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Statins are a group of drugs used to lower cholesterol by inhibiting the enzyme HMG-CoA reductase. HMG-CoA reductase plays a role in the synthesis of cholesterol in the liver. Increased blood levels of cholesterol are associated with cardiovascular diseases. Statins have shown benefit in treating people with hypercholesterolemia (high cholesterol), and they are also now being used in people at low risk of cardiovascular disease as prevention.
The benefits of statins are quite clear. They work, and they help a lot of people. Any talk of the risk of statins has to be there. But there has been uncertainty regarding the safety of these drugs in recent years. The most common side effects reported with statins include increases in liver function tests, muscle aches, and rhabdomyolysis, a breakdown of muscle fibers. This would lead to questions of just what the drug companies should be telling doctors and end users about the risks of these drugs.
In recent years, there has been another concern: the possible relationship of the development of diabetes in patients taking statins. In 2008, a study on rosuvastatin (Crestor) to determine efficacy on vascular events suggested that statin use may result in the development of diabetes.
In 2010, an article published in The Lancet reviewed and analyzed 13 placebo-controlled trials to determine if the finding of the development of diabetes was consistent between trials. Results of this meta-analysis showed that there was a 9% increase in the risk of development of diabetes, mostly seen in patients over 60 years of age. Though this finding may seem odd, especially when statins have been shown to lower cholesterol in diabetic patients, other cardiovascular drugs such as thiazide diuretics, and beta-blockers have also been shown to lead to a higher risk of developing diabetes.
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Another study published in 2010 suggested that the risk for the development of diabetes is 1 in 255 patients treated for 4 years with statins. It is estimated that 5.4 deaths or myocardial infarctions would be avoided during this four-year period, resulting in a benefit in preventing total vascular events to the risk of developing diabetes ratio of 9:1. Thus it was suggested that the benefits outweigh the risk. My questions are: for everyone or just most people? Should we be thinly slicing it?
In February 2012, the FDA added new safety warnings to cholesterol-reducing statin drugs regarding increased risks of Type 2 diabetes. The FDA’s safety warnings extended to labels, which must now include warnings for patients and doctors that the drugs may cause increases in blood sugar levels and Type 2 diabetes.
In a recent publication in the August 2012 issue of The Lancet, researchers presented data from the JUPITER (Justification for Use of statins in Prevention: an Intervention Trial Evaluating Rosuvastatin) study, a randomized, placebo-controlled, double-blind clinical study investigating Crestor compared to placebo in 17802 healthy men and women. The study confirmed the well established beneficial effects of Crestor on cholesterol. In subjects with no major diabetes risk factors, there was no difference between groups with respect to the development of diabetes. Thus, there was a cardiovascular benefit with no diabetes risk in these patients.
In contrast, the incidence of diabetes was more frequent in subjects with one or more major diabetes risk factors in the Crestor group (270 reports versus 216 in placebo), with an average time in diagnosis of diabetes of 84.3 weeks in the Crestor group and 89.7 weeks in the placebo group. Although statins increased the risk for diabetes in patients who have risk factors for diabetes, subjects were 39% less likely to suffer a cardiac event, 36% less likely to have venous thromboembolism, and 17% less likely to die.
The results of this recent study demonstrate that caution should be used in patients with risk factors for diabetes. In summary, to date, the evidence suggests that there is no increased risk for the development of diabetes in patients using stains who do not have any major risk factors for diabetes. Those with one or more major risk factors for diabetes are at increased risk for the development of diabetes when using statins. However, as the risk for suffering a major cardiac event and death decreases with the use of statins, data currently suggests that the benefits of statins outweigh the potential diabetogenic effect of statins.
In another recent study, it was found that new onset diabetes risk was increased in subjects using Crestor, Atorvastatin (Lipitor), and Simvastatin (Zocor) and was associated with dose and duration of use. Fluvastatin (Lescol) only demonstrated a duration effect. Additional research in larger studies is needed to determine if the diabetogenic effect is different with different statins and to determine the biological mechanisms induced by statins that lead to development of diabetes.
What the point of all of this? First, our firm is not bringing any lawsuits alleging that these drugs are causing diabetes. Are they? Yes, of course, But that does not mean a lawsuit is warranted. What is important is that everyone is looking at this issue and really deciding on a patient-by-patient basis where the risk of these drugs makes sense.