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Positive PREPARE-IT2 results on Monday would change our mood completely.
As you know, two large phase 3 studies demonstrated oral anti-inflammatory medications, Colchicine and Fluvoxamine, met primary endpoints and reduced hospitalization by 25% and 32%, respectively. Many of us on this board continue to have a strong conviction that Vascepa could do better than colchicine and fluvoxamine. Good luck to all!
https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(21)00222-8/fulltext
https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(21)00448-4/fulltext#:~:text=Treatment%20with%20fluvoxamine%20(100%20mg,transfer%20to%20a%20tertiary%20hospital.
https://eventpilotadmin.com/web/planner.php?id=AHA21&table=agenda&tid=S505
From AHA Online Planner under Late Breaking Science, you can find PREPARE-IT 2 (25 minutes)
Icosapent Ethyl Versus Placebo In Outpatients With Covid-19: The Main Results Of PREPARE-IT 2
Live
8:00am - 8:15am
Mon, Nov 15 (Eastern)
Discussant: PREPARE-IT
Live
8:15am - 8:20am
Mon, Nov 15 (Eastern)
Q&A
Live
8:20am - 8:25am
Mon, Nov 15 (Eastern)
Your experience was consistent with the first successful case of using VASCEPA to treat a COVID-19 patient reported in 2020. Vascepa helped a mother to recover much faster than her daughter (~ 30 years younger) who declined Vascepa.
Cross our fingers for positive PREPARE-IT 2 study results!
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7532870/
A 53-year-old woman (Patient #1) with hyperlipidemia and no other known medical conditions presented to the clinic after confirmed exposure as well as a positive test for COVID-19. Her 21-year-old healthy daughter (Patient #2) was similarly exposed at the same time. Both women were of good health, had no other known risk factors for COVID-19, and had a body mass index (BMI) of 21 and 17, respectively. They had not shown any symptoms and received no treatment until the fourth post-exposure day. Four days after being exposed to a confirmed COVID-19 case, both developed persistent fevers up to 101F and later sore throat, nasal congestion, and cough on symptom day (SD) 2 and anosmia on SD4. On SD2, after obtainment of informed consent, Patient #1 began a course of oral IPE (2g twice daily). This treatment was offered to her following our success with this regimen in patients with inflammatory response and shock (report under review for publication). Her daughter (Patient #2) declined IPE. They otherwise received only symptomatic care that did not differ between the two.
Fevers began to subside on SD2, however, symptoms persisted; on SD4, the 53-year-old patient no longer reported any symptoms outside of anosmia, which has later resolved on SD7, five days after beginning treatment with IPE. In comparison, her 21-year-old daughter continued to experience sore throat, nasal congestion, and anosmia through SD18. She had only started experiencing partial relief on SD18, significantly after the complete resolution of symptoms in her mother (see red vertical lines in Figure ?Figure1).1). Figure ?Figure11 displays the course of disease in both patients and emphasizes the difference in disease development with and without IPE treatment.
Nuke,
Vascepa is listed on Express Scripts 2018 National Preferred Formulary.
https://www.express-scripts.com/art/open_enrollment/INTEL_NPFList.pdf
You may try to call Express Scripts directly to confirm how much co-pay it requires. Good luck.
Details from 2013 Adcom meeting can be found by clicking on this link
https://wayback.archive-it.org/7993/20170403223914/https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/ucm331504.htm
North & BB, thank you for all your efforts and insights. I agree with North that it is almost certain that Amarin has shared Reduce-IT CV outcomes results (PE and SE) to the FDA. However, the formal Reduce-IT sNDA won't be submitted until 1Q 2019. One possible scenario is that the FDA will grant the Anchor label change in a near future (hopefully right after AHA meeting on Nov 10th). This would significantly expand insurance (Medicare, etc) coverage for Anchor population.
It would be interesting to read the 2nd voting question from 2013 Vascepa Adcom.
