Navigation Links
Amgen Announces Positive Top-Line Results From 52-Week Phase 3 DESCARTES Study Of Evolocumab (AMG 145) In Patients With High Cholesterol
Date:12/19/2013

THOUSAND OAKS, Calif., Dec. 19, 2013 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that the Phase 3 DESCARTES (Durable Effect of PCSK9 Antibody CompARed wiTh PlacEbo Study) study evaluating the long-term 52-week safety and efficacy of evolocumab for the treatment of high cholesterol met its primary endpoint of percent reduction from baseline in low-density lipoprotein cholesterol (LDL-C) at week 52. The mean percent reduction in LDL-C, or "bad" cholesterol, was consistent with the results observed in the 52-week analysis of the Phase 2 OSLER (Open Label Study of Long TERm Evaluation Against LDL-C) study.

Evolocumab is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove LDL-C from the blood.1

The DESCARTES study evaluated safety, tolerability and efficacy in 901 patients with high LDL-C and a range of cardiovascular risk. Background lipid-lowering therapy was optimized to one of four treatment groups (diet alone; diet plus atorvastatin 10 mg; diet plus atorvastatin 80 mg; and diet plus atorvastatin 80 mg plus ezetimibe 10 mg) for individual patients based on their LDL-C and cardiovascular risk. Patients with a fasting LDL-C ≥ 75 mg/dL were then randomized to receive monthly subcutaneous evolocumab 420 mg or placebo in combination with background lipid-lowering therapy.

Evolocumab significantly reduced LDL-C, as measured by the accepted standard, preparative ultracentrifugation, from baseline at week 52 compared to placebo.  LDL-C reduction at week 12 was consistent with the long-term efficacy at week 52.

Safety was balanced across treatment groups. The most common adverse events (> 5 percent
'/>"/>

SOURCE Amgen
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8

Related medicine technology :

