Results With PRALUENT
PRALUENT is proven to help reduce the risk of heart attack, stroke, and certain types of chest pain conditions (unstable angina) requiring hospitalization in adults with cardiovascular disease.
PRALUENT was studied in a large clinical trial of ~19,000 patients who had a previous heart attack or unstable angina requiring hospitalization. In this study, patients were taking the highest-tolerated dose of statin, with or without other cholesterol-lowering medications, and received either PRALUENT (9,462 patients) or placebo (9,462 patients).
Patients who received PRALUENT showed:
*Patients treated with PRALUENT had fewer heart attacks (6.6%) compared to placebo (7.6%).
†Patients treated with PRALUENT had fewer strokes (1.2%) compared to placebo (1.6%).
‡Patients treated with PRALUENT had fewer cases of unstable angina requiring hospitalization (0.4%) compared to placebo (0.6%).
In the same clinical study, fewer deaths were observed among patients treated with PRALUENT (3.5%) than those not treated with PRALUENT (4.1%).
PRALUENT has also been shown to effectively reduce bad cholesterol.
In clinical studies of adults with high blood cholesterol levels (including those with a type of high cholesterol called heterozygous familial hypercholesterolemia, also known as HeFH), adding PRALUENT reduced bad cholesterol levels by an average of
when taken alone or with other cholesterol-lowering medications and a healthy diet.
For patients with HeFH, clinical studies have shown that PRALUENT lowered bad cholesterol by up to 47% on average at 24 weeks when taken with other cholesterol-lowering medicines and a healthy diet.
Before starting PRALUENT
It’s important you tell your doctor about all of your medical conditions, including allergies, and if you are:
Pregnant or plan to become pregnant. It is not known if PRALUENT will harm your unborn baby. Tell your doctor if you become pregnant while taking PRALUENT.
Breastfeeding or plan to breastfeed. You and your doctor should decide if you would take PRALUENT or breastfeed. You should not do both without talking to your doctor first.
There is a pregnancy registry for women who take PRALUENT during pregnancy. The purpose of this registry is to collect information about your health and your baby’s health. You can talk to your healthcare provider or contact 1-877-311-8972 or go to https://mothertobaby.org/ongoing-study/praluent/ to enroll in this registry or get more information.
Tell your healthcare provider or pharmacist about any medicines you take, including prescription and over-the-counter medicines, vitamins or herbal supplements.
Possible side effects
PRALUENT can also cause serious side effects, including allergic reactions that can be severe and require treatment in a hospital. Call your healthcare provider or go to the nearest hospital emergency room right away if you have any symptoms of an allergic reaction including a severe rash, redness, severe itching, a swollen face, or trouble breathing.
The most common side effects include:
Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of PRALUENT. Ask your doctor or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
It is not known if PRALUENT is safe and effective in children.