X
Pharma Advancement
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development

    New Delivery Path Brings To Light Efficacy of Immunotherapy

    Nasal Spray Shows Its Effect Against New COVID Variants

    Mid-Point Regulatory Science Strategy Study Published By EMA

    AADC Inadequacy To Be Handled By A Novel Gene Therapy

    New Drug Explored For Epilepsy Gets $3M Funding In Australia

    Care Access Research Launches Alliance to Provide Infrastructure for COVID-19 Trials

    Faster Clinical Trial Nods Planned By The UK To Curb Issues

    Pharma Drugs Gain From Tardigrade Proteins, Says Research

    Pharma Drugs Gain From Tardigrade Proteins, Says Research

    U.S. FDA Approves DARZALEX Split-Dosing Regimen

    EMA Keeping A Close Watch On Critical Medicine Shortages

    Pathways Laid Down By The CMS For Drug Price Negotiations

    Pathways Laid Down By The CMS For Drug Price Negotiations

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development

    New Delivery Path Brings To Light Efficacy of Immunotherapy

    Nasal Spray Shows Its Effect Against New COVID Variants

    Mid-Point Regulatory Science Strategy Study Published By EMA

    AADC Inadequacy To Be Handled By A Novel Gene Therapy

    New Drug Explored For Epilepsy Gets $3M Funding In Australia

    Care Access Research Launches Alliance to Provide Infrastructure for COVID-19 Trials

    Faster Clinical Trial Nods Planned By The UK To Curb Issues

    Pharma Drugs Gain From Tardigrade Proteins, Says Research

    Pharma Drugs Gain From Tardigrade Proteins, Says Research

    U.S. FDA Approves DARZALEX Split-Dosing Regimen

    EMA Keeping A Close Watch On Critical Medicine Shortages

    Pathways Laid Down By The CMS For Drug Price Negotiations

    Pathways Laid Down By The CMS For Drug Price Negotiations

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
Pharma Advancement
No Result
View All Result
Home Press Statements

Pfizer research program assess role of PCSK9 inhibitors in reducing risk of cardiovascular events in high-risk patients

Yuvraj_pawp by Yuvraj_pawp
3rd May 2016
in Press Statements

Pfizer Inc announced patient enrollment completion in the global SPIRE-2 cardiovascular outcome trial for its investigational agent bococizumab. SPIRE-2 is evaluating the efficacy and safety of bococizumab compared to placebo in reducing the risk of major cardiovascular events among approximately 10,600 patients at high risk for cardiovascular disease – including those without a prior history of cardiovascular events – who are on highly-effective statins or with documented statin intolerance.

 

The SPIRE-2 study is one of two cardiovascular outcome trials that are part of the SPIRE Phase 3 global clinical development program that will evaluate the investigational Proprotein Convertase Subtilisin Kexin type 9 inhibitor (PCSK9i) bococizumab in approximately 32,000 patients with high cholesterol. Many factors impact the duration of cardiovascular outcome studies, including that they are time-to-event trials, which can make it difficult to predict when the studies will accrue the required number of events. Based on current estimates, the SPIRE-2 study is expected to complete in the second half of 2017.

 

James M. Rusnak, MD, PhD, Therapeutic Area Clinical Head for Cardiovascular and Metabolic Disease, Global Product Development said,Pfizer has been a leader in redefining the management of cardiovascular risk for decades, and we are applying our deep understanding of cardiovascular disease to the SPIRE Phase 3 program.We have designed our cardiovascular outcome trials differently from other PCSK9i outcome trials to include both primary and secondary prevention patients at high risk for a cardiovascular event.

 

The SPIRE program for bococizumab is the only PCSK9i research program explicitly assessing cardiovascular outcomes in a broad range of high-risk primary and secondary prevention patients – including those with diabetes, chronic kidney disease, peripheral vascular disease, familial hypercholesterolemia, and history of heart attack or stroke or cardiovascular revascularization procedures – with low-density lipoprotein cholesterol (LDL-C)=100mg/dL, despite the use of highly effective statins or with documented statin intolerance.

 

In the multicenter, double-blind SPIRE-2 trial, patients with LDL-C =100 mg/dL or non-HDL-C =130 mg/dL were randomized to receive either bococizumab 150mg or placebo every two weeks in addition to highly-effective statins unless patients had documented statin intolerance. The primary endpoint in SPIRE-2 is time to first occurrence of a major cardiovascular event, which includes cardiovascular-related death, non-fatal heart attack, non-fatal stroke, and hospitalization for unstable angina needing urgent revascularization (i.e., heart bypass, angioplasty). The study is evaluating other endpoints as well, including the safety and tolerability of bococizumab.

