LEQVIO is for LDL-C reduction in patients with primary hyperlipidemia along with diet and statin therapy.1
In LEQVIO Phase III clinical trials over 18 months, most common adverse reactions in ≥3% of patients treated with LEQVIO and more frequently than placebo1
aIncludes related terms such as injection site pain, erythema, and rash.
2.5% of patients discontinued LEQVIO vs 1.9% with placebo1
Injection site reactions were the most common causes for treatment discontinuation (0.2% of patients taking LEQVIO vs 0% taking placebo)1
The safety profile of LEQVIO was consistent across all subgroups, including elderly, hepatic, and renally impaired patient populations1*
The majority of adverse events were mild to moderate in severity1,11,29
*LEQVIO was not studied in patients with end-stage renal disease or severe hepatic impairment.
No contraindications, warnings and precautions, or clinically significant drug-drug interactions expected as per the prescribing information.1
In ORION-8, an open-label extension study in patients with ASCVD or at increased risk of CVD‡ (N=3274):
Long-Term Safety Data Were Consistent with Phase III Clinical Trials1,8
No New Safety Signals1,8
†209 (6.4%) patients had exposure to LEQVIO for 6+ years, 213 (6.5%) patients had exposure to LEQVIO for 5+ years, 1553 (47.4%) patients had exposure for 4+ years, and 2095 (64%) patients had exposure for 3+ years.30
‡Factors that increase risk of CVD include HeFH, T2DM, or 10-year risk of ≥20%.2
‡Factors that increase risk of CVD include HeFH, T2DM, or 10-year risk of ≥20%.2
Study Description: ORION-8, an open-label extension trial that included 3274 patients from ORION-9, ORION-10, ORION-11, and ORION-3, was designed to assess the long-term safety, efficacy, and tolerability of LEQVIO in patients with ASCVD or increased risk for CVD‡ and elevated LDL-C, despite ongoing treatment with lipid-lowering therapy.8,9
Limitations: 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 results, allowing comparisons only to baseline values.
THERE’S MORE TO KNOW ABOUT LEQVIO
Effective and sustained LDL-C reduction is possible for your patients1‡
ASCVD, atherosclerotic cardiovascular disease; CVD, cardiovascular disease; T2DM, type 2 diabetes mellitus
‡Greater LDL-C reduction was maintained during each 6-month dosing interval vs placebo as a complement to a maximally tolerated statin.1
‡Greater LDL-C reduction was maintained during each 6-month dosing interval vs placebo as a complement to a maximally tolerated statin.1