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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.