Shelley Wood

April 24, 2012

April 24, 2012 (Dubai, United Arab Emirates) — Controversy over the risk of diabetes associated with high-dose statins has prompted investigators across a wide range of studies to delve back into their data sets to look for a diabetes signal. In the case of the EFFECT study investigators, who presented results from their analysis at last week's World Congress of Cardiology 2012, a careful chart review through their 7746-patient study turned up no signal of increased diabetes risk for high-dose vs low-/moderate-dose statins.

Speaking with heartwire , Dr Altayyeb Yousef (Institute for Clinical Evaluative Sciences, Toronto, ON), lead author on the new analysis, noted that physicians for the most part believe that benefits outweigh risks for statins, but the recent FDA warning has created some reluctance to prescribe high-dose statins.

Yousef and colleagues used propensity matching to look at deaths, deaths or ACS, or new-onset diabetes in the EFFECT study cohort--all patients who had been hospitalized for acute MI. Comparing results among 2870 matched patients, they found no significant differences in any of those three end points out to five years. At each year out to five years, the risk of diabetes was actually lower, numerically, among the intensive-statin group as compared with the moderate-dose group, although differences were not statistically significant.

Likewise, the risk of death/MI was numerically higher among patients taking the lower-dose statins than among those taking higher doses, but not statistically different.

"The message for the public is that statins have documented benefits over many years. The risk of developing diabetes with a statin vs placebo is probably there, but when we talk about dose relationships, we can't find any evidence of a difference between doses," Yousef told heartwire .

Of note, the risk of developing diabetes in both the lower- and higher-dose statin groups was 4% at one year, something Yousef said was consistent with other studies. His group was able to track diabetes incidence out to five years, where it reached roughly 16% in both groups.

Yousef stated repeatedly, as have others, that the benefits of statins clearly outweigh the risk of diabetes. That said, no study has yet taken into account the contribution of new diabetes to long-term cardiovascular risk, he noted. He also stressed the need for large prospective studies looking at the statin risk/benefit profile in groups known to be at high risk for diabetes, including women with a history of gestational diabetes, as well as Asians and Native Americans.

In the meantime, he said, these groups might be best suited to pravastatin. "In WOSCOPS," Yousef said, "they found that pravastatin actually was beneficial in terms of reducing the risk of diabetes," although here again, there are no prospective statin comparisons supporting this strategy.