Subcutaneous methylnaltrexone for treatment of opioid-induced constipation in patients with chronic, nonmalignant pain: A randomized controlled study

Journal of Pain

Volumn 12, Issue 5, 2011, Pages 554-562

  Michna, Edward ^a   Blonsky, E Richard ^b   Schulman, Seth ^c   Tzanis, Evan ^c   Manley, Amy ^c   Zhang, Haiying ^c   Iyer, Shrividya ^c   Randazzo, Bruce ^c  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

^b Pain and Rehabilitation Clinic of Chicago   (United States)

^c PFIZER INC   (United States)

Author keywords

abdominal pain; chronic disease; constipation; Methylnaltrexone; mu opioid receptor antagonist; opioid related disorders; opioids; palliative care

Indexed keywords

17 METHYLNALTREXONE; 17 METHYLNALTREXONE BROMIDE; OPIATE;

ABDOMINAL DISTENSION; ABDOMINAL PAIN; ADULT; AGED; ARTICLE; CHRONIC PAIN; COLD SENSATION; CONSTIPATION; CONTROLLED STUDY; DEHYDRATION; DIARRHEA; DIZZINESS; DOSAGE SCHEDULE COMPARISON; DOUBLE BLIND PROCEDURE; DRUG EFFECT; DRUG EFFICACY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EXTRASYSTOLE; FEMALE; HOT FLUSH; HUMAN; HYPERHIDROSIS; HYPOKALEMIA; KIDNEY CANCER; LEUKOCYTOSIS; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MYOCLONUS; NAUSEA; OPIOID INDUCED CONSTIPATION; PANCREATITIS; PHASE 3 CLINICAL TRIAL; PNEUMONIA; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; REFLEX; SIDE EFFECT; TRAFFIC ACCIDENT; TREATMENT OUTCOME; UPPER ABDOMINAL PAIN; VOMITING;

ADULT; AGED; ANALGESICS, OPIOID; CHI-SQUARE DISTRIBUTION; CONSTIPATION; DEFECATION; DOUBLE-BLIND METHOD; FEMALE; HUMANS; INTENTION TO TREAT ANALYSIS; MALE; MIDDLE AGED; NALTREXONE; NARCOTIC ANTAGONISTS; PAIN; QUATERNARY AMMONIUM COMPOUNDS; QUESTIONNAIRES; TREATMENT OUTCOME;

EID: 79955597302     PISSN: 15265900     EISSN: 15288447     Source Type: Journal    
DOI: 10.1016/j.jpain.2010.11.008     Document Type: Article

References (33)

