Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Pitavastatin
Drug ID BADD_D02463
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 used to lower serum levels of total cholesterol, LDL-C, apolipoprotein B, and triglycerides, and raise levels of HDL-C for the treatment of dyslipidemia.
Marketing Status Not Available
ATC Code C10AA08
DrugBank ID DB08860
KEGG ID D01862
MeSH ID C108475
PubChem ID 5282452
TTD Drug ID D0G1WL
NDC Product Code Not Available
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 C25H24FNO4
CAS Registry Number 147511-69-1
SMILES C1CC1C2=NC3=CC=CC=C3C(=C2C=CC(CC(CC(=O)O)O)O)C4=CC=C(C=C4)F
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.0010.001856%
Abdominal pain07.01.05.002--
Alanine aminotransferase abnormal13.03.01.0010.001856%Not Available
Alanine aminotransferase increased13.03.01.0030.003712%
Alopecia23.02.02.0010.002784%
Anaemia01.03.02.001--
Angina pectoris24.04.04.002; 02.02.02.0020.002784%
Arthralgia15.01.02.0010.004640%
Aspartate aminotransferase abnormal13.03.01.0040.001856%Not Available
Aspartate aminotransferase increased13.03.01.0060.002784%
Atrial fibrillation02.03.03.0020.001856%
Back pain15.03.04.0050.003712%
Blood cholesterol increased13.12.01.0020.002784%
Blood creatine phosphokinase increased13.04.01.0010.018562%
Blood pressure decreased13.14.03.0020.001856%Not Available
C-reactive protein increased13.09.01.0070.003712%Not Available
Cardiac failure congestive02.05.01.002--Not Available
Cerebral haemorrhage24.07.04.001; 17.08.01.0030.000726%Not Available
Cerebral infarction24.04.06.002; 17.08.01.0040.005568%Not Available
Colon cancer16.13.01.001; 07.21.01.0010.001856%Not Available
Constipation07.02.02.001--
Death08.04.01.001--
Dehydration14.05.05.0010.003712%
Depression19.15.01.001--
Diabetic ketoacidosis14.07.03.001; 05.07.03.0010.001856%Not Available
Diarrhoea07.02.01.001--
Disturbance in attention19.21.02.002; 17.03.03.0010.001856%
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.004--
Drug eruption23.03.05.001; 10.01.01.005; 08.01.06.0150.006497%Not Available
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