Lubiprostone<i>vs Senna</i>in postoperative orthopedic surgery patients with opioid-induced constipation: A double-blind, active-comparator trial

Marciniak, Christina; Toledo, Santiago D.; Lee, Jung Hwa; Jesselson, Michael; Bateman, Jillian; Grover, Benjamin; Tierny, Joy

doi:10.3748/wjg.v20.i43.16323

Cited by 27 publications

(23 citation statements)

References 28 publications

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“…Concerning prucalopride, there is only one published study available showing that both the 2 mg and 4 mg once-daily doses significantly increase spontaneous bowel movements in these patients, but only during the first two weeks of treatment [ 29 ]. Concerning lubiprostone, the available data (two published studies [ 142 , 145 ] and four abstracts [ 38 , 40 , 41 , 44 ]) seem to suggest that the drug may be useful in the treatment of OIC, even though it is possible that this effect is limited to some subtypes of patients. Compared with placebo, lubiprostone was able to improve symptoms related to OIC [ 142 ].…”

Section: Methodsmentioning

confidence: 99%

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Opioid-Induced Constipation and Bowel Dysfunction: A Clinical Guideline

et al. 2016

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ObjectiveTo formulate timely evidence-based guidelines for the management of opioid-induced bowel dysfunction.SettingConstipation is a major untoward effect of opioids. Increasing prescription of opioids has correlated to increased incidence of opioid-induced constipation. However, the inhibitory effects of opioids are not confined to the colon, but also affect higher segments of the gastrointestinal tract, leading to the coining of the term “opioid-induced bowel dysfunction.”MethodsA literature search was conducted using Medline, EMBASE, and EMBASE Classic, and the Cochrane Central Register of Controlled Trials. Predefined search terms and inclusion/exclusion criteria were used to identify and categorize relevant papers. A series of statements were formulated and justified by a comment, then labeled with the degree of agreement and their level of evidence as judged by the Strength of Recommendation Taxonomy (SORT) system.ResultsFrom a list of 10,832 potentially relevant studies, 33 citations were identified for review. Screening the reference lists of the pertinent papers identified additional publications. Current definitions, prevalence, and mechanism of opioid-induced bowel dysfunction were reviewed, and a treatment algorithm and statements regarding patient management were developed to provide guidance on clinical best practice in the management of patients with opioid-induced constipation and opioid-induced bowel dysfunction.ConclusionsIn recent years, more insight has been gained in the pathophysiology of this “entity”; new treatment approaches have been developed, but guidelines on clinical best practice are still lacking. Current knowledge is insufficient regarding management of the opioid side effects on the upper gastrointestinal tract, but recommendations can be derived from what we know at present.

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Section: Methodsmentioning

confidence: 99%

“…Compared with placebo, lubiprostone was able to improve symptoms related to OIC [ 142 ]. Another study showed no advantage over the less expensive senna [ 145 ].…”

Section: Methodsmentioning

confidence: 99%

Opioid-Induced Constipation and Bowel Dysfunction: A Clinical Guideline

et al. 2016

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“…However, little is known about the occurrence of OIC or the health care utilization and costs associated with OIC in these patients. 19 , 20 …”

Section: Introductionmentioning

confidence: 99%

Resource use and costs associated with opioid-induced constipation following total hip or total knee replacement surgery

