Comparison with other Statins

Comparison with other Statins

Compare ZYPITAMAG with your current statin.

 

Pravachol® (pravastatin)

Pravachol

* Average percent change in LDL cholesterol after 12 weeks taking pitavastatin or pravastatin.

Zypitamag provides a 10% greater reduction in bad cholesterol

Pitavastatin (2 mg, 4 mg) reduced LDL-C better than Pravachol® (20 mg, 40 mg, respectively) in people 65 years or older.*

Things to Consider when Choosing a Statin

For those taking other cholesterol lowering medications

With Pravastatin, there is a drug interaction with Nexletol® (bempedoic acid) tablets, another cholesterol lowering drug, which can increase the risk of side effects, like muscle pain. Pravastatin greater than 40 mg should not be used in combination with Nexletol.1

For people who drink grapefruit juice

Like pravastatin, you can continue to drink your grapefruit juice while on Zypitamag. This is not the case for many other statins like atorvastatin (Lipitor®), simvastatin (Zocor®), and lovastatin (Mevacor®).

If you are currently taking Pravachol or pravastatin, talk to your doctor to see if Zypitamag may be right for you.

Conversation guide

Pravachol is a registered trademark of Bristol-Myers Squibb Company.

Lipitor is a registered trademark of Pfizer, Inc.

Zocor is a registered trademark of Merck & Co., Inc.

Mevacor is a registered trademark of Merck Sharp & Dohme Corpe, a subsidiary of Merck & Co. Inc.

Study 306: 12 week, randomized, multicenter, double-blind, double-dummy, active-controlled, non-inferiority (NI) study. NI was met if the lower bound of the 95% Cl for the mean treatment difference was greater than -6% for the mean percent change in LDL-C.

* Pitavastatin was not studied against Pravastatin 80 mg.

 

Lipitor® (atorvastatin)

Lipitor

* Average percent change in LDL cholesterol after 12 weeks taking pitavastatin or atorvastatin.

Zypitamag has been shown to lower cholesterol similarly to Lipitor

A clinical study compared how pitavastatin and Lipitor compared in people who had high cholesterol*. In terms of ability to lower bad cholesterol (LDL-C), the study showed that:

  • 2 mg of pitavastatin is comparable to the 10 mg dose of atorvastatin
  • 4 mg of pitavastatin is comparable to the 20 mg dose of atorvastatin

Things to Consider when Choosing a Statin

For those taking other medications

Zypitamag is processed differently by most statins, by a process called glucuronidation. This is different from Lipitor® (atorvastatin) which is mainly processed by an enzyme called CYP3A4, part of the CYP450 family of enzymes. The CYP450 family of enzymes is responsible for 70-80% of all drug-metabolisms.1 Because of this key difference, Zypitamag has a reduce potential for interactions with foods and many commonly prescribed medications.

For people who drink grapefruit juice

Unlike Lipitor®, Zypitamag has no interaction with grapefruit juice, and therefore, when taking Zypitamag you can continue to enjoy your grapefruit juice!

For people who have type 2 diabetes

Increases in blood sugar levels have been seen with statin medications, including Zypitamag. In a clinical study, 4 mg pitavastatin was compared to 20 mg atorvastatin in people who had type 2 diabetes.2 In this study, there was no clinically significant difference in terms of reduction in bad cholesterol (LDL-C). However, when looking at changes in blood glucose levels of patients taking pitavastatin, there was a non-significant change in blood glucose levels compared to the patient's baseline blood glucose levels. In contrast, atorvastatin did significant increase blood glucose levels compared to baseline. If you have Type 2 Diabetes, ask your doctor if Zypitamag may be the right statin for you!

For people who take certain antifungals

Unlike Lipitor®, Zypitamag has no dose restrictions or limitations when used with certain antifungals such as itraconazole.

For people who take certain antiretroviral therapies

Unlike Lipitor®, Zypitamag can be used together with certain antiretroviral therapies (ARTs) such as lopinavir and ritonavir.

If you are currently taking Lipitor or atorvastatin, talk to your doctor to see if Zypitamag may be right for you.

Conversation guide

Study 301: 12 week, randomized, multicenter, double-blind, double-dummy, active-controlled, non-inferiority (NI) study. NI was met if the lower bound of the 95% Cl for the mean treatment difference was greater than -6% for the mean percent change in LDL-C.

* Pitavastatin was not studied against Atorvastatin 40 mg and 80 mg doses.

The main mechanism of Zypitamag metabolism is conjugation with glucuronic acid through liver glucuronosyltransferases leading to the formation of pitavastatin lactone. Pitavastatin is marginally metabolized by CYP2C9 and to a lesser extent by CYP2C8.

1 https://ghr.nlm.nih.gov/primer/genefamily/cytochromep450

2 Gumprecht et al. Diabetes Obesity and Metabolism. 2011;13:1047-1055

Lipitor is a registered trademark of Pfizer, Inc.

 

Crestor® (rosuvastatin)

With 4 mg Zypitamag you can expect up to a 44% reduction in bad cholesterol (LDL-C) and a 7% increase in good cholesterol (HDL-C). Unfortunately, at this time there had been no head-to-head studies to compare Zypitamag with rosuvastatin (Crestor®).

Crestor

Things to Consider when Choosing a Statin

For those taking other medications

Zypitamag is processed differently by most statins, by a process called glucuronidation. This is different from Crestor® (rosuvastatin) which is mainly processed by an enzyme called CYP2C9, part of the CYP450 family of enzymes. The CYP450 family of enzymes is responsible for 70-80% of all drug-metabolisms.1 Because of this key difference, Zypitamag has a reduce potential for interactions with foods and many commonly prescribed medications.

