RESEARCH - Pregabalin reduces pain, improves sleep in FM

[Guest guest]

Pregabalin reduces pain, improves sleep in FM

Rheumawire

Apr 29, 2005

Janis

Lexington, KY - Pregabalin (Lyrica, Pfizer), a drug recently approved for

the treatment of neuropathic pain, has shown clinically significant benefits

in fibromyalgia in a large clinical trial. Dr Crofford (University of

Kentucky, Lexington) reports in the April 2005 issue of Arthritis &

Rheumatism that the drug is effective for reducing pain and improving sleep

in patients with fibromyalgia (FM) [1].

" Pregabalin at 450 mg/day significantly reduced the average severity pain

[compared with placebo], . . . and significantly more patients in this group

had a >50% improvement in pain at the end point, " Crofford writes. The

results from this study were first presented at the 2002 meeting of the

American College of Rheumatology and reported at that time by rheumawire.

Pregabalin reduced pain, fatigue; improved quality of life

This study was a multicenter, double-blind, 8-week, randomized clinical

trial comparing 3 doses of pregabalin (150, 300, or 450 mg/day) with placebo

in patients with FM. Study end points included pain, sleep, fatigue, and

health-related quality of life (QoL).

Crofford found that pregabalin at 450 mg/day produced significant

improvements in FM-associated pain, sleep problems, fatigue, and

health-related QoL measures.

" Based on work in animal models, investigators have determined that the

mechanism of pregabalin action is based on the interaction of the drug with

a component of a neuronal calcium channel, the 2- chain. As a consequence of

drug binding, there is reduced calcium influx and reduced release of

neurotransmitters such as glutamate and substance P, " Crofford says.

" In most patients, dizziness was mild and did not lead to a need to

discontinue treatment. In some patients, it resolved quickly, while in

others it persisted at a low level, " Crofford says.

" We don't know about longer-term outcomes yet. Studies of longer duration

are both under way and planned, including a study of 6 months' duration, "

Crofford says.

Pfizer may seek FM indication

Crofford tells rheumawire that if the ongoing trials demonstrate pregabalin

efficacy in FM, she expects that Pfizer will seek that indication for the

drug. " The FDA appears willing to consider approving drugs for a

fibromyalgia indication providing the companies demonstrate improvement in

symptoms and global health and function for a sustained period of time, "

Crofford says.

Since pregabalin has been approved for treatment of neuropathic pain, some

clinicians are likely to consider prescribing it off-label for fibromyalgia

patients. Crofford has some advice: " I would ask that physicians consider

referring patients for clinical trials if they meet study criteria so that

we can attain the goal of having drugs approved for FM. If physicians

prescribe pregabalin to patients off-label, I would recommend objective and

ongoing evaluation of efficacy for important FM domains, including pain,

sleep, and fatigue in each individual patient to determine whether their

patient is a responder at a clinically meaningful level. "

Source

1. Crofford LJ, Rowbotham MC, Mease PJ, et al. Pregabalin for

the treatment of fibromyalgia syndrome. Results of a randomized,

double-blind, placebo-controlled trial. Arthritis Rheum 2005; 52:1264-1273.

Not an MD

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org