(170) Milnacipran is safe and well tolerated in the treatment of fibromyalgia syndrome

Gendreau, J.; Palmer, R.; Thacker, Kimberley

doi:10.1016/j.jpain.2008.01.090

Cited by 5 publications

(14 citation statements)

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“…Milnacipran is particularly recommended for the management of fibromyalgia [ 16 ] but only 40% of patients are relieved (30% less pain) [ 18 ]. Adding to this high variability in the response to milnacipran, discontinuation of treatment is also due to adverse events in 25% of patients compared with 12% in those receiving placebo [ 25 ]. Considering that many patients have no improvement of pain symptoms, it is therefore important to explore the status of the pain modulatory system and evaluate whether DNICs could be a predictive factor of the efficacy of milnacipran in patients with fibromyalgia.…”

Section: Discussionmentioning

confidence: 99%

Fibromyalgia, milnacipran and experimental pain modulation: study protocol for a double blind randomized controlled trial

Macian

Pereira²,

Shinjo

et al. 2015

Trials

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BackgroundThe prevalence of fibromyalgia increases worldwide and is characterized by widespread and chronic pain. Treatment is difficult and includes both drug and non-drug approaches. Milnacipran, an antidepressant, is used for fibromyalgia, with a possible beneficial effect on central pain modulation. Our hypothesis is that the efficacy of milnacipran in fibromyalgia depends on the performance of pain inhibitory controls.Methods/designA randomized, double blind, clinical trial (NCT01747044) with two parallel groups, in 48 women with fibromyalgia, is planned in the Clinical Pharmacology Center, University Hospital, Clermont-Ferrand, France. Conditioned pain modulation (estimated with thermal stimuli using a numeric pain rating scale), the primary endpoint measure, is evaluated before and one month after treatment with milnacipran or placebo. Secondary outcome measures include the predictability of pain descending pathways performance for milnacipran efficacy, tolerance and cognitive function. Data analysis is performed using mixed models; the tests are two-sided, with a type I error set at alpha = 0.05. Not only will this trial allow estimation of the beneficial effect of milnacipran on pain and on descending pain pathways but it will also evaluate whether the performance of this modulatory system could be predictive of its efficacy in alleviating pain.DiscussionThis method would allow clinicians to take a pro-active attitude by performing a rapid psychophysical test before starting milnacipran treatment and would avoid unnecessary prescription while preventing therapeutic failure in patients who often face this recurrent problem.Trial registrationClinicalTrials.gov NCT01747044.

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Section: Discussionmentioning

confidence: 99%

Fibromyalgia, milnacipran and experimental pain modulation: study protocol for a double blind randomized controlled trial

Macian

Pereira²,

Shinjo

et al. 2015

Trials

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“…71 Nausea and palpitations were the only AEs resulting in discontinuation in 2% of milnacipran patients and at an incidence greater than placebo. Treatment-emergent AEs (TEAEs) in the milnacipran trials were generally mild to moderate in severity, with nausea being the most common TEAE in all treatment groups.…”

Section: Safety and Tolerabilitymentioning

confidence: 98%

“…The placebo-corrected rates of nausea for milnacipran 100 mg/day and 200 mg/day were 14.9% and 19.7%, respectively. 71 Nausea typically occurred early in treatment and was generally manageable by recommending that medication be taken with food, incorporating gradual dose escalation, and providing patient counseling. While the clinical trials were designed to have relatively inflexible dose escalation phases lasting 2 weeks, recent anecdotal reports from commercial usage suggest that a slower, more flexible approach to dose increases may be beneficial.…”

Section: Safety and Tolerabilitymentioning

confidence: 99%

“…71 TEAEs that occurred in 5% of all milnacipran-treated patients at an incidence at least twice that of placebo were constipation, hot flush, hyperhidrosis (sweating), palpitations, vomiting, increased heart rate, dry mouth, and hypertension. Most of the aforementioned TEAEs would appear to be directly related to the effect of increased norepinephrine levels in the periphery.…”

