Tolerability, Safety, and Effectiveness of Oxycodone DETERx in Elderly Patients ≥65 Years of Age with Chronic Low Back Pain: A Randomized Controlled Trial

Abstract

Trial DesignThis was a phase III, randomized withdrawal, double-blind, placebo-controlled, enriched enrollment, parallel-group, multicenter study intended to demonstrate the safety, tolerability, and analgesic efficacy of oxycodone DETERx® (Xtampza™ ER) compared with matching placebo.MethodsThis post hoc analysis was performed using data from a subpopulation of enrolled patients who were ≥65 years of age. The study enrolled male and female patients with a clinical diagnosis of moderate-to-severe chronic low back pain for a minimum of 6 months prior to screening who required around-the-clock opioid therapy. To be eligible for enrollment, patients were required to have an average 24-h pain intensity score of ≥5 and ≤9 on an 11-point (0–10) Pain Intensity—Numerical Rating Scale at the screening visit. The study enrolled both opioid-experienced and opioid-naïve patients. The study consisted of an open-label titration phase followed by a 12-week double-blind maintenance phase. The dose range was 40–160 mg oxycodone hydrochloride equivalent per day. This post hoc analysis evaluated the safety, tolerability, and effectiveness of oxycodone DETERx among patients ≥65 years of age. The effectiveness of oxycodone DETERx was evaluated based on average pain intensity scores, Patient Global Impression of Change, responder analysis, and Kaplan–Meier survival analysis. The safety and tolerability of oxycodone DETERx were also evaluated. Patients were randomized to either oxycodone DETERx or placebo using a blocked randomization scheme in a 1:1 ratio. Randomization was stratified by previous opioid use (naïve or experienced). The study drug was coded in a manner that maintained the blinding. Study personnel and patients remained blinded to the assigned treatments throughout the study.ResultsFor this post-hoc analysis, the intent-to-treat and randomized safety populations included 52 patients ≥65 years old, 26 each in the oxycodone DETERx and placebo groups, who participated in the study during the titration phase and were randomized to the double-blind maintenance phase. Clinically important pain reduction from screening was achieved with oxycodone DETERx, with the median pain intensity score decreasing from 7.50 at screening to 2.69 at Week 12. A clinically meaningful treatment difference of −0.9 in pain score between oxycodone DETERx and placebo was observed. All 18 elderly patients who completed the study reported improvement in pain, with 62% showing ≥30% improvement and 54% showing ≥50% improvement in pain intensity compared with patients on placebo (p = 0.0128 and p = 0.0501, respectively). Patients on oxycodone DETERx remained in the study longer than those on placebo. Of the 26 patients ≥65 years old randomized to continue oxycodone DETERx during the double-blind maintenance phase, 18 (69%) completed the study; only two patients (8%) in the oxycodone DETERx group discontinued due to adverse events. The safety and tolerability profiles showed no new or unexpected safety concerns. The adverse event profiles were similar betw...

The Effect of Oxycodone on Post-operative Pain and Inflammatory Cytokine Release in Elderly Patients Undergoing Laparoscopic Gastrectomy

“…There are several research articles (17)(18)(19)(20) about the efficacy and safety of using oxycodone for elderly patients' analgesia that have similar findings to our research as well. Compared with common opioids, oxycodone has the advantage of having a better analgesic effect, especially for visceral analgesia, when used for relieving moderate and severe pain, with fewer adverse reactions, stable vital signs and a high level of safety.…”

The effect of oxycodone on postoperative pain and inflammatory cytokine release in elderly patients undergoing laparoscopic gastrectomy

“…There are several research articles [15,16,17,18] about the e cacy and safety of using oxycodone for elderly patients' analgesia that have similar ndings to our research. Compared with common opioids, oxycodone has the advantage of having a better analgesic effect, especially for visceral analgesia, when used for relieving moderate and severe pain, with fewer adverse reactions, stable vital signs and a high level of safety.…”

<p>Efficacy And Safety Of Controlled-Release Oxycodone For The Management Of Moderate-To-Severe Chronic Non-Cancer Pain In Japanese Patients: Results From An Open-Label Study</p>

“…These safety results are consistent with those from the concurrently performed study in patients with CLBP 25 and previous overseas studies. 18,21,[35][36][37] In the current study, patients with a history of drug dependency and patients whose major cause of pain was associated with psychosocial factors (BS-POP score of ≥11) were excluded based on pre-dose risk assessments for drug dependency. The BS-POP was developed by Japanese researchers as a tool to assess the association of psychosocial factors with pain in a convenient manner.…”