So what do tens of thousands of healthcare professionals know about LIVALO that you may not?

These healthcare professionals know that they can trust LIVALO as their go-to second-line statin when patients have complaints with their initial statin. LIVALO is a moderate-intensity statin that offers HCPs and their patients an effective, safe, and tolerable option after patients’ first generic trial.

Get In the Know With LIVALO® will give you the information you need to know about LIVALO based on what’s important to you when it comes to selecting a statin.

Have you ever prescribed LIVALO?

When you need to switch a patient’s statin, which attributes matter the most to you?
Please drag and drop to rank these attributes in order of most important to least important.

1 Efficacy/adequate LDL-C reduction
2 Safety and tolerability
3 Ease of prescribing
4 Fewer drug interactions
5 Specific patient considerations

Consider a switch to LIVALO when patients have complaints on their first generic statin

LIVALO 4 mg is a moderate-intensity statin that reduces LDL-C comparable to Lipitor® (atorvastatin) (20 mg) and Zocor® (simvastatin) (40 mg) and offers statistically superior LDL-C reduction to Pravachol® (pravastatin) (40 mg).1-4

In clinical trials, patients taking LIVALO achieved a mean change in LDL-C of up to -45% with the maximum dose of 4 mg.1-4

Lipitor is a registered trademark of Pfizer, Inc.

Zocor is a registered trademark of Merck & Co., Inc.

Pravachol is a registered trademark of Bristol-Myers Squibb Company.

Range of Changes in Lipid Parameters at Week 12 in Three 12-Week Trials Studying LIVALO1-4

In addition, at Week 12, LIVALO (2 mg and 4 mg, respectively) produced mean percent changes ranging from -30% to -31% and -35% to -37% in Apo B, -14% to -16% and -17% to -22% in triglycerides, and 2% to 6% and 4% to 6% in HDL-C.1-4

In clinical trials versus commonly prescribed statins, LIVALO demonstrated LDL-C reductions comparable to commonly prescribed strengths of Lipitor® (atorvastatin) and Zocor® (simvastatin) and was statistically superior to Pravachol® (pravastatin).1-4

Mean % Change in LDL-C at Week 12*†1-4

*

Pitavastatin was not studied against atorvastatin 40-mg and 80-mg doses, simvastatin 80-mg dose, or pravastatin 80-mg dose.

Non-inferiority of pitavastatin to a given dose of atorvastatin, simvastatin, or pravastatin was considered demonstrated if the lower bound of the 95% CI for the mean treatment difference was greater than -6% for the mean percent change in LDL-C.1-4

STUDY DESIGN

Three 12-week, randomized, multicenter, double-blind, double-dummy, Phase 3 studies in patients with primary hyperlipidemia or mixed dyslipidemia: Study 301: pitavastatin 2 mg (n=315) and 4 mg (n=298); Study 302: pitavastatin 2 mg (n=307) and 4 mg (n=319); Study 306: in patients ≥65 years, pitavastatin 1 mg (n=207), 2 mg (n=224), and 4 mg (n=210).

View head-to-head clinical trial data for LIVALO versus other commonly prescribed statins

LIVALO (2 mg, 4 mg) demonstrated LDL-C efficacy comparable to Lipitor® (atorvastatin) (10 mg, 20 mg, respectively)1,2

LIVALO (2 mg, 4 mg) demonstrated potent LDL-C efficacy comparable to commonly prescribed strengths of Lipitor® (atorvastatin) (10 mg, 20 mg).1,2 Below are the results of a pivotal head-to-head trial that evaluated LIVALO and Lipitor® (atorvastatin) across multiple lipid parameters.

Mean % Change in Lipid Parameters at Week 12*†1,2

Lipitor is a registered trademark of Pfizer, Inc.

*

Pitavastatin was not studied against atorvastatin 40-mg and 80-mg doses.

Non-inferiority of pitavastatin to a given dose of atorvastatin was considered demonstrated if the lower bound of the 95% CI for the mean treatment difference was greater than -6% for the mean percent change in LDL-C.

