Prevalence of drug-induced constipation and severity of associated biopsychosocial effects in patients with nonmalignant pain: a cross-sectional review of depersonalized data from the German Pain e-Registry

Abstract

Background

Drug-induced constipation (DIC) is a well-known comorbidity of cancer pain, however, data on its prevalence in nonmalignant pain (NMP) and its biopsychosocial effects are few.

Objective

To assess the prevalence and impact of DIC in patients with NMP.

Methods

Exploratory noninterventional, retrospective, cross-sectional analysis of depersonalized routine data of the German Pain e-Registry on 150,488 NMP patients (EUPAS identifier: 42286).

Results

DIC affects 33.5% of NMP patients. The most prevalent risk factors were the use of strong opioid analgesics and analgesic polymedication. Patients with DIC presented with significantly worse biopsychosocial scores as well as significantly higher percentages of individuals with severe deterioration of pain, daily life activities, physical and mental quality of life, mood, and overall wellbeing. Among patients with DIC, those who reported constipation as a clinical symptom and who documented bowel-function index (BFI) scores above the reference range were significantly more affected compared to those who either reported only constipation as an adverse event or elevated BFI scores. 55.9% of patients with DIC reported the use of laxatives, mostly over-the-counter preparations (43.6%), whereas prescription laxatives were taken by only 29.3%.

Conclusions

DIC is a frequent comorbidity of pain management and affects around one-third of patients with NMP. It interferes significantly with pain-related biopsychosocial effects and has to be addressed specifically to improve the overall burden in affected patients. However, the use of laxatives was significantly less frequent than recommended indicating significant room for improvement.

Keywords:

• Drug-induced constipation
• chronic nonmalignant pain
• laxative use
• adverse pain medication effects
• German Pain e-Registry

Transparency

Declaration of funding

The concept for this evaluation of routine data provided by the German Pain e-Registry was developed by M.A.U. at the Institute of Neurological Sciences (IFNAP) on behalf of the German Pain Association (Deutsche Gesellschaft für Schmerzmedizin, DGS) and the German Pain League (Deutsche Schmerzliga, DSL). Its realization has been funded by an unrestricted scientific grant from the IFNAP. No person or party exerted any influence on the data acquisition, the conduct of this analysis, or the interpretation and publication of the results.

The German Pain e-Registry is hosted by an independent contract research organization by order of the German Pain Association and under control of the Institute of Neurological Sciences (IFNAP) and collects standardized real-world data from daily routine medical care since January 2015

Declaration of financial/other relationships

M.A.U. is the medical director of the study sponsor and honorary member of the management boards of the German Pain Association and the German Pain League. U.E. is a medical research specialist working as a consultant for various pharmaceutical companies and several nonprofit organizations.

M.A.U. received financial support and/or expenses in form of research money, consultancy fees and/or renumerations for lecture activities from: Allergan, Almirall, Amicus Therapeutics, Aristo Pharma, Bionorica, Glaxo Smith Kline, Grünenthal, Hapa medical, Hexal, IMC, Kyowa-Kirin, Labatec, Mucos, Mundipharma, Nestle, Pfizer, Recordati, Servier, SGP-Pharma, Shionoghi, Spectrum Therapeutics, Teva, and Tilray. U.E. reports honoraria for consultancy services from: Almirall Hermal GmbH and Granzer Regulatory Consulting & Service. G.H.H.M-S reports consulting and/or speaker fees from: Allergan, Almirall, Grünenthal, Mundipharma, Pfizer, PharmAllergan, ProStrakan, and Teva. J.H. reports consulting and/or speaker fees from: Amgen, AOP Orphan, Aristo Pharma, Glaxo Smith Kline, Grünenthal, Janssen-Cilag, Kyowa-Kirin, Spectrum Therapeutics, TEVA and Tilray.

M.S. reports consulting and/or speaker fees from: Allergan, Almirall, Dr. Falk, Synformulas, CaraCare, Dr. Kade, Microbiotica, Bayer, Reckitt-Benckiser, Dr. Schwabe, Dr. Schär, Kyowa-Kirin, Nordmark, GE Healthcare, Medice, and Hexal. G.H.H.M-S, J.H., and M.S. are physicians and independent of any significant/relevant financial or other relationship to the sponsor.

Author contributions

All authors were involved in drafting, critical revision and approval of the manuscript. M.A.U. takes responsibility for the overarching work, for database data extraction and data handling.