The efficacy of standard laxative use for the prevention and treatment of opioid induced constipation during oxycodone use: a small Dutch observational pilot study

ABSTRACT

Background. Dutch clinical guidelines recommend that a standard laxative treatment (SLT) should be prescribed concomitantly when starting opioid treatment to prevent opioid-induced constipation (OIC).

Methods. Clinical evidence for SLT in the treatment of OIC is lacking, therefore an observational pilot study was performed to explore the efficacy and tolerability of SLT on OIC in patients treated with the opioid oxycodone.

Results. Twenty-four patients (58% female, median (range) age 65 (39–92)) were included in this pilot study. The analysis showed that 9 out of 21 patients (43%) were non-responders to SLT. When also taking into consideration patients tending to develop diarrhea 75% of patients are non-responsive to SLT.

Conclusion. This pilot study indicates that optimal laxative therapy (SLT) might not be effective and feasible for the prevention and treatment of OIC.

KEYWORDS:

• Opioid induced constipation
• oxycodone
• laxatives
• real-life data
• observational study
• pilot study

Acknowledgements

This study was designed by Mundipharma Pharmaceuticals BV and conducted by qualified investigators under the sponsorship of Mundipharma Pharmaceuticals BV. Data were gathered by the sponsor and evaluated jointly by the authors and the sponsor. All authors were involved in the development and writing of the manuscript. The authors would like to thank all participating patients, hospitals, physicians and research staff for participating in the study. Next to the authors, the following physicians participated as principal investigators within the centers: E. W. van den Bosch, Department of Anesthesiology and Pain Medicine, Medisch Centrum Leeuwarden, Leeuwarden, The Netherlands, V.C.P.C. van Dongen, Department of Anesthesiology and Pain Medicine, Orbis Medisch Centrum, Sittard-Geleen, The Netherlands, G.C.H. Tjiang Department of Anesthesiology and Pain Medicine, Amphia Ziekenhuis, Breda, The Netherlands, P.H.M. Passage, General Practitioner, Kerkrade, The Netherlands, J. Huijgens, General Practitioner, Wesepe, the Netherlands. The corresponding author takes responsibility for the integrity and the accuracy of the data analysis, and also had final responsibility for the decision to submit for publication.

Financial & competing interests disclosure

This study was designed by Mundipharma Pharmaceuticals BV and conducted by qualified investigators under the sponsorship of Mundipharma Pharmaceuticals BV. There is no financial interest linked to the preparation, scientific advice and authorship of the article for the authors. No grants, equipment or drugs were supplied by the sponsor. All authors were involved in the development, writing, critical reviewing and approval of this manuscript. Y.J.B. van Megen and G. Koopmans-Klein report personal fees from Mundipharma Pharmaceuticals BV, during the conduct of the study and personal fees from Mundipharma Pharmaceuticals BV, outside the submitted work.