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Further proof that it’s NOT “just” about TG reduction:
We know from PROMINENT, STRENGTH and from REDUCE-IT EPA Mediation Analysis (https://esc365.escardio.org/presentation/265872)
That TG reduction is not the main driver for residual risk. In this new JACC study (hot off the press), and co-authored by Deepak Bhatt:
“Triglyceride Levels, Alirocumab Treatment, and Cardiovascular Outcomes After an Acute Coronary Syndrome” https://www.jacc.org/doi/full/10.1016/j.jacc.2024.06.035
They sought to examine relations between triglyceride levels and the effect of alirocumab vs placebo on cardiovascular outcomes using prespecified and post hoc analyses of the ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) trial.
They concluded
It’s been reported that drug manufacturers commonly get about 70% of the Actual NHS price in the UK.
Monthly English Prescribing Data (EPD) is provided by NHS England for all approved and reimbursed prescriptions. The portal for that data is found here:
https://opendata.nhsbsa.net/dataset/english-prescribing-data-epd
The data is recorded as individual doses. In the case of VAZKEPA® or the three other drugs that I track it would be individual capsules or tablets. The drugs that I track are:
• Icosapent ethyl (VAZKEPA®)
• OMEGA-3 FA EE (OMACOR)
• Bempedoic Acid (NEXLETOL)
• Bempedoic Acid + Ezetimibe (NEXLIZET) combo drug
This report contains data from Jan 2022 to Jul 2024. You may view and download the three slides here:
https://drive.google.com/file/d/19MAuuGeQgu5Hly7kB2qUfitO2SNwMkdF/view?usp=sharing
Summary:
Slide #1: Monthly Line Graph for Total Capsules/Tablets of each drug Jan 2022 – Jul 2024
Slide #2: Same as Slide #1 as a “stacked” cumulative column.
Slide #3: Table 1, VAZKEPA® Monthly Caps and the NHS Actual Price paid. Bar Graph: Quarterly
$AMRN English Prescribing Data for July is in: VAZKEPA up 15.27%. I’ll have full report after close today.
Sorry! The video didn't post. UGG!
The Residual Cardiovascular Risk Manifesto Program in Spain that kicked off today (co-sponsored by Amarin) is part of a broader initiative to address the persistent cardiovascular risks that remain even after optimal treatment of traditional risk factors like high cholesterol and hypertension.
This program is part of the Residual Risk Reduction Initiative (R3i), which focuses on identifying and managing additional factors contributing to cardiovascular risk, such as triglyceride-rich lipoproteins, remnant cholesterol, and lipoprotein(a) see website here:
https://www.r3i.org/
The Manifesto and the presentation event were made possible thanks to the non-conditioning contribution of Amarin Corporation.
Watch the video Manifesto and help us spread it!
https://www.linkedin.com/feed/
Ok, sorry for the misunderstanding.
In the 5-years since REDUCE-IT and the 4-years since STRENGTH and the 3-years since EMA, the mineral oil conspiracy has been thoroughly debunked. Perhaps you’ve been asleep all that time. It should be apparent to any observer that JELIS, CHERRY, and RESPECT-EPA had consistent and dose dependent effectiveness in reducing MACE without a placebo. Furthermore, the FDA, EMA and Health Canada definitively rejected the MO theory.
https://academic.oup.com/eurheartjsupp/article/22/Supplement_J/J1/5918446
https://www.sciencedirect.com/science/article/pii/S2667089524000439
Eligibility for marine omega-3 fatty acid supplementation after acute coronary syndromes
The interesting thing about this study is not the fact that 1/3 of the patients in this prospective observational Swiss study were eligible for VASCEPA®/VAZKEPA® (IPE) post ASC (according to ESC Guidelines), but the fact that ¼ of those patients on statins + EZETIMIBE was still eligible after 1-year of follow-up.
BTW: REDUCE-IT Prior ACS demonstrated a 37% RRR in MACE with an NNT of 11. In other words, CVD Risk Reduction is not “Just” about LDL-c reduction. There’s lots of Residual Risk to be addressed. “It’s the EPA Stupid!”
All of the above except the latter.
$AMRN Wow!!!!!
Although >30.0% of patients had triglycerides ≥150 mg/dL at all time points, ≤6% were prescribed any non-statin triglyceride lowering therapy and 0.6% were prescribed icosapent ethyl. Persistent hypertriglyceridemia (≥150 mg/dL) was associated with recurrent MACE at 6-, 12-, and 24-months post-ACS (p<0.05), and the relative risk ranged between 1.20-1.35 at those timepoints.
