VASCEPA®, compared with placebo, considerably decreased main composite first and whole MACE (major adverse cardiovascular events) in publish hoc exploratory analyses of sufferers with a historical past of PCI by 34% and 39%, respectively, and okey secondary composite first arduous MACE, comprised of coronary heart assaults, stroke and cardiovascular dying, by 34%
Administration of VASCEPA resulted in robust absolute danger reductions of 8.5% and 5.4% and quantitys wanted to deal with (NNT) of 12 and 19, respectively, for each main and key secondary (arduous MACE) composite endpoints in publish hoc exploratory subgroup analyses
Constant and sturdy profit seen in publish hoc exploratory analyses of sufferers with a historical past of PCI throughout the hierarchy of endpoints prespecified for the complete examine cohort
DUBLIN, Eire and BRIDGEWATER, N.J., Oct. 15, 2020 (GLOBE NEWSWIRE) — Amarin Company plc (NASDAQ:AMRN) as we speak introduced the presentation of REDUCE-IT® PCI at Transcatheter Cardiovascular Therapeutics (TCT) Join, the 32nd annual scientific symposium of the Cardiovascular Analysis Basis, being held just about from October 14 – October 18, 2020 including to the rising physique of data on the scientific impression of VASCEPA® (icosapent ethyl). These new analyses supported by Amarin had been introduced in the course of the TCT Join 2020 Better of Abstracts session by Benjamin E. Peterson, M.D., Brigham and Girls’s Hospital Coronary heart & Vascular Heart and Harvard Medical Faculty.
“The chance to additional discover REDUCE-IT information and results in these sufferers with prior PCI supplies further understanding of the potential good thing about icosapent ethyl within the scientific setting,” commented Dr. Deepak L. Bhatt, M.D., M.P.H., Govt Director of Interventional Cardiovascular Applications at Brigham and Girls’s Hospital and Professor of Medication at Harvard Medical Faculty, principal investigator of REDUCE-IT and senior creator of the REDUCE-IT PCI analyses. “The findings of profit in at-risk sufferers with prior PCI are in line with beforehand introduced information on total reductions in first and whole coronary revascularization occasions of 34% and 36%, respectively. Furthermore, the statistically vital substantial profit in decreased coronary revascularization procedures seen as early as 11 months supplies clinicians with a possible further intervention in a affected person inhabitants for whom time is of the essence.”
The REDUCE-IT PCI evaluation checked out 3,408 (41.7%) of sufferers enrolled in REDUCE-IT who had undergone a previous PCI. These sufferers had been randomized a median of two.9 years after PCI. Baseline traits had been related amongst sufferers randomized to VASCEPA versus placebo. Post hoc exploratory analyses of the subgroup of three,408 sufferers with a previous PCI confirmed that, for the first composite endpoint of 5-point MACE, time to first occasion was considerably decreased with VASCEPA versus placebo by 34% (p<0.0001) and whole (first and subsequent) occasions had been additionally decreased by 39% (p<0.0001). For the important thing secondary composite endpoint of 3-point MACE, time to first occasion was decreased by 34% (p<0.0001) within the subgroup of sufferers with a previous PCI.
Coronary revascularization procedures, resembling stenting, are invasive, carry a number of dangers, and might have vital direct and oblique prices. Sufferers with elevated triglycerides regardless of statin remedy have elevated danger for ischemic occasions, together with coronary revascularizations. These procedures, whether or not pre-scheduled or carried out in an emergency, inevitably lead to further time spent in a healthcare setting. The most recent statistical replace from the American Coronary heart Affiliation (AHA) reveals that, in 2014, an estimated 480,000 inpatient PCI procedures had been carried out in america with a imply inpatient hospital cost for PCI of $84,813.1
“Revascularization procedures total considerably impression the healthcare system, with PCI procedures including to the burden and driving substantial prices,” mentioned Steven Ketchum, Ph.D., senior vp and president, analysis & growth and chief scientific officer, Amarin. “The subgroup information introduced at TCT Join 2020 mirror new findings demonstrating the substantial impression of VASCEPA on at-risk sufferers in REDUCE-IT with prior PCI procedures and the way the remedy can assist keep away from subsequent occasions that might have dire penalties.”
REDUCE-IT was not particularly powered to look at particular person cardiovascular endpoints or affected person subgroups, subsequently p-values introduced for these revascularization analyses are nominal and exploratory with no adjustment for a number of comparisons. As well as, coronary revascularization as an endpoint can generally be thought of subjective; nonetheless, these endpoints had been adjudicated by an unbiased, blinded scientific endpoint committee. Outcomes from the full coronary revascularization occasions analyses are constant throughout the varied recurrent occasion statistical fashions and are additionally in line with the primary coronary revascularization occasions outcomes. Collectively, the REDUCE-IT first and whole coronary revascularization occasions outcomes assist the robustness and consistency of the scientific good thing about VASCEPA remedy in lowering coronary revascularization.
