SAN DIEGO -- Patients with fibromyalgia who were taking antidepressants found that their pain was successfully managed with , a researcher said here.
In a 14-week crossover study, among patients on stable doses of selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors and randomized to pregabalin or placebo, treatment with pregabalin was associated with significantly less pain, with least squares mean pain scores of 4.84 versus 5.45, according to , of the University of Cincinnati.
Action Points
- Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
This represented a mean difference of -0.61 (95% CI minus 0.91-minus 0.31, P=0.0001), she said during a press briefing at the annual meeting of the American College of Rheumatology.
Up to 70% of patients with fibromyalgia have a lifetime history of depression, and about one in four have taken antidepressant medications.
"This is a common clinical problem," she said. However, because clinical trials of pregabalin excluded patients on antidepressant drugs, there is a lack of information about the safety and efficacy of using the two types of drugs together.
So she and her colleagues recruited 197 patients, almost all of whom were white women and whose mean age was 50.
They were diagnosed according to the , which included widespread pain and tender points.
Participants had moderate degrees of pain, with mean pain scores of 6.7 on a scale of 0 to 10.
The average time since patients had been diagnosed with depression was 12 years, and at the time of enrollment their depression scores suggested mild depression even with ongoing treatment.
Doses of pregabalin ranged from 300 to 450 mg per day, and a 2-week washout period separated the two 6-week courses of active treatment or placebo.
A total of 77.3% of patients receiving pregabalin experienced adverse events, as did 59.9% of those given placebo, with the most common being dizziness, in 28.2%, and somnolence, in 19.9%.
There were four serious adverse events, three in the pregabalin group, but these weren't considered to be treatment related.
During the course of the study, 6.1% of those on pregabalin and 3.4% of those on placebo withdrew because of adverse events.
There were no new safety signals, and no apparent drug interactions, she noted.
The study suggested that there is a potential role for pregabalin for treatment of pain in fibromyalgia patients who have concurrent depression, she concluded.
Disclosures
Arnold and her co-authors disclosed relationships with various companies, including Pfizer, Eli Lilly, Takeda, AstraZeneca, Forest Laboratories, Janssen, Merck Sharp and Dohme, and Roche.
Primary Source
American College of Rheumatology
Source Reference: Arnold L, et al "Efficacy and safety of pregabalin in patients with fibromyalgia and comorbid depression receiving concurrent antidepressant therapy: a randomized, 2-way crossover, double-blind, placebo-controlled study" ACR 2013; Abstract L6.