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

That LIVALO is a distinctly different statin that can benefit specific types of patients with high cholesterol.

Get In the Know With LIVALO® is an easy-to-use, self-guided tool that can give you the information you need to know about LIVALO. And since one statin won’t fit all patients, you’ll better understand where LIVALO can fit in your treatment practice.

In addition, if you opt-in to receiving communications about LIVALO, we’ll share the overall results so you can see how your responses compare with your peers’. See below for more information.

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

Explore the patient types below for which you are most interested in learning why LIVALO is an appropriate statin option.

  • Patients taking multiple medications

    Patients taking calcium channel blockers (CCBs)

    CCB Patient
    Unlike simvastatin, LIVALO does not require dose adjustment when prescribed with CCBs such as amlodipine or diltiazem1,2
    • The FDA issued additional restrictions and dose limitations for simvastatin and simvastatin-containing agents in combination with some CCBs3

    CCBs are commonly prescribed drugs

    • 108.5 million CCB prescriptions filled in the US in 20164
    • 81.0 million amlodipine prescriptions filled in the US in 20164
    • 8.5 million diltiazem prescriptions filled in the US in 20164

    Patients taking warfarin

    Warfarin Patient
    Unlike some commonly prescribed statins, LIVALO does not affect PT or INR in patients taking warfarin1
    • Certain statins may have potentially significant interactions with warfarin and may prolong PT/INR
    • Unlike simvastatin and rosuvastatin, LIVALO 4 mg had no clinically significant effect on PT or INR in patients taking warfarin; however, PT and INR should be monitored1,2,5
    • 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 patients6,7

    • Increases in INR are a concern for patients taking warfarin8
    • Approximately 70% of patients on warfarin are ≥65 years9
    • LIVALO has been extensively evaluated in patients ≥65 years (comprising 43% of participants in controlled clinical trials)1
    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. Simvastatin (Zocor) [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.
    • 5. Rosuvastatin (Crestor) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; May 2016.
    • 6. 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.
    • 7. Guyatt DH, Akl EA, Crowther M, et al. Executive summary: Antithrombic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012:141[2 Suppl]:7S-47S.
    • 8. 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.
    • 9. Warfarin Sodium Market TRx in 2015. Symphony Health Solutions; March 2015. DOF 03272015.
  • Patients with other medical concerns

    PATIENTS WITH TYPE 2 DIABETES (T2D)

    T2D Patient
    Blood Glucose
    LIVALO 4 mg demonstrated a nonsignificant change in blood glucose levels vs atorvastatin 20 mg1,2
    Blood Glucose Blood Glucose

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

    Efficacy
    LIVALO 4 mg and atorvastatin 20 mg were not statistically different on LDL-C*1,2
    LDL-C Atorvastatin LDL-C Atorvastatin *Non-inferiority objective was not achieved.

    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% (LIVALO 4 mg) vs -43% (atorvastatin 20 mg). Treatment difference (95% CI) in adjusted mean percent change in LDL-C was -2.3% (-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

    PATIENTS WITH 2 OR MORE RISK FACTORS FOR CORONARY HEART DISEASE (CHD)

    CHD Patient
    LIVALO—unlike simvastatin—has no restrictions, contraindications, or dose limitations when used with certain CCBs*1,3,4
    LDL-C Simvastatin LDL-C Simvastatin
    LIVALO demonstrated LDL-C reductions comparable to simvastatin1,5
    According to the NCEP ATP III, there are a number of modifiable risk factors for CHD, including6:
    • Dyslipidemia
      • Elevated LDL-C
      • Low HDL-C
      • Elevated TG
    • Hypertension
    • Thrombogenic state
    • Diabetes
    • Obesity
    • Physical inactivity
    • Atherogenic diet
    • Cigarette smoking

    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.

