Just How Safe Are Our Common Painkillers (NSAIDs etc)?
Fri, January 21, 2011 at 03:00AM It's been estimated that, in the USA, 5% of all visits to a physician are related to prescriptions of anti-inflammatory painkillers. Some years ago a new class of so-called non-steroid, anti-inflammatory-agents (NSAIDs) was introduced; the principal representative of this class, which was called the COX-2 inhibitors, was Vioxx® (rofecoxib). But Vioxx was withdrawn after two years because it was shown to have an unacceptably high risk of cardiovascular side effects. More recently, reports have suggested that all NSAID's – both the earlier and the later COX-2 inhibitors – are associated with severe, albeit infrequent, side effects. In an effort to determine the actual risks associated with the use of this type of painkiller, Swiss researchers have conducted a meta-analysis of published and unpublished controlled studies of 7 anti-inflammatory drugs to determine their relative cardiovascular risk profiles. Their findings have been published online in the British Medical Journal.
Data from adequate, well-controlled clinical studies were available for the following drugs: naproxen (Aleve®), ibuprophen (Advil®, Motrin®), diclofenac (Voltaren®), celecoxib (Celebrex®), etoricoxib (Arcoxia®), rofecoxib (Vioxx®), and lumiracoxib (Prexige®). This represents the three most popular "classical" NSAIDs, and four COX-2 inhibitors. Attention was focused on heart attack (myocardial infarction or MI). Other outcomes included stroke, death from cardiovascular disease, and death from any cause. The total number of trials was 31, covering 116,000 patients with more than 115,000 patient-years of follow-up.
Compared to placebo, Vioxx was associated with the highest risk of heart attack (approximately 2.12-times that of placebo), followed by Prexige (twice that of placebo). (Neither of these drugs is at present marketed in the USA.)
Ibuprophen was associated with the highest risk of stroke (3.36-times that of placebo), followed by Voltaren (2.86-times). Arcoxia and Voltaren were associated with the highest risk of cardiovascular death (4.07- and 3.98-times that of placebo).
The authors of this study state: "although uncertainty remains, little evidence exists to suggest that any of the investigated drugs are safe in cardiovascular terms. Cardiovascular risk needs to be taken into account when prescribing any non-steroid anti-inflammatory drug." (This also goes for people taking over-the-counter drugs in high doses for long periods.) Most interesting perhaps is the finding that both the "classical" NSAID's (which are COX-1 inhibitors) and the COX-2 inhibitors tested all presented increased cardiovascular risk, without any obvious differences between the two groups. This suggests that the mechanism of these risks is independent of the binding capabilities of the drugs to the COX receptors in the body. In this analysis, naproxen (Aleve) seems to be the least harmful painkiller. The authors intend, however, to conduct a similar type of analysis with regard to the gastrointestinal side-effects of painkilling drugs, which may provide further answers to these questions, or just raise more questions.
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