Validation of a Bowel Function Diary for Assessing Opioid-Induced Constipation

Camilleri, Michael; Rothman, Margaret; Ho, Kai Fai; Etropolski, Mila

doi:10.1038/ajg.2010.431

Cited by 25 publications

(48 citation statements)

References 22 publications

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“…Hence, a mean difference of one SBM per week between groups was identified as a probable clinically meaningful difference in patients suffering from constipation, based on the available data and guidance provided by clinical experts. 15 This assumption was later supported by the results of that study, which showed a significant (P<0.01) difference of approximately 1.4 in the number of SBMs per week among new opioid patients who reported some constipation (mean [SD]=5.7 [4.23]) and those who reported no constipation (mean [SD]=7.1[4.11]) 15. The results of that study also suggest that the statistically significant LS mean difference in number of SBMs between the tapentadol IR 50 and 75 mg doses and oxycodone HCl IR 10 mg in the present study are also clinically meaningful.…”

mentioning

confidence: 68%

“…oxycodone HCl IR 10 mg treatment, in patients with chronic pain, using the BFD validated in the previous study 15. The results of the BFD demonstrated, across measures, that treatment with oxycodone HCl IR 10 mg, compared with tapentadol IR 50 or 75 mg, significantly decreased the mean number of SBMs per week, a validated measure of OIC.…”

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confidence: 87%

“…For number of SBMs, a clinically important difference was defined as one SBM per week (SD=2.3 in both groups). 15 With 144 patients per group, the study had an overall power of 89.9%and accounted for the main gastrointestinal tolerability and efficacy assessments 15. The study was to be considered positive if at least one tapentadol IR dosage was superior to placebo in efficacy and superior to oxycodone HCl IR 10 mg in reducing incidence of constipation.…”

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confidence: 99%

“…This BFD was developed in accordance with the above guidance and validated in a multicenter, observational study in the target population. 15 Comparable doses of tapentadol ER with oxycodone controlled release (CR) were also assessed to gain information on tolerability and efficacy of those formulations.…”

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confidence: 99%

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Comparable efficacy and superior gastrointestinal tolerability (nausea, vomiting, constipation) of tapentadol compared with oxycodone hydrochloride

et al. 2011

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Tapentadol IR (50 mg, 75 mg) consistently demonstrated superior gastrointestinal tolerability, including for the most commonly reported events, such as nausea, vomiting, and constipation at doses that provide comparable efficacy with oxycodone HCl IR 10 mg. These findings validate and extend the tolerability findings of the two earlier studies that established comparable efficacy of these tapentadol and oxycodone HCl doses.

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confidence: 68%

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confidence: 87%

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confidence: 99%

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confidence: 99%

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Comparable efficacy and superior gastrointestinal tolerability (nausea, vomiting, constipation) of tapentadol compared with oxycodone hydrochloride

et al. 2011

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“…Another instrument that has been proposed for use in clinical studies for OIC utilizes a three-step module [Camilleri et al 2011].…”

Section: Diagnosis Of Oicmentioning

confidence: 99%

Opioid-induced constipation: advances and clinical guidance

Nelson

Camilleri

2016

Therapeutic Advances in Chronic Disease

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Currently opioids are the most frequently used medications for chronic noncancer pain. Opioid-induced constipation is the most common adverse effect associated with prolonged use of opioids, having a major impact on quality of life. There is an increasing need to treat opioid-induced constipation. With the recent approval of medications for the treatment of opioid-induced constipation, there are several therapeutic approaches. This review addresses the clinical presentation and diagnosis of opioid-induced constipation, barriers to its diagnosis, effects of opioids in the gastrointestinal tract, differential tolerance to opiates in different gastrointestinal organs, medications approved and in development for the treatment of opioid-induced constipation, and a proposed clinical management algorithm for treating opioid-induced constipation in patients with noncancer pain.

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Novel Oral Therapies for Opioid‐induced Bowel Dysfunction in Patients with Chronic Noncancer Pain

Holder

Rhee

2016

Pharmacotherapy

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Opioid analgesics are frequently prescribed and play an important role in chronic pain management. Opioid-induced bowel dysfunction, which includes constipation, hardened stool, incomplete evacuation, gas, and nausea and vomiting, is the most common adverse event associated with opioid use. Mu-opioid receptors are specifically responsible for opioid-induced bowel dysfunction, resulting in reduced peristaltic and secretory actions. Agents that reverse these actions in the bowel without reversing pain control in the central nervous system may be preferred over traditional laxatives. The efficacy and safety of these agents in chronic noncancer pain were assessed from publications identified through Ovid and PubMed database searches. Trials that evaluated the safety and efficacy of oral agents for opioid-induced constipation or opioid-induced bowel dysfunction, excluding laxatives, were reviewed. Lubiprostone and naloxegol are approved in the United States by the Food and Drug Administration for use in opioid-induced constipation. Axelopran (TD-1211) and sustained-release naloxone have undergone phase 2 and phase 1 studies, respectively, for the same indication. Naloxegol and axelopran are peripherally acting μ-opioid receptor antagonists. Naloxone essentially functions as a peripherally acting μ-opioid receptor antagonist when administered orally in a sustained-release formulation. Lubiprostone is a locally acting chloride channel (CIC-2) activator that increases secretions and peristalsis. All agents increase spontaneous bowel movements and reduce other bowel symptoms compared with placebo in patients with noncancer pain who are chronic opioid users. The most common adverse events were gastrointestinal in nature, and none of the drugs were associated with severe adverse or cardiovascular events. Investigations comparing these agents to regimens using standard laxative and combination therapy and trials in special populations and patients with active cancer are needed to further define their role in therapy.

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Validation of a Bowel Function Diary for Assessing Opioid-Induced Constipation

Abstract: BF-Diary items are generally reliable and valid assessments for OIC research. Specifically, number of SBM is a valid measure for differentiating opioid-treated patients with and without constipation.

Cited by 25 publications

References 22 publications

Comparable efficacy and superior gastrointestinal tolerability (nausea, vomiting, constipation) of tapentadol compared with oxycodone hydrochloride

Comparable efficacy and superior gastrointestinal tolerability (nausea, vomiting, constipation) of tapentadol compared with oxycodone hydrochloride

Opioid-induced constipation: advances and clinical guidance

Novel Oral Therapies for Opioid‐induced Bowel Dysfunction in Patients with Chronic Noncancer Pain

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