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EFFECTIVE & SUSTAINED
LDL-C REDUCTION1

Greater LDL-C reduction was
maintained during each 6-month dosing
interval vs placebo as a complement to
a maximally tolerated statin

In the ORION-10 clinical
trial,
on top of a maximally
tolerated statin, LEQVIO®
demonstrated:

52% LDL-C reduction

difference from placebo at month 17
(95% CI: -56%, -49%; P<0.0001)1

LDL-C reduction on top of a
maximally tolerated statin,
LEQVIO vs placebo1

% CHANGE IN LDL-C FROM BASELINE

On top of a maximally tolerated statin, LEQVIO demonstrated a 52% reduction from placebo at month 17
View study design
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LEQVIO was also studied in the
ORION-11 (n=712) clinical trial
with similar results to
ORION-10 (n=781).1

ORION-1 ONSET
OF ACTION

LDL-C REDUCTION WAS APPARENT WITHIN 14 DAYS AFTER THE FIRST DOSE OF LEQVIO

Study Description: ORION-1 was a phase II, multicenter, double-blinded, randomized, placebo-controlled clinical trial of 345 subjects with established ASCVD who were taking a maximally tolerated statin and required additional LDL-C reduction. Of those, 91 patients received the 284-mg dose of LEQVIO. The primary efficacy end point was the percent reduction in LDL-C from baseline to day 180 and was calculated for multiple time points at days 14, 30, 60, 90, 120, 150, 180, 210, and 240.1,3


8 out of 10 achieved LDL-C <70 mg/dL
8 out of 10 achieved LDL-C <70 mg/dL

84% of patients treated with LEQVIO achieved
the guideline-recommended LDL-C target of
<70 mg/dL

compared with 18% of patients
treated with placebo alone at month 17 in the
ORION-10 clinical trial.4,5

LEQVIO demonstrated consistent and significant
reduction across predefined subgroups6

Percent change in LDL-C from baseline at month 17 in a pooled analysis of ORION-10 and ORION-116

Percent change in LDL-C from baseline at month 17 in a pooled analysis of ORION-10 and ORION-11
Percent change in LDL-C from baseline at month 17 in a pooled analysis of ORION-10 and ORION-11
Percent change in LDL-C from baseline at month 17 in a pooled analysis of ORION-10 and ORION-11

*Patients with a history of statin intolerance.

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Study design
ORION-10 evaluated LDL-C
reduction over 18 months1

Trial design7

Phase III, multicenter, double-blind,
placebo controlled

LEQVIO trial design shows that patients with ASCVD and elevated LDL-C on a maximally tolerated statin with or without ezetimibe were randomized 1:1 and given either 284 mg of LEQVIO or placebo on days 0, 90, 270, and 450.

Patient characteristics4,7

Characteristic

LEQVIO
(n=781)

Placebo
(n=780)

Age in years (mean)

66.4

65.7

≥65 years (%)

62.0

57.3

Diabetes mellitus

47.5

42.4

Race/Ethnicity (%)

White

83.6

87.8

Black

14.1

11.2

Asian

1.2

0.1

Hispanic/Latino

13.8

13.3

Concomitant statin therapy (%)

Statin

89.8

88.7

High-intensity statin

67.2

68.8

Not on statinª

10.2

11.3

Mean LDL-C (mg/dL)

104.5

104.8

ªPatients with a history of statin intolerance.

The clinical trial design for ORION-11
was identical to ORION-10.5

THERE'S MORE TO KNOW ABOUT LEQVIO

Discover what makes LEQVIO dosing different

DIVE INTO DOSING arrow

ASCVD, atherosclerotic cardiovascular
disease; CI, confidence interval;
LDL-C, low-density lipoprotein cholesterol.

INDICATION AND IMPORTANT
SAFETY INFORMATION

COLLAPSE

EXPAND

INDICATION

LEQVIO (inclisiran) injection is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with clinical atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH) who require additional lowering of low-density lipoprotein cholesterol (LDL-C).

Limitations of Use: The effect of LEQVIO on cardiovascular morbidity and mortality has not been determined.

IMPORTANT SAFETY INFORMATION

Adverse reactions in clinical trials (≥3% of patients treated with LEQVIO and more frequently than placebo) were injection site reaction, arthralgia, urinary tract infection, diarrhea, bronchitis, pain in extremity and dyspnea.

Adverse reactions led to discontinuation in 2.5% and 1.9% of LEQVIO- and placebo-treated patients, respectively. Discontinuation due to injection site reactions, which included injection site pain, erythema and rash, were 0.2% and 0% of LEQVIO- and placebo-treated patients, respectively.

Please click here for LEQVIO full Prescribing Information.

