RESEARCH - Sodium oxybate reduces fibromyalgia pain and fatigue

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Sodium Oxybate Reduces Fibromyalgia Pain and Fatigue

October 27, 2009 (Phoenix, Arizona) — Sodium oxybate (Xyrem, Jazz

Pharmaceuticals Inc.), a novel sleep medication approved by the US

Food and Drug Administration (FDA) for the treatment of narcolepsy and

cataplexy, offers safe and significant reduction of pain and fatigue

in patients with fibromyalgia, according to a study presented here at

the American Association of Pain Management 20th annual clinical

meeting.

Sodium oxybate, the sodium salt of gamma-hydroxybutyrate, a metabolite

of gamma-aminobutyric acid (GABA), is used specifically for the

treatment of deep sleep pattern disturbances, and because studies have

shown that fibromyalgia patients commonly have deep sleep

disturbances, scientists suspected that the drug could help treat the

condition's symptoms.

Previous proof-of-concept studies offered evidence that sodium oxybate

can reduce pain and fatigue and provide polysomnographic improvements

in sleep in patients with fibromyalgia, compared with placebo.

The current phase 3 randomized double-blind study evaluated the

treatment in 548 patients with the condition.

The patients were assigned to receive sodium oxybate 4.5 g/night,

sodium oxybate 6.0 g/night, or placebo in divided doses at bedtime and

2.5 to 4 hours later, over the course of 14 weeks.

The 334 patients completing the study reproted reductions in pain as

early as the first week of the study. The percentage of patients in

the sodium oxybate 4.5 g and 6.0 g groups reporting reductions in pain

of 30% or more were significantly higher than that in the placebo

group (54.2% and 58.5% vs 35.2% respectively; P < .001).

Those reporting pain reductions of 50% or more were also higher in the

sodium oxybate groups than in the placebo group (44.7% and 43.3% vs

22.7%, respectively; P < .001).

Mean fatigue scores were significantly reduced in the sodium oxybate

4.5 g and 6.0 g groups, compared with the placebo group, throughout

the study, beginning in week 1 (P < .01) and at the study's end point

(–27.94 and –30.02 vs –17.57, respectively; P < .001).

The percentage of patients reporting global impression of change

scores of " much better " or " very much better " were also significantly

higher in the sodium oxybate 4.5 g and 6.0 g groups than in the

placebo group (48.3% and 45.4% vs 27.2%, respectively; P < .001) at

the study's end point.

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Read the rest of the article here:

http://www.medscape.com/viewarticle/711393

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