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Message: Re: CVOTs on the Horizon
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Oct 01, 2018 04:04PM
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Oct 01, 2018 04:22PM
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Oct 01, 2018 04:58PM
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Oct 01, 2018 05:48PM
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Oct 02, 2018 02:53AM

Early morning HARMONY (albiglutide GLP1-R agonist) CVOT data presentation at EASD and publication in Lancet. 22% RRR in 3-point MACE, primarily driven by significant 25% reduction in myocardial infarctions. Non-significant 14% reduction in stroke and non-significant 7% reduction in CVD death. 

Overall, results are very similar to semaglutide in SUSTAIN-6, which achieved 26% RRR in 3-point MACE driven by reduced MI and stroke, w/ no effect on CVD death. 

A good, but not great, result for albiglutide and GLP1-R agonists. HARMONY confirmed results of some other GLP1-R agonists, but GLP1-R agonists seem inferior to CVOT results from SGLT inhibts. SGLT2 inhibs are the class to beat, IMO. The lack of consistent CVD death reduction by the GLP1-R agonists make GLP1-R agonists an inferior choice relative to SGLT2 inhibs. Of course, we all hope and expect apabetalone to shock the world and dwarf these SGLT2 inhib or GLP1-R agonist CVOT results when BETonMACE reads out! 

From the Lancet article "Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial"

"The primary composite endpoint occurred in 338 (7%) of 4731 patients at an event rate of 4·57 events per 100 person-years in the albiglutide group and in 428 (9%) of 4732 patients at an event rate of 5·87 events per 100 person-years in the placebo group (HR 0·78, 95% CI 0·68–0·90), indicating that albiglutide was both non-inferior to placebo for cardiovascular safety (p<0·0001 for non-inferiority) and superior to placebo for efficacy (p=0·0006 for superiority; table 2 and figure 2). The HRs for each of the components of the composite were 0·93 (95% CI 0·73–1·19) for death from cardiovascular causes, 0·75 (0·61–0·90) for myocardial infarction, and 0·86 (0·66–1·14) for stroke."

BearDownAZ

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Oct 02, 2018 10:48AM
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