Repatha® has a demonstrated safety profile
in over 27,000 patients1
The Repatha® CV Outcomes Trial demonstrated the long-term
safety of Repatha® added to a statin over a median of 2.2 years1-3
|
Repatha® + statin
n = 13,784 26 mg/dL |
Median
achieved LDL-C* |
Placebo + statin
n = 13,780 89 mg/dL |
|
|---|---|---|---|
| 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 |
*Median LDL-C achieved at 48 weeks.2
†The total numbers 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
Long-term safety
Repatha® demonstrated a consistent safety profile over a 5-year period
in an open-label extension of primary hyperlipidemia trials up to 5 years4,*
-
Reported AE rates were generally consistent with AE rates from FOURIER and other phase 3 trials1,4
-
AE rates remained consistent over the treatment course4
-
Discontinuation rate due to AEs was 1.4%/year4
*1,255 patients (randomized 2:1 to Repatha® + SOC or SOC alone).4
Cognitive function
Lowering LDL-C with Repatha®
did not impair cognitive function1
EBBINGHAUS studied 1,974 patients
from the Repatha® CV Outcomes Trial1
-
Patients were assessed using neuropsychological function tests over a median follow-up of 19 months1
-
Noninferiority in select cognitive function domains was observed between Repatha® and placebo when added to statin1,2
AE = adverse event; CV = cardiovascular; LDL-C = low-density lipoprotein cholesterol; SOC = standard of care.
References: 1. Repatha® (evolocumab) prescribing information, Amgen. 2. Sabatine MS, Giugliano RP, Keech AC, et al. Evolocumab and clinical outcomes in patients with cardiovascular disease. N Engl J Med. 2017;376:1713-1722. 3. Data on file, Amgen:2017. 4. Koren MJ, Sabatine MS, Giugliano RP, et al. Long-term efficacy and safety of evolocumab in patients with hypercholesterolemia. J Am Coll Cardiol. 2019;74:2132-2146.