Reversal of clopidogrel-induced bleeding with rFVIIa in healthy subjects: a randomized, placebo-controlled, double-blind, exploratory study.

Background: Clopidogrel (Plavix®) therapy, although effective for minimizing risk of thrombotic events, is also associated with potential bleeding risk. Recombinant activated FVII (rFVIIa, NovoSeven®) induces hemostasis in hemophilia patients with inhibitors (alloantibodies) and has been proposed as potential treatment for mitigating clopidogrel therapy-mediated bleeding.

Methods: In this single-center, randomized, placebo-controlled, double-blind, dose-escalation, exploratory phase I trial, we assessed the safety and effects of rFVIIa in reversing clopidogrel-enhanced bleeding in an experimentally induced punch biopsy in healthy subjects.

Exploratory study on the reversal of warfarin with rFVIIa in healthy subjects.

The use of warfarin has a well-known bleeding risk. Recombinant activated factor VII (rFVIIa) is a non-plasma-derived, rapid-acting, and rapidly infused potential treatment. This randomized, single-center, placebo-controlled, double-blinded, dose-escalation, exploratory phase 1 trial assessed safety and effects of rFVIIa in reversing warfarin-induced changes in bleeding and coagulation parameters, using a punch biopsy-induced bleeding model in healthy subjects.

Accuracy and precision of the NovoPen 3 insulin delivery device after mechanical and temperature stresses.

Objective: To evaluate the precision, accuracy, and durability of an insulin pen injection device (NovoPen 3) at three preset doses (2 IU, 35 IU, and 70 IU) after exposure to various stress and durability tests that were intended to simulate daily use by patients.

Methods: Twenty-nine reusable NovoPen 3 insulin delivery devices were tested. The precision and accuracy of 10 insulin pen devices were evaluated after they were subjected to multiple thermal and vibration stress tests.