    *Antihypertensive CCBs such as amlodipine and diltiazem. In a study of patients with 2 or more risk factors for moderate-to-high CHD.1,5,6
    • 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.
    • 3. Simvastatin (Zocor) [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. 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.
  • Patients of specific demographics

    Elderly patients (≥65 years)

    Elderly Patient
    Efficacy
    LIVALO demonstrated statistically superior LDL-C reductions compared with pravastatin1,2
    LDL-C pravatastatin LDL-C pravatastatin *LIVALO 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% Cl for the mean treatment difference was greater than -6% for the mean percent change in LDL-C.
    Adverse Events
    LIVALO was comparable to pravastatin for treatment-related TEAE and discontinuation rates1,2
    TEAE
    TEAE TEAE=treatment-emergent adverse event.
    LIVALO has been extensively evaluated in elderly patients, comprising 43% of all participants in controlled clinical trials1

    STUDY DESIGN
    Study 306:
    12-week, randomized, multicenter, double-blind, double-dummy, parallel-group, active-controlled, non-inferiority, Phase 3 study in elderly patients (≥65 years) comparing LIVALO 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.

    Patients of Asian descent

    Asian Patient
    Unlike rosuvastatin, there is no recommendation to reduce the starting dose of LIVALO1,3
    • 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 study4
    • LIVALO was launched in Japan in 2003 and has been approved and launched in 5 other Asian countries5
    Cmax=maximum concentration observed. AUC=area under the curve.
    • 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.
    • 3. Rosuvastatin (Crestor) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; May 2016.
    • 4. 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.
    • 5. NK-104 Current Approval Situation; January 23, 2017. DOF 08142015.

It's understandable that coverage and cost concerns can be important factors for you and your patients. But did you know that an increasing number of managed care plans are covering LIVALO® and there are multiple ways that LIVALO can become more affordable for your patients?

First, LIVALO is covered on approximately 1800 national managed care plans and is continuing to gain coverage at the preferred level.1 So an even larger number of patients will have improved access to LIVALO.

If access still remains a barrier, take advantage of the CoverMyMeds® program. It is a free system for pharmacists, prescribers, and their staff that automates prior authorizations and can receive approvals in real time. For more information, visit covermymeds.com.

Savings Card

Last, there is also a LIVALO® Savings Card that may help eligible patients pay as little as $18 a month* on their LIVALO prescription. The LIVALO Savings Card:

  • Covers up to $75 monthly on out-of-pocket costs on each 30-day supply
  • Can be used with mail-order prescriptions
  • Can be used for each strength (1 mg, 2 mg, and 4 mg)

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.2

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.

  • References:
  • 1. LIVALO TRx Volume by Managed Care Plan. Kowa Pharmaceuticals America, Inc.; 2016. DOF 08122016.
  • 2. LIVALO eVoucher participating pharmacy lists. RelayHealth; 2016. DOF 08082016.

Even though you may never have heard of LIVALO®, it’s a potent statin option that has been available in the US since 2010.

LIVALO is taken once daily and available in 1-mg, 2-mg, and 4-mg doses. In addition, LIVALO has a robust amount of clinical information, including multiple head-to-head trials, and is metabolized in such a way that it helps patients avoid certain drug interactions.

First, it may be helpful to know that LIVALO demonstrated the proven efficacy you expect from a potent statin. 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 Moreover, 3 out of 4 patients attained their LDL-C goals.*2-5 In addition, LIVALO improves other atherogenic lipids such as HDL-C and triglycerides.1

Range of Changes in Lipids at Week 12 in Three 12-Week Trials Studying LIVALO

*Based on the National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III criteria.5

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

Furthermore, LIVALO demonstrated LDL-C reductions comparable to commonly prescribed strengths of atorvastatin and simvastatin and was statistically superior to pravastatin.1-4

Mean % Change in LDL-C at Week LIVALO 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.
STUDY DESIGN↓

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 below6:

Intensity chart Adapted from 2013 ACC/AHA Guidelines on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Risk in Adults.
Boldface type indicates specific statins and doses that were evaluated in randomized controlled trials (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.
ACC=American College of Cardiology. AHA=American Heart Association. BID=twice daily.
§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 in Endpoints 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.

As you may know, statin intensity recommendations can vary. Below are intensity-modifying factors for physicians to discuss with their patients who may otherwise be candidates for high-intensity statin therapy6:

Statin intensity modifying ALT=alanine aminotransferase. ULN=upper limit of normal.

