Most people with high cholesterol take a type of medicine called a statin. Although statins are very effective for lowering levels of “bad” cholesterol, some people may need to take more than one medicine to reach their target cholesterol levels.
In recent years, new medicines have been approved that work in a different way than statins to lower cholesterol levels. Leqvio is one of these new medicines that may be an option for people who still have high cholesterol levels even while taking a statin and making changes to their diet.
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.
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.
The key to treating hyperlipidemia is to lower the levels of “bad” fats in the blood. Lowering these levels can reduce the risk of heart disease and serious health events, such as heart attacks or strokes, even in people who have already had one of these events. Each person will have a “target” cholesterol level depending on their medical history. Most people will use a medicine called a statin to reach their target cholesterol level. But some people may need more than one medicine to reach this target level.
People with “primary hyperlipidemia,” which is passed down from parents to their children, are more likely to need more than one medicine to treat their cholesterol. Some forms of primary hyperlipidemia may be diagnosed with genetic testing, such as heterozygous familial hypercholesterolemia (HeFH). In other cases, however, people will be diagnosed with this type of hyperlipidemia because their cholesterol levels do not respond to normal treatments. For example, if a person with a family history of high cholesterol still has high levels after taking a high dose of a statin and making changes to their diet and lifestyle, they may be diagnosed with primary hyperlipidemia.
In recent years, new medicines have been approved to help lower cholesterol levels in people who do not get enough benefit from statins. Leqvio is one of these new 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 for use in people with primary hyperlipidemia who have already made changes to their diet and are also already taking a statin. If you have hyperlipidemia and still have high cholesterol even though you eat a low cholesterol diet and take a statin, your doctor may discuss Leqvio with you.
How Do I Use It?
Leqvio is a liquid that is injected under the skin by a health care professional 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 were done to see if Leqvio was safe and effective for lowering LDL cholesterol levels in certain adults:
- In two of these studies, everyone had heart disease and had not reached their target cholesterol levels while taking a statin. The average age in these studies was 65.
- In the other study, everyone had been diagnosed with heterozygous familial hypercholesterolemia (HeFH). The average age in this study was 56.
Almost everyone (92%) kept taking their statin while they were in the study. Most (67%) of the people in these studies were male and most (92%) were White. The race of the other people in these studies was not provided.
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%. This means that Leqvio can help to reduce LDL cholesterol levels by a large amount in people with HeFH who are already taking a statin.
LDL cholesterol levels in people with heart disease. After about 18 months, the people who used Leqvio had their LDL cholesterol levels decrease by an average of 46%-51%. The people who used placebo, on the other hand, had their LDL cholesterol levels increase by an average of 1%-4%. This means that Leqvio can help to reduce LDL cholesterol levels by a large amount in people with heart disease who are already taking a statin.
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?
It is well understood that using statins to keep your LDL cholesterol levels at the target level will lower your risk for heart disease, heart attack, and stroke. But Leqvio works in a very different way than statins.
Clinical studies show that Leqvio can reduce LDL cholesterol levels by a large amount. These studies only lasted for 18 months, which wasn’t long enough to see if Leqvio reduced the risk of a heart attack or stroke. Although it is likely that the large drop in LDL cholesterol levels from Leqvio will help to reduce the risk of these serious health events, no clinical studies have been done to confirm whether this is true.
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 professional 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 professional 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.
