3-year efficacy of milnacipran in patients with fibromyalgia: an open-label, flexible-dosing study

Milnacipran bei Fibromyalgie - Neueste Studienergebnisse 3-Year Efficacy of Milnacipran in Patients with Fibromyalgia: An
Open-Label, Flexible-Dosing Study
Lesley M. Arnold et al.; Abstracts of the American College of Rheumatology 2011 Background
Previous studies have demonstrated the efficacy of milnacipran in managing FM symptoms for up to 1 year. This study extends those findings by evaluating the long-term efficacy of milnacipran for a period of up to 3.25 years.
Conclusion:
The findings from this open-label study provide support for sustained long-term efficacy (in some cases exceeding 3 years of continuous treatment) of milnacipran in improving pain, global status, and physical functioning in patients with FM.
Arnold, Lesley M., Ma, Yimin, Palmer, Robert H., Spera, Allan, Baldecchi, Arlene; 3-Year Efficacy of Milnacipran in Patients with Fibromyalgia: An Open-Label, Flexible-Dosing Study. [abstract]. Arthritis Rheum 2011; 63 (Suppl 10): 1907 Milnacipran ist auch nach 3 Jahren Therapie immer noch wirksam.
Es kommt zu keinem "wearing-off" Effekt.
Milnacipran bei Fibromyalgie - Neueste Studienergebnisse Safety and Tolerability of Milnacipran in a 3-Year, Open-Label,
Flexible-Dosing Study of Patients with Fibromyalgia
Lesley M. Arnold et al.; Abstracts of the American College of Rheumatology 2011 Background
This open-label study enrolled patients from previous milnacipran trials, some of whom had been taking milnacipran for over 1 year, to assess further its long-term safety and tolerability.
Conclusion:
Milnacipran, at doses of 50 to 200 mg/day, was generally well-tolerated and safe for periods of up to 3.25 years. No new safety concerns were identified in this long-term study.
Arnold, Lesley M., Ma, Yimin, Palmer, Robert H., Spera, Allan, Baldecchi, Arlene; Safety and Tolerability of Milnacipran in a 3-Year, Open-Label, Flexible-Dosing Study of Patients with Fibromyalgia. [abstract]. Arthritis Rheum 2011; 63 (Suppl 10): 1905 Milnacipran wird auch nach 3 Jahren Therapie immer noch gut vertragen.
Milnacipran bei Fibromyalgie - Neueste Studienergebnisse A Multicenter, Randomized, Double-Blind, Placebo-Controlled
Switch Study to Evaluate the Safety, Tolerability, and Efficacy of
Milnacipran in Patients with An Inadequate Response to
Duloxetine for the Treatment of Fibromyalgia
Lucinda Bateman et al.; Abstracts of the American College of Rheumatology 2011 Background
As fibromyalgia (FM) treatments often do not have the same effectiveness in all FM patients; it is frequently necessary to switch therapies to achieve greater benefit or to avoid side effects.
This study evaluates the safety, tolerability, and efficacy of milnacipran following a direct switch from duloxetine in FM patients with inadequate response to duloxetine. Although both compounds are serotonin/norepinephrine reuptake inhibitors, their pharmacologic properties differ, which may result in different responses and adverse-effect profiles in some FM Conclusion:
These results suggest that FM patients with an inadequate response to duloxetine treatment may benefit from a switch to milnacipran for management of their symptoms. Additionally, a direct switch from duloxetine to milnacipran was safe and well tolerated in this study.
Bateman, Lucinda, Spera, Allan, Palmer, Robert H., Trugman, Joel M., Lin, Jennifer; A Multicenter, Randomized, Double-Blind, Placebo-Controlled Switch Study to Evaluate the Safety, Tolerability, and Efficacy of Milnacipran in Patients with An Inadequate Response to Duloxetine for the Treatment of Fibromyalgia. [abstract]. Arthritis Rheum 2011; 63 (Suppl Bei unzureichender Wirkung von Duloxetin ist ein Umstieg auf Milnacipran sinnvoll.
