ROME -- Adding milnacipran (Savella) for fibromyalgia patients with inadequate responses to pregabalin (Lyrica) monotherapy can boost efficacy without sacrificing safety, researchers said here.
In an open-label trial, patients classed as incomplete responders to pregabalin during a 12-week run-in period -- about one-third of those started on the drug -- showed a mean decrease in pain scores of about 20 points on a 100-point scale after having milnacipran added to their regimens.
Mildred Farmer, MD, of Meridien Research in St. Petersburg, Fla., reported the data during a poster session here at the European League Against Rheumatism annual meeting.
She said the trial screened patients who had at least moderately severe fibromyalgia and who were not obtaining adequate relief from their current treatment, which may not have been pregabalin. Patients agreeing to participate in the study then entered the pregabalin run-in phase.
The trial randomized the incomplete responders during the run-in to continue on the drug alone at 300-450 mg/day (same as their run-in dose) or to have milnacipran added at 100 mg/day.
Both drugs are currently approved for fibromyalgia. Farmer said this was the first trial to formally evaluate the two agents in combination for patients not responding fully to monotherapy.
http://www.medpagetoday.com/Rheumatology/Fibromyalgia/20767