Table 6Summary of Baseline Characteristics — ANCHOR Study

Icosapent ethyl 4 g

(N = 233)

Placebo

(N = 233)

Age (years), mean (SD)61.1 (10.03)61.2 (10.05)
Male sex, n (%)142 (61)145 (62)
Body mass index (kg/m2), mean (SD)32.7 (4.99)33.0 (5.04)
Ethnic background, n (%)
 White218 (96.0)219 (96.9)
 Black or African-American4 (1.8)2 (0.9)
 Asian3 (1.3)3 (1.3)
 American Indian or Alaskan Native1 (0.4)0
 Other1 (0.4)2 (0.9)
CV risk stratum, n (%)
 Established CV risk (secondary prevention)a233 (100)233 (100)
 At high CV risk (primary prevention)00
Diabetes, n (%)
 Type 11 (0.4)0
 Type 2170 (72.9)171 (73.3)
 No diabetes62 (26.6)62 (26.6)
History of CVD, n (%)
 Myocardial infarction46 (19.7)31 (13.3)
 Unstable angina32 (13.7)18 (7.8)
 Stable angina26 (11.1)28 (12.0)
 Angioplasty55 (23.6)40 (17.2)
 Bypass surgery21 (9.0)21 (9.0)
 Myocardial ischemia15 (6.4)9 (3.9)
 Peripheral artery disease8 (3.4)10 (4.3)
 Abdominal aortic aneurysm7 (3.0)3 (1.3)
 Transient ischemic attack9 (3.8)10 (4.3)
 Stroke of carotid origin6 (2.6)7 (3.0)
 Obstruction of carotid artery (> 50%)15 (6.4)11 (4.7)
Statin intensity/regimen, n (%)b
 Low16 (6.9)15 (6.4)
 Moderate148 (63.5)144 (61.8)
 High69 (29.6)74 (31.8)
Baseline ezetimibe use15 (6.43)18 (7.72)
TG levels (mg/dL), mean (SD)281.1 (82.88)270.6 (75.02)
Abnormal lipids, n (%)111 (47.6)97 (41.6)
 High HDL-c (≥ 1.6 mmol/L [60 mg/dL])12 (5.1)14 (6.0)
 Low HDL-c (< 1.0 mmol/L [40 mg/dL])99 (42.4)83 (35.6)
 TGs > 11.3 mmol/L (1,000 mg/dL)NANA
Renal impairment,c n (%)NANA
Hypertension, n (%)193 (82.8)195 (83.7)

IQR = interquartile range; CV = cardiovascular; CVD = cardiovascular disease; HDL-c = high-density lipoprotein cholesterol; TG = triglycerides; SD = standard deviation; NA = not available.

a

In this trial, patients included are categorized as high risk for CVD, yet, for the REDUCE-IT study, these would be equivalent to the secondary prevention or established CVD (Table 4).

b

Statin intensity, as defined in the American College of Cardiology/American Heart Association cholesterol guidelines (Appendix 4).29

c

Defined as estimated glomerular filtration rate < 60 mL/min/1.73 m2.

Source: Clinical Study Report for the REDUCE-IT1 and ANCHOR2 studies.

From: Clinical Evidence

Cover of Clinical Review Report: Icosapent Ethyl (Vascepa)
Clinical Review Report: Icosapent Ethyl (Vascepa): (HLS Therapeutics Inc.): Indication: Prevention of cardiovascular events in statin-treated patients [Internet].
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