Praluent (alirocumab) is a cholesterol-lowering injection used to reduce LDL cholesterol and lower the risk of heart attacks, strokes, and other serious cardiovascular events. It belongs to a class of drugs called PCSK9 inhibitors, and it’s typically prescribed when statins alone aren’t enough to bring cholesterol to safe levels.
FDA-Approved Uses
Praluent has three distinct approvals. First, it’s approved to reduce the risk of major cardiovascular events, including heart attack, stroke, death from coronary heart disease, and unstable angina requiring hospitalization, in adults who are already at elevated risk. Second, it’s approved alongside diet and exercise to lower LDL cholesterol in adults with high cholesterol (hypercholesterolemia) and in adults with two inherited forms of extremely high cholesterol: heterozygous familial hypercholesterolemia (HeFH) and homozygous familial hypercholesterolemia (HoFH). Third, it’s approved for children aged 8 and older with HeFH.
In practice, most people prescribed Praluent fall into one of two groups: those who’ve already had a heart attack or other cardiovascular event and need aggressive cholesterol control, or those with a genetic condition that keeps their cholesterol dangerously high despite taking statins.
How Praluent Lowers Cholesterol
Your liver clears LDL (“bad” cholesterol) from your blood using receptors on its surface that grab onto LDL particles and pull them out of circulation. Normally, a protein called PCSK9 breaks down those receptors after each use instead of letting them recycle back to the surface. Fewer receptors means less cholesterol gets removed, so LDL levels climb.
Praluent is a lab-made antibody that latches onto PCSK9 and blocks it from reaching those liver receptors. With PCSK9 out of the way, the receptors recycle and return to the liver’s surface in greater numbers. More receptors means more LDL gets pulled from the bloodstream, and cholesterol drops significantly.
How Much It Lowers LDL
The reductions are substantial. Across several large clinical trials, Praluent consistently cut LDL cholesterol by roughly 40 to 60 percent compared to placebo when added to existing therapy. In the ODYSSEY LONG TERM trial, patients saw an average 58% greater reduction in LDL compared to placebo at 24 weeks. Patients with familial hypercholesterolemia in the ODYSSEY FH trials experienced about a 54% treatment difference. Even the monthly dosing option delivered around a 56% reduction in the ODYSSEY CHOICE I trial.
These numbers represent the additional drop on top of whatever a patient’s existing medications (usually a statin) were already doing. For someone whose LDL is still stubbornly high at, say, 130 mg/dL on maximum statin therapy, adding Praluent could potentially bring that number down to the 55 to 75 mg/dL range.
Cardiovascular Benefits Beyond Cholesterol Numbers
Lowering LDL is the mechanism, but what patients care about is whether the drug actually prevents heart attacks and strokes. The landmark ODYSSEY OUTCOMES trial answered that question. It enrolled patients who had recently experienced an acute coronary event and found that Praluent reduced the rate of major adverse cardiovascular events to 9.5%, compared to 11.1% with placebo. That’s a 15% relative reduction in the combined risk of heart attack, stroke, cardiovascular death, and hospitalization for unstable angina. The results were statistically significant, which is why Praluent carries a specific FDA approval for cardiovascular risk reduction rather than just cholesterol lowering.
How It’s Taken
Praluent is a self-administered injection given under the skin of the thigh, abdomen, or upper arm. It comes in pre-filled pens or syringes, so there’s no mixing or measuring involved. The standard starting dose is 75 mg every two weeks. For people who prefer fewer injections, a 300 mg dose once a month is an option. If LDL doesn’t drop enough on the starting dose, the frequency can be increased to 150 mg every two weeks.
Most people achieve adequate LDL reduction on the lower 75 mg dose. Your cholesterol levels are typically rechecked 4 to 8 weeks after starting or changing a dose, which is how your doctor determines whether an adjustment is needed. The pens and syringes need to be stored in the refrigerator but can be left at room temperature for up to 30 minutes before injecting, which makes the shot more comfortable.
Who Is a Candidate
Praluent isn’t a first-line cholesterol treatment. It’s reserved for people whose LDL remains too high despite lifestyle changes and maximum-tolerated statin therapy, or for those who can’t take statins at all due to side effects like muscle pain. The most common candidates include people with established cardiovascular disease who need their LDL below a specific threshold, and people with familial hypercholesterolemia, a genetic condition where LDL levels can reach 200 to 500 mg/dL or higher even in childhood.
For the inherited forms of high cholesterol, diagnosis is made through genetic testing or clinical scoring systems that look at family history, physical signs (like cholesterol deposits around the eyes or tendons), and LDL levels. Children with HeFH can start Praluent at age 8, making it one of the few advanced cholesterol therapies available to pediatric patients.
What to Expect With Side Effects
The most commonly reported side effect is a reaction at the injection site: redness, itching, swelling, or pain where the needle went in. These reactions are generally mild and tend to improve over time as your body adjusts to the injections. Some people also experience cold-like symptoms, including a runny nose, sneezing, or a sore throat.
One concern doctors monitor is LDL dropping too low. While very low LDL hasn’t been definitively linked to serious harm in clinical trials, levels below 25 mg/dL prompt a conversation about dose adjustment. Allergic reactions are rare but possible, as with any injectable biologic. Most people tolerate Praluent well, and the dropout rates due to side effects in clinical trials were similar between Praluent and placebo groups.