Cardiovascular risks associated with low-dose ibuprofen and diclofenac as used OTC. (February 2014)

• Record Type: Journal Article
• Authors: Moore, Nicholas; Salvo, Francesco; Duong, Mai; Blin, Patrick; Pariente, Antoine
• Is Part Of: Expert opinion on drug safety. Volume 13:Number 2(2014:Mar.)
• Page Start: 167
• Page End: 179
• Publication Date: 2014-02
• Subjects: Drugs -- Side effects -- Periodicals; Drugs -- Toxicology -- Periodicals; Chemotherapy -- Periodicals; 615.704
• DOI: 10.1517/14740338.2014.846324
• Languages: English
• ISSNs: 1474-0338

Abstract

<abstract> <title> <x xml:space="preserve">Abstract</x> </title> <p> <bold> <italic>Introduction:</italic> </bold> The cardiovascular (CV) risks of non-steroidal anti-inflammatory drugs (NSAIDs) are dose- and duration-dependent. As over-the-counter (OTC) NSAIDs are widely used for the treatment of common painful disorders, without medical supervision, their cardiovascular risks need to be assessed.</p> <p> <bold> <italic>Areas covered:</italic> </bold> Individual clinical trials and observational studies of the CV risks associated with NSAIDs and meta-analyses thereof were retrieved and analysed. The article focuses on the risk associated with low-dose ibuprofen and diclofenac, two drugs available OTC in many countries. Very few studies reported on dose-related CV risks of NSAIDs. The usual cut-off for low-dose ibuprofen was 1200 mg daily, the upper limit of the approved OTC daily dose. For diclofenac, the usual cut-off was 100 mg, 33% above the approved daily dose for OTC preparations (75 mg/day). Only one study reported on the CV risks of doses at or below this limit. The studies retrieved found a clear dose-dependent risk with both drugs and no clearly increased cardiovascular risk for doses at or below the maximal approved OTC doses. No study looked at actual OTC usage.</p> <p> <bold> <italic>Expert opinion:</italic> </bold> At doses below the maximal daily OTC dose and for durations associated with OTC usage, there was no clear association with increased CV risk.</p> </abstract>