Results with PRALUENT
PRALUENT is proven to 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 (LDL) cholesterol.
In clinical studies (12-24 weeks) 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 from baseline by an average of
when taken alone or with other cholesterol-lowering medications and a healthy diet.
In a clinical trial of adults with homozygous familial hypercholesterolemia (HoFH), PRALUENT lowered bad cholesterol by an average of 36% compared to placebo when used with other cholesterol-lowering medications at 12 weeks.
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.
If you are pregnant during PRALUENT treatment, you are encouraged to call Regeneron at 1-844-734-6643 to share information about the health of you and your baby.
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. Stop using and 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, hives, severe itching, trouble breathing, or swelling of the face, lips, or tongue.
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.