Abstract | BACKGROUND AND AIM: METHODS: A systematic search of PubMed, CINAHL, Scopus, Cochrane database of systematic reviews, and ClinicalTrials.gov registry was performed in March 2018. Two independent reviewers systematically identified prospective RCTs published in the English language that compared the effect of oral naldemedine versus placebo in adults with OIC. Meta-analysis was performed using a random effects model to assess the primary outcome: spontaneous bowel movement (SBM) responder rates. Assessed secondary outcomes were: a change in SBM frequency per week from baseline during the treatment period, change from baseline in the frequency of complete SBM and incidence of treatment-emergent adverse events. Review Manager 5.3 software program was utilized for statistical analysis. RESULTS: Six RCTs met the inclusion criteria. A total of 2,762 patients were included in the meta-analysis. The proportion of SBM responders was significantly higher in the naldemedine group compared to the placebo group (56.4%, vs. 34.7%, p<0.00001). There was no statistically significant difference in treatment-emergent adverse events between naldemedine group and placebo group (mean odds ratio=1.18, p = 0.25, 95% CI: 0.89-1.55). Change in SBM frequency was higher in the naldemedine group versus placebo group (p<0.00001), as well as the change in complete SBM frequency. CONCLUSIONS:
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Authors | Mohammad Esmadi, Dina Ahmad, Alexander Hewlett |
Journal | Journal of gastrointestinal and liver diseases : JGLD
(J Gastrointestin Liver Dis)
Vol. 28
Issue 1
Pg. 41-46
(Mar 2019)
ISSN: 1842-1121 [Electronic] Romania |
PMID | 30851171
(Publication Type: Journal Article, Meta-Analysis, Systematic Review)
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Chemical References |
- Analgesics, Opioid
- Narcotic Antagonists
- naldemedine
- Naltrexone
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Topics |
- Analgesics, Opioid
(adverse effects)
- Constipation
(chemically induced, diagnosis, drug therapy, physiopathology)
- Defecation
(drug effects)
- Female
- Gastrointestinal Motility
(drug effects)
- Humans
- Male
- Middle Aged
- Naltrexone
(adverse effects, analogs & derivatives, therapeutic use)
- Narcotic Antagonists
(adverse effects, therapeutic use)
- Recovery of Function
- Treatment Outcome
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