Phase III research
Lacosamide has potential as first-line monotherapy for newly diagnosed epilepsy
A phase III trial, funded by UCB Pharma, compares lacosamide to carbamazepine in 886 patients aged over 16 years who were newly diagnosed with epilepsy.
Source: BSIP SA / Alamy Stock Photo
Lacosamide, a drug licensed as an add-on therapy for some patients with epilepsy, could be used as a first-line treatment for adults newly diagnosed with the condition, according to a study.
The researchers, who reported their results in The Lancet Neurology (online, 23 November 2016), suggest that the drug is well tolerated, and has a predictable metabolism and “low potential” for interactions with other drugs – including the contraceptive pill.
“Our findings suggest that lacosamide is a suitable treatment option for patients with newly diagnosed epilepsy,” they say.
The researchers base their conclusions on a phase III double-blind non-inferiority trial involving 886 patients aged over 16 years who were newly diagnosed with epilepsy. During the trial, which was funded by UCB Pharma, patients received either lacosamide or carbamazepine.
Some 444 patients received lacosamide – a non-enzyme-inducing antiepileptic drug – as a monotherapy. Dose started at 100mg per day and increased slowly to the maximum of 200mg daily for two weeks. Patients who were seizure-free for a week continued the treatment for six months.
The dose was titrated to the next level (400mg a day or 600mg daily) for two weeks if the patient had a seizure during the six months; patients who were stable for a week started the six month trial again. Patients who remained seizure-free for six months continued taking the drug for another six months as maintenance treatment.
A second group of 442 patients received controlled-release (CR) carbamazepine, the alternative epilepsy treatment.
The patients faced the same trial conditions but were started on a daily dose of 200mg a day, increased to a maximum of 400mg in the first two weeks. The maximum daily target dose was increased to between 800mg and 1200mg in patients who had a seizure during the six months.
Researchers found that 74% of patients in the lacosamide cohort completed six months without a seizure compared with 70% in the carbamazepine CR group.
The number of patients who did not have a seizure during the six months of treatment with lacosamide or carbamazepine CR rose to 90% or 91%, respectively, when the researchers censored patients with non-seizure-related withdrawals (absolute treatment difference -1.3%, 95% CI -5.5–2.8; relative treatment difference -6.0%).
Adverse events were reported in 328 (74%) patients receiving lacosamide, of which 32 (7%) were classified as “serious”. In the carbamazepine CR group, adverse events were recorded in 332 (75%) patients, of which 43 (10%) were recorded as “serious”.
The research is welcomed by Simon Wigglesworth, deputy chief executive of the patient group Epilepsy Action, who says many patients with epilepsy try a variety of drug combinations before they can control their seizures.
“For around 30% of people with epilepsy, the drugs currently available are not effective in controlling their seizures,” he says. “There are already several monotherapy drugs available for adults who are newly diagnosed with epilepsy. However, not every drug will work for every person. We look forward to seeing how the research into the use of lacosamide develops.”
Lacosamide has a European marketing authorisation as an adjunctive therapy for the treatment of partial-onset seizures in patients aged over 16 years. The authorisation was granted by the European Medicines Agency in 2008.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2016.20202031
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