— Findings Introduced on VASCEPA/VAZKEPA Utility in REDUCE-IT Affected person Subgroups by Baseline Excessive/Low Lp(a), LDL-C Ranges —
— Lp(a) Outcomes Revealed Concurrently within the Journal of the American School of Cardiology (JACC) –
DUBLIN, Eire and BRIDGEWATER, N.J., April 06, 2024 (GLOBE NEWSWIRE) — Amarin Company plc (NASDAQ:AMRN) right this moment highlighted two knowledge displays at ACC.24 describing the results of VASCEPA®/VAZKEPA® (icosapent ethyl) on decreasing MACE (Main Hostile Cardiovascular Occasions) in sufferers with baseline excessive or low Lipoprotein(a) [Lp(a)] ranges, in addition to decreasing the chance of cardiovascular (CV) occasions in sufferers regardless of baseline LDL-C degree. The REDUCE-IT evaluation outcomes relating Lp(a) concentrations with CV threat have been additionally revealed on-line right this moment within the Journal of the American School of Cardiology (JACC).
“These new findings present further essential proof concerning the scientific utility of VASCEPA/VAZKEPA and additional exhibit its worth in decreasing cardiovascular occasions in at-risk sufferers in key subgroups,” mentioned Nabil Abadir, MB. CH.B., Chief Medical Officer and Head of World Medical Affairs, Amarin. “At Amarin, we’re targeted on the continual technology of science to additional advance the medical group’s understanding of the function and worth of VASCEPA/VAZKEPA in decreasing cardiovascular occasions in at-risk sufferers globally, and we’re proud so as to add to the physique of analysis that additional demonstrates our dedication to worth creation.”
The subgroup analyses and their key findings are outlined beneath:
Excessive Lp(a) concentrations are related to elevated CV occasion threat, even when LDL-C ranges are well-managed. There aren’t any therapies presently authorized to scale back residual CV threat on high of up to date medical remedy in sufferers with excessive Lp(a) ranges.
On this submit hoc evaluation of REDUCE-IT, the connection between steady baseline Lp(a) focus and threat of MACE was analyzed in fashions that additionally accounted for baseline LDL-C, baseline triglycerides (TG), and double-blind remedy.
REDUCE-IT members have been randomized to obtain both 2g twice each day of icosapent ethyl (IPE) or matching placebo and adopted for a median 4.9 years. On this subanalysis, there have been 7,026 REDUCE-IT sufferers with baseline Lp(a) knowledge and a median Lp(a) worth of 11.6 (Q1-Q3: 5.0-37.4) mg/dL. Outcomes confirmed that baseline Lp(a) had a robust and important relationship with MACE regardless of baseline LDL-C, baseline TGs, and remedy task, and that the advantage of IPE was constant throughout Lp(a) concentrations. Importantly, the remedy good thing about IPE was evident throughout subgroups with each excessive (≥50 mg/dL) and low (<50 mg/dL) Lp(a) concentrations. Particularly, for first MACE, the relative IPE remedy results for Lp(a) ≥50 mg/dL and <50 mg/dL have been HR 0.79 (95% CI 0.64-0.97; P=0.0248) and HR 0.75 (95% CI 0.66-0.84; P<0.0001), respectively. Absolute threat reductions at 5 years with IPE have been 6.5% and 5.7% for Lp(a) ≥50 mg/dL and <50 mg/dL, respectively.1
Limitations embrace that members in REDUCE-IT weren’t chosen on the idea of their baseline Lp(a) focus and that not all REDUCE-IT sufferers had obtainable baseline Lp(a) knowledge.
“On this evaluation, IPE confirmed a transparent scientific profit for sufferers with each excessive and low Lp(a) ranges. IPE supplied a relative threat discount of 21% amongst sufferers with an Lp(a) degree of ≥50 mg/dL and 25% for these sufferers with an Lp(a) degree of <50 mg/dL,” mentioned Dr. Michael Szarek, professor, Division of Cardiology, College of Colorado Faculty of Medication and a school member at CPC Scientific Analysis. “These findings are essential, as excessive baseline Lp(a) concentrations are a predictor for MACE, and this evaluation reinforces IPE’s scientific profit in these at-risk affected person sub-populations.”
The evaluation and its findings have been revealed concurrently on-line in JACC.
Elevated low-density lipoprotein ldl cholesterol (LDL-C) is a well-established main CV threat issue supported by scientific proof displaying decreased atherosclerotic illness occasions when LDL-C is therapeutically lowered. Latest worldwide pointers suggest reducing LDL-C to <55 mg/dL in these sufferers who’re at very excessive threat for a future CV occasion.
On this submit hoc evaluation, investigators explored REDUCE-IT knowledge to find out if IPE reduces CV outcomes amongst high-risk CV sufferers regardless of baseline LDL-C. Sufferers have been stratified by LDL-C <55 vs ≥55 mg/dL. The first consequence was a composite of CV dying, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina.
