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Longterm therapeutic response to milnacipran treatment for fibromyalgia. A European 1-year extension study following a 3-month study.
J Rheumatol. 2011 Jul; 38(7):1403-12.JR

Abstract

OBJECTIVE

This double-blind, 1-year extension study investigated the longterm efficacy and safety of milnacipran 100, 150, and 200 mg/day in the treatment of fibromyalgia (FM) in completers of a 3-month European double-blind lead-in study of milnacipran 200 mg/day versus placebo.

METHODS

A total of 468 patients with FM successfully completing the lead-in study were either blindly maintained on milnacipran 200 mg/day (MLN200:MLN200, n = 198) or (if previously receiving placebo) rerandomized to milnacipran 100 mg/day (PBO:MLN100, n = 91), 150 mg/day (PBO:MLN150, n = 92), or 200 mg/day (PBO:MLN200, n = 87) for an additional 12 months (including a 4-week dose escalation). The main efficacy endpoint was a 2-measure composite responder rate (relative to lead-in study baseline) incorporating the weekly-recall pain score recorded on a visual analog scale and the Patient Global Impression of Change score. A panel of other assessments including the Fibromyalgia Impact Questionnaire explored the multidimensional aspects of FM. Descriptive analyses using the last observation carried forward approach were performed.

RESULTS

At the 1-year endpoint, the proportion of composite responders (relative to the lead-in study baseline) ranged from 27.5% (PBO:MLN100) to 35.9% (MLN200:MLN200), and had increased from the extension study baseline by 15.2% (PBO:MLN150) to 20.7% (PBO:MLN200 and MLN200:MLN200). At endpoint, an improvement from both baselines was shown in all groups on pain, fatigue, sleep, and quality of life measures. Up to 1 year, all doses of milnacipran were safe and well tolerated. The most common drug-related adverse events were hyperhidrosis and nausea.

CONCLUSION

Over 1 year, milnacipran 100, 150, and 200 mg/day exhibited sustained and safe therapeutic effects on predominant symptoms of FM. Registered as trial no. NCT00757731.

Authors+Show Affiliations

Faculdade Ciências Médicas, Universidade Nova de Lisboa, Serviço de Reumatologia, CHLO, EPE-Hospital Egas Moniz, Lisboa, PortugalNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

21459941

Citation

Branco, Jaime C., et al. "Longterm Therapeutic Response to Milnacipran Treatment for Fibromyalgia. a European 1-year Extension Study Following a 3-month Study." The Journal of Rheumatology, vol. 38, no. 7, 2011, pp. 1403-12.
Branco JC, Cherin P, Montagne A, et al. Longterm therapeutic response to milnacipran treatment for fibromyalgia. A European 1-year extension study following a 3-month study. J Rheumatol. 2011;38(7):1403-12.
Branco, J. C., Cherin, P., Montagne, A., & Bouroubi, A. (2011). Longterm therapeutic response to milnacipran treatment for fibromyalgia. A European 1-year extension study following a 3-month study. The Journal of Rheumatology, 38(7), 1403-12. https://doi.org/10.3899/jrheum.101025
Branco JC, et al. Longterm Therapeutic Response to Milnacipran Treatment for Fibromyalgia. a European 1-year Extension Study Following a 3-month Study. J Rheumatol. 2011;38(7):1403-12. PubMed PMID: 21459941.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Longterm therapeutic response to milnacipran treatment for fibromyalgia. A European 1-year extension study following a 3-month study. AU - Branco,Jaime C, AU - Cherin,Patrick, AU - Montagne,Agnes, AU - Bouroubi,Athmane, AU - ,, Y1 - 2011/04/01/ PY - 2011/4/5/entrez PY - 2011/4/5/pubmed PY - 2012/1/21/medline SP - 1403 EP - 12 JF - The Journal of rheumatology JO - J. Rheumatol. VL - 38 IS - 7 N2 - OBJECTIVE: This double-blind, 1-year extension study investigated the longterm efficacy and safety of milnacipran 100, 150, and 200 mg/day in the treatment of fibromyalgia (FM) in completers of a 3-month European double-blind lead-in study of milnacipran 200 mg/day versus placebo. METHODS: A total of 468 patients with FM successfully completing the lead-in study were either blindly maintained on milnacipran 200 mg/day (MLN200:MLN200, n = 198) or (if previously receiving placebo) rerandomized to milnacipran 100 mg/day (PBO:MLN100, n = 91), 150 mg/day (PBO:MLN150, n = 92), or 200 mg/day (PBO:MLN200, n = 87) for an additional 12 months (including a 4-week dose escalation). The main efficacy endpoint was a 2-measure composite responder rate (relative to lead-in study baseline) incorporating the weekly-recall pain score recorded on a visual analog scale and the Patient Global Impression of Change score. A panel of other assessments including the Fibromyalgia Impact Questionnaire explored the multidimensional aspects of FM. Descriptive analyses using the last observation carried forward approach were performed. RESULTS: At the 1-year endpoint, the proportion of composite responders (relative to the lead-in study baseline) ranged from 27.5% (PBO:MLN100) to 35.9% (MLN200:MLN200), and had increased from the extension study baseline by 15.2% (PBO:MLN150) to 20.7% (PBO:MLN200 and MLN200:MLN200). At endpoint, an improvement from both baselines was shown in all groups on pain, fatigue, sleep, and quality of life measures. Up to 1 year, all doses of milnacipran were safe and well tolerated. The most common drug-related adverse events were hyperhidrosis and nausea. CONCLUSION: Over 1 year, milnacipran 100, 150, and 200 mg/day exhibited sustained and safe therapeutic effects on predominant symptoms of FM. Registered as trial no. NCT00757731. SN - 0315-162X UR - https://www.unboundmedicine.com/medline/citation/21459941/Longterm_therapeutic_response_to_milnacipran_treatment_for_fibromyalgia__A_European_1_year_extension_study_following_a_3_month_study_ L2 - http://www.jrheum.org/cgi/pmidlookup?view=long&pmid=21459941 DB - PRIME DP - Unbound Medicine ER -