Presented at the 2013 AAPM Annual Meeting « Back

Measuring the Functional Impact of Adverse Events (AEs)

William Rogers, PhD, whrogers3@verizon.net¹, Hong Chang, PhD¹, Lien Vo², Gary Vorsanger, PhD, MD², (1) Tufts Medical Center, Boston, Massachusetts, (2) Janssen Scientific Affairs, LLC, Raritan, New Jersey

Introduction: Impact of treatment-emergent adverse events (TEAE) on patient functionality in opioid studies is widely understood but imprecisely measured. Materials and Methods: Post-hoc analysis of two 15-week IRB-approved randomized, double-blind, active and placebo-controlled clinical trials in subjects with moderate-severe chronic low back pain (N=1023) or knee osteoarthritis (N=965) was conducted. Subjects were randomized to tapentadol ER, oxycodone CR, or placebo. TEAEs were grouped into 14 function-based AE categories based on patient-reported descriptions of TEAEs during the study classified into preferred terms. We compared the 8 SF-36 scales scores for subjects with and without AE, controlling for pain relief level. Results: AEs lowered non-pain (physical, role, social functioning, vitality, and mental health) SF-36 scores by 4.8 points (median) compared with assessments without AEs; however, the magnitude varied by event type and SF-36 scale. For example, constipation reduced role-emotional functioning by 6.8 points but mental health by only 2.2 points. Effects were larger for more severe AEs and those requiring countermeasures but did not differ by age (<65 vs. ≥65), treatment, or patient population. Compared with placebo, treatments achieved pain relief with positive impact upon SF-36, but substantially and differentially increased the probability of some AEs. For example, 31%, 16% and 6% of oxycodone CR, tapentadol ER and placebo subjects had constipation, respectively (differences P<.01). Similar results were observed for nausea, dizziness, psychological, vitality-related, and dermatologic TEAE but equivalent rates were observed for 8 other types. Conclusions: The findings suggest opioid-associated TEAE alter the ability of patients to function and may interfere with pain management.

Funding: This research was supported by Janssen Scientific Affairs, LLC.