Treatment differences (95% Cl) in LDL-C1,2:

  • 0% (-3%, 3%) LIVALO 2 mg vs Lipitor® (atorvastatin) 10 mg
  • 1% (-2%, 4%) LIVALO 4 mg vs Lipitor® (atorvastatin) 20 mg

In addition, at Week 12, LIVALO (2 mg and 4 mg, respectively) produced mean percent changes of -30% and -35% in Apo B, -14% and -19% in triglycerides, and 4% and 5% in HDL-C.1,2

And based on American College of Cardiology/American Heart Association Guidelines, LIVALO (2 mg, 4 mg) aligns as a moderate-intensity statin along with Lipitor® (atorvastatin) (10 mg, 20 mg).5

STUDY DESIGN

Study 301: 12-week, randomized, multicenter, double-blind, double-dummy, active-controlled, non-inferiority, Phase 3 study comparing pitavastatin 2 mg (n=315) and 4 mg (n=298) with atorvastatin 10 mg (n=102) and 20 mg (n=102), respectively.

LIVALO (2 mg, 4 mg) demonstrated LDL-C efficacy comparable to Zocor® (simvastatin) (20 mg, 40 mg, respectively)1,3

LIVALO (2 mg, 4 mg) demonstrated potent LDL-C efficacy comparable to commonly prescribed strengths of Zocor® (simvastatin) (20 mg, 40 mg).1,3 Below are the results of a pivotal head-to-head trial that evaluated LIVALO and Zocor® (simvastatin) across multiple lipid parameters.

Mean % Change in Lipid Parameters at Week 12*†1,3

Zocor is a registered trademark of Merck & Co., Inc.

*

Pitavastatin was not studied against simvastatin 80-mg dose.

Non-inferiority of pitavastatin to a given dose of simvastatin was considered demonstrated if the lower bound of the 95% CI for the mean treatment difference was greater than -6% for the mean percent change in LDL-C.

Treatment differences (95% Cl) in LDL-C1,3:

  • 4% (1%, 7%) LIVALO 2 mg vs Zocor® (simvastatin) 20 mg (P=0.014)
  • 1% (-2%, 4%) LIVALO 4 mg vs Zocor® (simvastatin) 40 mg

In addition, at Week 12, LIVALO (2 mg and 4 mg, respectively) produced mean percent changes of -30% and -35% in Apo B, -16% and -17% in triglycerides, and 6% in HDL-C with both 2-mg and 4-mg dosage strengths.1,3

And based on American College of Cardiology/American Heart Association Guidelines, LIVALO (2 mg, 4 mg) aligns as a moderate-intensity statin along with Zocor® (simvastatin) (20 mg, 40 mg).5

STUDY DESIGN

Study 302: 12-week, randomized, multicenter, double-blind, double-dummy, active-controlled, non-inferiority, Phase 3 study comparing pitavastatin 2 mg (n=307) and 4 mg (n=319) with simvastatin 20 mg (n=107) and 40 mg (n=110), respectively.

LIVALO demonstrated statistically superior LDL-C reductions vs Pravachol® (pravastatin)1,2

LIVALO demonstrated statistically superior LDL-C reduction compared with Pravachol® (pravastatin).1,2 Below are the results of a pivotal head-to-head trial that evaluated LIVALO and Pravachol® (pravastatin) across multiple lipid parameters.

Mean % Change in Lipid Parameters at Week 12*†1,4

Pravachol is a registered trademark of Bristol-Myers Squibb Company.

*

Pitavastatin was not studied against pravastatin 80-mg dose.

Non-inferiority of pitavastatin to a given dose of pravastatin was considered demonstrated if the lower bound of the 95% CI for the mean treatment difference was greater than -6% for the mean percent change in LDL-C.

These statistically superior LDL-C reductions for LIVALO are based on three pairwise dose comparisons: LIVALO 1 mg, 2 mg, and 4 mg vs Pravachol® (pravastatin) 10 mg, 20 mg, and 40 mg, respectively.1,4

Statistically superior treatment differences (95% Cl) in LDL-C1,4:

  • 9% (6%, 12%) LIVALO 1 mg vs Pravachol® (pravastatin) 10 mg (P<0.001)
  • 10% (7%, 13%) LIVALO 2 mg vs Pravachol® (pravastatin) 20 mg (P<0.001)
  • 10% (7%, 13%) LIVALO 4 mg vs Pravachol® (pravastatin) 40 mg (P<0.001)

In addition, at Week 12, LIVALO (1 mg, 2 mg, and 4 mg, respectively) produced mean percent changes of -25%, -31%, and -37% in Apo B, -13%, -15%, and -22% in triglycerides, and 1%, 2%, and 4% in HDL-C.1,4

And based on American College of Cardiology/American Heart Association Guidelines, LIVALO (2 mg, 4 mg) aligns as a moderate-intensity statin along with Pravachol® (pravastatin) (40 mg, 80 mg).5

STUDY DESIGN

Study 306: 12-week, randomized, multicenter, double-blind, double-dummy, parallel group, active-controlled, non-inferiority, Phase 3 study in patients ≥65 years comparing pitavastatin 1 mg (n=207), 2 mg (n=224), and 4 mg (n=210) with pravastatin 10 mg (n=103), 20 mg (n=96), and 40 mg (n=102), respectively.

