Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Does changing statin "raise risk"?

The results of an observational study reported at the European Society of Cardiology Congress and due for publication in the British Journal of Cardiology claim that changing statin therapy from atorvastatin to simvastatin increases the relative risk of cardiovascular events and death by 30%. This story has been reported in the media and at PharmaTimes.

The data available so far are insufficient to support worthwhile conclusions however there are some points of interest:

  • The data analysed relate to 1997 to 2005, this predates the bulk of NHS led switching (this is probably why only 2,511 case of switching from atorvastatin to simvastatin were identified
  • There were no apparent corrections for the dose of statin used
  • No indication is given for why patients were switched
  • The study is observational and therefore does not demonstrate causality

Patients are likely to be alarmed by this story however more analysis needs to be conducted and the full results need wider discussion before decisions to alter treatments are made.

It is also worth noting the results of the recent ASPEN study published in Diabetes Care. This study recruited 2,410 patients with type 2 diabetes, randomised them to atorvastatin 10mg or placebo and followed them up for 4 years for coronary heart disease endpoints. Treatment with other lipid regulating drugs was ceased at least 4 weeks prior to screening.

At the end of this study there were no statistical differences in the primary endpoints. Explanations offered for the lack of significance in the results were the "overall study design, the types of subjects recruited, the nature of the primary end point, and the protocol changes required because of changing treatment guidelines".

Perhaps the main message to take from both of these studies is that cholesterol level is one risk factor among many. Treating cholesterol in isolation is unlikely to gain benefit unless some interventions are made into other key areas including diet, lifestyle, exercise, smoking and blood pressure.

Action: Clinicians should be aware of this story in the media and the limitations in the currently available information. Clinicians can reassure patients that cardiovascular risk is treated using several approaches, one of which is lipid lowering.

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