Lyrica significantly improves pain in fibromyalgia patients who are also being treated for depression, according to a new study presented this week at the annual meeting of the American College of Rheumatology in San Diego. Lyrica, which is made by Pfizer, is the brand name for the drug pregabalin.
The National Institutes of Health estimates that about 5 million Americans suffer from fibromyalgia, a poorly understood disorder characterized by deep tissue pain, fatigue, headaches, mood swings and insomnia. Between 50 and 70 percent of fibromyalgia patients also suffer from depression. About one in four have used antidepressants.
“Depression is common in patients with fibromyalgia,” said Lesley M. Arnold, MD, professor of psychiatry and behavioral neuroscience at the University of Cincinnati College of Medicine and lead investigator in the study.
“This is the first study to evaluate the efficacy and safety of pregabalin for treatment of fibromyalgia pain in patients who are also taking antidepressants for depression.”
Previous studies about pregabalin have excluded patients taking antidepressants. With that in mind, researchers in this study enrolled nearly 200 fibromyalgia patients who were taking an antidepressant medication – either a serotonin reuptake inhibitor (such as Celexa or Lexapro) or a serotonin-norepinephrine reuptake inhibitor (such as Cymbalta or Effexor). The antidepressant treatment was continued throughout the study.
The average age of the patients was about 50, they were overwhelmingly white and female, and they had suffered from depression for over 12 years on average.
During the 14-week study, patients received either pregabalin or a placebo for 6 weeks, with a two-week break in between these periods. None of the patients knew which treatment they were receiving at any point in the study.
Pregabalin was started at a dose of 150mg per day and was increased to 300-450mg per day based on patient response.
At the beginning of the study, the average pain score amongst participants was 6.7.
The average pain score dropped to 4.84 after treatment with pregabalin and to 5.45 after treatment with placebo.
“The results of this study demonstrate that pregabalin is safe and effective in reducing fibromyalgia pain in patients who are also taking an antidepressant to treat their depression,” says Dr. Arnold.
A large majority of patients (77%) in the study reported side effects from pregabalin, most often dizziness or drowsiness.
Many other patients who have taken the drug say they experienced a sudden weight gain, blurred vision, or had trouble concentrating.
Lyrica was the first medication approved by the Food and Drug Administration for the treatment of fibromyalgia. Lyrica is Pfizer’s top selling drug with worldwide sales in 2011 of $3.7 billion.