Successful graft deployment at the desired location was achieved in 59 patients (98%). A single patient had successful deployment of the device although it was located more distally than planned. Technical success was achieved in 54 patients (90%); one patient had a type I endoleak, four had type IV endoleaks, and one had an endoleak of undetermined click here origin. The primary safety end point was met in 56 of the 58 patients (97%) with complete core laboratory data at 1 month; two patients had type I endoleaks. There were no type III or IV endoleaks and no device or procedure-related major adverse events at 1 month. No limb thromboses or stent fractures were noted on postoperative
imaging studies and no patient required rehospitalization, a secondary procedure, or open surgical conversion
through 1 month of follow-up.
Conclusions: The INCRAFT endograft device holds promise as an innovative alternative to currently marketed devices and broadens the eligibility for endovascular aneurysm repair. More definitive observations will be generated as longer-term data from this trial become available. (J Vasc Surg 2013;57:906-14.)”
“Rationale Receptor occupancy study has been performed to evaluate pharmacokinetic profiles in new antipsychotic drug development. While these findings highlight the value of positron emission tomography (PET) for dose-finding study, what is unclear is if it is necessary to conduct these studies in patients with schizophrenia or whether studies in healthy volunteers are adequate.
Objectives To determine if it is necessary to conduct dopamine receptor LCL161 datasheet occupancy studies in patients with schizophrenia or whether studies in healthy volunteers are adequate for dose-finding study, we compared the concentration-occupancy relationship in terms of EC50 between patients and healthy volunteers.
Methods Ten healthy volunteers and eight patients with schizophrenia participated in the study. We measured dopamine receptor occupancy using [C-11]raclopride PET and plasma concentration of YKP1358, a novel antipsychotic all drug under clinical development, at a number of
time points after the administration of YKP1358. Pharmacokinetic data including area under the plasma concentration versus time curve, elimination half-life, maximum observed plasma concentration, and the time to reach the maximum observed plasma concentration were obtained. We explored the relationship between plasma concentration and dopamine D-2 receptor occupancy using E-max model and calculated EC50.
Results The elimination half-life was longer in healthy volunteers than in patients. Other pharmacokinetic parameters were not significantly different between two groups. The EC50 was 7.6 ng/ml (95% confidence interval (CI) 6.2-9.0) in healthy volunteers and 8.6 (95% CI 7.4-9.9) in patients.
Conclusions The antipsychotic concentration-occupancy relationship in patients can be estimated from the EC50 data of healthy volunteers.