Oxycodone-related side effects: Impact on degree of bother, adherence, pain relief, satisfaction, and quality of life

Kathryn P. Anastassopoulos, MS; Wing Chow, MPH, PharmD; Stacey J. Ackerman, MSE, PhD; Crisanta Tapia, MHS; Carmela Benson, MS; Myoung S. Kim, MBA, MA, PhD

doi:10.5055/jom.2010.0063

Authors

Kathryn P. Anastassopoulos, MS
Wing Chow, MPH, PharmD
Stacey J. Ackerman, MSE, PhD
Crisanta Tapia, MHS
Carmela Benson, MS
Myoung S. Kim, MBA, MA, PhD

DOI:

https://doi.org/10.5055/jom.2010.0063

Keywords:

oxycodone immediate-release, opioids, side effects, bother, quality of life, pain relief, patient satisfaction, oxycodone-related side effects

Abstract

Objectives: Oxycodone immediate-release, alone or in combination (hereafter, oxycodone), is widely used to treat pain and is often associated with bothersome side effects. The objective was to assess side effect frequency, degree of bother, and impact on health-related quality of life (HRQoL).
Methods: An online survey was completed by a nationwide convenience sample of patients currently taking oxycodone for nonmalignant pain. Detailed data on any oxycodone-related side effects were collected. Relationships between side effects, pain relief, and HRQoL (Physical Component Summary [PCS] and Mental Component Summary [MCS] of the Short Form 12-Item Health Survey) were explored.
Results: Among 601 respondents (average 45 years, 85.0 percent Caucasian, 69.1 percent female, 61.1 percent on oxycodone > 30 days), 84.0 percent were bothered by side effects with 30.8 percent quite a bit or extremely bothered. Over half were bothered by drowsiness (56.2 percent) and constipation (53.1 percent), over two-fifths by lightheadedness (43.6 percent) and dizziness (42.1 percent), approximately one-third by headache (33.1 percent) and nausea (31.3 percent), 27.6 percent itching, and 14.8 percent vomiting, which affected adherence to prescribed dosing regimens and, thus, is inversely associated with the level of pain relief. Patients who experienced less than 50 percent pain relief from oxycodone had worse PCS (33.9 vs 35.7; p = 0.038) and MCS (38.5 vs 42.4; p < 0.001) scores when compared with those who experienced 50 percent or more pain relief.
Conclusions: The majority of survey respondents experienced side effects of oxycodone, with a majority being bothered by side effects and impacting their QoL. This raises a question about the unmet need for pain medications with improved side effect profiles.

Author Biographies

Kathryn P. Anastassopoulos, MS

Covance Market Access Services Inc., Gaithersburg, Maryland.

Wing Chow, MPH, PharmD

Ortho-McNeil Janssen Scientific Affairs, LLC, Raritan, New Jersey.

Stacey J. Ackerman, MSE, PhD

Covance Market Access Services Inc., San Diego, California.

Crisanta Tapia, MHS

Covance Market Access Services Inc., San Diego, California.

Carmela Benson, MS

Ortho-McNeil Janssen Scientific Affairs, LLC, Raritan, New Jersey.

Myoung S. Kim, MBA, MA, PhD

Ortho-McNeil Janssen Scientific Affairs, LLC, Raritan, New Jersey.

References

National Center for Health Statistics: Health, United States, 2006, Special Feature on Pain with Chartbook on Trends in the Health of Americans. Hyattsville, MD: National Center for Health Statistics, 2006.

National Institutes of Health: NIH Guide: New Directions in Pain Research I; September 4, 1998. Available at http://grants.nih.gov/grants/guide/pa-files/PA-98-102.html. Accessed April 15, 2010.

McCarberg BH, Nicholson BD, Todd KH, et al.: The impact of pain on quality of life and the unmet needs of pain management: Results from pain sufferers and physicians participating in an internet survey. Am J Ther. 2008; 15(4): 312-320.

Benjamin R, Trescot AM, Datta S, et al.: Opioid complications and side effects. Pain Physician. 2008; 11: S105-S120.

Swegle JM, Logemann C: Management of common opioidinduced adverse effects. Ann Fam Physician. 2006; 74(8): 1347-1354.

