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Pregabalin lets Fibromyalgia patients sleep

Thursday 12 April 2012


From Medscape:


MedscapePregabalin Lets Fibromyalgia Patients Sleep

This report is part of a 12-month Clinical Context series.

By Nancy Walsh, Staff Writer, MedPage Today
Published: March 29, 2012

Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, RN, BC-ADM, Nurse Planner

Sleep difficulties commonly experienced by patients with fibromyalgia were greatly improved during 4 weeks of treatment with pregabalin (Lyrica), a randomized trial found.

Compared with patients given placebo, those receiving pregabalin spent 19.2 fewer minutes (95% CI −26.7 to −11.6, P<0.0001) awake after initially falling asleep, according to Thomas Roth, PhD, of the Henry Ford Health System in Detroit, and colleagues.

Total sleep time also increased with treatment by 25.5 minutes (95% CI 17.5 to 33.6, P<0.0001), the researchers reported in the April Arthritis Care & Research.

Fibromyalgia is characterized by chronic muscle pain and tenderness, and many patients also report problems with falling asleep, frequent awakenings, and sleep-disordered breathing.

"Pain and sleep disturbance exhibit a bidirectional relationship, where pain interferes with sleep, and sleep disturbance can increase a patient's experience of pain," Roth and colleagues wrote.

Pregabalin is an anticonvulsant and is used for neuropathic pain, and was approved for treatment of fibromyalgia in 2007.

A blinded polysomnographic study in healthy volunteers suggested improvements in certain aspects of sleep -- such as increased slow-wave sleep -- when pregabalin was compared with a benzodiazepine.

To see if sleep also improved in patients with fibromyalgia, Roth's group enrolled 119 patients, randomizing them to a target dose of 300 mg to 450 mg of pregabalin daily or placebo.

The study was double-blind and used a crossover design where patients spent 1 month on treatment and another on placebo, with a 2-week washout period between.

Participants spent 2 nights at the study center at the end of each treatment period, where they underwent 8 hours of polysomnography, and kept daily diaries throughout, rating their sleep and pain.

On the polysomnographic assessment, the time spent awake after initially falling asleep was 51.5 minutes for pregabalin and 70.7 minutes for placebo.

Total sleep time for the two groups was 6.6 hours and 6.2 hours in the two groups, respectively.

Other objective measures also showed improvement with pregabalin versus placebo:

  • Latency to persistent sleep, 41.6 versus 34.5 minutes (P=0.0447)
  • Sleep efficiency, 82.6% versus 77.2% (P<0.0001)
  • Slow-wave sleep, 17.2% versus 15% (P=0.0024)
  • Awakenings lasting at least 1 minute, 8.63 versus 10.2 (P=0.0008)

Frequent awakenings and disruptions in slow-wave sleep have been proposed as contributing to the etiology of fibromyalgia.

"These are common in [fibromyalgia] and may have an influence on bodily hypersensitivity and pain," explained the researchers.

On patients' subjective ratings, time spent awake after falling asleep decreased by 10.3 minutes and latency to sleep onset by 6.2 minutes.

Patient-rated total sleep time was 25 minutes longer with pregabalin than placebo.

Sleep quality also improved significantly (P<0.0001), as did daily tiredness (P=0.0003) and pain (P=0.0084).

Additional exploratory analyses identified a negative correlation between daily pain and total sleep time (−0.24) and a positive correlation with latency to persistent sleep (+0.25).

More patients reported treatment-related adverse events while on pregabalin (57.1%) than while taking placebo (20.7%, P<0.01), and one patient experienced severe dizziness while on placebo and withdrew.

The most common adverse events associated with pregabalin or placebo were dizziness (28.6% versus 9.9%), somnolence (20.5% versus 4.5%), nausea (6.3% versus 1.8%), and headache (7.1% versus 6.3%).

"Improvement in sleep and pain in patients with [fibromyalgia] may together contribute toward an overall improvement in patients' daily symptoms and quality of life," they observed.

However, they acknowledged that much more work is needed.

"Future studies are needed to measure more precisely the microstructure of sleep (e.g., spectral analyses, brief arousals) to understand the interrelationship between the myriad sleep abnormalities seen in [fibromyalgia]," they concluded.

The study was supported by Pfizer.

Co-authors reported research or consulting links with Pfizer, Aventis, Wyeth, Takeda, Abbott, GlaxoSmithKline, Hypnion, Eli Lilly, Merck, Novartis, Neurogen, and Schering-Plough.

Three co-authors own stock or stock options in Pfizer.

Primary source: Arthritis Care & Research
Source reference:
Roth T, et al "Effect of pregabalin on sleep in patients with fibromyalgia and sleep maintenance disturbance: a randomized, placebo-controlled, 2-way crossover polysomnography study" Arthritis Care Res 2012; 64: 597-606.


The above, with comment, originally appeared here.


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