A randomized, double-blind, 8-week crossover study of once-daily controlled-release tramadol versus immediate-release tramadol taken as needed for chronic noncancer pain

Beaulieu, André; Peloso, Paul M.; Bensen, W.; Clark, Alexander J.; Watson, C. Peter N.; Gardner-Nix, Jacqueline; Thomson, G. T. D.; Piraino, Paula S; Eisenhoffer, John; Harsanyi, Zoltan; Darke, Andrew C.

doi:10.1016/j.clinthera.2007.01.001

Cited by 38 publications

(33 citation statements)

References 48 publications

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“…42 However, the analgesic effects of short-and long-acting formulations of the same opioid were similar when dosed consistently in several trials.…”

Section: -41mentioning

confidence: 99%

A Comparison of Long- and Short-Acting Opioids for the Treatment of Chronic Noncancer Pain: Tailoring Therapy to Meet Patient Needs

Argoff

Silvershein

2009

Mayo Clinic Proceedings

115

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Management of chronic noncancer pain (CNCP) requires a comprehensive assessment of the patient, the institution of a structured treatment regimen, an ongoing reassessment of the painful condition and its response to therapy, and a continual appraisal of the patient's adherence to treatment. For many patients with CNCP, the analgesic regimen will include opioids. Physicians should consider the available evidence of efficacy, the routes of administration, and the pharmacokinetics and pharmacodynamics of the various formulations as they relate to the temporal characteristics of the patient's pain. When making initial decisions, physicians should decide whether to prescribe a shortacting opioid (SAO) with a relatively quick onset of action and short duration of analgesic activity, a long-acting opioid (LAO) with a longer duration of analgesic action but a potentially longer onset of action, or both. Studies suggest that SAOs and LAOs are both effective for most types of CNCP. A review of published studies found no data to suggest that either SAOs or LAOs are generally more efficacious for treating any particular CNCP condition. The LAOs may provide more stable analgesia with less frequent dosing; however, opioid therapy should be tailored to the pain state and the individual patient, and SAOs may be appropriate for some patients with CNCP. MEDLINE and PubMed searches were conducted to locate relevant studies published from January 1975 to April 2008 using the following search terms: opioids, short-acting opioids, long-acting opioids, chronic pain, chronic pain AND opioids, and narcotics. English-only randomized controlled trials and nonrandomized studies were considered.Mayo Clin Proc. 2009;84(7):602-612 ADL = activities of daily living; AE = adverse effect; ATC = around-theclock; BPI = Brief Pain Inventory; CNCP = chronic noncancer pain; CR = controlled-release; DN = diabetic neuropathy; ER = extended-release; IR = immediate-release; LAO = long-acting opioid; LBP = low back pain; NSAID = nonsteroidal anti-inflammatory drug; PHN = postherpetic neuralgia; QOL = quality of life; SAO = short-acting opioid; SNRI = serotonin norepinephrine reuptake inhibitor; SR = sustained-release; TCA = tricyclic antidepressant

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“…42 However, the analgesic effects of short-and long-acting formulations of the same opioid were similar when dosed consistently in several trials.…”

Section: -41mentioning

confidence: 99%

A Comparison of Long- and Short-Acting Opioids for the Treatment of Chronic Noncancer Pain: Tailoring Therapy to Meet Patient Needs

Argoff

Silvershein

2009

Mayo Clinic Proceedings

115

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“…Beaulieu et al study showed similar result with 370.2mg of Diclofenac versus 164.8 mg for tramadol. 16 In an earlier study, IR tramadol was compared with IR diclofenac in OA patients. 17 Both medications were given as needed, to a maximum dose of 300mg/day for tramadol and 150mg/day for diclofenac.…”

Section: Efficacy Comparison Of Study Intergroups In Present Studymentioning

confidence: 99%

Incremental cost-effectiveness and tolerability of Diclofenac + Proton pump inhibitor compared to tramadol in the treatment of knee osteoarthritis

