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Pregabalin (Lyrica) may support meaningful improvement in fibromyalgia sleep maintenance – Henry Ford Health study

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Article:
Effect of pregabalin on sleep in patients with fibromyalgia and sleep maintenance disturbance: A randomized, placebo-controlled, 2-way crossover polysomnography study
– Source: Arthritis Care & Research, April 2012

By Thomas Roth, PhD, et al.

[Ed Note: Wake after sleep onset (WASO) was measured. This “quantifies the night time minutes spent awake after falling into a persistent sleep state, and is considered one of the key sleep parameters for characterizing the effect of a hypnotic [sleep-inducing] drug.” In this study the average reduction in minutes of wake after sleep onset for FM patients taking a daily pregabalin dose of 300mg to 450mg was 19.2 minutes. Additionally, average total sleep time was 25.5 minutes greater for the pregabalen group – 6.6 hours vs 6.2 for placebo group. See a MedPage Today physician CME summary for details on other measures not mentioned in the abstract (http://www.medpagetoday.com/clinical-context/Fibromyalgia/31924.

Lead investigator Thomas Roth, PhD, directs the Henry Ford Health System Sleep Disorders and Research Center, Detroit.]

Abstract:
Objective: To assess the effect of pregabalin on polysomnographic (PSG) measures of sleep and patient-rated sleep, tiredness, and pain in fibromyalgia patients.

Methods:
We performed a randomized, double-blind, placebo-controlled, 2-period crossover PSG study.

Patients ages 18 years or older with fibromyalgia satisfied subjective and objective sleep disturbance criteria prior to randomization.

• Eligible patients were randomized (1:1) to pregabalin (300-450 mg/day) or placebo for crossover period 1, and vice versa for period 2.

• Each crossover period comprised a dose-adjustment and dose-maintenance phase, with a 2-week taper/washout between periods.

• In-laboratory PSGs were recorded during 2 consecutive nights at screening and at the end of each crossover period.

The primary end point was the difference in sleep maintenance defined by PSG-recorded wake after sleep onset (WASO; minutes) between 4 weeks of treatment with pregabalin and with placebo.

Other PSG measures; patient-rated sleep, tiredness, and pain; and tolerability were assessed.

Results:
Of 119 patients randomized (103 women [86.6%], mean age 48.4 years), 102 (85.7%) completed both periods.

• Patients treated with pregabalin showed a reduction in PSG-determined WASO versus treatment with placebo (week 4 difference: -19.2 minutes [95% confidence interval (95% CI) -26.7, -11.6]; P < 0.0001).

• Pain score improved (decreased) with pregabalin versus placebo treatment at all 4 weeks (week 4 difference: -0.52 [95% CI -0.90, -0.14]; P = 0.0084).

Modest (p = <0.3) but significant correlations were found between PSG sleep assessments and ratings of pain and sleep quality. [Note: the p score of <0.3 would indicate the chances of this result occurring by chance would be less than 3 in 10.]

Frequently reported all-causality adverse events (pregabalin versus placebo) were:

• Dizziness (30.4% versus 9.9%),

• Somnolence (20.5% versus 4.5%),

• And headache (8.9% versus 8.1%).

Conclusion:

• Patients with fibromyalgia treated with pregabalin had statistically significant and meaningful improvements in sleep, as assessed by PSG.

• Patients with fibromyalgia also reported decreased daily pain.

• Pregabalin was well tolerated.

ClinicalTrials.gov identifier: NCT00883740.

Source: Arthritis Care & Research, April 2012;64:597-606. PMID: 22232085, by Roth T, Lankford DA, Bhadra P, Whalen E, Resnick EM. Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan; Sleep Disorders Center of Georgia, Atlana; Pfizer Inc., New York, NY, USA. [Email: troth1@hfhs.org] Research funded by Pfizer Inc. For details on investigators’ research funding and stock ownership/options, see http://onlinelibrary.wiley.com/doi/10.1002/acr.21595/full

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2 thoughts on “Pregabalin (Lyrica) may support meaningful improvement in fibromyalgia sleep maintenance – Henry Ford Health study”

  1. pattycake says:

    I found out this side-effect of Lyrica by chance. I have fibromyalgia and in addition, I use a CPAP at night. These two factors in tandem make for a disturbed sleep. I tried taking Lyrica 3 times a day but this made me dizzy with poor memory and cognitive ability. By trial and error I found that taking the Lyrica (150 mg) before bedtime allowed me to sleep much better. Consequently, the fibromyalgia is also much better. Thanks for bringing this to our attention!

  2. CarolBuck says:

    The Lyrica study was way too short in duration. I teach a fatigue disorders class at a local free health information center. Nine of my students had been given Lyrica by their physicians, and eight of those people developed several serious and debilitating side effects after only a few short weeks or months on the drug. The ninth was just beginning to have some problems.

    In addition, the extra few minutes of sleep gained were not necessarily worth the expense and the dangers of taking this drug. This study was, in my belief, very incomplete and superficial, more designed to sell the drug than to comprehensively report on it.

    Help with sleep problems can be obtained for some people by what is called “warming” – drinking warm tea, taking a warm bath or shower, using a heating pad, etc. – any time from one hour before bedtime up to being in bed (the time varies between people). Massage therapy can help also, as can several types of herbs or aromatherapy. Soft, gentle music at bedtime can also help. Drugs are often not the answer, and Lyrica, despite its temporary help with sleep, may be a danger to the patient and to the patient’s finances, especially when that patient has to struggle for months to rid himself/herself of the nasty side effects that can occur.

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