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Message: Re: Question about Phase 2
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Mar 11, 2019 09:37PM
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Mar 11, 2019 09:56PM
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Mar 12, 2019 09:08AM
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Mar 12, 2019 09:18AM
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Mar 12, 2019 09:38AM
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Mar 12, 2019 09:50AM

"As for SOC the published trial protocol excludes participants with very high triglycerides; to me that would exclude most if not all taking Vascepa or Epanova from this trial so there is little if any SOC issue/ effect with them. All just my opinion of course, happy to be corrected  and enlightened."

I am also very curious as to what other standard of care drugs the patients in BETonMACE are allowed to take. If one looks at the ClinicalTrials.gov listing, it doesn't seem that too much is excluded. For triglycerides, the trial protocol excludes patients with "Triglycerides>400 mg/dL (4.52 mmol/L) at Visit 1." In Amarin's ANCHOR trial, they showed Vascepa lowered TG's in patients with baseline TGs in the 200 to 500 mg/dL range. Also, the trial protocol doesn't explicitly state that patients can't be on non-statin drugs such as PCSK9 antibodies. Additionally, these are diabetic patients. Some may be taking a SGLT2 inhibitor of an GLP1-R agonist. Vascepa, PCSK9 antibodies, GLP1-R agonists, SGLT2 inhibitors......all these have shown MACE reduction in recent clinical trials. 

So some BETonMACE patients may be on Vascepa, PCSK9 antibodies, SGLT2 inhibitors, or GLP1-R agonists .....unless I am missing something. It would be best for the success of BETonMACE if these were excluded. However, if apabetalone still shows MACE benefit on top of these other SoC drugs, then this would be amazing. I doubt too many BETonMACE patients will be on the Vascepa or PCSK9s. Personally, I am more concerned about the SGLT2 inhibitors and GLP1-R agonists.

As I stated in a prior post on this standard of care issue:

"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!"

BearDownAZ

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Mar 12, 2019 10:22AM
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