What is statin intolerance?
Trying to lower your LDL-C (a.k.a. Lipid Lurkers) and reduce your risk of heart attack? If you can't take a statin or take the dose needed, you have options.
The NLA defines statin intolerance as experiencing one or more adverse effects from statin therapy that improve or resolve when the dosage is reduced or the medication is discontinued.
Statin intolerance can be partial or complete:
- Partial means you can take a lower dose, but not enough to reach your therapy objective.
- Complete means you can’t take any statin at all.
If you struggle with your statin dose, you’re not alone.
As many as 5% to 30% of patients are statin intolerant and remain at risk for a heart attack, according to the National Lipid Association.
Are you unable to take your recommended statin dose?
Statins are currently the standard of care to lower bad cholesterol, and not all patients can take a statin or get to the dose they need—often due to statin intolerance symptoms like muscle pain, a common side effect.
Statin intolerance can make managing your cholesterol feel more difficult—especially since higher levels of bad cholesterol can increase your risk of cardiovascular death, heart attack, stroke, heart stent or bypass surgery.
NEXLIZET contains an oral nonstatin proven to reduce the risk* of serious heart events† in statin intolerant people.
If you’re wondering what to do if you can’t tolerate statins, NEXLIZET could be a statin alternative for you. That’s because NEXLIZET works differently and is not active in skeletal muscle.
*Bempedoic acid.
†Serious heart event=cardiovascular death, heart attack, stroke, heart stent or bypass surgery.
What are other people saying about this statin alternative?
The American Diabetes Association (ADA) gives a Level A recommendation for bempedoic acid, one of the ingredients in NEXLIZET, for statin-intolerant people with diabetes who need to lower their bad cholesterol.
Level A is the highest rating the ADA gives for its recommendations. It means the advice is based on strong evidence from large, well-designed studies that included many people.
What are NEXLIZET and NEXLETOL?
- Along with diet and exercise:
- NEXLETOL is used, with other cholesterol-lowering medicines, or alone when use with other cholesterol-lowering medicines is not possible, to reduce low-density lipoprotein (LDL) or bad cholesterol in adults with high blood cholesterol levels called hypercholesterolemia, including a type of high blood cholesterol called heterozygous familial hypercholesterolemia.
- NEXLIZET is used to reduce LDL in adults with high blood cholesterol levels called hypercholesterolemia, including a type of high cholesterol called heterozygous familial hypercholesterolemia.
- Bempedoic acid, a component of NEXLIZET and NEXLETOL is used to lower the risk of major adverse cardiovascular events, such as death from cardiovascular disease, heart attack, stroke, stent placement or bypass surgery in adults at increased risk for these events who are unable to take recommended statin treatment or are not taking a statin.
IMPORTANT SAFETY INFORMATION
Do not take NEXLIZET if you are allergic to ezetimibe or bempedoic acid, or any ingredients in NEXLIZET or NEXLETOL. If you have any of the following signs and symptoms of a serious allergic reaction, call your healthcare provider or go to the nearest emergency room:
- swelling of your face, lips, mouth, or tongue
- wheezing
- severe itching
- fast heartbeat or pounding in your chest
- trouble breathing
- skin rashes, redness, or swelling
- dizziness or fainting
Before taking NEXLIZET or NEXLETOL, tell your healthcare provider if you:
- have or had gout
- have or had tendon problems
- are pregnant or breastfeeding or may become pregnant or plan to breastfeed. NEXLIZET or NEXLETOL may pass into your breastmilk. You and your healthcare provider should decide if you will take NEXLIZET or NEXLETOL or breastfeed.
- have moderate or severe liver problems
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements especially if you take or plan to take simvastatin, pravastatin, cyclosporine, fibrates, or cholestyramine.
NEXLIZET and NEXLETOL can cause serious side effects, including:
- increased levels of uric acid in the blood, which can lead to gout. Call your doctor if you have any of the following symptoms: severe foot pain, especially in the toe joint, warm joints, swelling, tender joints or joint redness.
- tendon rupture or injury. The risk of getting tendon problems while you take NEXLIZET or NEXLETOL is increased (1.2% vs 0.9% in placebo in Trial 1; 0.5% vs 0% in placebo in Trial 2). Stop taking NEXLIZET or NEXLETOL immediately and get medical help if you experience signs of tendon rupture such as snap or pop in tendon area, bruising after an injury in a tendon area, or unable to move or put weight on the affected area.
