Tags

Type your tag names separated by a space and hit enter

Efficacy and safety of milnacipran 100 mg/day in patients with fibromyalgia: results of a randomized, double-blind, placebo-controlled trial.
Arthritis Rheum 2010; 62(9):2745-56AR

Abstract

OBJECTIVE

To assess the efficacy and safety of milnacipran at a dosage of 100 mg/day (50 mg twice daily) for monotherapy treatment of fibromyalgia.

METHODS

A double-blind, placebo-controlled trial was performed to assess 1,025 patients with fibromyalgia who were randomized to receive milnacipran 100 mg/day (n = 516) or placebo (n = 509). Patients underwent 4-6 weeks of flexible dose escalation followed by 12 weeks of stable-dose treatment. Two composite responder definitions were used as primary end points to classify the response to treatment. The 2-measure composite response required achievement of ≥30% improvement from baseline in the pain score and a rating of "very much improved" or "much improved" on the Patient's Global Impression of Change (PGIC) scale. The 3-measure composite response required satisfaction of these same 2 improvement criteria for pain and global status as well as improvement in physical function on the Short Form 36 (SF-36) physical component summary (PCS) score.

RESULTS

After 12 weeks of stable-dose treatment, a significantly greater proportion of milnacipran-treated patients compared with placebo-treated patients showed clinically meaningful improvements, as evidenced by the proportion of patients meeting the 2-measure composite responder criteria (P < 0.001 in the baseline observation carried forward [BOCF] analysis) and 3-measure composite responder criteria (P < 0.001 in the BOCF). Milnacipran-treated patients also demonstrated significantly greater improvements from baseline on multiple secondary outcomes, including 24-hour and weekly recall pain score, PGIC score, SF-36 PCS and mental component summary scores, average pain severity score on the Brief Pain Inventory, Fibromyalgia Impact Questionnaire total score (all P < 0.001 versus placebo), and Multidimensional Fatigue Inventory total score (P = 0.036 versus placebo). Milnacipran was well tolerated by most patients, with nausea being the most commonly reported adverse event (placebo-adjusted rate of 15.8%).

CONCLUSION

Milnacipran administered at a dosage of 100 mg/day improved pain, global status, fatigue, and physical and mental function in patients with fibromyalgia.

Authors+Show Affiliations

University of Cincinnati College of Medicine, Cincinnati, Ohio 45219, USA. lesley.arnold@uc.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20496365

Citation

Arnold, Lesley M., et al. "Efficacy and Safety of Milnacipran 100 Mg/day in Patients With Fibromyalgia: Results of a Randomized, Double-blind, Placebo-controlled Trial." Arthritis and Rheumatism, vol. 62, no. 9, 2010, pp. 2745-56.
Arnold LM, Gendreau RM, Palmer RH, et al. Efficacy and safety of milnacipran 100 mg/day in patients with fibromyalgia: results of a randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2010;62(9):2745-56.
Arnold, L. M., Gendreau, R. M., Palmer, R. H., Gendreau, J. F., & Wang, Y. (2010). Efficacy and safety of milnacipran 100 mg/day in patients with fibromyalgia: results of a randomized, double-blind, placebo-controlled trial. Arthritis and Rheumatism, 62(9), pp. 2745-56. doi:10.1002/art.27559.
Arnold LM, et al. Efficacy and Safety of Milnacipran 100 Mg/day in Patients With Fibromyalgia: Results of a Randomized, Double-blind, Placebo-controlled Trial. Arthritis Rheum. 2010;62(9):2745-56. PubMed PMID: 20496365.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of milnacipran 100 mg/day in patients with fibromyalgia: results of a randomized, double-blind, placebo-controlled trial. AU - Arnold,Lesley M, AU - Gendreau,R Michael, AU - Palmer,Robert H, AU - Gendreau,Judy F, AU - Wang,Yong, PY - 2010/5/25/entrez PY - 2010/5/25/pubmed PY - 2010/11/10/medline SP - 2745 EP - 56 JF - Arthritis and rheumatism JO - Arthritis Rheum. VL - 62 IS - 9 N2 - OBJECTIVE: To assess the efficacy and safety of milnacipran at a dosage of 100 mg/day (50 mg twice daily) for monotherapy treatment of fibromyalgia. METHODS: A double-blind, placebo-controlled trial was performed to assess 1,025 patients with fibromyalgia who were randomized to receive milnacipran 100 mg/day (n = 516) or placebo (n = 509). Patients underwent 4-6 weeks of flexible dose escalation followed by 12 weeks of stable-dose treatment. Two composite responder definitions were used as primary end points to classify the response to treatment. The 2-measure composite response required achievement of ≥30% improvement from baseline in the pain score and a rating of "very much improved" or "much improved" on the Patient's Global Impression of Change (PGIC) scale. The 3-measure composite response required satisfaction of these same 2 improvement criteria for pain and global status as well as improvement in physical function on the Short Form 36 (SF-36) physical component summary (PCS) score. RESULTS: After 12 weeks of stable-dose treatment, a significantly greater proportion of milnacipran-treated patients compared with placebo-treated patients showed clinically meaningful improvements, as evidenced by the proportion of patients meeting the 2-measure composite responder criteria (P < 0.001 in the baseline observation carried forward [BOCF] analysis) and 3-measure composite responder criteria (P < 0.001 in the BOCF). Milnacipran-treated patients also demonstrated significantly greater improvements from baseline on multiple secondary outcomes, including 24-hour and weekly recall pain score, PGIC score, SF-36 PCS and mental component summary scores, average pain severity score on the Brief Pain Inventory, Fibromyalgia Impact Questionnaire total score (all P < 0.001 versus placebo), and Multidimensional Fatigue Inventory total score (P = 0.036 versus placebo). Milnacipran was well tolerated by most patients, with nausea being the most commonly reported adverse event (placebo-adjusted rate of 15.8%). CONCLUSION: Milnacipran administered at a dosage of 100 mg/day improved pain, global status, fatigue, and physical and mental function in patients with fibromyalgia. SN - 1529-0131 UR - https://www.unboundmedicine.com/medline/citation/20496365/Efficacy_and_safety_of_milnacipran_100_mg/day_in_patients_with_fibromyalgia:_results_of_a_randomized_double_blind_placebo_controlled_trial_ L2 - https://doi.org/10.1002/art.27559 DB - PRIME DP - Unbound Medicine ER -