Amongst statin-treated REDUCE-IT sufferers with baseline LDL-C knowledge, 1,058 (12.9%) had LDL-C <55 mg/dL and seven,117 (87.1 %) had LDL-C ≥55 mg/dL. The first consequence fee amongst sufferers with LDL-C <55 mg/dL was 16.2% within the IPE group and 22.8% within the placebo group, HR 0.66 (95% CI 0.50-0.87; P=0.003). Findings have been constant within the LDL-C ≥55 mg/dL subgroup, with charges of 17.4% within the IPE group and 21.9% within the placebo group, HR 0.76 (95% CI 0.69-0.85; P<0.0001). No important interplay by baseline LDL-C was noticed.
Limitations are that randomization was not stratified by baseline LDL-C, nonetheless, baseline traits have been comparable among the many two baseline LDL-C subgroups. REDUCE-IT sufferers have been on statin remedy, however with low charges or unavailability of different lipid therapies similar to ezetimibe, proprotein convertase subtilisin-kexin sort 9 (PCSK9) inhibitors, or small interfering RNA (siRNA) therapies.
“As we all know, LDL-C is a well-established main CV threat issue. These knowledge are essential and present that amongst adults with elevated CV threat and elevated TGs, icosapent ethyl clearly decreased the speed of CV outcomes regardless of baseline LDL-C, together with in these with very properly managed LDL-C <55 mg/dL,” mentioned Deepak L. Bhatt, MD, MPH, MBA, Director of Mount Sinai Fuster Coronary heart Hospital.
All analyses highlighted above have been funded by Amarin. Dr. Deepak L. Bhatt served because the principal investigator for REDUCE-IT and his establishment acquired analysis funding from Amarin.
About Amarin
Amarin is an modern pharmaceutical firm main a brand new paradigm in heart problems administration. We’re dedicated to growing the scientific understanding of the cardiovascular threat that persists past conventional therapies and advancing the remedy of that threat for sufferers worldwide. Amarin has places of work in Bridgewater, New Jersey in the US, Dublin in Eire, Zug in Switzerland, and different nations in Europe in addition to industrial companions and suppliers around the globe.
About REDUCE-IT®
REDUCE-IT was a worldwide cardiovascular outcomes examine designed to judge 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 threat components 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 a minimum of one different cardiovascular threat issue (main prevention cohort).
REDUCE-IT, carried out over seven years and accomplished in 2018, adopted 8,179 sufferers at over 400 scientific websites in 11 nations with the biggest variety of websites positioned inside the US. REDUCE-IT was carried out 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.2 The first outcomes of REDUCE-IT have been revealed in The New England Journal of Medication in November 2018.3 The entire occasions outcomes of REDUCE-IT have been revealed within the Journal of the American School of Cardiology in March 2019.4 These and different publications could be discovered within the R&D part on the corporate’s web site at www.amarincorp.com.
About Cardiovascular Danger
Heart problems is the primary explanation for dying on the earth. In the US alone, heart problems leads to 859,000 deaths per yr.5 And the variety of deaths in the US attributed to heart problems continues to rise. As well as, in the US there are 605,000 new and 200,000 recurrent coronary heart assaults per yr (roughly 1 each 40 seconds). Stroke charges are 795,000 per yr (roughly 1 each 40 seconds), accounting for 1 of each 19 U.S. deaths. In combination, in the US alone, there are greater than 2.4 million main hostile cardiovascular occasions per yr from heart problems or, on common, 1 each 13 seconds.
Controlling dangerous ldl cholesterol, also called LDL-C, is one solution to cut back a affected person’s threat for cardiovascular occasions, similar to coronary heart assault, stroke or dying. Nonetheless, even with the achievement of goal LDL-C ranges, thousands and thousands of sufferers nonetheless have important and protracted threat of cardiovascular occasions, particularly these sufferers with elevated triglycerides. Statin remedy has been proven to regulate LDL-C, thereby decreasing the chance of cardiovascular occasions by 25-35%.6 Vital cardiovascular threat stays after statin remedy. Folks with elevated triglycerides have 35% extra cardiovascular occasions in comparison with individuals with regular (in vary) triglycerides taking statins.7,8,9
About VASCEPA®/VAZKEPA® (icosapent ethyl) Capsules
VASCEPA (icosapent ethyl) capsules are the primary prescription remedy authorized by the U.S. Meals and Drug Administration (FDA) comprised solely of the energetic ingredient, icosapent ethyl (IPE), a singular type of eicosapentaenoic acid. VASCEPA was launched in the US in January 2020 as the primary drug authorized by the U.S. FDA for remedy of the studied high-risk sufferers with persistent cardiovascular threat regardless of being on statin remedy. VASCEPA was initially launched in the US in 2013 based mostly on the drug’s preliminary FDA authorized indication to be used as an adjunct remedy to weight-reduction plan to scale back triglyceride ranges in grownup sufferers with extreme (≥500 mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been prescribed greater than twenty million occasions. VASCEPA is roofed by most main medical insurance coverage. Along with the US, VASCEPA is authorized and offered in Canada, China, Lebanon and the United Arab Emirates. In Europe, in March 2021 advertising and marketing authorization was granted to icosapent ethyl within the European Union for the discount of threat of cardiovascular occasions in sufferers at excessive cardiovascular threat, below the model title VAZKEPA. In April 2021 advertising and marketing authorization for VAZKEPA (icosapent ethyl) was granted in Nice Britain (making use of to England, Scotland and Wales). VAZKEPA (icosapent ethyl) is presently authorized and offered in Europe in Sweden, Denmark, Finland, Austria, the UK, Spain and the Netherlands.