Ein direkter Wechsel (ohne Ausschleichen oder wash out-Periode) wird generell gut
vertragen.
Milnacipran bei Fibromyalgie - Neueste Studienergebnisse Milnacipran Improves Health Outcomes in Fibromyalgia Patients
Who Have Had An Inadequate Response to Duloxetine Treatment
As Measured by PROMIS Computer Adaptive Testing
Steven I. Blum et al.; Abstracts of the American College of Rheumatology 2011 Background
This study sought to evaluate whether fibromyalgia (FM) patients who failed to achieve adequate treatment response to duloxetine (DLX) for FM would show improvement in health outcomes following a direct switch to milnacipran (MLN) treatment. Outcomes were measured using four different PROMIS® computer adaptive testing (CAT) instruments.
PROMIS is a National Institutes of Health (NIH) funded initiative to develop new self- reported health measures using modern measurement tools like item response theory, item banking and CAT. PROMIS instruments can be used across a wide variety of chronic diseases/conditions and in the general population.
Conclusion:
Among patients who received an inadequate response to DLX treatment for FM, switching to MLN may improve health outcomes as measured by PROMIS CAT. Patients switched to MLN experienced improvements in each PROMIS domain (fatigue, physical function, social satisfaction, and sleep-related impairment) measured. To our knowledge, this is one of the first clinical trials to have used PROMIS CAT in assessing drug efficacy. Additional research is needed to further validate the use of PROMIS CAT and assess the clinical relevance of Blum, Steven I., Tourkodimitris, Stavros, Spera, Allan; Milnacipran Improves Health Outcomes in Fibromyalgia Patients Who Have Had An Inadequate Response to Duloxetine Treatment As Measured by PROMIS Computer Adaptive Testing. [abstract]. Arthritis Rheum Bei unzureichender Wirkung von Duloxetin ist ein direkter Umstieg auf Milnacipran
sinnvoll. Fatigue, körperliche Funktion, soziale Zufriedenheit sowie Schlafstörungen,
gemessen mit dem PROMIS® Computer Adaptive Test (CAT), werden verbessert.
Milnacipran bei Fibromyalgie - Neueste Studienergebnisse Effect of Adding Milnacipran to Pregabalin for Managing
Fibromyalgia: A Randomized, Open-Label, Controlled Study
Mildred V. Farmer et al.; Abstracts of the American College of Rheumatology 2010 Background
Medications used to manage FM often do not treat the full spectrum of symptoms that a patient with FM may experience. Patients may benefit from augmenting their current treatment regimen with medications that have complementary mechanisms of action. This randomized, open-label, controlled study evaluated the efficacy and tolerability of milnacipran 50 mg BID when added to pregabalin 150 mg BID or 225 mg BID in FM patients who had an incomplete response to pregabalin during a 4- to 12-week open-label run-in Conclusion:
This open-label study is the first randomized controlled study to demonstrate that adding milnacipran to pregabalin therapy is both tolerable and effective in improving global status and reducing pain in patients with FM experiencing an incomplete response to pregabalin Farmer, Mildred V., Trugman, Joel M., Wang, Yong, Gendreau, R. Michael; Effect of Adding Milnacipran to Pregabalin for Managing Fibromyalgia: A Randomized, Open-Label, Controlled Study. [abstract]. Arthritis Rheum 2010; 62 (Suppl 10): 648 Bei ungenügender Wirksamkeit von Pregabalin ist die Augmentierung mit Milnacipran
sowohl effektiv als auch gut verträglich.
Milnacipran bei Fibromyalgie - Neueste Studienergebnisse Effects of Milnacipran Added to Pregabalin on Cognition and
Mental Clarity in Fibromyalgia Patients
Robert S. Katz et al.; Abstracts of the American College of Rheumatology 2010 Background
Fibromyalgia (FM) is characterized by chronic widespread pain accompanied by a host of symptoms that include perceived cognitive dysfunction, which is also known as fibrofog.
