Evaluation of study discontinuations with tapentadol immediate release and oxycodone immediate release in patients with low back or osteoarthritis pain

Gary Vorsanger, PhD, MD; Jim Xiang, PhD; Akiko Okamoto, ScD; David Upmalis, MD; Bruce Moskovitz, MD

doi:10.5055/jom.2010.0015

Authors

Gary Vorsanger, PhD, MD
Jim Xiang, PhD
Akiko Okamoto, ScD
David Upmalis, MD
Bruce Moskovitz, MD

DOI:

https://doi.org/10.5055/jom.2010.0015

Keywords:

tapentadol, low back pain, osteoarthritis pain, study discontinuations, gastrointestinal tolerability, oxycodone

Abstract

Objective: To examine discontinuations due to nausea and/or vomiting or constipation with tapentadol immediate release (IR) or oxycodone IR treatment.
Design: Post hoc analyses of a 90-day, phase 3, randomized, double-blind, flexibledose study.
Setting: United States, Canada, United Kingdom.
Patients: Adults with moderate to severe low back or osteoarthritis (OA) pain for ≥3 months.
Interventions: Tapentadol IR 50 or 100 mg or oxycodone HCl IR 10 or 15 mg every 4-6 hours as needed.
Main outcome measures: Adverse events and discontinuations were recorded.
Results: Post hoc analyses included data from 679 patients receiving tapentadol IR and 170 receiving oxycodone IR (4:1 randomization). Tapentadol IR 50 or 100 mg and oxycodone HCl IR 10 or 15 mg provided similar levels of pain relief. Overall, 21.2 percent of patients receiving tapentadol IR discontinued treatment for adverse events versus 31.2 percent of patients receiving oxycodone IR. The percentage of patients who discontinued for nausea and/or vomiting was significantly lower with tapentadol IR (5.9 percent) than oxycodone IR (14.7 percent; p = 0.0003); patients treated with oxycodone IR discontinued because of nausea and/or vomiting significantly earlier than with tapentadol IR (p < 0.0001). The percentage of patients who discontinued because of constipation was significantly lower with tapentadol IR (1.5 percent) than with oxycodone IR (5.9 percent; p = 0.0023); patients treated with oxycodone IR discontinued because of constipation significantly earlier versus tapentadol IR (p = 0.0003).
Conclusions: A lower percentage of patients discontinued because of nausea and/or vomiting or constipation with tapentadol IR versus oxycodone IR while receiving comparable pain relief, suggesting tapentadol may improve the management of low back and OA pain.

Author Biographies

Gary Vorsanger, PhD, MD

Senior Director, Clinical Development, Ortho-McNeil Janssen Scientific Affairs, LLC, Raritan, New Jersey.

Jim Xiang, PhD

Technical Associate Director, Biostatistics, Ortho-McNeil Janssen Scientific Affairs, LLC, Raritan, New Jersey; Johnson & Johnson Pharmaceutical Services, L.L.C., Raritan, New Jersey.

Akiko Okamoto, ScD

Director, Clinical Biostatistics, Biometrics and Reporting GDO, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Titusville, New Jersey.

David Upmalis, MD

Senior Director, Neuroscience, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Titusville, New Jersey.

Bruce Moskovitz, MD

Therapeutic Area Head, Analgesia, Ortho-McNeil Janssen Scientific Affairs, LLC, Raritan, New Jersey.

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