Some people may be able to lower their cholesterol by taking a newly approved drug along with statins and a balanced diet.
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- Federal regulators have approved the new drug Leqvio to be used to help lower cholesterol levels in some people.
- The medication is designed to be taken along with statins and a balanced diet.
- Leqvio is designed to be taken twice a year, which experts say should help people adhere to a medication schedule.
Around 30 million adults in the United States have atherosclerotic cardiovascular disease (ASCVD).
Slightly more than half of them, 16 million, take statins to help lower their cholesterol. However, many are still not at their recommended target range for cholesterol levels.
Leqvio (inclisiran), a medication from Novartis recently approved by the Food and Drug Administration (FDA), might help lower cholesterol levels with only 2 doses per year.
What are statins?
Statins work by blocking substances that your body needs to make cholesterol. These medications typically must be taken at least once a day, some twice a day. Statins help by:
- lowering the chance of heart disease and stroke
- stabilizing plaques on blood vessel walls
- reducing the chance of a particular type of blood clot
People with low-density lipoproteins (LDL), frequently called “bad cholesterol,” with 190 mg/dL or higher, often benefit from daily statins.
If you had a heart attack in the past, your doctor might recommend statins, even if you don’t have high cholesterol.
One of the main reasons statins are not always effective is because people often tend to have a difficult time adhering to the medication schedule. This is frequently because of the cost of the medication, its side effects, or a person’s lack of accessibility to prescription drugs.
However, not taking statins regularly is associated with significant increases in deaths from cardiovascular disease.
How can Leqvio help?
Leqvio is an adjunct treatment to a balanced diet and statins for lowering LDL.
People take an initial dose, another dose in 3 months, and then doses twice a year.
Three recent studies report LDL reductions between 40 percent and 51 percent when compared to a placebo for certain people with ASCVD who take statins.
Statins, nonetheless, will remain as first-line treatments.
“Leqvio works differently than other cholesterol treatments,” said Dr. Norman Lepor, FACC, a clinical investigator in the phase 3 clinical program, in a Novartis statement. “With twice-yearly dosing, it is a compelling option for millions of people with ASCVD who have a difficult time reaching their LDL-C target.”
The company statement said the medication works by improving the liver’s natural ability to prevent the production of a protein that keeps cholesterol levels high. It is a subcutaneous injection given by a qualified healthcare professional.
Because of the dosing schedule, experts say Leqvio may be helpful for people having difficulty sticking to a regular medication schedule.
“Leqvio is a game-changer in the world of cardiovascular disease treatment,” said Dr. Spencer Kroll, FNLA, an internal medicine specialist and a nationally recognized cholesterol and lipid disease expert.
“It leads to profound reductions in serum LDL levels,” Kroll told Healthline. “Multiple studies have found that the lower the LDL, the lower the cases of recurrent cardiovascular events in high-risk patients.”
Who can take Leqvio?
Leqvio is an add-on treatment that works alongside diet changes and statins to manage cholesterol.
The FDA approved it for adults with heterozygous familial hypercholesterolemia or clinical ASCVD.
People with mild, moderate, or severe kidney impairment can take Leqvio. People with mild or moderate liver impairment can also take Leqvio.
There are no current studies of Leqvio in people with severe liver impairment.
There is currently no data on the use of Leqvio during pregnancy for risk of congenital disabilities, miscarriage, or adverse maternal or fetal outcomes.
Until further information is known, the recommendation is that people who are pregnant should stop taking the medication.
Possible side effects
Some people experienced irritation at the injection site. Other side effects include:
- arthralgia
- urinary tract infection
- bronchitis
- diarrhea
- pain in extremity
- dyspnea
- joint stiffness
- difficulty breathing
About 2 percent of people stopped taking Leqvio because of adverse reactions.