Background Duloxetine, milnacipran, and pregabalin are the only drugs approved by the Food and Drug Administration (FDA) for fibromyalgia. The recommended dosages are duloxetine 60 mg once a day, milnacipran 100 mg/day in two divided doses; may be increased to 200 mg/day, and pregabalin 150 to 300 mg/day in two divided doses. However, data on the relative efficacy and safety of the drugs approved by the FDA with different dosages are limited, because it is difficult to integrate information regarding the relative efficacy and safety of all tested drugs at different doses due to the lack of multiple comparisons in classical meta-analysis.
Objectives The aim of this study was to assess the relative efficacy and tolerability of duloxetine, pregabalin, and milnacipran at the recommended doses in patients with fibromyalgia.
Methods Randomized controlled trials (RCTs) examining the efficacy and safety of duloxetine 60 mg, pregabalin 300 mg, pregabalin 150 mg, milnacipran 200 mg, and milnacipran 100 mg compared to placebo in patients with fibromyalgia were included in this Bayesian network meta-analysis.
Results Nine RCTs including 5,140 patients met the inclusion criteria. The proportion of patients with >30% improvement from baseline in pain was significantly higher in the duloxetine 60 mg, pregabalin 300 mg, milnacipran 100 mg, and milnacipran 200 mg groups than in the placebo group (pairwise odds ratio (OR) 2.33, 95% credible interval (CrI) 1.50–3.67; OR 1.68, 95% CrI 1.25–2.28; OR 1.62, 95% CrI 1.16–2.25; and OR 1.61; 95% CrI 1.15–2.24, respectively). Ranking probability based on the surface under the cumulative ranking curve (SUCRA) indicated that duloxetine 60 mg had the highest probability of being the best treatment for achieving the response level (SUCRA =0.9431), followed by pregabalin 300 mg (SUCRA =0.6300), milnacipran 100 mg (SUCRA =0.5680), milnacipran 200 mg (SUCRA =0.5617), pregabalin 150 mg (SUCRA =0.2392), and placebo (SUCRA =0.0580). The risk of withdrawal due to adverse events was lower in the placebo group than in the pregabalin 300 mg, duloxetine 60 mg, milnacipran 100 mg, and milnacipran 200 mg groups. However, there was no significant difference in the efficacy and tolerability between the medications at the recommended doses.
Conclusions Duloxetine 60 mg, pregabalin 300 mg, milnacipran 100 mg, and milnacipran 200 mg were more efficacious than placebo. However, there was no significant difference in the efficacy and tolerability between the medications at the recommended doses.
Disclosure of Interest None declared