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| |  Lamictal (Lamotrigine) Relieves Pain of Diabetic Neuropathy RESEARCH TRIANGLE PARK, NC -- September 4, 2001 -- A new study reports that a drug currently used to treat epilepsy may also be effective at reducing pain associated with diabetic neuropathy, a potentially serious complication that could result in limb amputation. The research, published in the August issue of Neurology, showed that Lamictal® (lamotrigine), at doses slowly titrated to 200 to 400 mg/day, had significantly superior analgesic effect compared with placebo. "This supports preliminary research showing that Lamictal may be effective for this serious pain syndrome," said Elon Eisenberg, MD, Director, Pain Relief Unit at Rambam Medical Center in Israel, and lead investigator of this study. "Additional controlled studies are needed to establish the most effective dose of Lamictal for this disorder." According to the American Diabetes Association (ADA), neuropathy is a painful and sometimes debilitating condition resulting in nerve damage. It affects more than half of all people with diabetes. Distal symmetric polyneuropathy (DSP) is the most common among four types of neuropathy, and affects the legs, feet and occasionally the hands. Symptoms range from the feeling of "pins and needles" or tingling to more severe pain, and sometimes a lack of sensation altogether. The latter symptom, if untreated, can lead to limb amputation. All patients in this study had an established diagnosis of diabetes with stable medications to treat it, medical evidence of peripheral neuropathy, and pain from peripheral neuropathy for at least six months. The primary findings from this double-blind, placebo-controlled, randomized, parallel-group, single-center study are based on data from 53 patients (27 receiving Lamictal, 26 on placebo) who had similar characteristics including type and severity of diabetes at baseline. However, the Lamictal group had a significantly longer duration of diabetes than the placebo group (13.9 years versus 9.6 years, on average, respectively). Primary and secondary measures used to evaluate patients' responses included daily patient diaries recording pain ratings based on a zero-10 scale; the use of "rescue" pain medication; completion of questionnaires on pain, depression and disability administered before and at the end of the eight-week treatment phase; and a global assessment of efficacy and tolerability on a zero-10 scale. Patients were seen at four office visits during the treatment phase and at the end of the post-treatment phase. Lamictal was administered over the course of eight weeks at a starting daily dose of 25 mg for the first two weeks, then adjusted to twice-daily dosing as follows: 50 mg for the next two weeks, 100 mg for the fifth week, and an additional 100 mg added each week for the remaining three weeks of the study, up to 400 mg/day. Patient-rated pain intensity scores were significantly reduced from baseline to end of treatment at week eight with Lamictal 200 to 400 mg/day versus placebo (p<0.001). Additionally, almost half of the patients receiving the study drug achieved a 50 percent reduction in pain. Most patients receiving Lamictal who needed "rescue" pain medication at the start of the study were able to reduce the use of the additional pain medication by end of treatment, while those receiving the placebo continued to need the pain medication throughout the treatment period. The process of slowly increasing the dose meant that patients received doses of 200 mg/day starting at week six, and the statistically significant differences between Lamictal and placebo were seen from weeks six through eight. The researchers found that the incidence of side effects was similar in both groups. Thirteen patients did not complete the study due to adverse effects or lack of compliance (five from the Lamictal group, eight from the placebo group). Two patients receiving Lamictal discontinued use of the medication due to the development of rash, which resolved shortly after treatment discontinuation. SOURCE: GlaxoSmithKline Related Links: Lamictal (lamotrigine) and GlaxoSmithKline.
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