Elective PCI were included in the study. Patients were randomized into two different groups. One group took ASA 80 mg once daily and clopidogrel 75 mg once a day, and the other one took ASA 80 mg once a day and ticagrelor 90 mg twice a day. After six months of close follow-up, patients were asked to give a score to their dyspnea and asked about the major advance cardiovascular events ( MACE)

开始日期2022-10-01

申办/合作机构

Shiraz University of Medical Sciences

NCT05573958 / Not yet recruiting临床4期IIT

Open-label Randomized Control Trial to Assess the Efficacy and Safety of Dual Anticoagulants i.e. Rivaroxaban Plus Aspirin and Clopidogrel Plus Aspirin in Patients Suffering From an Acute Coronary Syndrome

Direct-acting oral anticoagulants (DOACs) have provided benefits to patients requiring anticoagulation for certain diseases by decreasing the burden of subcutaneous injections and the requirement for frequent monitoring through regular blood tests. DOACs do not require monitoring, have a more predictable pharmacokinetic (dosing) profile and have fewer interactions with other drugs. Various studies have reported the efficacy and safety of different dual-acting anticoagulants around the globe. However, there is little data available from Pakistan. Therefore, investigators propose this study to assess the efficiency and safety of rivaroxaban and clopidogrel along with aspirin in patients suffering from acute coronary syndrome. The objective of this study is to investigate the efficacy of dual anticoagulants i.e. aspirin plus rivaroxaban versus aspirin plus clopidogrel in patients suffering from acute coronary syndrome in terms of secondary prophylaxis. All the patient records will be documented in Case Report Form (CRF) at each visit. All data will be recorded in individual source documents. All CRF information is to be filled in by site staff. If an item is not available or is not applicable, this fact should be indicated. Blank spaces should not be present unless otherwise directed. The study monitor will perform source data verification of data entered into the CRF. The data entered into the CRF will be subject to data validation checks for consistency and completeness by the data management group. All CRFs should be maintained on the system with details of any changes logged accordingly.

开始日期2022-10-01

申办/合作机构

Punjab Institute of Cardology

[+2]

KCT0007210 / RecruitingN/AIIT

Clopidogrel versus Aspirin MOnotherapy after 1- to 3-month of Dual-antiplatelet thErapy following zotarolimus-eluting Resolute stents implantation

开始日期2022-07-26

申办/合作机构

Yonsei University Severance Hospital

100 项与萘二磺酸氯吡格雷相关的临床结果

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100 项与萘二磺酸氯吡格雷相关的转化医学

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100 项与萘二磺酸氯吡格雷相关的专利（医药）

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项与萘二磺酸氯吡格雷相关的文献（医药）

2024-02-13·Neurology

One-Year Outcomes of Early Therapy With Ticagrelor vs Clopidogrel in CYP2C19 Loss-of-Function Carriers With Stroke or TIA Trial.

Article

作者: Xia Meng ; Anxin Wang ; Xue Tian ; Claiborne Johnston ; Hao Li ; Philip M Bath ; Qin Xu ; Yijun Zhang ; Xuewei Xie ; Jing Jing ; Jinxi Lin ; Yilong Wang ; Xingquan Zhao ; Zixiao Li ; Yong Jiang ; Liping Liu ; Yongjun Wang

BACKGROUND AND OBJECTIVES:

The Ticagrelor or Clopidogrel with Aspirin in High-Risk Patients with Acute Nondisabling Cerebrovascular Events II (CHANCE-2) trial showed that among Chinese patients with minor ischemic stroke or transient ischemic attack (TIA) who were carriers of CYP2C19 loss-of-function alleles, dual-antiplatelet therapy with ticagrelor-aspirin reduced the 90-day risk of stroke without increased severe or moderate bleeding compared with clopidogrel-aspirin. However, whether dual-antiplatelet therapy with ticagrelor was superior to clopidogrel beyond the 90 days of follow-up remained unclear. In this study, we reported 1-year follow-up outcomes of the CHANCE-2 trial.

METHODS:

The CHANCE-2 trial is a randomized, double-blind, placebo-controlled trial at 202 centers in China. Patients with a minor stroke or TIA who carried CYP2C19 loss-of-function alleles were randomized within 24 hours after symptom onset, in a 1:1 ratio, to receive ticagrelor and placebo clopidogrel or to receive clopidogrel and placebo ticagrelor for 90 days; both groups received aspirin for the first 21 days. After day 90, treatment was as per the choice of the clinician and the patient.

RESULTS:

Among 6,412 patients, the proportion of patients on ticagrelor plus aspirin, clopidogrel plus aspirin, ticagrelor alone, clopidogrel alone, aspirin alone, other antiplatelet, and no antiplatelet beyond month 3 to 1 year was 0.09%, 1.56%, 0.13%, 2.66%, 73.65%, 0.78%, and 21.13% in the ticagrelor-aspirin group and 0.03%, 1.63%, 0.19%, 2.60%, 72.83%, 0.66%, and 22.06% in the clopidogrel-aspirin group, respectively. The primary outcome of new stroke occurred in 252 patients (7.91%) in the ticagrelor-aspirin group and 310 patients (9.73%) in the clopidogrel-aspirin group by 1 year of follow-up (hazard ratio 0.80; 95% CI 0.68-0.95; p = 0.007); new stroke beyond 3 months to 1 year occurred in 61 patients (2.07%) and 67 patients (2.32%) (p = 0.48), respectively. Primary safety outcome of severe or moderate bleeding occurred in 17 patients (0.53%) in the ticagrelor-aspirin group and 20 patients (0.63%) in the clopidogrel-aspirin group (p = 0.61).

DISCUSSION:

For CYP2C19 loss-of-function allele carriers, early dual-antiplatelet therapy with ticagrelor is superior to clopidogrel at 1 year in reducing recurrent stroke.

TRIAL REGISTRATION INFORMATION:

URL: clinicaltrials.gov. Unique identifier: NCT04078737.

CLASSIFICATION OF EVIDENCE:

This study provides Class II evidence that for patients with minor stroke or TIA with TIACYP2C19 loss-of-function, ticagrelor plus aspirin for 21 days is superior to clopidogrel plus aspirin in reducing the 1-year risk of recurrent stroke.

2024-01-12·Scientific reports

Co-release of cytokines after drug-eluting stent implantation in acute myocardial infarction patients with PCI.

