Background At the present time three drugs (pregabalin, duloxetine, milnacipran) are approved by the American Food and Drug Administration (FDA) for the treatment of fibromyalgia. There is no medication currently that is capable of complete symptom control, as the available drugs have been shown to improve only one or two fibromyalgia symptoms.
Objectives The aim of the present study was to assess the potential additive or synergistic effects of combined pharmacotherapy in comparison to monotherapy in treatment of fibromyalgia.
Methods This was a retrospective study reviewing 785 patients diagnosed with fibromyalgia. Pregabalin, flexibly dosed (50-450 mg/day), was administered to 122 fibromyalgia patients in combination with Duloxetine, also flexibly dosed (30-120 mg/day), or Milnacipran (25-200 mg/day). Three hundred and thirty-four patients were administered one of the three FDA approved drugs alone. Outcome measures included the Fibromyalgia Impact Questionnaire (FIQ), The Brief Pain Inventory (BPI) and the patients’ Global Improvement scale (PGI). Emergent adverse reactions were also recorded.
Results Treatment with pregabalin in combination with either duloxetine or milnacipran was superior to monotherapy in regards to improvements in fibromyalgia severity, sleep quality, depression and pain interference with daily activity. Combination therapy resulted in an improvement in the pain score of 29.3% when compared to that of monotherapy.
Conclusions Treatment with combined pharmacotherapy significantly improved fibromyalgia severity and associated symptomatology. Combination therapy is synergistic in their effects and yields greater results in multiple symptom domains compared to that of monotherapy. Larger, prospective trials should be developed to test this conclusion and to assess safety and tolerability of combination therapy.
Disclosure of Interest S. Metyas Consultant for: Pfizer Pharmaceuticals, M. Ibrahim: None Declared, E. Ortiz: None Declared, S. Maher: None Declared, D. Arkfeld Consultant for: Cypress Pharmaceuticals