Cognitive impairments associated with fibrofog include problems with attention, mental confusion, and short-term memory loss. A recent clinical trial evaluating the efficacy of milnacipran when added to pregabalin utilized the Mental Clutter Scale, a new 16-item measure of fibrofog, to assess improvements in cognitive disability in FM patients.
Conclusions:
When added to pregabalin, milnacipran resulted in significant improvements in the cognitive impairments perceived by FM patients, as measured by a new self-report tool intended to measure cognition and mental clarity.
Katz, Robert S., Palmer, Robert H., Wang, Yong, Gendreau, R. Michael; Effects of Milnacipran Added to Pregabalin on Cognition and Mental Clarity in Fibromyalgia Patients.
[abstract]. Arthritis Rheum 2010; 62 (Suppl 10): 98 Fibromyalgie führt zu kognitiven Beeinträchtigungen ("fibrofog"). Bei ungenügender
Wirkung von Pregabalin alleine kann die Augmentierung mit Milnacipran die kognitive
Leistung signifikant verbessern.
Milnacipran bei Fibromyalgie - Neueste Studienergebnisse The Effects of Milnacipran On Self-Reported Complaints of
Decreased Cognitive Functioning in Fibromyalgia Patients
Alan Manevitz et al.; The 2009 ACR/ARHP Annual Scientific Meeting Background
Fibromyalgia (FM) patients report a number of symptoms in addition to chronic widespread pain, including a heterogeneous collection of problems relating to cognitive dysfunction (commonly termed "fibrofog"). Objective measures of cognitive functioning have shown that FM patients show decrements in terms of their attention, susceptibility to distraction, as well as their working and episodic memory (eg, Glass 2008). Irrespective of documented cognitive decrements, many FM patients report experiencing problems with fibrofog. These analyses evaluate the effect of milnacipran on self-reported problems with cognition in patients with Conclusion:
Milnacipran 200 mg/day resulted in significant improvements in self-reported measures of cognitive complaints in patients with FM.
Manevitz, Alan, Palmer, Robert H., Chen, Wei, Gendreau, R. Michael; The Effects of Milnacipran On Self-Reported Complaints of Decreased Cognitive Functioning in Fibromyalgia Patients [abstract]. Arthritis Rheum 2009; 60 (Suppl 10): 1413 Milnacipran verbessert die kognitive Leistung bei "fibrofog" signifikant.
Milnacipran bei Fibromyalgie - Neueste Studienergebnisse Milnaciprans Effect On Body Weight by Baseline BMI: Results
Across 3 Randomized, Double-Blind, Placebo-Controlled
Fibromyalgia Trials
Lesley M. Arnold et al.; The 2009 ACR/ARHP Annual Scientific Meeting Background
Obesity is a common comorbid condition in FM. Weight gain in overweight or obese patient populations can exacerbate negative health effects and adversely affect patients' willingness to continue therapy. Using data from 3 randomized, double-blind, placebo (PBO)-controlled trials, this analysis evaluated the effects of milnacipran (MLN), an FDA-approved medication, on body weight in FM patients stratified by baseline body mass index (BMI).
Gewichtsveränderung
Conclusion:
Baseline BMI exceeded the threshold for obesity in each of the 3 studies. MLN treatment for 3 months resulted in weight loss across all 3 studies, with MLN-treated patients who were overweight or obese at baseline showing modest, but statistically significant amounts of weight loss compared with patients on PBO.
Arnold, Lesley M., Palmer, Robert H., Hufford, Michael R., Chen, Wei; Milnaciprans Effect On Body Weight by Baseline BMI: Results Across 3 Randomized, Double-Blind, Placebo- Controlled Fibromyalgia Trials [abstract]. Arthritis Rheum 2009; 60 (Suppl 10): 1422 Unter Milnacipran kommt es in allen Fibromyalgie-Studien zu einer signifikanten
Gewichtsreduktion im Vergleich zu Placebo.