Article

作者: Minying Wan ; Kun Hu ; Yi Lu ; Cheng Wang ; Bin Mao ; Qing Yang ; Zhenzhong Zheng ; Hao Wu ; Yihong Luo ; Amit K Maiti

Acute Myocardial Infarction (AMI) after Percutaneous Coronary Intervention (PCI) often requires stent implantation leading to cardiovascular injury and cytokine release. Stent implantation induces cytokines production including TNFα, Hs-CRP, IL-1ß, IL2 receptor, IL6, IL8, and IL10, but their co-release is not extensively established. In 311 PCI patients with Drug-Eluting Stent (DES) implantation, we statistically evaluate the correlation of these cytokines release in various clinical conditions, stent numbers, and medications. We observed that TNFα is moderately correlated with IL-1ß (r² = 0.59, p = 0.001) in diabetic PCI patients. Similarly, in NSTEMI (Non-ST Segment Elevation) patients, TNFα is strongly correlated with both IL-1ß (r² = 0.97, p = 0.001) and IL8 (r² = 0.82, p = 0.001). In CAD (Coronary Artery Disease)-diagnosed patients TNFα is highly correlated (r² = 0.84, p = 0.0001) with IL8 release but not with IL-1ß. In patients with an increased number of stents, Hs-CRP is significantly coupled with IL8 > 5 pg/ml (t-statistic = 4.5, p < 0.0001). Inflammatory suppressor drugs are correlated as TNFα and IL8 are better suppressed by Metoprolol 23.75 (r² = 0.58, p < 0.0001) than by Metoprolol 11.87 (r² = 0.80, p = 0.5306). Increased TNFα and IL-1ß are better suppressed by the antiplatelet drug Brilinta (r² = 0.30, p < 0.0001) but not with Clopidogrel (r² = 0.87, p < 0.0001). ACI/ARB Valsartan 80 (r² = 0.43, p = 0.0011) should be preferred over Benazepril 5.0 (r² = 0.9291, p < 0.0001) or Olmesartan (r² = 0.90, p = 0.0001). Thus, the co-release of IL-1ß, IL8 with TNFα, or only IL8 with TNFα could be a better predictor for the outcome of stent implantation in NSTEMI and CAD-diagnosed AMI patients respectively. Cytokine suppressive medications should be chosen carefully to inhibit further cardiovascular damage.

2024-01-10·The International journal of neuroscience

Effect of Atorvastatin Calcium plus Clopidogrel in the Treatment of Patients with Transient Ischemic Attacks and its Effect on Blood Lipids and Platelets.

Article

作者: Maocheng Bian ; Fei Zhong ; Jian Wan

Objective: To explore the clinical effect of atorvastatin calcium combined with clopidogrel in the treatment of patients with transient ischemic attacks (TIAs) and its effect on blood lipids and platelets.Methods: Low-density lipoprotein cholesterol (LDL-C)], platelet-related parameters [prothrombin time (PT), activated partial thromboplastin time (APTT), platelet count (PLT)], incidence of cerebral infarction, and adverse reactions. Results: The clinical outcomes of the experimental group patients were significantly better than those of the control group patients (P < 0.05). The experimental group exhibited notably lower levels of TG, TC, and LDL-C compared to the control group (P < 0.05). Platelet-related indices-PT, APTT, and PLT-showed no significant differences between groups before and after treatment (P > 0.05). The incidence of cerebral infarction was notably lower in the experimental group (P < 0.005), while the occurrence of adverse reactions showed no significant difference between groups (P > 0.05).Conclusion: Atorvastatin calcium combined with clopidogrel demonstrates a positive impact on individuals with TIAs by significantly lowering levels of LDL, total cholesterol, and triglycerides. However, it is noteworthy that platelet-related indices did not exhibit significant differences between the experimental and control groups. While the observed improvements in blood lipids are attributed to the effects of atorvastatin, the combination with clopidogrel did not show a substantial influence on platelet-related parameters. Thus, the overall therapeutic impact, particularly on platelet-related indices, may require further investigation and clarification. Despite these nuances, our findings suggest potential benefits in reducing the risk of adverse reactions and cerebral infarction, supporting the consideration of this approach for wider clinical use.

项与萘二磺酸氯吡格雷相关的新闻（医药）

2024-04-06

·GlobeNewswire-Health Care

New REDUCE-IT® Analyses Show VASCEPA®/VAZKEPA® (Icosapent Ethyl) Benefit in High-Risk Cardiovascular Disease Patient Subgroups

