Alirocumab (Praluent) for the treatment of hypercholesterolemia and mixed dyslipidemia

Introduction

Alirocumab (trade name: Praluent) has been approved in Germany since September 2015 for the treatment of hypercholesterolemia or mixed dyslipidemia in adults. It is an option for several groups of patients:

  • People who can't lower their cholesterol levels enough despite using the maximum tolerated dose of .
  • People who can't lower their enough through their diet and other medications
  • People who can't have treatment with or who can't tolerate them due to side effects

Cholesterol is an essential raw material for our bodies. It is needed to produce certain and is an important building block in cell walls. There are two types:

  • “LDL” cholesterol: “LDL” stands for “low-density lipoprotein.” Cholesterol is transported in this form from the liver to where the body needs it. High levels of LDL cholesterol are associated with a higher risk of cardiovascular disease, which is why it is sometimes referred to as “bad” cholesterol.
  • “HDL” cholesterol: “HDL” stands for “high-density lipoprotein.” In this form, cholesterol is transported back to the liver from the body’s tissues. Because high levels of HDL cholesterol are associated with a lower risk of cardiovascular disease, it is sometimes called “good” cholesterol.

Triglycerides also play an important role. They are found in food and are an important source of energy for our body.

People are considered to have hypercholesterolemia (high cholesterol) if their LDL are too high. If their triglyceride levels are too high as well, it is known as mixed dyslipidemia. These people have a higher risk of cardiovascular diseases such as coronary artery disease. How high a person's actual risk is also depends on other individual risk factors too, though.

Alirocumab helps the liver to break down LDL cholesterol, and is thought to lower the risk of cardiovascular diseases.

Application

Alirocumab is injected under the skin using a pre-filled pen or syringe (75 mg or 150 mg). The recommended starting dose is 75 mg every two weeks. People who need to lower their LDL cholesterol more also have the option of starting with 150 mg every two weeks or 300 mg every four weeks. After that, the dose is adjusted on an individual basis. Patients can also inject themselves after being instructed how to do so by a doctor.

Treatment with alirocumab is combined with a low-fat diet. It can also be used together with other lipid-lowering drugs.

Other treatments

The standard treatment is a change in diet combined with lipid-lowering drugs such as . If medication and diet aren't enough, blood cleansing (LDL apheresis) combined with medication is an alternative. In LDL apheresis, some of the LDL is filtered out of the blood.

Assessment

In 2019, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) wanted to look into the advantages and disadvantages of alirocumab compared with the standard treatments for hypercholesterolemia and mixed dyslipidemia in adults.

The manufacturer provided one relevant study involving people who can't lower their enough despite using the maximum tolerated dose of . One group of participants (262 people) received alirocumab, and another group (140 people) had standard treatment with the drug ezetimibe. All participants continued taking their previous dose of and followed a low-cholesterol diet. The results of this study are described below. They are based on a treatment duration of about 2 years.

What are the advantages or disadvantages of alirocumab?

Alirocumab wasn’t found to have any advantages or disadvantages compared to ezetimibe.

No differences

  • Life expectancy: The study showed no difference between the two treatment groups in terms of life expectancy. In each group, 2 out of 100 people passed away.
  • No difference was found between treatment with alirocumab and ezetimibe in terms of the following, either:
    • Non-fatal heart attacks
    • Strokes
    • Hospital stays due to a cardiovascular condition
    • Severe side effects and stopping treatment due to side effects
    • Allergic reactions and skin reactions at the injection site

What remains unanswered?

Quality of life: No data was available concerning the effect of alirocumab on quality of life.

More information

This information summarizes the main results of reviews produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The reviews were commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of the reviews and the hearings received, the G-BA passed a resolution on the added benefit of alirocumab (Praluent).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Alirocumab – Benefit assessment according to §35a Social Code Book V. Dossier assessment; Commission A15-47. February 11, 2016. (IQWiG reports; Volume 326).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Alirocumab – Addendum to Commission A15-47. Commission A16-16. April 16, 2016. (IQWiG reports; Volume 383).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Alirocumab (primary hypercholesterolaemia or mixed dyslipidaemia) – Benefit assessment according to §35a Social Code Book V (new scientific findings). Dossier assessment, Commission A18-74. January 30, 2019. (IQWiG reports; Volume 720).

IQWiG health information is written with the aim of helping people understand the advantages and disadvantages of the main treatment options and health care services.

Because IQWiG is a German institute, some of the information provided here is specific to the German health care system. The suitability of any of the described options in an individual case can be determined by talking to a doctor. informedhealth.org can provide support for talks with doctors and other medical professionals, but cannot replace them. We do not offer individual consultations.

Our information is based on the results of good-quality studies. It is written by a team of health care professionals, scientists and editors, and reviewed by external experts. You can find a detailed description of how our health information is produced and updated in our methods.

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Updated on February 28, 2019
Next planned update: 2022

Authors/Publishers:

Institute for Quality and Efficiency in Health Care (IQWiG, Germany)

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