Amarin Company plc is a quickly rising, progressive pharmaceutical firm targeted on creating and commercializing therapeutics to cost-effectively enhance cardiovascular well being. Amarin’s lead product, VASCEPA® (icosapent ethyl), is offered by prescription in america, Canada, Lebanon and the United Arab Emirates. VASCEPA will not be but accredited and out there in some other nations. Amarin, by itself or along with its business companions in choose geographies, is pursuing further regulatory approvals for VASCEPA in China, Europe and the Center East. For extra details about Amarin, go to www.amarincorp.com.
About Cardiovascular Threat
The variety of deaths in america attributed to heart problems continues to rise. There are 605,000 new and 200,000 recurrent coronary heart assaults per yr (roughly 1 each 40 seconds), in america. Stroke charges are 795,000 per yr (roughly 1 each 40 seconds), accounting for 1 of each 19 U.S. deaths. Heart problems leads to 859,000 deaths per yr in america.1 In mixture, there are greater than 2.4 million main hostile cardiovascular occasions per yr from heart problems or, on common, one each 13 seconds in america alone.
Controlling dangerous ldl cholesterol, also called LDL-C, is one technique to cut back a affected person’s danger for cardiovascular occasions, resembling coronary heart assault, stroke or dying. Nevertheless, even with the achievement of goal LDL-C ranges, tens of millions of sufferers nonetheless have vital and protracted danger of cardiovascular occasions, particularly these sufferers with elevated triglycerides. Statin remedy has been proven to regulate LDL-C, thereby lowering the danger of cardiovascular occasions by 25-35%.2 Important cardiovascular danger stays after statin remedy. Individuals with elevated triglycerides have 35% extra cardiovascular occasions in comparison with folks with regular (in vary) triglycerides taking statins.3,4,5
REDUCE-IT was a world cardiovascular outcomes examine designed to guage the impact of VASCEPA in grownup sufferers with LDL-C managed to between 41-100 mg/dL (median baseline 75 mg/dL) by statin remedy and varied cardiovascular danger elements together with persistent elevated triglycerides between 135-499 mg/dL (median baseline 216 mg/dL) and both established heart problems (secondary prevention cohort) or diabetes mellitus and not less than one different cardiovascular danger issue (main prevention cohort).
REDUCE-IT, performed over seven years and accomplished in 2018, adopted 8,179 sufferers at over 400 scientific websites in 11 nations with the most important variety of websites situated inside america. REDUCE-IT was performed based mostly on a particular protocol evaluation settlement with FDA. The design of the REDUCE-IT examine was revealed in March 2017 in Scientific Cardiology.6 The first outcomes of REDUCE-IT had been revealed in The New England Journal of Medication in November 2018.7 The overall occasions outcomes of REDUCE-IT had been revealed within the Journal of the American School of Cardiology in March 2019.8 These and different publications will be discovered within the R&D part on the corporate’s web site at www.amarincorp.com.
About VASCEPA® (icosapent ethyl) Capsules
VASCEPA (icosapent ethyl) capsules are the first-and-only prescription therapy accredited by the FDA comprised solely of the energetic ingredient, icosapent ethyl (IPE), a novel type of eicosapentaenoic acid. VASCEPA was initially launched in america in 2013 based mostly on the drug’s preliminary FDA accredited indication to be used as an adjunct remedy to food regimen to cut back triglyceride ranges in grownup sufferers with extreme (≥500 mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been prescribed over eight million instances. VASCEPA is roofed by most main medical insurance policy. The brand new, cardiovascular danger indication for VASCEPA was accredited by the FDA in December 2019.
Indications and Limitation of Use
VASCEPA is indicated:
|•||As an adjunct to maximally tolerated statin remedy to cut back the danger of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in grownup sufferers with elevated triglyceride (TG) ranges (≥ 150 mg/dL) and|
|•||established heart problems or|
|•||diabetes mellitus and two or extra further danger elements for heart problems.|
|•||As an adjunct to food regimen to cut back TG ranges in grownup sufferers with extreme (≥ 500 mg/dL) hypertriglyceridemia.|
The impact of VASCEPA on the danger for pancreatitis in sufferers with extreme hypertriglyceridemia has not been decided.
