May 07, 2010
Comorbid Migraine Does Not Affect Efficacy of Milnacipran in Management of FibromyalgiaBALTIMORE, Md.—In patients with fibromyalgia, milnacipran efficacy is not affected by the presence of comorbid migraine headache, examination of pooled data from three randomized, double-blind, placebo-controlled clinical trials of the dual serotonin- and norepinephrine-reuptake inhibitor has found.
Using patient self-reports and history, the investigators identified comorbid migraine at baseline in 987 of 3109 (31.8%) patients with fibromyalgia enrolled in the three trials. (In contrast, 12% of the general population has migraine.) In the studies, patients were randomized to receive milnacipran 100 mg/day (n=1139), milnacipran 200 mg/day (n=837), or placebo (n=1133), according to Alan M. Rapoport, MD, Director Emeritus and Co-founder of The New England Center for Headache in Stamford, Conn., and colleagues.
After 12 weeks of stable dose treatment, milnacipran efficacy was assessed in fibromyalgia patients with and without comorbid migraine, using three responder analyses to measure pain and global improvements. Pain responders were those patients who reported a ≥30% improvement from baseline in Patient Experience Diary Visual Analog Scale (PED VAS) 24-hour recall pain, collected via an electronic diary. Patient Global Impression of Change (PGIC) responders were patients who rated themselves “very much improved” (score= 1) or “much improved” (score= 2). Those who concurrently met the requirements for both pain and PGIC responses were designated “2-measure composite responders.”
Both doses of milnacipran resulted in statistically significant increases in the number of pain responders, PGIC responders, and 2-measure composite responders (all P<0.01) in patients both with and without comorbid migraine headache. Treatment effects were similar (odds ratios, 1.9 to 2.7). Please see corresponding PowerPoint slides for more information.
Effect of milnacipran on migraine itself was not evaluated in this study, investigators told attendees at the American Pain Society's 29th Annual Scientific Meeting.