In addition, based on ACC/AHA Guidelines for statin intensity, LIVALO 2-4 mg is considered a moderate-intensity statin along with the statins and their doses listed below5:

Boldface type indicates specific statins and doses that were evaluated in RCTs. All of these RCTs demonstrated a reduction in major cardiovascular events. Italic type indicates statins and doses that have been approved by the FDA but were not tested in the RCTs reviewed.

Statin intensity recommendations can vary. Below are intensity-modifying factors for patients who may otherwise be candidates for high-intensity statin therapy5:

ACC=American College of Cardiology. AHA=American Heart Association. BID=twice daily. RCT=randomized controlled trial. ALT=alanine aminotransferase. ULN=upper limit of normal.

Individual responses to statin therapy varied in the RCTs and should be expected to vary in clinical practice. There might be a biological basis for a less-than-average response.

§Evidence from 1 RCT only: down-titration if unable to tolerate atorvastatin 80 mg in the IDEAL (Incremental Decrease through Aggressive Lipid Lowering) study.

Although simvastatin 80 mg was evaluated in RCTs, initiation of simvastatin 80 mg or titration to 80 mg is not recommended by the FDA because of the increased risk of myopathy, including rhabdomyolysis.

Adapted from 2013 ACC/AHA Guidelines on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults.

References:

  1. LIVALO [prescribing information]. Montgomery, AL: Kowa Pharmaceuticals America, Inc.; November 2016.
  2. Budinski D, Arneson V, Hounslow N, Gratsiansky N. Pitavastatin compared with atorvastatin in primary hypercholesterolemia or combined dyslipidemia. Clin Lipidol. 2009;4(3):291-302.
  3. Ose L, Budinski D, Hounslow N, Arneson V. Comparison of pitavastatin with simvastatin in primary hypercholesterolaemia or combined dyslipidaemia [published correction appears in Curr Med Res Opin. 2010;26(5):1046]. Curr Med Res Opin.2009;25(11):2755-2764.
  4. Stender S, Budinski D, Gosho M, Hounslow N. Pitavastatin shows greater lipid-lowering efficacy over 12 weeks than pravastatin in elderly patients with primary hypercholesterolaemia or combined (mixed) dyslipidaemia. Eur J Prev Cardiol. 2013;20(1):40-53.
  5. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):2889-2934.

When issues with tolerability require a statin switch, LIVALO is a demonstrated safe and tolerable statin option1

When tolerability issues require a switch to a different statin, consider LIVALO for its clinical safety and tolerability profile which includes1:

  • ~3% of patients taking LIVALO 4 mg experienced myalgia in pivotal trials
  • Only 1 in 200 patients discontinued LIVALO 4 mg due to myalgia

Adverse reactions reported by ≥2% of patients treated with LIVALO and ≥placebo in short-term controlled studies lasting up to 12 weeks are listed below.1

Discontinuation rates due to adverse reactions were low, <4%, and similar across all doses in controlled, short-term clinical trials and their open-label extensions from 44-60 weeks. In short- and long-term trials out to 72 weeks, only ~3% of patients experienced myalgia at the highest dose of 4 mg, with only 0.5% discontinuing due to it. 0.6% of patients on 4 mg discontinued due to elevated creatine phosphokinase.1

Reference:

  1. LIVALO [prescribing information]. Montgomery, AL: Kowa Pharmaceuticals America, Inc.; November 2016.

When patients require a statin switch, improved coverage facilitates prescribing LIVALO after one generic trial

LIVALO commercial and Medicare Part D coverage has greatly improved. On a growing number of managed care plans, LIVALO can be prescribed after a single step edit.

  • Over 143 million patients have commercial coverage of LIVALO
  • Over 23 million patients have Medicare part D coverage of LIVALO

Source: Managed Markets Insight & Technology, LLC.

Visit LivaloHCP.com to get information on local LIVALO formulary coverage.

Commercially insured patients may also take advantage of the LIVALO® Savings Card with which they may pay as little as $18 a month* for their LIVALO prescription.