Milnacipran bei Fibromyalgie - Neueste Studienergebnisse A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
of Milnacipran 100 Mg/Day for the Management of Fibromyalgia:
Results From a 2-Week Discontinuation Phase
Philippe A. Saxe et al.; The 2009 ACR/ARHP Annual Scientific Meeting Background
Patients completing 12 weeks of stable-dose treatment were rerandomized to a 2-week, double-blind, placebo-controlled discontinuation phase to assess durability of efficacy and possible withdrawal effects of MLN 100 mg/d Conclusion:
Patients discontinuing milnacipran experienced a loss of therapeutic effect in multiple efficacy parameters, including the proportion of 3-measure composite responders compared with patients maintained on milnacipran. Abrupt withdrawal of milnacipran did not appear to result in new safety concerns in this study.
Saxe, Philippe A., Arnold, Lesley M., Gendreau, R. Michael, Spera, Allan, Gendreau, Judy, Wang, Yong; A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Milnacipran 100 Mg/Day for the Management of Fibromyalgia: Results From a 2-Week Discontinuation Phase [abstract]. Arthritis Rheum 2009; 60 (Suppl 10): 1421 Ein plötzlicher Therapieabbruch führt zu keinen neuen Nebenwirkungen, allerdings
verschlechtern sich die Fibromyalgie-Symptome nach 2 Wochen signifikant.
Milnacipran bei Fibromyalgie - Neueste Studienergebnisse Return of Pain and Functional Impairment After Discontinuation
of Milnacipran in Patients with Fibromyalgia
Philip J. Mease et al.; Abstracts of the American College of Rheumatology 2011 Background
The objective of this analysis was to evaluate the effect of discontinuing long-term (18–54 months) milnacipran treatment on functional outcomes in FM patients.
Conclusion:
These results further support the enduring efficacy of milnacipran for improving function in patients with FM, as demonstrated by the deterioration of functional outcomes following discontinuation of long-term treatment.
Mease, Philip J., Clauw, Daniel J., Ma, Yimin, Baldecchi, Arlene, Trugman, Joel M., Palmer, Robert H.; Return of Pain and Functional Impairment After Discontinuation of Milnacipran in Patients with Fibromyalgia. [abstract]. Arthritis Rheum 2011; 63 (Suppl 10): 1904 Milnacipran bleibt auch bei Langzeitanwendung wirksam. Wird es abgesetzt,
verschlechtern sich die Fibromyalgie-Symptome in kurzer Zeit wieder.
Milnacipran bei Fibromyalgie - Neueste Studienergebnisse Continuing Efficacy of Milnacipran Demonstrated After Long-
Term Treatment of Fibromyalgia
Daniel J. Clauw et al.; Abstracts of the American College of Rheumatology 2011 Background
This study was designed to evaluate the effect of discontinuation of long-term milnacipran Conclusion:
In patients treated with milnacipran for up to 3.25 years, the loss of therapeutic response upon discontinuation of long-term treatment provides evidence of the continuing efficacy of Clauw, Daniel J., Mease, Philip J., Ma, Yimin, Baldecchi, Arlene, Palmer, Robert H., Trugman, Joel M.; Continuing Efficacy of Milnacipran Demonstrated After Long-Term Treatment of Fibromyalgia. [abstract]. Arthritis Rheum 2011; 63 (Suppl 10): 931 Milnacipran bleibt auch bei Langzeitanwendung wirksam. Wird es abgesetzt,
verschlechtern sich die Fibromyalgie-Symptome in kurzer Zeit wieder.
Milnacipran bei Fibromyalgie - Neueste Studienergebnisse Milnacipran Improves Fatigue in Fibromyalgia: Pooled Analyses
From 3 Randomized, Placebo-Controlled Clinical Trials
Mease et al.; The 2009 ACR/ARHP Annual Scientific Meeting Background
This current analysis of 3 Randomized, Placebo-Controlled Clinical Trials further evaluates the effect of milnacipran on fatigue in patients with FM.
Conclusion:
Among patients with FM, 3 months of milnacipran treatment resulted in significant improvements relative to placebo in multiple dimensions of their fatigue. Milnacipran may be effective in treating symptoms of fibromyalgia beyond pain, including fatigue.