-- Findings Presented on VASCEPA/VAZKEPA Utility in REDUCE-IT Patient Subgroups by Baseline High/Low Lp(a), LDL-C Levels -- -- Lp(a) Results Published Simultaneously in the Journal of the American College of Cardiology (JACC) – DUBLIN, Ireland and BRIDGEWATER, N.J., April 06, 2024 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today highlighted two data presentations at ACC.24 describing the effects of VASCEPA®/VAZKEPA® (icosapent ethyl) on reducing MACE (Major Adverse Cardiovascular Events) in patients with baseline high or low Lipoprotein(a) [Lp(a)] levels, as well as reducing the risk of cardiovascular (CV) events in patients irrespective of baseline LDL-C level. The REDUCE-IT analysis results relating Lp(a) concentrations with CV risk were also published online today in the Journal of the American College of Cardiology (JACC). “These new findings provide additional important evidence about the clinical utility of VASCEPA/VAZKEPA and further demonstrate its value in reducing cardiovascular events in at-risk patients in key subgroups,” said Nabil Abadir, MB. CH.B., Chief Medical Officer and Head of Global Medical Affairs, Amarin. “At Amarin, we’re focused on the continuous generation of science to further advance the medical community’s understanding of the role and value of VASCEPA/VAZKEPA in reducing cardiovascular events in at-risk patients globally, and we are proud to add to the body of research that further demonstrates our commitment to value creation.” The subgroup analyses and their key findings are outlined below: Icosapent Ethyl Reduces MACE in Patients with Elevated Triglycerides and High or Low Lipoprotein(a) Concentrations: A REDUCE-IT Subanalysis High Lp(a) concentrations are associated with increased CV event risk, even when LDL-C levels are well-managed. There are no treatments currently approved to reduce residual CV risk on top of contemporary medical therapy in patients with high Lp(a) levels. In this post hoc analysis of REDUCE-IT, the relationship between continuous baseline Lp(a) concentration and risk of MACE was analyzed in models that also accounted for baseline LDL-C, baseline triglycerides (TG), and double-blind treatment. REDUCE-IT participants were randomized to receive either 2g twice daily of icosapent ethyl (IPE) or matching placebo and followed for a median 4.9 years. In this subanalysis, there were 7,026 REDUCE-IT patients with baseline Lp(a) data and a median Lp(a) value of 11.6 (Q1-Q3: 5.0-37.4) mg/dL. Results showed that baseline Lp(a) had a strong and significant relationship with MACE irrespective of baseline LDL-C, baseline TGs, and treatment assignment, and that the benefit of IPE was consistent across Lp(a) concentrations. Importantly, the treatment benefit of IPE was evident across subgroups with both high (≥50 mg/dL) and low (<50 mg/dL) Lp(a) concentrations. Specifically, for first MACE, the relative IPE treatment effects for Lp(a) ≥50 mg/dL and <50 mg/dL were 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 risk reductions at 5 years with IPE were 6.5% and 5.7% for Lp(a) ≥50 mg/dL and <50 mg/dL, respectively.1 Limitations include that participants in REDUCE-IT were not selected on the basis of their baseline Lp(a) concentration and that not all REDUCE-IT patients had available baseline Lp(a) data. “In this analysis, IPE showed a clear clinical benefit for patients with both high and low Lp(a) levels. IPE provided a relative risk reduction of 21% among patients with an Lp(a) level of ≥50 mg/dL and 25% for those patients with an Lp(a) level of <50 mg/dL,” said Dr. Michael Szarek, professor, Division of Cardiology, University of Colorado School of Medicine and a faculty member at CPC Clinical Research. “These findings are important, as high baseline Lp(a) concentrations are a predictor for MACE, and this analysis reinforces IPE’s clinical benefit in these at-risk patient sub-populations.” The analysis and its findings were published simultaneously online in JACC. Efficacy of Icosapent Ethyl for Reducing Cardiovascular Outcomes by Baseline Low Density Lipoprotein Cholesterol Level Elevated low-density lipoprotein cholesterol (LDL-C) is a well-established major CV risk factor supported by clinical evidence showing decreased atherosclerotic disease events when LDL-C is therapeutically lowered. Recent international guidelines recommend lowering LDL-C to <55 mg/dL in those patients who are at very high risk for a future CV event. In this post hoc analysis, investigators explored REDUCE-IT data to determine if IPE reduces CV outcomes among high-risk CV patients irrespective of baseline LDL-C. Patients were stratified by LDL-C <55 vs ≥55 mg/dL. The primary outcome was a composite of CV death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina. Among statin-treated REDUCE-IT patients with baseline LDL-C data, 1,058 (12.9%) had LDL-C <55 mg/dL and 7,117 (87.1 %) had LDL-C ≥55 mg/dL. The primary outcome rate among patients with LDL-C <55 mg/dL was 16.2% in the IPE group and 22.8% in the placebo group, HR 0.66 (95% CI 0.50-0.87; P=0.003). Findings were consistent in the LDL-C ≥55 mg/dL subgroup, with rates of 17.4% in the IPE group and 21.9% in the placebo group, HR 0.76 (95% CI 0.69-0.85; P<0.0001). No significant interaction by baseline LDL-C was observed. Limitations are that randomization was not stratified by baseline LDL-C, however, baseline characteristics were similar among the two baseline LDL-C subgroups. REDUCE-IT patients were on statin therapy, but with low rates or unavailability of other lipid therapies such as ezetimibe, proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors, or small interfering RNA (siRNA) therapies. “As we know, LDL-C is a well-established major CV risk factor. These data are important and show that among adults with increased CV risk and elevated TGs, icosapent ethyl clearly reduced the rate of CV outcomes irrespective of baseline LDL-C, including in those with very well controlled LDL-C <55 mg/dL,” said Deepak L. Bhatt, MD, MPH, MBA, Director of Mount Sinai Fuster Heart Hospital. All analyses highlighted above were funded by Amarin. Dr. Deepak L. Bhatt served as the principal investigator for REDUCE-IT and his institution received research funding from Amarin. About AmarinAmarin is an innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. We are committed to increasing the scientific understanding of the cardiovascular risk that persists beyond traditional therapies and advancing the treatment of that risk for patients worldwide. Amarin has offices in Bridgewater, New Jersey in the United States, Dublin in Ireland, Zug in Switzerland, and other countries in Europe as well as commercial partners and suppliers around the world. About REDUCE-IT® REDUCE-IT was a global cardiovascular outcomes study designed to evaluate the effect of VASCEPA in adult patients with LDL-C controlled to between 41-100 mg/dL (median baseline 75 mg/dL) by statin therapy and various cardiovascular risk factors including persistent elevated triglycerides between 135-499 mg/dL (median baseline 216 mg/dL) and either established cardiovascular disease (secondary prevention cohort) or diabetes mellitus and at least one other cardiovascular risk factor (primary prevention cohort). REDUCE-IT, conducted over seven years and completed in 2018, followed 