10-Jun-15 4:00 PM  CST

New Cholesterol Lowering Drugs Show Promise

The most common way of treating high cholesterol or hyperlipidemia is by prescribing a classification of drugs known as “statins”. Statins or HMG-CoA reductase inhibitors, lower cholesterol levels by impeding the production of the enzyme HMG-CoA found primarily in the liver. High cholesterol levels have been positively linked to an increased risk for cardiovascular events such as heart attack or stroke. Frequently used statins on the US market today include, Lipitor (atorvastatin), Mevacor (lovastatin), Zocor (simvastatin), Crestor (rosuvastatin), Pravachol (pravastatin), as well as many others.


Statins have been responsible for helping to save countless numbers of lives, but not without the risk of some very serious and potentially life threatening side effects. In recent years evidence has shown that a cholesterol lowering therapy that includes the use of statins may lead to an increased risk of developing diabetes. Additionally, the use of statins has shown to potentially cause myositis, inflammation of the muscles that may lead to permanent damage of muscle tissue, as well as rhabdomyolysis, a condition that causes extreme pain and can cause an excessive amount of inflammation and damage to muscles. Rhabdmyolysis may also release proteins into the blood from damaged muscles that have the potential for causing severe damage to the kidneys.


It is because of these potentially serious and harmful side effects that statins have come under attack over the last several years. Since their entrance into the US market more than 17 million people have been placed on a cholesterol lowering therapy that includes a statin. However, earlier this week a FDA advisor panel recommended approval of a new class of cholesterol lowering drug. The drug, which is primarily meant for those who do not respond to or are unable to tolerate statins, may be a game changer in the cholesterol lowering drug market.  


PCSK9 inhibitors are one of the first new drug classifications to hit the US market in years. Repatha (evolocumab) marketed by Amgen and Praluent (alirocumab) by Sanfi are expected to receive full FDA approval later this year. Both drugs are said to have the potential to decrease LDL cholesterol levels as much as 60% in as little as 24 weeks.  Furthermore, individuals involved in the clinical trials for Repatha and Praluent maintained consistently lower LDL levels for as long as 78 weeks. Both Repatha and Praluent must be given as an injection, which may make their use limiting to some. Additionally, the new drugs come with a whopping price tag as well.


The cost of therapy for PCSK9 inhibitors or proprotein convertase subtillisin/kexin type 9 will potentially cost patients as much as $10,000 a year. While the FDA does take cost of new drug therapies into consideration they also weigh the potential of life saving benefit even more heavily. Although the drugs have not yet received full FDA approval, extensive clinical trials are expected to continue into 2017, the FDA is expected to take the advisory committee’s recommendations for approval.




Lieb, G., (2015), “FDA Advisory Panel Gives Green Light To New Class Of Cholesterol Medications”, Pioneer News, http://www.piercepioneer.com/fda-advisory-panel-gives-green-light-to-a-new-class-of-cholesterol-medication/41582, retrieved, 10 June 2015


Szabo, L., (2015), “New-Cholesterol Lowering Drugs Hold Promise, At A Huge Price Tag”, USA Today, http://www.usatoday.com/story/news/2015/06/08/pcsk9-inhibitors-fda-review/28696877/, retrieved, 10 June 2015  

For additional information on this article, please contact:
Kelley Simmons
Source: Sandy Andrews, CPhT, BLS  

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