Duloxetine and pregabalin: safe and effective for the long-term treatment of fibromyalgia?

This Practice Point commentary discusses the first two trials of long-term drug treatment in fibromyalgia. In Russell et al.'s study, 33% of patients receiving 6-month treatment with 60 mg/day duloxetine responded to therapy; the number needed to treat was seven. In the three treatment arms, 15% (60 mg/day duloxetine), 27% (120 mg/day duloxetine) and 13% (placebo) of patients discontinued treatment because of adverse events (the most common being nausea [24%] and fatigue [14%]). In Crofford et al.'s study, 32% of patients who received pregabalin had loss of therapeutic response, compared with 61% of patients treated with placebo. The discontinuation rate due to adverse events (dizziness in 36% of cases and somnolence in 22%) during the randomized treatment phase was 16% with pregabalin and 7% with placebo. This commentary discusses the implications of these trials for clinical practice and considers areas for future research in the field. In view of the current results, duloxetine and pregabalin could be administered together and as part of multimodal and multidisciplinary therapy, but treatment should 'start low and go slow'.