Mease, Philip, Palmer, Robert H., Wang, Yong, Gendreau, R. Michael; Milnacipran Improves Fatigue in Fibromyalgia: Pooled Analyses From 3 Randomized, Placebo-Controlled Clinical Trials [abstract]. Arthritis Rheum 2009; 60 (Suppl 10): 1423 Milnacipran ist hochwirksam gegen Fatigue.
Milnacipran bei Fibromyalgie - Neueste Studienergebnisse Improvements in Fatigue Are Incompletely Explained by
Improvements in Pain in Fibromyalgia Patients Treated with
Milnacipran
Philip J. Mease et al.; Abstracts of the American College of Rheumatology 2011 Background
Results from several clinical trials have shown that milnacipran significantly improves pain and fatigue in patients with FM. Based on pooled data from 3 of these studies, this analysis explores the relationship between pain and fatigue, including the effects of baseline fatigue severity on pain improvements and the influence of pain improvements on fatigue improvements in milnacipran-treated patients.
Conclusion:
These results suggest that milnacipran treatment improves pain in FM patients regardless of baseline levels of fatigue, although patients with higher levels of fatigue may gain additional benefit from a higher milnacipran dose. Additionally, milnacipran had a substantial direct effect on fatigue that was not attributable to improvements in pain. Taken together, these results suggest that neither of these domains can be taken as a surrogate for the other, and that both are domains that should be assessed independently.
Mease, Philip J., Palmer, Robert H., Wang, Yong, Gendreau, R. Michael; Improvements in Fatigue Are Incompletely Explained by Improvements in Pain in Fibromyalgia Patients Treated with Milnacipran. [abstract]. Arthritis Rheum 2011; 63 (Suppl 10): 1908 Schmerz und Fatigue sind voneinander unabhängige Symptome der Fibromyalgie.
Milnacipran führt zu einer signifikanten Besserung beider Symptome.
Milnacipran bei Fibromyalgie - Neueste Studienergebnisse Milnacipran Improves Pain and Global Status Independent of
Changes in Depressive Symptoms in Patients with Fibromyalgia
Lesley M. Arnold et al.; Abstracts of the American College of Rheumatology 2010 Background
Milnacipran is effective in improving multiple symptom domains in fibromyalgia (FM), including pain, physical function, and depressive symptomatology. This post hoc analysis was conducted to elucidate the relationship between changes in pain and patient global status and changes in depressive symptomatology.
Conclusion:
In patients with FM, treatment with milnacipran 100 mg/day significantly improves multiple domains, including pain, global status, and depressive symptoms. Much of the improvement in pain and global status with milnacipran is independent of improvements in depressive Arnold, Lesley M., Gendreau, R. Michael, Gendreau, Judy, Spera, Allan, Chen, Wei; Milnacipran Improves Pain and Global Status Independent of Changes in Depressive Symptoms in Patients with Fibromyalgia. [abstract]. Arthritis Rheum 2010; 62 (Suppl 10): Milnacipran verbessert die Symptome der FM signifikant, unabhängig von einer
allfälligen Begleitdepression.
Milnacipran bei Fibromyalgie - Neueste Studienergebnisse Baseline Characteristics of Fibromyalgia Patients in 4 Clinical
Trials of Milnacipran
Robert H. Palmer et al.; The 2009 ACR/ARHP Annual Scientific Meeting Background
This analysis compares the key baseline demographic and disease characteristics of FM patients enrolled in 3 US and 1 European (EU) trials.
Conclusion:
Baseline demographic and disease characteristics of FM patients were generally similar among 4 randomized, placebo-controlled trials of milnacipran. With the exception of body weight, there were no remarkable baseline differences between the US and EU study Palmer, Robert H., Clauw, Daniel, Mainguy, Yves, Wang, Yong, Gendreau, R. Michael; Baseline Characteristics of Fibromyalgia Patients in 4 Clinical Trials of Milnacipran [abstract]. Arthritis Rheum 2009; 60 (Suppl 10): 1407 Amerikanische und europäische Fibromyalgie-Patienten sind gleich, nur der BMI ist
höher in den USA.

Source: http://www.milnacipran.at/fibromyalgie.pdf