The most common side effects observed in trials of:
- NEXLETOL includes symptoms of the common cold or flu-like symptoms, muscle spasms, back pain, stomach pain, bronchitis, pain in shoulder, legs, or arms, anemia, increased liver enzymes, kidney problems, and gallstones.
- NEXLIZET includes symptoms of the common cold or flu-like symptoms, muscle spasms, back pain, stomach pain, bronchitis, pain in shoulder, legs, or arms, anemia, increased liver enzymes, diarrhea, joint pain, swelling of sinuses, and fatigue.
These are not all the possible side effects of NEXLIZET and NEXLETOL. Ask your healthcare provider or pharmacist for more information.
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see full Prescribing Information for NEXLIZET and NEXLETOL, including Patient Product Information for NEXLIZET and NEXLETOL.
What are NEXLIZET and NEXLETOL?
- Along with diet and exercise:
- NEXLETOL is used, with other cholesterol-lowering medicines, or alone when use with other cholesterol-lowering medicines is not possible, to reduce low-density lipoprotein (LDL) or bad cholesterol in adults with high blood cholesterol levels called hypercholesterolemia, including a type of high blood cholesterol called heterozygous familial hypercholesterolemia.
- NEXLIZET is used to reduce LDL in adults with high blood cholesterol levels called hypercholesterolemia, including a type of high cholesterol called heterozygous familial hypercholesterolemia.
- Bempedoic acid, a component of NEXLIZET and NEXLETOL is used to lower the risk of major adverse cardiovascular events, such as death from cardiovascular disease, heart attack, stroke, stent placement or bypass surgery in adults at increased risk for these events who are unable to take recommended statin treatment or are not taking a statin.
IMPORTANT SAFETY INFORMATION
Do not take NEXLIZET if you are allergic to ezetimibe or bempedoic acid, or any ingredients in NEXLIZET or NEXLETOL. If you have any of the following signs and symptoms of a serious allergic reaction, call your healthcare provider or go to the nearest emergency room:
- swelling of your face, lips, mouth, or tongue
- wheezing
- severe itching
- fast heartbeat or pounding in your chest
- trouble breathing
- skin rashes, redness, or swelling
- dizziness or fainting
Before taking NEXLIZET or NEXLETOL, tell your healthcare provider if you:
- have or had gout
- have or had tendon problems
- are pregnant or breastfeeding or may become pregnant or plan to breastfeed. NEXLIZET or NEXLETOL may pass into your breastmilk. You and your healthcare provider should decide if you will take NEXLIZET or NEXLETOL or breastfeed.
- have moderate or severe liver problems
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements especially if you take or plan to take simvastatin, pravastatin, cyclosporine, fibrates, or cholestyramine.
NEXLIZET and NEXLETOL can cause serious side effects, including:
- increased levels of uric acid in the blood, which can lead to gout. Call your doctor if you have any of the following symptoms: severe foot pain, especially in the toe joint, warm joints, swelling, tender joints or joint redness.
- tendon rupture or injury. The risk of getting tendon problems while you take NEXLIZET or NEXLETOL is increased (1.2% vs 0.9% in placebo in Trial 1; 0.5% vs 0% in placebo in Trial 2). Stop taking NEXLIZET or NEXLETOL immediately and get medical help if you experience signs of tendon rupture such as snap or pop in tendon area, bruising after an injury in a tendon area, or unable to move or put weight on the affected area.
The most common side effects observed in trials of:
- NEXLETOL includes symptoms of the common cold or flu-like symptoms, muscle spasms, back pain, stomach pain, bronchitis, pain in shoulder, legs, or arms, anemia, increased liver enzymes, kidney problems, and gallstones.
- NEXLIZET includes symptoms of the common cold or flu-like symptoms, muscle spasms, back pain, stomach pain, bronchitis, pain in shoulder, legs, or arms, anemia, increased liver enzymes, diarrhea, joint pain, swelling of sinuses, and fatigue.
These are not all the possible side effects of NEXLIZET and NEXLETOL. Ask your healthcare provider or pharmacist for more information.
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see full Prescribing Information for NEXLIZET and NEXLETOL, including Patient Product Information for NEXLIZET and NEXLETOL.