Proprotein convertase subtilisinkexin type 9 (PCSK9) Inhibitors on Cardiovascular and Heart Failure Outcomes

Lead Investigator: Joao Ferreira, University of Porto
Title of Proposal Research: Proprotein convertase subtilisinkexin type 9 (PCSK9) Inhibitors on Cardiovascular and Heart Failure Outcomes
Vivli Data Request: 9410
Funding Source: None
Potential Conflicts of Interest: None

Summary of the Proposed Research:

Background on Heart Failure
Heart failure is a condition where the heart is not able to effectively pump and circulate blood around the body. When the heart cannot pump enough blood, the body’s cells may not receive enough oxygen and nutrients to function correctly, leading to tiredness, shortness of breath, and other health issues. Millions of people around the world live with heart failure, making it a significant public health concern. Finding effective treatments for heart failure can help improve daily life and longevity for these individuals.

Understanding PCSK9 Inhibitors and Bococizumab
PCSK9 inhibitors are a type of medicine that helps lower cholesterol levels in the blood by stopping a protein (called PCSK9) from working. When this protein is hindered, the liver is able to remove more cholesterol from the human body, which may help prevent heart problems like subsequent heart attacks. Bococizumab is a specific PCSK9 inhibitor that is used like this. Even though it is meant to reduce the risk of heart problems, researchers are not sure how well it works for those with heart failure.

Necessity of the Research
Our research is essential because it aims to fill in the gaps in our understanding of how well Bococizumab and similar drugs can help people with heart failure. By finding out if these medications reduce the risk of severe heart problems or the need to be hospitalized due to heart failure, our study could lead to better treatment strategies and outcomes for patients—potentially extending lives and improving their quality of life.

How the Research Will Be Conducted
To conduct this research, we will look back at data from past clinical trials, specifically the SPIRE 1 and 2 trials, where Bococizumab was studied in many patients. We will select information from these trials that concern patients with heart failure and analyze it to draw conclusions about the effectiveness and benefits of Bococizumab for those with this condition. This type of study design—a retrospective analysis of previous trials—is chosen because it allows us to utilize existing data to answer new questions without the time and cost of starting new trials.

Requested Studies:

PHASE 3 MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP EVALUATION OF THE EFFICACY, SAFETY, AND TOLERABILITY OF BOCOCIZUMAB (PF-04950615) IN REDUCING THE OCCURRENCE OF MAJOR CARDIOVASCULAR EVENTS IN HIGH RISK SUBJECTS.
Data Contributor: Pfizer Inc.
Study ID: NCT01975376
Sponsor ID: NCT01975376

PHASE 3 MULTI CENTER, DOUBLE BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP EVALUATION OF THE EFFICACY, SAFETY, AND TOLERABILITY OF BOCOCIZUMAB (PF-04950615), IN REDUCING THE OCCURRENCE OF MAJOR CARDIOVASCULAR EVENTS IN HIGH RISK SUBJECTS
Data Contributor: Pfizer Inc.
Study ID: NCT01975389
Sponsor ID: NCT01975389