Safety of the PCSK9 inhibitor alirocumab: insights from 47 296 patient-years of observation

The ODYSSEY OUTCOMES trial, comprising over 47 000 patient-years of placebo-controlled observation, demonstrated important reductions in the risk of recurrent ischaemic cardiovascular events with the monoclonal antibody to proprotein convertase subtilisin/kexin type 9 alirocumab, as well as lower all-cause death. These benefits were observed in the context of substantial and persistent lowering of low-density lipoprotein cholesterol with alirocumab compared with that achieved with placebo. The safety profile of alirocumab was indistinguishable from matching placebo except for a ∼1.7% absolute increase in local injection site reactions. Further, the safety of alirocumab compared with placebo was evident in vulnerable groups identified before randomization, such as the elderly and those with diabetes mellitus, previous ischaemic stroke, or chronic kidney disease. The frequency of adverse events and laboratory-based abnormalities was generally similar to that in placebo-treated patients. Thus, alirocumab appears to be a safe and effective lipid-modifying treatment over a duration of at least 5 years

Combinatorial laser synthesis of biomaterial thin films: selection and processing for medical applications.

A new generation of implantable biomaterials should possess smart surfaces and interfaces able to modulate cellular behaviour and directly address specific clinical issues. This chapter provides an overview of recent advances in the field of laser-based combinatorial synthesis of thin biomaterial films with gradient of composition on solid substrates for medical applications. Laser processing methods and selected applications for tissue engineering and regenerative medicine are reviewed in sequel