Abstract 16598: Simulation of Impact on Cardiovascular Events With Lipid-lowering Treatment Intensification in Patients With Atherosclerotic Cardiovascular Disease in the US
Introduction: Recent developments in lipid-lowering therapies (LLT) include the approval of proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) and reductions in cardiovascular (CV) events with ezetimibe (EZE). We explored the impact on CV events due to LLT intensification in a real-world cohort with atherosclerotic cardiovascular disease (ASCVD).
Methods: ASCVD patients in the MarketScan Research database in 2012-2013 were classified according to LLT use: high-intensity statin (HIS), moderate-to-low intensity statin (MIS), non-statin LLT, or no LLT. One million patients were sampled with replacement (bootstrapping) and entered into a simulation model which applied a stepwise LLT intensification logic and predicted LDL-C levels and probabilistic occurrence of CV events over 5 years. Patients not initially on a statin were given atorvastatin 20 mg, else started the model based on their current LLT. The following intensification steps were applied until achievement of LDL-C < 70 mg/dL: uptitration to atorvastatin 80 mg, add-on EZE, add-on alirocumab (ALI). Efficacies and standard deviations were based on literature and CV risk reduction on Cholesterol Treatment Trialists’ Collaboration.
Results: Overall 105,269 patients were included. Mean age was 66 years; 55% were male; 71%, 26% and 36% respectively had coronary, cerebrovascular and peripheral disease; and 38% had comorbid diabetes. Proportion of the cohort requiring LLT initiation/intensification steps were: 46% MIS, 40% HIS; 29% add-on EZE; 14% add-on ALI75; 3% uptitration ALI150. The figure summarizes number of predicted CV events per 1,000 patients before and after treatment intensification steps.
Conclusions: In a cohort of 1 million ASCVD patients, assuming no tolerability and compliance issues, oral LLT could be initiated or intensified in 80% and result in 51,000 CV events prevented over 5 years. PCSK9i could be added in 14% and result in an additional 7,000 CV events prevented.
Author Disclosures: I. Khan: Employment; Significant; Sanofi Inc. C.P. Cannon: Research Grant; Significant; Arisaph, AstraZeneca, Bristol-Myers Squibb, Boehringer-Ingelheim, GlaxoSmithKline, Janssen, Merck, and Takeda. Consultant/Advisory Board; Modest; Alnylam, Amgen, Arisaph, Boehringer-Ingelheim, Boehringer-Ingelheim/Lilly, Bristol-Myers Squibb, GlaxoSmithKline, Kowa, Merck, Takeda, Pfizer. Consultant/Advisory Board; Significant; Lipimedix, Regeneron and Sanofi. A. Klimchak: Consultant/Advisory Board; Significant; Working for Axtria Inc., which has been hired as a consulting firm for Sanofi. M.R. Reynolds: None. R.J. Sanchez: Employment; Significant; Regeneron Pharmaceuticals Inc.. Ownership Interest; Significant; Regeneron Pharmaceuticals Inc. (stock options). W.J. Sasiela: Employment; Significant; Regeneron Pharmaceuticals Inc..
- © 2016 by American Heart Association, Inc.