Lyrica may improve fibromyalgia pain in patients taking antidepressants
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Lyrica improved pain in patients with fibromyalgia who received antidepressants for comorbid depression, according to results of a recently published study.
Patients with fibromyalgia (FM) who received antidepressants were enrolled in a randomized, double-blind, placebo-controlled two-period, two-way crossover study from 38 centers in Canada, Italy, Spain and the U.S. between November 2011 and July 2013. One hundred eighty-one patients were randomly assigned to receive Lyrica (pregabalin, Pfizer) for 6 weeks, which was then tapered for 2 weeks and followed by placebo for 6 weeks, and 177 patients were randomly assigned to receive placebo first followed by a 2-week wash-out period and 6 weeks of pregabalin. The same number of pills was administered throughout the trial to preserve blindness to the study. Antidepressants included Celexa (citalopram, Forest Laboratories), dapoxetine, Pristiq (desvenlafaxine, Pfizer), Cymbalta (duloxetine, Lilly USA), Lexapro (escitalopram, Forest Laboratories), fluoxetine, fluvoxamine, paroxetine, Zoloft (sertraline, Pfizer) and Viibryd (vilazodone, Forest Laboratories) and were taken concomitantly throughout the trial.
Patient questionnaires, including the Hospital Anxiety and Depression Score (HADS), Fibromyalgia Impact Questionnaire (FIO), the Subjective Sleep Questionnaire (SSQ), and the Patient Global Impression of Change (PGIC) were used to assess pain, function and depression.
Twenty-two patients each discontinued pregabalin or placebo, and 149 completed the study. At baseline, patients had mild depression and severe FM symptoms based on FIQ and HADS scores, and minimal variability was seen between patients taking different antidepressants.
At the study endpoint, the pain scores were significantly lower for patients taking pregabalin compared with those taking placebo, and improvements were seen in as early as 1 week in some patients, according to the researchers.
Pain improvements were sustained across the treatment time, and significantly more patients taking pregabalin achieved 30% or 50% improvements in pain compared with those taking placebo. FIQ, sleep scores and other measures improved in patients who received pregabalin compared with placebo.
Four patients had serious adverse event that were not considered to be related to treatment. Dizziness, somnolence and constipation were the most commonly reported side effects, according to the researchers. – by Shirley Pulawski
Disclosure: The researchers report the study was sponsored by Pfizer.