Anti Inflammatory Drugs Can Hurt Your Heart
Andrea Arfè, a Bocconi PhD student in Statistics, is the first signer of a research that could change the habits of hundreds of thousands of Europeans. Published in the British Medical Journal, the large observational study Non-steroidal anti-inflammatory drugs and risk of heart failure in four European countries: nested case-control study shows that non-steroidal anti-inflammatory prescribed drugs (NSAIDs) are associated with a 19% increase of risk of hospital admission for heart failure.
The link between the use of NSAIDs and an increased risk of heart failure had already been suggested and in some cases proved. The new study calculates the increase of risk and, most importantly, provides estimates for single drugs. The report may have a regulatory outcome: it was commissioned by the European Commission on behalf of EMA, the European Medicines Agency, to the project consortium Safety of Non-Steroidal Anti-Inflammatory Drugs (SOS).
NSAIDs are widely used for their anti-inflammatory, analgesic and antipyretic effects. The traditional ones, such as ibuprofen, inhibit the action of two co-enzymes, cyclooxygenase, or COX 1 and 2. When it was discovered that the inhibition of COX 1 led to an increased risk of gastrointestinal problems, new drugs that selectively inhibit COX 2 have been developed. They are the so-called Coxibs. New suspicions arose about the cardio-vascular risks of the latter selective inhibition, hence the call of the European Commission to study all anti-inflammatory drugs available on the market.
The research focused on twenty-seven drugs. It came out that the risk of hospitalization for heart failure increases when taking seven traditional NSAIDs (diclofenac, ibuprofen, indomethacin, ketorolac, naproxen, nimesulide, piroxicam) and two COX-2 inhibitors (etoricoxib and rofecoxib). «That's the most interesting result», Arfè says. «We found out that there is no difference between traditional NSAIDs and Coxibs. Indeed, some traditional NSAIDs bring a higher risk of hospitalization than some Coxibs. The association, therefore, is not dependent on the drug class. In some cases, the risk of admission for heart failure is doubled when some NSAIDs are used at very high doses. Now doctors have one more tool to decide which drug to prescribe».
The study lasted five years. Twenty international researchers led by Giovanni Corrao of the Università degli Studi Milano Bicocca have harmonized and processed the data featured in five healthcare databases from four European countries (the Netherlands, Italy, Germany, and the United Kingdom). The medical history of individuals that had used prescribed NSAIDs in the fourteen days preceding hospitalization for heart failure (mean age: 77) was compared with that of those who entered the hospital for the same reason, but weren't treated with NSAIDs.
Andrea Arfè was just 25 when the study began. «It was like being thrown into a high water pool, not knowing how to swim». A graduate in Statistics and Information Management at the Bicocca university, with a specialization in Biostatistics, Arfè has always had the ambition to combine theory and practical application. «It's the reason why I left the faculty of Mathematics to enroll in Statistics. The PhD in Statistics at Bocconi, which has a strong methodological and mathematics content, has strenghtened my knowledge. My aim now is to apply the methodological tools in medicine and epidemiology».
Given the massive use of anti-inflammatory drugs, some of which can be bought over the counter, the report has already attracted much attention by European media, from the BBC to the main Italian newspapers. Three more studies at this time under peer review may start a new discussion. They are authored by the same scholars and based on the same target population. Their aim is to verify the association between the use of NSAIDs and gastrointestinal events (bleeding of the upper digestive tracts), acute myocardial infarction and strokes.