Duloxetine, milnacipran and pregabalin improve fibromyalgia pain for one in 10 patients
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Key takeaways:
- Duloxetine, milnacipran and pregabalin can relieve pain for a small proportion of adults with fibromyalgia.
- Other treatments had no data or low-quality evidence with potential bias.
Duloxetine, milnacipran and pregabalin can yield significant pain relief over at least 12 weeks for approximately one out of 10 adults with fibromyalgia, according to an analysis of Cochrane reviews published in Rheumatology.
“Pharmacological interventions are recommended as part of a multidisciplinary approach combined with physical and/or cognitive interventions for severe forms of [fibromyalgia syndrome],” Andrew Moore, formerly a consultant with the National Health Service in the United Kingdom, and colleagues wrote. “Treatment is often by antidepressants (typically duloxetine and amitriptyline) or antiepileptics (typically gabapentin or pregabalin). Substantial (worthwhile) pain relief is achieved by a small proportion of patients.”
To assess the current evidence on the efficacy and safety of various drugs for fibromyalgia, Moore and colleagues conducted an analysis of 21 Cochrane reviews, encompassing 87 trials and 17,631 patients. The reviews all covered randomized controlled trials with placebo control groups, while outcomes were measured as close as possible to 13 weeks post-treatment.
Using the AMSTAR-2 criteria, the researchers found there was high confidence in the certainty of evidence in six reviews and moderate confidence in 15. An independent assessment with GRADE methodology found that four reviews had “trustworthy evidence of clinically relevant effect,” the researchers wrote.
According to the analysis, three pharmacological treatments demonstrated “consistent evidence” for reduced pain intensity and improved Patient Global Impression of Change. These drugs were duloxetine (60 mg and 20 mg daily), milnacipran (100 mg and 200 mg daily) and pregabalin (300 mg, 450 mg and 600 mg daily). Compared with placebo, these three agents showed “modest” risk differences ranging from 0.09 to 0.14, while the numbers needed to treat ranged from 6.9 to 14, according to the researchers.
On average, withdrawal rates due to adverse events from any of the three drugs ranged from 6% to 9%, while rates of serious adverse events never registered a statistically significant separation from placebo.
“Duloxetine, milnacipran and pregabalin have good evidence of efficacy in a small proportion of patients and might be recommended for use in primary care for a trial period of 4 to 6 weeks,” Moore and colleagues wrote. “Treatment should cease if substantial pain relief is not experienced by 6 weeks.
“Since relatively few trial participants achieved substantial pain relief with duloxetine, milnacipran and pregabalin, it is important to establish stopping rules, so that when someone does not respond within a specified time, they can be switched to a suitable alternative treatment,” they added. “This would reduce the number of individuals exposed to adverse events from medications in the absence of benefit.”
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