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Milnacipran and Fibromyalgia
Tuesday 3 November 2009
ACR: Drug Delivers Two-Fisted Punch to Fibromyalgia
By John Gever, Senior Editor, MedPage Today
PHILADELPHIA -- Milnacipran (Savella) improved pain and mental functioning in patients suffering from fibromyalgia, researchers said here.
"Significant improvements in pain were seen by the second week of the dose escalation period and were sustained throughout the three-month treatment period," said Lesley M. Arnold, MD, a psychiatrist at the University of Cincinnati College of Medicine.
"An important benefit of milnacipran therapy may be the demonstrated ability to improve mental functioning in addition to pain," she told attendees at the American College of Rheumatology meeting.
Arnold said patients with fibromyalgia suffer a "constellation of symptoms that affect all parts of the body." The symptoms often interfere with sleep, and in turn cause difficulty concentrating.
Milnacipran is a selective, dual serotonin-norepinephrine reuptake inhibitor that was approved by the FDA earlier this year for the management of fibromyalgia.
Arnold reported that 27.7% of patients on milnacipran experienced at least a 50% decrease in 24-hour recall pain scores from baseline to endpoint compared with 18.1% of patients taking placebo (P<0.001).
In addition, after three months of therapy, a greater proportion of patients treated with milnacipran experienced at least a 30% reduction in pain from baseline and also rated themselves as "very much improved" or "much improved" based on the patient global assessment.
"Some patients who rated themselves as globally "much" or "very much" improved experienced a decrease in pain as early as week one of treatment with a stable dose of milnacipran that persisted throughout the study," Arnold told MedPageToday.
Patients also showed significant improvements with the drug relative to placebo on the Mental Component Summary of the Short Form-36 (SF-36) assessment and the Fibromyalgia Impact Questionnaire (FIQ), which evaluates patients' overall ability to function.
Whereas placebo patients had a 0.5-point decrease in SF-36 mental scores from baseline, those on milnacipran had an increase of 1.54 points (P<0.001).
There was also a 5-point improvement in FIQ scores with milnacipran relative to placebo (P<0.001), Arnold reported.
She said the results are consistent with previous trials that have demonstrated the safety and efficacy of milnacipran at doses of 100 mg/day and 200 mg/day.
This phase III, double-blind, placebo-controlled trial of 1,025 fibromyalgia patients was designed to further evaluate the efficacy and tolerability of milnacipran 100 mg/day.
Arnold and her colleagues randomly assigned 516 patients to milnacipran 100 mg/day. Another 509 patients were assigned placebo. The patients underwent four to six weeks of flexible dose escalation, followed by 12 weeks of stable-dose treatment followed by a two-week randomized, double-blind discontinuation phase.
"Fibromyalgia is a huge problem for a great many people," said Daniel Lewis, MD, of the Deakin University Integrative Health Research Unit in Melbourne, Australia. "This study shows that milnacipran appears to be helpful in reducing pain, but its impact in other areas is worth noting."
Lewis said the sleep disturbances and mental confusion are major problems for patients with fibromyalgia.
Arnold reported that the most common adverse event in both treatment groups was nausea, which, like other adverse events, tended to be mild to moderate in severity, with approximately 70% of the incidences in both groups resolved within three weeks after onset.
Discontinuations due to adverse events were 13.9% in the placebo group and 17.8% in the milnacipran group. About eight serious adverse events were experienced by milnacipran patients, six occurred among placebo patients.
"For most patients, milnacipran was well tolerated during the three-month treatment period," Arnold said.
The trial was funded by Forest Laboratories and its licensor, Cypress Bioscience.
Arnold disclosed financial relationships with Eli Lilly and Company, Pfizer, Cypress Biosciences, Wyeth Pharmaceuticals, sanofi-aventis, Boehringer Ingelheim, Allergan, Forest, Sepracor, Vivus, Organon, Takeda, UCB and Theravance.
Lewis had no financial disclosures.
Primary source: American College of Rheumatology
The article originally appeared here.
The results of the study were also reported on Doctor's Guide:
The abstract of the study can be found on the AACR/ARHP Annual Scientific Meeting website:
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