8,179 patients at over 400 clinical sites in 11 countries with the largest number of sites located within the United States. REDUCE-IT was conducted based on a special protocol assessment agreement with FDA. The design of the REDUCE-IT study was published in March 2017 in Clinical Cardiology.2 The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018.3 The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019.4 These and other publications can be found in the R&D section on the company’s website at www.amarincorp.com. About Cardiovascular Risk Cardiovascular disease is the number one cause of death in the world. In the United States alone, cardiovascular disease results in 859,000 deaths per year.5 And the number of deaths in the United States attributed to cardiovascular disease continues to rise. In addition, in the United States there are 605,000 new and 200,000 recurrent heart attacks per year (approximately 1 every 40 seconds). Stroke rates are 795,000 per year (approximately 1 every 40 seconds), accounting for 1 of every 19 U.S. deaths. In aggregate, in the United States alone, there are more than 2.4 million major adverse cardiovascular events per year from cardiovascular disease or, on average, 1 every 13 seconds. Controlling bad cholesterol, also known as LDL-C, is one way to reduce a patient’s risk for cardiovascular events, such as heart attack, stroke or death. However, even with the achievement of target LDL-C levels, millions of patients still have significant and persistent risk of cardiovascular events, especially those patients with elevated triglycerides. Statin therapy has been shown to control LDL-C, thereby reducing the risk of cardiovascular events by 25-35%.6 Significant cardiovascular risk remains after statin therapy. People with elevated triglycerides have 35% more cardiovascular events compared to people with normal (in range) triglycerides taking statins.7,8,9 About VASCEPA®/VAZKEPA® (icosapent ethyl) CapsulesVASCEPA (icosapent ethyl) capsules are the first prescription treatment approved by the U.S. Food and Drug Administration (FDA) comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. VASCEPA was launched in the United States in January 2020 as the first drug approved by the U.S. FDA for treatment of the studied high-risk patients with persistent cardiovascular risk despite being on statin therapy. VASCEPA was initially launched in the United States in 2013 based on the drug’s initial FDA approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been prescribed more than twenty million times. VASCEPA is covered by most major medical insurance plans. In addition to the United States, VASCEPA is approved and sold in Canada, China, Lebanon and the United Arab Emirates. In Europe, in March 2021 marketing authorization was granted to icosapent ethyl in the European Union for the reduction of risk of cardiovascular events in patients at high cardiovascular risk, under the brand name VAZKEPA. In April 2021 marketing authorization for VAZKEPA (icosapent ethyl) was granted in Great Britain (applying to England, Scotland and Wales). VAZKEPA (icosapent ethyl) is currently approved and sold in Europe in Sweden, Denmark, Finland, Austria, the UK, Spain and the Netherlands. United StatesIndications and Limitation of UseVASCEPA is indicated: As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and established cardiovascular disease ordiabetes mellitus and two or more additional risk factors for cardiovascular disease. As an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. Important Safety Information VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components.VASCEPA was associated with an increased risk (3% vs 2%) of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter.It is not known whether patients with allergies to fish and/or shellfish are at an increased risk of an allergic reaction to VASCEPA. Patients with such allergies should discontinue VASCEPA if any reactions occur.VASCEPA was associated with an increased risk (12% vs 10%) of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel or warfarin.Common adverse reactions in the cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%).Common adverse reactions in the hypertriglyceridemia trials (incidence >1% more frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs 0.3%).Adverse events may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.Patients receiving VASCEPA and concomitant anticoagulants and/or anti-platelet agents should be monitored for bleeding. FULL U.S. FDA-APPROVED VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM. Europe For further information about the Summary of Product Characteristics (SmPC) for VAZKEPA® in Europe, please click here. Globally, prescribing information varies; refer to the individual country product label for complete information. Forward-Looking Statements This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including beliefs about the potential for VASCEPA (marketed as VAZKEPA in Europe); beliefs about icosapent ethyl (IPE)’s role concerning appropriate patients suffering from cardiovascular disease (CVD) and potential population health impact, as well as general beliefs about the safety and effectiveness of VASCEPA. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. 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 Amarin’s annual report on Form 10-K for the full year ended 2023. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. Amarin undertakes no obligation to update or revise the information contained in its forward-looking statements, 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 Amarin communicates with its investors and the public using the company website (www.amarincorp.com) and the investor relations website (amarincorp.com/investor-relations), including but not limited to investor presentations and 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 & Media Inquiries:Mark MarmurAmarin Corporation plcPR@amarincorp.comInvestor.relations@amarincorp.com 1 Szarek M, Bhatt DL, Miller M, et al. Lipoprotein(a) blood levels and cardiovascular risk reduction with icosapent ethyl. J Am Coll Cardiol. 2024; epub ahead of print.2 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;40:138-148.3 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;380:11-22.4 Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Effects of Icosapent Ethyl on Total Ischemic Events: From REDUCE-IT. J Am Coll Cardiol. 2019;73:2791-2802.5 American Heart Association. Heart Disease and Stroke Statistics—2020 Update: A Report From the American Heart Association. Circulation. 2020;141:e139-e596.6 Ganda OP, Bhatt DL, Mason RP, et al. Unmet need for adjunctive dyslipidemia therapy in hypertriglyceridemia management. J Am Coll Cardiol. 2018;72(3):330-343.7 Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.8 Toth PP, Granowitz C, Hull M, et al. High triglycerides are associated with increased cardiovascular events, medical costs, and resource use: A real-world administrative claims analysis of statin-treated patients with high residual cardiovascular risk. J Am Heart Assoc. 2018;7(15):e008740.9 Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic cardiovascular disease - New insights from epidemiology, genetics, and biology. Circ Res. 2016;118:547-563

