Statin Use Way Up: Pitavastatin Introduced to the U.S as a Next-Generation Statin

Your doctor may have recommended that you take a medication called a statin if you have high cholesterol and you haven’t been able to get it under control with diet, exercise, or weight loss alone.

Statins remain the first-line of defence for managing cholesterol. They are generally well-tolerated and have a favorable safety profile. There is a large body of evidence that supports the wide-spread use of statins with their ability to reduce the risk of developing heart disease^*.

Updated Guidelines Recommend Statins for More Patients

The guidelines by the American Heart Association and American College of Cardiology updated their recommendations for managing cholesterol in 2018. The four main categories where statin use is recommended includes:

• People diagnosed with cardiovascular disease
• People who have high levels of LDL-C, or bad cholesterol (greater than 190 mg/dL)
• People with diabetes between the age of 40 to 75, regardless of their cholesterol levels
• People with elevated LDL-C (over 100 mg/dL) with an increased risk of developing heart disease (e.g., family history)

History of Statins

The first statin, lovastatin, was approved in the United States over 30 years ago on September 1^st, 1987. Since then, tens of millions of Americans have taken a statin to help manage their cholesterol levels. Statin use has increased steadily over the years and has more then doubled in the last 20 years. With the recent changes to the guidelines, this use will undoubtedly increase further.

The most commonly used statin in the U.S right now is atorvastatin, which was approved in 1996. While the majority of statins currently available are several decades old, there are newer statin options available.  Pitavastatin was introduced to the U.S. in 2009 and is the most recently approved statin type.

About Pitavastatin

Pitavastatin is a third-generation statin that helps to lower the LDL-C levels in your body. It is currently available in the U.S. as Livalo (pitavastatin calcium) or Zypitamag (pitavastatin magnesium). Livalo was approved in 2009 and Zypitamag was approved in 2017.

The biggest difference between Livalo and Zypitamag is the price. Livalo costs over $1000 for a 90-day prescription, whereas Zypitamag is as little as just $1 a day, or $90 for a 90-day prescription.

Beside the price, the FDA has deemed the two products to be bioequivalent.

What makes Pitavastatin different

• It produces dose-dependent reductions in LDL-C (bad cholesterol)
• The maximum approved dose of 4 mg reduces LDL-C by an average of 45%
• It provides sustained LDL-C lowering and has been studied for several years
• It has been shown to increase HDL-C (good cholesterol) in the body
• It has less potential for certain drug-drug interactions compared to some of the already existing statins in the market. See how it compares with other statins
• It is clinically superior to pravastatin in lowering LDL-C
• Is well-tolerated, with discontinuation rates at the highest dose (4 mg) of less than 4%
• Has been studied people living with type 2 diabetes and shown to effectively reduce cholesterol levels

Click here to learn more about how Zypitamag (pitavastatin) is different.

* The effect of pitavastatin on cardiovascular morbidity and mortality has not been determined.

This article contains information about an FDA-approved product, Zypitamag (pitavastatin) tablets. This medication is available by prescription only. Talk to your doctor to see if Zypitamag is right for you. Please refer to the Zypitamag (pitavastatin) tablets Important Safety Information below and Prescribing Information for more information.

IMPORTANT SAFETY INFORMATION for ZYPITAMAG^® (pitavastatin) tablets

Who should NOT take ZYPITAMAG?

ZYPITAMAG is not right for everyone. Do not take ZYPITAMAG if:

• You have a known allergy to ZYPITAMAG or any of its ingredients.
• You have active liver problems, including some abnormal liver test results.
• You are nursing, pregnant or may become pregnant, as it may harm the baby.
• You are currently taking cyclosporine or gemfibrozil.

What is the most important information I should know and talk to my doctor about?

• Call your healthcare provider or get help right away if you experience any symptoms of an allergic reaction, such as rash, itching, or hives.
• Muscle problems may be an early sign of rare, serious conditions. Tell your doctor right away if you have any unexplained muscle pain, weakness, or tenderness, particularly if accompanied by malaise or fever, or if these muscle signs or symptoms persist after discontinuing ZYPITAMAG.
• Serious liver problems have been reported rarely in patients taking statins, including pitavastatin. Your doctor should do liver tests before you start, and if you have symptoms of liver problems while you are taking ZYPITAMAG. Tell your healthcare provider right away if you feel more tired than usual, have a loss of appetite, upper belly pain, dark-colored urine, or yellowing of the skin or eyes.
• Tell your doctor about all your medical conditions and medications you take including nonprescription medicines, vitamins, or herbal supplements.
• Increases in blood sugar levels have been reported with statins, including pitavastatin.
• Tell your doctor about your alcohol use.
• Tell your healthcare provider of a known or suspected pregnancy.

What are the most common side effects of ZYPITAMAG?

The most common side effects of ZYPITAMAG in clinical studies were:

• Back pain
• Constipation
• Diarrhea
• Muscle pain
• Pain in the legs or arms

This is not a complete list of side effects. Talk to your healthcare provider for more information.

You are encouraged to report negative side effects of all drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

How should I store and take ZYPITAMAG?

• Store ZYPITAMAG tablets at room temperature, in a dry place, and out of the reach of children.
• Take ZYPITAMAG orally once daily with or without food at the same time each day.
• Swallow the tablet whole. Do not split, crush, dissolve, or chew.
• The maximum recommended dosage is ZYPITAMAG 4 mg once daily.
• If you take too much ZYPITAMAG or you or someone else takes an overdose, call your doctor and/or local Poison Control Center.

Other important information I should know about ZYPITAMAG.

• ZYPITAMAG has not been studied to evaluate its effect on reducing heart-related disease or death.
• ZYPITAMAG is available by prescription only.

For additional information, please see the full Prescribing Information.