Clinical trial: alvimopan for the management of post-operative ileus after abdominal surgery: results of an international randomized, double-blind, multicentre, placebo-controlled clinical study
| Autor: | R. Williamson, Y. Flamant, Markus W. Büchler, J. R. T. Monson, J. F. B. Altman, C. M. Seiler, M. M. Byrne, E. R. Mortensen, Mark Thompson-Fawcett |
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| Rok vydání: | 2008 |
| Předmět: |
Male
medicine.medical_specialty Ileus medicine.medical_treatment Narcotic Antagonists Stomach Diseases Placebo law.invention Postoperative Complications Randomized controlled trial Double-Blind Method Piperidines law medicine Alvimopan Clinical endpoint Humans Pharmacology (medical) Defecation Aged Pain Measurement Hepatology Dose-Response Relationship Drug business.industry Gastroenterology Bowel resection Middle Aged medicine.disease Surgery Clinical trial Treatment Outcome Anesthesia Female business Gastrointestinal Motility medicine.drug Abdominal surgery |
| Zdroj: | Alimentary pharmacologytherapeutics. 28(3) |
| ISSN: | 0269-2813 |
| Popis: | Aliment Pharmacol Ther 28, 312–325 Summary Background Post-operative ileus (POI) affects most patients undergoing abdominal surgery. Aim To evaluate the effect of alvimopan, a peripherally acting mu-opioid receptor antagonist, on POI by negating the impact of opioids on gastrointestinal (GI) motility without affecting analgesia in patients outside North America. Methods Adult subjects undergoing open abdominal surgery (n = 911) randomly received oral alvimopan 6 or 12 mg, or placebo, 2 h before, and twice daily following surgery. Opioids were administered as intravenous patient-controlled analgesia (PCA) or bolus injection. Time to recovery of GI function was assessed principally using composite endpoints in subjects undergoing bowel resection (n = 738). Results A nonsignificant reduction in mean time to tolerate solid food and either first flatus or bowel movement (primary endpoint) was observed for both alvimopan 6 and 12 mg; 8.5 h (95% CI: 0.9, 16.0) and 4.8 h (95% CI: −3.2, 12.8), respectively. However, an exploratory post hoc analysis showed that alvimopan was more effective in the PCA (n = 317) group than in the non-PCA (n = 318) group. Alvimopan was well tolerated and did not reverse analgesia. Conclusion Although the significant clinical effect of alvimopan on reducing POI observed in previous trials was not reproduced, this trial suggests potential benefit in bowel resection patients who received PCA. |
| Databáze: | OpenAIRE |
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