Adjunctive therapy versus alternative monotherapy in patients with partial epilepsy failing on a single drug: a multicentre, randomised, pragmatic controlled trial

Beghi, Ettore; Gatti, G.; Tonini, Clara; Ben‐Menachem, Elinor; Chadwick, David; Nikanorova, Marina; Gromov, S. A.; Smith, Philip E. M.; Specchio, Luigi Maria; Perucca, Emilio

doi:10.1016/j.eplepsyres.2003.09.007

Cited by 133 publications

(76 citation statements)

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“…Even with differences in remission rates compared to other reports [5,6,20], our findings confirm the results of randomized trials [6,20] and suggest that when a first monotherapy fails, the probability of subsequent success is largely independent of treatment strategy.…”

Section: Discussionsupporting

confidence: 74%

“…In addition, the adverse events reported by the two treatment cohorts were similar as regards severity, attribution to drug, and outcome. These findings are in keeping with randomized trials comparing mono-and polytherapy, which showed a lower cumulative number of adverse effects in patients on polytherapy [6] and fewer polytherapy patients withdrawing from the study because of adverse effects [20]. This slight (nonsignificant) difference cannot be explained by the lower target daily doses in patients receiving add-on therapy than those switched to alternative monotherapy, as this was true only for lamotrigine and oxcarbazepine, two drugs for which the incidence ratio of adverse events was among the lowest.…”

Section: Discussionsupporting

confidence: 72%

“…For those who continue to have seizures, the physician has two options, an alternative monotherapy (substitution) or a combination therapy (add-on), which generally involves adding a second drug to the current monotherapy. As randomized trials [5,6] did not provide evidence of which strategy should be preferred, clinical practice will presumably present various treatment patterns, as shown by a collaborative survey on prescribing strategies in Mediterranean countries [7] and a survey of expert opinions in the USA [8]. In this complex scenario, with few exceptions [9,10], the utilization of "classical" and "new" antiepileptic drugs is poorly understood.…”

Section: Introductionmentioning

confidence: 99%

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Alternative monotherapy or add-on therapy in patients with epilepsy whose seizures do not respond to the first monotherapy: An Italian multicenter prospective observational study

Millul

Iudice

Adami

et al. 2013

Epilepsy & Behavior

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This article appeared in a journal published by Elsevier. The attached copy is furnished to the author for internal non-commercial research and education use, including for instruction at the authors institution and sharing with colleagues.Other uses, including reproduction and distribution, or selling or licensing copies, or posting to personal, institutional or third party websites are prohibited. A prospective multicenter observational study was undertaken on children and adults with epilepsy in whom first monotherapy failed, to assess indications and effects of alternative monotherapy vs. polytherapy. Patients were followed until 12-month remission, drug withdrawal, or up to 18 months. Monotherapy and polytherapy were compared for patients' baseline features, indication, retention time, remission, adverse events (AE), quality of life, and direct and indirect costs. Included were 157 men and 174 women, aged 2-86 years. Of the patients, 72.2% were switched to alternative monotherapy. Baseline treatment was changed for lack of efficacy (73.9%) or adverse events (26.1%). Two hundred forty-three completed the study (remission: 175; 72.0%). Retention time, hospital admissions, days off-work and off-school, and quality of life did not differ between the two treatment groups. Patients were followed for 365.3 person-years. Three hundred eighty-three incident AEs were reported by 46.4% of patients in monotherapy and 40.2% in polytherapy (serious AEs: 9.6% vs. 8.7%, mostly nondrug-related).

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Section: Discussionsupporting

confidence: 74%

Section: Discussionsupporting

confidence: 72%

Section: Introductionmentioning

confidence: 99%

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Alternative monotherapy or add-on therapy in patients with epilepsy whose seizures do not respond to the first monotherapy: An Italian multicenter prospective observational study

Millul

Iudice

Adami

et al. 2013

Epilepsy & Behavior

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“…Seizures in 30% of patients are refractory to medical therapy (Kwan and Brodie, 2000) and require treatment with multiple drugs (Beghi et al, 2003;Peltola et al, 2008), although there is little guidance as to which combinations may be most beneficial. Dravet syndrome (DS) is caused by loss-of-function mutations in the SCN1A gene encoding brain voltage-gated sodium channel type-I, Na V 1.1 (De Jonghe, 2011).…”

Section: Introductionmentioning

confidence: 99%

Synergistic GABA-Enhancing Therapy against Seizures in a Mouse Model of Dravet Syndrome

