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Durability of therapeutic response to milnacipran treatment for fibromyalgia. Results of a randomized, double-blind, monotherapy 6-month extension study.
Pain Med 2010; 11(2):180-94PM

Abstract

OBJECTIVE

To evaluate the durability of improvement and long-term efficacy of milnacipran treatment in fibromyalgia, to assess efficacy in patients re-randomized from placebo to milnacipran, and to collect additional information on the tolerability and efficacy of long-term treatment with milnacipran.

DESIGN

A total of 449 patients who successfully completed a 6-month lead-in study enrolled in this 6-month extension study (87.7% of eligible subjects). Patients initially receiving milnacipran 200 mg/day during the lead-in study were maintained at 200 mg/day (n = 209); patients initially assigned to placebo or milnacipran 100 mg/day were re-randomized (1:4) to either 100 mg/day (n = 48) or 200 mg/day (n = 192) of milnacipran for an additional 6 months of treatment. Efficacy assessments included visual analog scale pain ratings, Fibromyalgia Impact Questionnaire (FIQ) total score, and Patient Global Impression of Change (PGIC).

RESULTS

Patients continuing on milnacipran demonstrated a sustained reduction in pain over the full 12-month period. Additional beneficial effects were also maintained, as indicated by the PGIC and FIQ. Patients initially assigned to either placebo or milnacipran 100 mg/day in the lead-in study and subsequently re-randomized to milnacipran 200 mg/day in the extension study experienced further improvements in their mean pain scores, FIQ total scores, and PGIC ratings at 1 year. Milnacipran treatment was generally well tolerated. The most commonly reported newly emergent adverse event was nausea.

CONCLUSIONS

In addition to confirming that milnacipran safely and effectively improves the multiple symptoms of fibromyalgia, these data indicate that milnacipran provides 1-year durable efficacy in this patient population.

Authors+Show Affiliations

Department of Medicine, Newton-Wellesley Hospital, Newton, Massachusetts 02462, USA. dgoldenb@massmed.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

20002596

Citation

Goldenberg, Don L., et al. "Durability of Therapeutic Response to Milnacipran Treatment for Fibromyalgia. Results of a Randomized, Double-blind, Monotherapy 6-month Extension Study." Pain Medicine (Malden, Mass.), vol. 11, no. 2, 2010, pp. 180-94.
Goldenberg DL, Clauw DJ, Palmer RH, et al. Durability of therapeutic response to milnacipran treatment for fibromyalgia. Results of a randomized, double-blind, monotherapy 6-month extension study. Pain Med. 2010;11(2):180-94.
Goldenberg, D. L., Clauw, D. J., Palmer, R. H., Mease, P., Chen, W., & Gendreau, R. M. (2010). Durability of therapeutic response to milnacipran treatment for fibromyalgia. Results of a randomized, double-blind, monotherapy 6-month extension study. Pain Medicine (Malden, Mass.), 11(2), pp. 180-94. doi:10.1111/j.1526-4637.2009.00755.x.
Goldenberg DL, et al. Durability of Therapeutic Response to Milnacipran Treatment for Fibromyalgia. Results of a Randomized, Double-blind, Monotherapy 6-month Extension Study. Pain Med. 2010;11(2):180-94. PubMed PMID: 20002596.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Durability of therapeutic response to milnacipran treatment for fibromyalgia. Results of a randomized, double-blind, monotherapy 6-month extension study. AU - Goldenberg,Don L, AU - Clauw,Daniel J, AU - Palmer,Robert H, AU - Mease,Philip, AU - Chen,Wei, AU - Gendreau,R Michael, Y1 - 2009/12/09/ PY - 2009/12/17/entrez PY - 2009/12/17/pubmed PY - 2010/8/13/medline SP - 180 EP - 94 JF - Pain medicine (Malden, Mass.) JO - Pain Med VL - 11 IS - 2 N2 - OBJECTIVE: To evaluate the durability of improvement and long-term efficacy of milnacipran treatment in fibromyalgia, to assess efficacy in patients re-randomized from placebo to milnacipran, and to collect additional information on the tolerability and efficacy of long-term treatment with milnacipran. DESIGN: A total of 449 patients who successfully completed a 6-month lead-in study enrolled in this 6-month extension study (87.7% of eligible subjects). Patients initially receiving milnacipran 200 mg/day during the lead-in study were maintained at 200 mg/day (n = 209); patients initially assigned to placebo or milnacipran 100 mg/day were re-randomized (1:4) to either 100 mg/day (n = 48) or 200 mg/day (n = 192) of milnacipran for an additional 6 months of treatment. Efficacy assessments included visual analog scale pain ratings, Fibromyalgia Impact Questionnaire (FIQ) total score, and Patient Global Impression of Change (PGIC). RESULTS: Patients continuing on milnacipran demonstrated a sustained reduction in pain over the full 12-month period. Additional beneficial effects were also maintained, as indicated by the PGIC and FIQ. Patients initially assigned to either placebo or milnacipran 100 mg/day in the lead-in study and subsequently re-randomized to milnacipran 200 mg/day in the extension study experienced further improvements in their mean pain scores, FIQ total scores, and PGIC ratings at 1 year. Milnacipran treatment was generally well tolerated. The most commonly reported newly emergent adverse event was nausea. CONCLUSIONS: In addition to confirming that milnacipran safely and effectively improves the multiple symptoms of fibromyalgia, these data indicate that milnacipran provides 1-year durable efficacy in this patient population. SN - 1526-4637 UR - https://www.unboundmedicine.com/medline/citation/20002596/Durability_of_therapeutic_response_to_milnacipran_treatment_for_fibromyalgia__Results_of_a_randomized_double_blind_monotherapy_6_month_extension_study_ L2 - https://academic.oup.com/painmedicine/article-lookup/doi/10.1111/j.1526-4637.2009.00755.x DB - PRIME DP - Unbound Medicine ER -