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Single-dose zaltoprofen 160 mg shows noninferior antipyretic and analgesic effects when compared with loxoprofen 60 mg in acute upper respiratory tract infection.
A multicenter, placebo-controlled, randomized clinical trial evaluated whether a single dose of zaltoprofen 160 mg could deliver fever and pain relief comparable to loxoprofen sodium 60 mg for acute upper respiratory tract infection (URTI) management.
The study enrolled 330 patients, with 322 included in the final analysis, and allocated them to three groups: zaltoprofen, loxoprofen, and placebo. Each patient received a single dose and was closely monitored over a 4-hour post-dose period. Arata Azuma and other researchers assessed fever reduction through body temperature measurements and pain relief using a visual analog scale (VAS). Influenza A and B antigen testing was also performed, identifying a subgroup of 73 influenza-positive patients.
Within just 4 hours, both active treatments showed a clear clinical response—remarkable reductions in body temperature and pain scores when compared with baseline and placebo. Importantly, the magnitude of improvement was similar between zaltoprofen and loxoprofen across the overall population as well as in influenza-positive cases. On the key statistical endpoint, zaltoprofen successfully fulfilled the criteria for noninferiority, confirming that its antipyretic and analgesic effects are comparable to the established NSAID loxoprofen after a single dose.
Both interventions were well-tolerated, with no clinically meaningful safety concerns reported. Overall, the study highlights zaltoprofen as a fast-acting, effective alternative to loxoprofen, offering reliable relief from fever and pain in acute URTI—including influenza-related illness—within a short 4-hour window.
Pharmacology
Antipyretic and Analgesic Effects of Zaltoprofen for the Treatment of Acute Upper Respiratory Tract Infection: Verification of a Noninferiority Hypothesis Using Loxoprofen Sodium
Arata Azuma et al.
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