For people of Asian descent

Unlike Crestor®, there are no recommended dose restrictions for people of Asian descent who take Zypitamag.

For people who take certain antiretroviral therapies

Unlike Crestor®, Zypitamag can be used together with certain antiretroviral therapies (ARTs) such as lopinavir and ritonavir without any dose limitations or restrictions.

If you are currently taking Crestor or rosuvastatin, talk to your doctor to see if Zypitamag may be right for you!

Conversation guide

The main mechanism of Zypitamag metabolism is conjugation with glucuronic acid through liver glucuronosyltransferases leading to the formation of pitavastatin lactone. Pitavastatin is marginally metabolized by CYP2C9 and to a lesser extent by CYP2C8.

1 https://ghr.nlm.nih.gov/primer/genefamily/cytochromep450

Crestor is a registered trademark of the AstraZeneca group of companies.

 

Zocor® (simvastatin)

Zocor

* Average percent change in LDL cholesterol after 12 weeks taking pitavastatin or simvastatin.

Pitavastatin 2 mg has been shown to lower bad cholesterol significantly more than Zocor 20 mg

Pitavastatin 4 mg has also been compared to simvastatin 40 mg, and showing a similar reduction in lowering bad cholesterol (LDL-C); 44% vs. 43%, respectively*

Things to Consider when Choosing a Statin

For those taking other medications

Zypitamag is processed differently by most statins, by a process called glucuronidation. This is different from Zocor® (simvastatin) which is mainly processed by an enzyme called CYP3A4, part of the CYP450 family of enzymes. The CYP450 family of enzymes is responsible for 70-80% of all drug-metabolisms.1 Because of this key difference, Zypitamag has a reduce potential for interactions with foods and many commonly prescribed medications.

For people who drink grapefruit juice

Unlike Zocor®, Zypitamag has no interaction with grapefruit juice, and therefore, when taking Zypitamag you can continue to enjoy your grapefruit juice!

For people who take certain calcium channel blockers

Unlike Zocor®, Zypitamag does not require a dose limitation for calcium channel blockers (CCBs) such as amlodipine and diltiazem.

For people who take warfarin

Unlike Zocor®, Zypitamag has no effect on prothrombin time (PT) or international normalized ratio (INR) when co-administered with warfarin. However, PT and INR should still be routinely monitored by your doctor.

For people who take certain antiretroviral therapies

Unlike Zocor®, Zypitamag can be used in combination with antiretroviral therapies (ARTs) such as atazanavir, darunavir/ritonavir, and lopinavir/ritonavir.

For people who take certain antifungals

Unlike Zocor®, Zypitamag has no dose restrictions or limitations when used with certain antifungals such as itraconazole.

If you are currently taking Zocor or simvastatin, talk to your doctor to see if Zypitamag may be right for you!

Conversation guide

Zocor is a registered trademark of Merck & Co., Inc.

Study 302: 12 week, randomized, multicenter, double-blind, double-dummy, active-controlled, non-inferiority (NI) study. NI was met if the lower bound of the 95% Cl for the mean treatment difference was greater than -6% for the mean percent change in LDL-C.

The main mechanism of Zypitamag metabolism is conjugation with glucuronic acid through liver glucuronosyltransferases leading to the formation of pitavastatin lactone. Pitavastatin is marginally metabolized by CYP2C9 and to a lesser extent by CYP2C8.

1 https://ghr.nlm.nih.gov/primer/genefamily/cytochromep450

 

Mevacor® (lovastatin)

With 4 mg Zypitamag you can expect up to a 44% reduction in bad cholesterol (LDL-C) and a 7% increase in good cholesterol (HDL-C). Unfortunately, at this time there had been no head-to-head studies to compare Zypitamag with lovastatin (Mevacor®).

Mevacor

Things to Consider when Choosing a Statin

For those taking other medications

Zypitamag is processed differently by most statins, by a process called glucuronidation. This is different from Mevacor® (lovastatin) which is mainly processed by an enzyme called CYP3A4, part of the CYP450 family of enzymes. The CYP450 family of enzymes is responsible for 70-80% of all drug-metabolisms.1 Because of this key difference, Zypitamag has a reduce potential for interactions with foods and many commonly prescribed medications.

For people who drink grapefruit juice

Unlike Mevacor®, Zypitamag has no interaction with grapefruit juice, and therefore, when taking Zypitamag you can continue to enjoy your grapefruit juice!

For people who take warfarin

Unlike Mevacor®, Zypitamag has no effect on prothrombin time (PT) or international normalized ratio (INR) when co-administered with warfarin. However, PT and INR should still be routinely monitored by your doctor.

For people who take certain antiretroviral therapies

Unlike Mevacor®, Zypitamag can be used in combination with antiretroviral therapies (ARTs) such as atazanavir, darunavir/ritonavir, and lopinavir/ritonavir.

For people who take certain antifungal medications

Unlike Mevacor®, Zypitamag has no dose restrictions or limitations when use with certain antifungals such as itraconazole.

If you are currently taking Mevacor or lovastatin, talk to your doctor to see if Zypitamag may be right for you!

Conversation guide

The main mechanism of Zypitamag metabolism is conjugation with glucuronic acid through liver glucuronosyltransferases leading to the formation of pitavastatin lactone. Pitavastatin is marginally metabolized by CYP2C9 and to a lesser extent by CYP2C8.

1 https://ghr.nlm.nih.gov/primer/genefamily/cytochromep450

Mevacor is a registered trademark of Merck Sharp & Dohme Corpe, a subsidiary of Merck & Co. Inc

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.

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