In other words Residual Risk is between 20-35% in HTG patients after ACS and yet only <0.6% were Rx’d IPE.
BTW: VASCEPA/VAZKEPA reduces MACE 36% post ACS (NNT = 11) let that sink in, 36% NNT = 11 which literally wipes out all the RR!
Oh, did you notice the competing interest of Novartis and AZN in this study?
The Medicines Company (MDCO) that was sold to Novartis by Denner
Got it. Was your comment sincere or did you imply sarcastically that I'm a "Mr. Know-It-All"?
Well, in that case I offer this:
Significant reductions in HF for IPE patients above 104ug/ml EPA levels.
https://www.jacc.org/doi/abs/10.1016/S0735-1097%2821%2901935-5
Other than that. It's Fine!
The Doctor was incorrect. In the EMPA-REG OUTCOME trial the Primary Composite MACE-5 had a RRR of 14% (p=0.04). However, in the Key Secondary Composite (MACE-3) there were no significant differences between the Jardiance Arm and the placebo arm (p=0.08). Also, no significance in MI or Stroke. I think your friend should have another talk with their doctor.
Interesting. These guys have filed hundreds of AC’s. They know the rules.
The Association for Accessible Medicines (AAM) is nothing more than A Schill for generic manufacturers and distributors. They flagrantly encourage generics to ignore IP rights of inventors who bring new medicines to millions of patients at great expense. Their Mission Statement is “to improve access to safe, quality and effective medicine.” What they don’t mention is that generic piracy is an acceptable means to achieve that mission.
AAM has literally submitted an Amicus Curiae against Amarin in every case involving a generic opponent. In this filing (Case 23-1169, Document 56-2 (09/05/2024) they say:
“It was undisputed here that the generic had carved-out infringing uses from its label and it was undisputed that the generic’s label did not induce infringement as a matter of law. Yet the panel held that simply calling a product a “generic” drug and referencing the total market size of the brand drug is sufficient, in “totality,” to show active inducement. To make things worse, the decision provides no guidance to generic manufacturers seeking to avoid inducement liability in future cases.
This is a blatant lie. Here’s the guidance that CAFC issued in its Decision:
Here’s a common thread between this ApoTex vs. Janssen case and our case against Hikma:
That threshold would considerably limit the TAM for IPE. I believe the current TG criteria is even too limiting. With all that we've discovered in the past 5-6 years, TG reduction is not that effective in RR (~4%). Furthermore, I believe that anyone with a prior MACE should be prescribed a statin + V no matter the LDC-c, or TG numbers. I'm not a doctor so, don't take my word for it.
Yes, this topic has been discussed many times here. This is the Bhatt article that you referenced:
https://academic.oup.com/eurheartjsupp/article/22/Supplement_J/J1/5918446
What about Residual Risk? Go beyond LDL-c w/icosapent ethyl (IPE). How does it work? I asked AI Co-Pilot. Then I made this slide. I have details and references if interested.@Amarincorp @CBallantyneMD @ErinMichos @SABOURETCardio @gabrielsteg @mmillermd1 @DLBHATTMD @VietHeartPA pic.twitter.com/4kGPPuL1l3
— Mike Everts (@GeoWizz_) September 4, 2024
Hello $AMRN Friends,
There’s been a lot of talk lately about new Lipid Lowering Therapies. Almost all of these new therapies target LDL-c. The mantra has been “the lower, the longer, the better”. It starts with the Standard of Care (SOC) the highest tolerated Statin, then proceeds to add-on drugs like PCSK9’s, Ezetimibe, Bempedoic Acid and others.
In all this rush to lower LDL-c there remains a significant Residual Risk. I was thinking about IPE works to attack this RR and I asked Microsoft’s Co-Pilot AI tool to summarize the pleiotropic benefits of icosapent ethyl which goes beyond LDL-c. I then created a PowerPoint slide deck (3 slides) from the results.
