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Message: Trying to understand placebo rste of MACE

I posted a few week's ago on the Standard of Care (SoC) topic and stated:

"Standard of care includes much more than just LDL-C control by statins. Other standard of care drugs include ezetimibe (for LDL-C), PCSK9 antibodies (for LDL-C), ezetimibe (for LDL-C), Vascepa (for triglycerides), anti-platelet agents, anti-coagulants, various anti-hypertensive agents (i.e. beta blockers, calcium channel blockers, diuretics, renin-angiotensin system blocking agents), and various anti-diabetes therapies (i.e. insulin, metformin, thiazolidinediones, sulfonulureas, SGLT2 inhibitors, GLP1-R agonists), niacin and probably many others that I missed!"

Yesterday's ACC poster on the cognition sub-study offered a glimpse into the SoC being used in BETonMACE. I'm just copying and pasting the SoC info for the total population, but the poster also contains info for those patients who completed the baseline MoCA test and for those with baseline MoCA score <25.

The high prevalence of CV medications for BETonMACE patients isn't too surprising, since these folks are very high risk with an ACS event within 90 days of enrollment. I'm happy to see not too many patients on the SGLT2 inhibitors or GLP1-R agonists, since these two agents have recently been shown to be MACE reducing diabetes drugs. These haven't really been adopted as SoC yet, though their usage is increasing in the wake of the SGLT2 and GLP1-R agonist CVOTs. Also I don't see Vascepa on the list, which doesn't necessarily mean some patients aren't on it. However, Vascepa is not considered a standard of care treatment yet so I wouldn't be surprised if no patients were on it (its approved label is actually for those w/ triglycerides above 500 mg/dL, which is an exclusion criteria for BETonMACE). Vascepa may become SoC after its label is expanded. However, Amarin hasn't submitted their application post-REDUCE-IT to the FDA yet. 

Concomitant Statins

Atorvastatin 1,245 (51.3%)

Rosuvastatin 1,180 (48.7%)

 

Diabetes Medications:

Insulin 878 (36.2%)

Metformin 1,933 (79.7%)

Sulfonylureas 685 (28.2%) 

GLP-1 Agonists 10 (0.4%) 

DPP-4 Inhibitors 277 (11.4%) 

SGLT2 Inhibitors 266 (11.0%) 

 

CV Medications:

ACE Inhibitors 1,746 (72.0%) 

ARBs 693 28.6% 154 (33.0%)

Beta-Blockers 2,180 (89.9%) 

Anti-Platelet Agents 2,394 (98.7%) 

DAPT 2,103 (86.7%)

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