What’s more, LIVALO is only minimally metabolized via the CYP450 system.1 Because of this, LIVALO may have reduced potential for clinically significant drug interactions mediated by the CYP450 system.7,8

CYP450 Pathway

Since LIVALO is metabolized differently than most statins, it has several distinct benefits for your patients already taking multiple medications, such as1:

  • LIVALO does not require a dose adjustment when taken with certain calcium channel blockers, such as amlodipine and diltiazem
  • LIVALO does not affect PT or INR when taken together with warfarin. However, PT and INR should still be routinely monitored
  • LIVALO does not significantly affect concentrations of digoxin when used in combination
PT=prothrombin time. INR=international normalized ratio.

With LIVALO, there are no contraindications, dose restrictions, or limitations when used in combination with the specific medications listed below.1

use with other medications
  • 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. 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.
  • 6. 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 July 1;63(25 Pt B):2889-2934.
  • 7. 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.
  • 8. 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.
  • 9. Atorvastatin (Lipitor) [prescribing information]. New York, NY: Pfizer, Inc.; March 2015.
  • 10. Simvastatin (Zocor) [prescribing information]. Whitehouse Station, NJ: Merck & Co., Inc.; March 2015.
  • 11. Statin Market TRx by Year. Symphony Health Solutions data as of the end of October 2015.
  • 12. Guengerich FP. Cytochrome P450 and chemical toxicology. Chem Res Toxicol. 2008;21(1):70-83.
  • 13. 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.

Atorvastatin is prescribed by many practitioners to help manage their patients’ cholesterol levels—but doctors who prescribe LIVALO® know that LIVALO (2 mg, 4 mg) demonstrated potent LDL-C efficacy comparable to commonly prescribed strengths of atorvastatin (10 mg, 20 mg).1,2 Below are the results of a pivotal head-to-head trial that evaluated LIVALO and atorvastatin across multiple lipid parameters.

Livalo vs Atorvastatin chart

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

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

STUDY DESIGN ↓

What’s more, LIVALO is only minimally metabolized via the CYP450 system and because of this, LIVALO may have reduced potential for clinically significant drug interactions mediated by the CYP450 system.1,4,5

CYP450 Pathway

So unlike atorvastatin, LIVALO is not dependent on the CYP450 system and has several distinct benefits for your patients already taking multiple medications1,6:

  • LIVALO is not contraindicated, and does not have any limitations or restrictions when used with protease inhibitors
  • LIVALO has no dose restrictions or limitations when used in combination with azole antifungals, such as itraconazole
  • LIVALO does not significantly affect concentrations of digoxin when used in combination
  • LIVALO does not have the potential to interact with grapefruit juice
  • 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. 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. 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.
  • 5. 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.
  • 6. Atorvastatin (Lipitor) [prescribing information]. New York, NY: Pfizer, Inc.; March 2015.
  • 7. Simvastatin (Zocor) [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.
  • 9. Guengerich FP. Cytochrome P450 and chemical toxicology. Chem Res Toxicol. 2008;21(1):70-83.
  • 10. 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.

Pravastatin is prescribed by many practitioners to help manage their patients’ cholesterol levels—but doctors who prescribe LIVALO® know that LIVALO is also not dependent on the CYP450 system for its metabolism, has a reduced potential for CYP450-mediated drug interactions, and demonstrated statistically superior LDL-C reduction compared with pravastatin.1-3 Below are the results of a pivotal head-to-head trial that evaluated LIVALO and pravastatin across multiple lipid parameters.

Livalo vs Pravastatin chart

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

Statistically superior treatment differences (95% Cl) in LDL-C1,2:

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

STUDY DESIGN ↓
  • 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.
  • 3. Pravastatin (Pravachol) [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Company, Inc.; July 2016.
  • 4. 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.