1. T. Bell, K. Annunziata, and J.B. Leslie Opioid-induced constipation negatively impacts pain management, productivity, and health-related quality of life: Findings from the National Health and Wellness Survey J Opioid Manag 5 2009 137 144
2. Blonsky ER, Michna E, Schulman S, Tzanis E, Manley A, Zhang H, Randazzo B: Subcutaneous methylnaltrexone for the treatment of opioid-induced constipation in patients with chronic non-malignant pain [abstract]. Presented at the 28th Annual Scientific Meeting of the American Pain Society, San Diego, CA, May 7-9, 2009
3. Blonsky ER, Watier A, Schulman S, Tzanis E, Manley A, Zhang H, Randazzo B: Subcutaneous methylnaltrexone for the treatment of opioid-induced constipation in patients with chronic non-malignant pain: Open-label results [abstract]. Presented at the 28th Annual ESRA Congress, Salzburg, Austria, September 9-12, 2009
4. M.A. Caudill-Slosberg, L.M. Schwartz, and S. Woloshin Office visits and analgesic prescriptions for musculoskeletal pain in US: 1980 vs. 2000 Pain 109 2004 514 519 (Pubitemid 38638730)
5. Duerden M, Weil A, Yu D, Schulman S, Tzanis E, Zhang H, Manley A, Randazzo B: Subcutaneous methylnaltrexone for the treatment of opioid-induced constipation in patients with chronic, nonmalignant pain: Safety results in patients treated for 12 weeks [abstract]. Presented at the 29th Annual Scientific Meeting of the American Pain Society, Baltimore, MD, May 6-8, 2010
6. C. Harstall, and M. Ospina How prevalent is chronic pain? Pain Clin Update 11 2003 1 4
7. S. Iyer, B. Randazzo, E. Tzanis, S. Schulman, H. Zhang, W. Wang, and A. Manley Effect of subcutaneous (SC) methylnaltrexone on patient reported constipation specific quality of life in a randomized double blind clinical trial [abstract] Value in Health 12 2009 A349
8. E. Kalso, J.E. Edwards, R.A. Moore, and H.J. McQuay Opioids in chronic non-cancer pain: Systematic review of efficacy and safety Pain 112 2004 372 380 (Pubitemid 39550738)
9. S.J. Lewis, and K.W. Heaton Stool form scale as a useful guide to intestinal transit time Scand J Gastroenterol 32 1997 920 924 (Pubitemid 27382038)
10. J.D. Loeser, S.H. Butler, C.R. Chapman, and D.C. Turk Bonica's Management of Pain 3rd ed 2001 Lippincott Williams & Wilkins Philadelphia, PA
11. L. Manara, and A. Bianchetti The central and peripheral influences of opioids on gastrointestinal propulsion Annu Rev Pharmacol Toxicol 25 1985 249 273 (Pubitemid 15090982)
12. P. Marquis, L.C. De La, D. Dubois, A. McDermott, and O. Chassany Development and validation of the Patient Assessment of Constipation Quality of Life questionnaire Scand J Gastroenterol 40 2005 540 551 (Pubitemid 40676247)
13. E. McNicol, N. Horowicz-Mehler, R.A. Fisk, K. Bennett, M. Gialeli-Goudas, P.W. Chew, J. Lau, and D. Carr Management of opioid side effects in cancer-related and chronic noncancer pain: A systematic review J Pain 4 2003 231 256 (Pubitemid 36807905)
14. D.B. Murphy, J.A. Sutton, L.F. Prescott, and M.B. Murphy Opioid-induced delay in gastric emptying: A peripheral mechanism in humans Anesthesiology 87 1997 765 770 (Pubitemid 27456227)
15. M. Noble, S.J. Tregear, J.R. Treadwell, and K. Schoelles Long-term opioid therapy for chronic noncancer pain: A systematic review and meta-analysis of efficacy and safety J Pain Symptom Manage 35 2008 214 228
16. M. Pappagallo Incidence, prevalence, and management of opioid bowel dysfunction Am J Surg 182 suppl 5A 2001 11S 18S (Pubitemid 34072942)
17. L. Plaisance, and J.A. Ellis Opioid-induced constipation. Management is necessary but prevention is better Am J Nurs 102 2002 72 73
18. Relistor [package insert], Wyeth Pharmaceuticals Inc and Progenics Pharmaceuticals, Philadelphia, PA, and Tarrytown, NY, 2009
19. N. Slatkin, J. Thomas, A.G. Lipman, G. Wilson, M.L. Boatwright, C. Wellman, D.S. Zhukovsky, R. Stephenson, R. Portenoy, N. Stambler, and R. Israel Methylnaltrexone for treatment of opioid-induced constipation in advanced illness patients J Support Oncol 7 2009 39 46
20. B.H. Smith, W.A. Chambers, and W.C. Smith Chronic pain: Time for epidemiology J R Soc Med 89 1996 181 183
21. J.M. Swegle, and C. Logemann Management of common opioid-induced adverse effects Am Fam Physician 74 2006 1347 1354 (Pubitemid 44607306)
22. J. Thomas, S. Karver, G.A. Cooney, B.H. Chamberlain, C.K. Watt, N.E. Slatkin, N. Stambler, A.B. Kremer, and R.J. Israel Methylnaltrexone for opioid-induced constipation in advanced illness N Engl J Med 328 2008 2332 2343 (Pubitemid 351749157)
23. G. Vanegas, C. Ripamonti, A. Sbanotto, and C.F. De Side effects of morphine administration in cancer patients Cancer Nurs 21 1998 289 297 (Pubitemid 28364171)
24. J.E. Ware, M. Kosinski, J.E. Dewey, and B. Gandek How to Score and Interpret Single-Item Health Status Measures: A Manual for Users of the SF-8 Health Survey 2001 QualityMetric Incorporated Lincoln, RI
25. C.S. Yuan Methylnaltrexone mechanisms of action and effects on opioid bowel dysfunction and other opioid adverse effects Ann Pharmacother 41 2007 984 993
26. C.S. Yuan, H. Doshan, M.R. Charney, M. O'Connor, T. Karrison, S.A. Maleckar, R.J. Israel, and J. Moss Tolerability, gut effects, and pharmacokinetics of methylnaltrexone following repeated intravenous administration in humans J Clin Pharmacol 45 2005 538 546 (Pubitemid 40562944)
27. C.S. Yuan, and J.F. Foss Antagonism of gastrointestinal opioid effects Reg Anesth Pain Med 25 2000 639 642
28. C.S. Yuan, and J.F. Foss Methylnaltrexone: Investigation of clinical applications Drug Dev Res 50 2000 133 141 (Pubitemid 30658862)
29. C.S. Yuan, and J.F. Foss Oral methylnaltrexone for opioid-induced constipation JAMA 284 2000 1383 1384
30. C.S. Yuan, J.F. Foss, M. O'Connor, T. Karrison, J. Osinski, M.F. Roizen, and J. Moss Effects of enteric-coated methylnaltrexone in preventing opioid-induced delay in oral-cecal transit time Clin Pharmacol Ther 67 2000 398 404 (Pubitemid 30246817)
31. C.S. Yuan, J.F. Foss, M. O'Connor, J. Osinski, T. Karrison, J. Moss, and M.F. Roizen Methylnaltrexone for reversal of constipation due to chronic methadone use: A randomized controlled trial JAMA 283 2000 367 372 (Pubitemid 30051755)
32. C.S. Yuan, J.F. Foss, M. O'Connor, J. Osinski, M.F. Roizen, and J. Moss Effects of intravenous methylnaltrexone on opioid-induced gut motility and transit time changes in subjects receiving chronic methadone therapy: A pilot study Pain 83 1999 631 635
33. C.S. Yuan, J.F. Foss, M. O'Connor, A. Toledano, M.F. Roizen, and J. Moss Methylnaltrexone prevents morphine-induced delay in oral-cecal transit time without affecting analgesia: A double-blind randomized placebo-controlled trial Clin Pharmacol Ther 59 1996 469 475 (Pubitemid 26151630)