Table 4 Key information of the CLEAR Outcomes trial [55]

Class &

Cardiovascular (CV) outcomes

HR (95% CI)

p-value‡

Primary efficacy endpoint

Composite of 4P-MACE: CV death, nonfatal MI, nonfatal stroke, or coronary revascularization

0.87 (0.79 to 0.96)

0.004

Key secondary efficacy endpoints

Composite of 3P-MACE: CV death, nonfatal stroke, or nonfatal MI

0.85 (0.76 to 0.96)

0.006

Fatal or nonfatal MI

0.77 (0.66 to 0.91)

0.002

Coronary revascularization

0.81 (0.72 to 0.92)

0.001

Fatal or nonfatal stroke

0.85 (0.67 to 1.07)

0.16

CV death

1.04 (0.88 to 1.24)

Death from any cause

1.03 (0.90 to 1.18)

Adverse events of special interest

Event rate (%) active vs. placebo group

Any adverse event that started or worsened after the first dose

of a trial agent

86.3 vs. 85.0

Any muscle disorder adverse event

15.0 vs. 15.4

Myalgia

5.6 vs. 6.8

New onset diabetes in patients without diabetes at baseline

16.1 vs. 17.1

Worsening hyperglycemia

22.7 vs. 23.1

Hypoglycemia

4.3 vs. 3.8

Metabolic acidosis

0.2 vs. 0.2

Elevated hepatic-enzyme level

4.5 vs. 3.0

Renal impairment

11.5 vs. 8.6

Hyperuricemia

10.9 vs. 5.6

Gout

3.1 vs. 2.1

Cholelithiasis

2.2 vs. 1.2