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Updated September 01, 2015.

Praluent (alirocumab) is a LDL cholesterol-lowering medication that is currently indicated for anyone who has either been diagnosed with heterozygous familial hypercholesterolemia (HeFH) or atherosclerotic cardiovascular disease and has elevated LDL levels despite taking the highest tolerated dose of a statin. Praluent is a monoclonal antibody and is the first medication approved in a new class of cholesterol-lowering drugs, referred to as proprotein convertase substilisin kexin type 9 (PCSK9) inhibitors.

This medication was approved for use in the United States by the Food and Drug Administration in July 2015.

Praluent has been evaluated in a series of clinical trials known as the ODYSSEY trials, which examine the effectiveness and safety of Praluent in a variety of clinical situations. The current studies that have been completed and published for the current indications include: 

• ODYSSEY FH I and II - Clinical trials examining the effectiveness and safety of Praluent when added onto statin therapy in study participants diagnosed with HeFH. 
• ODYSSEY COMBO I and II - Clinical trials examining the effectiveness and safety of Praluent when added onto statin therapy in individuals who are at high risk of cardiovascular disease. COMBO II compared Praluent with Zetia.

In the studies conducted so far, LDL cholesterol was lowered in these participants by anywhere between about 30% and 60% compared to placebo after 24 weeks of therapy. There also did not appear to any notable differences in side effects experienced by participants taking Praluent versus those individuals taking a placebo.

There are several other studies that are continuing to investigate the use of Praluent in combination with other treatments - such as Zetia or LDL apheresis - in individuals who are at high risk of heart disease. Praluent is also being studied as an individual treatment in lowering LDL. 

 

How Does Praluent Work?

Praluent is a human monoclonal antibody that is very specific for and binds to a protein in the body referred to as proprotein convertase substilisin kexin type 9 (PCSK9). PCSK9 functions in the body by attaching to LDL receptors on liver cells, causing the receptor to break down in the liver. When LDL receptors are broken down, LDL cholesterol cannot be properly cleared – resulting in high LDL cholesterol levels in the blood. LDL receptors function by clearing LDL cholesterol circulating in the body. By blocking the action of PCSK9 with Praluent, LDL receptors will be able to continue to function by removing LDL cholesterol from circulation. This will cause LDL cholesterol to be lowered in the bloodstream.

 

How Should I Take This Medication?

This medication should be injected subcutaneously as directed by your healthcare provider every two weeks. Your healthcare provider may increase your dose, depending upon your response to the drug. Your healthcare provider will show you how to properly prepare and administer Praluent. While taking this medication, you should also be following a lipid-lowering diet. Your healthcare provider may test your blood periodically to check your LDL cholesterol levels.

 

What Side Effects Should I Expect While Taking Praluent?

The more common side effects that occurred during studies examining the effectiveness and safety of Praluent were injection site reactions, which included pain, redness, and swelling at the injection site. Muscle pain, nasopharyngitis, and influenza were also side effects experienced by some individuals. A slight elevation in liver enzymes was also observed in up to 2.5% of individuals taking Praluent. Less than 1% of patients in one study experienced amnesia, confusion, and memory impairment.

A small percentage of people taking Praluent also experienced allergic reactions from the medication. These reactions ranged from the development of a rash to more serious reactions, such as anaphylaxis, resulting in hospitalization. 

 

Who Should Not Take This Medication?

If you have ever had a serious allergic reaction to Praluent previously, you should not take this medication. This medication has not been tested in children, pregnant women, or women who are breastfeeding. Therefore, your healthcare provider will weigh the benefits and risks of administering Praluent to anyone fitting into these categories.

Although there are no recommendations for adjusting the dose in anyone who has mildly or moderately impaired kidney or liver function, Praluent has not been studied in individuals who have severe liver or renal disease.

 

Will This Medication Interact with Other Drugs that I Am Taking?

Currently, there do not appear to be many drug interactions between Praluent and other medications. In one study, it was noted that the half-life of Praluent was lowered by about 12 days when taken with statin therapy. However, there are no recommendations to change the current dosing regimen. You should notify your healthcare provider of any medications, over-the-counter drugs, and supplements that you are taking so that they can screen for potential drug interactions.

 

Bottom Line

Praluent is part of a newer class of LDL-lowering medications that is currently indicated in anyone who has been diagnosed with heterozygous familial hypercholesterolemia or is at very high risk of cardiovascular disease and is still in need of LDL - despite statin therapy. It is also being studied in combination with other LDL-lowering therapies, as an individual treatment, and in individuals who cannot tolerate statins.

Long-term studies are also still in the works. One recently published long-term study examined the use of Praluent compared to a placebo in participants at high risk or with established cardiovascular disease taking a statin for over 78 weeks. There were no distinct difference in side effects between the two groups. Additionally, LDL was still lowered by an average of about 50% at the conclusion of the study compared to placebo. Cardiovascular events -  including heart attack, stroke, or death due to such a condition - was also lowered in individuals taking Praluent. 

 

<sub>Sources:

Praluent® (alirocumab) Package Insert. Sanofi-Aventis US Pharmaceuticals. July 2015.

Robinson JG, Farnier M, Krempf M, et al. Efficacy and safety of alirocumab in reducing lipids and cardiovascular events. New Eng J Med 2015;372:1489-1499.

Kastelsein JJP, Robinson JG, Farnier M, et al. Efficacy and Safety of Alirocumab in Patients with Heterozygous Familial Hypercholesterolemia not Adequately Controlled with Current Lipid-Lowering Therapy: Design and Rationale of the ODYSSEY FH Studies. Cardiovasc Drugs Ther 2014;28:281-289.

Calhoun H, Robinson JG, Farnier M, et al. Efficacy and safety of alirocumab, a fully human PCSK9 monoclonal antibody, in high cardiovascular risk patients with poorly controlled hypercholesterolemia on maximally tolerated doses of statins: rationale and design of the ODYSSEY COMBO I and II trials. BMC Cardiovascular Disorders 2014, 14:121-131.

US National Institutes of Health Clinical Trials Website. www.clinicaltrials.gov. Accessed 29 August 2015</sub>