"VOTE: Taking into account the described efficacy and safety data for Vascepa, do you believe that its effects on the described lipid/lipoprotein parameters are sufficient to grant approval for co-administration with statin therapy for the treatment of patients with September 10, 2013 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee 5 mixed dyslipidemia and CHD or CHD risk equivalent prior to the completion of REDUCE-IT? Please provide the rationale underlying your recommendation. Yes: 2 No: 9 Abstain: 0 Committee Discussion: The majority of the committee (9 of 11) voted no, stating that although the triglyceride-lowering effect was clear, the clinical benefit remained uncertain. Most expressed that the results of ANCHOR were promising, but FDA should wait on the final results of the CV outcome trial, REDUCE-IT, before approval. Several committee members remarked that the most contemporary evidence has not supported the hypothesis that lowering triglycerides with a drug leads to CV benefit. Several members stated their concern for approval based on surrogate endpoints, advising FDA to require evidence for impact on hard endpoints. One committee member stated he was concerned about the potential for overuse of Vascepa among those not on statins if this were to be approved without a clear benefit shown on CV outcomes. One of the committee members that voted yes (2) stated that he felt as though there was a favorable balance of safety and efficacy for Vascepa in this patient population even if the data regarding CV benefit were inadequate at this time. It was stated that ANCHOR demonstrated a substantial triglyceride-lowering effect for Vascepa, even if the magnitude of effect was subject to interpretation, and the combination of a potential benefit to patients with a favorable safety profile supported a vote for approval of the treatment indication before the completion of the outcomes trial. The other member who voted yes noted that “maybe” was not an option; therefore, he based his vote for approval on demonstrated changes to the lipid profile and the lack of a clear safety signal."
Hi Rick, yes, the saving card works for off-label use. I have been using VASCEPA off-label since April 2016. All you need to do is to give a copy of the saving card to the pharmacy when you refill your prescription next month . To save co-pay, I asked your doctor for a 90-day prescription with 3 refills. In this way, I only needed to “bother” my doctor for a new prescription once a year (at annual checkups) and paid $3 per month. Good luck, George
http://www.vascepa.com/savings-program
With the VASCEPA Savings Card, I paid $9 co-pay for 90 days
Mortality rates
Kiwi,the price of $260 per month is quite steep. I guess I just got lucky. My insurance co-pay was $20, which was further reduced to $9 with a saving card.
As you know, the mortality rates after MI reported in different studies could be quite different. No one will be sure about the true mortality rates in Reduce IT study until the study is stopped and unblinded. However, in my view, the following two CV outcome studies provide us a glimpse of background mortality rate that could be similar to the Reduce IT study. The 1st study GISSI-P(Dietary supplementation with n-3 polyunsaturated fatty acids and vitamin E after myocardial infarction: results of the GISSI-Prevenzione trial, Lancet 1999; 354: 447–55) showed that the control group (2828 subjects followed for 3.5 years) had 3.0% per year all fatal event and 1.9% per year CV death. N-3 PUFA significantly reduced all fatal event to 2.4% per year and CV death to 1.4% per year, respectively (% values were calculated by dividing observed percentage of patient death reported in the study by 3.5 years). LDL and TG levels at baseline in that study was 139 and 162, respectively.
A more recent study (Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes; N Engl J Med 2015;372:2387-97) showed that the control group (simvastatin, 9067 subjects with 40026 patient years) had 1231 death from any cause (3.08% per year), 538 cardiovascular death (1.34% per year). LDL and TG levels at baseline were 94 and 138, respectively. Ezetimide did not reduce any mortality rates at all.
If the Reduce IT study has a similar or better efficacy in reducing mortality rates than the GISSI-P trial, Vascepa will be a game changer. It is not only for our investment return, but more importantly for us to live a healthier and more abundant life.
Abstract of GISSI-Prevenzione trial
Background There is conflicting evidence on the benefits of
foods rich in vitamin E (?-tocopherol), n-3 polyunsaturated
fatty acids (PUFA), and their pharmacological substitutes. We
investigated the effects of these substances as supplements
in patients who had myocardial infarction.
Methods From October, 1993, to September, 1995, 11 324
patients surviving recent (_3 months) myocardial infarction
were randomly assigned supplements of n-3 PUFA (1 g daily,
n=2836), vitamin E (300 mg daily, n=2830), both (n=2830),
or none (control, n=2828) for 3•5 years. The primary
combined efficacy endpoint was death, non-fatal myocardial
infarction, and stroke. Intention-to-treat analyses were done
according to a factorial design (two-way) and by treatment
group (four-way).