临床结果上市批准AHA会议临床研究

2024-04-04

·PRNewswire

Johnson & Johnson to Showcase its Broad Scientific Leadership and Latest Innovations to Combat Cardiovascular Disease at ACC.24

Clinical and real-world evidence presentations highlight how the Company is transforming care for patients who are fighting some of the most common and devastating cardiovascular diseases NEW BRUNSWICK, N.J., April 4, 2024 /PRNewswire/ -- Johnson & Johnson announced today that clinical and real-world evidence from its cardiovascular portfolio will be featured at the American College of Cardiology 73rd Annual Scientific Session & Expo (ACC.24) taking place April 6-8, 2024, in Atlanta, Georgia. Eleven abstracts, including five oral presentations, will showcase data from Company-sponsored studies demonstrating therapeutic benefit of breakthrough medicines, such as XARELTO® (rivaroxaban), and interventional technologies, such as those from Abiomed® and Biosense Webster®, to help treat cardiovascular diseases, including atrial fibrillation (AF) and peripheral artery disease (PAD). "Cardiovascular disease remains the leading cause of death for adults worldwide and millions more may be at risk of stroke and other life-threatening cardiovascular conditions as the population ages.1 As a global leader in healthcare, we are determined to improve these statistics and empower those living with cardiovascular disease to lead fuller, healthier lives," said Katie Devine, President, US General Medicines, Canada and Puerto Rico, Johnson & Johnson Innovative Medicine. "At ACC.24, we look forward to sharing the latest research and innovation from our broad portfolio, including XARELTO®, to equip clinicians and researchers with knowledge and insights that can help transform cardiovascular care for all." Improving the outlook for people with cardiovascular disease Johnson & Johnson is committed to elevating the standard of care in cardiovascular diseases and unlocking the potential of medicines and solutions of tomorrow. Several data presentations at ACC.24 demonstrate how the Company is improving outcomes for people living with cardiovascular disease, including older adults and other patient populations often considered hard to treat. These include: Data from the PIONEER AF-PCI Phase 3 clinical trial evaluating the safety and efficacy of rivaroxaban for reducing the rate of bleeding among elderly and non-elderly patients with nonvalvular AF undergoing percutaneous coronary intervention (Abstract #906-04). Data from the Real-World Experience of Catheter Ablation for the Treatment of Symptomatic Paroxysmal and Persistent Atrial Fibrillation Using Novel Contact Force Technologies (REAL AF) Registry study evaluating the impact of scar burden on ablation strategy (Abstract #916-10). Data about Impella® heart pumps will be featured in more than 50 presentations, abstracts and posters, including the Danish-German Cardiogenic Shock Trial (DanGer), which is a Late Breaking Clinical Trial (Abstract #406-14). "Our advancements have changed how cardiovascular diseases are diagnosed and treated and have had a meaningful impact on the lives of millions of patients and families. The data we're presenting at ACC.24 demonstrate how we're continuing to deliver on our commitment," said Tim Schmid, Executive Vice President and Worldwide Chairman, Johnson & Johnson MedTech. "We are intent on elevating the standard of care in cardiovascular diseases and, with our partners, are leading research in areas like nonvalvular AF, stroke, and acute coronary syndrome. The real-world and clinical evidence presented at ACC.24 will provide cardiology teams with critical information to help deliver improved care for their patients." The list of Company-sponsored abstracts follows: About XARELTO ® (rivaroxaban) XARELTO® is a prescription medicine used to: reduce the risk of stroke and blood clots in adults who have a medical condition called atrial fibrillation that is not caused by a heart valve problem. With atrial fibrillation, part of the heart does not beat the way it should. This can lead to the formation of blood clots, which can travel to the brain, causing a stroke, or to other parts of the body treat blood clots in the veins of your legs (deep vein thrombosis or DVT) or lungs (pulmonary embolism or PE) reduce the risk of blood clots from happening again in adults who continue to be at risk for DVT or PE after receiving treatment for blood clots for at least 6 months help prevent a blood clot in the legs and lungs of adults who have just had hip or knee replacement surgery help prevent blood clots in certain adults hospitalized for an acute illness and after discharge, who are at risk of getting blood clots because of the loss of or decreased ability to move around (mobility) and other risks for getting blood clots, and who do not have a high risk of bleeding XARELTO® is used with low dose aspirin to: reduce the risk of serious heart problems, heart attack and stroke in adults with coronary artery disease (a condition where the blood supply to the heart is reduced or blocked) reduce the risk of a sudden decrease in blood flow to the legs, major amputation, serious heart problems or stroke in adults with peripheral artery disease (a condition where the blood flow to the legs is reduced) and includes adults who have recently had a procedure to improve blood flow to the legs XARELTO® is used in children to: treat blood clots or reduce the risk of blood clots from happening again in children from birth to less than 18 years, after receiving at least 5 days of treatment with injectable or intravenous medicines used to treat blood clots help prevent blood clots in children 2 years and older with congenital heart disease after the Fontan procedure XARELTO® was not studied and is not recommended in children less than 6 months of age who: were less than 37 weeks of growth (gestation) at birth had less than 10 days of oral feeding, or had a body weight of less than 5.7 pounds (2.6 kg) IMPORTANT SAFETY INFORMATION WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT XARELTO ® ? XARELTO ® may cause serious side effects, including: Increased risk of blood clots if you stop taking XARELTO ® . People with atrial fibrillation (an irregular heart beat) that is not caused by a heart valve problem (nonvalvular) are at an increased risk of forming a blood clot in the heart, which can travel to the brain, causing a stroke, or to other parts of the body. XARELTO® lowers your chance of having a stroke by helping to prevent clots from forming. If you stop taking XARELTO®, you may have increased risk of forming a clot in your blood. Do not stop taking XARELTO ® without talking to the doctor who prescribes it for you. Stopping XARELTO ® increases your risk of having a stroke. If you have to stop taking XARELTO®, your doctor may prescribe another blood thinner medicine to prevent a blood clot from forming. Increased risk of bleeding. XARELTO® can cause bleeding which can be serious and may lead to death. This is because XARELTO® is a blood thinner medicine (anticoagulant) that lowers blood clotting. During treatment with XARELTO® you are likely to bruise more easily, and it may take longer for bleeding to stop. You may be at higher risk of bleeding if you take XARELTO® and have certain other medical problems. You may have a higher risk of bleeding if you take XARELTO ® and take other medicines that increase your risk of bleeding, including: Aspirin or aspirin-containing products Long-term (chronic) use of non-steroidal anti-inflammatory drugs (NSAIDs) Warfarin sodium (Coumadin®, Jantoven®) Any medicine that contains heparin Clopidogrel (Plavix®) Selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) Other medicines to prevent or treat blood clots Tell your doctor if you take any of these medicines. Ask your doctor or pharmacist if you are not sure if your medicine is one listed above. Call your doctor or get medical help right away if you or your child develop any of these signs or symptoms of bleeding: Unexpected bleeding or bleeding that lasts a long time, such as: Nosebleeds that happen often Unusual bleeding from gums Menstrual bleeding that is heavier than normal, or vaginal bleeding Bleeding that is severe or you cannot control Red, pink, or brown urine Bright red or black stools (looks like tar) Cough up blood or blood clots Vomit blood or your vomit looks like "coffee grounds" Headaches, feeling dizzy or weak Pain, swelling, or new drainage at wound sites Spinal or epidural blood clots (hematoma). People who take a blood thinner medicine (anticoagulant) like XARELTO®, and have medicine injected into their spinal and epidural area, or have a spinal puncture, have a risk of forming a blood clot that can cause long-term or permanent loss of the ability to move (paralysis). Your risk of developing a spinal or epidural blood clot is higher if: A thin tube called an epidural catheter is placed in your back to give you certain medicine You take NSAIDs or a medicine to prevent blood from clotting You have a history of difficult or repeated epidural or spinal punctures You have a history