Section: Safety and Tolerabilitymentioning

confidence: 99%

“…71 Potentially clinically significant increases in supine diastolic blood pressure (110 mmHg with an increase of 15 mmHg) occurred in 0.9% of patients receiving milnacipran, compared with 0.3% of patients receiving placebo. Potentially clinically significant increases in supine pulse rate (120 bpm with an increase of 20 bpm) occurred in 0.7% and 0% of patients receiving milnacipran and placebo, respectively (pooled data on file).…”

mentioning

confidence: 98%

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Role and rationale for the use of milnacipran in the management of fibromyalgia

Kranzler¹,

Gendreau

2010

NDT

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Fibromyalgia (FM) is a complex syndrome characterized by chronic widespread musculoskeletal pain which is often accompanied by multiple other symptoms, including fatigue, sleep disturbances, decreased physical functioning, and dyscognition. Due to these multiple symptoms, as well as high rates of comorbidity with other related disorders, patients with FM often report a reduced quality of life. Although the pathophysiology of FM is not completely understood, patients with FM experience pain differently from the general population, most likely due to dysfunctional pain processing in the central nervous system leading to both hyperalgesia and allodynia. In many patients with FM, this aberrant pain processing, or central sensitization, appears to involve decreased pain inhibition within the spinal tract, which is mediated by descending pathways that utilize serotonin, norepinephrine, and other neurotransmitters. The reduced serotonin and norepinephrine levels observed in patients with FM suggest that medications which increase the levels of these neurotransmitters, such as serotonin and norepinephrine reuptake inhibitors (SNRIs), may have clinically beneficial effects in FM and other chronic pain conditions. Milnacipran is an SNRI that has been approved for the management of FM. In clinical trials, treatment with milnacipran for up to 1 year has been found to improve the pain and other symptoms of FM. Because FM is characterized by multiple symptoms that all contribute to the decreased quality of life and ability to function, the milnacipran pivotal trials implemented responder analyses. These utilized a single composite endpoint to identify the proportion of patients who reported simultaneous and clinically significant improvements in pain, global disease status, and physical function. Other domains assessed during the milnacipran trials include fatigue, multidimensional functioning, mood, sleep quality, and patient-reported dyscognition. This review article provides information intended to help clinicians make informed decisions about the use of milnacipran in the clinical management of patients with FM. It draws primarily on results from 2 of the pivotal clinical trials that formed the basis of approval of milnacipran in the United States by the Food and Drug Administration.

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Milnacipran: a selective serotonin and norepinephrine dual reuptake inhibitor for the management of fibromyalgia

Palmer¹,

Periclou²,

Banerjee³

2010

Therapeutic Advances in Musculoskeletal

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Milnacipran, a serotonin and norepinephrfrine reuptake inhibitor with preferential inhibition of norepinephrine reuptake over serotonin, is approved in the United States for the management of fibromyalgia. Owing to its effects on norepinephrine and serotonin, as well as its lack of activity at other receptor systems, it was hypothesized that milnacipran would provide improvements in pain and other fibromyalgia symptoms without some of the unpleasant side effects associated with other medications historically used for treating fibromyalgia. The clinical safety and efficacy of milnacipran 100 and 200 mg/day in individuals with fibromyalgia has been investigated in four large, randomized, double-blind, placebo-controlled studies and three long-term extension studies. The clinical studies used composite responder analyses to identify the proportion of individual patients reporting simultaneous and clinically significant improvements in pain, global status, and physical function, in addition to assessing improvement in various symptom domains such as fatigue and dyscognition. In the clinical studies, patients receiving milnacipran reported significant improvements in pain and other symptoms for up to 15 months of treatment. Most adverse events were mild to moderate in severity and were related to the intrinsic pharmacologic properties of the drug. Long-term exposure to milnacipran did not result in any new safety concerns. As with other serotonin and norepinephrine reuptake inhibitors, increases in heart rate and blood pressure have been observed in some patients with milnacipran treatment.

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(170) Milnacipran is safe and well tolerated in the treatment of fibromyalgia syndrome

Cited by 5 publications

References 0 publications

Fibromyalgia, milnacipran and experimental pain modulation: study protocol for a double blind randomized controlled trial

Fibromyalgia, milnacipran and experimental pain modulation: study protocol for a double blind randomized controlled trial

Role and rationale for the use of milnacipran in the management of fibromyalgia

Milnacipran: a selective serotonin and norepinephrine dual reuptake inhibitor for the management of fibromyalgia

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