Rosuvastatin is prescribed by many practitioners to help manage their patients’ cholesterol levels—but doctors who prescribe LIVALO® know that LIVALO also demonstrated the proven efficacy you expect from a potent statin.1

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 Moreover, 3 out of 4 patients attained their LDL-C goals.*2-5 In addition, LIVALO improves other atherogenic lipids such as HDL-C and triglycerides.1

Range of Changes in Lipids at Week 12 in Three 12-Week Trials Studying LIVALO

*Based on the National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III criteria.5

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

LIVALO is metabolized differently than rosuvastatin and as such, LIVALO may have reduced potential for clinically significant drug interactions, particularly for your patients who are already taking multiple medications.1,7-9

CYP450 Pathway

So unlike rosuvastatin, LIVALO is not dependent on the CYP450 system and has several distinct benefits for your patients already taking multiple medications1,7:

  • LIVALO does not affect PT§ or INR when taken together with warfarin. However, PT or INR should still be routinely monitored
  • There are no recommended dosing restrictions for patients of Asian descent who take LIVALO
  • LIVALO has no dose limitations with certain HIV protease inhibitors, such as atazanavir, lopinavir, and ritonavir
§PT=prothrombin time.
INR=international normalized ratio.
  • 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. 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.
  • 6. 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.
  • 7. Rosuvastatin (Crestor) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; May 2016.
  • 8. 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.
  • 9. 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.
  • 10. Atorvastatin (Lipitor) [prescribing information]. New York, NY: Pfizer, Inc.; March 2015.
  • 11. Simvastatin (Zocor) [prescribing information]. Whitehouse Station, NJ: Merck & Co., Inc.; March 2015.
  • 12. Statin Market TRx by Year. Symphony Health Solutions data as of the end of October 2015.
  • 13. Guengerich FP. Cytochrome P450 and chemical toxicology. Chem Res Toxicol. 2008;21(1):70-83.
  • 14. 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.

Simvastatin is prescribed by many practitioners to help manage their patients’ cholesterol levels—but doctors who prescribe LIVALO® (2 mg, 4 mg) know that it demonstrated potent LDL-C efficacy comparable to commonly prescribed strengths of simvastatin (20 mg, 40 mg).1,2 Below are the results of a pivotal head-to-head trial that evaluated LIVALO and simvastatin across multiple lipid parameters.

Livalo vs Simvastatin chart

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

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

STUDY DESIGN ↓

What’s more, LIVALO is only minimally metabolized via the CYP450 system and because of this, LIVALO may have reduced potential for clinically significant drug interactions mediated by the CYP450 system.1,4,5

CYP450 Pathway

So, unlike simvastatin, LIVALO is not dependent on the CYP450 system and has several distinct benefits for your patients already taking multiple medications1,7:

  • LIVALO does not have a limitation in dose when taken with certain calcium channel blockers, such as amlodipine and diltiazem
  • 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 can be used without dose restrictions with HIV protease inhibitors such as atazanavir, lopinavir, ritonavir, and darunavir
  • LIVALO is not contraindicated when used in combination with itraconazole and has no dose restrictions when used with azole antifungals
  • Patients taking LIVALO do not need to avoid grapefruit juice
PT=prothrombin time.
INR=international normalized ratio.
  • References:
  • 1. LIVALO [prescribing information]. Montgomery, AL: Kowa Pharmaceuticals America, Inc.; November 2016.
  • 2. 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.
  • 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. 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.
  • 5. 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.
  • 6. Atorvastatin (Lipitor) [prescribing information]. New York, NY: Pfizer, Inc.; March 2015.
  • 7. Simvastatin (Zocor) [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.
  • 9. Guengerich FP. Cytochrome P450 and chemical toxicology. Chem Res Toxicol. 2008;21(1):70-83.
  • 10. 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.

Even though you might not be aware of the extent of clinical data for LIVALO®, it has a robust amount of clinical information, including multiple head-to-head trials. Please explore which topic(s) below you would like more information about.

  • Potent clinical efficacy

    Doctors who prescribe LIVALO know that it demonstrated the proven efficacy you expect from a potent statin. 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 Moreover, 3 out of 4 patients attained their LDL-C goals.*2-5 In addition, LIVALO improves other atherogenic lipids such as HDL-C and triglycerides.1

    Range of Changes in Lipids at Week 12 in Three 12-Week Trials Studying LIVALO

    *Based on the National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III criteria.5

    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

    Furthermore, LIVALO demonstrated LDL-C reductions comparable to commonly prescribed strengths of atorvastatin and simvastatin and was statistically superior to pravastatin.1-4

    Mean % Change in LDL-C at Week

    LIVALO 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.

