Overview
Pitavastatin, also known as the brand name product Livalo, is a lipid-lowering drug belonging to the statin class of medications. By inhibiting the endogenous production of cholesterol within the liver, statins lower abnormal cholesterol and lipid levels and ultimately reduce the risk of cardiovascular disease. More specifically, statin medications competitively inhibit the enzyme hydroxymethylglutaryl-coenzyme A (HMG-CoA) Reductase, which catalyzes the conversion of HMG-CoA to mevalonic acid. This is the third step in a sequence of metabolic reactions involved in the production of several compounds involved in lipid metabolism and transport including cholesterol, low-density lipoprotein (LDL) (sometimes referred to as "bad cholesterol"), and very low-density lipoprotein (VLDL). Prescribing of statin medications is considered standard practice following any cardiovascular events and for people with a moderate to high risk of development of CVD, such as those with Type 2 Diabetes. The clear evidence of the benefit of statin use coupled with very minimal side effects or long term effects has resulted in this class becoming one of the most widely prescribed medications in North America. Pitavastatin and other drugs from the statin class of medications including atorvastatin, pravastatin, rosuvastatin, fluvastatin, and lovastatin are considered first-line options for the treatment of dyslipidemia. Increasing use of the statin class of drugs is largely due to the fact that cardiovascular disease (CVD), which includes heart attack, atherosclerosis, angina, peripheral artery disease, and stroke, has become a leading cause of death in high-income countries and a major cause of morbidity around the world. Elevated cholesterol levels, and in particular, elevated low-density lipoprotein (LDL) levels, are an important risk factor for the development of CVD. Use of statins to target and reduce LDL levels has been shown in a number of landmark studies to significantly reduce the risk of development of CVD and all-cause mortality. Statins are considered a cost-effective treatment option for CVD due to their evidence of reducing all-cause mortality including fatal and non-fatal CVD as well as the need for surgical revascularization or angioplasty following a heart attack. Evidence has shown that even for low-risk individuals (with <10% risk of a major vascular event occurring within 5 years) statins cause a 20%-22% relative reduction in major cardiovascular events (heart attack, stroke, coronary revascularization, and coronary death) for every 1 mmol/L reduction in LDL without any significant side effects or risks. While all statin medications are considered equally effective from a clinical standpoint, rosuvastatin is considered the most potent; doses of 10 to 40mg rosuvastatin per day were found in clinical studies to result in a 45.8% to 54.6% decrease in LDL cholesterol levels. Study data has confirmed that pitavastatin's potency in lowering LDL-C is comparable to that of other statins but also has increased efficacy in increasing HDL-C (also known as "good cholesterol"). Despite these differences in potency, several trials have demonstrated only minimal differences in terms of clinical outcomes between statins.
Indication
用于治疗高胆固醇症(高脂血症)、家族性高胆固醇症。
Associated Conditions
- Apolipoprotein B increased
- Elevation of serum triglyceride levels
- Increases in serum total low-density lipoprotein (LDL)
- Increases in total cholesterol
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/05/21 | Phase 1 | Recruiting | |||
2025/03/25 | Phase 1 | Completed | |||
2025/02/07 | Phase 1 | Recruiting | |||
2024/12/09 | Phase 4 | Not yet recruiting | |||
2024/04/11 | Phase 4 | Completed | |||
2024/03/19 | Phase 3 | Recruiting | |||
2023/08/04 | Early Phase 1 | Completed | C.Dirven | ||
2023/01/31 | Not Applicable | Recruiting | |||
2022/09/13 | Phase 4 | Active, not recruiting | |||
2021/06/30 | Phase 4 | UNKNOWN | Chinese Academy of Medical Sciences, Fuwai Hospital |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
AvKARE | 42291-907 | ORAL | 4.18 mg in 1 1 | 1/16/2024 | |
Zydus Pharmaceuticals USA Inc. | 68382-483 | ORAL | 4 mg in 1 1 | 3/20/2024 | |
Zydus Pharmaceuticals USA Inc. | 68382-482 | ORAL | 2 mg in 1 1 | 3/20/2024 | |
Kowa Pharmaceuticals America, Inc. | 66869-104 | ORAL | 1.045 mg in 1 1 | 1/1/2024 | |
Teva Pharmaceuticals, Inc. | 0480-3632 | ORAL | 2.09 mg in 1 1 | 12/10/2023 | |
Upsher-Smith Laboratories, LLC | 0832-6048 | ORAL | 1 mg in 1 1 | 1/31/2023 | |
Zydus Lifesciences Limited | 70771-1786 | ORAL | 4 mg in 1 1 | 11/3/2023 | |
Mylan Pharmaceuticals Inc. | 0378-5057 | ORAL | 4 mg in 1 1 | 2/15/2023 | |
Teva Pharmaceuticals, Inc. | 0480-3633 | ORAL | 4.18 mg in 1 1 | 12/10/2023 | |
Medicure International Inc | 25208-202 | ORAL | 4 mg in 1 1 | 9/25/2020 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
LIVALO FILM-COATED TABLETS 2MG | SIN15859P | TABLET, FILM COATED | 2.0mg | 11/22/2019 | |
LIVALO FILM-COATED TABLETS 4MG | SIN15860P | TABLET, FILM COATED | 4.00mg | 11/22/2019 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Pitavastatin Calcium Dispersible Tablets | 国药准字H20130114 | 化学药品 | 片剂 | 6/25/2023 | |
Pitavastatin Calcium Dispersible Tablets | 国药准字H20130115 | 化学药品 | 片剂 | 6/25/2023 | |
Pitavastatin Calcium Tablets | 国药准字H20110051 | 化学药品 | 片剂 | 1/14/2021 | |
Pitavastatin Calcium Tablets | 国药准字H20110050 | 化学药品 | 片剂 | 1/14/2021 | |
Pitavastatin Calcium Tablets | 国药准字HJ20140101 | 化学药品 | 片剂 | 8/13/2020 | |
Pitavastatin Calcium Tablets | 国药准字H20233861 | 化学药品 | 片剂 | 6/30/2023 | |
Pitavastatin Calcium Tablets | 国药准字H20205017 | 化学药品 | 片剂 | 7/12/2023 | |
Pitavastatin Calcium Tablets | 国药准字H20234414 | 化学药品 | 片剂 | 10/27/2023 | |
Pitavastatin Calcium Tablets | 国药准字HJ20140416 | 化学药品 | 片剂 | 8/13/2020 | |
Pitavastatin Calcium Tablets | 国药准字H20205066 | 化学药品 | 片剂 | 12/11/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
LIVALO pitavastatin 4 mg film-coated tablet blister pack | 176659 | Medicine | A | 8/27/2013 | |
LIVALO pitavastatin 2 mg film-coated tablet blister pack | 176658 | Medicine | A | 8/27/2013 | |
LIVALO pitavastatin 1 mg film-coated tablet blister pack | 176640 | Medicine | A | 8/27/2013 |
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