Charles H. Hennekens, M.D., Dr.P.H, FACPM, FACC Sir Richard Doll Professor and Senior Academic Advisor Charles E. Schmidt College of Medicine Florida Atlantic University
PainRelief.com: What is the
background for this study? What are the
Response: About 29 million Americans use over-the-counter nonsteroidal anti-inflammatory drugs (NSAIDs) to treat pain. Every year in the United States (US), NSAID use is attributed to approximately 100,000 hospitalizations and 17,000 deaths. In addition, the U.S. Food and Drug Administration recently strengthened its warning about risks of non-aspirin NSAIDs on heart attacks and strokes.
While each over the counter and prescription pain reliever has benefits and risks, deciding which to use is complicated for healthcare providers and their patients.
Prof Chris Frampton PhD Department of Medicine
University of Otago
Christchurch, New Zealand
PainRelief.com: What is the background for this study?
Response: Acute pain is a significant burden to the individual and to society. In light of the ongoing opioid crisis, there is a need for effective nonopioid pain medications that provide improved analgesia over common analgesics, without compromising tolerability. Multimodal analgesia combines multiple drugs with different mechanisms of action to improve pain relief while limiting side effects. Fixed-dose combination tablets containing acetaminophen and ibuprofen are already available in many countries; however, the therapeutic advantages of such products are not available to patients in the United States. The US Food and Drug Administration (FDA) has restricted the dose of acetaminophen in prescription drugs to 325 mg per tablet, therefore an existing product containing acetaminophen 500 mg + ibuprofen 150 mg per tablet (two tablets per dose) has been downscaled to comply with FDA restrictions (acetaminophen 325 mg + ibuprofen 97.5 mg, three tablets per dose). The goal of this study was to determine the efficacy of the new fixed-dose combination of acetaminophen 975 mg and ibuprofen 292.5 mg (FDC 975/292.5) relative to acetaminophen or ibuprofen monotherapy, or placebo following the surgical removal of at least two impacted third molars.
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