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

    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 below6:

    Intensity chart

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

    Boldface type indicates specific statins and doses that were evaluated in randomized controlled trials (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. ACC=American College of Cardiology. AHA=American Heart Association. BID=twice daily. §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 in Endpoints 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.


    As you may know, statin intensity recommendations can vary. Below are intensity-modifying factors for physicians to discuss with their patients who may otherwise be candidates for high-intensity statin therapy6:

    Statin intensity modifying

    ALT=alanine aminotransferase. ULN=upper limit of normal.

    • 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. 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.
    • 6. 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 July 1;63(25 Pt B):2889-2934.
  • Avoiding certain drug interactions

    As you know, managing patients who are taking multiple medications can be challenging. In fact, in the largest survey of current and former statin users ever conducted in the United States (10,138 respondents), 84% of all respondents used at least one prescription, OTC, or herbal/vitamin product, which may have the potential for drug-drug interactions with statin therapy.1

    Drug interaction potential

    Doctors who prescribe LIVALO know that unlike the most commonly prescribed statins, LIVALO is only minimally metabolized via the CYP450* system.2-5 Because of this, LIVALO may have reduced potential for clinically significant drug interactions.6,7 The image below goes into additional detail regarding pathway metabolism.

    CYP450 Pathway
    • References:
    • 1. Cohen JD, Brinton EA, Ito MK, Jacobson TA. Understanding Statin Use in America and Gaps in Patient Education (USAGE): an internet-based survey of 10,138 current and former statin users. J Clin Lipidol. 2012;6(3):208-215.
    • 2. LIVALO [prescribing information]. Montgomery, AL: Kowa Pharmaceuticals America, Inc.; November 2016.
    • 3. Atorvastatin (Lipitor) [prescribing information]. New York, NY: Pfizer, Inc.; March 2015.
    • 4. Simvastatin (Zocor) [prescribing information]. Whitehouse Station, NJ: Merck & Co., Inc.; March 2015.
    • 5. Statin Market TRx by Year. Symphony Health Solutions data as of the end of October 2015.
    • 6. 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.
    • 7. 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.
    • 8. Guengerich FP. Cytochrome P450 and chemical toxicology. Chem Res Toxicol. 2008;21(1):70-83.
    • 9. 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.
  • Use with other medications

    Patients taking a statin may often be using additional medications to help manage other conditions. So if you are concerned about the risk of drug interactions or the need for dosing adjustments when prescribing a statin, consider LIVALO. With LIVALO, there are no contraindications, dose restrictions, or limitations when used in combination with the specific medications listed below.1

    Use with other medications
    • Reference:
    • 1. LIVALO [prescribing information]. Montgomery, AL: Kowa Pharmaceuticals America, Inc.; November 2016.
  • Adverse reactions and discontinuation rates

    LIVALO is a well-studied statin with a demonstrated clinical safety and tolerability profile. 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

    Livalo safety adverse reaction table

    Discontinuation rates due to adverse reactions were low, <4%, and similar across all doses in controlled, short-term clinical studies and their open-label extensions from 44-60 weeks.1 The most common adverse reactions that led to treatment discontinuation were: elevated creatine phosphokinase (0.6% on 4 mg) and myalgia (0.5% on 4 mg).1

    Livalo discontinuation rate
    • Reference:
    • 1. LIVALO [prescribing information]. Montgomery, AL: Kowa Pharmaceuticals America, Inc.; November 2016.

Have you ever prescribed LIVALO to manage your patients’ cholesterol levels?

Good to hear that you may already be In the Know with LIVALO! Prescribing a statin medication such as LIVALO, as adjunctive therapy to diet, can help manage patients’ overall cholesterol levels.

About how often do you prescribe LIVALO?

  • More than once a week
  • Once a week
  • Once every few weeks
  • Once a month
  • Once every few months

Thank you for sharing your prescribing frequency for LIVALO®—a statin that can benefit certain patients who are in need of cholesterol management.

Of the choices listed below, what is the main reason why you are not prescribing LIVALO more often?

  • Managed care coverage and cost concerns
  • Prefer another statin
  • Unsure of extent of clinical data and benefits
  • Haven't found the right patient type

There are many statin options available, but hopefully learning more about LIVALO can help you get In the Know and better understand where LIVALO can fit in your treatment practice.

