According to experts, the blockbuster cholesterol drug Lipitor may increase the risk of diabetes.
What is Lipitor?
Lipitor (atorvastatin) is a statin-based cholesterol drug manufactured by the Pfizer subsidiary Warner-Lambert. The cholesterol drug is a best seller and has achieved blockbuster status. Lipitor has produced more than $125 billion in sales before the patent expired in 2011. Now off patent, several generic Lipitor versions are available.
Lipitor Mechanism of Action
Lipitor and similar medications are known as “statins”, Lipitor is an HMG-CoA reductase inhibitor, which blocks a key enzyme in the bodies production of cholesterol. Lipitor is prescribed to reduce the amounts of cholesterol in the blood. Plaintiffs claim that Pfizer failed to adequately warn that Lipitor side effects may increase the risk of diabetes.
Lipitor Diabetes Risk
A number of medical studies have found that there is an association between Lipitor and type 2 diabetes. Type 2 diabetes is a serious medical side effect to develop from the use of lipitor, and can increase cardiac and kidney complications.
Possible Lipitor Diabetes Mechanisms
Several possible mechanism are postulated to play a role, either singularly or in various combination of factors, that could explain the increased risk of new onset diabetes among patients receiving Lipitor.
There is an increased production of plasma derived low density lipoprotein (LDL) cholesterol as a compensatory response to reduction of liver produced cholesterol, that might result in direct inflammation and oxidation within the β cell of the pancreas which produces Insulin.
In other words, by reducing the liver production of cholesterol, the body compensates by increasing blood production of cholesterol, which inflames and attacks the cells in the pancreas that produces Insulin. This leads to reduced Insulin and then Diabetes.
Additionally, metabolic receptor effects interfere with cellular glucose uptake, energy production, and insulin secretion.
Statins can also block calcium mediated pancreatic insulin release and decrease expression of the β cell glucose transporters GLUT-2 and GLUT-4.
Finally, statins are also known to interfere with the synthesis of ubiquinone (CoQ10), which could independently alter insulin secretion.
FDA Warning
In February 2012, the FDA announced a new label warnings on Lipitor and other statins to alert patients to the possible increased risk of diabetes.
Medical Studies of Diabetes Risk
- In a The Lancet study, in February 2010, researchers found that side effects of statins, which include Lipitor and other drugs, may increase the risk of being diagnosed with type 2 diabetes. Researchers from University of Glasgow analyzed 13 different prior studies to identify the potential risk of diabetes with Lipitor and other statins.
- In a study in the Journal of the American College of Cardiology, March 2011, researchers found that Lipitor patients had about a 33% higher risk fo developing type 2 diabetes over five years when compared to those taking a placebo. The study looked specifically at the link between Lipitor and diabetes.
- In a study in the Journal of the American Medical Association (JAMA), in June 2011, researchers found that high doses of Lipitor and other statins were linked to onset of diabetes. Among individuals given intensive-dose statin therapy, the rate of diabetes was about 1 out of every 500 users.
- In a study in the Archives of Internal Medicine, January 2012, researchers found that older women taking Lipitor and other statins may face a 50% increased risk of developing type 2 diabetes. Researchers examined data on more than 160,000 women who participated in the Women’s Health Initiative (WHI) between the ages of 50 and 79, finding that nearly 10% of women who took statins developed type 2 diabetes within 9 years, compared with 6.4% of those who did not take statins but still developed diabetes.
- Risk of incident diabetes among patients treated with statins: population based study, BMJ May 2013, found the highest risk of diabetes with Lipitor use.
Plaintiff Lawsuit Complaints
Plaintiffs allege that Pfizer knew or should have known about this potential side effect for years, and failed to provide accurate information to patients or their doctors about the potential diabetes risk or the importance of closely monitoring blood glucose levels to see if Lipitor affects blood sugar levels.