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Milnacipran Has Long-Term Benefits for Patients With Fibromyalgia: Presented at ACR/ARHP

By Liz Meszaros

PHILADELPHIA -- October 25, 2009 -- Milnacipran improves pain as well as the multidimensional symptoms of fibromyalgia, particularly when dosed at 200 mg/day, according to data presented here October 20 at the 2009 Annual Scientific Meeting of the American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP).

Jaime C. Branco, MD, Rheumatology Unit, Hospital Egas Moniz, Lisbon, Portugal, and colleagues conducted a dose-blinded, 1-year extension study of milnacipran in 468 patients with fibromyalgia who had completed a 3-month, European, lead-in, phase 3 study of milnacipran 200 mg/day versus placebo.

For an additional 12 months, 198 patients from the lead-in study were kept on the previous dosage of milnacipran 200 mg/day, while those patients who received placebo during the lead-in study were randomised to milnacipran 100 mg/day (n = 91), 150 mg/day (n = 92), or 200 mg/day (n = 87). This time frame included a 4-week dose-escalation period.

Efficacy endpoint of the study was a 2-measure composite responder rate that required a 30% or greater reduction in weekly-recall pain score on a paper 100-mm visual analogue scale (VAS) and a "much" or "very much" improved scoring of Patient Global Impression of Change.

Endpoint composite responder rates were 27.5% in the 100-mg milnacipran group, 31.5% in the 150-mg group, and 32.2% in the 200-mg group; and in the group maintained on milnacipran 200 mg/day, 35.9%.

The greatest increase in composite responder rate from baseline occurred in the groups receiving milnacipran 200 mg/day, regardless of their lead-in study treatment.

Durability of composite response was also highest in this group, at 44.1% in the group maintained on the 200-mg dose, and 45.2% in the group re-randomised to this dose, compared with 39% (150-mg group) and 35.3% (100-mg group).

All groups showed improvements from baseline in all measures of pain, physical quality of life, fatigue, and sleep measures. Greater improvements were seen in the 150- and 200-mg groups in mean changes from lead-in study baseline in weekly-recall pain VAS scores (-26.5 to -27.9 mm compared with -20.9 mm in the 100-mg group), and in all fatigue and sleep scores.

All doses of milnacipran were well tolerated, with the most common adverse events being hyperhidrosis (22%) and nausea (20%).

[Presentation title: Long-Term Therapeutic Response to Milnacipran Treatment for Fibromyalgia. A European 1-Year Extension Study Following a 3-Month Study. Abstract 1414]

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