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GO LOWER WITH
EFFECTIVE AND

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

MONTH

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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

VIEW 4-YEAR DATA arrow

8 OUT OF 10

ACHIEVED LDL-C <70 mg/dL4

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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ORION-1 ONSET OF ACTION

LDL-C REDUCTION WAS APPARENT WITHIN

14

DAYS AFTER THE FIRST
DOSE OF LEQVIO1,3

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

In the 4-year, ORION-3 open-label
extension of a Phase II clinical trial in
statin-treated patients with ASCVD,
LDL-C reduction was consistent with
ORION-10 and ORION-111,14

LEQVIO REDUCED LDL-C BY
~50% AT DAY 210 AND WAS
CONSISTENT OVER 4 YEARS
WITH TWICE-YEARLY
DOSING (n=181)14

49.5%; 95% CI: -53.0%, -45.9%; P<0.0001.

Study Design: ORION-3, an open-label extension study of the Phase II ORION-1 trial, was designed to assess the efficacy and safety of LEQVIO up to 4 years in adult patients with ASCVD despite maximally tolerated lipid-lowering therapy. Patients who completed ORION-1 were eligible to enroll in ORION-3. Patients receiving LEQVIO in ORION-1 were started on the every-6-months dosing schedule, which was maintained throughout the duration of ORION-3. Total inclisiran exposure from ORION-1 through ORION-3 was 794 patient-years.14,15

Limitations: The open-label extension study was not blinded nor controlled and includes inherent self-selection bias for continuing onto the extension trial. The open-label design and absence of a control group may present difficulties in the interpretation of the efficacy and safety results, allowing comparisons only to baseline values.14,15


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

Take a moment to refresh your
understanding of the LEQVIO clinical story

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

IMPORTANT SAFETY INFORMATION
AND INDICATION

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.

Please click here for LEQVIO full Prescribing Information.

References: 1. LEQVIO [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp. 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. 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. European Medicines Agency. Annex I. Summary of Product Characteristics. Published December 9, 2020. Accessed August 4, 2022. https://www.ema.europa.eu/en/documents/product-information/leqvio-epar-product-information_en.pdf 9. 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 10. Jacobson TA, 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(3):415-424. 11. Jones PH, Nair R, 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 12. 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 13. 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 14. Data on file. ORION-3 (MDCO-PCS-16-01) ASCVD-only population. Novartis Pharmaceuticals Corp; 2022. 15. Ray KK, Troquay RPT, Visseren FLJ, et al. Long-term efficacy and safety of inclisiran in patients with high cardiovascular risk and elevated low-density lipoprotein cholesterol (ORION-3): results from the 4-year open-label extension of the ORION-1 trial. Oral presentation at: American Heart Association (AHA) Scientific Sessions 2022; November 5-7, 2022; Chicago, IL.

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.

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.

Please click here for LEQVIO full Prescribing Information.

References: 1. LEQVIO [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp. 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. 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. European Medicines Agency. Annex I. Summary of Product Characteristics. Published December 9, 2020. Accessed August 4, 2022. https://www.ema.europa.eu/en/documents/product-information/leqvio-epar-product-information_en.pdf 9. 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 10. Jacobson TA, 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(3):415-424. 11. Jones PH, Nair R, 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 12. 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 13. 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 14. Data on file. ORION-3 (MDCO-PCS-16-01) ASCVD-only population. Novartis Pharmaceuticals Corp; 2022. 15. Ray KK, Troquay RPT, Visseren FLJ, et al. Long-term efficacy and safety of inclisiran in patients with high cardiovascular risk and elevated low-density lipoprotein cholesterol (ORION-3): results from the 4-year open-label extension of the ORION-1 trial. Oral presentation at: American Heart Association (AHA) Scientific Sessions 2022; November 5-7, 2022; Chicago, IL.