New Cholesterol Drug May Provide Alternative to Statins: Study

A new type of cholesterol drug could soon present people with an alternative to Lipitor, Crestor and other statins, according to the findings of new research presented over the weekend.  

The findings from studies examining the safety and effectiveness of a drug being called evolocumab were presented at the American College of Cardiology (ACC) annual meeting in Washington. The drug is one of a number being developed that blocks a substance known as PCSK9, which inhibits the liver from filtering out cholesterol.

Evolucumab is being developed by Amgen, but there are other PCSK9 blockers being developed as well, including Alirocumab, being developed by Sanofi SA and regeneron Pharmaceuticals; and Bococizumab, being developed by Pfizer.

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All appear to have effectively lowered LDL cholesterol, also known as “bad” cholesterol, in humans, according to the research presented. Evolucumab lowered LDL cholesterol between 55% and 65%; Alirocumab by 47% and Bococizumab by 45% to 67%, depending on the dose. However, observers say the studies do not indicate whether the drugs actually lowered the risk of heart disease; the main reason LDL cholesterol often needs to be lowered.

The new drugs are not without some potential drawbacks. They are shots that must be given either once a month or every two weeks, which users will likely be able to give themselves with a pen-like device. In addition, because they are proteins and not chemicals, the new drugs are likely to be far more expensive than statins, which can cost only pennies a day. Side effects revealed during the clinical trial included muscle aches and nausea.

None of the drugs have yet been approved by the FDA.

The PCSK9 blockers come as statins continue to dominate the cholesterol drug market and look poised to become further entrenched, thanks to recent policy changes by the ACC and the American Heart Association.

Late last year, the groups issued new directives to doctors on managing heart disease, saying at-risk Americans should be placed on statins and left on them indefinitely. The new policy discards the idea of goal LDL numbers and emphasizes that only statins should be used.

Some have estimated that the policy will result in millions of new statin users in the U.S. who have no hope of every getting off the drugs, which have been linked to a number of side effects.

Statins are among the best-selling drugs in the United States, with $14.5 billion in combined sales in 2008. They use the liver to block the body’s creation of cholesterol, which is a key contributor to coronary artery disease. However, a number of studies have linked the drugs to an increased risk of potentially serious injuries, including muscle damage, kidney problems, and diabetes.

In February 2012, the FDA required the makers of Lipitor, Crestor and other statins to add new warnings about the potential impact of the medication on blood glucose levels. However, many critics have suggested that the warnings are not strong enough for certain medications, indicating that users and the medical community should be provided with more accurate information about the diabetes risks with Lipitor, Crestor and other statins.

Pfizer currently faces hundreds of Lipitor diabetes lawsuits filed by women throughout the United States, who allege that use of the medication as a preventative measure to prevent heart failure has caused them to develop diabetes, which carries a number of health risks, including an increased risk of heart disease. Plaintiffs claim that the drug maker knew or should have known about Lipitor diabetes problems for years, but withheld information to avoid a negative impact on sales and growth of the blockbuster medication.

AstraZeneca also faces a number of Crestor lawsuits filed on behalf of former users of the cholesterol drug who were diagnosed with diabetes. Most of those cases are currently pending in California state court.

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