Table 4.

Key information of the CLEAR Outcomes trial [55]

CLEAR Outcomes
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

‡ p-values after the first nonsignificant p-value are not presented

CI, confidence interval; CV, cardiovascular; HR, hazard ratio; MACE, major adverse cardiovascular event; MI, myocardial infarction