INDICATIONS
Repatha® is indicated:
For US healthcare professionals
Repatha® is indicated:
For US healthcare professionals
Repatha® has been studied in
50
Clinical Trials
FOURIER-OLE is the longest trial of PCSK9i mAb to date, with some Repatha® patients followed continuously for up to 8.4 years across FOURIER and FOURIER-OLE3
No new safety signals were detected, and the incidence of serious AEs did not increase over time. The incidence of serious AEs was similar in patients achieving very low LDL-C levels (<20 mg/dL) and those with higher LDL-C1,3
Discontinuation rate due to AEs attributed to Repatha® during FOURIER-OLE was 0.1%1
FOURIER open-label extension study (FOURIER-OLE): Open-label extension of FOURIER trial. Analyses were pooled across the two OLE studies. 6,635 patients received Repatha® 140 mg every 2 weeks or 420 mg once a month (3,355 randomized to Repatha®, 3,280 to placebo in the parent trial). Median time on therapy was 7.1 years for those originally randomized to Repatha® (evolocumab) and 5 years for those originally randomized to placebo in the parent trial. The primary endpoint was the subject incidence of treatment-emergent events.
| Repatha® + statin N=13,784 Median achieved LDL-C‡ 26 mg/dL1 | Statin + placebo N=13,780 Median achieved LDL-C‡ 89 mg/dL1 | |
|---|---|---|
| Number of patients | n=13,769 | n=13,756 |
| Adverse events (% of patients) | ||
| Diabetes | 8.8 | 8.2 |
| Adjudicated case of new-onset diabetes | 8.1 | 7.7 |
| Nasopharyngitis | 7.8 | 7.4 |
| Upper respiratory tract infection | 5.1 | 4.8 |
| Muscle-related event | 5.0 | 4.8 |
| Allergic reaction | 3.1 | 2.9 |
| Injection-site reaction | 2.1 | 1.6 |
| Cataract | 1.7 | 1.8 |
| Neurocognitive event | 1.6 | 1.5 |
| Rhabdomyolysis | 0.1 | 0.1 |
Hemorrhagic stroke: 0.21% statin + Repatha® (n=13,784), 0.18% statin + placebo (n=13,780)§
EBBINGHAUS studied 1,974 patients from the Repatha® CV Outcomes Trial4
*Threshold for very high-risk patients.
†The 2022 ACC Consensus Decision Pathway (referred herein as ACC Consensus Pathway) was designed to address current gaps in care for LDL-C lowering to reducing ASCVD risk. This effort relies extensively on the evidence established by the 2013 ACC/AHA and 2018 AHA/ACC/Multisociety cholesterol guidelines, and provides further recommendations regarding the use of newer nonstatin therapies. It should be noted that this process did not involve formal systematic reviews, grading of evidence, or synthesis of evidence. The goal was to provide practical guidance for situations not covered by the previously published guidelines until the next round of formal review of scientific evidence.
‡Median LDL-C achieved at 48 weeks.
§The total number of patients were 8,337 in the Repatha® + statin group and 8,339 in the placebo + statin group because patients with prevalent diabetes at the start of the trial were excluded.2
