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Table 2 Safety summary (pool of DM-INSULIN and DM-DYSLIPIDEMIA; safety population)

From: Alirocumab therapy in individuals with type 2 diabetes mellitus and atherosclerotic cardiovascular disease: analysis of the ODYSSEY DM-DYSLIPIDEMIA and DM-INSULIN studies

n (%)

Alirocumab (n = 213)

Control (n = 104)

TEAEs

142 (66.7)

70 (67.3)

Treatment-emergent SAEs

28 (13.1)

10 (9.6)

TEAEs leading to death

1 (0.5)

1 (1.0)

TEAEs occurring in ≥ 2% of individuals by preferred term

 Urinary tract infection

8 (3.8)

6 (5.8)

 Diarrhea

8 (3.8)

6 (5.8)

 Hypertension

8 (3.8)

4 (3.8)

 Influenza

7 (3.3)

4 (3.8)

 Headache

7 (3.3)

1 (1.0)

 Musculoskeletal pain

7 (3.3)

3 (2.9)

 Nasopharyngitis

6 (2.8)

5 (4.8)

 Back pain

6 (2.8)

2 (1.9)

 Dizziness

6 (2.8)

3 (2.9)

 Fatigue

5 (2.3)

3 (2.9)

 Cataract

5 (2.3)

1 (1.0)

 Myalgia

5 (2.3)

1 (1.0)

 Nausea

4 (1.9)

3 (2.9)

 Pain in extremity

4 (1.9)

3 (2.9)

 Arthralgia

3 (1.4)

3 (2.9)

 Bronchitis

3 (1.4)

3 (2.9)

 Hypotension

2 (0.9)

3 (2.9)

 Cough

1 (0.5)

3 (2.9)

 Hyperglycemia

0 (0.0)

3 (2.9)

  1. SAE serious adverse event, TEAE treatment-emergent adverse event