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Let's reveal why these specific patients with high cholesterol may benefit from LIVALO

Patients taking calcium channel blockers (CCBs)

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 calcium channel blockers (CCBs) Bald_Guy_CalciumChannelBlockers

Patients taking warfarin

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 years 9
  • 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.

Blonde_Female_Warfarin Patients taking warfarin

Patients with type 2 diabetes (T2D)

Blood Glucose

LIVALO 4 mg demonstrated a nonsignificant change in blood glucose levels vs atorvastatin 20 mg1,10

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*1,10

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.1,10

Beard_Guy_TY2Dyslipidemia Patients with type 2 diabetes (T2D)

Elderly patients (≥65 years)

Efficacy

LIVALO demonstrated statistically superior LDL-C reductions compared with pravastatin1,11

Adverse Events

LIVALO was comparable to pravastatin for treatment-related TEAE and discontinuation rates1,11

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.

Elderly_Female_Patient Elderly patients (≥65 years old)

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

LIVALO—unlike simvastatin—has no restrictions, contraindications, or dose limitations when used with certain CCBs*1-3

LDL-C Simvastatin LDL-C Simvastatin

LIVALO demonstrated LDL-C reductions comparable to simvastatin1,12

According to the NCEP ATP III, there are a number of modifiable risk factors for CHD, including13:

  • 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.1,12,13

Goatee_Guy_HeartDisease Patients with at least 2 additional risk factors for coronary heart disease (CHD)

Patients of Asian descent

Unlike rosuvastatin, there is no recommendation to reduce the starting dose of LIVALO1,5

  • 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 study14

  • LIVALO was launched in Japan in 2003 and has been approved and launched in 5 other Asian countries15

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

Asian_Female_Patient Patients of Asian descent
metabolism

LIVALO helps patients avoid certain drug interactions

  • Unlike the most commonly prescribed statins, LIVALO is only minimally metabolized via the CYP450 system and may have reduced potential for clinically significant drug interactions1,2,16-19

CYP450=cytochrome P450.

efficacy

LIVALO delivers the efficacy you expect from a potent statin

  • LIVALO (4 mg) offers a mean LDL-C reduction of up to 45%–comparable to atorvastatin (20 mg) and simvastatin (40 mg)1,20,21

STUDY DESIGN
Three 12-week, randomized, multicenter, double-blind, double-dummy, 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).

Now that you have a better understanding of specific types of patients who may benefit from LIVALO, here are some helpful resources for getting your patients started on treatment

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.
  10. 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.
  11. 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.
  12. 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.
  13. 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.
  14. 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.
  15. NK-104 Current Approval Situation; January 23, 2017. DOF 08142015.
  16. Atorvastatin (Lipitor) [prescribing information]. New York, NY: Pfizer, Inc.; March 2015.
  17. Statin Market TRx by Year. Symphony Health Solutions data as of the end of October 2015.
  18. 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.
  19. 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.
  20. 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.
  21. 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.
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After downloading, complete and sign the bottom section of the form, then fax to:
1-334-272-6034

Please allow 7 to 10 business days for delivery.

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