Oakley

Cho

Cheah

et al. 2013

J Pharmacol Exp Ther

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“…It should be noted that, as pointed out by Landmark and colleagues 18 in their study, the total number of polytherapies may be overestimated due to therapy ad justments; sometime two drugs are simultaneously administered, while one is being titrated and the other is still in the process of withdrawal. Even on this convergent scenario of high prevalence of polytherapies among different studies, it is important to consider that there are no evidences that polytherapies are better than monotherapies in achieving seizure control, based on randomized controlled trials 25 . The occurrence of adverse effects was spontaneously reported only by 24.1% of our cohort, which partially conflicts with the high prevalence of complex polytherapies and their high mean AED load (3.3; range 0.4-7.7).…”

mentioning

confidence: 99%

Drug utilization profile in adult patients with refractory epilepsy at a tertiary referral center

Freitas‐Lima

Baldoni

Alexandre

et al. 2013

Arq. Neuro-Psiquiatr.

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Objective: To evaluate the utilization profile of antiepileptic drugs in a population of adult patients with refractory epilepsy attending a tertiary center. Method: Descriptive analyses of data were obtained from the medical records of 112 patients. Other clinical and demographic characteristics were also registered. Results: Polytherapies with ≥3 antiepileptic drugs were prescribed to 60.7% of patients. Of the old agents, carbamazepine and clobazam were the most commonly prescribed (72.3% and 58.9% of the patients, respectively). Among the new agents, lamotrigine was the most commonly prescribed (36.6% of the patients). At least one old agent was identified in 103 out of the 104 polytherapies, while at least one new agent was prescribed to 70.5% of the population. The most prevalent combination was carbamazepine + clobazam + lamotrigine. The mean AED load found was 3.3 (range 0.4-7.7). Conclusion: The pattern of use of individual drugs, although consistent with current treatment guidelines, is strongly influenced by the public health system. Keywords: epilepsy, refractory epilepsy, antiepileptic drugs, polytherapy, drug utilization. RESUMOObjetivo: Avaliar o perfil de utilização de fármacos antiepilépticos em uma população de pacientes adultos com epilepsia refratária atendidos em um centro terciário. Método: Análises descritivas dos dados obtidos dos registros médicos de 112 pacientes. Também foram consideradas as características clínicas e demográficas. Resultados: Foram prescritas politerapias com ≥3 antiepilépticos a 60,7% dos pacientes. Em relação aos fármacos de primeira geração, carbamazepina e clobazam foram os mais frequentemente prescritos (a 72,3% e 58,9% dos pacientes, respectivamente). Dentre os novos antiepilépticos, a lamotrigina foi o mais prescrito (36,6% dos pacientes). Ao menos um antiepiléptico de primeira geração foi encontrado em 103 das 104 politerapias; ao menos um novo antiepiléptico foi prescrito a 70,5% da população. A combinação mais prevalente foi carbamazepina+clobazan+lamotrigina. A carga média de antiepilépticos foi 3.3 (0.4 a 7.7). Conclusão: O padrão de utilização de antiepilépticos, embora concordante com guias atuais, é fortemente influenciado pelo sistema público de saúde.Palavras-chave: epilepsia, epilepsia refratária, fármacos antiepilépticos, politerapia, utilização de fármacos.Approximately one-third of the patients with epilepsy have recurrent seizures in spite of adequate pharmacological treatment and good compliance, characterizing what is known as refractory epilepsy 1 . The lack of control over seizure recurrence has a major impact not only on the patients' clinical and psychosocial status but also on economic consequences that could potentially overload the health care system due to avoidable expenses with regard to medications, hospitalizations, and examinations 2 .An important portion of the high costs related to the treatment of refractory epilepsy is devoted to the purchase of second-generation antiepileptic drugs (AED), which are more expensive than f...

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Adjunctive therapy versus alternative monotherapy in patients with partial epilepsy failing on a single drug: a multicentre, randomised, pragmatic controlled trial

Cited by 133 publications

References 34 publications

Alternative monotherapy or add-on therapy in patients with epilepsy whose seizures do not respond to the first monotherapy: An Italian multicenter prospective observational study

Alternative monotherapy or add-on therapy in patients with epilepsy whose seizures do not respond to the first monotherapy: An Italian multicenter prospective observational study

Synergistic GABA-Enhancing Therapy against Seizures in a Mouse Model of Dravet Syndrome

Drug utilization profile in adult patients with refractory epilepsy at a tertiary referral center

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