Abstract
Background
Statin (HMG-CoA reductase inhibitor) therapy is the mainstay dyslipidemia treatment and reduces the risk of a cardiovascular (CV) event (CVE) by up to 35%. However, adherence to statin therapy is poor. One reason patients discontinue statin therapy is musculoskeletal pain and the associated risk of rhabdomyolysis. Research is ongoing to develop a pharmacogenomics (PGx) test for statin-induced myopathy as an alternative to the current diagnosis method, which relies on creatine kinase levels. The potential economic value of a PGx test for statin-induced myopathy is unknown.
Methods
We developed a lifetime discrete event simulation (DES) model for patients 65 years of age initiating a statin after a first CVE consisting of either an acute myocardial infarction (AMI) or a stroke. The model evaluates the potential economic value of a hypothetical PGx test for diagnosing statin-induced myopathy. We have assessed the model over the spectrum of test sensitivity and specificity parameters.
Results
Our model showed that a strategy with a perfect PGx test had an incremental cost-utility ratio of 4273 Canadian dollars ($Can) per quality-adjusted life year (QALY). The probabilistic sensitivity analysis shows that when the payer willingness-to-pay per QALY reaches $Can12,000, the PGx strategy is favored in 90% of the model simulations.
Conclusion
We found that a strategy favoring patients staying on statin therapy is cost effective even if patients maintained on statin are at risk of rhabdomyolysis. Our results are explained by the fact that statins are highly effective in reducing the CV risk in patients at high CV risk, and this benefit largely outweighs the risk of rhabdomyolysis.
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Notes
In the Canadian Health Measures Survey, dyslipidemia was defined as having unhealthy blood concentrations of low-density lipoprotein cholesterol (LDL-C) (≥ 3.5 mmol/L), a total cholesterol (TC):high-density lipoprotein cholesterol (HDL-C) ratio ≥ 5.0, or self-reported use of a lipid-modifying medication.
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Funding
This research was supported by Genome Canada and Genome Québec. Jason R. Guertin is the recipient a of an establishment fund from the Centre de Recherche du CHU de Québec – Université Laval and from the Fondation du CHU de Québec.
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DM contributed to the conception and design of the study, data acquisition, analysis and interpretation of data, drafting the article, and final approval. JRG, AD, MPD, JCT, ACI, FFA, AM, and JL contributed to the conception and design of the study analysis and interpretation of data, drafting the article, and final approval.
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Dominic Mitchell, Jason R. Guertin, Anick Dubois, Marie-Pierre Dubé, Jean-Claude Tardif, Ange Christelle Iliza, Fiorella Fanton-Aita, Alexis Matteau, and Jacques LeLorier declare that they have no conflicts of interest that are directly relevant to the content of this review.
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Mitchell, D., Guertin, J.R., Dubois, A. et al. A Discrete Event Simulation Model to Assess the Economic Value of a Hypothetical Pharmacogenomics Test for Statin-Induced Myopathy in Patients Initiating a Statin in Secondary Cardiovascular Prevention. Mol Diagn Ther 22, 241–254 (2018). https://doi.org/10.1007/s40291-018-0323-2
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DOI: https://doi.org/10.1007/s40291-018-0323-2