Wittbrodt¹,

Gan²,

Datto³

et al. 2018

JPR

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PurposeConstipation is a well-known complication of surgery that can be exacerbated by opioid analgesics. This study evaluated resource utilization and costs associated with opioid-induced constipation (OIC).Patients and methodsThis retrospective, observational, and propensity-matched cohort study utilized the Premier Healthcare Database. The study included adults ≥18 years of age undergoing total hip or total knee replacement as inpatients who received an opioid analgesic and were discharged between January 1, 2012, and June 30, 2015. Diagnosis codes identified patients with OIC who were then matched 1:1 to patients without OIC. Generalized linear and logistic regression models were used to compare inpatient resource utilization, total hospital costs, inpatient mortality, and 30-day all-cause readmissions and emergency department visits.ResultsOf 788,448 eligible patients, 40,891 (5.2%) had OIC. Covariates were well balanced between matched patients with and without OIC (n=40,890 each). In adjusted analyses, patients with OIC had longer hospital lengths of stay (3.6 versus 3.3 days; p<0.001), higher total hospital costs (US$17,479 versus US$16,265; p<0.001), greater risk of intensive care unit admission (odds ratio [OR]=1.12, 95% CI: 1.01–1.24), and increased likelihood of 30-day hospital read-missions (OR=1.16, 95% CI: 1.11–1.22) and emergency department visits (OR=1.38, 95% CI: 1.07–1.79) than patients without OIC. No statistically significant difference was found with inpatient mortality (OR=0.89, 95% CI: 0.59–1.35).ConclusionOIC was associated with greater resource utilization and hospital costs for patients undergoing primarily elective total hip or total knee replacement surgery. These results support OIC screening and management strategies as part of perioperative care management.

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“…Over 18 clinical studies have used the PAC-SYM, since its validation in 1999: 14 of these have been reported since 2010. [3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20] Moreover, these trials have examined a range of interventions including sacral nerve stimulation, 20 lifestyle changes 19 and pharmacological agents. 6,11 Historically, a reduction in total score of 1 point or more has been used as the cut-off to define a positive response to treatment, 2 implying that this is a meaningful improvement.…”

Section: Introductionmentioning

confidence: 99%

ThePAC‐SYMquestionnaire for chronic constipation: defining the minimal important difference

Yiannakou

Tack

Piessevaux

et al. 2017

Aliment Pharmacol Ther

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SummaryBackgroundThe Patient Assessment of Constipation‐Symptoms (PAC‐SYM) questionnaire is frequently used in clinical trials of constipation. However, the threshold for reduction in total PAC‐SYM score used to define a clinical response on this 0‐4 point scale has not undergone formal appraisal, and its relationship with clinical benefit as perceived by patients has not been defined.AimTo determine the minimal important difference in PAC‐SYM score, and the optimum cut‐off value for defining responders.MethodsThe minimal important difference was estimated using data from six international phase 3/4, double‐blind, randomised controlled trials of prucalopride in patients with chronic constipation (NCT01147926, NCT01424228, NCT01116206, NCT00485940, NCT00483886, NCT00488137), with anchor‐ and distribution‐based approaches. Five appropriate patient‐reported outcomes were selected as anchors. In addition, receiver operating characteristics (ROC) curve analyses were used to investigate responder discrimination for each anchor.ResultsData from 2884 patients were included. Minimal important difference estimates ranged from –0.52 to –0.63 across the five anchors. Estimates were not affected by study location but were consistently lower for rectal symptoms than for abdominal and stool symptoms. Distribution‐based estimates were considerably lower than anchor‐based estimates. ROC curve analyses showed optimum cut‐off scores for discriminating responders to be similar to anchor‐based minimal important difference estimates.ConclusionsAnchor‐based methods gave consistent results for the minimal important difference, at approximately –0.6, and this value was close to the ROC‐determined optimal cut‐off scores for responder discrimination. This value could be considered in clinical practice. A slightly more conservative threshold (eg –0.75) could be used in clinical trials to reduce the placebo response rate.

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Lubiprostonevs Sennain postoperative orthopedic surgery patients with opioid-induced constipation: A double-blind, active-comparator trial

Abstract: Both lubiprostone and Senna improved constipation-related symptoms and QOL in opioid-induced constipation, with no significant between-group differences.

Cited by 27 publications

References 28 publications

Opioid-Induced Constipation and Bowel Dysfunction: A Clinical Guideline

Opioid-Induced Constipation and Bowel Dysfunction: A Clinical Guideline

Resource use and costs associated with opioid-induced constipation following total hip or total knee replacement surgery

ThePAC‐SYMquestionnaire for chronic constipation: defining the minimal important difference

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