Pregabalin (Lyrica®) can significantly improve FM pain in people who also are being treated for depression, according to research presented at the American College of Rheumatology (ACR) Annual Meeting in San Diego. And my recent slow tapering off of Lyrica, and then returning to it (after way too much pain) confirmed this to me.
I also suffer from depression. In fact, 50 to 70 per cent of people with FM report a lifetime history of depression, and approximately 25 per cent have a history of taking antidepressants.
Pregabalin is approved for the treatment of FM in the United States, Japan, Australia and other countries. But, because prior studies excluded the use of antidepressants in treatment, information about the effectiveness and safety of pregabalin for the treatment of pain in people with FM who are also being treated with antidepressants for their depression is lacking.
“Depression is common in patients with fibromyalgia,” explains Lesley M. Arnold, MD; professor of psychiatry and behavioral neuroscience; University of Cincinnati College of Medicine, Cincinnati, Ohio; and lead investigator in the study. “Many patients present to their doctor for treatment of fibromyalgia pain already taking antidepressants for their depression. 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.”
With this in mind, researchers completed a study to determine if pregabalin would affect pain levels in people with FM who were also being treated for depression. The study included 197 patients who were, on average, 50 years of age and overwhelmingly white females. To join the study, patients had to meet the 1990 ACR Criteria (including manual tender point exam), have an average pain level of at least four out of 10 on the Numeric Rating Scale, (0 = no pain and 10 = worst possible pain), have a documented diagnosis of depression and be taking a stable dose of an antidepressant medication — either a selective serotonin reuptake inhibitor (such as Celexa®, Lexapro®, Prozac®, Paxil® or Zoloft®) or a serotonin-norepinephrine reuptake inhibitor (such as Cymbalta®, Effexor®, or Pristiq®). The antidepressant treatment was continued throughout the study.
Patients were on study treatment for a total of 14 weeks. There were two six-week treatment periods when patients received either pregabalin or placebo, with a two-week break in between these periods. Each patient was randomly assigned to receive either pregabalin in the first six weeks, then placebo in the last six weeks, or to receive placebo first, then pregabalin. 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 increased to 300-450mg per day, based on each patient’s response; this dose was continued for the rest of the treatment period.
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. Pregabalin treatment significantly improved patients’ pain compared to placebo.
Side effects were reported in 77.3 per cent of those on pregabalin and 59.9 per cent of those on placebo. For pregabalin treatment the most common events were dizziness (28.2 per cent) and drowsiness (19.9 per cent). A total of four serious adverse events were reported; however, the researchers concluded these events were not related to the treatment.
“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.