Flexible Multiday Dosing of Etoricoxib Reduces Recall Pain and Rescue Medication Use
Though generally implemented as a single-day study used to assess the efficacy of analgesic medications, investigators designed a 3-day, double-blind, randomized, placebo-controlled study to evaluate the use of analgesic medications on Days 2 and 3 following third-molar extraction.
Patients with ≥2 third-molar extractions (≥1 impacted) were randomized to receive etoricoxib 90mg (n=190), etoricoxib 120mg (n=95), placebo (n=45), ibuprofen 600mg (n=190) four times daily, or acetaminophen/codeine 600mg/60mg (n=57) four times daily. Patients were permitted to take doses of their study medication as needed on Days 2 and 3, plus rescue medication (acetaminophen 325mg). Efficacy endpoints included average and worst recall pain (0–10 scale), as well as the frequency and use of study and rescue medication.
On Day 2, for “daily recall of worst recall,” the least squares mean differences from placebo were -0.97 (etoricoxib 90mg), -1.42 (etoricoxib 120mg), -0.79 (ibuprofen), and -0.48 (acetaminophen/codeine); on Day 3, the differences from placebo were -0.78 (etoricoxib 90mg), -0.37 (etoricoxib 120mg), 0.21 (ibuprofen), and -0.62 (acetaminophen/codeine). The percentage of patients requiring study medication and rescue medication on Day 2 was, respectively, 82.2% and 57.8% (placebo), 75.8% and 23.2% (etoricoxib 90mg), 53.2% and 17.9% (etoricoxib 120mg), 85.8% and 23.2% (ibuprofen), and 71.9% and 26.3% (acetaminophen/codeine).Jean Brown from Jean Brown Research, Salt Lake City, UT, and colleagues from the Premier Research Group, Austin, TX, and Merck Sharp & Dohme Corp., Whitehouse Station, NJ, concluded that these data show greater sensitivity for the analgesic agents compared with placebo on Day 2 than Day 3 and suggested a carryover effect from Day 1. This effect led to greater improvements in the worst recall pain endpoint as well as a reduced amount of study and rescue medication used on Day 2 for etoricoxib 120mg.