Back on 1/23/2018, Amarin announced for their CVOT trial, REDUCE-IT, that it has reached the 90% mark for reported and documented primary events. REDUCE-IT is investigating whether reducing plasma triglycerides (TG) in patients with hypertriglyceridemia will reduce cardiovascular events. Icosapent ethyl (Vascepa), a highly purified ethyl ester of a long-chain omega-3 fatty acid called eicosapentaenoic acid (EPA), that reduces plasma TG without raising LDL-cholesterol. 

Today, Amarin announced that REDUCE-IT "is estimated to have reached the onset of the targeted 1,612 primary major adverse cardiovascular events (MACE)....Amarin anticipates that MACE from the study will be adjudicated through Q2 2018, consistent with the company's objective of reporting top-line results from this important study before the end of Q3 2018."

Amarin also had an interim efficacy analysis back in August 2017 after 80% of the 1612 target events were adjudicated. Very interesting how forthcoming/transparent Amarin is with the status of the MACE accumulation toward the end of their CVOT trial. Seems like a long lag period between completing adjudication by end Q2 2018 and reporting top-line data by end Q3 2018.

Assuming that BETonMACE trial design remains unchanged after the 75% mark/sample-size re-estimation analysis (i.e. still ~2400 patients, 250 target MACE events), I wonder if we will get some similar press releases between the SSRA at 75% of events and top-line data release. 

BearDownAZ