Headlines Attack Anti-Inflammatory Drugs But Data Is 'Homogenized'
Last week's reports about Ibuprofen and other non-steroidal anti-inflammatory drugs (NSAIDs) creating higher risks for stroke and heart disease might have been a bit more balanced.
You see the data was taken from a 'meta-analysis,' a review of existing research studies, that were all conducted in different ways, at different times, and on different drugs, as opposed to coming from one study that systematically compared risk factors for each drug.
The review of 31 clinical trials involving more than 116,000 patients was conducted by researchers at the University of Bern in Switzerland, and is published this month in the British Medical Journal. Looking at various studies of the drugs naproxen, ibuprofen, diclofenac, celecoxib, etoricoxib, rofecoxib, lumiracoxib, and placebo, it was found that all of the NSAIDs resulted in two, three, or four times higher risk for heart disease and stroke than the placebo. The highest risks for cardiac death were associated with etoricoxib (Arcoxia) and diclofenac (Voltaren, Cataflam); the lowest withnaproxen.
"Our study provides the best available evidence on the safety of this class of drugs," the researchers wrote. "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-steroidal anti-inflammatory drug," the Bern researchers concluded.
That much appears to be so. But again, the manner in which the data was collected cannot conclusively establish risk for each drug. This was expressed very clearly by Dr. Eric J. Topol, directly of the Scripps Translational Science Institute, and one of the researchers who exposed the risks associated with Vioxx.
"Pooling large data sets like this winds up with ambiguity as it homogenizes differences in patient population characteristics, dose of drugs, how endpoints were ascertained and when, etc.," Topol said. "I am not sure if the conclusions reflect or agree with other meta-analysis results."
"Despite the limitations, this study has made many excellent contributions on the NSAID issue, so we need to factor these into the mix," Topol said.