Fixed-dose ibuprofen–acetaminophen combo a viable nonopioid option for acute pain
Fixed-dose combination of ibuprofen (IBU) and acetaminophen (APAP) produces better analgesic effects compared with either drug alone, as the combination acts rapidly, relieves pain for >8 hours, and is well tolerated, a study has shown.
Researchers examined data from two phase III dental pain studies involving healthy young patients who had moderate-to-severe pain after ≥3 molar extractions. The patients had received a single-dose fixed-dose combination of IBU/APAP 250 mg/500 mg (FDC), IBU 250 mg, APAP 650 mg, or placebo. Effects were evaluated over 12 hours (trial 1) or over 48 hours (trial 2).
A total of 568 patients were included in trial 1 and 123 in trial 2. The primary outcomes were time-weighted sum of pain intensity differences over 8 (SPID0–8) and 24 (SPID0–24) hours, respectively. Other assessments were time to meaningful pain relief (TMPR), duration of pain relief and tolerability.
In trial 1, results for SPID0–8 significantly favoured FDC over placebo, IBU and APAP (p<0.001, p=0.008 and p<0.001, respectively). The same was true in trial 2, where FDC produced greater improvements in SPID0–24 compared with placebo (p<0.001), in addition to having sustained efficacy during multiple dosing.
FDC demonstrated a rapid onset of action, with TMPR occurring within 1 hour of administration. Pain relief duration was >8 hours in both trials.
In terms of safety, FDC was well tolerated. The rates of adverse events were lowest with the combination.