Center for Global Research Data

Efficacy & Safety of Proprotein Convertase Subtilisin/Kexin type 9 Inhibitors: a Systematic Review and Meta-analysis of Real-World Data

Lead Investigator: Jeanine Roeters van Lennep, Erasmus University Medical Center
Title of Proposal Research:  Efficacy & Safety of Proprotein Convertase Subtilisin/Kexin type 9 Inhibitors: a Systematic Review and Meta-analysis of Real-World Data
Vivli Data Request: 7819
Funding Source: None
Potential Conflicts of Interest: None

Summary of the Proposed Research:

Cardiovascular disease (CVD) is worldwide the most common cause of mortality. Cholesterol contributes the most as CVD-risk factor after hypertension and in high-income countries, cholesterol is already the number one modifiable cause. Cholesterol can be decreased with treatment. Traditional cholesterol lowering therapy are statins and ezetimibe, but also bile acid sequestrants. “Bile acid sequestrants” are medicines that help lower your LDL (bad) cholesterol. Too much cholesterol in your blood can stick to the walls of your arteries and narrow or block them. These medicines work by blocking bile acid in your stomach from being absorbed in your blood.

Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors have been added to these treatment options. “Proprotein convertase subtilisin/kexin type 9 (PCSK9)” is an enzyme that binds to low-density lipoprotein receptors (LDL receptors), which stops LDL being removed from the blood, leading to an increase in blood levels of LDL.

There has been extensive research into the efficacy and safety of PCSK9 inhibitors. Additionally, systematic reviews and meta-analyses have analyzed this data collectively. However, this has only been done with trial (‘experimental’) data so far while there have been several observational (‘real-world’) studies in patients receiving PCSK9 inhibitors. Patients participating in trials can be different from patients being treated at outpatient clinics. Therefore, this study aims to specifically analyze the currently published observational studies containing the “real world” PCSK9 inhibitor data. Our systematic review and meta-analysis will focus on analyzing the efficacy and safety of PCSK9 inhibitors using individual participant data.

 

Requested Studies:

PEARL: A Non-interventional Study of Real-World Alirocumab Use in German Clinical Practice.
Data Contributor: Sanofi
Sponsor ID: ALIROL07871

Efficacy and tolerability of alirocumab in Austrian clinical practice: results of the non-interventional PEARL-AT study.
Data Contributor: Sanofi
Sponsor ID: ALIROL08230

Intensified lipid-lowering treatment with alirocumab in patients with coronary heart disease.
Data Contributor: Sanofi
Sponsor ID: ALIROL09029

Prescribing Patterns of Proprotein Convertase Subtilisin-Kexin Type 9 Inhibitors in Eligible Patients With Clinical Atherosclerotic Cardiovascular Disease or Heterozygous Familial Hypercholesterolemia. Alirocumab in high-risk patients: Observations from the open-label expanded use program.
Data Contributor: Sanofi
Sponsor ID: CUP14366

Long-term safety and efficacy of alirocumab in patients with heterozygous familial hypercholesterolemia: An open-label extension of the ODYSSEY program.
Data Contributor: Sanofi
Sponsor ID: LTS13463

PMID: 31741198 – A Retrospective Observational Study to Determine Baseline Characteristics and Early Prescribing Patterns for Patients Receiving Alirocumab in UK Clinical Practice.
Data Contributor: Sanofi
Sponsor ID: ALIROL08924