Statins switching ‘may increase patients’ cardiovascular risk’

By Lilian Anekwe

Switching patients from branded to generic statins may increase their risk of cardiovascular events, according to new research.

A study presented at the European Society of Cardiology congress in Stockholm last weekend showed patients in the Netherlands switched from atorvastatin to simvastatin had a small but significant increase in cardiovascular events.

GPs have been set targets and come under increasing pressure in recent years to switch patients en masse from branded statins such as atorvastatin to equivalent doses of cheaper, generic statins as PCTs sought to save money by slashing primary care prescribing budgets.

Prescribing incentive schemes offered by PCTs came under threat of legislation last year, whenthe European Court of Justice initially recommended the schemes should be banned, claiming they meant GPs were being offered ‘inducements' to prescribe one drug instead of another.

But two months later the EC was forced to perform a major U-turn and gave PCTs the go-ahead to continue to offer financial incentives to encourage GPs to switch patients from branded to generic drugs, after the Medicines and Healthcare products Regulatory Agency argued PCTs were exempt from the law, which applied only to schemes of a commercial nature.

The Netherlands has adopted a similar approach to drug switching as was proposed by the previous Government – requiring all GPs to justify the prescription of a branded statin as of January 2009.

Data from a pharmacy database covering the majority of drugs dispensed in the Netherlands gave researchers patterns of switching from atorvastatin to generic simvastatin in nearly 40,000 Dutch patients in the first three months of 2009.

33.7%, 47.2% and 19.1% of Dutch patients initially on atorvastatin were switched to less potent, equipotent and more potent doses of simvastatin, respectively.

Of the patients on atorvastatin, 207 or 19.8% were predicted to develop cardiovascular disease over 20 years. In the switched-to-simvastatin group, the predicted number was 229 or 21.9%, equating to a number needed to harm of 48.

Associate professor Danny Liew, consultant physician at the University of Melbourne, concluded: ‘In the Netherlands, patients are being switched from atorvastatin to generic simvastatin at inferior doses, which might lead to a significant increase in future cardiovascular events. Maintaining patients on atorvastatin is sound from a health economic perspective.'

European Heart Journal (2010) 31 (abstract supplement) 597-598