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Table 1 Pharmacokinetic parameters of riociguat in healthy participants and in individuals with mild, moderate or severe renal impairment

From: Pharmacokinetics of the soluble guanylate cyclase stimulator riociguat in individuals with renal impairment

Parameter

Group 1 (CRCL > 80 mL/min) n = 16

Group 2 (CRCL 50–80 mL/min) n = 15

Group 3 (CRCL 30–49 mL/min) n = 16

Group 4a (CRCL < 30 mL/min) n = 16

AUC, μg·h/L

245.7 (51)

347.5 (111)

499.0 (110)

523.0 (70.4)b

Cmax, μg/L

36.6 (17)

44.2 (21)

42.0 (32)

40.56 (37.8)b

AUCnorm, kg·h/L

20.6 (56)

29.4 (126)

42.1 (109)

29.7 (102)

Cmax,norm, kg/L

3.07 (17)

3.48 (25)

3.54 (30)

2.97 (40)

t½, h

6.19 (50)

10.1 (116)

11.4 (103)

9.52 (75)

  1. aIn the first study, individuals with severe renal impairment (group 4) received riociguat 0.5 mg; all other participants in both studies received riociguat 1 mg.
  2. bAUC and Cmax values shown for individuals with severe renal impairment (group 4) are taken from the second study (n = 8), in which individuals with severe renal impairment received riociguat 1.0 mg.
  3. Values are geometric means (percentage coefficient of variation). AUC, area under the plasma concentration–time curve from time 0 to infinity; AUCnorm, AUC divided by dose per kilogram of body weight for total riociguat; Cmax, maximum concentration in plasma; Cmax,norm, Cmax divided by dose per kilogram of body weight for total riociguat; t½, terminal elimination half-life for total riociguat.