Tramadol and acetaminophen combination tablets in the treatment of fibromyalgia pain: a double-blind, randomized, placebo-controlled study

Bennett, Robert M.; Kamin, Marc; Karim, Rezaul; Rosenthal, Norman

doi:10.1016/s0002-9343(03)00116-5

Cited by 352 publications

(179 citation statements)

References 31 publications

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“…Most patients were women (90.6%) and white (90.3%); mean age was 49.4 years. Mean VAS pain scores at randomization ranged from 66.8 to 67.6, indicating moderate to severe pain in this patient population [Bennett et al 2003]. Patients also had impaired physical and mental function at randomization, as indicated by mean SF-36 PCS and MCS scores [Ware and Sherbourne, 1992].…”

Section: Patientsmentioning

confidence: 99%

Milnacipran combined with pregabalin in fibromyalgia: a randomized, open-label study evaluating the safety and efficacy of adding milnacipran in patients with incomplete response to pregabalin

Mease

Farmer

Palmer³

et al. 2013

Therapeutic Advances in Musculoskeletal

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Objective: To evaluate the safety, tolerability, and efficacy of adding milnacipran to pregabalin in patients with fibromyalgia who have experienced an incomplete response to pregabalin. Methods: In this randomized, multicenter, open-label study, patients received pregabalin 300 or 450 mg/day during a 4-to 12-week run-in period. Patients with weekly recall visual analog scale (VAS) pain score of at least 40 and up to 90, Patient Global Impression of Severity score of at least 4, and Patient Global Impression of Change (PGIC) score of at least 3 were classified as incomplete responders and randomized to continue pregabalin alone (n = 180) or receive milnacipran 100 mg/day added to pregabalin (n = 184). The primary efficacy parameter was responder status based on PGIC score of up to 2. The secondary efficacy parameter was change from randomization in weekly recall VAS pain score. Safety parameters included adverse events (AEs), vital signs, and clinical laboratory tests. Results: The percentage of PGIC responders was significantly higher with milnacipran added to pregabalin (46.4%) than with pregabalin alone (20.8%; p < 0.001). Mean improvement from randomization in weekly recall VAS pain scores was greater in patients receiving milnacipran added to pregabalin (−20.77) than in patients receiving pregabalin alone (−6.43; p < 0.001). During the run-in period, the most common treatment-emergent AEs with pregabalin were dizziness (22.8%), somnolence (17.3%), and fatigue (9.1%). During the randomized period, the most common treatment-emergent AEs with milnacipran added to pregabalin were nausea (12.5%), fatigue (10.3%), and constipation (9.8%). Conclusions: In this exploratory, open-label study, adding milnacipran to pregabalin improved global status, pain, and other symptoms in patients with fibromyalgia with an incomplete response to pregabalin treatment.

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Section: Patientsmentioning

confidence: 99%

Milnacipran combined with pregabalin in fibromyalgia: a randomized, open-label study evaluating the safety and efficacy of adding milnacipran in patients with incomplete response to pregabalin

Mease

Farmer

Palmer³

et al. 2013

Therapeutic Advances in Musculoskeletal

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“…Tramadol, (a central-acting analgesic that inhibits the reuptake of serotonin and norepinephrine, while having an agonist action on the mu opioid receptors), associated with acetaminophen, demonstrated better pain control and improvement in quality of life compared with a placebo. 11 Among antiepileptic drugs used as analgesics, pregabalin has been the first drug approved in USA by the Food and Drug Administration (FDA) to treat fibromyalgia. 12 Among antidepressants, the efficacy of selective serotonin reuptake inhibitions (SSRIs) is controversial for fluoxetine, citalopram, sertraline or paroxetine.…”

Section: Central Sensitization Common With Other Dysfunctional Disormentioning

confidence: 99%

Pharmacotherapy of Fibromyalgia: Focus on Duloxetine

Serra

Andréjak

2009

Clinical Medicine. Therapeutics

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Context: Fibromyalgia syndrome (FMS) is a frequent medical condition characterized by chronic widespread pain and reduced pain threshold. Associated symptoms include fatigue, non restorative sleep, and psychological distress. As usual in medicine, even if the pathogenesis is unclear, some treatments are useful to help patients. Objectives: Tricyclic antidepressants were the first drugs used to treat FMS. More recently, among serotonin-norepinephrine reuptake inhibitors, duloxetine was approved by US Food and Drug Administration to treat FMS. Duloxetine is used for the management of major depressive disorder, neuropathic pain, generalized anxiety disorder, and stress incontinence. In the pharmacotherapy of fibromyalgia, a focus is presented on the drug duloxetine. Results: Mechanism of action, metabolism and pharmacokinetic profile are presented. Clinical studies of Duloxetine showed an acceptable efficacy for this chronic condition: Number Need to Treat (NTT) of 4.7 to 9.9, through two 3-month placebo-controlled trials and two 6-month trials. Evaluation criteria are discussed. Safety of this medication has been found to be satisfactory, with nausea as the most common adverse event, in almost 20% of cases. Conclusion: Treatment algorithm for duloxetine is presented inside FMS treatment strategy. With duloxetine, it is important to start low and increase slowly to prevent or minimize adverse events: 30 mg/day up to 60 mg/day in the second week and if necessary up to 90-120 mg/day. It is possible to treat for 3 to 6 months, possibly up to 12 months. The drug could be decreased 2 to 4 weeks before stopping, with regular assessments during this time. International recommendations insist on multimodal treatments: drug and non drug. Also effective for anxiety and depression, duloxetine ranks among the first place drugs for FMS.

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“…Tramadol is a weak μ-receptor agonist with SNRI effect, currently classified as a Schedule IV control substance. In one RCT [58] with over 300 FM patients, tramadol/acetaminophen (titrated up to 300 mg/2600 mg a day) resulted significantly greater benefit for improving FM and sleep symptoms relative to placebo. Given the promising results, further research on the effectiveness of tramadol for FM is warranted.…”

Section: • Opioidsmentioning

confidence: 99%

Management of Fibromyalgia Syndrome

2005

JAMA

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Tramadol and acetaminophen combination tablets in the treatment of fibromyalgia pain: a double-blind, randomized, placebo-controlled study

Cited by 352 publications

References 31 publications

Milnacipran combined with pregabalin in fibromyalgia: a randomized, open-label study evaluating the safety and efficacy of adding milnacipran in patients with incomplete response to pregabalin

Milnacipran combined with pregabalin in fibromyalgia: a randomized, open-label study evaluating the safety and efficacy of adding milnacipran in patients with incomplete response to pregabalin

Pharmacotherapy of Fibromyalgia: Focus on Duloxetine

Management of Fibromyalgia Syndrome

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