The U.S. Food and Drug Administration (FDA) announced on February 28th that the prescribing information for cholesterol reducing drugs in the statin class will include warnings about risk of increased blood sugar levels, HbA1c, and diagnoses of diabetes.
Drugs in the statin class include:
- Lipitor (atorvastatin)
- Lescol (fluvastatin)
- Mevacor (lovastatin)
- Altoprev (lovastatin extended-release)
- Livalo (pitavastatin)
- Pravachol (pravastatin)
- Crestor (rosuvastatin)
- Zocor (simvastatin)
Combination products that contain statins include:
- Advicor (lovastatin/niacin extended-release)
- Simcor (simvastatin/niacin extended-release)
- Vytorin (simvastatin/ezetimibe)
The FDA arrived at this decision based on results from two large statin studies and a review of other data. In Justification for the Use of Statins in Primary Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER) study the risk of diabetes was 27% higher in patients that received rosuvastatin (Crestor) than placebo treated patients. In the JUPITER study 3% of patients that received rosuvastatin compared to 2.4% of patients that received placebo developed diabetes. In Pravastatin or Atorvastatin Evaluation and Infection Therapy – Thrombolysis In Myocardial Infarction 22 (PROVE-IT TIMI 22) sub-study high-dose atorvastatin (Lipitor) was associated with increased blood glucose. Analysis of other published studies also showed that statins increase HbA1c and/or fasting blood glucose, and the risk of being diagnosed with diabetes regardless of the dose or statin used in the studies. Based on available evidence the FDA concluded that the public should be aware of this risk. The FDA also pointed out that the risk is small and the new information should not scare people. Interestingly, the change in prescribing information does not include pravastatin (Pravachol) because of the West of Scotland Coronary Prevention Study (WOSCOPS) where the incidence of diabetes was reduced by 30% in pravastatin treated patients compared to patients that did not receive pravastatin.
What does this all mean
There is no need to panic. Statins have been used for many years by millions of people, including diabetics, and their benefit on preventing heart attacks, strokes, and death outweighs the small increased risk of increased fasting blood glucose levels and diagnosis of diabetes.
Like other drug related side effects not all patients receiving statins will experience an increase in glucose levels or be diagnosed with diabetes. Most patients taking statins will not experience this side effect.
Your healthcare provider may check your blood glucose at your next scheduled visit.
There are other drug classes (for example, thiazide diuretics) that also increase blood glucose. They are still used because their benefits justify the risk. Healthcare providers screen for side effects and use alternative agents when needed.
This is a good time to discuss with your physician whether adhering to a better diet and regular exercise will greatly improve your cholesterol levels and remove the need to take a statin. Diet and exercise also reduces the risk for diabetes.
For healthcare providers:
The common belief that statins should be prescribed for everyone needs to be re-examined.
Patients with borderline reasons to be on a statin should probably be encouraged to stick to a better diet and exercise regimen.
A refocus on diet and exercise and elimination of other modifiable risk factors for heart disease is needed.
Patients taking statins should be screened periodically for diabetes.
This is an opportunity for healthcare providers to engage their patients in discussing their health.
- FDA Drug Safety Communication: Important safety label changes to cholesterol-lowering statin drugs.
- Ridker PM et al. Rosuvastatin to Prevent Vascular Events in Men and Women with Elevated C-Reactive Protein (JUPITER). N Engl J Med 2008;359:2195ş207.
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