What’s more, nearly 50,000 US pharmacies can automatically apply the savings offer at checkout—which is helpful if your patients forget to bring the LIVALO® Savings Card with them to the pharmacy.1

To download the LIVALO® Savings Card or to find out more information, visit LivaloHCP.com.

*Certain rules and restrictions apply. Please see eligibility criteria, along with offer terms and details, on the LIVALO® Savings Card.

Reference:

  1. LIVALO eVoucher participating pharmacy lists. RelayHealth; 2016. DOF 08082016.

Unlike other commonly prescribed statins, minimal metabolism of LIVALO via the CYP450 system offers the potential for fewer drug interactions

When selecting a second-line statin for your patients, especially those taking multiple medications, LIVALO offers a reduced potential for certain drug interactions because it is metabolized differently than most statins and not primarily dependent on CYP450 (CYP).1

Patients taking a statin may often be using additional medications to help manage other conditions. LIVALO—unlike many commonly prescribed statins including Lipitor® (atorvastatin), Zocor® (simvastatin), and Crestor® (rosuvastatin)—has no contraindications, dose restrictions, or limitations when used in combination with the specific medications listed below.1

View drug interaction, contraindication, and dose restriction/limitation information for other commonly prescribed statins

Unlike Lipitor® (atorvastatin), LIVALO is not dependent on the CYP system and has several distinct benefits for your patients already taking multiple medications1,2:

  • LIVALO has no dose restrictions or limitations when used with azole antifungals, such as itraconazole
  • LIVALO does not significantly affect concentrations of digoxin when used in combination
  • LIVALO is not contraindicated and has no limitations or restrictions when used with protease inhibitors
  • LIVALO does not have the potential to interact with grapefruit juice

Unlike Zocor® (simvastatin), another commonly prescribed statin, LIVALO is not dependent on the CYP system and has several distinct benefits for your patients already taking multiple medications1,3:

  • LIVALO has no dose limitation when taken with certain calcium channel blockers, such as amlodipine and diltiazem
  • LIVALO is not contraindicated when used in combination with itraconazole and has no dose restrictions when used with azole antifungals
  • LIVALO does not affect PT or INR when taken together with warfarin. However, PT and INR should still be routinely monitored
  • LIVALO is not contraindicated and has no dose restrictions when used with HIV protease inhibitors such as atazanavir, lopinavir, ritonavir, and darunavir
  • Patients taking LIVALO do not need to avoid grapefruit juice

PT=prothrombin time. INR=international normalized ratio.

Unlike Crestor® (rosuvastatin), LIVALO is not dependent on the CYP system and has several distinct benefits for your patients already taking multiple medications1,4:

  • LIVALO does not affect PT or INR when taken together with warfarin. However, PT and INR should still be routinely monitored
  • LIVALO has no dose limitations when used with HIV protease inhibitors such as atazanavir, lopinavir, and ritonavir
  • LIVALO has no recommended dose restrictions for patients of Asian descent

PT=prothrombin time. INR=international normalized ratio.

Lipitor is a registered trademark of Pfizer, Inc.
Zocor is a registered trademark of Merck & Co., Inc.
Crestor is a registered trademark of the AstraZeneca group of companies.

References:

  1. LIVALO [prescribing information]. Montgomery, AL: Kowa Pharmaceuticals America, Inc.; November 2016.
  2. Lipitor (atorvastatin) [prescribing information]. New York, NY: Pfizer, Inc.; June 2017.
  3. Zocor (simvastatin) [prescribing information]. Whitehouse Station, NJ: Merck & Co., Inc.; March 2015.
  4. Crestor (rosuvastatin) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; August 2017.

For many patients, especially those with comorbid medical conditions or who take multiple medications, LIVALO may be the right statin to switch to

As you know, every patient is unique and one statin won’t fit all patients. LIVALO is a potent statin option that may be most appropriate for the specific types of patients with high cholesterol listed below, especially those who are already taking other medications.

Explore the patient type categories below that you are most interested in learning why LIVALO may be an appropriate statin option.

