When evaluating the complete body of evidence derived from the randomized trials on coxibs, it is evident that relatively few major trials have been conducted and most of these were not designed specifically to answer whether coxibs carry an increased thromboembolic risk.The analyses from the various trials are not unanimous, but they raise a clear warning sign concerning the cardiovascular risk associated with use of selective COX-2 inhibitors in general.
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Aspirin is indicated for pain relief in high doses (≥500 mg).
In low doses (75–150 mg), aspirin is not an effective analgesic, but contains its inhibitory effect on platelet aggregation by irreversible blockage of the COX-1 enzyme.
Results of such studies should be interpreted with caution due to their non-randomized design.
A particular concern is confounding by indication, i.e.
In 2006, the Multinational Etoricoxib and Diclofenac Arthritis Long-term (MEDAL) study compared etoricoxib with diclofenac (i.e. older COX-2 inhibitors) and found no difference in rates of thrombotic cardiovascular events.
The same year the Randomized, Controlled Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT) showed that naproxen carried an increased risk of cardiovascular and cerebrovascular disease in elderly patients with dementia.
The importance of the drug potency and plasma half-life can be illustrated by diclofenac.
Because diclofenac has a short half-life of 1–2 h, it is prescribed at high doses to produce the drug concentration necessary for effective analgesia throughout the entire dosing interval.
Given the current uncertainty regarding the safety of this class of agents and the rapidly accumulating data on their cardiovascular risks, this review summarizes the current evidence from randomized and observational studies on the cardiovascular safety of non-aspirin NSAIDs and presents a position for their use.
Non-steroidal anti-inflammatory drugs exhibit their anti-inflammatory effect by inhibiting COX, which is the rate-limiting enzyme in prostaglandin synthesis ( COX-1 is stimulated by hormones or growth factors.
Kearney The meta-analysis concluded that coxibs (RR = 1.42, 95% CI: 1.13–1.78), as well as high-dose diclofenac (1.63, 1.12–2.37) and ibuprofen (1.51, 0.96–2.37), were associated with a higher risk of vascular events, mainly myocardial infarction (1.86, 1.33–2.59), whereas high-dose naproxen was not (0.92, 0.67–1.26). Here, the safety profiles of individual NSAIDs varied considerably depending on the outcome, but naproxen seemed least harmful and not associated with myocardial infarction (0.82, 0.37–1.67) or cardiovascular death (0.98, 0.41–2.37).