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Pitavastatin

Generic Name
Pitavastatin
Brand Names
Livalo, Zypitamag
Drug Type
Small Molecule
Chemical Formula
C25H24FNO4
CAS Number
147511-69-1
Unique Ingredient Identifier
M5681Q5F9P

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.

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