Table 4.
Overview of the studies including a pharmacokinetic analysis. Ordered by drug and date of publication
| Author | Number of samples per subject | Drug | Study design | Analysis summary |
|---|---|---|---|---|
| Lanreotide | ||||
| Garrido et al. [20] | 10 | Lanreotide autogel | Phase II, multicenter, randomized in acromegaly patients | Population PK/PD model linking the PK to individual GH (mean of 7 measurements with 30 min interval) and IGF-1 response |
| Shimatsu et al. [44] | Not reported | Lanreotide | Phase II multicenter, open-label, randomized, parallel-group and phase III open-label, dose-adjustment, long-term treatment | Mean ± SD of Cmax, AUC and Cmin at sampled time points |
| Giustina et al. [21] | 3 | Lanreotide autogel | Prospective, multicenter, randomized, open-label | Graphical analysis of individual serum concentrations and mean of 2 individual serum concentrations versus IGF-1 concentrations, with linear regression |
| Octreotide | ||||
| Gadelha et al. [35] | 25 | Octreotide implant | Phase II, open-label, randomized | Mean ± SD of Cmax, AUC0−6 months, tmax. Graphical analysis of concentrations with mean ± SD |
| Chieffo et al. [36] | 16 | Octreotide LAR Octreotide implant |
Phase III, open-label, multicenter, randomized | Graphical analysis with mean ± SE at sampled time points per cohort |
| Melmed et al. [34] | 14 | Oral octreotide | Phase III, multicenter, open-label, dose-titration | Mean ± SD for the C0, AUC and t1/2. Graphical analysis showing the mean ± SE |
| Pasireotide | ||||
| Petersenn et al. [46] | 3 per scheduled visit, with ~ 20 visits per subject | Pasireotide | Open-ended extension of a phase II study | Individual dose normalized Ctrough concentration–time profiles |
| Petersenn et al. [22] | 16 | Pasireotide LAR | Phase I, randomized, multicenter, open-label | Graphical analysis of mean ± SE Ctrough concentrations over 84 days and mean ± SE of post-first injection day. Median and mean ± SD for the Cmax, Ctrough, AUC and accumulation ratio |
| Pegvisomant | ||||
| Higham et al. [66] | 2 | Pegvisomant | Prospective, multicenter, open-label | Mean ± SD of concentrations at 2 time points |
PK pharmacokinetics, PD pharmacodynamics, IGF-1 insulin-like growth factor 1, SD standard deviation, SE standard error, Cmax apparent maximum concentration, AUC area under the concentration–time curve, Cmin apparent minimal concentration, C0 apparent initial concentration, Ctrough apparent concentration before next dosing, t1/2 half-life