PMID- 23858335
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20130716
LR  - 20211021
IS  - 1759-720X (Print)
IS  - 1759-7218 (Electronic)
IS  - 1759-720X (Linking)
VI  - 5
IP  - 3
DP  - 2013 Jun
TI  - Milnacipran combined with pregabalin in fibromyalgia: a randomized, open-label 
      study evaluating the safety and efficacy of adding milnacipran in patients with 
      incomplete response to pregabalin.
PG  - 113-26
LID - 10.1177/1759720X13483894 [doi]
AB  - OBJECTIVE: To evaluate the safety, tolerability, and efficacy of adding 
      milnacipran to pregabalin in patients with fibromyalgia who have experienced an 
      incomplete response to pregabalin. METHODS: In this randomized, multicenter, 
      open-label study, patients received pregabalin 300 or 450 mg/day during a 4- to 
      12-week run-in period. Patients with weekly recall visual analog scale (VAS) pain 
      score of at least 40 and up to 90, Patient Global Impression of Severity score of 
      at least 4, and Patient Global Impression of Change (PGIC) score of at least 3 
      were classified as incomplete responders and randomized to continue pregabalin 
      alone (n = 180) or receive milnacipran 100 mg/day added to pregabalin (n = 184). 
      The primary efficacy parameter was responder status based on PGIC score of up to 
      2. The secondary efficacy parameter was change from randomization in weekly 
      recall VAS pain score. Safety parameters included adverse events (AEs), vital 
      signs, and clinical laboratory tests. RESULTS: The percentage of PGIC responders 
      was significantly higher with milnacipran added to pregabalin (46.4%) than with 
      pregabalin alone (20.8%; p < 0.001). Mean improvement from randomization in 
      weekly recall VAS pain scores was greater in patients receiving milnacipran added 
      to pregabalin (-20.77) than in patients receiving pregabalin alone (-6.43; p < 
      0.001). During the run-in period, the most common treatment-emergent AEs with 
      pregabalin were dizziness (22.8%), somnolence (17.3%), and fatigue (9.1%). During 
      the randomized period, the most common treatment-emergent AEs with milnacipran 
      added to pregabalin were nausea (12.5%), fatigue (10.3%), and constipation 
      (9.8%). CONCLUSIONS: In this exploratory, open-label study, adding milnacipran to 
      pregabalin improved global status, pain, and other symptoms in patients with 
      fibromyalgia with an incomplete response to pregabalin treatment.
FAU - Mease, Philip J
AU  - Mease PJ
AD  - Swedish Medical Center; University of Washington School of Medicine; Seattle 
      Rheumatology Associates 601 Broadway, Suite 600, Seattle, WA 98122, USA.
FAU - Farmer, Mildred V
AU  - Farmer MV
FAU - Palmer, Robert H
AU  - Palmer RH
FAU - Gendreau, R Michael
AU  - Gendreau RM
FAU - Trugman, Joel M
AU  - Trugman JM
FAU - Wang, Yong
AU  - Wang Y
LA  - eng
PT  - Journal Article
PL  - England
TA  - Ther Adv Musculoskelet Dis
JT  - Therapeutic advances in musculoskeletal disease
JID - 101517322
PMC - PMC3707344
OTO - NOTNLM
OT  - clinical trials
OT  - fibromyalgia
OT  - milnacipran
OT  - pain
OT  - pregabalin
COIS- Conflict of interest statement: Dr Mease has received research/grant funding, 
      consultation fees, and speaker honoraria from Forest Laboratories, Inc., Cypress 
      Bioscience, Inc., Jazz Pharmaceuticals, Eli Lilly and Company, Pfizer Inc., and 
      UCB, Inc. Dr Farmer has received research/grant funding and consultation fees 
      from Forest Laboratories, Inc. Dr Gendreau was formerly an officer at Cypress 
      Bioscence, Inc., one of the companies involved in the development of milnacipran 
      for the management of fibromyalgia. Drs Palmer, Trugman, and Wang are full-time 
      employees of Forest Research Institute, Inc., a subsidiary of Forest 
      Laboratories, Inc, and own stock in that company.
EDAT- 2013/07/17 06:00
MHDA- 2013/07/17 06:01
PMCR- 2013/06/01
CRDT- 2013/07/17 06:00
PHST- 2013/07/17 06:00 [entrez]
PHST- 2013/07/17 06:00 [pubmed]
PHST- 2013/07/17 06:01 [medline]
PHST- 2013/06/01 00:00 [pmc-release]
AID - 10.1177_1759720X13483894 [pii]
AID - 10.1177/1759720X13483894 [doi]
PST - ppublish
SO  - Ther Adv Musculoskelet Dis. 2013 Jun;5(3):113-26. doi: 10.1177/1759720X13483894.