Patients...

with type 2 diabetes (T2D)

≥65 years

taking calcium channel blockers (CCBs)

with 2 or more risk factors for coronary heart disease (CHD)

taking multiple medications

taking warfarin

of Asian descent

with HIV

For patients with type 2 diabetes (T2D),

LIVALO effectively lowers LDL-C with no significant changes in blood glucose levels1,2

LIVALO 4 mg demonstrated a nonsignificant change in blood glucose levels vs Lipitor® (atorvastatin) 20 mg1,2

Mean % Change in Blood Glucose at Week 121,2

Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors, including LIVALO.1

LIVALO 4 mg and Lipitor® (atorvastatin) 20 mg were not statistically different on LDL-C*1,2

Mean % Change in LDL-C at Week 121,2

STUDY DESIGN

Study 305: 12-week, randomized, multicenter, double-blind, double-dummy, parallel-group, active-controlled, non-inferiority, Phase 3 study of pitavastatin vs atorvastatin in 410 patients with combined dyslipidemia and type 2 diabetes mellitus. Mean percent change from baseline in LDL-C at Week 12 was -41% (pitavastatin 4 mg) vs -43% (atorvastatin 20 mg). Treatment difference (95% CI) in adjusted mean percent change in LDL-C was -2% (-6.2%, 1.5%), P=0.235. However, the -6.2% lower limit of CI slightly exceeded the -6% non-inferiority limit so that the non-inferiority objective was not achieved.1,2

Lipitor is a registered trademark of Pfizer, Inc.

*

Non-inferiority objective was not achieved.

References:

  1. LIVALO [prescribing information]. Montgomery, AL: Kowa Pharmaceuticals America, Inc.; November 2016.
  2. Gumprecht J, Gosho M, Budinski D, Hounslow N. Comparative long-term efficacy and tolerability of pitavastatin 4 mg and atorvastatin 20–40 mg in patients with type 2 diabetes mellitus and combined (mixed) dyslipidemia. Diabetes Obes Metab. 2011;13(11):1047-1055.

For patients ≥65 years,

LIVALO effectively lowers LDL-C with reduced potential for drug interactions1

LIVALO demonstrated statistically superior LDL-C reductions vs Pravachol® (pravastatin)1,2

Mean % Change in LDL-C at Week 12*†1,2

LIVALO was comparable to Pravachol® (pravastatin) for treatment-related TEAEs and discontinuation rates1,2

LIVALO has been extensively evaluated in patients 65 to 89 years of age, comprising 43% of all participants in controlled clinical trials.1

STUDY DESIGN

Study 306: 12-week, randomized, multicenter, double-blind, double-dummy, parallel-group, active-controlled, non-inferiority, Phase 3 study in patients ≥65 years comparing pitavastatin 1 mg (n=207), 2 mg (n=224), and 4 mg (n=210) with pravastatin 10 mg (n=103), 20 mg (n=96), and 40 mg (n=102), respectively.

Pravachol is a registered trademark of Bristol-Myers Squibb Company.

TEAE=treatment-emergent adverse event.

*

Pitavastatin was not studied against pravastatin 80-mg dose.

Non-inferiority of pitavastatin to a given dose of pravastatin was considered demonstrated if the lower bound of the 95% CI for the mean treatment difference was greater than -6% for the mean percent change in LDL-C.

References:

  1. LIVALO [prescribing information]. Montgomery, AL: Kowa Pharmaceuticals America, Inc.; November 2016.
  2. Stender S, Budinski D, Gosho M, Hounslow N. Pitavastatin shows greater lipid-lowering efficacy over 12 weeks than pravastatin in elderly patients with primary hypercholesterolaemia or combined (mixed) dyslipidaemia. Eur J Prev Cardiol. 2013;20(1):40-53.

For patients taking calcium channel blockers (CCBs),

LIVALO effectively lowers LDL-C without the need for dose adjustments in combination with certain CCBs1,2

Unlike Zocor® (simvastatin), LIVALO does not require dose adjustments when prescribed with CCBs like amlodipine and diltiazem1,2

  • The FDA issued additional restrictions and dose limitations for Zocor® (simvastatin) and simvastatin-containing agents in combination with some CCBs3

CCBs are commonly prescribed drugs4

  • 108.5 million CCB prescriptions filled in the US in 2016
  • 81.0 million amlodipine prescriptions filled in the US in 2016
  • 8.5 million diltiazem prescriptions filled in the US in 2016

Zocor is a registered trademark of Merck & Co., Inc.

References:

  1. LIVALO [prescribing information]. Montgomery, AL: Kowa Pharmaceuticals America, Inc.; November 2016.
  2. Zocor (simvastatin) [prescribing information]. Whitehouse Station, NJ: Merck & Co., Inc.; March 2015.
  3. FDA Drug Safety Communication: New restrictions, contraindications, and dose limitations for Zocor (simvastatin) to reduce the risk of muscle injury. http://www.fda.gov/drugs/drugsafety/ucm256581.htm. Accessed December 16, 2015.
  4. Symphony PHAST data. Symphony Health Solutions; April 2017. DOF 04192017.

