The antiepileptic drug lacosamide is effective in reducing painful diabetic neuropathy without serious side effects, according to results from two phase 3 trials, one in the United States and one in the European Union, researchers reported at the American Academy of Neurology (AAN) 61st Annual Meeting.
In one of the two trials for painful diabetic neuropathy reported at the AAN meeting April 29, lacosamide reduced patient-reported pain scores on the Likert Scale (0 being no pain and 10 being maximum pain) from 6.3 to about 2.4 among US participants. The reduced pain was sustained throughout the 2 years the patients were monitored.
The second trial measured pain reduction in European patients using the Patient Global Impression of Change scale. Eighty-eight percent of these patients reported their pain as “mildly moderate” or “much better” at their 2-year follow-up.
The results were drawn from two open-label studies (trials SP745 and SP830), which were in turn drawn from two double-blind studies. Trial SP745 enrolled 451 patients at 88 US sites; trial SP830 enrolled 371 patients at 57 European sites. Patients were followed for 2 years once titrated to an optimum dose of 400 or 600 mgs. Patients achieved the greatest benefit at 400 mg, according to the investigators.
“The decrease in pain intensity was rapid and sustained for 2 years,” said lead investigator Ronald Graf, MD, endocrinologist and independent clinical researcher, Tacoma, Washington. “Lacosamide is effective in treating painful diabetic neuropathy with an acceptable degree of adverse side effects.”
Seventy-eight (17%) of the US patients withdrew from the study because of adverse events. Side effects most commonly reported in the SP745 trial were dizziness (21%), upper respiratory tract infection (14%), nausea (12%), and headache (10%).
Adverse events reported in the EU SP830 trial correlated closely with the US trial. Seventy (18.9%) patients in the EU withdrew due to the side effects.
[Presentation title: Long-Term Treatment of Diabetic Neuropathy With Lacosamide: Results From Two Long-Term Open-Label Trials. Abstract P05.019]
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