Cited by 136Lipoproteins and Cardiovascular HealthCancer, Lipids, and MetabolismCholesterol and Lipid Metabolism

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Pitavastatin: Efficacy and Safety Profiles of A Novel Synthetic HMG‐CoA Reductase Inhibitor

Kajinami, Kouji, Takekoshi, Noboru, Saito, Yasushi·2003·Cardiovascular Drug Reviews

DOI 10.1111/j.1527-3466.2003.tb00116.x

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Abstract

The use of 3‐hydroxy‐3‐methylglutaryl coenzyme A (HMG‐CoA) reductase inhibitors, statins, has been shown to reduce major cardiovascular events in both primary and secondary prevention, and statins became one of the most widely prescribed classes of drugs throughout the world. Previously, statins have been well tolerated and have shown favorable safety profiles. However, the voluntary withdrawal of cerivastatin from the market because of a disproportionate number of reports of rhabdomyolysis‐associated deaths drew attention to the pharmacokinetic profile of statins, which may possibly have been related to serious drug‐drug interactions. Pitavastatin (NK‐104, previously called itavastatin or nisvastatin, Kowa Company Ltd., Tokyo) is a novel, fully synthetic statin, which has a potent cholesterol‐lowering action. The short‐term and long‐term lipid‐modifying effects of pitavastatin have already been investigated in subjects with primary hypercholesterolemia, heterozygous familial hypercholesterolemia, hypertriglyceridemia, and type‐2 diabetes mellitus accompanied by hyperlipidemia. Within the range of daily doses from 1 to 4 mg, the efficacy of pitavastatin as a lipid‐lowering drug seems to be similar, or potentially superior, to that of atorvastatin. According to the results of pharmacokinetic studies, pitavastatin showed favorable and promising safety profile; it was only slightly metabolized by the cytochrome P450 (CYP) system, its lactone form had no inhibitory effects on the CYP3A4‐mediated metabolism of concomitantly administered drugs; P‐glycoprotein‐mediated transport did not play a major role in its disposition, and pitavastatin did not inhibit P‐glycoprotein activity. It could be concluded that pitavastatin could provide a new and potentially better thera‐peutic choice for lipid‐modifying therapy than do the currently available statins. The ef‐ficacy and safety of higher dose treatment, as well as its long‐term effects in the pre‐vention of coronary artery disease, should be further investigated.

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Pitavastatin for the treatment of primary hyperlipidemia and mixed dyslipidemia
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“On the other hand, pitavastatin, a novel synthetic statin, is not metabolized by the CYP3A4 system.(33) Although we hypothesized that statins would affect CYP3A4 activity according to the CYP3A4 metabolic dependency, the different types of statins did not influence the pharmacokinetics of midazolam.”
Background
One‐Pot Synthesis of 4‐Substituted 1H‐[1,2,3]triazolo[4,5‐c]quinolines Through CuO‐Promoted Tandem Cyclization Reactions of (E)‐3‐(2‐Bromoaryl)‐1‐arylprop‐2‐en‐1‐ones with Sodium Azide
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Solid-phase extraction and liquid chromatography/tandem mass spectrometry assay for the determination of pitavastatin in human plasma and urine for application to Phase I clinical pharmacokinetic studies
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Pitavastatin, a new HMG-CoA reductase inhibitor, induces phototoxicity in human keratinocytes NCTC-2544 through the formation of benzophenanthridine-like photoproducts
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Integrated Backscatter and Intima-Media Thickness of the Thoracic Aorta Evaluated by Transesophageal Echocardiography in Hypercholesterolemic Patients: Effect of Pitavastatin Therapy
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Degradation Pathway for Pitavastatin Calcium by Validated Stability Indicating UPLC Method
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“It is likely that pitavastatin will be approved for use in hypercholesterolaemia [1-2].”
Background
An Injectable Gel Platform for the Prolonged Therapeutic Effect of Pitavastatin in the Management of Hyperlipidemia
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Effects of Rosuvastatin and Pitavastatin on Ischemia-Induced Myocardial Stunning in Dogs
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Self-citation
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Determination of Pitavastatin in Human Plasma by LC–MS–MS
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A Validated Stability-Indicative UPLC Method for Nilotinib Hydrochloride for the Determination of Process-Related and Degradation Impurities
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Statins and Hemostasis: Therapeutic Potential Based on Clinical Evidence
Prado, Y., Aravena, D., Llancalahuén, F. M., Aravena, C., Eltit, F., Echeverría, C., Gatica, S., Riedel, C. A., & Simón, F. (2023) · Advances in experimental medicine and biology · doi:10.1007/978-3-031-26163-3_2 · Cited by 10
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“Pitavastatin (NK-104, previously called itavastatin or nisvastatin) is a novel, fully synthetic statin with the chemical name of (þ)-monocalcium bis(3R,5S,6E)-7-[2-cyclopropyl-4-(4fluorophenyl)-3-quinolyl]-3,5-dihydroxy-6-heptenoate (C50H46CaF2N2O8) [6,7].”
Background
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Background
Development and validation of RP-HPLC method for pitavastatin calcium in bulk and formulation using experimental design
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Authors: Kajinami, K., Takekoshi, N., & Saito, Y.
Affiliations: Kanazawa Medical University (JP)
Chiba University (JP)
Corresponding author: Kajinami, Kouji
ORCID: Saito, Yasushi
Venue: Cardiovascular Drug Reviews
Publisher: Wiley
Published: 2003-09
Volume: 21
Issue: 3
Pages: 199-215
ISSN: 0897-5957 (ISSN-L)
1527-3466
DOI: 10.1111/j.1527-3466.2003.tb00116.x
OpenAlex: W2074541010
Cited by: 136
References: 77
Citations by year: 2026: 5 · 2025: 4 · 2024: 2 · 2023: 3 · 2022: 8 · 2021: 8 · 2020: 4 · 2019: 3 · 2018: 1 · 2017: 5 · 2016: 6 · 2015: 3 · 2014: 6 · 2013: 4 · 2012: 2
FWCI: 8.31
Type: journal article
Language: en
Open access: closed
Licence: onlinelibrary.wiley.com/termsAndConditions#vor (vor, 1010 d)
Locations: Cardiovascular Drug Reviews (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipoproteins and Cardiovascular Health
Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Cancer, Lipids, and Metabolism
Life Sciences › Biochemistry, Genetics and Molecular Biology › Biochemistry › Cholesterol and Lipid Metabolism
Keywords: pitavastatin, statins, lipid-lowering therapy, hypercholesterolemia, familial hypercholesterolemia, hypertriglyceridemia, type 2 diabetes, pharmacokinetics, drug-drug interactions, cytochrome P450, P-glycoprotein, rhabdomyolysis, atorvastatin comparison, coronary heart disease prevention
MeSH terms: Animals, Arteriosclerosis, Clinical Trials as Topic, Cytochrome P-450 Enzyme System, Drug Interactions, Humans, Hypercholesterolemia, Lipoproteins, Quinolines, Hydroxymethylglutaryl-CoA Reductase Inhibitors, ATP Binding Cassette Transporter, Subfamily B, Member 1

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Pitavastatin: Efficacy and Safety Profiles of A Novel Synthetic HMG‐CoA Reductase Inhibitor

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