The most recent study was published in BMJ (British Medical Journal) on May 29. It was conducted by researchers in Canada, who included data from six Canadian provinces and two international databases in an attempt to evaluate the increase in new onset diabetes linked to higher potency statins as compared with lower potency statins. Included in the study were almost 140 000 patients aged 40 and over who began taking statins between January 1, 1997 and March 31, 2011.
In their report, researchers note that two meta-analysis showed an increased risk of diabetes in patients who took statin medications. It was based on those two meta-analyses that the US Food and Drug Administration (FDA) approved a label change to statin drugs. The researchers did note, however, that there were issues with existing clinical trials of statins, including that they were not based on real-world use and not restricted to secondary prevention.
Researchers in the BMJ study found a “moderately increased risk of new onset diabetes in patients prescribed higher potency statins compared with lower potency statins.” The risk, approximately 15 percent higher in patients using high-potency statins, was noted over a two-year period, with the highest risk in the first four months of use.
They noted that although the increased risk was small, it warrants consideration because other studies comparing the effectiveness of high- and low-potency statins did not find a difference in mortality or serious adverse events.
In other words, for patients who use statins as a secondary prevention, high-potency statins may not offer any added benefit over low-potency statins but may come with slightly increased risks.
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One of the issues that makes studying the effects of statins difficult is that the risk of diabetes, which has been linked in studies to statin use, may also be increased by factors linked to the conditions patients take statins to treat. For example, patients who suffer myocardial infarction may be put on a statin, but lifestyle factors such as obesity, stress and diet may already increase their risk of diabetes. So statin users may already be at an increased risk of developing diabetes without using the statin, making it difficult to tell whether lifestyle or treatment is linked to the diabetes.
Lawsuits have been filed against the makers of statin drugs alleging patients were not adequately warned about the risks of taking the medications.