of problems with your spine or have had surgery on your spine If you take XARELTO® and receive spinal anesthesia or have a spinal puncture, your doctor should watch you closely for symptoms of spinal or epidural blood clots. Tell your doctor right away if you have: back pain tingling numbness muscle weakness (especially in your legs and feet) or loss of control of the bowels or bladder (incontinence) XARELTO® is not for use in people with artificial heart valves. XARELTO® is not for use in people with antiphospholipid syndrome (APS), especially with positive triple antibody testing. Do not take XARELTO ® if you or your child: Currently have certain types of abnormal bleeding. Talk to your doctor before taking XARELTO® if you currently have unusual bleeding. Are allergic to rivaroxaban or any of the ingredients of XARELTO®. Before taking XARELTO ® , tell your doctor about all your medical conditions, including if you or your child: Have ever had bleeding problems Have liver or kidney problems Have antiphospholipid syndrome (APS) Are pregnant or plan to become pregnant. It is not known if XARELTO® will harm your unborn baby. Tell your doctor right away if you become pregnant during treatment with XARELTO®. Taking XARELTO® while you are pregnant may increase the risk of bleeding in you or in your unborn baby. Females who are able to become pregnant: Talk with your doctor about pregnancy planning during treatment with XARELTO®. Talk with your doctor about your risk for severe uterine bleeding if you are treated with blood thinner medicines, including XARELTO®. If you take XARELTO® during pregnancy, tell your doctor right away if you have any signs or symptoms of bleeding or blood loss. See "What is the most important information I should know about XARELTO ® ?" for signs and symptoms of bleeding. Are breastfeeding or plan to breastfeed. XARELTO® may pass into your breast milk. Talk to your doctor about the best way to feed your baby during treatment with XARELTO®. Tell all of your doctors and dentists that you or your child are taking XARELTO®. They should talk to the doctor who prescribed XARELTO® for you before you have any surgery, medical or dental procedure. Tell your doctor about all the medicines you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some of your other medicines may affect the way XARELTO® works, causing side effects. Certain medicines may increase your risk of bleeding. See "What is the most important information I should know about XARELTO ® ?" HOW SHOULD I TAKE XARELTO ® ? Take XARELTO® exactly as prescribed by your doctor. Do not change your dose or stop taking XARELTO ® unless your doctor tells you to. Your doctor may change your dose if needed. Your doctor will decide how long you should take XARELTO®. XARELTO® may need to be stopped for one or more days before any surgery or medical or dental procedure. Your doctor will tell you when to stop taking XARELTO® and when to start taking XARELTO® again after your surgery or procedure. If you need to stop taking XARELTO® for any reason, talk to the doctor who prescribed XARELTO® to you to find out when you should stop taking it. Do not stop taking XARELTO® without first talking to the doctor who prescribes it to you. If you have difficulty swallowing XARELTO® tablets whole, talk to your doctor about other ways to take XARELTO®. Do not run out of XARELTO®. Refill your prescription of XARELTO® before you run out. When leaving the hospital following a hip or knee replacement, be sure that you will have XARELTO® available to avoid missing any doses. If you take too much XARELTO®, go to the nearest hospital emergency room or call your doctor right away. If you take XARELTO ® for: Atrial Fibrillation that is not caused by a heart valve problem: Take XARELTO® 1 time a day with your evening meal. If you miss a dose of XARELTO®, take it as soon as you remember on the same day. Take your next dose at your regularly scheduled time. Blood clots in the veins of your legs or lungs: Take XARELTO® 1 or 2 times a day as prescribed by your doctor. For the 10-mg dose, XARELTO® may be taken with or without food. For the 15-mg and 20-mg doses, take XARELTO® with food at the same time each day. If you miss a dose: If you take the 15-mg dose of XARELTO ® 2 times a day (a total of 30 mg of XARELTO ® in 1 day): Take XARELTO® as soon as you remember on the same day. You may take 2 doses at the same time to make up for the missed dose. Take your next dose at your regularly scheduled time. If you take XARELTO ® 1 time a day: Take XARELTO® as soon as you remember on the same day. Take your next dose at your regularly scheduled time. Hip or knee replacement surgery: Take XARELTO® 1 time a day with or without food. If you miss a dose of XARELTO®, take it as soon as you remember on the same day. Take your next dose at your regularly scheduled time. Blood clots in people hospitalized for an acute illness: Take XARELTO® 1 time a day, with or without food, while you are in the hospital and after you are discharged as prescribed by your doctor. If you miss a dose of XARELTO®, take it as soon as you remember on the same day. Take your next dose at your regularly scheduled time. Reducing the risk of serious heart problems, heart attack and stroke in coronary artery disease: Take XARELTO® 2.5 mg 2 times a day with or without food. If you miss a dose of XARELTO®, take your next dose at your regularly scheduled time. Take aspirin 75 to 100 mg once daily as instructed by your doctor. Reducing the risk of a sudden decrease in blood flow to the legs, major amputation, serious heart problems or stroke in people with peripheral artery disease, including those who have recently had a procedure to improve blood flow to the legs: Take XARELTO® 2.5 mg 2 times a day with or without food. If you miss a dose of XARELTO®, take your next dose at your regularly scheduled time. Take aspirin 75 to 100 mg once daily as instructed by your doctor. For children who take XARELTO ® : The dose of XARELTO® depends on your child's body weight and will be calculated by your child's doctor. Your child's doctor will tell you if XARELTO® can be given to your child with or without food. The adult caregiver should give the dose. If your child is taking the tablet, the tablet should be taken whole and should not be split in an attempt to provide a lower dose of XARELTO®. If your child is taking the oral suspension, use the syringes provided in the original carton. The suspension will be prepared by the pharmacy. See the Instructions for Use included in the carton on how to properly give a dose of XARELTO® oral suspension to your child. Do not switch between the XARELTO® oral suspension or tablet without first talking to your doctor. If your child vomits or spits up: right after or within 30 minutes of taking the oral suspension, give a new full dose. more than 30 minutes after taking the oral suspension, do not give the dose again. Give the next dose at the regularly scheduled time. if vomiting or spitting up persists, contact your child's doctor right away. If your child misses a dose: If your child is taking XARELTO® 1 time a day, give the dose as soon as you remember on the same day. If this is not possible, skip this dose and give the next dose at the regularly scheduled time. If your child is taking XARELTO® 2 times a day, give the missed morning dose as soon as you remember. You may give the missed morning dose together with the evening dose. However, a missed evening dose can only be taken in the same evening. If your child is taking XARELTO® 3 times a day, skip the missed dose and give the next dose at the regularly scheduled time. WHAT ARE THE POSSIBLE SIDE EFFECTS OF XARELTO ® ? XARELTO ® may cause serious side effects: See "What is the most important information I should know about XARELTO ® ?" The most common side effect of XARELTO ® in adults was bleeding. The most common side effects of XARELTO ® in children include: bleeding vomiting cough inflamed stomach and gut Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Janssen Pharmaceuticals, Inc., at 1-800-JANSSEN (1-800-526-7736). Please read full Prescribing Information , including Boxed Warnings, and Medication Guide for XARELTO ® . Trademarks are those of their respective owners. Janssen and Bayer together are developing rivaroxaban. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at or at . Janssen Research & Development, LLC, Janssen Biotech, Inc. and Janssen Pharmaceuticals, Inc. are Johnson & Johnson companies. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of rivaroxaban. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen Pharmaceuticals, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at , or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen Pharmaceuticals, Inc. nor Johnson & Johnson undertake to update any forward-looking statement as a result of new information or future events or developments. © Johnson & Johnson, Inc. 2024. All rights reserved. 1 World Health Organization. Cardiovascular diseases (CVDs). 2021. Accessed February 15, 2024. Available at: (cvds). SOURCE Johnson & Johnson

