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Table 7 Adverse events in 72 patients on Alirocumab or Evolocumab, by entry statin intolerance group

From: Efficacy, safety, Low density lipoprotein cholesterol lowering, and calculated 10-year cardiovascular risk reduction of alirocumab and evolocumab in addition to maximal tolerated cholesterol lowering therapy: a post-commercialization study

 

All (n = 72) F45, M27 Follow up length median 25 weeks

Statin tolerant, taking statin (n = 30) F15, M15 Follow up length median 24 weeks

Statin intolerant (n = 42) F30, M12 Follow up length median 23 weeks

Flu-like myositis

8 (10%)

1 (3%)

7 (17%)

Respiratory tract infection/symptoms

6 (8%)

2 (7%)

4 (9%)

Inject site reaction

4 (6%)

2 (7%)

2 (5%)

Fatigue

1 (1%)

 

1 (2%)

Headache/mental acuity/mood

2 (3%)

 

2 (5%)

Urticaria/itchiness

2 (3%)

 

2 (5%)

G.I. symptom

2 (3%)

 

2 (5%)

Weight gain

1 (1%)

 

1 (2%)

Hair loss

1 (1%)

 

1 (2%)

Any adverse events

22 (31%)

5 (17%)

17 (40%)

No adverse events

50 (69%)

25 (83%)

25 (60%)

  1. Comparing adverse events (any vs none), there were fewer adverse events in the statin tolerant group, taking statin + ALI or EVO than in the statin intolerant group taking ALI or EVO only (Fisher’s p = .039)