REDUCE-IT was comprised of lower risk patients than BETonMACE. 3-point MACE in REDUCE-IT placebo patients occured in 14.8% of patients after a median follow up of 4.9 years. Recall that EXAMINE and ELIXA trials had 3-point MACE event rates of about 12% at median follow up of 18 months and 13% at median follow up of 25 months. EXAMINE and ELIXA were CVOTs in diabetics with requirements for recent ACS of within 90 days and 180 days, respectively. Since BETonMACE has additional low-HDL requirement and ACS event within 15-90 days requirement, I wouldn't be surprised to see placebo group in BETonMACE have a ~15% 3-point MACE event rate at median follow up of ~2 years. The time factor (median follow up period) is very important for interpreting risk and NNT.

In REDUCE-IT, eligible patients had to have fasting triglycerides of 150 to 499 mg/dL. REDUCE-IT didn't require low-HDL, any prior ACS, or diabetes. REDUCE-IT ended up with ~58% of patients with diabetes, ~71% with established cardiovascular disease (secondary prevention; no recent ACS requirement), ~29% with no established cardiovascular disease (primary prevention), median age of 64 years, median TG of 216 mg/dL, median LDL-C of 75 mg/dL and a median HDL of 40 mg/dL. 

In BETonMACE, 100% of patients will have diabetes and established cardiovascular disease (all secondary prevention with ACS event within 15-90 days of randomization). Median HDL-C is 33 mg/dL, median LDL-C is 65 mg/dL, median age is 62, median TG not yet reported but only excludes patients if TG greater than 400 mg/dL.

BearDownAZ