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Study Shows Durability of Pregabalin for Fibromyalgia Pain: Presented at ACR

By Bruce Sylvester

BOSTON, MA -- November 12, 2007 -- In the first long-term study of pregabalin treatment for fibromyalgia, researchers report durability of efficacy for treatment of fibromyalgia-related pain.

The findings were presented here on November 10 at the 71st annual meeting of the American College of Rheumatology (ACR).

"The patients in this 1-year extension trial were maintained for therapeutic effect and, notably, this is a difficult group to treat, with a mean 9-year-since-diagnosis history," said Jennifer Barrett, MD, Senior Medical Director, Pfizer Global Pharmaceuticals, New York, New York. "Here we see demonstrated long-term durability for this treatment for fibromyalgia, which is the only FDA-approved treatment for the condition."

Prior to this 1-year, open-label extension study, eligible subjects had been enrolled in a 13-week randomized, placebo-controlled trial of pregabalin dosed at 300 to 600 mg/d (BID or twice daily) as treatment for fibromyalgia-associated pain.

Upon completion of the randomized trial, subjects had the option of continuing pregabalin treatment in this open-label study, starting at 300 mg/day and escalating to 150 to 600 mg/day.

Investigators assessed efficacy changes using the Short-Form McGill Pain Questionnaire (SF-MPQ), including sensory and affective pain descriptors and total score, Present Pain Intensity (PPI), and Visual Analog Scale (VAS).

The investigators enrolled 429 of 431 patients from the randomized trial, and 249 (58%) completed the study, 70 (16.3%) discontinued due to an adverse event, 44 (10.3%) defaulted, and 66 (15.4%) discontinued for other reasons.

Of the total group, 399 (93%) were women, 396 (92.3%) were white, and the mean age was 48.3 years (range 19-75). The mean duration of fibromyalgia was 9.4 years (range, 0.5-52 years).

Median duration of treatment with pregabalin was 357 days (range 1-402 days). Two hundred eighty-six subjects (66.7%) had received pregabalin for >=26 weeks and 114 had received pregabalin for >=1 year.

Overall exposure at baseline was 303 patient-years, the greatest exposure occurred at the 600 mg/d (BID) dose, with 100.5 patient-years.

The investigators reported that mean change from baseline to endpoint in SF-MPQ sensory, affective, and total scores, and mean change from baseline to endpoint in VAS and PPI scores indicated improvement in measures of pain: VAS decreased 21 points (0-100 scale) and PPI decreased 0.9 point (0-5 scale).

Adverse events were mild to moderate in intensity, and of limited duration. Dizziness led to 6 discontinuations, and somnolence and increased weight led to 5 discontinuations each. The researchers reported that 22 patients (5.1%) had serious adverse events and 5 of these patients discontinued. However, the serious adverse events in all but 2 patients were deemed to be unrelated to pregabalin treatment.

"We can now say with confidence that this is a treatment that is durable," added Dr. Barrett.


[Presentation title: Efficacy and Safety of Pregabalin as Long-Term Treatment of Pain Associated With Fibromyalgia: A 1-Year, Open-Label Study. Abstract 1523]

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