Navigation Links
Amarin's AMR101 Phase 3 ANCHOR Trial Meets all Primary and Secondary Endpoints with Statistically Significant Reductions in Triglycerides at Both 4 Gram and 2 Gram Doses and Statistically Significant Decrease in LDL-C
Date:4/17/2011

reductions in triglyceride levels of 21.5% and 10.1% for the 4 grams and 2 grams per day dose groups, respectively.  These reductions were both statistically significant (p<0.0001 and p = 0.0005, respectively). The median baseline triglyceride levels were 259 mg/dL, 265 mg/dL and 254 mg/dL for the patient groups treated with placebo, 4 grams and 2 grams of AMR101 per day, respectively.  Even greater reductions in triglycerides were noted with higher potency statin regimens. Results were positive and statistically significant in both the diabetic and non-diabetic patient groups.

LDL-C Reductions Surpass Target of LDL-C Neutrality

The trial's key secondary endpoint was to demonstrate a lack of elevation of LDL-C in order to avoid offset to the primary target of cholesterol lowering therapy. The trial's non-inferiority criterion for LDL-C was met at both AMR101 doses.  The upper confidence boundaries for both doses were below the pre-specified +6% LDL-C threshold limit.  In fact, at the 4 gram dose the upper confidence boundary was below zero (-1.7%) and at the 2 gram dose the upper confidence boundary was close to zero (0.05%). Moreover, for the 4 grams per day AMR101 group, LDL-C decreased significantly by 6.2% from baseline versus placebo, demonstrating superiority over placebo (p=0.0067). For the 2 grams per day group, LDL-C decreased by 3.6% from baseline versus placebo (p=0.0867).

Additional Findings and Safety Profile were Positive

In addition, the ANCHOR trial demonstrated statistically significant decreases in all predefined secondary endpoints at both doses studied. These endpoints were non-HDL-C, Apo B (Apolipoprotein B), Lp-PLA2 (lipoprotein phospholipase A2) and VLDL-cholesterol. Non-HDL-C decreased in the 4 grams per day group by 13.6% (p<0.0001) and in the 2 grams per day group by 5.5% (p=0.0054) compared to placebo. These are important lipid biomarkers as they represent predictors of
'/>"/>

SOURCE Amarin Corporation plc
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8

Related medicine technology :

