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Primary endpoint of slowed coronary plaque progression reported to have been met with VASCEPA
Significant coronary plaque regression of low attenuation plaque (LAP) reported with VASCEPA provides further insight to potential mechanisms of action
VASCEPA is the first and only agent studied on top of statins reported to exhibit coronary plaque regression in hypertriglyceridemic patients
DUBLIN, Ireland and BRIDGEWATER, N.J., Aug. 29, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that the trial results from Effect of Icosapent Ethyl on Progression of Coronary Atherosclerosis in Patients with Elevated Triglycerides on Statin Therapy: Final results of the EVAPORATE Trial were presented at ESC Congress 2020, the annual meeting of the European Society of Cardiology, on August 29, 2020, 9:13 am CEST (Central European Summer Time) by Matthew Budoff, M.D., Director of Cardiovascular CT at The Lundquist Institute and Professor of Medicine at the David Geffen School of Medicine at UCLA, the study sponsor. VASCEPA® (icosapent ethyl) demonstrated significant, 17% regression of low attenuation plaque (LAP) volume on multidetector computed tomography (MDCT) compared with placebo over 18 months. As referenced below, these final results can be found in the concurrent publication in European Heart Journal.
“EVAPORATE provides important mechanistic data on coronary plaque characteristics that are potentially relevant to the overall REDUCE-IT® results and clinical use of icosapent ethyl,” commented Matthew Budoff, M.D., Director of Cardiovascular CT at The Lundquist Institute and Professor of Medicine at the David Geffen School of Medicine at UCLA. “The REDUCE-IT REVASC analysis presented at American Society for Preventive Cardiology last month reported an early coronary revascularization benefit signal with sustained statistical significance attained by 11 months. EVAPORATE is the first demonstration of imaging results with icosapent ethyl using MDCT. The coronary plaque reduction shown in EVAPORATE is consistent with the benefits of icosapent ethyl in cardiovascular event outcomes shown in REDUCE-IT, a separate study.”
A total of 80 patients were enrolled in the randomized, double-blind, placebo-controlled EVAPORATE trial. Patients had to have coronary atherosclerosis as documented by MDCT (1 or more angiographic stenoses with ≥20% narrowing), be on statin therapy, and have persistently elevated triglyceride (TG) levels (mean TG at baseline was 259.1 mg/dL [+/- 78.1]). Patients underwent an interim scan at 9 months and a final scan at 18 months. The prespecified primary endpoint was a comparison of change in LAP volume at 18 months between icosapent ethyl and placebo. EVAPORATE was not powered for long-term outcomes.
The final results showed a significant reduction in the primary endpoint; icosapent ethyl reduced LAP plaque volume by 17% from baseline to the 18-month scan, whereas there was a progression of LAP plaque volume in the placebo group. There were significant differences between icosapent ethyl and placebo at study end for secondary endpoints of other types of plaque volume changes, including and sequentially total, total non-calcified, fibrofatty, and fibrous plaque volumes. All regressed in the icosapent ethyl group and progressed in the placebo group, (p1% more frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs 0.3%).
Key clinical effects of VASCEPA on major adverse cardiovascular events are included in the Clinical Studies section of the prescribing information for VASCEPA, as set forth below:
Effect of VASCEPA on Time to First Occurrence of Cardiovascular Events in Patients with Elevated Triglyceride levels and Other Risk Factors for Cardiovascular Disease in REDUCE-IT
| VASCEPA | Placebo | VASCEPA vs Placebo | |||
| N = 4089n (%) | Incidence Rate (per 100 patient years) | N = 4090n (%) | Incidence Rate (per 100 patient years) | Hazard Ratio (95% CI) | |
| Primary composite endpoint | |||||
| Cardiovascular death, myocardial infarction, stroke, coronary revascularization, hospitalization for unstable angina (5-point MACE) | 705(17.2) | 4.3 | 901(22.0) | 5.7 | 0.75(0.68, 0.83) |
| Key secondary composite endpoint | |||||
| Cardiovascular death, myocardial infarction, stroke (3-point MACE) | 459(11.2) | 2.7 | 606(14.8) | 3.7 | 0.74(0.65, 0.83) |
| Other secondary endpoints | |||||
| Fatal or non-fatal myocardial infarction | 250(6.1) | 1.5 | 355(8.7) | 2.1 | 0.69(0.58, 0.81) |
| Emergent or urgent coronary revascularization | 216(5.3) | 1.3 | 321(7.8) | 1.9 | 0.65(0.55, 0.78) |
| Cardiovascular death [1] | 174(4.3) | 1.0 | 213(5.2) | 1.2 | 0.80(0.66, 0.98) |
| Hospitalization for unstable angina [2] | 108(2.6) | 0.6 | 157(3.8) | 0.9 | 0.68(0.53, 0.87) |
| Fatal or non-fatal stroke | 98(2.4) | 0.6 | 134(3.3) | 0.8 | 0.72(0.55, 0.93) |
| [1] Includes adjudicated cardiovascular deaths and deaths of undetermined causality.[2] Determined to be caused by myocardial ischemia by invasive/non-invasive testing and requiring emergent hospitalization. | |||||
FULL VASCEPA PRESCRIBING INFORMATIONCAN BE FOUND AT WWW.VASCEPA.COM.
Forward-Looking Statements This press release contains forward-looking statements, including statements regarding the potential impact of VASCEPA in various clinical uses. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein include the following: uncertainties associated generally with research and development and clinical trials such as further clinical evaluations failing to confirm earlier findings. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin's filings with the U.S. Securities and Exchange Commission, including its most recent Quarterly Report on Form 10-Q. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Amarin undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. Amarin’s forward-looking statements do not reflect the potential impact of significant transactions the company may enter into, such as mergers, acquisitions, dispositions, joint ventures or any material agreements that Amarin may enter into, amend or terminate.
Availability of Other Information About AmarinInvestors and others should note that Amarin communicates with its investors and the public using the company website (www.amarincorp.com), the investor relations website (investor.amarincorp.com), including but not limited to investor presentations and investor FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media, and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin’s investor relations website and may include social media channels. The contents of Amarin’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.
Amarin Contact InformationInvestor Inquiries:Elisabeth SchwartzInvestor RelationsAmarin Corporation plcIn U.S.: +1 (908) 719-1315IR@amarincorp.com (investor inquiries)
Lee M. SternSolebury TroutIn U.S.: +1 (646) 378-2992lstern@soleburytrout.com
Media Inquiries:Alina KolomeyerCommunicationsAmarin Corporation plcIn U.S.: +1 (908) 892-2028PR@amarincorp.com (media inquiries)
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7 Bhatt DL, Steg PG, Brinton E, et al., on behalf of the REDUCE-IT Investigators. Rationale and Design of REDUCE‐IT: Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial. Clin Cardiol. 2017;40:138-148.
8 Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019;380:11-22.
9 Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Reduction in first and total ischemic events with icosapent ethyl across baseline triglyceride tertiles. J Am Coll Cardiol. 2019;74:1159-1161.
