Characteristics of the adult data sets used for carvedilol model development

No.PopulationNo. of SubjectsDose (mg)ApplicationAge (years)Body Weight (kg)Ref.
1Healthy10a12.5i.v. infusionb29.521–3973.956.5–98(Neugebauer et al., 1990)
2Healthy312.5i.v. infusionb(Spahn et al., 1990)
3Healthy10a50Oral29.521–3973.956.5–98(Neugebauer et al., 1990)
4Healthy350Oral(Spahn et al., 1990)
5Healthy925Oral28.4c82.1c(Zhou and Wood, 1995)
6Healthy725Oral32d89.0d(Zhou and Wood, 1995)
7Healthy76.4eOral29.724–377156–100(Behn, 2001)
8Heart failuref,g206.25Oral5539–6489.560.8–113.1(Tenero et al., 2000)
9Heart failuref,g2012.5Oral5539–6489.560.8–113.1
10Heart failuref,g2025Oral5539–6489.560.8–113.1
11Heart failuref,g2050Oral5539–6489.560.8–113.1
  • a The number of patients included in pharmacokinetic analysis of S-carvedilol after i.v. and oral application were 6 and 7, respectively.

  • b Intravenous infusion was given over 1 hour.

  • c S.E.M. for age ±1.3 years and for weight ±3.2 kg.

  • d S.E.M. for age ±2.4 years and for weight ±6.9 kg.

  • e Dose administered as 0.09 mg/kg but normalized to total dose by multiplying with the average weight of the participants in the clinical trial.

  • f Twenty patients completed the study (10 patients with NYHA III and 10 with NYHA IV heart failure).

  • g The presented values for age and weight are the reported values for the initial study population (n = 22).