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Table 3 Safety summary (randomized 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

 

DM-DYSLIPIDEMIA

DM-INSULIN

Alirocumab (n = 95)

UC (n = 47)

Alirocumab (n = 118)

Placebo (n = 57)

TEAEs occurring in ≥ 2% of individuals by preferred term, n (%)

 Urinary tract infection

5 (5.3)

2 (4.3)

3 (2.5)

4 (7.0)

 Diarrhea

5 (5.3)

3 (6.4)

3 (2.5)

3 (5.3)

 Hypertension

3 (3.2)

1 (2.1)

5 (4.2)

3 (5.3)

 Influenza

3 (3.2)

3 (6.4)

4 (3.4)

1 (1.8)

 Musculoskeletal pain

4 (4.2)

1 (2.1)

3 (2.5)

2 (3.5)

 Back pain

2 (2.1)

2 (4.3)

4 (3.4)

0

 Dizziness

3 (3.2)

1 (2.1)

3 (2.5)

2 (3.5)

 Fatigue

2 (2.1)

2 (4.3)

3 (2.5)

1 (1.8)

 Cataract

1 (1.1)

1 (2.1)

4 (3.4)

0

 Myalgia

2 (2.1)

1 (2.1)

3 (2.5)

0

 Nausea

2 (2.1)

1 (2.1)

2 (1.7)

2 (3.5)

 Pain in extremity

2 (2.1)

2 (4.3)

2 (1.7)

1 (1.8)

 Bronchitis

0

2 (4.3)

3 (2.5)

1 (1.8)