References: 1. LEQVIO [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2021. 2. Cubanski J, Damico A, Neuman T, Jacobson G. Sources of supplemental coverage among Medicare beneficiaries in 2016. KFF. November 28, 2018. Accessed November 5, 2021. https://www.kff.org/medicare/issue-brief/sources-of-supplemental-coverage-among-medicare-beneficiaries-in-2016/# 3. Ray KK, Landmesser U, Leiter LA, et al. Inclisiran in patients at high cardiovascular risk with elevated LDL cholesterol. N Engl J Med. 2017;376(15):1430-1440. doi:10.1056/NEJMoa1615758 4. Data on file. Novartis Pharmaceuticals Corp; 2019. 5. Grundy SM, Stone NJ, Bailey AL, et al. AHN/AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the management of blood cholesterol: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019;139(25):e1082-e1143. doi:10.1161/CIR.0000000000000625 6. Data on file. Novartis Pharmaceuticals Corp; 2020. 7. Ray KK, Wright RS, Kallend D, et al; ORION-10 and ORION-11 Investigators. Two phase 3 trials of inclisiran in patients with elevated LDL cholesterol. N Engl J Med. 2020;382(16):1507-1519. doi:10.1056/NEJMoa1912387 8. McClellan M, Brown N, Califf RM, Warner JJ. Call to action: urgent challenges in cardiovascular disease: a presidential advisory from the American Heart Association. Circulation. 2019;139(9):e1-e11. doi:10.1161/CIR.0000000000000652 9. Jacobson T, Cheeley MK, Jones PH, et al. The STatin Adverse Treatment Experience Survey: experience of patients reporting side effects of statin therapy. J Clin Lipidol. 2019;13(6):405-424. 10. Jones PH, Radhika N, Thakker KM. Prevalence of dyslipidemia and lipid goal attainment in statin-treated subjects from 3 data sources: a retrospective analysis. J Am Heart Assoc. 2012;1(6):1-10. doi:10.1161/JAHA.112.001800 11. Fox KM, Tai M-H, Kostev K, Hatz M, Qian Y, Laufs U. Treatment patterns and low-density lipoprotein cholesterol (LDL-C) goal attainment among patients receiving high- or moderate-intensity statins. Clin Res Cardiol. 2018;107(5):380-388. doi:10.1007/s00392-017-1193-z 12. Wong ND, Young D, Zhao Y, et al. Prevalence of the American College of Cardiology/American Heart Association statin eligibility groups, statin use, and low-density lipoprotein cholesterol control in US adults using the National Health and Nutrition Examination Survey 2011–2012. J Clin Lipidol. 2016;10(5):1109-1118. doi:10.1016/j.jacl.2016.06.011

INDICATION

LEQVIO (inclisiran) injection is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with clinical atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH) who require additional lowering of low-density lipoprotein cholesterol (LDL-C).

Limitations of Use: The effect of LEQVIO on cardiovascular morbidity and mortality has not been determined.

IMPORTANT SAFETY INFORMATION

Adverse reactions in clinical trials (≥3% of patients treated with LEQVIO and more frequently than placebo) were injection site reaction, arthralgia, urinary tract infection, diarrhea, bronchitis, pain in extremity and dyspnea.

Adverse reactions led to discontinuation in 2.5% and 1.9% of LEQVIO- and placebo-treated patients, respectively. Discontinuation due to injection site reactions, which included injection site pain, erythema and rash, were 0.2% and 0% of LEQVIO- placebo-treated patients, respectively.

Please click here for LEQVIO full Prescribing Information.

References: 1. LEQVIO [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2021. 2. Cubanski J, Damico A, Neuman T, Jacobson G. Sources of supplemental coverage among Medicare beneficiaries in 2016. KFF. November 28, 2018. Accessed November 5, 2021. https://www.kff.org/medicare/issue-brief/sources-of-supplemental-coverage-among-medicare-beneficiaries-in-2016/# 3. Ray KK, Landmesser U, Leiter LA, et al. Inclisiran in patients at high cardiovascular risk with elevated LDL cholesterol. N Engl J Med. 2017;376(15):1430-1440. doi:10.1056/NEJMoa1615758 4. Data on file. Novartis Pharmaceuticals Corp; 2019. 5. Grundy SM, Stone NJ, Bailey AL, et al. AHN/AHA/ACC/AACVPR/AAPA/ABC/ACPM/
ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the management of blood cholesterol: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019;139(25):e1082-e1143. doi:10.1161/CIR.0000000000000625 6. Data on file. Novartis Pharmaceuticals Corp; 2020. 7. Ray KK, Wright RS, Kallend D, et al; ORION-10 and ORION-11 Investigators. Two phase 3 trials of inclisiran in patients with elevated LDL cholesterol. N Engl J Med. 2020;382(16):1507-1519. doi:10.1056/NEJMoa1912387 8. McClellan M, Brown N, Califf RM, Warner JJ. Call to action: urgent challenges in cardiovascular disease: a presidential advisory from the American Heart Association. Circulation. 2019;139(9):e1-e11. doi:10.1161/CIR.0000000000000652 9. Jacobson T, Cheeley MK, Jones PH, et al. The STatin Adverse Treatment Experience Survey: experience of patients reporting side effects of statin therapy. J Clin Lipidol. 2019;13(6):405-424. 10. Jones PH, Radhika N, Thakker KM. Prevalence of dyslipidemia and lipid goal attainment in statin-treated subjects from 3 data sources: a retrospective analysis. J Am Heart Assoc. 2012;1(6):1-10. doi:10.1161/JAHA.112.001800 11. Fox KM, Tai M-H, Kostev K, Hatz M, Qian Y, Laufs U. Treatment patterns and low-density lipoprotein cholesterol (LDL-C) goal attainment among patients receiving high- or moderate-intensity statins. Clin Res Cardiol. 2018;107(5):380-388. doi:10.1007/s00392-017-1193-z 12. Wong ND, Young D, Zhao Y, et al. Prevalence of the American College of Cardiology/American Heart Association statin eligibility groups, statin use, and low-density lipoprotein cholesterol control in US adults using the National Health and Nutrition Examination Survey 2011–2012. J Clin Lipidol. 2016;10(5):1109-1118. doi:10.1016/j.jacl.2016.06.011