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Long-term oral acetaminophen use shows inconclusive hepatic safety compared with loxoprofen and celecoxib in routine clinical practice.
A large-scale Japanese study has investigated the real-world risk of liver injury associated with oral acetaminophen compared with two commonly prescribed non-steroidal anti-inflammatory drugs (NSAIDs), loxoprofen and celecoxib. Using an electronic medical record database from 219 medical institutions, researchers analyzed 83,976 patients who received prescriptions for at least 28 days between January 2015 and December 2019.
The primary focus was on liver injury, defined as a diagnosis of liver disease plus elevated alanine aminotransferase (ALT) levels exceeding three times the normal upper limit. The study aimed to determine whether acetaminophen is non-inferior to loxoprofen or celecoxib in terms of liver safety, using a predefined non-inferiority margin of 1.39. Key findings revealed liver injury rates of 0.64, 0.52, and 0.41 events per 100 person-years for acetaminophen, loxoprofen, and celecoxib, respectively—differences that did not achieve non-inferiority.
Secondary outcomes exhibited rates of liver disease diagnosis at 1.51, 1.38, and 1.11 per 100 person-years, and ALT elevation at 9.69, 7.75, and 7.90 per 100 person-years, respectively. Three out of four secondary comparisons met the non-inferiority threshold. These results indicate that the liver safety of acetaminophen compared with NSAIDs remains inconclusive in real-world clinical practice, emphasizing the importance of monitoring liver function during prolonged intervention.
The Journal of Clinical Pharmacology
Real-World Hepatic Safety of Oral Acetaminophen Versus Loxoprofen/Celecoxib: Using a Nationwide Electronic Medical Record Database
Yasuyuki Okumura et al.
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