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Livalo (Pitavastatin Calcium) - Summary

 
 



LIVALO SUMMARY

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

See all Livalo indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Livalo (Pitavastatin)

Pitavastatin and Atorvastatin double-blind randomized comPArative study among hiGh-risk patients, including thOse with Type 2 diabetes mellitus, in Taiwan (PAPAGO-T Study). [2013]
CONCLUSION: Both pitavastatin (2 mg/day) and atorvastatin (10 mg/day) were well

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.

more studies >>

Clinical Trials Related to Livalo (Pitavastatin)

Pharmacokinetic Study of Livalo� Fixed Combination Drug in Healthy Subjects [Completed]
The purpose of this study is to compare pharmacokinetics between Pitavastatin and Valsartan co-administration and Livalo fixed combination drug in healthy male subjects.

Pharmacokinetic Study of Livalo� 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.

to Evaluate the Safety and Efficacy of Pitavastatin in Patients With IFG and Hyperlipidemia [Recruiting]
Primary Objective : To evaluate that there is no different effect on HbA1c between routine lipid lowering therapy(Livalo 2mg) and intensive lipid lowering therapy(Livalo 4mg) in the hyperlipidemic patients with impaired fasting glucose (IFG). H0: µT-µC ≥ 0. 4 vs H1: µT-µC < 0. 4 µT = the change of HbA1c in the test drug (Pitavastatin 4 MG) µC = the change of HbA1c in the control drug (Pitavastatin 2 MG)

Pharmacokinetic Study of Pitavastatin and Ritonavir-Boosted Darunavir or Efavirenz [Active, not recruiting]
The main goal of this study is to determine how taking efavirenz affects the levels of pitavastatin in the bloodstream when both drugs are taken together and to see how darunavir with ritonavir affects the levels of pitavastatin in the bloodstream. Secondary goals are to see how taking pitavastatin affects the levels in the blood of efavirenz when both drugs are taken together and to see how taking pitavastatin affects the levels in the blood of darunavir.

Follow-On Study of Pitavastatin Versus Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia [Completed]
This is a sixteen-week double-blind active-controlled follow-on and 28-week single-blind extension study for patients who participated in study NK-104-305.

more trials >>

Reports of Suspected Livalo (Pitavastatin) Side Effects

Rhabdomyolysis (28)Myalgia (21)Blood Creatine Phosphokinase Increased (17)Back Pain (12)Pain in Extremity (10)Liver Disorder (9)Alanine Aminotransferase Increased (9)Arthralgia (9)Aspartate Aminotransferase Increased (9)Hepatic Function Abnormal (8)more >>


Page last updated: 2014-11-30

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