Alirocumab (Praluent): A new treatment option for patient suffering from high cholesterol
Last Updated on December 9, 2015 by Joseph Gut – thasso
August 01, 2015 – On July 24, 2015, the American Food and Drug Administration (FDA) approved Alirocumab (Praluent) injection, the first cholesterol-lowering treatment approved in a new class of drugs known as proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors.
Alirocumab (Praluent) is approved for use in addition to diet and maximally tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia (HeFH) or patients with clinical atherosclerotic cardiovascular disease such as heart attacks or strokes, who require additional lowering of LDL cholesterol.
HeFH is an inherited condition that causes high levels of low-density lipoprotein (LDL) cholesterol. A high level of LDL cholesterol (known as “bad” cholesterol) in the blood is linked to cardiovascular disease. Heart disease is the number one cause of death for Americans, both men and women.
According to the Centers for Disease Control and Prevention, about 610,000 people die of heart disease in the United States every year– that equals one in every four deaths. Multiple clinical trials have demonstrated that statins lower the risk of having a heart attack or stroke. A trial evaluating the effect of adding Praluent to statins on reducing cardiovascular risk is ongoing.
Alirocumab (Praluent) is an antibody that targets a specific protein, called PCSK9, which works by reducing the number of receptors on the liver that remove LDL cholesterol from the blood. By blocking PCSK9’s ability to work, more receptors are available to get rid of LDL cholesterol from the blood and, as a result, lower LDL cholesterol levels.
The efficacy and safety of Alirocumab (Praluent) were evaluated in five placebo-controlled trials, involving 2,476 participants exposed to Alirocumab (Praluent). All participants had HeFH or were otherwise at high risk for heart attack or stroke, and were taking maximally tolerated doses of a statin, with or without other lipid‑modifying therapies. Participants taking Alirocumab (Praluent) had an average reduction in LDL cholesterol ranging from 36 to 59 percent, compared to placebo.
Patients should be aware that Alirocumab (Praluent) also comes with a series of adverse effects. The most common unwanted (side) effects of Alirocumab (Praluent) in the clinical trial setting included itching, swelling, pain, or bruising where injection was given, nasopharyngitis, and flu. Allergic reactions, such as hypersensitivity vasculitis (a skin rash usually appearing as purple-colored spots on the skin associated with inflammation of small blood vessels) and hypersensitivity reactions requiring hospitalization, have been reported with the use of Alirocumab (Praluent). Patients should stop using Alirocumab (Praluent) and get medical help if they experience symptoms of a serious allergic reaction. In addition, the true spectrum of adverse effects will only become visible after the use of Alirocumab (Praluent) in the general patient population as opposed to the carefully selected (based on inclusion and exclusion criteria) patients that have been included in the clinical trials.
Please note that as of July 24, 2015, the European Medicines Agency (EMA) has likewise recommended the granting of a marketing authorisation for Alirocumab (Praluent).
Sept...September 6, 2015
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The FDA just approved Repatha (Evolocumab), the second drug of the PCSK9 class of inibitors.