Detailed Outcome Data

Appendix 3Detailed Outcome Data

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

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

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

Publication Details

Copyright

The copyright and other intellectual property rights in this document are owned by CADTH and its licensors. These rights are protected by the Canadian Copyright Act and other national and international laws and agreements. Users are permitted to make copies of this document for non-commercial purposes only, provided it is not modified when reproduced and appropriate credit is given to CADTH and its licensors.

Except where otherwise noted, this work is distributed under the terms of a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International licence (CC BY-NC-ND), a copy of which is available at http://creativecommons.org/licenses/by-nc-nd/4.0/

Publisher

Canadian Agency for Drugs and Technologies in Health, Ottawa (ON)

NLM Citation

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 3, Detailed 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 death	673 (16.5)	878 (21.5)	0.737 (0.667 to 0.815)	< 0.0001
Primary censored at drug discontinuation	577 (14.1)	732 (17.9)	0.739 (0.662 to 0.824)	< 0.0001
Primary censored at drug discontinuation + 30 days	596 (14.6)	776 (19.0)	0.721 (0.648 to 0.802)	< 0.0001
Primary with silent MI censored at last normal	705 (17.2)	901 (22.0)	0.752 (0.682 to 0.830)	< 0.0001
Primary with silent MI censored at mid-point	705 (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 Category				0.1388
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 diabetes				0.5598
Diabetes	433/2,394 (18.1)	536/2,393 (22.4)	0.769 (0.678 to 0.873)
No diabetes	272/1,695 (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 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.