In the ORION-10 clinical
trial,
on top of a maximally
tolerated statin, LEQVIO®
demonstrated:
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
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
8 OUT OF 10
ACHIEVED LDL-C <70 mg/dL4
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
*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
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
ASCVD, atherosclerotic cardiovascular
disease; CI, confidence interval;
LDL-C, low-density lipoprotein cholesterol.