1. Amarin Proceeding to Phase 3 With AMR101 for Hypertriglyceridemia
2. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
3. Thomson Scientific Publishes The Ones to Watch - A Quarterly Review of Phase Changes in the Pharmaceutical Pipeline
4. Progen Engages Leading CRO to Assist with Phase 3 Trial of PI-88
5. The Multiple Myeloma Research Consortium (MMRC) and Proteolix Initiate Phase 2 Clinical Trial Investigating Carfilzomib for the Treatment of Multiple Myeloma
6. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
7. Multiple Myeloma Research Consortium (MMRC) Partners with Novartis to Advance Phase II Study of Deacetylase Inhibitor
8. Positive Kuvan(TM) Pivotal Phase 3 Trial Results Published in The Lancet
9. Potential Safety Issue Identified in Ongoing Phase 2 Clinical Study of HCV-796
10. TaiGen Biotechnology Successfully Completes Patient Recruitment for Phase II Trial of Nemonoxacin for Treatment of Adult Community Acquired Pneumonia (CAP)
11. DOV Pharmaceutical, Inc. Announces Successful Phase Ib Results for DOV 21,947
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/11/2014)... -- Neurelis, Inc. ("Neurelis") today announced an agreement with ... by Biotie to purchase Neurelis, clearing the way for ... for pediatric and adult epilepsy patients who experience acute ... has advanced the development program for NRL-1 and worked ... required for NDA submission to the FDA.  Given the ...
(Date:7/10/2014)... -- Integrated Silicon Solution, Inc. (Nasdaq: ISSI ... solutions, today announced that it will host its earnings ... a.m. Pacific Time (10:00 a.m. Eastern Time) to discuss ... quarter ended June 30, 2014. To access ... a.m. Pacific time on July 24, 2014.  The participant ...
(Date:7/10/2014)... --  Ventana Medical Systems, Inc.  (Ventana), a member of ... an agreement with Merck KGaA, Darmstadt, Germany ... the United States and ... division on the development and commercialization of a companion ... diagnostic assays. In alignment with Merck KGaA,s strategic approach ...
Breaking Medicine Technology:Neurelis Regains Rights to Intranasal Diazepam Program 2Neurelis Regains Rights to Intranasal Diazepam Program 3Ventana Medical Systems, Inc. and Merck KGaA, Darmstadt, Germany to develop companion diagnostic test for cancer treatment 2Ventana Medical Systems, Inc. and Merck KGaA, Darmstadt, Germany to develop companion diagnostic test for cancer treatment 3
... Takeda Pharmaceuticals International, Inc., a wholly-owned subsidiary ... its Pharmaceutical Development Division has entered into strategic ... and Quintiles, two of the world,s largest full-service ... the agreements, Covance and Quintiles will work in ...
... Viral Genetics, Inc. (Pink Sheets: VRAL ) ... and Advisor Mr. Richard Gerstner will receive the Lauren F. ... award presentation is set for the Illusions of Lyme Gala, ... being recognized for her research on Targeted Peptide treatment for ...
Cached Medicine Technology:Takeda Enters Into Global Strategic Partnerships With Covance and Quintiles 2Viral Genetics' Researcher and Advisor Set to Share Award 2Viral Genetics' Researcher and Advisor Set to Share Award 3
(Date:7/13/2014)... Texas (PRWEB) July 13, 2014 Epidemiologists ... aGVHD in the 6MM, from 8,062 diagnosed incident cases ... at an Annual Growth Rate (AGR) of 4.35%, during ... the highest number of diagnosed incident cases of aGVHD ... Spain will have the lowest number of diagnosed incident ...
(Date:7/13/2014)... According to the Kidney Disease Solution book review recently updated ... what to do to eliminate the root cause of ... review that readers can easily learn what foods to avoid ... Vkool also informs in its Kidney Disease Solution review that ... naturally. The book consists of a collection of natural remedies ...
(Date:7/13/2014)... 2014 Celebrity fitness trainer and former ... promotional partnership with Aqua Health Labs for their flagship ... supplement . The collaboration was recently announced live on ... trainer , actor, model, and a two time World ... celebrities, he has prepared stars including Demi Moore, Hilary ...
(Date:7/13/2014)... If Dr. Lawrence Power has his way, the innovative ... http://www.HealthYourself101.com will expand people’s understanding of the causes, consequences, ... out to provide a health education platform on this modern ... say it? – entertaining to dig into and learn from. ... remote learner – the solitary individual signing on from a ...
(Date:7/13/2014)... Recently, iFitDress.com, one of the most popular suppliers of ... a new selection of beautiful evening dresses ... promotion for these evening gowns. Now, everybody can enjoy ... thousands of graceful gowns in its online store. Most ... Italy and many other countries. They are highly appreciated ...
Breaking Medicine News(10 mins):Health News:Graft-Versus-Host Disease Market (GVHD) Growing at 4.35% AGR to 2023 Says a New Report Available at ReportsnReports.com 2Health News:Graft-Versus-Host Disease Market (GVHD) Growing at 4.35% AGR to 2023 Says a New Report Available at ReportsnReports.com 3Health News:Graft-Versus-Host Disease Market (GVHD) Growing at 4.35% AGR to 2023 Says a New Report Available at ReportsnReports.com 4Health News:Kidney Disease Solution Book Review Exposes Duncan Capicchiano's Newly Updated Kidney Disease Treatment Plan – Vkool.com 2Health News:Kidney Disease Solution Book Review Exposes Duncan Capicchiano's Newly Updated Kidney Disease Treatment Plan – Vkool.com 3Health News:Celebrity Fitness Expert Supports Revolutionary New Health Supplement 2Health News:Retired Ann Arbor Physician and Professor Wields New Media to Teach Health Science 2Health News:Retired Ann Arbor Physician and Professor Wields New Media to Teach Health Science 3Health News:Retired Ann Arbor Physician and Professor Wields New Media to Teach Health Science 4Health News:New and Beautiful Evening Dresses Unveiled by iFitDress.com 2
... cause of death in the Intensive Care Unit (ICU) is ... central nervous system// and cardiovascular system. The study also revealed ... who are out of the ICU but still in hospital ... ,This study is published in the journal Critical Care. Investigation ...
... were performed, much has been learned about illegal transplants of ... are quite common in countries like India and China ... Africa, people sell their kidneys to foreigners. ,Much ... news was in Jan 2006, about an Indian who died ...
... feelings either way has been brought up by senior doctors ... mercy killing of// new borns who are severely disabled. ... this recommendation as the solution to the incresing numbers of ... alive because of the advanced technology in the medical ...
... injuries like low back pain and disc disorder now ... gas could bring better results than conventional// surgery. ... started gaining ground in western countries, according to senior ... subject., ,'Ozonucleolysis or ozone discectomy for curing spinal ...
... charged with cheating the organisation he earlier worked for has ... Cell of Delhi Police arrested Alok Tomar, a former editor ... ,Tomar was arrested after he flew into the capital ... Deputy Commissioner of Police Alok Kumar. ,Kumar said ...
... rabies, a farmer's extended family in Bihar has to now ... as they had drunk the milk of the infected cows. ... in Dakhin Tola in Purnea district, were bitten by a ... weeks, according to local media reports here. ,The farmer's ...
Cached Medicine News:Health News:Consider Euthanasia For Severely Disabled Babies, College Tells Doctors 2Health News:Ozone Treatment - A Good Alternative For Spinal Injury 2