Majeed

Rasool

Ahmad

2018

Int J Basic Clin Pharmacol

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Background: In a climate of economic uncertainty, cost effectiveness analysis is a potentially important tool for making choices about health care interventions. Patients with knee osteoarthritis are treated mostly with Diclofenac (NSAID) + Proton Pump Inhibitors (PPI) and Tramadol (Opioids) in everyday practice.Aim: Present study was aimed to assess clinical effectiveness, adverse events and cost-effectiveness between Diclofenac + PPI and Tramadol.Methods: Authors conducted prospective randomised control open label study on 40 patients at Orthopedic OPD of tertiary care hospital. Patients were given either Tramadol controlled releases tablets (200mg CR OD) or Diclofenac sustained release tablets (100mg SR OD) + PPI (Omeprazole 20mg OD) for two weeks. Clinical effectiveness was assessed by KOOS osteoarthritis index score consisting of five parameters and visual analogue scale. Suspected ADRs were recorded and incremental cost effective ratio for both drugs was calculated.Results: After application of KOOS questionnaire Authors found net quality gain in symptoms was 24.45 in diclofenac +PPI group which was much higher against 14.15 found in tramadol group. Again ADR profile of tramadol was 29 with nausea and somnolence topping the list which was far more than only 10 in DIC +PPI group. Lastly cost-effective analysis was done where again DIC+PPI showed average cost effective ratio 5.73 verses tramadol 11.8 with an incremental cost-effectiveness ratio (ICER) of -2.72.Conclusions: Diclofenac +PPI is as effective as tramadol in the treatment of pain due to knee osteoarthritis with the potential for feAuthorsr side effects. Diclofenac + PPI was also found to be cost-effective when compared with tramado.

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“…The aim of opioid medications should be to relieve pain and improve functional capacity and quality of life. Evidence from published literature including the results from controlled clinical trials indicates that opioid medications can relieve pain in a variety of pain syndromes 24,25,46…”

Section: Discussionmentioning

confidence: 99%

“…Based on experience from numerous clinical studies as well as global post-marketing experience, the efficacy and safety profile of both immediate-and extended-release Tramadol makes it a suitable drug as a long-term treatment for a variety of chronic non-cancer pain syndromes 25,46. Results from several controlled clinical studies have shown that the efficacy of once-daily or extended-release formulations of Tramadol is similar to other Tramadol formulations for the management of chronic non-cancer pain 38,46–50. The extended-release or controlled-release formulations of Tramadol allow patients to maintain an acceptable level of analgesia following the administration of a single daily dose 50,51…”

Section: Discussionmentioning

confidence: 99%

Review of extended-release formulations of Tramadol for the management of chronic non-cancer pain: focus on marketed formulations

Kizilbash¹,

Ngô-Minh²

2014

JPR

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Patients with chronic non-malignant pain report impairments of physical, social, and psychological well-being. The goal of pain management should include reducing pain and improving quality of life. Patients with chronic pain require medications that are able to provide adequate pain relief, have minimum dosing intervals to maintain efficacy, and avoid breakthrough pain. Tramadol has proven efficacy and a favourable safety profile. The positive efficacy and safety profile has been demonstrated historically in numerous published clinical studies as well as from post-marketing experience. It is a World Health Organization “Step 2” opioid analgesic that has been shown to be effective, well-tolerated, and valuable, where treatment with strong opioids is not required. A number of extended release formulations of Tramadol are available in Canada and the United States. An optimal extended release Tramadol formulation would be expected to provide consistent pain control with once daily dosing, few sleep interruptions, flexible dosing schedules, and no limitation on taking with meals. Appropriate treatment options should be based on the above proposed attributes. A comparative review of available extended release Tramadol formulations shows that these medications are not equivalent in their pharmacokinetic profile and this may have implications for selecting the optimal therapy for patients with pain syndromes where Tramadol is an appropriate analgesic agent. Differences in pharmacokinetics amongst the formulations may also translate into varied clinical responses in patients. Selection of the appropriate formulation by the health care provider should therefore be based on the patient’s chronic pain condition, needs, and lifestyle.

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A randomized, double-blind, 8-week crossover study of once-daily controlled-release tramadol versus immediate-release tramadol taken as needed for chronic noncancer pain

Cited by 38 publications

References 48 publications

A Comparison of Long- and Short-Acting Opioids for the Treatment of Chronic Noncancer Pain: Tailoring Therapy to Meet Patient Needs

A Comparison of Long- and Short-Acting Opioids for the Treatment of Chronic Noncancer Pain: Tailoring Therapy to Meet Patient Needs

Incremental cost-effectiveness and tolerability of Diclofenac + Proton pump inhibitor compared to tramadol in the treatment of knee osteoarthritis

Review of extended-release formulations of Tramadol for the management of chronic non-cancer pain: focus on marketed formulations

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