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. 2020 Jan 28;30(1):33–49. doi: 10.1089/nat.2019.0796

Table 4.

Mean (±Standard Deviation) Revusiran-Related Clinical Chemistry Changes in 6- and 39-Week Toxicity Studies in Monkeys

  6-Week toxicity study
Males
Females
Dose (mg/kg)
0
30
100
300
0
30
100
300
No. animals/group
5 5 5 5 5 5 5 5
ALP (U/L) Pre-study (week 2)
582 ± 182.2 517 ± 151.0 680 ± 118.8 702 ± 260.7 442 ± 60.6 428 ± 82.9 489 ± 146.5 513 ± 76.0
Day 6
447 ± 122.0 582 ± 240.7 1,182 ± 343.4* 1,536 ± 559.6*** 373 ± 64.6 485 ± 114.6 891 ± 302.6*** 1,284 ± 337.3***
Day 37a
551 ± 140.3 623 ± 209.6 818 ± 186.0 1,076 ± 596.2 433 ± 80.9 522 ± 104.6 819 ± 278.5* 852 ± 194.5**
  39-Week toxicity study
Males
Females
Dose (mg/kg)
0
15
75
200
0
15
75
200
No. animals/group
6 6 6 6 6 6 6 6
ALP (U/L) Pre-study (week 2)
403 ± 103.2
340 ± 46.3
309 ± 84.6
293 ± 57.6
178 ± 48.2
180 ± 39.8
166 ± 50.0
154 ± 30.3
Pre-study (week 1)
421 ± 110.1
335 ± 30.7
308 ± 92.2
314 ± 50.9
176 ± 48.0
174 ± 48.1
166 ± 48.0
142 ± 29.4
Day 275b
316 ± 92.9 284 ± 62.9 344 ± 89.3 459 ± 113.6* 172 ± 38.5 183 ± 30.2 251 ± 58.6 250 ± 58.0*
a

All findings reversed by end of 4-week recovery period.

b

All findings reversed by end of 13-week recovery period.

*

P ≤ 0.05, **P ≤ 0.01, ***P ≤ 0.001.