Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Pitavastatin calcium
Drug ID BADD_D01785
Description 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,[A181421] 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.[A181087, A181406] 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.[A181087, A181406] 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.[A181084] Elevated cholesterol levels, and in particular, elevated low-density lipoprotein (LDL) levels, are an important risk factor for the development of CVD.[A181087,A181553] 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.[A181090,A181093,A181096,A181427,A181475,A181538] 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.[A181087, A181406] 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.[A181397, A181403] 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.[A181409,A181535,A181538,A1793] 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").[A182000,A182003,A182006] Despite these differences in potency, several trials have demonstrated only minimal differences in terms of clinical outcomes between statins.[A181438, A181427]
Indications and Usage Pitavastatin is indicated for the treatment of 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). It is also indicated for the treatment of pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH) to reduce elevated TC, LDL-C, and Apo B.[F4667] 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. Statin-indicated conditions include diabetes mellitus, clinical atherosclerosis (including myocardial infarction, acute coronary syndromes, stable angina, documented coronary artery disease, stroke, trans ischemic attack (TIA), documented carotid disease, peripheral artery disease, and claudication), abdominal aortic aneurysm, chronic kidney disease, and severely elevated LDL-C levels.[A181087, A181406]
Marketing Status approved
ATC Code C10AA08
DrugBank ID DB08860
KEGG ID D01862
MeSH ID C108475
PubChem ID 11251522
TTD Drug ID D0G1WL
NDC Product Code 66869-104; 44343-001; 14501-0061; 65015-807; 65977-0101; 66869-404; 66869-204; 62496-100; 17337-0311; 65862-811
UNII IYD54XEG3W
Synonyms pitavastatin | itavastatin | (E,3R,5S)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid | P 872441 | P-872441 | NK 104 | NK-104 | pitavastatin calcium | itavastatin calcium | pitavastatin lactone | nisvastatin
Chemical Information
Molecular Formula C50H46CaF2N2O8
CAS Registry Number 147526-32-7
SMILES C1CC1C2=NC3=CC=CC=C3C(=C2C=CC(CC(CC(=O)[O-])O)O)C4=CC=C(C=C4)F.C1CC1C2=NC3=CC=CC =C3C(=C2C=CC(CC(CC(=O)[O-])O)O)C4=CC=C(C=C4)F.[Ca+2]
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.001---
Abdominal pain07.01.05.002--
Amnesia17.03.02.001; 19.20.01.001--
Arthralgia15.01.02.001--
Asthenia08.01.01.001---
Back pain15.03.04.005--
Blood alkaline phosphatase13.04.02.010---
Blood bilirubin13.03.04.015---
Blood creatine phosphokinase increased13.04.01.001--
Blood glucose13.02.02.009---
Confusional state17.02.03.005; 19.13.01.001--
Constipation07.02.02.001--
Death08.04.01.001--
Depression19.15.01.001--
Dermatitis23.03.04.002---
Diarrhoea07.02.01.001--
Discomfort08.01.08.003---
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.007--
Dyspepsia07.01.02.001--
Fatigue08.01.01.002--
Feeling abnormal08.01.09.014---
Gastrointestinal pain07.01.05.005--
Headache17.14.01.001--
Hepatic failure09.01.03.002--
Hepatitis09.01.07.004---
Hypersensitivity10.01.03.003--
Hypoaesthesia17.02.06.023; 23.03.03.081---
Influenza11.05.03.001; 22.07.02.001---
Insomnia17.15.03.002; 19.02.01.002--
Interstitial lung disease10.02.01.033; 22.01.02.003---
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