LIVALO (pitavastatin) is an inhibitor of HMG-CoA reductase. It is a synthetic lipid-lowering agent for oral administration.
LIVALO (pitavastatin) is a HMG-CoA reductase inhibitor indicated for:
- Patients with primary hyperlipidemia and mixed dyslipidemia as an adjunctive therapy to diet 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)
Limitations of Use:
- Doses of LIVALO greater than 4 mg once daily were associated with an increased risk for severe myopathy in premarketing clinical studies. Do not exceed 4 mg once daily dosing of LIVALO.
- The effect of LIVALO on cardiovascular morbidity and mortality has not been determined
- LIVALO has not been studied in patients with severe renal impairment (glomerular filtration rate < 30 mL/min/1.73 m2), not yet on hemodialysis. LIVALO should not be used in this patient population.
- LIVALO has not been studied with the protease inhibitor combination lopinavir/ritonavir. LIVALO should not be used with this combination of protease inhibitors
- LIVALO has not been studied in Fredrickson Type I, III, and V dyslipidemias
Published Studies Related to Livalo (Pitavastatin)
Comparative efficacy of pitavastatin and simvastatin in high-risk patients: a randomized controlled trial. [2011.09]
INTRODUCTION: Despite the proven efficacy of 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) in lowering total and low-density lipoprotein cholesterol (LDL-C), many patients do not reach recommended lipid targets. This study compared pitavastatin, a new and highly effective statin, and simvastatin in patients at high risk of coronary heart disease (CHD). The primary objective was to demonstrate noninferiority of pitavastatin to simvastatin... CONCLUSION: Pitavastatin 4 mg is as effective as simvastatin 40 mg in lowering LDL-C in dyslipidemic patients at high risk of CHD, with additional effects on HDL-C and triglycerides. Therefore, pitavastatin may be appropriate for the management of dyslipidemic patients at high cardiovascular risk.
The effect of pitavastatin calcium on endothelial dysfunction induced by hypercholesterolemia. [2011.07]
OBJECTIVE: To investigate whether endothelial function can be improved by the treatment of pitavastatin calcium via its antioxidant properties in hypercholesteremia patients... CONCLUSIONS: Endothelial dysfunction induced by hypercholesteremia can be ameliorated by pitavastatin calcium treatment, which occurs in part through its antioxidative properties. (c) 2011 Informa UK, Ltd.
Distinct effects of pitavastatin and atorvastatin on lipoprotein subclasses in patients with Type 2 diabetes mellitus. [2011.07]
AIMS: Effects of pitavastatin and atorvastatin on the lipid profile and lipoprotein subclasses were compared in patients with Type 2 diabetes with dyslipidaemia... CONCLUSIONS: The impact on lipoprotein subclass profiles was different between pitavastatin and atorvastatin. It may be beneficial to determine lipoprotein subclass profile and select the appropriate statin for each profile in patients with diabetes with an additional cardiovascular risk such as low HDL cholesterol or hypertriglyceridaemia. (c) 2011 The Authors. Diabetic Medicine (c) 2011 Diabetes UK.
Pitavastatin prevents postprandial endothelial dysfunction via reduction of the serum triglyceride level in obese male subjects. [2011.07]
Obesity is a well-established risk factor for the development and progression of coronary heart disease. Moreover, endothelial dysfunction is an early event in atherosclerosis and is known to be associated with postprandial hypertriglyceridemia... Pitavastatin might prevent endothelial dysfunction caused by postprandial hypertriglyceridemia within 2 weeks of therapy in obese subjects.
Randomized head-to-head comparison of pitavastatin, atorvastatin, and rosuvastatin for safety and efficacy (quantity and quality of LDL): the PATROL trial. [2011.05.25]
CONCLUSIONS: The safety and efficacy of these 3 strong statins are equal. It is suggested that the use of these 3 statins be completely dependent on physician discretion based on patient background.
Clinical Trials Related to Livalo (Pitavastatin)
Pharmacokinetic Study of Livaloï¿½ Fixed Combination Drug in Healthy Subjects [Not yet recruiting]
The purpose of this study is to compare pharmacokinetics between Pitavastatin and Valsartan
co-administration and Livalo fixed combination drug in healthy male subjects.
Efficacy and Safety Study of Pitavastatin Compared to atoRvastatin in Type 2 dIabeTes Mellitus With Hypercholesterolemia [Recruiting]
A randomized, open label, dose titration study to evaluate the efficacy and safety of
Pitavastatin compared to atorvastatin in Type 2 Diabetes Mellitus with hypercholesterolemia
Randomized Evaluation of Aggressive or Moderate Lipid Lowering Therapy With Pitavastatin in Coronary Artery Disease (REAL-CAD) [Recruiting]
The purpose of this study is to evaluate the prevention of cardiovascular disease by
moderate cholesterol lowering therapy, pitavastatin 1mg/day or aggressive cholesterol
lowering therapy, pitavastatin 4mg/day in patients with stable coronary artery disease.
Efficacy and Safety Study of Pitavastatin and Atorvastatin in High Risk Hypercholesterolemic Patients [Not yet recruiting]
This is a 12-week, randomized, multicenter, double-blind, active-controlled, non-inferiority
study (TATPITA20101005) to compare the efficacy and safety of pitavastatin (Livalo®) and
atorvastatin (Lipitor®) in high risk hypercholesterolemic patients.
Differential Intervention Trial by Standard Therapy Versus Pitavastatin in Patients With Chronic Hemodialysis (DIALYSIS) [Recruiting]
The purpose of this study is to verify whether pitavastatin prevents from cardiovascular
events and improves the mortality in chronic hemodialysis patients with hypercholesteremia.
Reports of Suspected Livalo (Pitavastatin) Side Effects
Blood Creatine Phosphokinase Increased (17),
Back Pain (12),
Pain in Extremity (10),
Liver Disorder (9),
Alanine Aminotransferase Increased (9),
Aspartate Aminotransferase Increased (9),
Hepatic Function Abnormal (8), more >>
Page last updated: 2011-12-09