Pharmacokinetics and safety of teneligliptin in subjects with hepatic impairment.

The pharmacokinetics of teneligliptin was compared in 3 groups of 8 subjects assigned according to their degree of hepatic impairment (mild, moderate, or matched healthy subjects). Hepatic impairment was associated with an increase in maximal plasma concentration (Cmax ) and overall exposure (AUC0-∞ ) to teneligliptin. Geometric least square mean ratios for Cmax in subjects with mild and moderate hepatic impairment were 25% and 38% higher than in healthy subjects, and those for AUC0-∞ were 46% and 59% higher than in healthy subjects, respectively.

Pharmacokinetics of Teneligliptin in Subjects With Renal Impairment.

The pharmacokinetics of teneligliptin was compared in renally impaired and healthy subjects. Subjects were assigned to one of four groups of eight subjects, according to the stage of disease [mild, moderate, severe or end stage renal disease (ESRD)], while matched healthy subjects were allocated to one of two reference groups. Mild, moderate and severe renal impairment had no effect on maximum plasma concentration (Cmax ) following a single oral dose of 20 mg teneligliptin, as defined in the FDA guideline.

Pharmacokinetic and pharmacodynamic profile of new biosimilar filgrastim XM02 equivalent to marketed filgrastim Neupogen: single-blind, randomized, crossover trial.

Objective: Filgrastim XM02 is a biosimilar non-glycosylated recombinant methionyl form of human granulocyte colony-stimulating factor (r-MetHuG-CSF) expressed in Escherichia coli for subcutaneous and intravenous administration in the treatment of different forms of neutropenia and stem cell mobilization. This study was conducted to compare the pharmacokinetic and pharmacodynamic characteristics of the new biosimilar filgrastim XM02 with the marketed filgrastim (Neupogen).

Methods: Two filgrastim doses (5 and 10 microg/kg) of the new biosimilar filgrastim XM02 and the marketed filgrastim were administered either as intravenous infusion or subcutaneous injection in four single-dose, crossover, randomized substudies, conducted in 36 subjects each.

Risk factors for symptomatic stone recurrence after transpapillary laser lithotripsy for difficult bile duct stones using a laser with a stone recognition system.

Background: Laser-induced shock-wave lithotripsy (LISL) is successfully used for the treatment of difficult bile duct stones. The aim of this study was to assess the long-term risk for a symptomatic bile duct stone recurrence after LISL and to detect risk factors predicting recurrence.

Methods: Between 1993 and 2001, 80 patients with difficult bile duct stones were successfully treated by intracorporeal LISL through the papilla of Vater.

What is the "optimal" follow-up schedule for ICD patients?

Background: In the absence of comparative studies, recommended routine follow-up (FU) intervals for implantable cardioverter defibrillator (ICD) patients range from 1 to 6 months; most patients are followed at 3 month intervals.

Methods: Six hundred and eighteen ICD patients were routinely seen 4 weeks after implant and then every 3 months. Unplanned visits (UPV) were either patient initiated or due to manufacturer recalls.

[Eptifibatide in patients with percutaneous coronary intervention in clinical practice. Results of a prospective registry].

Background And Purpose: The use of potent platelet inhibitors has been shown to reduce the rate of ischemic complications in patients with percutaneous coronary intervention (PCI) in randomized clinical trials. Eptifibatide is a small-molecule glycoprotein (GP) IIb/IIIa receptor inhibitor. Eptifibatide given with a double bolus of 180 microg/kg 10 min apart followed by an infusion of 2.

The impact of intensive serial plasmapheresis and iron supplementation on iron metabolism and Hb concentration in menstruating women: a prospective randomized placebo-controlled double-blind study.

Background: Iron (Fe) depletion is common among regular whole-blood donors, but can be prevented through regular oral Fe supplementation. Little is known, however, about the Fe metabolism of donors undergoing intensive plasmapheresis. These donors lose considerable amounts of blood drawn for laboratory analyses and remaining in the disposable plastic sets.