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Lyrica (pregabalin) is approved in the United States to treat fibromyalgia and nerve pain from diabetes and herpes, but little was known about its safety and effectiveness when also taken with antidepressants, the researchers explained.
"For those people with fibromyalgia who also have depression, which is very common, and who take an antidepressant but still have pain, taking [Lyrica] can reduce the severity of the pain while they continue on their antidepressant," said study author Dr. Lesley Arnold, professor of psychiatry and behavioral neuroscience at the University of Cincinnati College of Medicine.
"And it appears to be safe and tolerable for most people," Arnold added.
Arnold is scheduled to present the findings this week at the American College of Rheumatology annual meeting in San Diego. She is a consultant for Pfizer, the maker of Lyrica, and other pharmaceutical companies, including Takeda, Eli Lilly, AstraZeneca and others.
Fibromyalgia is a long-term syndrome that involves pain at different points throughout the body and tenderness in the joints, muscles, tendons and other soft tissues. The syndrome has been linked to fatigue, sleep problems, anxiety and depression, but its cause is unknown. Women aged 20 to 50 are most often affected.
The new study was done because the original research on Lyrica for fibromyalgia indications excluded people taking antidepressants, Arnold said. About 50 percent to 70 percent of those with fibromyalgia report a lifetime history of depression, and about one in four has taken antidepressants, Arnold said said.
For the new study, Arnold's team evaluated 197 patients, mostly women, with diagnosed fibromyalgia. Their average pain level was at least four on a scale of zero to 10, with 10 being the worst. All also had clinical depression and were taking antidepressants. Their average age was 50.
The researchers randomly assigned the patients to two six-week treatments, with a two-week break in between. Patients either got Lyrica or placebo the first six weeks, then received the other treatment for the next six-week period. They didn't know which treatment they were getting.
Lyrica was started at a dose of 150 milligrams (mg) a day and increased to 300 mg to 450 mg, based on response.
At the start, the average pain score was 6.7 of 10. After taking Lyrica, the pain score dropped to 4.84 and after taking the placebo it fell to 5.45. The drug worked better than placebo. "It was a noticeable improvement in pain," Arnold said.
Side effects with the drug included dizziness and drowsiness, Arnold said. Four serious adverse effects occurred but were unrelated to the drug, she said.
The drug is thought to reduce pain by reducing pain signals in the central nervous system, Arnold said.
Online, a month's supply of Lyrica in the 300 mg- dosage sells for about $100, although prices vary depending on supplier.
Doctors and other health care providers have prescribed Lyrica along with antidepressants for years, said Dr. Patrick Wood, director of the Fibromyalgia Specialty Center at Madison River Oaks Medical Center Hospital in Madison County, Miss.
"This [study] provides some small reassurance that what people have been doing all along is 'safe,''' he said.
However, Wood noted, the drug -- approved for fibromyalgia treatment in 2007 in the United States -- doesn't provide total relief. The score reported after taking the drug -- 4.8 of 10 -- is ''still a lot of pain," he said. "A pain-free person has a zero to one."
Data and conclusions presented at meetings are typically considered preliminary until published in a peer-reviewed medical journal.
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