Repatha® CV Outcomes Study: Adverse events and laboratory test results2,3

Outcome

Repatha® + Statin (n = 13,769)

Placebo + Statin (n = 13,756)

Median LDL-C*

26 mg/dL

92 mg/dL

Adverse events—no. 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

Laboratory results—no. of patients/total no. (%)

Aminotransferase level > 3 times the upper limit of the normal range

1.8

1.8

Creatine kinase level > 5 times the upper limit of the normal range

0.7

0.7

  • In EBBINGHAUS, a substudy of 1,974 patients enrolled in the Outcomes trial, Repatha® was non-inferior to placebo on selected cognitive function domains as assessed with the use of neuropsychological function tests over a median follow-up of 19 months3

*Median LDL-C achieved at 48 weeks.3

The total number of patients was 8,337 in the Repatha® group and 8,339 in the placebo group, because patients with prevalent diabetes at the start of the trial were excluded.2

CV = cardiovascular; LDL-C = low-density lipoprotein cholesterol.