Federal Judge Invalidates Icosapent Ethyl Patents – But Based on a Common Statistical Mistake

2020 ◽  
Author(s):  
Gregory Curfman
Keyword(s):  
Icosapent Ethyl ◽  
Federal Judge

Federal judge invalidates icosapent ethyl patents — but on the basis of a common statistical mistake

2020 ◽  
Vol 38 (8) ◽  
pp. 939-941
Author(s):  
Gregory Curfman ◽  
Deepak L. Bhatt ◽  
Michael Pencina
Keyword(s):  
Icosapent Ethyl ◽  
Federal Judge

scholarly journals Risk of Total Events With Icosapent Ethyl

2019 ◽  
Vol 73 (22) ◽  
pp. 2803-2805 ◽  
Author(s):  
Christopher B. Granger ◽  
Adam J. Nelson ◽  
Neha J. Pagidipati
Keyword(s):  
Icosapent Ethyl

scholarly journals PCV55 Cost-Effectiveness of Icosapent Ethyl (IPE) for the Reduction of the Risk of Ischemic Cardiovascular Events in Canada.

2020 ◽  
Vol 23 ◽  
pp. S496
Author(s):  
J. Lachaine ◽  
J.N. Charron ◽  
J.C. Gregoire ◽  
R.A. Hegele ◽  
L.A. Leiter
Keyword(s):  
Cost Effectiveness ◽  
Cardiovascular Events ◽  
Icosapent Ethyl

REDUCE-IT: outcomes by baseline statin type

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
D Bhatt ◽  
M Miller ◽  
P.G Steg ◽  
E.A Brinton ◽  
T.A Jacobson ◽  
...  
Keyword(s):  
Statin Therapy ◽  
Risk Reduction ◽  
Coronary Revascularization ◽  
Secondary Endpoint ◽  
Nonfatal Stroke ◽  
Funding Source ◽  
Icosapent Ethyl ◽  
Prescription Form ◽  
One Year ◽  
The Impact

Abstract Background REDUCE-IT (Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial) randomized 8,179 statin-treated patients with elevated triglycerides and increased cardiovascular (CV) risk to either icosapent ethyl (IPE), a pure, stable prescription form of eicosapentaenoic acid, 4g/day or placebo. IPE significantly reduced time to first occurrence of the primary composite endpoint of major adverse CV events (CV death, nonfatal myocardial infarction [MI], nonfatal stroke, coronary revascularization, or hospitalization for unstable angina) (HR 0.75, CI 0.68–0.83) and key secondary endpoint events (composite of CV death, nonfatal MI, or nonfatal stroke) (HR 0.74, CI 0.65–0.83) versus placebo (all p<0.0001). A modest reduction in placebo-corrected LDL-C was observed (−6.6%; p<0.0001). The mechanisms for the CV benefit of icosapent ethyl are not fully understood. Purpose Explore the impact of statin type and lipophilic/lipophobic category on outcomes, and on LDL-C, to further consider the possible relevance of LDL-C pathways to the observed CV benefit of icosapent ethyl. Methods Primary and key secondary endpoint analyses and LDL-C changes from baseline were explored by individual statin type (atorvastatin, simvastatin, rosuvastatin, or pravastatin) at baseline, and then by categorizing these statins into lipophilic (i.e., hydrophobic: atorvastatin, simvastatin) and lipophobic (i.e., hydrophilic: rosuvastatin, pravastatin) statin groups; 96.1% of patients fell within these individual statin groups. Results CV outcomes were similar across statin types (interaction p=0.61) and lipophilic/lipophobic categories (interaction p=0.51) (Figure). Statin type and category had a similar lack of meaningful impact on the modest placebo-corrected median LDL-C changes from baseline to one year, which ranged from −5.8 to −8.4% (all p≤0.0003). Conclusion No meaningful treatment differences in the primary or key secondary endpoints across statin type or lipophilic/lipophobic category were observed. A similar lack of treatment difference was observed in LDL-C changes from baseline to one year. Therefore, the LDL-C changes and CV risk reduction in REDUCE-IT appear independent of the type of concomitant statin therapy. These data provide clinicians with additional insight regarding concomitant statin therapy considerations when prescribing icosapent ethyl and suggest there are important mechanisms of action for the substantial CV risk reduction observed with icosapent ethyl that are distinct from the LDL receptor pathway. Funding Acknowledgement Type of funding source: Other. Main funding source(s): The study was funded by Amarin Pharma, Inc.

Law for special environments: jurisdiction over polar activities

Polar Record ◽  
1973 ◽  
Vol 16 (104) ◽  
pp. 701-705
Author(s):  
Daniel Wilkes
Keyword(s):  
United States ◽  
Mexican American ◽  
The United States ◽  
Ellesmere Island ◽  
Federal Judge ◽  
High Seas

The T-3 ice island case involved two trials in the United States of a Mexican-American, Mario Escamilla, for allegedly causing the death of a Negro coworker, Bennie Lightsey, on an ice island then at lat 84°45.8'N, long 106°24.4'W, on the High Seas, about 240 km north of Ellesmere Island on 16 July 1970. A federal judge in Virginia allowed Escamilla's first trail to proceed without definitively deciding on objections to jurisdiction, for he expected a ruling on this point on appeal. Issues raised by that trial are covered elsewhere (Pharand, 1971; Wilkes, 1972).

scholarly journals Usefulness of Icosapent Ethyl (Eicosapentaenoic Acid Ethyl Ester) in Women to Lower Triglyceride Levels (Results from the MARINE and ANCHOR Trials)

2017 ◽  
Vol 119 (3) ◽  
pp. 397-403 ◽  
Author(s):  
Lori Mosca ◽  
Christie M. Ballantyne ◽  
Harold E. Bays ◽  
John R. Guyton ◽  
Sephy Philip ◽  
...  
Keyword(s):  
Eicosapentaenoic Acid ◽  
Ethyl Ester ◽  
Acid Ethyl Ester ◽  
Icosapent Ethyl ◽  
Eicosapentaenoic Acid Ethyl Ester

scholarly journals Icosapent ethyl for the treatment of severe hypertriglyceridemia

2014 ◽  
pp. 485
Author(s):  
Carl J (Chip) Lavie ◽  
Hassan Fares ◽  
James O'Keefe ◽  
James James DiNicolantonio ◽  
Richard Milani
Keyword(s):  
Icosapent Ethyl ◽  
Severe Hypertriglyceridemia
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