Patients Who May Benefit

Those with Type II Diabetes

Pitavastatin has been studied in several patient types, including those with type II diabetes.
Please refer to Important Safety Information below.

Pitavastatin 4 mg and Atorvastatin 20 mg lower LDL-C comparably in Patients with Type II Diabetes1

Pitavastatin demonstrated effective LDL-cholesterol lowering of up to 41% with 4 mg pitavastatin compared to 20 mg Lipitor®
(atorvastatin) which showed a 43% decrease in LDL cholesterol.1

Statins Can Increase Glucose Levels and HbA1C

Increases in glucose levels and HbA1c have been reported with pitavastatin. Optimize lifestyle measures, including regular exercise, maintaining a healthy body weight, and making healthy food choices.

Pitavastatin demonstrated a non-significant change in blood glucose levels compared to baseline at both 12 and 44 weeks in contrast to atorvastatin which did show significant increases compared to baseline.1

* Mean per cent changes in blood glucose from core study baseline to week 12 and to extension study week 44. CI, 95% confidence interval; NS, not significant vs. baseline. *p < 0.05 vs. baseline.
† Seven patients up-titrated their dose of atorvastatin from 20 to 40 mg/day at extension study week 0.

Moderate-Intensity Statins are Class I Recommendation in T2DM2


In patients 40 to 75 years of age with diabetes mellitus and LDL-C ≥ 70 mg/dL (≥ 1.8 mmol/L), the 2018 ACC/AHA Guidelines recommend patients to start a moderate-intensity statin therapy, regardless of estimated 10-year ASCVD risk (Class I recommendation)..2

However, the 2018 ACC/AHA Guidelines also indicate that statins modestly increase the risk of incident or statin-associated new-onset diabetes mellitus in individuals with:2

  • Predisposing risk factors for diabetes mellitus
  • Components of the metabolic syndrome
  • Higher-intensity statin use

 

Help your patient find the Right Statin, Right Away

Zypitamag is accessible like a generic statin.

Learn about Access

About Zypitamag

  • ZYPITAMAG is indicated as an adjunctive therapy to diet in adult patients with primary hyperlipidemia or mixed dyslipidemia.

  • ZYPITAMAG is a moderate-intensity statin available in 2mg and 4mg tablets.

  • ZYPITAMAG 4mg lowers LDL-C by a mean of 44% and raises HDL-C by a mean of 7%*

  • Compared to most statins, ZYPITAMAG has a reduced potential to interact with certain medications and foods.

  • At ZYPITAMAG's highest dose, only 3.1% of patients experienced muscle pain vs. 1.4% taking placebo.

  • 0.5% of patients discontinued ZYPITAMAG due to myalgia.

* Mean percent change from baseline at week 12 in randomized clinical study (NK- 104-304) with 4 mg pitavastatin
1. Gumprecht J et al. Comparative long-term efficacy and tolerability of pitavastatin 4 mg and atorvastatin 20-40 mg in patients with type 2 diabetes mellitus and combined (mixed) dyslipidaemia.
Diabetes Obes Metab. 2011;13:1047-55
2. Grundy SM et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Journal of the American College of Cardiology. 2019;73(24):e285-e350

Click another example of a patient group who may benefit from Zypitamag:

Have type II diabetes

Are ≥ 65 years old

Are taking multiple medications

Are currently taking Pravastatin

Are of Asian descent

Are living with HIV

Important Safety Information for Zypitamag® (pitavastatin) tablets

INDICATIONS & USAGE

ZYPITAMAG is indicated as an adjunctive therapy to diet in adult patients with primary hyperlipidemia or mixed dyslipidemia to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C). Limitations of Use: The effect of ZYPITAMAG on cardiovascular morbidity and mortality has not been determined.

CONTRAINDICATIONS: ZYPITAMAG is contraindicated in patients with a known hypersensitivity to product components, in patients with active liver disease (which may include unexplained persistent elevations in hepatic transaminase levels), in women who are pregnant or may become pregnant, in nursing mothers, or in co-administration with cyclosporine.

WARNINGS & PRECAUTIONS

  • Myopathy and Rhabdomyolysis: Risk factors include age 65 and greater, renal impairment, inadequately treated hypothyroidism, concomitant use of certain drugs, and higher doses of ZYPITAMAG. ZYPITAMAG is contraindicated in patients taking cyclosporine and not recommended in patients taking gemfibrozil. The following drugs when used concomitantly with ZYPITAMAG may also increase the risk of myopathy and rhabdomyolysis: lipid-modifying dosages of niacin (>1 g/day), fibrates, and colchicine. Discontinue ZYPITAMAG if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Temporarily discontinue ZYPITAMAG in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis; e.g., sepsis; shock; severe hypovolemia; major surgery; trauma; severe metabolic, endocrine, or electrolyte disorders; or uncontrolled epilepsy. Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing the ZYPITAMAG dosage. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever.
  • Immune-Mediated Necrotizing Myopathy (IMNM): There have been rare reports of IMNM, an autoimmune myopathy, associated with statin use. IMNM is characterized by: proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; positive anti-HMG CoA reductase antibody; muscle biopsy showing necrotizing myopathy; and improvement with immunosuppressive agents.
  • Hepatic Dysfunction: Increases in serum transaminases can occur. Rare postmarketing reports of fatal and non-fatal hepatic failure have occurred. Consider liver enzyme testing before initiating therapy and as clinically indicated thereafter. If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue ZYPITAMAG.
  • Increases in HbA1c and Fasting Serum Glucose Levels: Increases of each have been reported with statins, including ZYPITAMAG. Optimize lifestyle measures, including regular exercise, maintaining a healthy body weight, and making healthy food choices.

ADVERSE REACTIONS: The most frequent adverse reactions (rate ≥ 2%) are myalgia, back pain, diarrhea, constipation and pain in extremity. This is not a complete list of all reported adverse events.

For additional information, refer to full Prescribing Information.

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

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