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A European multicenter randomized double-blind placebo-controlled monotherapy clinical trial of milnacipran in treatment of fibromyalgia.
J Rheumatol. 2010 Apr; 37(4):851-9.JR

Abstract

OBJECTIVE

This randomized, double-blind, placebo-controlled, multicenter study investigated the efficacy and safety of milnacipran in the treatment of fibromyalgia (FM) in a European population.

METHODS

Outpatients diagnosed with FM according to 1990 American College of Rheumatology criteria (N = 884) were randomized to placebo (n = 449) or milnacipran 200 mg/day (n = 435) for 17 weeks (4-week dose escalation, 12-week stable dose, 9-day down-titration), followed by a 2-week posttreatment period. The primary efficacy criterion was a 2-measure composite responder analysis requiring patients to achieve simultaneous improvements in pain (>or= 30% improvement from baseline in visual analog scale, 24-hour morning recall) and a rating of "very much" or "much" improved on the Patient Global Impression of Change scale. If responder analysis was positive, Fibromyalgia Impact Questionnaire (FIQ) was included as an additional key primary efficacy measure.

RESULTS

At the end of the stable dose period (Week 16), milnacipran 200 mg/day showed significant improvements from baseline relative to placebo in the 2-measure composite responder criteria (p = 0.0003) and FIQ total score (p = 0.015). Significant improvements were also observed in multiple secondary efficacy endpoints, including Short-Form 36 Health Survey (SF-36) Physical Component Summary (p = 0.025), SF-36 Mental Component Summary (p = 0.007), Multidimensional Fatigue Inventory (p = 0.006), and Multiple Ability Self-Report Questionnaire (p = 0.041). Milnacipran was safe and well tolerated; nausea, hyperhidrosis, and headache were the most common adverse events.

CONCLUSION

Milnacipran is an effective and safe treatment for pain and other predominant symptoms of FM. Registered as trial no. NCT00436033.

Authors+Show Affiliations

Faculdade Ciências Médicas, Universidade Nova de Lisboa, Serviço de Reumatologia, CHLO, EPE-Hospital Egas Moniz, Lisboa, Portugal.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

20156949

Citation

Branco, Jaime C., et al. "A European Multicenter Randomized Double-blind Placebo-controlled Monotherapy Clinical Trial of Milnacipran in Treatment of Fibromyalgia." The Journal of Rheumatology, vol. 37, no. 4, 2010, pp. 851-9.
Branco JC, Zachrisson O, Perrot S, et al. A European multicenter randomized double-blind placebo-controlled monotherapy clinical trial of milnacipran in treatment of fibromyalgia. J Rheumatol. 2010;37(4):851-9.
Branco, J. C., Zachrisson, O., Perrot, S., & Mainguy, Y. (2010). A European multicenter randomized double-blind placebo-controlled monotherapy clinical trial of milnacipran in treatment of fibromyalgia. The Journal of Rheumatology, 37(4), 851-9. https://doi.org/10.3899/jrheum.090884
Branco JC, et al. A European Multicenter Randomized Double-blind Placebo-controlled Monotherapy Clinical Trial of Milnacipran in Treatment of Fibromyalgia. J Rheumatol. 2010;37(4):851-9. PubMed PMID: 20156949.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A European multicenter randomized double-blind placebo-controlled monotherapy clinical trial of milnacipran in treatment of fibromyalgia. AU - Branco,Jaime C, AU - Zachrisson,Olof, AU - Perrot,Serge, AU - Mainguy,Yves, AU - ,, Y1 - 2010/02/15/ PY - 2010/2/17/entrez PY - 2010/2/17/pubmed PY - 2010/6/23/medline SP - 851 EP - 9 JF - The Journal of rheumatology JO - J. Rheumatol. VL - 37 IS - 4 N2 - OBJECTIVE: This randomized, double-blind, placebo-controlled, multicenter study investigated the efficacy and safety of milnacipran in the treatment of fibromyalgia (FM) in a European population. METHODS: Outpatients diagnosed with FM according to 1990 American College of Rheumatology criteria (N = 884) were randomized to placebo (n = 449) or milnacipran 200 mg/day (n = 435) for 17 weeks (4-week dose escalation, 12-week stable dose, 9-day down-titration), followed by a 2-week posttreatment period. The primary efficacy criterion was a 2-measure composite responder analysis requiring patients to achieve simultaneous improvements in pain (>or= 30% improvement from baseline in visual analog scale, 24-hour morning recall) and a rating of "very much" or "much" improved on the Patient Global Impression of Change scale. If responder analysis was positive, Fibromyalgia Impact Questionnaire (FIQ) was included as an additional key primary efficacy measure. RESULTS: At the end of the stable dose period (Week 16), milnacipran 200 mg/day showed significant improvements from baseline relative to placebo in the 2-measure composite responder criteria (p = 0.0003) and FIQ total score (p = 0.015). Significant improvements were also observed in multiple secondary efficacy endpoints, including Short-Form 36 Health Survey (SF-36) Physical Component Summary (p = 0.025), SF-36 Mental Component Summary (p = 0.007), Multidimensional Fatigue Inventory (p = 0.006), and Multiple Ability Self-Report Questionnaire (p = 0.041). Milnacipran was safe and well tolerated; nausea, hyperhidrosis, and headache were the most common adverse events. CONCLUSION: Milnacipran is an effective and safe treatment for pain and other predominant symptoms of FM. Registered as trial no. NCT00436033. SN - 0315-162X UR - https://www.unboundmedicine.com/medline/citation/20156949/A_European_multicenter_randomized_double_blind_placebo_controlled_monotherapy_clinical_trial_of_milnacipran_in_treatment_of_fibromyalgia_ L2 - http://www.jrheum.org/cgi/pmidlookup?view=long&pmid=20156949 DB - PRIME DP - Unbound Medicine ER -