Table 7Patient Disposition

REDUCE-ITANCHOR

Icosapent ethyl 4 g

(N = 4,089)

Placebo

(N = 4,090)

Icosapent ethyl 4 g

(N = 233)

Placebo

(N = 233)

Screened, N19,2122,309
Randomized, N8,179702
Randomized to each group, N (%)4,0894,090233233
Discontinued, N (%)405 (9.9)460 (11.2)12 (5.2)16 (6.9)
Reason for discontinuation, N (%)
 Adverse events005 (2.1)7 (3.0)
 Lost to follow-up63 (1.5)89 (2.2)1 (0.4)0 (0)
 Withdrew consent281 (6.9)297 (7.3)4 (1.7)6 (2.6)
 Investigator judgment12 (0.29)12 (0.29)1 (0.4)0 (0)
 Death before final visit265 (6.4)a295 (7.2)a0 (0)1 (0.4)
 Other49 (1.2)62 (1.5)1 (0.4)2 (0.9)
ITT, N4,0894,090226227
PP, N3,3603,299215205
Safety, N4,0894,090233233

ITT = intention-to-treat; PP = per-protocol.

a

Deaths before final visit are part of the evaluated outcomes, therefore, authors did not count them as discontinuations.

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

From: Clinical Evidence

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