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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)