 

About cardiovascular disease

 

Cardiovascular disease remains the leading cause of death worldwide.1 High LDL-C is a known modifiable risk factor for cardiovascular events such as heart attack and stroke.2,3,4,5 Despite the availability of highly effective lipid-lowering therapies, such as statins, many patients remain at high risk for cardiovascular events.6,7,8,9 Of note, in the U.S., more than 70% of heart attacks occur in patients without a previous cardiovascular event.10

 

About SPIRE

 

Pfizer has created SPIRE (Studies of PCSK9 Inhibition and the Reduction of vascular Events), an extensive research program to study bococizumab, its investigational PCSK9i. The SPIRE Phase 3 global clinical development program will include approximately 32,000 patients and consists of six lipid-lowering studies (SPIRE-SI, SPIRE-AI, SPIRE-HR, SPIRE-FH, SPIRE-LL and SPIRE-LDL) as well as two cardiovascular outcome studies (SPIRE-1 and SPIRE-2).

 

The lipid-lowering studies are evaluating the LDL-C lowering efficacy, safety, and tolerability of bococizumab in adult patients at risk of cardiovascular events, while the two cardiovascular outcome studies are investigating the ability of bococizumab to reduce the risk of cardiovascular events in a broad range of high-risk primary and secondary prevention patients, including those with diabetes, chronic kidney disease, peripheral vascular disease or familial hypercholesterolemia, in addition to those with previous cardiovascular events such as heart attack, stroke, or cardiovascular revascularization procedures.

 

Pfizer’s cardiovascular outcome program for bococizumab is the only PCSK9i research program explicitly assessing cardiovascular outcomes in high-risk primary and secondary prevention patients with an LDL-C =100mg/dL, despite the use of highly-effective statins or with documented partial or complete statin intolerance.

 

About bococizumab

 

Bococizumab is an investigational compound and has not received regulatory approval in any country.
Bococizumab is a PCSK9i being studied for its potential to lower LDL-C and improve cardiovascular outcomes in a broad range of high-risk primary and secondary prevention patients. It works by blocking the function of the PCSK9 protein, which interferes with the clearance of LDL-C, a leading known risk factor for heart disease.

 

About Pfizer Inc. Working together for a healthier world

 

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of healthcare products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us.

Previous Post

Merck And Pfizer Announce First Patient Treated with Avelumab And INLYTA

Next Post

Pfizer Gets Europe Approval For New Multi-Dose Vial Vaccine

Related Posts

Cathay Cargo signs global airline partnership with Tower Cold Chain
Packaging & Logistic

Cathay Cargo signs global airline partnership with Tower Cold Chain

31st March 2023
Pharmapack 2023 a pivotal moment for sustainability in drug delivery and packaging
Europe

Pharmapack 2023 a pivotal moment for sustainability in drug delivery and packaging

3rd March 2023
Canada's National Carrier Air Canada Cargo and the Cool Tech Company ColdChase join Pharma.Aero
Manufacturing

Canada’s National Carrier Air Canada Cargo and the Cool Tech Company ColdChase join Pharma.Aero

22nd February 2023
Amyris and Immunitybio Complete Joint Venture for Next Generation Covid-19 RNA Vaccine
Drug Development

Clover Launches COVID-19 Booster Vaccine in the People’s Republic of China

21st February 2023
Labcorp Unveils New Name for Future Independent Clinical Development Business - Fortrea
Clinical Trials

Labcorp Unveils New Name for Future Independent Clinical Development Business – Fortrea

21st February 2023
Agilent Announces New NovoCyte Flow Cytometer System Software for 21 CFR Part 11 Compliance
IPR Data Management

Agilent Announces New NovoCyte Flow Cytometer System Software for 21 CFR Part 11 Compliance

21st February 2023
Next Post

Pfizer Gets Europe Approval For New Multi-Dose Vial Vaccine

Latest News

Drug Development

New Delivery Path Brings To Light Efficacy of Immunotherapy

1st April 2023
Cathay Cargo signs global airline partnership with Tower Cold Chain
Packaging & Logistic

Cathay Cargo signs global airline partnership with Tower Cold Chain

31st March 2023
Quotient Sciences completes integration of drug substance into Translational Pharmaceutics Platform
Facilities & Operation

£277m Funding Set To Benefit UK Life Sciences Manufacturing

31st March 2023
Drug Development

Nasal Spray Shows Its Effect Against New COVID Variants

27th March 2023
FDA Approvals

Mid-Point Regulatory Science Strategy Study Published By EMA

27th March 2023
Pharma Advancement

About Us

Pharma Advancement is a leading Pharma information centric website. On one side Pharmaadvancement.com has established itself as one of the most efficient and comprehensive source of Pharma information online, dedicated to providing decision makers in all the Pharma industry sectors with reliable, accurate and useful insights into happenings in the Pharma sector.

Qucik Links

  • Drug Development
  • Manufacturing
  • News
  • Events & Conferences
  • Newsletter Archive

Resources

  • Advertise with us
  • Contact Us
  • Download Mediapack

System

  • Search
  • Sitemap
  • RSS Feed

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

No Result
View All Result
  • Home
  • Drug Development
  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

Login to your account below

Forgotten Password?

Fill the forms bellow to register

All fields are required. Log In

Retrieve your password

Please enter your username or email address to reset your password.

Log In