For patients with 2 or more risk factors for coronary heart disease (CHD),

LIVALO effectively lowers LDL-C with reduced potential for interactions with medications used to treat certain CHD risk factors1

According to the NCEP ATP III, there are non-modifiable risk factors for CHD, including age and family history for premature CHD, as well as a number of modifiable risk factors for CHD, including2:

  • Dyslipidemia
    • Elevated LDL-C
    • Low HDL-C
    • Elevated TG
  • Hypertension
  • Thrombogenic state
  • Diabetes
  • Obesity
  • Physical inactivity
  • Atherogenic diet
  • Cigarette smoking

LIVALO—unlike Zocor® (simvastatin)—has no restrictions, contraindications, or dose limitations when used with certain CCBs used to treat hypertension*1,3,4

  • In patients with 2 or more risk factors for CHD, LIVALO 4 mg demonstrated LDL-C reductions comparable to Zocor® (simvastatin) 40 mg1,5

Mean % Change in LDL-C at Week 12†1,5

STUDY DESIGN

Study 304: 12-week, randomized, multicenter, double-blind, double-dummy, active-controlled, non-inferiority, Phase 3 study of pitavastatin vs simvastatin in 351 patients with primary hyperlipidemia or mixed dyslipidemia and 2 or more risk factors for CHD.

LIVALO 4 mg—unlike Zocor® (simvastatin) and Crestor® (rosuvastatin)—had no clinically significant effect on PT or INR in patients taking warfarin for thrombogenic state1,3,6

  • PT and INR should still be routinely monitored

Zocor is a registered trademark of Merck & Co., Inc.

Crestor is a registered trademark of the AstraZeneca group of companies.

CCB=calcium channel blocker.

*

Antihypertensive CCBs such as amlodipine and diltiazem.

In a study of patients with 2 or more risk factors for moderate-to-high CHD.1,2,5

References:

  1. LIVALO [prescribing information]. Montgomery, AL: Kowa Pharmaceuticals America, Inc.; November 2016.
  2. Third report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) Final Report. Circulation. 2002;106(25):3143-3421.
  3. Zocor (simvastatin) [prescribing information]. Whitehouse Station, NJ: Merck & Co., Inc.; March 2015.
  4. FDA Drug Safety Communication: New restrictions, contraindications, and dose limitations for Zocor (simvastatin) to reduce the risk of muscle injury. http://www.fda.gov/drugs/drugsafety/ucm256581.htm. Accessed December 16, 2015.
  5. Eriksson M, Budinski D, Hounslow N. Comparative efficacy of pitavastatin and simvastatin in high-risk patients: a randomized controlled trial. Adv Ther. 2011;28(9):811-823.
  6. Crestor (rosuvastatin) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; August 2017.

For patients taking multiple medications,

LIVALO metabolism offers a reduced potential for certain drug interactions1-3

Drug-drug interactions are a potential risk factor for clinically significant side effects3,4

  • ~75% of all drugs metabolized depend on CYP450 (CYP) for their metabolism, including most commonly prescribed statins5-8
  • As such, co-administration of other drugs with certain statins may interfere with statin metabolism and have the potential for clinically significant drug interactions4,5

LIVALO is metabolized differently than most statins and is not dependent on CYP450 (CYP)1

  • LIVALO is predominantly metabolized via a non-CYP pathway and is only minimally metabolized via CYP5
  • Based on this, LIVALO, in combination with most drugs, has a reduced potential for certain drug interactions1-3
    • The principal route of LIVALO metabolism is conjugation with glucuronic acid via liver UGTs with subsequent formation of pitavastatin lactone

LIVALO was studied with CYP-dependent medications with no clinically significant interactions noted

No dose adjustment of LIVALO is required or recommended with1:

  • Amlodipine/diltiazem LA
  • Itraconazole
  • Warfarin: does not prolong PT/INR*
  • Enalapril
  • Digoxin
  • Protease inhibitors:
    • Atazanavir
    • Lopinavir/ritonavir
    • Darunavir/ritonavir

CYP=cytochrome P450. UGT=uridine 5'-diphosphate (UDP) glucuronosyltransferase. PT=prothrombin time. INR=international normalized ratio.

*

PT and INR should still be routinely monitored.