United States
Indications and Limitation of Use
VASCEPA is indicated:
- As an adjunct to maximally tolerated statin remedy to scale back the chance 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 threat components for heart problems.
- As an adjunct to weight-reduction plan to scale back TG ranges in grownup sufferers with extreme (≥ 500 mg/dL) hypertriglyceridemia.
The impact of VASCEPA on the chance for pancreatitis in sufferers with extreme hypertriglyceridemia has not been decided.
Essential Security Data
- 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 threat (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 threat 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 threat (12% vs 10%) of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was larger in sufferers receiving concomitant antithrombotic drugs, similar to aspirin, clopidogrel or warfarin.
- Frequent 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%).
- Frequent 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.
FULL U.S. FDA-APPROVED VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.
Europe
For additional details about the Abstract of Product Traits (SmPC) for VAZKEPA® in Europe, please click here.
Globally, prescribing data varies; seek advice from the person nation product label for full data.
Ahead-Wanting Statements
This press launch comprises forward-looking statements that are made pursuant to the secure harbor provisions of the Personal Securities Litigation Reform Act of 1995, together with beliefs concerning the potential for VASCEPA (marketed as VAZKEPA in Europe); beliefs about icosapent ethyl (IPE)’s function regarding acceptable sufferers affected by heart problems (CVD) and potential inhabitants well being impression, in addition to basic beliefs concerning the security and effectiveness of VASCEPA. These forward-looking statements aren’t guarantees or ensures and contain substantial dangers and uncertainties. An additional record and outline of those dangers, uncertainties and different dangers related to an funding in Amarin could be present in Amarin’s filings with the U.S. Securities and Alternate Fee, together with Amarin’s annual report on Kind 10-Okay for the complete yr ended 2023. Current and potential buyers are cautioned to not place undue reliance on these forward-looking statements, which communicate solely as of the date they’re made. Amarin undertakes no obligation to replace or revise the knowledge contained in its forward-looking statements, whether or not because of new data, future occasions or circumstances or in any other case. Amarin’s forward-looking statements don’t replicate the potential impression of serious transactions the corporate could enter into, similar to mergers, acquisitions, inclinations, joint ventures or any materials agreements that Amarin could enter into, amend or terminate. Availability of Different Data About Amarin communicates with its buyers and the general public utilizing the corporate web site (www.amarincorp.com) and the investor relations web site (amarincorp.com/investor-relations), together with however not restricted to investor displays and FAQs, Securities and Alternate Fee filings, press releases, public convention calls and webcasts. The data that Amarin posts on these channels and web sites may very well be deemed to be materials data. In consequence, Amarin encourages buyers, the media and others curious about Amarin to evaluate the knowledge that’s posted on these channels, together with the investor relations web site, regularly. This record of channels could also be up to date infrequently on Amarin’s investor relations web site and will embrace social media channels. The contents of Amarin’s web site or these channels, or another 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 Data
Investor & Media Inquiries:
Mark Marmur
Amarin Company plc
PR@amarincorp.com
Investor.relations@amarincorp.com
1 Szarek M, Bhatt DL, Miller M, et al. Lipoprotein(a) blood ranges and cardiovascular threat discount with icosapent ethyl. J Am Coll Cardiol. 2024; epub forward of print.
2 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.
3 Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Cardiovascular Danger Discount with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019;380:11-22.
4 Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Results of Icosapent Ethyl on Whole Ischemic Occasions: From REDUCE-IT. J Am Coll Cardiol. 2019;73:2791-2802.
5 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.
6 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.
7 Budoff M. Triglycerides and triglyceride-rich lipoproteins within the causal pathway of heart problems. Am J Cardiol. 2016;118:138-145.
8 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 threat. J Am Coronary heart Assoc. 2018;7(15):e008740.
9 Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic heart problems – New insights from epidemiology, genetics, and biology. Circ Res. 2016;118:547-563
The submit New REDUCE-IT® Analyses Present VASCEPA®/VAZKEPA® (Icosapent Ethyl) Profit in Excessive-Danger Cardiovascular Illness Affected person Subgroups appeared first on FinanceGrabber.