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Table 2 Overview of TEAEs (safety population)

From: Effect of alirocumab on individuals with type 2 diabetes, high triglycerides, and low high-density lipoprotein cholesterol

n (%)Alirocumab (n = 128)Usual carea (n = 58)
Any TEAE86 (67.2)41 (70.7)
Any treatment-emergent SAE8 (6.3)3 (5.2)
Any TEAE leading to death00
Any TEAE leading to permanent treatment discontinuation4 (3.1)2 (3.4)
TEAEs occurring in ≥ 2% of individuals (preferred level term)b
 Anemia3 (2.3)0
 Arthralgia2 (1.6)4 (6.9)
 Back pain1 (0.8)2 (3.4)
 Bronchitis1 (0.8)5 (8.6)
 Cellulitis3 (2.3)0
 Cough1 (0.8)3 (5.2)
 Diarrhea6 (4.7)4 (6.9)
 Dizziness2 (1.6)2 (3.4)
 Dyspnea1 (0.8)2 (3.4)
 Fall3 (2.3)2 (3.4)
 Fatigue5 (3.9)1 (1.7)
 Headache2 (1.6)3 (5.2)
 Hyperinsulinemic hypoglycemia3 (2.3)0
 Hypoglycemia2 (1.6)2 (3.4)
 Hypotension1 (0.8)2 (3.4)
 Influenza6 (4.7)2 (3.4)
 Injection-site bruising3 (2.3)0
 Injection-site pruritus4 (3.1)0
 Injection-site reaction5 (3.9)0
 Muscle spasms3 (2.3)1 (1.7)
 Musculoskeletal pain4 (3.1)2 (3.4)
 Myalgia3 (2.3)1 (1.7)
 Nausea4 (3.1)2 (3.4)
 Osteoarthritis02 (3.4)
 Pain in extremity1 (0.8)2 (3.4)
 Sinusitis1 (0.8)2 (3.4)
 Type 2 diabetes mellitus1 (0.8)2 (3.4)
 Upper respiratory tract infection5 (3.9)2 (3.4)
 Urinary tract infection11 (8.6)2 (3.4)
 Viral upper respiratory tract infection7 (5.5)1 (1.7)
 Vitamin D deficiency02 (3.4)
  1. SAE serious adverse event, TEAE treatment-emergent adverse event
  2. aOptions included ezetimibe, fenofibrate, no additional lipid-lowering therapy, omega-3 fatty acid, and nicotinic acid
  3. bGiven in alphabetical order