Injectable naltrexone tops disulfiram, acamprosate as safer option in alcohol use disorder
Key takeaways:
- Injectable naltrexone showed a more favorable safety profile than its oral counterpart and other alcohol use disorder medications.
- Therefore, it may be a better option for patients sensitive to side effects.
Injectable naltrexone had a more favorable gastrointestinal and liver safety profile compared with other medications for alcohol use disorder, according to a research letter published in Clinical Gastroenterology and Hepatology.
“Currently, only three medications are FDA-approved for AUD: disulfiram, acamprosate and naltrexone,” Soo Young Hwang, MD, a resident physician at University of Maryland Medical Center and research assistant in the gastroenterology unit at Massachusetts General Hospital, and colleagues wrote. “While prior studies evaluated the effectiveness and side effects individually, comparisons of safety profiles, particularly between oral and injectable naltrexone, remain unexplored.”
Image: Adobe Stock
To examine the GI and liver adverse effects of the FDA-approved medications for alcohol use disorder (AUD), Hwang and colleagues analyzed 2004 to 2023 reports from the FDA Adverse Event Reporting System (FAERS) database.
The researchers performed a disproportionality analysis to identify GI and liver adverse events associated with disulfiram, acamprosate, oral naltrexone and injectable naltrexone (Vivitrol, Alkermes), calculating the information component (IC) to measure the association between each drug and adverse event.
Overall, they collected 891 reports on disulfiram, 985 reports on acamprosate, 7,489 reports on oral naltrexone and 17,617 reports on injectable naltrexone.
Among all reports, the most common adverse side effects were elevated liver enzymes (n = 568), vomiting (n = 295), nausea (n = 209) and abdominal pain (n = 195).
Disulfiram had the strongest association with GI adverse events (median IC = 4.34; 95% CI, 4.07-4.54), followed by acamprosate (median IC = 0.92; 95% CI, –0.02 to 1.56), oral naltrexone (median IC = –1.42; 95% CI, –2.49 to –0.69) and injectable naltrexone (median IC = –2.22; 95% CI, –2.94 to –1.72).
The researchers observed that oral naltrexone had a reporting odds ratio (ROR) — which indicates the likelihood of an adverse event being reported for one drug compared with others — of 3.81 (95% CI, 2.89-5.01) in nausea and 2.19 (95% CI, 1.57-3.05) in vomiting, whereas injectable naltrexone had an ROR of 3.11 (95% CI, 2.57-3.81) in nausea and 1.14 (95% CI, 0.91-1.44) in vomiting. Disulfiram had an ROR of 2.91 (95% CI, 1.94-4.24) in abdominal pain and acamprosate had an ROR of 4.23 (95% CI, 2.97-5.93) in diarrhea, although both had figures lower than 1 for nausea.
Additionally, they found that the ROR for elevated liver enzymes was 0.53 (95% CI, 0.33-0.8) for oral naltrexone and 0.14 (95% CI, 0.1-0.19) for injectable naltrexone, compared with 7.08 (95% CI, 5.25-9.45) for disulfiram and 3.99 (95% CI, 2.79-5.6) for acamprosate.
“The treatment of AUD and prevention of [alcohol-associated liver disease] are crucial, but concerns about medication safety often hinder treatment initiation, particularly in chronic liver disease,” the researchers wrote. “Our findings suggest that injectable naltrexone demonstrated a more favorable safety profile compared to other AUD medications.”
Hwang and colleagues acknowledged several study limitations, including the fact that incidence rates could not be determined using the FAERS database.
Collapse
Read more about