Control of seizures in different stages of partial epilepsy: LACO-EXP, a Spanish retrospective study of lacosamide

Villanueva, Vicente; López, Francisco J.; Serratosa, Joan; González-Giráldez, Beatriz; Campos, Dulce; Molins, A; Uranga, Juan; Salas-Puig, Javier; Toledo, Manuel; Sánchez-Álvarez, J C; Moreno, António; Serrano-Castro, Pedro J.; Saiz-Díaz, Rosa Ana; Aleja, Jesús González de la; Peña, Pilar de la; Asensio, M

doi:10.1016/j.yebeh.2013.07.024

Cited by 39 publications

(69 citation statements)

References 24 publications

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“…In the current study, the seizure freedom rates for the lacosamide SCB(−) and SCB(+) combinations were 48.7% versus 42.1%. These seizure freedom rates are in the range of other observational data, such as the LACO‐EXP study . The LACO‐EXP study was a retrospective, observational study in patients with POS starting on adjunctive lacosamide at baseline .…”

Section: Discussionmentioning

confidence: 78%

“…Some studies suggest additive or synergistic effects in efficacy as well as tolerability of the certain AED combinations . In this study, lacosamide‐treatment response also was analyzed according to concomitant baseline AED.…”

Section: Discussionmentioning

confidence: 99%

“…These seizure freedom rates are in the range of other observational data, such as the LACO-EXP study. 18 The LACO-EXP study was a retrospective, observational study in patients with POS starting on adjunctive lacosamide at baseline. 18 When lacosamide was used early in treatment (as with many VITOBA study patients) as the first and second add-on, seizure freedom rates were 57.8% and 27.8%, respectively, and response rates were 80.0% and 70.4%.…”

Section: Discussionmentioning

confidence: 99%

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A noninterventional study evaluating the effectiveness and safety of lacosamide added to monotherapy in patients with epilepsy with partial‐onset seizures in daily clinical practice: The VITOBA study

Runge

Arnold²,

Brandt

et al. 2015

Epilepsia

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SummaryObjectiveEvidence for the efficacy and safety of adjunctive lacosamide in the treatment of partial‐onset seizures (POS) was gained during placebo‐controlled clinical trials in patients with treatment‐resistant seizures who were taking one to three concomitant antiepileptic drugs (AEDs). The VITOBA study (NCT01098162) evaluated the effectiveness and tolerability of adjunctive lacosamide added to one baseline AED in real‐world clinical practice.MethodsWe conducted a 6‐month observational study at 112 sites across Germany. Adult patients (≥16 years) with POS received lacosamide adjunctive to only one baseline AED. Seizure frequency reduction at the end of the observation period was compared with a 3‐month retrospective baseline period.ResultsFive hundred seventy‐one patients received lacosamide at least once (Safety Set [SS]); 520 provided evaluable seizure records (Full Analysis Set [FAS]); and 499 took in‐label dosages of lacosamide (up to 400 mg) and were evaluated for effectiveness (modified FAS). Median baseline seizure frequency was 2.0 per 28 days: 47.1% of patients (235/499, mFAS) took a concomitant sodium channel–blocking (SCB) AED; 38.1% (190/499) had only one lifetime AED; and 18.4% (92/499) were aged ≥65 years (mFAS). At the final visit, 72.5% (358/494) of patients showed a ≥50% reduction in seizure frequency from baseline, 63.8% (315/494) showed a ≥75% reduction, and 45.5% (225/494) were seizure‐free. Seizure freedom rates were higher in patients aged ≥65 years (56.7%) compared with patients aged <65 years (43.1%), in patients with ≤5 years epilepsy duration (52.5%) versus >5 years duration (41.0%), and when added to first monotherapy (60.5%) rather than as a later therapy option. Treatment‐emergent adverse events (TEAEs) were reported by 48.5% (277/571) of patients (SS), with a profile similar to that observed in pivotal trials; 466 of patients (81.6%, SS) continued lacosamide therapy after the trial.SignificanceThese results suggest that lacosamide use, added to one concomitant AED, was effective at improving seizure control and was well tolerated in patients treated in routine clinical practice.

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Section: Discussionmentioning

confidence: 78%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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A noninterventional study evaluating the effectiveness and safety of lacosamide added to monotherapy in patients with epilepsy with partial‐onset seizures in daily clinical practice: The VITOBA study

Runge

Arnold²,

Brandt

et al. 2015

Epilepsia

View full text Add to dashboard Cite

show abstract

“…Бла-годаря хорошей фармакокинетике лакосамида, его эф-фективность была достаточно высока, независимо от ба-зового ПЭП. Об этом свидетельствуют и данные много-центровых предрегистрационных исследований, которые проводились во многих странах, в том числе и в России [64,65], и данные постмаркетинговых исследований, ко-торые проводились в Европе в последние годы [66,67]. Наибольшая эффективность лакосамида была отмечена в случае добавления его сразу после неэффективной моно-терапии.…”

Section: рациональные комбинации пэпunclassified

“…Безусловно, рацио-нально выбирать препараты с разным механизмом дей-ствия. Так, ретроспективный анализ применения лакоса-мида в качестве дополнительной терапии у 474 пациентов старше 18 лет с фокальной эпилепсией в течение 1 года в условиях 13 клиник Испании показал, что наиболее эф-фективными комбинациями по числу пациентов с ре-миссией оказались сочетания лакосамида с вальпроатами (47,1%), леветирацетамом (32,8%) и ламотриджином (27,3%) [66]. Это объяснимо с позиций особого механиз-ма действия лакосамида (медленная инактивация натри-евых каналов) и фармакокинетических свойств препара-та, которые позволяют сочетать лакосамид с любым дру-гим ПЭП [64].…”

Section: вероятность эффективности терапии при первой неудачеunclassified