Essential Security Info
|•||VASCEPA is contraindicated in sufferers with identified hypersensitivity (e.g., anaphylactic response) to VASCEPA or any of its parts.|
|•||VASCEPA was related to an elevated danger (3% vs 2%) of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was larger in sufferers with a earlier historical past of atrial fibrillation or atrial flutter.|
|•||It’s not identified whether or not sufferers with allergy symptoms to fish and/or shellfish are at an elevated danger of an allergic response to VASCEPA. Sufferers with such allergy symptoms ought to discontinue VASCEPA if any reactions happen.|
|•||VASCEPA was related to an elevated danger (12% vs 10%) of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was larger in sufferers receiving concomitant antithrombotic drugs, resembling aspirin, clopidogrel or warfarin.|
|•||Widespread hostile reactions within the cardiovascular outcomes trial (incidence ≥3% and ≥1% extra frequent than placebo): musculoskeletal ache (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%).|
|•||Widespread hostile reactions within the hypertriglyceridemia trials (incidence >1% extra frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal ache (1% vs 0.3%).|
|•||Hostile occasions could also be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.|
|•||Sufferers receiving VASCEPA and concomitant anticoagulants and/or anti-platelet brokers needs to be monitored for bleeding.|
Key scientific results of VASCEPA on main hostile cardiovascular occasions are included within the Scientific Research part of the prescribing info for VASCEPA as set forth beneath:
Impact of VASCEPA on Time to First Incidence of Cardiovascular Occasions in Sufferers with
Elevated Triglyceride ranges and Different Threat Components for Cardiovascular Illness in REDUCE-IT
|N = 4089
(per 100 affected person years)
|N = 4090
(per 100 affected person years)
|Hazard Ratio (95% CI)|
|Main composite endpoint|
|Cardiovascular dying, myocardial infarction, stroke, coronary revascularization, hospitalization for unstable angina (5-point MACE)||705
|Key secondary composite endpoint|
|Cardiovascular dying, myocardial infarction, stroke (3-point MACE)||459
|Different secondary endpoints|
|Deadly or non-fatal myocardial infarction||250
|Emergent or pressing coronary revascularization||216
|Cardiovascular dying ||174
|Hospitalization for unstable angina ||108
|Deadly or non-fatal stroke||98
| Contains adjudicated cardiovascular deaths and deaths of undetermined causality.
 Decided to be brought on by myocardial ischemia by invasive/non-invasive testing and requiring emergent hospitalization.
This press launch incorporates forward-looking statements, together with statements relating to the potential impression of VASCEPA in varied scientific makes use of. These forward-looking statements should not guarantees or ensures and contain substantial dangers and uncertainties. Among the many elements that might trigger precise outcomes to vary materially from these described or projected herein embody the next: uncertainties related typically with analysis and growth and scientific trials resembling additional scientific evaluations failing to substantiate earlier findings. An extra record and outline of those dangers, uncertainties and different dangers related to an funding in Amarin will be present in Amarin’s filings with the U.S. Securities and Alternate Fee, together with its most up-to-date Quarterly Report on Type 10-Q. Current and potential buyers are cautioned to not place undue reliance on these forward-looking statements, which converse solely as of the date hereof. Amarin undertakes no obligation to replace or revise the knowledge contained on this press launch, whether or not on account of new info, future occasions or circumstances or in any other case. Amarin’s forward-looking statements don’t mirror the potential impression of serious transactions the corporate might enter into, resembling mergers, acquisitions, tendencies, joint ventures or any materials agreements that Amarin might enter into, amend or terminate.
Availability of Different Info About Amarin
Traders and others ought to be aware that Amarin communicates with its buyers and the general public utilizing the corporate web site (www.amarincorp.com), the investor relations web site (investor.amarincorp.com), together with however not restricted to investor shows and investor FAQs, Securities and Alternate Fee filings, press releases, public convention calls and webcasts. The knowledge that Amarin posts on these channels and web sites could possibly be deemed to be materials info. Because of this, Amarin encourages buyers, the media, and others thinking about Amarin to evaluation the knowledge that’s posted on these channels, together with the investor relations web site, frequently. This record of channels could also be up to date infrequently on Amarin’s investor relations web site and should embody social media channels. The contents of Amarin’s web site or these channels, or some other web site that could be accessed from its web site or these channels, shall not be deemed included by reference in any submitting below the Securities Act of 1933.
Amarin Contact Info
Amarin Company plc
In U.S.: +1 (908) 719-1315
[email protected] (investor inquiries)
Lee M. Stern
In U.S.: +1 (646) 378-2992
Amarin Company plc
In U.S.: +1 (908) 892-2028
[email protected] (media inquiries)
|1||American Coronary heart Affiliation. Coronary heart Illness and Stroke Statistics—2020 Replace: A Report From the American Coronary heart Affiliation. Circulation. 2020;141:e139–e596.|
|2||Ganda OP, Bhatt DL, Mason RP, et al. Unmet want for adjunctive dyslipidemia remedy in hypertriglyceridemia administration. J Am Coll Cardiol. 2018;72(3):330-343.|
|3||Budoff M. Triglycerides and triglyceride-rich lipoproteins within the causal pathway of heart problems. Am J Cardiol. 2016;118:138-145.|
|4||Toth PP, Granowitz C, Hull M, et al. Excessive triglycerides are related to elevated cardiovascular occasions, medical prices, and useful resource use: An actual-world administrative claims evaluation of statin-treated sufferers with excessive residual cardiovascular danger. J Am Coronary heart Assoc. 2018;7(15):e008740.|
|5||Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic heart problems – New insights from epidemiology, genetics, and biology. Circ Res. 2016;118:547-563.|
|6||Bhatt DL, Steg PG, Brinton E, et al., on behalf of the REDUCE-IT Investigators. Rationale and Design of REDUCE‐IT: Discount of Cardiovascular Occasions with Icosapent Ethyl–Intervention Trial. Clin Cardiol. 2017;40:138-148.|
|7||Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Cardiovascular Threat Discount with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019;380:11-22.|
|8||Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Discount in first and whole ischemic occasions with icosapent ethyl throughout baseline triglyceride tertiles. J Am Coll Cardiol. 2019;74:1159-1161.|