1. Amgen Announces 2014 First Quarter Dividend
2. Amgen To Present At The Oppenheimer 24th Annual Healthcare Conference
3. Amgen To Webcast Investor Meeting At Upcoming American Heart Association Scientific Sessions 2013
4. Amgens Third Quarter 2013 Revenues Increased 10 Percent To $4.7 Billion And Adjusted Earnings Per Share (EPS) Increased 16 Percent To $1.94
5. Amgen Acquires Filgrastim Franchise Rights From Roche In 100 Markets
6. Amgen Successfully Completes Onyx Pharmaceuticals Tender Offer
7. Amgen and Onyx Pharmaceuticals Announce Early Termination of HSR Waiting Period for Amgens Acquisition of Onyx
8. Amgen And Cytokinetics Announce The First Presentation Of Data From Phase 2 ATOMIC-AHF Study Of Omecamtiv Mecarbil
9. Amgen To Participate At Citis 8th Annual Biotech Conference
10. Healthcare Briefing - Leading Medical Companies in the News: Bio-Solutions, Catalyst Pharmaceutical, MannKind, Amgen, Accuray
11. Amgen to Highlight New Data at Upcoming ESC Congress 2013
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/2/2015)... March 2, 2015 Isis Pharmaceuticals, Inc. (NASDAQ: ... $15 million milestone payment from GSK related to advancing the ... familial amyloid polyneuropathy (FAP).  "We are very ... , and plan to report data from the Phase 2/3 ... fifteen months of dosing and are now receiving ISIS-TTR Rx ...
(Date:3/2/2015)... BETHESDA, Md. , March 2, 2015 /PRNewswire/ ... treating and preventing autoimmune diseases, announced today that it ... 714) from Amgen (NASDAQ: AMGN ). Under ... the rights to develop, manufacture and commercialize AMG 714 ... . Concurrently, Amgen has been granted an exclusive option ...
(Date:3/2/2015)... Texas , March 2, 2015   Lexicon ... biopharmaceutical company focused on developing breakthrough treatments for human ... 2014 financial results on Wednesday, March 4, 2015 before ... conference call and webcast to discuss clinical development progress ... end of 2014 at 10:00 a.m. Eastern Time on ...
Breaking Medicine Technology:Isis Pharmaceuticals Earns $15 Million From GSK for Advancing ISIS-TTR Rx 2Isis Pharmaceuticals Earns $15 Million From GSK for Advancing ISIS-TTR Rx 3Celimmune Announces Anti-IL-15 Antibody Licensing and Option Agreements with Amgen 2Celimmune Announces Anti-IL-15 Antibody Licensing and Option Agreements with Amgen 3Lexicon To Report Fourth Quarter And Year End 2014 Financial Results On March 4, 2015 2
... Part D beneficiaries who enter the "donut hole," where ... prescription costs, are twice as likely to discontinue  their ... or generic medications, a new study published today in ... The study conducted by researchers from Harvard ...
... Aug. 16, 2011 BD (Becton, Dickinson and Company) ... technology company, today announced the completion of its acquisition ... the PhaSeal® System, the leading closed-system drug transfer device ... packaged in vials.  The acquisition expands the scope of ...
Cached Medicine Technology:CVS Caremark, Harvard and Brigham and Women's Researchers Say Medicare 'Donut Hole' Can Lead to a Decrease in Medication Adherence 2CVS Caremark, Harvard and Brigham and Women's Researchers Say Medicare 'Donut Hole' Can Lead to a Decrease in Medication Adherence 3BD Completes Acquisition of Carmel Pharma 2BD Completes Acquisition of Carmel Pharma 3
(Date:3/2/2015)... 02, 2015 This year, the National Multiple ... will provide opportunities for people across the country to unite, ... people with MS live their best lives. MS Awareness Week ... inspire others to join the Society’s vision of a world ... often disabling disease of the central nervous system, interrupts the ...
(Date:3/2/2015)... 02, 2015 Regulatory Compliance Associates® ... quality, regulatory and technical consulting, announces Mr. Seyed ... Officer. , Before joining RCA, Mr. Khorashahi ... teams in all aspects of developing safety-critical medical ... Covidien (Medtronic), Regulatory Compliance Associates Inc., Baxter Healthcare, ...
(Date:3/2/2015)... March 02, 2015 Many mainstream media ... cases of measles. But how much of that news ... their toddlers to prevent measles, but whose youngsters later ... lectures from 150 speakers comprised of professionals, clinicians, researchers, ... recent news stories and questions about the body and ...
(Date:3/1/2015)... March 02, 2015 To ... and manage their practices compliantly and profitably, ... all-inclusive solution. The interoperability between a ... a medical practice management system is necessary ... financial sustainability. A referral management and development ...
(Date:3/1/2015)... Comparing a new source of vehicle insurance ... Pros portal this year. A broad range of agencies ... are being supplied through the finder at http://quotespros.com/auto-insurance.html ... available for each policy is now provided in exchange ... will first be asked to present their unique zip ...
Breaking Medicine News(10 mins):Health News:Every Connection Counts During MS Awareness Week 2Health News:Every Connection Counts During MS Awareness Week 3Health News:Every Connection Counts During MS Awareness Week 4Health News:Regulatory Compliance Associates® Inc. Welcomes Seyed Khorashahi as Chief Operating Officer 2Health News:Growing List of Professionals Gather for World’s Most Comprehensive Autism Conference in Chicago, May 2015 2Health News:Power Up Physician and Patient Referral Management While Qualifying for ARRA Incentives 2Health News:Power Up Physician and Patient Referral Management While Qualifying for ARRA Incentives 3Health News:Power Up Physician and Patient Referral Management While Qualifying for ARRA Incentives 4Health News:United Auto Insurance Rates Now Quoted at Consumer Insurance Portal Online 2
... emerged a heartening development.The World Health Organisation (WHO) has ... based Institute for OneWorld Health, a non-profit drug firm, ... ,Paromomycin IM Injection is a cost-effective treatment ... parasitic disease after malaria. ,It is ...
... A new study has found that single tablets containing ... to controlling increasing blood pressure in people with ... ACCOMPLISH (Avoiding Cardiovascular Events through Combination Therapy in Patients ... of researchers led by Ken Jamerson at the University ...
... on stem cells as a cure for infertility has made ... to grow mature sperm from adult stem cells, says Dr.Karim ... Dr. Nayernia, a professor of stem biology at the ... team had successfully coaxed the embryonic stem cells of mice ...
... Calcutta will reach out to more poor people with free ... the three healthcare units we have opened in Kolkata are ... target to reach out to more number of people by ... Gupta told a press conference Tuesday. ,"We have ...
... taken ill Wednesday after inhaling methane gas leaking from a colliery ... leak was reported early morning from the Bathdih colliery of Bharat ... ,The 10 people of Barari Basti area who fell ... to be in critical condition. ,BCCL officials have rushed ...
... girl dragged along by her headlocks, on the ground then, covering ... her head is smashed with a concrete block, blood oozes from ... heard. ,In the eyes of many in her ... was to love a boy from another religion. She was a ...
Cached Medicine News:Health News:A Non-profit Drug Firms Injection to Fight Kala Azar Included in WHOs Model List 2Health News:A Non-profit Drug Firms Injection to Fight Kala Azar Included in WHOs Model List 3Health News:Single-tablet With Two Drugs may Help Control High BP Better 2Health News:Stem Cell Answer to Infertility in Five Years, Says Scientist 2Health News:Women in Iraq More Unsafe Than Ever 2
The vertebral body replacement (VBR) is used for the anterior thoracic and lumbar spine. It is intended for use in the thoracic and lumbar spine to replace a collapsed, damaged, or unstable vertebral...
Vertigraft Humerus/Tibia Shaft an Cross-sections with even Anterior and Posterior heights may be processed from either the humerus or tibia. Anterior lumbar interbody fusion, corpectomy. Freeze-drie...
... Mesh System is indicated for use in the ... body resected or excised for the treatment of ... cord and neural tissues, and to restore the ... System is also indicated for treating fractures of ...
... cage system provides anterior column support for ... from T1 to L5. The system consists ... polymer cages that are stacked to a ... Peek Carbon fiber reinforced polymer material emulates ...
Medicine Products: