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Press Release

Amgen Highlights Repatha® (Evolocumab) GLAGOV Imaging Study Amongst Data To Be Presented At AHA Scientific Sessions 2016

Amgen
Posted on: 31 Oct 16

THOUSAND OAKS, Calif., Oct. 31, 2016 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that it will present detailed results from the Phase 3 coronary intravascular imaging trial, the GLAGOV (GLobal Assessment of Plaque ReGression with a PCSK9 AntibOdy as Measured by IntraVascular Ultrasound) study, at the upcoming American Heart Association (AHA) Scientific Sessions 2016, being held Nov. 12-16 in New Orleans.

The GLAGOV study evaluated whether Repatha® (evolocumab), a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor for the treatment of certain patients with high low-density lipoprotein cholesterol (LDL-C), would modify atherosclerotic plaque build-up in the coronary arteries of patients already treated with optimized statin therapy. Amgen announced in September that the study met its primary and secondary endpoints. The detailed results from this study will be featured as a late-breaking oral presentation on Tuesday, Nov. 15 at 10:58 a.m. CT.

"Amgen is committed to unlocking the full potential of biotechnology in the global fight against cardiovascular disease," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "The robust clinical, observational and health economics data to be presented at AHA 2016 continue to grow our body of knowledge and demonstrate our dedication to improving care for patients with cardiovascular disease."

A second late-breaking oral presentation will review results of a genome-wide association study (GWAS) exploring whether genetic factors influence statin-associated muscle symptoms. In addition, a new analysis of left atrial size and function from the COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure) study evaluating omecamtiv mecarbil, a novel and investigational cardiac myosin activator for treatment of chronic heart failure, will be presented.

Data from Amgen's Center for Observational Research and Global Health Economics providing real-world data on the potential use and impact of some of the medicines in Amgen's cardiovascular portfolio will also be shown.

Amgen-sponsored abstracts at AHA Scientific Sessions 2016 include:

Repatha

Clinical

GLAGOV – Effect of Evolocumab on Progression of Coronary Atherosclerosis in Statin-Treated Patients: A Placebo-Controlled Intravascular Ultrasound Trial
Session LBCT.03, Late-Breaking Clinical Trials, Tuesday, Nov. 15, 10:58 – 11:08 a.m. CT (Main Event 1)

GAUSS-3 – A Genome-Wide Association Study (GWAS) Identifies Novel Loci Associated With Clinically Defined Statin-Associated Muscle Symptoms in a Double-Blind Cross-Over Re-Challenge Trial
Session CSSR.02, Clinical Science: Special Report, Tuesday, Nov. 15, 3:45 – 4 p.m. CT (Main Event 2)

Effect of Evolocumab on Lipoprotein Profiles in Patients With and Without Diabetes
Abstract M 2056, Abstract Poster Session, Monday, Nov. 14, 10:45 a.m. – noon CT (Science and Technology Hall, Population Science)

Observational Research

Lipid Lowering Therapy Prescriptions Immediately Before and After the Diagnosis of Diabetes or Atherosclerotic Cardiovascular Disease
Abstract S 2048, Abstract Poster Session, Sunday, Nov. 13, 2 – 3:15 p.m. CT (Science and Technology Hall, Population Science)

Low Density Lipoprotein Cholesterol Response After Statin Initiation Among HIV-Positive Persons With High Risk for Cardiovascular Disease Events
Abstract T 2020, Abstract Poster Session, Tuesday, Nov. 15, 10:45 a.m. – noon CT (Science and Technology Hall, Population Science)

Age, Sex, and Race Differences in Statin Discontinuation and Side Effect Patterns. The REasons for Geographic And Racial Differences in Stroke (REGARDS) Study
Abstract T 2019, Abstract Poster Session, Tuesday, Nov. 15, 10:45 a.m. – noon CT (Science and Technology Hall, Population Science)

Reasons for Statin Discontinuation With and Without a Physician's Advice: Data From the Reasons for Geographic and Racial Differences in Stroke (REGARDS) Study
Abstract T 2011, Abstract Poster Session, Tuesday, Nov. 15, 10:45 a.m. – noon CT (Science and Technology Hall, Population Science)

