Critical Scrutiny Needed
The following observations should be made in relation to this article regarding opiate-induced constipation and the recommendation for oxycodone/naloxone therapy for treatment-refractory or opiate-induced ileus (1):
- The anticonstipation effect of oxycodone/naloxone seems to be of little or no clinical significance.
- The reference cited for this recommendation in the article stated above is based on the S3 guideline, which gives a level Ib recommendation (2).
- However, study availability for this drug combination is known to be poor, and the guideline refers to only one observational study with no control. Not only did this study include only a small number (15) of patients; it also (like other studies on the combination of oxycodone/naloxone) lists employees of the drug manufacturer, Mundipharma (M. Hopp, G. Mundin), among its authors (3).
In other studies on oxycodone/naloxone in patients without tumors, patients who were so constipated that they were unable to cope with the reduced study protocol—in other words, the most constipated patients—were excluded from the study. The authors employed by Mundipharma were involved here, too (4).
- The discrepancies between clinical effect and a supposedly level 1b recommendation thus seem to be caused by insufficient research or objectivity on the part of the guideline team. Guideline recommendations should therefore be critically scrutinized, not simply accepted wholesale.
Where appropriate, a positive trend in OIC can be expected with oxycodone/naloxone; however, the recommendation for use in treatment-refractory cases of opiate-induced ileus stated in the article seems hard to comprehend.
Dr. med. Thorsten Nickel
Schmerztherapie und Palliativmedizin
imland Klinik Rendsburg
Conflict of interest statement
Dr. Nickel has received conference participation fees and reimbursement of travel and accommodation costs from Mundipharma.
|1.||Vilz TO, Stoffels B, Straßburg C, Schild HH, Kalff JC: Ileus in adults—pathogenesis, investigation and treatment. Dtsch Arztebl Int 2017; 114: 508–18 VOLLTEXT|
|2.||AWMF: S2k Leitlinie Chronische Obstipation beim Erwachsenen. www.awmf.org/uploads/tx_szleitlinien/021–019l_S2k_Chronische_Obstipation_2013–06_01.pdf [last accessed on 20 June 2017])|
|3.||Smith K, Hopp M, Mundin G, et al.: Naloxone as part of a prolonged release oxycodone/naloxone combination reduces oxycodone-induced slowing of gastrointestinal transit in healthy volunteers. Expert Opin Investig Drugs 2011; 20: 427–39 CrossRef MEDLINE|
|4.||Simpson K, Leyendecker P, Hopp M, et al.: Fixed-ratio combination oxycodone/|
naloxone compared with oxycodone alone for the relief of opioid-induced constipation in moderate-to-severe noncancer pain. Curr Med Res Opin 2008; 24: 3503–12 CrossRef MEDLINE