title: Durability of therapeutic response to milnacipran treatment for fibromyalgia. Results of a randomized, double-blind, monotherapy 6-month extension study.
abstract: OBJECTIVE
  To evaluate the durability of improvement and long-term efficacy of milnacipran treatment in fibromyalgia, to assess efficacy in patients re-randomized from placebo to milnacipran, and to collect additional information on the tolerability and efficacy of long-term treatment with milnacipran.
  
  
  METHODS
  A total of 449 patients who successfully completed a 6-month lead-in study enrolled in this 6-month extension study (87.7% of eligible subjects). Patients initially receiving milnacipran 200 mg/day during the lead-in study were maintained at 200 mg/day (n = 209); patients initially assigned to placebo or milnacipran 100 mg/day were re-randomized (1:4) to either 100 mg/day (n = 48) or 200 mg/day (n = 192) of milnacipran for an additional 6 months of treatment. Efficacy assessments included visual analog scale pain ratings, Fibromyalgia Impact Questionnaire (FIQ) total score, and Patient Global Impression of Change (PGIC).
  
  
  RESULTS
  Patients continuing on milnacipran demonstrated a sustained reduction in pain over the full 12-month period. Additional beneficial effects were also maintained, as indicated by the PGIC and FIQ. Patients initially assigned to either placebo or milnacipran 100 mg/day in the lead-in study and subsequently re-randomized to milnacipran 200 mg/day in the extension study experienced further improvements in their mean pain scores, FIQ total scores, and PGIC ratings at 1 year. Milnacipran treatment was generally well tolerated. The most commonly reported newly emergent adverse event was nausea.
  
  
  CONCLUSIONS
  In addition to confirming that milnacipran safely and effectively improves the multiple symptoms of fibromyalgia, these data indicate that milnacipran provides 1-year durable efficacy in this patient population.
authors.affiliation: Department of Medicine, Newton-Wellesley Hospital, Newton, Massachusetts 02462, USA. dgoldenb@massmed.org
authors.forename: Don L
authors.initials: DL
authors.lastname: Goldenberg
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Clauw
authors.forename: Robert H
authors.initials: RH
authors.lastname: Palmer
authors.forename: Philip
authors.initials: P
authors.lastname: Mease
authors.forename: Wei
authors.initials: W
authors.lastname: Chen
authors.forename: R Michael
authors.initials: RM
authors.lastname: Gendreau
mesh_terms: D000293:Adolescent; D018759:Adrenergic Uptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D003521:Cyclopropanes / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005356:Fibromyalgia / Q000188:drug therapy*; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D000078764:Milnacipran; D010147:Pain Measurement; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018759:Adrenergic Uptake Inhibitors; D003521:Cyclopropanes; D000078764:Milnacipran