Bill Chapman
(919) 483-2839
#98-048
Release under Embargo June 5, 1998 5:00pm CST
Early Data Suggest Possible Role for Lamictal(r) in Treatment of HIV-Related Peripheral Neuropathy
Chicago, (June 5, 1998) -- Pain and tingling resulting from HIV or AIDS associated peripheral neuropathy were significantly reduced in patients treated with Lamictal(r) (lamotrigine), according to preliminary results from a small study (n=42) presented today at the Eighth Annual Neuroscience of HIV Infection meeting in Chicago.
In the study, patients receiving Lamictal reported less pain than patients receiving placebo. The reduction in pain from baseline to week 14 of this study was significantly greater in the nine patients receiving Lamictal compared to the 20 patients receiving placebo. Some patients noted pain relief as early as two weeks of treatment with Lamictal.
"While these data are preliminary and involve a very small number of patients, they clearly suggest that Lamictal may be effective in alleviating some of the discomfort associated with HIV-related peripheral neuropathy," said David Simpson, M.D., Director of Neurophysiology Labs at The Mount Sinai Hospital in New York City.
Of 42 patients originally enrolled in the study, 13 did not complete the 14 week study period. Five of the 13 patients who failed to complete the study discontinued due to rash, one patient discontinued due to GI upset and seven discontinued for non-medical reasons.
Peripheral neuropathy is a common complication of HIV and AIDS which, in many cases, occurs for unknown reasons. However, treatment of HIV patients with dideoxynucleoside (antiretroviral) therapy is recognized as a cause of painful neuropathy, which often persists long after the discontinuation of the therapy.
It is estimated that 20 - 35 percent of patients with HIV or AIDS suffer from some degree of peripheral neuropathy. This number could range from 120,000 to 180,000 persons with HIV or AIDS. Symptoms of this condition usually include pain in the soles and dorsum of the feet, diminished feeling in the feet, decreased ankle reflexes and minimal foot weakness.
Lamictal is an anticonvulsant which is currently approved and available as adjunctive therapy in the treatment of partial seizures in adults with epilepsy. Safety and efficacy in pediatric patients below the age of 16 have not been established. The idea for the study reported today resulted from anecdotal reports of the efficacy of Lamictal in the treatment of painful neuropathies.
The study was conducted at three sites and was a randomized, double-blind, placebo-controlled design. Patients randomized to receive Lamictal began the study taking 25 mg per day and had their doses gradually increased over six weeks to 300 mg per day. The titration schedule was as follows: 25mg a day for two weeks; 50mg a day for two weeks; 100mg a day for one week; 200mg a day for one week; then 300mg a day for eight weeks. The primary endpoint of the study was the change in pain on the modified Gracely scale. The Gracely Scale is a well-validated and reliable assessment of pain intensity.
Before initiating the study, there were no differences in pain scores between the two groups, with both groups reporting painful neuropathies. After 14 weeks of treatment, patients receiving Lamictal reported less pain than patients in the placebo group.
In controlled trials for the approved indication of Lamictal, the most commonly reported adverse experiences vs placebo were: dizziness (38.4% v. 13.4%), headache (29.1% v. 19.1%), diplopia (27.6% v. 6.7%), ataxia (21.7% v. 5.5%), nausea (18.6% v. 9.5%), blurred vision (15.5% v. 4.5%), somnolence (14.2% v. 6.9%), rash (10.0% v. 5.0%) and vomiting (9.4% v. 4.3%). Serious rashes requiring hospitalization and discontinuation of treatment have been reported in association with Lamictal. The incidence of these rashes, which have included Stevens Johnson Syndrome (SJS) is approximately one in every 100 pediatric patients (age < 16 years) and three in every 1,000 adults.
"Based on the results of this study," added Dr. Simpson, "a larger controlled study of lamotrigine is definitely warranted."
Glaxo Wellcome Inc., headquartered in Research Triangle Park, N.C., is one of the nation's leading research-based pharmaceutical firms. A subsidiary of London-based Glaxo Wellcome plc, the company is committed to fighting disease by bringing innovative medicines and services to patients and to the healthcare providers who serve them.
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