Lipoprotein(a) and Risk of Cardiovascular Disease Events an analysis of a large US national database
Lipoprotein(a) and Risk of Cardiovascular Disease Events an analysis of a large US national database
Diane E MacDougall 1 ,Mary P McGowan1 , Xingdi Hu2 , Wess Boatwright2, Theresa Stern3, Bonnie Hartsuff3, Katherine A Wilemon1 1Family Heart Foundation, Fernandina Beach, FL; 2 Novartis Pharmaceuticals Corp, East Hanover, NJ; 3 BIAClinical Group, Ann Arbor, MI
Diane
MacDougall,
MS VP, Research Family Heart
Foundation
Diane E MacDougall and Katherine A Wilemon: Current employees of Family Heart Foundation
Mary P McGowan: Past employee of Family Heart Foundation and consultant for Novartis
Xingdi Hu and Wess Boatwright: Current employees of Novartis
Theresa Stern and Bonnie Hartsuff: Current employees of BIA Clinical Group
This study was sponsored by Novartis Pharmaceuticals Corporation, East Hanover NJ, USA
Study Design and Entry Criteria
Hypothesis: Higher Lp(a), with and without ASCVD, is associated with increasing risk ofASCVD events
Design: Non-interventional, retrospective cohort study
Population: Individuals with and without ASCVD
Data source: Family Heart Database 2012-2021
Entry Criteria:
o Adults >18 years
o >1 Lp(a) test in nmol/L from 2013-2020
o >1 medical claim pre and post index date
Study Period: 2012 to 2021
Cohort Identification Period: 2013 to 2020
Baseline
Follow-up (1st event or last activity up to Q42021)
Index Date
[Date of 1st Lp(a) Test]
Overview of the Family Heart Database
Specialized Analysis Methods
• Lipid-lowering therapies # Unique Individuals
• ASCVD and associated conditions
• ASCVD events
Study Design and Lp(a) Categories
Lp(a) measures: completed by multiple vendors; all used immunoturbidimetric methodology and reported results in nmol/L.
Primary endpoint: time to occurrence of ASCVD event during follow-up period using a Cox proportional hazard model.
ASCVD events:
• MI, unstable angina or ischemic stroke
• PCI or CABG
Lp(a) categories:
• Generally categorized by <20th , 20-80th, and >80th percentile of ALL individuals
Age (mean): 56 years Women: 58%
Median Lp(a): 30 nmol/L
>125 nmol/L: 21%
>175 nmol/L: 13% Age (mean): 62 years Women: 51%
Median Lp(a): 37 nmol/L >125 nmol/L: 24% >175 nmol/L: 16%
Risk
of ASCVD Events by Ascending Lp(a) Categories and ASCVD Status
Follow-up:
Median: 2.5 yrs
Mean: 3.0 yrs
Range: up to 8.4 yrs
Cox regression analyses covariates:
Summary and Conclusions
• This study is one of the largest examination of Lp(a) in a contemporary setting. Based on 393K individuals, higher Lp(a) consistently predicted increased risk of CVD events in individuals with ASCVD and without ASCVD.
• These findings highlight the substantial unmet need for Lp(a) screening to support risk stratification and subsequent care.
• Additionally, findings demonstrate an unmet need for safe and effective Lp(a) lowering treatments.
The Family Heart Foundation is a 501c3 public charity research and advocacy organization that receives contributions and sponsorships from individuals, foundations, and pharmaceutical companies. This research was partially funded Novartis.
