Actor portrayal.
Well-tolerated with a proven safety profile1
Most common adverse reactions in ≥3% of patients treated with LEQVIO® and more frequently than placebo
In LEQVIO adult phase 3 clinical trials over 18 months
Most Common Adverse Reactions* (Adult Phase 3 Pivotal Trials) | LEQVIO (n=1833), % | Placebo (n=1822), % |
|---|---|---|
Injection-site reaction† | 8 | 2 |
Arthralgia | 5 | 4 |
Bronchitis | 4 | 3 |
*Occurring in ≥3% of patients treated with LEQVIO and more frequently than placebo in adult phase 3 clinical trials over 18 months.
†Includes related terms such as injection site pain, erythema, and rash.
- 2.5% of patients discontinued LEQVIO vs 1.9% of patients 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 severity1-3
"[My LDL-C] has gone down remarkably…I didn’t have any injection site discomfort, bruising, or pain, I never felt ill or anything from the injection. That gave me confidence and hope that the next one would be the same.”
– Sharon W., LEQVIO patient compensated for her time.
Individual results may vary.
Consistent safety profile beyond 6 years4§
In ORION-8, an open-label extension study in adults with hypercholesterolemia and ASCVD or at increased risk of CVD‖ (N=3274), demonstrated:
- Long-term safety data were consistent with adult phase 3 clinical trials1,4
- No new safety signals4
Study Description: ORION-8, an open-label extension trial that included 3274 adults 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 LDL-C–lowering therapy.4
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.
‖Factors that increase risk of CVD include HeFH, T2DM, or 10-year risk of ≥20%.6
ASCVD, atherosclerotic cardiovascular disease; CVD, cardiovascular disease; HeFH, heterozygous familial hypercholesterolemia; LDL-C, low-density lipoprotein cholesterol; T2DM, type 2 diabetes mellitus.