Although several other studies have demonstrated the overall analgesic superiority of ibuprofen to acetaminophen, this study demonstrated that the liquigel formulation also provides a clinically relevant advantage for time to analgesic effects.

Background :  Delineation of non‐steroidal anti‐inflammatory drug (NSAID) gastrointestinal toxicity has largely depended on retrospective epidemiologic studies which demonstrate that lower doses of NSAIDs pose a lower risk of gastrointestinal toxicity. Ibuprofen, a propionic acid NSAID, has, in most such studies, exhibited a favourable profile in terms of gastrointestinal bleeding. Since 1984, ibuprofen has been available as a non‐prescription analgesic/antipyretic with a limit of 1200 mg/day for 10 days of continuous use. Trials and spontaneously reported adverse experiences suggest that gastrointestinal symptoms and bleeding are rare. Methods : This study prospectively evaluated the gastrointestinal tolerability, as compared to placebo, of the maximum non‐prescription dose and duration of ibuprofen use in healthy subjects representative of a non‐prescription analgesic user population. Results : Gastrointestinal adverse experiences were similar in the placebo and ibuprofen groups (67 out of 413, 16% with placebo vs. 161 out of 833, 19% with ibuprofen). There was no difference between the two groups in the proportion discontinuing due to a gastrointestinal event. Gastrointestinal adverse experiences reported by ≥ 1% of subjects were: dyspepsia, abdominal pain, nausea, diarrhoea, flatulence, and constipation. Seventeen (1.4%) subjects had positive occult blood tests: their frequency was comparable between treatments. Conclusions : When used as directed to treat episodic pain, non‐prescription ibuprofen at the maximum dose of 1200 mg/day for 10 days, is well‐tolerated.

The Children's Analgesic Medicine Project (CAMP) was a multicenter, all-comers, openlabel, prospective study to compare the safety of ibuprofen suspension with acetaminophen suspension in children with fever and/or pain. Four hundred and twenty four (424) pediatricians enrolled 41 810 children (aged 1 month to 18 years old) at 69 US clinics. Safety data included information concerning medication use and adverse events (AEs) summarized by severity and analyzed by age groups (younger and older than 2 years). Among 30 144 children who took at least one dose of ibuprofen or acetaminophen, 14 281 were younger (< 2 yrs) and 15 863 were older ([Symbol: see text] 2 to < 12 yrs). Within both age groups, the incidence rates for specific AEs, including abdominal pain, insomnia, and hyperkinesia were rare and generally < 1% for both treatments. For younger children, fever, vomiting, diarrhea, rhinitis, rash and otitis media were the only AEs with an incidence rate > 1% (in either treatment group). For older children, the only AEs with an incidence rate > 1% in either group were rhinitis, pharyngitis and otitis media. AEs were generally mild to moderate for both treatments within the two age groups. There were no serious AEs, including anaphylaxis, Reye's syndrome, renal failure, GI bleeding/perforation or necrotizing fasciitis. There was a slightly higher overall incidence of side effects in the ibuprofen group (17.6% vs. 15.0%) for the younger children; and similar results were seen in the older children (11.9% vs. 10.7%). This may have been due to the preference of physicians to treat the sicker children with ibuprofen. There were four deaths, all unrelated to study medication, all occurring in children < 2 yrs (herpes encephalitis, sepsis due to 5. pneumoniae, medulloblastoma, and sudden infant death syndrome). The safety of ibuprofen suspension in children < 2 yrs was demonstrated in this study. The safety profile in children < 2 yrs is consistent with the excellent profile observed in children [Symbol: see text] 2 yrs. Overall, ibuprofen exhibited an AE profile similar to acetaminophen in both younger and older children.

Many clinicians appear confused about the purported clinical advantages of the new generation COX-2 inhibitors compared to both over-the-counter and prescription nonsteroidal anti-inflammatory analgesic agents (NSAIDs). Infact, there is a paucity of published information comparing the safety and efficacy of these two classes of drugs when used to treat acute pain. This study was designed to compare the safety and analgesic efficacy of an over-the-counter (OTC) analgesic, ibuprofen (Advil Liqui-Gels), to the leading prescription COX-2 inhibitor celecoxib (Celebrex). Ibuprofen liquigel is an encapsulated, solubilized potassium salt of ibuprofen that has a higher Cmax and shorter tmax than traditional ibuprofen solid-dosage formulations. This trial evaluated the maximum approved OTC dosing regimen (400 mg x 3, q4-6h) of ibuprofen liquigels compared to a single dose of celecoxib (200 mg) and placebo in 174 patients with moderate orsevere pain following surgical extraction of impacted third molars. The study design was multiple dose, randomized (stratified by baseline pain and gender), placebo controlled, double blind, double dummy, and parallel group. The onset of pain relief was determined using a two-stopwatch procedure. Treatments were also compared using standard indices of pain intensity and pain relief. The study demonstrated assay sensitivity in that both active medications were significantly more effective than placebo for all efficacy measures. In comparing the two active medications, the time to meaningful relief was significantly shorter, and the mean 4-, 8-, and 12-hour summed pain relief combined with pain intensity difference scores were significantly higher for ibuprofen liquigels compared with celecoxib (p < 0.001). Analyses of other key efficacy variables, including the time to rescue medication and the patients' overall assessment of study medication, confirmed the superior efficacy of ibuprofen liquigels over celecoxib. Both active treatments were well tolerated, with no differences in incidence or severity of adverse events. Of particular interest, there were no differences in gastrointestinal-related side effects when comparing these doses of ibuprofen liquigels to celecoxib. In conclusion, ibuprofen liquigels were a significantly more effective analgesic and provided relief significantly faster compared with celecoxib in the treatment of postsurgical pain.

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