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October 09, 2021
10/9/2021 7:45:00 AM - 10/12/2021 3:00:00 PM
Room Virtual
Elevated Body Mass Index Does Not Affect Adverse Events Associated With Oliceridine, An Intravenous Opioid Agonist
Joseph Answine, M.D., Timothy L. Beard, M.D., Cathy Michalsky, M.S., Kanaka Sridharan, M.S., Linda Wase, M.D., Mark A. Demitrack, M.D., Ashraf S. Habib, M.D.
UPMC Pinnacle, Harrisburg, Pennsylvania, United States
Disclosures:   J. Answine: Consulting Fees; Self; Trevena, Inc. T.L. Beard: Consulting Fees; Self; Trevena, Inc. C. Michalsky: Salary; Self; Trevena,Inc.. Stock Options; Self; Trevena, Inc. K. Sridharan: Salary;
Background: In the postoperative setting, obesity has been shown to increase the likelihood of opioid-related adverse events (ORAEs), including respiratory and gastrointestinal events by 11%.1 This has a negative impact on patient health outcomes and can compromise optimal pain management.1 Oliceridine, a new class of intravenous opioid analgesics acting at µ-opioid receptors, is selective for G-protein signaling (achieving analgesia) with limited recruitment of β-arrestin (associated with ORAEs).2 Previously in an exploratory analysis of a subgroup of patients undergoing a broad range of surgical procedures from the Phase 3 ATHENA open-label, multicenter study; we reported that the incidence of respiratory events associated with oliceridine was not affected by elevated body mass index (BMI).3 Here we report the overall ORAEs from the ATHENA study by BMI categories (<30 kg/m2, 30-40 kg/m2 and >40 kg/m2). Methods: Men and women aged ≥ 18 years experiencing moderate to severe acute pain (a score ≥ 4 on an 11-point numeric pain rating scale [NRS]) following surgery or with a painful nonsurgical medical condition, received IV oliceridine as needed via bolus dosing (1 to 3 mg q1−3h) and/or patient-controlled analgesia (PCA loading dose: 1.5 mg; demand dose: 0.5 mg; 6-min lockout interval). Multimodal non-opioid analgesics were permitted. For this exploratory analysis, safety and tolerability of oliceridine assessed by the incidence of observed or self-reported AEs, coded based on verbatim reported terms, using the Medical Dictionary for Regulatory Activities (MedDRA, Version 19.0) are reported by BMI categories (<30 kg/m2, 30-40 kg/m2 and >40 kg/m2). Results: A total of 768 patients were treated with oliceridine (up to 6 days). Among these, 416 (54.2%) had a BMI < 30 kg/m2, 279 (36.3%) had a BMI 30-40 kg/m2, and 73 (9.5%) had a BMI > 40 kg/m2. Mean age (± SD) was 52.6 ±17.5 , 56.9±14.0 and 51.6 ± 13.4 years, and age ≥ 65 years was 29.8%, 37.9% and 23.3%, in the three BMI categories, respectively. Baseline NRS pain score was 6.2 ± 2.0, 6.3 ± 2.2 and 6.6 ± 2.5 in patients with BMI < 30 kg/m2, 30-40 kg/m2 and > 40 kg/m2, respectively. At least half of all patients in both BMI 30-40 kg/m2 and > 40 kg/m2 categories and 58.4% of patients with BMI < 30 kg/m2 received oliceridine as a bolus dosing. Overall, 84% of the patients received multimodal non-opioid analgesic therapy (acetaminophen, NSAIDs, gabapentinoids) concomitantly with oliceridine. The cumulative dose and duration of exposure of oliceridine were comparable across the BMI categories (Table 1). The most common ORAEs were nausea, vomiting, constipation, headache, hypokalemia and pruritus. The incidence of ORAEs was comparable across the BMI categories (Table 2). Conclusion: Elevated BMI was not associated with increased risk of ORAEs in this analysis. Use of Oliceridine IV in the management of moderate to severe acute pain may be clinically appropriate in obese/morbidly obese individuals.1Kessler ER, et al Pharmacotherapy 2013; 33: 383-391. 2DeWire SM, et al J Pharmacol Exp Ther 2013; 344: 708-717. 3Brzezinski M, et al Pain and therapy 2021.
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