References:

  1. LIVALO [prescribing information]. Montgomery, AL: Kowa Pharmaceuticals America, Inc.; November 2016.
  2. Neuvonen PJ. Drug interactions with HMG-CoA reductase inhibitors (statins): the importance of CYP enzymes, transporters and pharmacogenetics. Curr Opin Investig Drugs. 2010;11(3):323-332.
  3. Corsini A, Ceska R. Drug-drug interactions with statins: will pitavastatin overcome the statins’ Achilles’ heel? Curr Med Res Opin. 2011;27(8):1551-1562.
  4. Huang SM, Temple R, Throckmorton DC, Lesko LJ. Drug interaction studies: study design, data analysis, and implications for dosing and labeling. Clin Pharmacol Ther. 2007;81(2):298-304.
  5. Guengerich FP. Cytochrome P450 and chemical toxicology. Chem Res Toxicol. 2008;21(1):70-83.
  6. Lipitor (atorvastatin) [prescribing information]. New York, NY: Pfizer, Inc.; June 2017.
  7. Zocor (simvastatin) [prescribing information]. Whitehouse Station, NJ: Merck & Co., Inc.; March 2015.
  8. Statin Market TRx by Year. Symphony Health Solutions data as of the end of October 2015.

For patients taking warfarin,

LIVALO effectively lowers LDL-C without affecting PT or INR1

  • Unlike Zocor® (simvastatin) and Crestor® (rosuvastatin), LIVALO 4 mg had no clinically significant effect on PT or INR in patients taking warfarin; however, PT and INR should be monitored1-3
  • Co-administration of LIVALO did not result in clinically significant changes in the AUC or Cmax of warfarin1

Anticoagulation is an important clinical parameter for many patients4,5

  • Increases in INR are a concern for patients taking warfarin6
  • Approximately 70% of patients on warfarin are ≥65 years7
  • LIVALO has been extensively evaluated in patients 65 to 89 years of age (comprising 43% of participants in controlled clinical trials)1

Zocor is a registered trademark of Merck & Co., Inc.

Crestor is a registered trademark of the AstraZeneca group of companies.

PT=prothrombin time. INR=international normalized ratio. AUC=area under the curve. Cmax=maximum concentration observed.

References:

  1. LIVALO [prescribing information]. Montgomery, AL: Kowa Pharmaceuticals America, Inc.; November 2016.
  2. Zocor (simvastatin) [prescribing information]. Whitehouse Station, NJ: Merck & Co., Inc.; March 2015.
  3. Crestor (rosuvastatin) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; August 2017.
  4. January CT, Wann LS, Alpert JS, et al. 2014 AHH/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2014;64(21):2246-2280.
  5. Guyatt DH, Akl EA, Crowther M, et al. Executive summary: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2 Suppl):7S-47S.
  6. Liu CP, Li XM, Chen HW, et al. Depression, anxiety and influencing factors in patients with acute pulmonary embolism. Chin Med J. 2011;124(16):2438-2442.
  7. Warfarin Sodium Market TRx in 2015. Symphony Health Solutions; March 2015. DOF 03272015.

For patients of Asian descent,

LIVALO effectively lowers LDL-C without the need for dose limitations1

  • Unlike Crestor® (rosuvastatin), there is no recommendation to reduce the starting dose of LIVALO1,2
  • Without the need for dose reductions or limitations, patients of Asian descent can receive the full intended dose of LIVALO1

Clinical guidelines recommend extra diligence with regard to statin safety in patients of Asian descent3,4

  • There were no significant differences in Cmax and AUC in a pharmacokinetic study comparing Japanese and Caucasian participants taking LIVALO1
  • LIVALO has been studied in nearly 20,000 Asian patients in a large, 2-year Japanese surveillance study5
  • LIVALO was launched in Japan in 2003 and has been approved and launched in 5 other Asian countries6

Crestor is a registered trademark of the AstraZeneca group of companies.

Cmax=maximum concentration observed. AUC=area under the curve.

References:

  1. LIVALO [prescribing information]. Montgomery, AL: Kowa Pharmaceuticals America, Inc.; November 2016.
  2. Crestor (rosuvastatin) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; August 2017.
  3. Stone NJ, Robinson J, Lichtenstein AH, et al. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):2889-2934.
  4. Jacobson TA, Ito MK, Maki KC, et al. National Lipid Association recommendations for patient-centered management of dyslipidemia: part 1 – executive summary. J Clin Lipidol. 2014;8(5):473-488.
  5. Kurihara Y, Douzono T, Kawakita K, Nagasaka Y. A large-scale, long-term, prospective post-marketing surveillance of pitavastatin (LIVALO tablet)—LIVALO Effectiveness and Safety (LIVES) Study. Jpn Pharmacol Ther. 2008;36(8):709-731.
  6. NK-104 Current Approval Situation; January 23, 2017. DOF 08142015.