Findings Treatment with n-3 PUFA, but not vitamin E,
significantly lowered the risk of the primary endpoint (relative risk
decrease 10% [95% CI 1–18] by two-way analysis, 15%
[2–26] by four-way analysis). Benefit was attributable to a
decrease in the risk of death (14% [3–24] two-way, 20%
[6–33] four-way) and cardiovascular death (17% [3–29] two way,
30% [13–44] four-way). The effect of the combined
treatment was similar to that for n-3 PUFA for the primary
endpoint (14% [1–26]) and for fatal events (20% [5–33]).
Interpretation Dietary supplementation with n-3 PUFA led to
a clinically important and statistically significant benefit.
Vitamin E had no benefit. Its effects on fatal cardiovascular
events require further exploration.
Lancet 1999; 354: 447–55
Kiwi, the 4.8% composite rate JL mentioned is likely derived from two recent Amarin press releases (Estimated composite rate = 967 events/20000 patient years = 4.835%)
“Approximately 20,000 patient years of study experience have been accumulated in REDUCE-IT since enrollment commenced in 2011.” February 25, 2016
“Since the study commenced in 2011, over 20,000 patient years of study have been accumulated in REDUCE-IT. “ March 31, 2016
BTW, you may like to hear that my cardiologist told me yesterday that he self-prescribed statin even though his lipid profile was perfectly fine. He believes that statin could prevent or at least delay the onset of his own cardiovascular events. I gave him the same rationale when I asked him to write an off-label Vascepa prescription for me.
Thanks North. I did read through most references Zumantu shared. I provided two relevant review papers to my cardiologist. He appreciated it.
Many members of this iHub message board have very impressive breadth and depth of science and knowledge about the potential benefits of EPA. The collective intelligence of this board is similar or even better than many teams at pharmaceutical companies.
No pre-authorization for my insurance and the co-pay is $20. I am not sure whether it is tier 2 or tier 3.
First off-label prescription of Vascepa
Dancing in the dark, thanks for your help. It was not hard for me to "persuade" my cardiologist to write a prescription. In addition, he gave me some free samples and a Vascepa saving card. However, he has not heard anything about the Reduce-IT CV outcome trial. I told him that I would make another appointment with him if the interim stop happens. After I mentioned that positive outcome study results could cause a paradigm change (as JL predicted), he said he would look into and may invest in AMRN stock. I gave him the two manuscriptions I brought with me.
Seek help with off-label prescriptions of Vascepa
I have a doc appointment later today and would like to ask for any advices on how to persuade my cardiologist to write a prescription for me (for prevention, not as a treatment). My lipid levels (trig, LDL, etc) are in the normal range, but have family history of cardiovascular diseases. I plan to bring a copy of Ken Borow's paper on Biological plausibility, celluar effects and molecular mechanisms of EPA in atherosclerosis, but I am not sure my doctor would be willing to listen.
Thank you in advance for any insights on this topic.
PLEIOTROPIC EFFECTS OF STATINS, Annual Review of Pharmacology and Toxicology, Vol. 45: 89-118 (2005)
http://www.annualreviews.org/doi/full/10.1146/annurev.pharmtox.45.120403.095748
JL, thanks for your insights. I found this paper, which is consistent with your view on statin.
"Statins are potent inhibitors of cholesterol biosynthesis. In clinical trials, statins are beneficial in the primary and secondary prevention of coronary heart disease. However, the overall benefits observed with statins appear to be greater than what might be expected from changes in lipid levels alone, suggesting effects beyond cholesterol lowering. Indeed, recent studies indicate that some of the cholesterol-independent or “pleiotropic” effects of statins involve improving endothelial function, enhancing the stability of atherosclerotic plaques, decreasing oxidative stress and inflammation, and inhibiting the thrombogenic response. Furthermore, statins have beneficial extrahepatic effects on the immune system, CNS, and bone. Many of these pleiotropic effects are mediated by inhibition of isoprenoids, which serve as lipid attachments for intracellular signaling molecules. In particular, inhibition of small GTP-binding proteins, Rho, Ras, and Rac, whose proper membrane localization and function are dependent on isoprenylation, may play an important role in mediating the pleiotropic effects of statins."