Willingness to Reinitiate Statins by Cardiovascular Disease Risk: Data From the Reasons for Geographic and Racial Differences in Stroke (REGARDS) Study
Abstract T 2015, Abstract Poster Session, Tuesday, Nov. 15, 10:45 a.m. – noon CT (Science and Technology Hall, Population Science)

Statin Use and Titration Patterns in the First Year Following a Cardiovascular Event in Commercially-Insured Populations
Abstract T 2010, Abstract Poster Session, Tuesday, Nov. 15, 10:45 a.m. – noon CT (Science and Technology Hall, Population Science)

Statin Use and Titration Patterns in the First Year Following a T2DM Diagnosis in Commercially-Insured Populations
Abstract T 2017, Abstract Poster Session, Tuesday, Nov. 15, 10:45 a.m. – noon CT (Science and Technology Hall, Population Science)

Health Economics

Effect of 2013 ACC/AHA Blood Cholesterol Guidelines on Statin Treatment Patterns and Low Density Lipoprotein Cholesterol (LDL-C) Levels in Patients With Atherosclerotic Cardiovascular Disease (ASCVD)
Abstract M 2107, Abstract Poster Session, Monday, Nov. 14, 10:45 a.m. – noon CT (Science and Technology Hall, Population Science)

Omecamtiv Mecarbil

Clinical

Cardiac Myosin Activator Omecamtiv Mecarbil Improves Left Atrial Structure and Function in Chronic Heart Failure (COSMIC-HF)
Abstract M 4180, Abstract Poster Session, Monday, Nov. 14, 2 – 3:15 p.m. CT (Science and Technology Hall, Clinical Science Section)

Observational Research

Shorter Left Ventricular Ejection Time is Associated With Adverse Outcomes in Heart Failure Patients With Reduced Ejection Fraction
Abstract S 4046, Abstract Poster Session, Sunday, Nov. 13, 2 – 3:15 p.m. CT (Science and Technology Hall, Clinical Science)

Amgen Webcast Investor Meeting
Amgen will host a webcast investor meeting at AHA on Tuesday, Nov. 15, 2016, at 7 p.m. CT. Sean E. Harper, M.D., executive vice president of Research and Development at Amgen, along with members of Amgen's clinical development team and clinical investigators, will participate at the investor meeting to discuss Amgen's data presented at AHA, including the Repatha coronary imaging study (GLAGOV) Phase 3 results.

Live audio of the investor meeting will be simultaneously broadcast over the internet and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen's business given by management at certain investor and medical conferences, can be found on Amgen's website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen's Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event. 

GLAGOV Study Design
GLAGOV (GLobal Assessment of Plaque ReGression with a PCSK9 AntibOdy as Measured by IntraVascular Ultrasound) is a Phase 3, multicenter, double-blind, randomized, placebo-controlled trial designed to evaluate the effect of Repatha on the change in burden of coronary artery disease (CAD) in 968 patients undergoing cardiac catheterization and on optimized background statin therapy. Patients were required to have been treated with a stable statin dose for at least four weeks and to have a LDL-C ≥80 mg/dL or between 60 and 80 mg/dL with one major (defined as non-coronary atherosclerotic vascular disease, myocardial infarction or hospitalization for unstable angina in the preceding two years or type 2 diabetes mellitus) or three minor cardiovascular risk factors (defined as current cigarette smoking, hypertension, low levels of HDL cholesterol, family history of premature coronary heart disease, high sensitivity C-reactive protein (hs-CRP) ≥2mg/dL or age ≥50 years in men and 55 years in women). Patients were randomized 1:1 into two treatment groups to either receive monthly Repatha 420 mg or placebo subcutaneous injections. The primary endpoint was change in percent atheroma volume (PAV) from baseline to week 78 compared to placebo, as determined by intravascular ultrasound (IVUS). IVUS is a high-resolution imaging tool that allows for the quantification of coronary atheroma in the coronary arteries.

Secondary endpoints included PAV regression (any reduction from baseline); change in total atheroma volume (TAV) from baseline to week 78; and regression (any reduction from baseline) in TAV.

For more information:
www.prnewswire.com/news-releases/amgen-highlights-repatha-evolocumab-glagov-imaging-study-amongst-data-to-be-presented-at-aha-scientific-sessions-2016-300354291.html

Editor's Details

Mike Wood
PharmiWeb.com
www.pharmiweb.com
editor@pharmiweb.com

Last updated on: 31/10/2016

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