Randomised clinical trial: The long-term safety and tolerability of naloxegol in patients with pain and opioid-induced constipation

Alimentary Pharmacology and Therapeutics

Volumn 40, Issue 7, 2014, Pages 771-779

  Webster, L ^a   Chey, W D ^b   Tack, J ^c   Lappalainen, J ^d   Diva, U ^d   Sostek, M ^d  

^a PRA HEALTH SCIENCES   (United States)

^b UNIVERSITY OF MICHIGAN HEALTH SYSTEM   (United States)

^c UNIVERSITY OF LEUVEN   (Belgium)

^d ASTRAZENECA   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

BISACODYL; HYDROCODONE BITARTRATE PLUS PARACETAMOL; LAXATIVE; MORPHINE; NALOXEGOL; NARCOTIC ANALGESIC AGENT; OXYCODONE; OXYCODONE PLUS PARACETAMOL; TRAMADOL; MACROGOL DERIVATIVE; MORPHINAN DERIVATIVE; NARCOTIC ANTAGONIST;

ABDOMINAL PAIN; ACUTE HEART INFARCTION; ADULT; AGED; ARTHRALGIA; ARTICLE; BACKACHE; BRAIN ISCHEMIA; BRONCHITIS; CONSTIPATION; CONTROLLED STUDY; DEPRESSED BLOOD PRESSURE; DIARRHEA; DRUG DOSE REDUCTION; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; ELEVATED BLOOD PRESSURE; FAINTNESS; FEMALE; FLATULENCE; GASTROINTESTINAL SYMPTOM; GENERALIZED EPILEPSY; HEADACHE; HUMAN; HYPERHIDROSIS; INTESTINE PERFORATION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; OPEN STUDY; OPIOID INDUCED CONSTIPATION; ORTHOSTATIC HYPOTENSION; PAIN; PARALLEL DESIGN; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SINUSITIS; UNSPECIFIED SIDE EFFECT; UPPER ABDOMINAL PAIN; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; VOMITING; CHEMICALLY INDUCED; CLINICAL TRIAL; MIDDLE AGED;

ADULT; AGED; ANALGESICS, OPIOID; CONSTIPATION; FEMALE; HUMANS; LAXATIVES; MALE; MIDDLE AGED; MORPHINANS; MORPHINE; NARCOTIC ANTAGONISTS; PAIN; POLYETHYLENE GLYCOLS;

EID: 84908140708     PISSN: 02692813     EISSN: 13652036     Source Type: Journal    
DOI: 10.1111/apt.12899     Document Type: Article

References (15)

1. Bell TJ, Panchal SJ, Miaskowski C, Bolge SC, Milanova T, Williamson R. The prevalence, severity, and impact of opioid-induced bowel dysfunction: results of a US and European Patient Survey (PROBE 1). Pain Med 2009; 10: 35-42.
2. Panchal SJ, Müller-Schwefe P, Wurzelmann JI. Opioid-induced bowel dysfunction: prevalence, pathophysiology and burden. Int J Clin Pract 2007; 61: 1181-7.
3. Camilleri M. Opioid-induced constipation: challenges and therapeutic opportunities. Am J Gastroenterol 2011; 106: 835-42.
4. Pappagallo M. Incidence, prevalence, and management of opioid bowel dysfunction. Am J Surg 2001; 182(5A Suppl.): 11S-8S.
5. Boudreau D, Von Korff M, Rutter CM, et al. Trends in long-term opioid therapy for chronic non-cancer pain. Pharmacoepidemiol Drug Saf 2009; 18: 1166-75.
6. Diego L, Atayee R, Helmons P, Hsiao G, von Gunten CF. Novel opioid antagonists for opioid-induced bowel dysfunction. Expert Opin Investig Drugs 2011; 20: 1047-56.
7. Liu LW. Chronic constipation: current treatment options. Can J Gastroenterol 2011; 25(Suppl. B): 22B-8B.
8. Holzer P. Non-analgesic effects of opioids: management of opioid-induced constipation by peripheral opioid receptor antagonists: prevention or withdrawal? Curr Pharm Des 2012; 18: 6010-20.
9. Amitiza® (lubiprostone capsules). Full Prescribing Information. Sucampo Pharma Americas, LLC, Bethesda, MD and Takeda Pharmaceuticals America, Inc., Deerfield, IL, 2013.
10. Chey WD, Webster L, Sostek M, Lappalainen J, Barker PN, Tack J. Naloxegol for opioid-induced constipation in patients with noncancer pain. N Engl J Med 2014; 370: 2387-96.
11. Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole RM. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain 2001; 94: 149-58.
12. Culpepper-Morgan JA, Inturrisi CE, Portenoy RK, et al. Treatment of opioid-induced constipation with oral naloxone: a pilot study. Clin Pharmacol Ther 1992; 52: 90-5.
13. Himmelsbach CK. The morphine abstinence syndrome, its nature and treatment. Ann Intern Med 1941; 15: 829-39.
14. International Conference on Harmonisation. Harmonised Tripartite Guideline (E1) "The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life Threatening Conditions," Step 4, finalized version. Geneva: Switzerland, October 1994.
15. Lipman AG, Karver S, Cooney GA, Stambler N, Israel RJ. Methylnaltrexone for opioid-induced constipation in patients with advanced illness: a 3-month open-label treatment extension study. J Pain Palliat Care Pharmacother 2011; 25: 136-45.