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European multicenter randomized double-blind placebo-control mono-therapy clinical trial of [Savella] milnacipran in the treatment of fibromyalgia – Source: Journal of Rheumatology, Feb 15, 2010

  [ 16 votes ]   [ 2 Comments ]
By Jaime C Branco, Yves Mainguy, et al. • www.ProHealth.com • February 20, 2010


Objective: This randomized, double-blind, placebo-controlled, multicenter study investigated the efficacy and safety of milnacipran [brand name Savella] in the treatment of fibromyalgia (FM) in a European population.

Methods: Outpatients diagnosed with FM according to 1990 American College of Rheumatology criteria (N = 884) were randomized to placebo (n = 449) or milnacipran 200 mg/day (n = 435) for 17 weeks (4-week dose escalation, 12-week stable dose, 9-day down-titration), followed by a 2-week posttreatment period.

The primary efficacy criterion was a 2-measure composite responder analysis requiring patients to achieve simultaneous improvements in pain (>/= 30% improvement from baseline in visual analog scale, 24-hour morning recall) and a rating of "very much" or "much" improved on the Patient Global Impression of Change scale.

If responder analysis was positive, Fibromyalgia Impact Questionnaire (FIQ) was included as an additional key primary efficacy measure.

Results:

• At the end of the stable dose period (Week 16), milnacipran 200 mg/day showed significant improvements from baseline relative to placebo in the 2-measure composite responder criteria (p = 0.0003) and FIQ total score (p = 0.015).

• Significant improvements were also observed in multiple secondary efficacy endpoints, including Short-Form 36 Health Survey (SF-36) Physical Component Summary (p = 0.025), SF-36 Mental Component Summary (p = 0.007), Multidimensional Fatigue Inventory (p = 0.006), and Multiple Ability Self-Report Questionnaire (p = 0.041).

• Milnacipran was safe and well tolerated; nausea, hyperhidrosis [excessive sweating], and headache were the most common adverse events.

Conclusion: . Milnacipran is an effective and safe treatment for pain and other predominant symptoms of FM

Registered as trial no. NCT00436033.

Source: Journal of Rheumatology, Feb 15, 2010. PMID: 20156949, by Branco JC, Zachrisson O, Perrot S, Mainguy Y.  Faculdade Ciencias Medicas, Universidade Nova de Lisboa, Servico de Reumatologia, CHLO, EPE-Hospital Egas Moniz, Lisboa, Portugal; Gottfries Clinic AB, Molndal, Sweden; Service de Medecine Interne, Hotel Dieu Hospital, Paris Descartes University, Paris; Pierre Fabre Médicament, Boulogne, France. [Email: yves.mainguy@pierre-fabre.com]





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Article Comments Post a Comment

SAVELLA
Posted by: toots2
Feb 24, 2010
The side effect of excessive sweating that comes with taking Savella is something I can no unfortunately no longer tolerate which is sad because Savella taken as directed works so well on the pain. I have not had to completely give up the Savella but have cut my dosage in half which means it does not take care of the pain as well but well enough I believe to still help. I wish somethinig could be done about the sweating as it seems to affect so many of us that take Savella and because taken at full strength it works better than any narcotic pain medication I have ever taken. Just my thoughts on this wonderful new medication. Suzanne
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Savella
Posted by: cpacos
Feb 25, 2010
This medicine has been such a blessing! It controlls the pain pretty good, but the energy that I am experiencing now is so wonderful! I can finally keep up with life, no more afternoon naps! I can have a full time job, and come home and cook dinner! This has been so wonderful!I have been on it for almost 10 months.
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