountain, Nathan B.; Kaubrys, Gintaras; Ben‐Menachem, Elinor; McShea, Cindy; Isojärvi, Jouko; Doty, Pamela

doi:10.1016/j.yebeh.2014.09.074

Cited by 48 publications

(67 citation statements)

References 17 publications

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“…In the current study, lacosamide was well-tolerated and efficacious with a significant decrease in seizure frequency and 50% responder rates which are comparable with those in larger studies [1][2][3][4][5][6]. The most commonly reported AEs were mild headaches, dizziness, mild tiredness, and gastrointestinal symptoms.…”

Section: Discussionsupporting

confidence: 79%

“…Three randomized, controlled trials (RCTs) of lacosamide as adjunct treatment for medically intractable epilepsy [1][2][3] and three long-term follow-up studies [4][5][6] revealed a significant anticonvulsant effect. Lacosamide has also demonstrated a good safety profile with a small degree of adverse events.…”

Section: Introductionmentioning

confidence: 99%

“…Lacosamide has also demonstrated a good safety profile with a small degree of adverse events. The most common adverse events reported were diplopia, dizziness, nausea, and headaches [1][2][3][4][5][6].…”

Section: Introductionmentioning

confidence: 99%

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The effects of lacosamide on cognition, quality-of-life measures, and quality of life in patients with refractory partial epilepsy

Lancman

Fertig

Trobliger

et al. 2016

Epilepsy & Behavior

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Section: Discussionsupporting

confidence: 79%

Section: Introductionmentioning

confidence: 99%

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The effects of lacosamide on cognition, quality-of-life measures, and quality of life in patients with refractory partial epilepsy

Lancman

Fertig

Trobliger

et al. 2016

Epilepsy & Behavior

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“…The approval of LCM as adjunctive therapy in focal epilepsy was based on the results of three pivotal trials,13, 14, 15 all followed by open‐label extensions 16, 17, 18. In the pivotal trials, patients with highly refractory disease received LCM in a fixed titration scheme added to a variety of AEDs—up to 82% had a SCB in their treatment regimen 9, 19.…”

Section: Discussionmentioning

confidence: 99%

Lacosamide and sodium channel-blocking antiepileptic drug cross-titration against levetiracetam background therapy

et al. 2016

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ObjectiveTo assess prospectively the effectiveness of lacosamide (LCM) added to levetiracetam (LEV) after down‐titration of a concomitant sodium channel blocker (SCB) among patients with focal epilepsy not adequately controlled on LEV and SCB.MethodsIn this open‐label trial, LCM was initiated at 100 mg/day and up‐titrated to 200‐600 mg/day over 9 weeks; SCB down‐titration started when LCM dose reached 200 mg/day. Patients remained on stable LCM/LEV doses for 12 weeks’ maintenance (21‐week treatment period). The primary outcome was retention rate on LCM.ResultsDue to recruitment challenges, fewer than the planned 300 patients participated in the trial, resulting in the trial being underpowered. Overall, 120 patients (mean age 39.7 years) started and 93 completed the trial. The most frequently used SCBs were lamotrigine (39.2%), carbamazepine (30.8%) and oxcarbazepine (27.5%). Eighty‐four patients adhered to protocol and discontinued their SCB after cross‐titration, but there was insufficient evidence for 36 patients. Retention rate was 73.3% (88/120) for all patients and 83.3% (70/84) for those with evidence of SCB discontinuation. Seizure freedom for patients completing maintenance was 14.0% (13/93). Discontinuation due to adverse events (6.7%) and lack of efficacy (3.3%) occurred primarily during cross‐titration. Most frequently reported adverse events during treatment were dizziness (23.3%), headache (15.0%) and fatigue (8.3%).ConclusionsIn patients with uncontrolled seizures on LEV/SCB, the LCM/LEV combination appeared to be effective and well tolerated. A cross‐titration schedule—flexible LCM up‐titration, concomitant SCB down‐titration and stable background LEV—could present a feasible and practical approach to initiating LCM while minimizing pharmacodynamic interactions with a SCB.

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“…This is consistent with three OLE studies of adjunctive lacosamide. [12][13][14] The median modal LCM dose was 500 mg/day both for all 322 patients, and for the 292 who achieved LCM Figure 2. Proportion of patients with (A) ≥50% reduction, (B) ≥75% reduction, or (C) 100% reduction in seizure frequency per 28 days compared with the baseline from SP902.…”

Section: Discussionmentioning

confidence: 99%

Long‐term exposure and safety of lacosamide monotherapy for the treatment of partial‐onset (focal) seizures: Results from a multicenter, open‐label trial

Vossler

Wechsler²,

Williams

et al. 2016

Epilepsia

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SUMMARYObjective: To assess long-term use and safety of lacosamide (LCM) ≤800 mg/day monotherapy in patients with partial-onset seizures (POS) enrolled previously in a historical-controlled, conversion-to-monotherapy study (SP902; NCT00520741). Methods: Patients completing or exiting SP902 with LCM as monotherapy or as adjunctive therapy were eligible to enter this 2-year open-label extension (OLE) trial (SP904; NCT00530855) at a starting dose AE100 mg/day of their final SP902 dose. Investigators could adjust the LCM dose to 100-800 mg/day and add up to two antiepileptic drugs to optimize tolerability and seizure reduction. Results: Three hundred twenty-two patients received LCM: 210 patients (65.2%) completed and 112 (34.8%) discontinued, most commonly owing to withdrawal of consent (9.3%). Two hundred fifty-eight patients (80.1%) had ≥1 year of and 216 (67.1%) had ≥2 years of LCM exposure, of whom 179/258 (69.4%) achieved LCM monotherapy lasting for any 12-month period, and 126/216 (58.3%) patients exposed for ≥24 months achieved LCM monotherapy for any 24-month period. Total exposure = 525.5 patient-years. The median modal dose was 500 mg/day. Two hundred ninety-two patients (90.7%) achieved LCM monotherapy at some point during the study. Sixty-five of 87 patients who exited and 193/235 who completed SP902 were exposed for ≥12 months, and 43.1% and 78.2%, respectively, achieved LCM monotherapy for ≥12 months. Median LCM monotherapy duration was 587.0 days (2-791 days); 91.0% of patients reported treatment-emergent adverse events, of which the most common were dizziness (27.3%), headache (17.1%), and nausea (14.3%). Compared with the SP902 study baseline, 74.2% of patients had a ≥50% seizure reduction and 5.6% were seizure-free at 24 months. Significance: The majority of patients were receiving LCM monotherapy at 0, 12, and 24 months in this OLE. Lacosamide monotherapy (median dose of 500 mg/day) had a safety profile similar to that of adjunctive therapy studies. These results support the use of lacosamide as long-term monotherapy treatment for adults with POS.

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Safety and efficacy of adjunctive lacosamide among patients with partial-onset seizures in a long-term open-label extension trial of up to 8 years

Cited by 48 publications

References 17 publications

The effects of lacosamide on cognition, quality-of-life measures, and quality of life in patients with refractory partial epilepsy

The effects of lacosamide on cognition, quality-of-life measures, and quality of life in patients with refractory partial epilepsy

Lacosamide and sodium channel-blocking antiepileptic drug cross-titration against levetiracetam background therapy

Long‐term exposure and safety of lacosamide monotherapy for the treatment of partial‐onset (focal) seizures: Results from a multicenter, open‐label trial

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