临床3期上市批准

2024-03-25

·GlobeNewswire-Health Care

Research Evaluating Benefits of VASCEPA®/VAZKEPA® (icosapent ethyl) to be Presented at the American College of Cardiology’s (ACC) Annual Scientific Session & Expo

-- Subgroup Analyses from REDUCE-IT® and Mechanistic Data on Icosapent Ethyl(IPE)/Eicosapentaenoic Acid (EPA) Featured at the Meeting -- DUBLIN, Ireland and BRIDGEWATER, N.J., March 25, 2024 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that additional patient subgroup analyses from the landmark REDUCE-IT outcomes trial and mechanistic data on icosapent ethyl (IPE)/eicosapentaenoic acid (EPA) will be presented at the American College of Cardiology’s Annual Scientific Session & Expo, April 6 – 8, 2024 in Atlanta, GA. "The data being featured at ACC.24 continues to support and explain the clinical utility and value of VASCEPA®/VAZKEPA® (icosapent ethyl), not only in the overall REDUCE IT patient population, but in the different sub-populations analyzed so far,” said Nabil Abadir, MB. CH.B., SVP, Chief Medical Officer, and Head of Global Medical Affairs at Amarin "The data highlight VASCEPA/VAZKEPA’s effect on reducing MACE in patients with different baseline levels of Lipoprotein(a) [Lp(a)] including among those with clinically relevant Lp(a) elevation as well as among patients with high and low LDL-C baseline levels. These data demonstrate the molecule’s impact in reducing patients’ residual cardiovascular event risk across these patient sub-groups regardless of their baseline Lp(a) or LDL-C levels. Additionally, the meeting provides an opportunity to highlight further evidence regarding the potential mechanistic activity of EPA in reducing cardiovascular events in at-risk patients." “This latest research reaffirms Amarin's commitment to advancing cardiovascular care and should help further advance the medical community’s understanding of the role, the value and the potential mechanism of action of VASCEPA/VAZKEPA to reduce cardiovascular events in at-risk patients globally,” concluded Abadir. Featured Amarin-supported abstracts to be presented by international academic collaborators at ACC Scientific Sessions 2024 include: Moderated Poster Presentations Icosapent Ethyl Reduces MACE in Patients with Elevated Triglycerides and High or Low Lipoprotein(a) Concentrations: A REDUCE-IT SubanalysisMichael Szarek, Deepak L. Bhatt, Elliot A. Brinton, Michael Miller, et al.–Available April 6th, 3:30-3:40 PM-Moderated Poster Theater 06 Efficacy of Icosapent Ethyl for Reducing Cardiovascular Outcomes by Baseline Low Density Lipoprotein Cholesterol LevelRahul Aggarwal, Deepak L. Bhatt, Philippe Gabriel Steg, Michael Miller, et al.-Available Apil 6th, 12:15-12:25 PM-Moderated Poster Theater 08 Eicosapentaenoic Acid (EPA) Inhibits Lipoprotein(a) [Lp(a)] Oxidation due to Scavenging Mechanisms in VitroSamuel C.R. Sherratt, Peter Libby, Deepak L. Bhatt, R. Preston Mason, et al.-Available April 7th, 9:30-9:40 AM-Moderated Poster Theater 06 Poster Presentations Eicosapentaenoic Acid (EPA) and a High Intensity Statin Enhanced Expression of Proteins for Detoxification of Reactive Oxygen Species During Angiotensin II Challenge in Endothelial CellsSamuel C.R. Sherratt, Peter Libby, Deepak L. Bhatt, R. Preston Mason, et al.-Available April 7th, 1:15-2:00 PM-Hall B4-5 Eicosapentaenoic Acid and Rosuvastatin Modulate Expression of Endothelial Proteins that Regulate Function and Platelet Activity During Angiotensin II StimulationSamuel C.R. Sherratt, Peter Libby, Deepak L. Bhatt, R. Preston Mason, et al.-Available April 7th, 1:15-2:00 PM-Hall B4-5 Effects of Icosapent Ethyl on Vascular Regenerative Cells in Individuals with Elevated Triglycerides: Insights From the IPE-Prevention Cardiolink-14 TrialEhab Bakbak, Aishwarya Krishnaraj, Deepak L. Bhatt, Brady Park, et al.–Available April 8th, 12:45-1:30 PM- Hall B4-5 About Amarin Amarin is an innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. We are committed to increasing the scientific understanding of the cardiovascular risk that persists beyond traditional therapies and advancing the treatment of that risk for patients worldwide. Amarin has offices in Bridgewater, New Jersey in the United States, Dublin in Ireland, Zug in Switzerland, and other countries in Europe as well as commercial partners and suppliers around the world.  About Cardiovascular RiskCardiovascular disease is the number one cause of death in the world. In the United States alone, cardiovascular disease results in 859,000 deaths per year.1 And the number of deaths in the United States attributed to cardiovascular disease continues to rise. In addition, in the United States there are 605,000 new and 200,000 recurrent heart attacks per year (approximately 1 every 40 seconds). Stroke rates are 795,000 per year (approximately 1 every 40 seconds), accounting for 1 of every 19 U.S. deaths. In aggregate, in the United States alone, there are more than 2.4 million major adverse cardiovascular events per year from cardiovascular disease or, on average, 1 every 13 seconds. Controlling bad cholesterol, also known as LDL-C, is one way to reduce a patient’s risk for cardiovascular events, such as heart attack, stroke or death. However, even with the achievement of target LDL-C levels, millions of patients still have significant and persistent risk of cardiovascular events, especially those patients with elevated triglycerides. Statin therapy has been shown to control LDL-C, thereby reducing the risk of cardiovascular events by 25-35%.2 Significant cardiovascular risk remains after statin therapy. People with elevated triglycerides have 35% more cardiovascular events compared to people with normal (in range) triglycerides taking statins.3,4 About VASCEPA®/VAZKEPA® (icosapent ethyl) Capsules  VASCEPA (icosapent ethyl) capsules are the first prescription treatment approved by the U.S. Food and Drug Administration (FDA) comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. VASCEPA was launched in the United States in January 2020 as the first drug approved by the U.S. FDA for treatment of the studied high-risk patients with persistent cardiovascular risk despite being on statin therapy. VASCEPA was initially launched in the United States in 2013 based on the drug’s initial FDA approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been prescribed more than twenty million times. VASCEPA is covered by most major medical insurance plans. In addition to the United States, VASCEPA is approved and sold in Canada, China, Lebanon and the United Arab Emirates. In Europe, in March 2021 marketing authorization was granted to icosapent ethyl in the European Union for the reduction of risk of cardiovascular events in patients at high cardiovascular risk, under the brand name VAZKEPA. In April 2021 marketing authorization for VAZKEPA (icosapent ethyl) was granted in Great Britain (applying to England, Scotland and Wales). VAZKEPA (icosapent ethyl) is currently approved and sold 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 therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and  established cardiovascular disease or  diabetes mellitus and two or more additional risk factors for cardiovascular disease.  As an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.  The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.    Important Safety Information  VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components.  VASCEPA was associated with an increased risk (3% vs 2%) of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter.  It is not known whether patients with allergies to fish and/or shellfish are at an increased risk of an allergic reaction to VASCEPA. Patients with such allergies should discontinue VASCEPA if any reactions occur.  VASCEPA was associated with an increased risk (12% vs 10%) of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel or warfarin.  Common adverse reactions in the cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%).  Common adverse reactions in the hypertriglyceridemia trials (incidence >1% more frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs 0.3%).  Adverse events may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.  Patients receiving VASCEPA and concomitant anticoagulants and/or anti-platelet agents should be monitored for bleeding.  FULL U.S. FDA-APPROVED VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM. Europe For further information about the Summary of Product Characteristics (SmPC) for VAZKEPA® in Europe, please click here. Globally, prescribing information varies; refer to the individual country product label for complete information.  Forward-Looking Statements This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including beliefs about the potential for VASCEPA (marketed as VAZKEPA in Europe); beliefs about icosapent ethyl (IPE)’s role concerning appropriate patients suffering from cardiovascular disease (CVD) and potential population health impact, as well as general beliefs about the safety and effectiveness of VASCEPA. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. 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 Amarin’s annual report on Form 10-K for the full year ended 2023. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. Amarin undertakes no obligation to update or revise the information contained in its forward-looking statements, 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 Amarin communicates with its investors and the public using the company website (www.amarincorp.com) and the investor relations website (investor.amarincorp.com), including but not limited to investor presentations and 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 Information Investor & Media Inquiries:Mark MarmurAmarin Corporation plcPR@amarincorp.comInvestor.relations@amarincorp.com 1 American Heart Association. Heart Disease and Stroke Statistics—2020 Update: A Report From the American Heart Association. Circulation. 2020;141:e139-e596.2 Ganda OP, Bhatt DL, Mason RP, et al. Unmet need for adjunctive dyslipidemia therapy in hypertriglyceridemia management. J Am Coll Cardiol. 2018;72(3):330-343.3 Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.4 Toth PP, Granowitz C, Hull M, et al. High triglycerides are associated with increased cardiovascular events, medical costs, and resource use: A real-world administrative claims analysis of statin-treated patients with high residual cardiovascular risk. J Am Heart Assoc. 2018;7(15):e008740.

