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Title: Pregabalin Cuts Pain in Tough-to-Treat Patients With Neuropathic Pain and Fibromyalgia Syndrome: Presented at AAN

"Pregabalin Cuts Pain in Tough-to-Treat Patients With Neuropathic Pain and Fibromyalgia Syndrome: Presented at AAN"

By Jill Stein MIAMI, FL -- April 13, 2005 -- Use of pregabalin and concomitant analgesics if required is able to maintain stable pain reduction in patients with diabetic peripheral neuropathy (DPN), postherpetic neuralgia (PHN), or fibromyalgia syndrome (FMS) that is refractory to therapy with tricyclics, gabapentin, and other analgesics. Pregabalin was recently approved in the United States for the treatment of neuropathic pain associated with painful DPN and PHN. The new findings were reported by Joao Siffert, MD, medical director for worldwide neurology, Pfizer Global Pharmaceuticals, New York, New York, United States, here on April 12[^th at the American Academy of Neurology 57^th Annual Meeting.

Dr. Siffert presented findings from the first 15 months of an ongoing open-label trial that is examining the effectiveness and safety of pregabalin in treatment-refractory patients with DPN and PHN as well as pain associated with FMS.

The 106 patients in whom data were reported had participated in double-blind, placebo-controlled pregabalin trials and had documented inadequate pain relief or intolerable adverse effects during at least 2 weeks of treatment with a tricyclic antidepressant (75 mg/day or more), gabapentin (1800 mg/day or more), and at least 1 third-line neuropathic pain treatment.

During the trial, patients were allowed to continue concomitant medications, including gabapentin, and were allowed to initiate use of other pain medications.

Subjects received pregabalin 150 to 600 mg/day adjusted to effectiveness and tolerability.

The study included 4 quarterly drug holidays followed by relapse visits where patients indicated if their pain worsened on a 5-point scale where 0 meant "not at all" and 4 meant that their pain was "very much worse".

Relapse was defined as a response of "moderately worse" (3 points) or greater. Only patients who relapsed during a drug holiday resumed pregabalin treatment.

Visual Analogue Scale (VAS) mean pain scores at baseline were 73 for DPN patients, 74 for PHN patients, and 75 for FMS patients. Pregabalin treatment yielded significant reductions in pain scores at the end of the study, with mean VAS pain scores of 47 for DPN, 55 for PHN, and 48 for FMS.

The mean duration of drug holidays was 7 days.

Pregabalin drug holidays were consistently associated with a return of pain VAS scores to baseline levels, further establishing the association of pregabalin use and pain reduction, Dr. Siffert noted.

Adverse events associated with treatment were typical of those observed with pregabalin in prior clinical trials and indicated generally good tolerability.

The study was sponsored by Pfizer Inc.

[Presentation title: Long-Term Treatment of Neuropathic Pain and Fibromyalgia Syndrome With Pregabalin in Treatment-Refractory Patients. Abstract P02.156]

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