Hale M, Upmalis D, Okamoto A, et al.: Tolerability of tapentadol immediate release in patients with lower back pain or osteoarthritis of the hip or knee over 90 days: A randomized, double-blind study. Curr Med Res Opin. 2009; 25(5): 1095-1104.

Bell T, Annuziata K, Leslie J: Opioid-induced constipation negatively impacts pain management, productivity, and healthrelated quality of life: Findings from the National Health and Wellness Survey. J Opioid Manage. 2009; 5(3): 137-144.

Clinical Study Report Protocol R331333-PAI-3004 (KF5503/34): Randomized, double-blind, active-controlled, parallel-group, multiple-dose trial conducted in subjects with chronic pain from low back pain or osteoarthritis of the hip or knee of 3 months duration. Document ID No.: EDMS-PSDB-6898318:2;J&JPRD, November 8, 2007.

Ware JE Jr, Kosinski M, Turner-Bowker DM, et al.: User’s Manual for the SF-12v2¨ Health Survey (with a Supplement Documenting Version 1). Lincoln, RI: QualityMetric Incorporated, 2002. 10. Cleeland CS: The Brief Pain Inventory User Guide. Houston, TX: University of Texas MD Anderson Cancer Center, 2009.

Dworkin RH, Turk DC, Wyrwich KW, et al.: Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008; 9: 105-121.

Cohen J: Statistical Power Analysis for the Behavioral Sciences. 2nd ed. New Jersey: Lawrence Erlbaum, 1988.

Coe R: It’s the effect size, stupid: What effect size is and why it is important. Paper presentation at the Annual Conference of the British Educational Research Association, University of Exeter, England, September 12-14, 2002.

Purdue Pharma L.P.: OXYIR® package insert. Stamford, CT: Purdue Pharma L.P., February 12, 2007.

Endo Pharmaceuticals: Percocet® package insert. Chadds Ford, PA: Endo Pharmaceuticals, November 2006.

Salzman RT, Roberts MS, Wild J, et al.: Can a controlledrelease oral dose form of oxycodone be used as readily as an immediate-release form for the purpose of titrating to stable pain control? J Pain Symptom Manage. 1999; 18: 271-279.

Aparasu R, McCoy K: Opioid-induced emesis among hospitalized nonsurgical patients: Effect on pain and quality of life. J Pain Symptom Manage. 1999; 18(4): 280-288.

Brown J, Klapow J, Doleys D, et al.: Disease-specific and generic health outcomes: A model for the evaluation of long-term intrathecal opioid therapy in noncancer low back pain patients. Clin J Pain. 1999; 15(2): 122-131.

Kosinski MR, Schein J, Vallow S, et al.: An observational study of health-related quality of life and pain outcomes in chronic low back pain patients treated with fentanyl transdermal system. Curr Med Res Opin. 2005; 21(6): 649-662.

Brown R, Zuelsdorff S, Fleming M: Adverse effects and cognitive function among primary care patients taking opioids in chronic nonmalignant pain. J Opioid Manage. 2006; 2(3): 137-146.

Cook SF, Lanza L, Zhou X, et al.: Gastrointestinal side effects in chronic opioid users: Results from a population-based survey. Aliment Pharmacol Ther. 2008; 27: 1224-1232.

U.S. Census Bureau: Home computers and internet use in the United States; October 2007. Available at www.census.gov/population/www/socdemo/computer/2007.html. Accessed September 17, 2009.

Hale ME, Fleischmann R, Salzman R, et al.: Efficacy and safety of CR versus IR oxycodone: Randomized, double-blind evaluation in patients with chronic back pain. Clin J Pain. 1999; 15: 179-183.

Caldwell JR, Hale ME, Boyd RE, et al.: Treatment of osteoarthritis pain with CR oxycodone or fixed combination oxycodone plus acetaminophen added to nonsteroidal anti-inflammatory drugs: A double bind, randomized, multicenter, placebo controlled trial. J Rheumatol. 1999; 25: 862-869.

Gammaitoni AR, Galer BS, Lacouture P, et al.: Effectiveness and safety of new oxycodone/acetaminophen formulations with reduced acetaminophen for the treatment of low back pain. Pain Med. 2003; 4: 21-20.