上市批准AHA会议

100 项与萘二磺酸氯吡格雷相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
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血栓形成	批准上市	德国更多	Hanmi Pharmaceutical Co., Ltd. 更多

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02317198 (POPular AG, Pubmed) 人工标引	临床4期	非 ST 段抬高急性冠脉综合征	1,002	Clopidogrel	(衊衊築膚網範簾壓顧簾) = 願壓積觸夢鏇醖醖壓醖築簾蓋糧鏇繭鹽窪廠鑰 (夢夢蓋鏇鬱選鏇鹽齋壓 ) 更多	积极	2020-04-25
				ticagrelor+prasugrel	(衊衊築膚網範簾壓顧簾) = 齋鬱築願齋選繭製製餘築簾蓋糧鏇繭鹽窪廠鑰 (夢夢蓋鏇鬱選鏇鹽齋壓 ) 更多
FRENCHIE (ESC2023)	N/A	急性心肌梗塞	10,190	Acetylsalicylic acid (ASA)	(糧築衊憲繭製醖憲簾夢) = 淵蓋齋糧遞艱獵簾製遞遞壓鑰艱壓築衊襯齋夢 (構夢遞選艱糧鏇獵積鏇 ) 更多	-	2023-08-25
				Clopidogrel	(糧築衊憲繭製醖憲簾夢) = 簾顧鹽積壓築獵鹹選獵遞壓鑰艱壓築衊襯齋夢 (構夢遞選艱糧鏇獵積鏇 ) 更多
ALPHEUS study (ESC2023)	N/A	不稳定型心绞痛	1,866	Ticagrelor	網淵壓憲顧選鑰範繭鬱(淵蓋鏇鏇網鹽衊構壓範) = 獵鹹餘鏇範積憲網鑰淵夢糧遞觸繭夢醖製繭構 (衊顧齋壓選網齋糧製觸 ) 更多	-	2023-08-26
				Clopidogrel	網淵壓憲顧選鑰範繭鬱(淵蓋鏇鏇網鹽衊構壓範) = 窪餘鑰餘製觸顧膚願鏇夢糧遞觸繭夢醖製繭構 (衊顧齋壓選網齋糧製觸 ) 更多
NCT03381742 (SUPERIOR, Pubmed \| Platelets) 人工标引	临床2/3期	冠心病	3,043	ticagrelor+clopidogrel	蓋淵遞淵壓餘遞衊壓鹽(願積顧襯鏇醖齋網窪衊) = There were no significant differences between T45BID and T90QD in the trough plasma concentrations of ticagrelor and its active metabolite 艱壓餘製鹽餘範積遞窪 (壓構蓋遞願製艱構憲繭 )	积极	2021-01-02
				ticagrelor
HOST-EXAM Extended (ESC2023)	N/A	血栓形成 \| 出血维持	-	Clopidogrel	鹽襯鑰網夢鏇壓壓顧鹽(衊願簾築淵膚範製積鹽): HR = 2.7 (95% CI, 2.29 ~ 3.18)	-	2023-08-26
				Aspirin
ACS-DM Registry (ESC2023)	N/A	急性冠状动脉综合征 \| 糖尿病	539	Ticagrelor	願選遞齋積觸願選淵窪(衊獵壓廠夢鹽網鑰獵糧): HR = 2.53 (95% CI, 1.32 ~ 4.84) 更多	不佳	2023-08-27
				Clopidogrel
ALPHEUS Naive sub-study (ESC2023)	N/A	不稳定型心绞痛	1,882	Ticagrelor	艱網夢築範夢簾襯鏇糧(積艱積積鹽窪遞廠醖鏇) = 繭廠窪選鹹簾壓網網窪積鏇鬱積襯淵鬱夢築醖 (構艱鑰淵廠齋衊鹹選選 ) 更多	-	2023-08-26
				Clopidogrel	艱網夢築範夢簾襯鏇糧(積艱積積鹽窪遞廠醖鏇) = 鏇選構廠夢鏇觸鏇築遞積鏇鬱積襯淵鬱夢築醖 (構艱鑰淵廠齋衊鹹選選 ) 更多
NCT00991029 (POINT, Pubmed) 人工标引	临床3期	短暂性脑缺血发作 \| 急性缺血性卒中	4,881	Aspirin+Clopidogrel	(衊鬱遞鑰積醖憲餘繭艱) = 淵積鹽簾廠願顧蓋築蓋齋蓋構壓衊膚蓋遞構鹽 (淵築憲範壓窪廠蓋範範 ) 更多	不佳	2018-07-19
				Aspirin+Placebo	(衊鬱遞鑰積醖憲餘繭艱) = 鬱廠積襯鑰鏇醖衊選遞齋蓋構壓衊膚蓋遞構鹽 (淵築憲範壓窪廠蓋範範 ) 更多
TARDIS (ISC2023)	N/A	缺血性卒中	3,096	Clopidogrel	積齋遞淵選齋衊簾膚膚(壓醖觸衊衊糧艱構積艱) = 醖願艱鏇遞醖簾積壓淵蓋積願築鑰鬱鹹淵艱壓 (觸鏇齋齋製鹹繭淵簾窪 )	-	2023-02-01
				Aspirin and dipyridamole	積齋遞淵選齋衊簾膚膚(壓醖觸衊衊糧艱構積艱) = 鹽醖鹹淵繭窪觸鹹鬱範蓋積願築鑰鬱鹹淵艱壓 (觸鏇齋齋製鹹繭淵簾窪 )
CHANCE and POINT (AAN2023)	N/A	中性粒细胞减少	-	Aspirin	(鏇顧鹽糧構蓋網廠憲顧) = severe neutropenia can occur with even brief use of clopidogrel 窪鹹醖簾齋範顧選壓遞 (願顧繭鹽鹹夢醖憲糧醖 )	不佳	2023-04-25
				Clopidogrel