TKA Study: 32% Less Opioids With Meloxicam

New multicenter work which was sponsored by the manufacturer of the product under study, has produced novel data on the safety and efficacy of a preop ANJESO (meloxicam) injection in patients undergoing unilateral total knee arthroplasty (TKA) when used as part of a multimodal analgesic regimen.

The study, “Safety and Efficacy of Perioperative Intravenous Meloxicam for Moderate-to-Severe Pain Management in Total Knee Arthroplasty: A Randomized Clinical Trial,” appears in the January 27, 2021 edition of Pain Medicine.

This work, a randomized, double-blind, placebo-controlled trial, is based on 181 adults who had elective primary TKA. Patients either received ANJESO (manufactured by Malvern, Pennsylvania-based Baudaux Bio) 30 mg or placebo every 24 hours. The investigators primarily looked at total opioid use over a 24-hour period following surgery.

“Patients typically report high levels of pain after orthopedic surgery and managing this pain can be challenging. In this study we administered ANJESO prior to the start of the surgery helping us to stay ahead of the pain. Which is a critical component of patient care,” said Richard Berkowitz, M.D., University Orthopedic and Joint Replacement Center in Tamarac, Florida.

“In the past there has been a tendency to resort to opioids for pain control, given the risks associated with opioids such as addiction, gastrointestinal adverse events, pruritus, and respiratory depression, among others, there has been an increased need for alternative medications for patients undergoing elective or nonelective surgical procedures and it is encouraging to see these results.”

The Specifics

During the first 24 hours, ANJESO patients used ~32% less opioids and reported ~22% greater pain reduction than those who received the placebo. The researchers wrote, “Additionally, ANJESO-treated patients had significantly lower opioid consumption during the first postsurgical day, with a 31.7% reduction compared to placebo (mean 19mg vs. 28mg)…ANJESO-treated patients had a significantly longer time to first opioid rescue after surgery compared to placebo treated patients.

ANJESO-treated subjects had lower incidences of all cause hospital readmissions, fewer patients admitted to skilled nursing facilities upon discharge, and fewer emergency room visits, and doctor calls related to pain during the follow-up period.”

As noted by the researchers, adverse events were primarily mild or moderate and were unrelated to study treatment. There was a higher incidence of adverse events in the placebo group; the incidence of serious adverse events was higher in the placebo group.

OTW asked co-author Steward McCallum, M.D., about the development of ANJESO and he explained, “Overall, we studied over 1,500 patients in our clinical programs, and when we unblinded our efficacy and safety trials, we were very pleased to see the consistent trends of superior pain control, while using less rescue analgesics. Additionally, when we reviewed the adverse event profile, we observed similar rates to those patients treated with placebo.”

But why TKA as opposed to another kind of surgery?

Dr. McCallum chose an orthopedic speciality that was both common and put patients through painful post-op experiences. “We wanted to choose a condition many orthopedic specialists regard as particularly painful,” explained McCallum. “[We wanted to] conduct a study involving real world multimodal analgesia for one trial arm, and real world multimodal analgesia PLUS IV meloxicam (ANJESO) in another arm, to compare patient outcomes, and impact on health economics in both arms. These were the reasons to use the TKA study design. Our orthopedic colleagues advised us that using ANJESO in a multi-modal setting and pre-operatively would be important with respect to evaluating the safety and efficacy in this population.”

“ANJESO is a non-opioid IV pain management product that offers potent pain relief that is long-lasting (once a day IV dosing), and which has been well tolerated in use in a broad variety of orthopedic procedures. The double blind placebo controlled, randomized TKA trial has provided real world pharmaco-economic evidence that adding ANJESO as the NSAID [non steroidal anti-inflammatory] in a multimodal analgesic regimen can save the health system or the hospital significant costs (est. $1,800-2,000/patient) while being well tolerated and contributing potent pain management on a once a day basis. Many of the orthopedic surgeons we work with have reported to us that they believe ANJESO has contributed to their patients leaving the PACU [post-anesthesia care unit] and the ASC [ambulatory surgery center] or hospital sooner, along with fewer calls related to pain control after discharge.”