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Milnacipran effective for Fibromyalgia independent of depression
Sunday 5 December 2010
Milnacipran Effective for Fibromyalgia Independent of Depression
November 22, 2010 (Atlanta, Georgia) — Milnacipran improves pain and global status independent of changes in depressive symptoms, and reduces the overall severity of symptoms in patients with fibromyalgia (FM), according to analyses from a double-blind randomized placebo-controlled trial.
The first study to demonstrate this was performed by Lesley M. Arnold, MD, from the University of Cincinnati in Ohio, and colleagues. They presented their findings here at the American College of Rheumatology 2010 Annual Meeting.
Milnacipran is a dual serotonin- and norepinephrine-reuptake inhibitor that was approved for the treatment of FM in January 2009. Dr. Arnold and colleagues sought to determine whether the effect of milnacipran on FM symptoms is dependent on improving depressive symptoms in patients who are not currently experiencing major depressive episodes.
Patients in the phase 3 trial were randomized to receive either milnacipran 100 mg/day (n = 516) or placebo (n = 509) for 12 weeks.
Outcome measures, evaluated after the 12-week treatment period, included pain response (>30% improvement from baseline in pain visual analog scale [VAS] scores), global status (Patient Global Impression of Change [PGIC] responder analysis of "very much improved" or "much improved"), and a composite responder analysis of both pain and PGIC improvement. Changes in depressive symptoms were assessed with the Beck Depression Inventory (BDI).
Milnacipran treatment significantly decreased BDI scores relative to placebo (–2.12 vs –1.24; P = .008). Additionally, in patients with no improvement or a worsening of BDI scores, milnacipran treatment resulted in significantly higher responder rates than placebo on pain, PGIC, and 2-measure composite responder analyses (P < .05 for all measures).
Of the milnacipran effect, Dr. Arnold's team determined that 87.2% of the response (90% confidence interval, 76.3 to 95.2) was independent of improvements in depressive symptomatology.
A second analysis of the same phase 3 trial was conducted by Robert H. Palmer, MD, from the Forest Research Institute in Jersey City, New Jersey, and colleagues. A post hoc analysis of the trial found that milnacipran was effective for the treatment of FM, as determined by patients' responses on the Fibromyalgia Impact Questionnaire (FIQ), a measure of FM-related symptoms.
The majority of patients in the study exhibited moderate (FIQ score, 39 to 59; 48.5% of patients) or severe (FIQ score >59; 43.4% of patients) symptoms.
At each study visit, the patients treated with milnacipran had significantly higher decreases in FIQ scores relative to placebo (P = .001). Of patients with moderate or severe FM at baseline, 52.2% of milnacipran patients improved by at least 1 category, compared with 42.0% of patients receiving placebo (odds ratio, 1.5; P = .002).
A third study, conducted by Mildred Farmer, MD, and colleagues from Meridien Research in St. Petersburg, Florida, showed that milnacipran benefited incomplete responders when added to pregabalin. Patients with FM with an incomplete response to pregabalin after a 4- to 12-week run-in phase (n = 184) were randomized to pregabalin alone or to milnacipran plus pregabalin for 11 weeks.
After 11 weeks, milnacipran plus pregabalin resulted in a significantly higher percentage of PGIC responders than pregabalin alone (46.4% vs 20.8%; P < .001). Adding milnacipran to pregabalin also resulted in a greater reduction in VAS pain score (–20.8 vs –6.4; P < .001). However, the incidence of nausea was increased with the addition of milnacipran.
"Milnacipran needs to be titrated carefully for patients to avoid nausea," Dr. Palmer told Medscape Medical News. "Many people will get nausea early on, and they can get discouraged before the drug has had the time to work. But if one slows the titration down, they seem to get less nausea, [are] able to tolerate it, the beneficial effect of the drug kicks in, and then patients are satisfied," he said.
The study were funded by Forest Laboratories. Dr. Arnold reports receiving consulting fees from multiple commercial sources, including Forest Laboratories. Dr. Palmer is employed by Forest Laboratories. Dr. Farmer reports receiving consulting fees from Forest Laboratories.
ACR 2010 Annual Meeting: Abstracts 648, 805, and 806. Presented November 8 and 9, 2010.
The above originally appeared here.
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