Patients were titrated to 12 mg/day (or their individual maximum tolerated dose) during the blinded conversion period, followed by open-label maintenance.
Hypoglycemia rate per patient for 30 days was analyzed using a negative binomial model with treatment, treatment sequence, period, and dose conversion as independent variables, and the unstructured variance-covariance was used to model the within-patient correlation.
All other patients were switched to a stable-dose regimen of insulin glargine ≥15 units/day during a conversion period of up to 10 weeks (consisting of a 2- to 4-week dose-adjustment phase and a 6-week stable-dose phase).
The purpose of this study was to evaluate the use of dose conversion ratios and tiered dose conversion with and without an ESA-free period as dosing strategies for peginesatide.
AFFIRM (Aranesp Efficiency Relative to Mircera) was a retrospective, multi-site, observational study designed to estimate the population mean maintenance dose conversion ratio [DCR; dose ratio achieving comparable hemoglobin level (Hb) between two evaluation periods] in European hemodialysis patients whose treatment was switched from DA to PEG-Epo.
At the start of the conversion period, patients taking concurrent metformin ≥1,500 mg/day were allowed to continue their metformin dose, whereas those taking metformin <1,500 mg/day or other concurrent oral antihyperglycemic agents had their treatment discontinued.
In contrast, the primary goal of AFFIRM was to calculate the population mean maintenance dose conversion ratio, defined as the dose ratio achieving comparable Hb level between pre- and post-switch periods.
Dose adjustments of perampanel, and concomitant AEDs, were allowed at the investigator's discretion after the end of the conversion period.
For this purpose, MCNPX flux to dose conversion factors reused.
Tomasek L, Rogel A, Laurier D, Tirmarche M (2008b) Dose conversion of radon exposure according to new epidemiologic findings.
