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Clinical Review Report: Icosapent Ethyl (Vascepa): (HLS Therapeutics Inc.): Indication: Prevention of cardiovascular events in statin-treated patients [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2020 Aug.

Appendix 3Detailed Outcome Data

Table 16Stratified Analysis of Time to the Primary Composite End Point From Date of Randomization: Sensitivity Analyses֪ — ITT Population

End point, n (%)

Icosapent ethyl

N = 4,089

Placebo

N = 4,090

HR (95% CI)P value
Primary composite – excluding undetermined death673 (16.5)878 (21.5)0.737 (0.667 to 0.815)< 0.0001
Primary censored at drug discontinuation577 (14.1)732 (17.9)0.739 (0.662 to 0.824)< 0.0001
Primary censored at drug discontinuation + 30 days596 (14.6)776 (19.0)0.721 (0.648 to 0.802)< 0.0001
Primary with silent MI censored at last normal705 (17.2)901 (22.0)0.752 (0.682 to 0.830)< 0.0001
Primary with silent MI censored at mid-point705 (17.2)901 (22.0)0.752 (0.682 to 0.830)< 0.0001

CI = confidence interval; HR = hazard ratio; MI = myocardial infarction.

Table 17Subgroup Analysis Hazard Ratios (95% CI) for Primary Composite End Point by Subgroups — ITT Population

Icosapent ethyl, n/N (%)Placebo n/N (%)HR (95% CI)Interaction P value
Primary composite (ITT)705/4,089 (17.2)901/4,090 (22.0)0.752 (0.682 to 0.830)
Risk Category0.1388
 Established CVD (secondary prevention)559/2,892 (19.3)738/2,893 (25.5)0.726 (0.650 to 0.810)
 At high risk for CVD (primary prevention)146/1,197 (12.2)163/1,197 (13.6)0.876 (0.700 to 1.095)
Baseline diabetes0.5598
 Diabetes433/2,394 (18.1)536/2,393 (22.4)0.769 (0.678 to 0.873)
 No diabetes272/1,695 (18.0)365/1,694 (21.5)0.726 (0.620 to 0.849)

CI = confidence interval; CVD = cardiovascular disease; HR = hazard ratio; ITT = intention-to-treat.

Figure 3. Forest Plot of Analyses of Individual Components of the Primary and Key Secondary Outcomes (ITT Population, REDUCE-IT).

Figure 3Forest Plot of Analyses of Individual Components of the Primary and Key Secondary Outcomes (ITT Population, REDUCE-IT)

AMR101 = icosapent ethyl; CI = confidence interval; ITT = intention-to-treat.

Source: Clinical Study Report for REDUCE-IT1.

Copyright © 2020 Canadian Agency for Drugs and Technologies in Health.

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