Physicians Call for Better Guidance on the use of Statins

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On World Diabetes Day, outputs from a consultation with physicians, including cardiologists and diabetologists, held during the World Congress on Prevention of Diabetes and its Complications (WCPD) in Madrid, has highlighted a requirement for improved guidance on how to treat cardiovascular disease risk in patients at risk of developing diabetes.

This call for guidance has come in response to further evidence presented at the WCPD that demonstrates how statins differ in their effect on developing diabetes. In addition, consulted physicians noted that recent warnings about the potential for statins to cause diabetes in certain patients were causing other treating physicians to be more cautious about prescribing these lipid-lowering drugs.

"Although no-one doubts the huge benefit of statins in reducing cardiovascular disease," said Prof Kausik Ray, Professor of Cardiovascular Disease Prevention,St George's, University of London, "these insights demonstrate how the medical community is taking the diabetogenic risk of statins seriously and highlight the need for further research and guidance in how to treat patients with high cholesterol who are at risk of developing diabetes."

Although statins are considered safe and well-tolerated, conflicting data exist regarding the effects of some statins on the risk of developing diabetes. The largest meta-analysis of these data included 13 trials with a total of 91,140 participants and concluded that statin therapy is associated with a 9 percent increased risk of new-onset diabetes. These studies resulted in a change made to the labels of some statins to include a warning of this risk.

Mechanisms explaining the potentially higher incidence of diabetes with statin therapy have not yet been identified and studies looking at statins' effect on glucose metabolism suggest that the effect may differ between statins. There are a number of markers that can be used to measure impacts on glucose metabolism such as increased fasting plasma glucose and HbA1c in the blood. Some statins (e.g. atorvastatin) have been associated with increased HbA1c levels in patients receiving intensive, but not moderate, therapy. Other statins (e.g. pitavastatin) have demonstrated neutral or favourable effects on glucose control in patients with and without diabetes or metabolic syndrome.

New data presented during the WCPD demonstrated that both pitavastatin and pravastatin have no effect on fasting plasma glucose over 12 weeks in elderly patients and over six months in a group of patients with carefully defined metabolic syndrome who have multiple risk factors for diabetes. These data add to the building body of evidence suggesting pitavastatin has a positive effect on glucose metabolism and hence may not carry the same risk of developing diabetes as other statins. The J-PREDICT trial, currently being undertaken in Japan, will aim to clarify these data by evaluating the effect of pitavastatin on the risk for diabetes in more than 1,200 people with impaired glucose tolerance. This study is due to finish in 2015.