But of the choices listed below, what is the main reason why you are not prescribing LIVALO?

  • Managed care coverage and cost concerns
  • Prefer another statin
  • Unsure of extent of clinical data and benefits
  • Haven't found the right patient type
  • I've never heard of LIVALO

Thank you for sharing. With a wide selection of available cholesterol medications, healthcare professionals may rely upon a specific statin when managing patients with high cholesterol.

Of the commonly prescribed statins listed below, which is your preferred statin treatment?

  • Atorvastatin
  • Simvastatin
  • Pravastatin
  • Rosuvastatin

We hope this information resolved your concerns about managed care coverage and cost for LIVALO®. If you would like to learn more about LIVALO please choose a topic listed below.

Another reason why I am not prescribing LIVALO more often is:

  • Managed care coverage and cost concerns
  • Prefer another statin
  • Unsure of extent of clinical data and benefits
  • Haven't found the right patient type
  • I have no additional questions or concerns about LIVALO

We hope this information explained how LIVALO compares with atorvastatin and how it may benefit your patients already taking multiple medications

If you would like to learn more about LIVALO, please choose a topic listed below.

  • Managed care coverage and cost concerns
  • Prefer another statin
  • Unsure of extent of clinical data and benefits
  • Haven't found the right patient type
  • I have no additional questions or concerns about LIVALO

We hope this information explained how LIVALO compares with pravastatin and how it may benefit your patients already taking multiple medications. If you would like to learn more about LIVALO, please choose a topic listed below.

Another reason why I am not prescribing LIVALO more often is:

  • Managed care coverage and cost concerns
  • Prefer another statin
  • Unsure of extent of clinical data and benefits
  • Haven't found the right patient type
  • I have no additional questions or concerns about LIVALO

We hope this information explained how LIVALO compares to rosuvastatin and how it may benefit your patients already taking multiple medications. If you would like to learn more about LIVALO, please choose a topic listed below.

Another reason why I am not prescribing LIVALO more often is:

  • Managed care coverage and cost concerns
  • Prefer another statin
  • Unsure of extent of clinical data and benefits
  • Haven't found the right patient type
  • I have no additional questions or concerns about LIVALO

We hope this information explained how LIVALO compares to simvastatin and how it may benefit your patients already taking multiple medications. If you would like to learn more about LIVALO, please choose a topic listed below.

Another reason why I am not prescribing LIVALO more often is:

  • Managed care coverage and cost concerns
  • Prefer another statin
  • Unsure of extent of clinical data and benefits
  • Haven't found the right patient type
  • I have no additional questions or concerns about LIVALO

We hope this information clearly demonstrated the clinical data of LIVALO and how it can benefit managing your patients’ cholesterol levels. If you would like to learn more about LIVALO please choose a topic listed below.

Another reason why I am not prescribing LIVALO more often is:

  • Managed care coverage and cost concerns
  • Prefer another statin
  • Unsure of extent of clinical data and benefits
  • Haven't found the right patient type
  • I have no additional questions or concerns about LIVALO

We hope this information helped clarify the specific patient types who may be most appropriate for LIVALO. If you would like to learn more about LIVALO please choose a topic listed below.

Another reason why I am not prescribing LIVALO more often is:

  • Managed care coverage and cost concerns
  • Prefer another statin
  • Unsure of extent of clinical data and benefits
  • Haven't found the right patient type
  • I have no additional questions or concerns about LIVALO

We hope this information helped you Get In the Know With LIVALO® and by better understanding how LIVALO can benefit patients in need of statin therapy. If you would like to learn more about LIVALO please choose a topic listed below.

Another reason why I am not prescribing LIVALO more often is:

  • Managed care coverage and cost concerns
  • Prefer another statin
  • Unsure of extent of clinical data and benefits
  • Haven't found the right patient type
  • I have no additional questions or concerns about LIVALO

Thank you for taking the time to

We hope this provided you with relevant information to help make LIVALO a more prominent part of your statin-prescribing routine.

To stay on top of all the latest information about LIVALO, including overall results so you can see how your responses compare with your peers’ as well as Managed Care updates, please provide the information below.

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