*Below you will see the main slide.
yes i do
I believe this post hoc analy. strengthens the argument that VASCEPA®/VAZKEPA® can be effectively added to patients on Statins + Alirocumab who have well controlled LDL-c but still have elevated TG’s. This should get you an additional 25-31% RRR benefit!https://t.co/Vet3lsY1ED pic.twitter.com/MyIWR128tO
— Mike Everts (@GeoWizz_) September 4, 2024
Point of Interest for CVD patients and $AMRN investors:
Patients with recent Acute Coronary Syndrome (ACS) in a subgroup analysis of the CLEAR OUTCOMES Trial found that Among patients with recent ACS on optimized statin therapy, baseline triglycerides were associated with cardiovascular risk. However, the reduction in triglycerides with alirocumab did not contribute to its clinical benefit. (ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment with Alirocumab; NCT01663402)
https://www.jacc.org/doi/10.1016/j.jacc.2024.06.035?utm_medium=email_newsletter&utm_source=jacc&utm_campaign=toc&utm_content=20240903
I believe this strengthens the argument that VASCEPA®/VAZKEPA® can be effectively added to patients on Statins + Alirocumab who have well controlled LDL-c but still have elevated TG’s to get additional 25-31% RRR benefit!
What? No IPE? icosapent ethyl is truly pleiotropic and has MOA's that are Lipid-Lowering (TG), anti-thrombotic and anti-inflammatory. A red-headed stepchild.
— Mike Everts (@GeoWizz_) September 2, 2024
Hello $AMRN Friends:
Yesterday I posted my visualization of the Event Rates (%) for the Primary Composite End Points, and the Key Secondary End Points from the ESC 24 Poster Presentation titled, “Icosapent Ethyl by Baseline Small Dense Low-Density Lipoprotein Cholesterol: An Analysis of REDUCE-IT”.
View the Abstract here:
https://esc365.escardio.org/ESC-Congress/sessions/11423
In this study patients with measured and monitored sdLDL-c serum levels from the REDUCE-IT RCT were divided into two Groups and compared with the placebo.
1- Low Risk Group (N=7690) sdLDL-c <46 mg/dl)
2- High Risk Group (N=459) sdLDL-c >=46 mg/dl)
Today I post a visualization showing the Event Rates (Individual End Points) of IPE intervention vs. placebo for the two subgroups. P-values and NNT’s are shown in the Figures and Tables of the Abstract. Individual End Points. Individual End Points outside the design of RCT’s like REDUCE-IT seldom show Statistical Significance because they are not designed to do so. It should be noted that some of these end points show SS nonetheless.
Sorry, that was directed at North40000
Check back with me in 11 years to see if I’m still moving without aids. Or if I’m moving at all!
Congrats
@RahulAggarwalMD @DLBHATTMD @gabrielsteg @mmillermd1 @Amarincorp Congrats on your outstanding session “Icosapent Ethyl by Baseline Small Dense Low-Density Lipoprotein Cholesterol: An Analysis of REDUCE-IT” I made a visualization. Hope you approve. pic.twitter.com/6hMSSK1m9e
— Mike Everts (@GeoWizz_) September 1, 2024
Hello Amarin Friends,
The ESC 24 conference in London has just concluded. Dr. Rahul Aggarwal presented an outstanding poster session titled “Icosapent Ethyl by Baseline Small Dense Low-Density Lipoprotein Cholesterol: An Analysis of REDUCE-IT” on behalf of the REDUCE-IT authors. This research continues to explore the diverse effects of IPE. Recently, much of the cardiovascular disease (CVD) research has focused on reducing residual CVD risk by targeting key biomarkers such as LDL-c, hsCRP, and ApoB. It is well-documented that small dense Low-Density Lipoprotein Cholesterol (sdLDL-c) has a higher atherogenic potential compared to other LDL subfractions in predicting CVD.
https://onlinelibrary.wiley.com/doi/10.1155/2017/1273042
Here is my visualization of some of the data collected in this study. The full dataset of REDUCE-IT showed that icosapent ethyl (VASCEPA®) reduced the risk of a MACE-5 and a MACE-3 vs. a placebo by 25% and 26% respectively. When looking at patients with baseline levels of sdLDL-c above and below 46 mg/dl, a threshold of which marks a Low Risk for a CVE (<46) and a High Risk (>46), this study revealed a Relative Risk Reduction of 42% of the Primary Composite Endpoint (MACE-5) in the sdLDL-c High Risk Group (p-value = 0.009, NNT = 10). This is a huge finding that may explain some of the MOA for VASCEPA®/VAZKEPA®!
New REDUCE-IT Subgroup Analysis (sdLDL-c) presented at ESC 24:
Note: tirzepatide aka Mourjaro (brand name) is FDA indicated for T2D and Zep bound (brand name) for weight loss.
Both cost about $1100/month. Insurance coverage is difficult.