Sometimes diet and exercise are not enough to lower cholesterol levels. Many different medicine options exist, including Leqvio, which can be used alone or with other medicines to help people reach their target cholesterol levels. Leqvio (inclisiran) is an injectable medicine that lowers LDL cholesterol in adults with high cholesterol. It has been studied in people with atherosclerotic cardiovascular disease (ASCVD), a condition in which plaque buildup narrows the arteries.
How Does Leqvio Work for Hyperlipidemia?
Hyperlipidemia or dyslipidemia, often referred to as high cholesterol, is a common condition that occurs more often as people age. People with this condition have high levels of certain types of fats in the blood. Although these fats play an important role in the body, over time, high levels can increase a person’s risk for heart disease, stroke, heart attack, and other issues.
One of these fats – low-density lipoprotein (LDL) cholesterol – is known as “bad” cholesterol because it can build up in the arteries, eventually causing heart disease. Triglycerides are another type of fat that can cause health issues when levels get too high. A different type of fat – high-density lipoprotein (HDL) cholesterol – is known as “good” cholesterol because it helps the liver to use and get rid of LDL (“bad”) cholesterol.
Over time, LDL cholesterol can build up as plaque in the artery walls, a process called atherosclerosis. When plaque leads to problems such as a heart attack, a stroke, or poor blood flow in the legs, the condition is called atherosclerotic cardiovascular disease, or ASCVD. People with ASCVD are generally advised to keep their LDL cholesterol especially low.
In most adults, hyperlipidemia is caused by a combination of diet, lifestyle, and health issues. For example:
- Certain foods, such as red meats and fried foods, contain large amounts of saturated fat. Eating a diet high in these foods can increase cholesterol levels.
- Many lifestyle factors are associated with high cholesterol levels, such as smoking, drinking large amounts of alcohol, having high levels of stress, and not getting enough exercise.
- Some medical conditions can increase a person’s risk of hyperlipidemia, such as diabetes, liver or kidney problems, low thyroid function (hypothyroidism), and sleep apnea.
Some people have increased LDL cholesterol because of a problem with a gene. These people are born with a condition called heterozygous familial hypercholesterolemia (HeFH). The gene problem makes it harder for LDL cholesterol to be removed from the blood. The key to reducing the risk of heart disease and serious health events, such as heart attacks or strokes, in people with high LDL cholesterol is to lower their levels. Each person will have a “target” cholesterol level depending on their medical history.
In recent years, new medicines have been approved to help lower cholesterol levels. Leqvio is one of these newer medicines. The active ingredient, inclisiran, is a type of medicine known as a small interfering RNA (siRNA). It works by increasing the liver’s ability to absorb LDL (or “bad”) cholesterol. After the liver absorbs the cholesterol, it either uses or gets rid of it, which reduces the levels of LDL cholesterol in the blood.
Can Anyone With High Cholesterol Use Leqvio?
Leqvio is approved, along with diet and exercise, to lower LDL cholesterol in:
- Adults with high LDL cholesterol (hypercholesterolemia)
- Adults and children 12 and older with heterozygous familial hypercholesterolemia (HeFH)
- Children 12 and older with homozygous familial hypercholesterolemia (HoFH)
Having ASCVD is not a requirement for using Leqvio. But if you have ASCVD and your LDL cholesterol is still above your target, your health care provider may discuss Leqvio with you.
How Do I Use It?
Leqvio is a liquid that is injected under the skin by a health care provider in a health care setting. Each injection can be given into the thigh, stomach, or outer area of the upper arm. Once you have started Leqvio, your second dose will be given 3 months after your first dose. Then you will receive a dose every 6 months.
How Was It Studied?
Three studies, each lasting about 18 months, compared Leqvio with placebo in adults who still needed lower LDL cholesterol despite taking the highest statin dose they could tolerate.
- Two studies enrolled adults with ASCVD, such as a history of heart attack or stroke. One of these also included people at increased risk for ASCVD. The average age was about 65.
- The third study enrolled adults with HeFH. The average age was 55.
Almost everyone kept taking their statin while they were in the studies. About 68% of the people in these studies were male. Most (92%) were White, 6% were Black or African American, and 1% were Asian. Fewer than 1% were of other races.
The studies measured efficacy by comparing LDL cholesterol levels before and after the study. Each study lasted for about 18 months and compared Leqvio with placebo. No one knew whether they were receiving the medicine or the placebo.
What Benefits Were Seen in These Studies?
LDL cholesterol levels in people with HeFH. After about 18 months, the people who used Leqvio had their LDL cholesterol levels decrease by an average of 40%. The people who used placebo, on the other hand, had their LDL cholesterol levels increase by an average of 8%.
LDL cholesterol levels in people with ASCVD or at increased risk. After about 18 months, people who used Leqvio had LDL cholesterol decrease by an average of 46%-51%. People who used placebo had an average increase of 1%-4%.
How Quickly Will Leqvio Lower Cholesterol Levels?
If Leqvio is working for you, it should start to lower your LDL cholesterol levels within the first 3 months. Most people will see the largest drop in their levels during this time. If you continue to receive your injections on the appropriate schedule, your LDL cholesterol should stay at this new, lower level.
Make sure to keep all of your appointments for Leqvio injections. If you miss an appointment for an injection, call to reschedule as soon as possible. Your LDL cholesterol levels may start to rise again if you do not get your doses on the schedule prescribed by your health care provider.
Will Leqvio Reduce My Risk of a Heart Attack or Stroke?
Studies of statins and other LDL-lowering medicines have shown that lowering LDL cholesterol reduces the risk of heart attack and stroke in people at increased risk, which includes people with ASCVD. Leqvio’s studies measured changes in LDL cholesterol, not heart attacks or strokes, and the Leqvio label does not state that Leqvio itself lowers that risk. Talk with your health care provider about how Leqvio fits into your overall plan to protect your heart.
How Can I Prevent or Manage Side Effects?
One possible side effect of Leqvio is a skin reaction at the injection site, which may involve redness, itching, or pain. Your health care provider should be careful not to inject the drug into skin that is sensitive for any reason, such as from a sunburn, a skin rash, or an infection. Make sure to let them know if a certain injection site has been more painful for you during previous injections so that they can try a different injection site instead.
These are not all of the possible side effects. Talk with your health care provider if you are having symptoms that bother you. If you experience anything that you think may be caused by Leqvio, you can also report side effects to the FDA at 800-FDA-1088.
Are There Any Interactions With Other Medicines?
There are no known interactions between Leqvio and other medicines. But, it is still important for your health care provider to be aware of all the prescription and over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you take or have recently taken.
Are There Any Special Steps Required to Get Leqvio?
Leqvio is a type of medicine called a specialty medicine. This means that it may require prior authorization from your insurance company. Each dose of Leqvio will be administered by a health care provider in a healthcare setting. Depending on your insurance, the medicine will either be shipped to you or to your health care provider. If it is shipped to you, you will need to bring it with you to your appointment.
Is There a Coupon Card Available?
There is a savings coupon available from the manufacturer that may allow you to pay as little as $0 for your prescription. Whether you are eligible depends on whether you have prescription insurance and what type of insurance you have. You can find out more at www.leqvio.com/savings-and-support.
