Sunday, November 10, 2019 12:37:15 AM
Some basic definitions
Primary Prevention .....Primary prevention includes those measures that prevent the onset of illness before the disease process begins.//my emphasis .
So if you have a family history of heart disease and your lipid panel (blood test ) comes back with a high LDL cholesterol reading ...say 180mg/dl ...you are prescribed a statin to lower your LDL cholesterol to delay / prevent the onset of coronary artery disease ( CAD ) plus better diet , more exercise , no smoking etc
If you can't tolerate the statin or can't hit a target of say LDL under 100 mg/dl you are prescribed Ezetimibe as well ( or instead ) ....the aim is to lower your LDL ...no one takes it to lower Tg's.
So if the FDA wanted to target all in the category of primary prevention they would target all those prescribed statins ( since that is the first line drug to prevent onset of CAD and R-IT was run with statins in both arms ) .. and not just the T2 diabetics that were considered primary prevention in R-IT .
The only ( or most of ) the primary prevention patients in the trial were primary prevention diabetics ( as far as I know ) ...thus I expect only the primary prevention diabetics with 1 extra risk factor etc ...to be on the label .......NOT everyone technically considered a primary prevention patient.
I have yet to understand why you think the FDA will not include the diabetic primary prevention group with 12% RRR when they approved Ezetimibe with only a 6% RRR .
Both R-IT and Improve-it ( Ezetimibe ) were Outcome trials
Will chk in with U tomorrow
Kiwi
Recent AMRN News
- Amarin Announces Two Upcoming Investor Events • GlobeNewswire Inc. • 10/01/2024 12:00:00 PM
- Research Highlighting the Clinical Impact of VASCEPA®/VAZKEPA (icosapent ethyl) in Patients with Diabetes and High Cardiovascular Risk and the Anti-Lp(a) Oxidation Mechanistic Effect of Eicosapentaenoic Acid (EPA) to be Presented at the 60th Annual Europe • GlobeNewswire Inc. • 09/09/2024 11:30:00 AM
- Latest Research Highlighting VASCEPA®/VAZKEPA® (icosapent ethyl) REDUCE-IT® Subgroup Data and New Mechanistic Insights into Eicosapentaenoic Acid (EPA) to be Presented at European Society of Cardiology (ESC) Congress • GlobeNewswire Inc. • 08/22/2024 12:30:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/05/2024 09:30:03 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/01/2024 08:54:53 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/01/2024 08:54:46 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/31/2024 11:05:34 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 07/31/2024 11:05:26 AM
- Amarin Reports Second Quarter 2024 Financial Results and Provides Business Update • GlobeNewswire Inc. • 07/31/2024 11:00:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/29/2024 09:30:08 PM
- Amarin Receives National Reimbursement for VAZKEPA® (icosapent ethyl) in Portugal • GlobeNewswire Inc. • 07/17/2024 08:15:00 PM
- Amarin to Report Second Quarter 2024 Financial Results and Host Conference Call on July 31, 2024 • GlobeNewswire Inc. • 07/17/2024 12:00:00 PM
- Amarin Partner EddingPharm Receives Regulatory Approval for VASCEPA® (Icosapent Ethyl) in Mainland China for Cardiovascular Risk Reduction (CVRR) • GlobeNewswire Inc. • 07/08/2024 11:30:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/04/2024 11:30:10 AM
- Amarin Board of Directors Announces CEO Transition • GlobeNewswire Inc. • 06/04/2024 11:30:00 AM
- Amarin Receives National Reimbursement for VAZKEPA® (icosapent ethyl) in Greece and Announces Exclusive Marketing and Commercialization Agreement with Vianex S.A. • GlobeNewswire Inc. • 05/28/2024 12:15:23 PM
- Amarin to Present at H.C. Wainwright 2nd Annual BioConnect Investor Conference • GlobeNewswire Inc. • 05/06/2024 12:00:00 PM
- Amarin Reports First Quarter 2024 Business Update and Financial Results • GlobeNewswire Inc. • 05/01/2024 11:00:00 AM
- Amarin Applauds HealthyWomen’s Citizen’s Petition Urging FDA To Take Further Action On Fenofibrate Prescribing in Patients at Risk of Cardiovascular Event • GlobeNewswire Inc. • 04/24/2024 06:00:01 PM
- Amarin Announces Results of Annual General Meeting of Shareholders • GlobeNewswire Inc. • 04/22/2024 12:00:25 PM
- Amarin to Report First Quarter 2024 Financial Results and Host Conference Call on May 1, 2024 • GlobeNewswire Inc. • 04/15/2024 12:00:00 PM
- Amarin Highlights Key Data Providing Mechanistic Insights into Eicosapentaenoic Acid (EPA) at ACC.24 • GlobeNewswire Inc. • 04/08/2024 12:00:00 PM
- New REDUCE-IT® Analyses Show VASCEPA® (Icosapent Ethyl) Benefit in High-Risk Cardiovascular Disease Patient Subgroups • PR Newswire (Canada) • 04/08/2024 10:30:00 AM
- New REDUCE-IT® Analyses Show VASCEPA®/VAZKEPA® (Icosapent Ethyl) Benefit in High-Risk Cardiovascular Disease Patient Subgroups • GlobeNewswire Inc. • 04/06/2024 07:30:00 PM
- Amarin Provides Update on VAZKEPA® (Icosapent Ethyl) Intellectual Property Portfolio in Europe • GlobeNewswire Inc. • 04/03/2024 12:00:00 PM
FEATURED SMX and FinGo Enter Into Collaboration Mandate to Develop a Joint 'Physical to Digital' Platform Service To Enhance Natural Rubber Industry's Ability to Report on Sustainable and Ethical Supply Chains • Oct 3, 2024 7:00 AM
Basanite, Inc. Appoints Ali Manav as Interim Chief Executive Officer • BASA • Oct 3, 2024 9:15 AM
Integrated Ventures Announces Launch of MedWell Facilities, LLC and Lease Agreement with Giant Fitness Clubs • INTV • Oct 3, 2024 8:45 AM
Beyond the Horizon: Innovative Drug Combinations Offer New Hope for Alzheimer's and More • NVS • Oct 3, 2024 8:45 AM
Transforming Alzheimer's Treatment: Innovative Combinations to Boost Cognition • PFE • Oct 2, 2024 9:00 AM
Unitronix Corp Unveils Cryptocurrency Investment Portfolio Strategy • UTRX • Oct 2, 2024 8:40 AM