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Efficacy of milnacipran in patients with fibromyalgia.
J Rheumatol 2005; 32(10):1975-85JR

Abstract

OBJECTIVE

Fibromyalgia (FM) is a common musculoskeletal condition characterized by widespread pain, tenderness, and a variety of other somatic symptoms. Current treatments are modestly effective. Arguably, the best studied and most effective compounds are tricyclic antidepressants (TCA). Milnacipran, a nontricyclic compound that inhibits the reuptake of both serotonin and norepinephrine, may provide many of the beneficial effects of TCA with a superior side effect profile.

METHODS

One hundred twenty-five patients with FM were randomly assigned in a 3:3:2 ratio to receive milnacipran twice daily, milnacipran once daily, or placebo for 3 months in a double-blind dose-escalation trial; 92% of twice-daily and 81% of once-daily participants achieved dose escalation to the target milnacipran dose of 200 mg.

RESULTS

The primary endpoint was reduction of pain. Both the once- and twice-daily groups showed statistically significant improvements in pain, as well as improvements in global well being, fatigue, and other domains. Response rates for patients receiving milnacipran were equal in patients with and without comorbid depression, but placebo response rates were considerably higher in depressed patients, leading to significantly greater overall efficacy in the nondepressed group.

CONCLUSION

In this Phase II study, milnacipran led to statistically significant improvements in pain and other symptoms of FM. The effect sizes were equal to those previously found with TCA, and the drug was generally well tolerated.

Authors+Show Affiliations

Cypress Biosciences, 4350 Executive Drive, San Diego, CA 92121, USA. mgendreau1@cypressbio.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

16206355

Citation

Gendreau, R Michael, et al. "Efficacy of Milnacipran in Patients With Fibromyalgia." The Journal of Rheumatology, vol. 32, no. 10, 2005, pp. 1975-85.
Gendreau RM, Thorn MD, Gendreau JF, et al. Efficacy of milnacipran in patients with fibromyalgia. J Rheumatol. 2005;32(10):1975-85.
Gendreau, R. M., Thorn, M. D., Gendreau, J. F., Kranzler, J. D., Ribeiro, S., Gracely, R. H., ... Clauw, D. J. (2005). Efficacy of milnacipran in patients with fibromyalgia. The Journal of Rheumatology, 32(10), pp. 1975-85.
Gendreau RM, et al. Efficacy of Milnacipran in Patients With Fibromyalgia. J Rheumatol. 2005;32(10):1975-85. PubMed PMID: 16206355.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy of milnacipran in patients with fibromyalgia. AU - Gendreau,R Michael, AU - Thorn,Michael D, AU - Gendreau,Judy F, AU - Kranzler,Jay D, AU - Ribeiro,Saulo, AU - Gracely,Richard H, AU - Williams,David A, AU - Mease,Philip J, AU - McLean,Samuel A, AU - Clauw,Daniel J, PY - 2005/10/6/pubmed PY - 2005/12/15/medline PY - 2005/10/6/entrez SP - 1975 EP - 85 JF - The Journal of rheumatology JO - J. Rheumatol. VL - 32 IS - 10 N2 - OBJECTIVE: Fibromyalgia (FM) is a common musculoskeletal condition characterized by widespread pain, tenderness, and a variety of other somatic symptoms. Current treatments are modestly effective. Arguably, the best studied and most effective compounds are tricyclic antidepressants (TCA). Milnacipran, a nontricyclic compound that inhibits the reuptake of both serotonin and norepinephrine, may provide many of the beneficial effects of TCA with a superior side effect profile. METHODS: One hundred twenty-five patients with FM were randomly assigned in a 3:3:2 ratio to receive milnacipran twice daily, milnacipran once daily, or placebo for 3 months in a double-blind dose-escalation trial; 92% of twice-daily and 81% of once-daily participants achieved dose escalation to the target milnacipran dose of 200 mg. RESULTS: The primary endpoint was reduction of pain. Both the once- and twice-daily groups showed statistically significant improvements in pain, as well as improvements in global well being, fatigue, and other domains. Response rates for patients receiving milnacipran were equal in patients with and without comorbid depression, but placebo response rates were considerably higher in depressed patients, leading to significantly greater overall efficacy in the nondepressed group. CONCLUSION: In this Phase II study, milnacipran led to statistically significant improvements in pain and other symptoms of FM. The effect sizes were equal to those previously found with TCA, and the drug was generally well tolerated. SN - 0315-162X UR - https://www.unboundmedicine.com/medline/citation/16206355/Efficacy_of_milnacipran_in_patients_with_fibromyalgia_ L2 - http://www.jrheum.org/cgi/pmidlookup?view=long&pmid=16206355 DB - PRIME DP - Unbound Medicine ER -