For patients with HIV,

LIVALO effectively lowers LDL-C with no contraindications or dose limitations when prescribed with HIV protease inhibitors*1,2

  • Co-administration of LIVALO with atazanavir, lopinavir/ritonavir, or darunavir/ritonavir did not result in clinically significant changes in the AUC or Cmax of LIVALO1
  • Based on its metabolism, LIVALO may have reduced potential for clinically significant drug interactions mediated by the CYP450 system1,3,4

The FDA issued contraindications and dose limitations for most statins when used with HIV protease inhibitors†2

FDA statin-prescribing recommendations for concomitant HIV protease inhibitor therapy‡2

The Infectious Diseases Society of America also cautions about the use of statins with HIV protease inhibitors5

  • Some statins can have potentially serious drug-drug interactions with HIV protease inhibitors, resulting in contraindications or dose limitations5
  • Unlike other commonly prescribed statins, LIVALO and Pravachol® (pravastatin) do not have contraindications or dose limitations when prescribed with HIV protease inhibitors1,5,6
  • In head-to-head studies, LIVALO demonstrated statistically superior LDL-C reductions vs Pravachol® (pravastatin) in both HIV-positive and HIV-negative patients with dyslipidemia1,7-9

Pravachol is a registered trademark of Bristol-Myers Squibb Company.

AUC=area under the curve. Cmax=maximum concentration observed.

*

LIVALO has only been evaluated with certain HIV protease inhibitors.

HIV protease inhibitors are a common component in highly active antiretroviral therapy (HAART), a complex drug regimen used to treat patients living with HIV.

Chart is modified from FDA statin-prescribing recommendations for concomitant HIV and hepatitis C virus therapy. No head-to-head studies were performed with the statins to determine dosing limitations or restrictions.

§

Pitavastatin row not highlighted in original FDA chart.

References:

  1. LIVALO [prescribing information]. Montgomery, AL: Kowa Pharmaceuticals America, Inc.; November 2016.
  2. FDA Drug Safety Communication: Interactions between certain HIV or hepatitis C drugs and cholesterol-lowering statin drugs can increase the risk of muscle injury. https://www.fda.gov/Drugs/DrugSafety/ucm293877.htm. Accessed August 11, 2017.
  3. Neuvonen PJ. Drug interactions with HMG-CoA reductase inhibitors (statins): the importance of CYP enzymes, transporters and pharmacogenetics. Curr Opin Investig Drugs. 2010;11(3):323-332.
  4. Corsini A, Ceska R. Drug-drug interactions with statins: will pitavastatin overcome the statins’ Achilles’ heel? Curr Med Res Opin. 2011;27(8):1551-1562.
  5. Aberg JA, Gallant JE, Ghanem KG, Emmanuel P, Zingman BS, Horberg MA. Primary care guidelines for the management of persons infected with HIV: 2013 update by the HIV Medicine Association of the Infectious Diseases Society of America. Clin Infect Dis. 2014;58(1):1-10.
  6. Pravachol (pravastatin) [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Company, Inc.; July 2016.
  7. Kowa Research Institute, Inc. A 12-week study comparing pitavastatin 4 mg vs. pravastatin 40 mg in HIV-infected subjects. https://clinicaltrials.gov/ct2/show/NCT01301066. NLM identifier: NCT01301066. Accessed August 11, 2017. Final CSR December 2013. DOF07232015.
  8. Sponseller CA, Morgan RE, Kryzhanovski VA, Campbell SE, Davidson MH. Comparison of the lipid-lowering effects of pitavastatin 4 mg versus pravastatin 40 mg in adults with primary hyperlipidemia or mixed (combined) dyslipidemia: a Phase IV, prospective, US, multicenter, randomized, double-blind, superiority trial. Clin Ther. 2014;36(8):1211-1222.
  9. Stender S, Budinski D, Gosho M, Hounslow N. Pitavastatin shows greater lipid-lowering efficacy over 12 weeks than pravastatin in elderly patients with primary hypercholesterolaemia or combined (mixed) dyslipidaemia. Eur J Prev Cardiol. 2013;20(1):40-53.
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