Comparing PCSK9 Monoclonal Antibody Treatment Strategies Following Myocardial Infarction Using Negative Control Outcomes: A Target Trial Emulation Study
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Le résumé fourni par la source
BACKGROUND: Initiation of proprotein convertase subtilisin/kexin type 9 monoclonal antibody (PCSK9 mAb) for lipid-lowering following myocardial infarction (MI) is likely affected by patients' prognostic factors, potentially leading to bias when comparing real-world treatment effects. METHODS: Using target-trial emulation, we assessed potential confounding when comparing two treatment strategies post-MI: initiation of PCSK9 mAb within 1 year and no initiation of PCSK9 mAb. We identified MI hospitalizations during July 2015-June 2020 for patients aged ≥18 years in Optum's de-identified Clinformatics Data Mart (CDM) and MarketScan, and those aged ≥66 in the US Medicare claims database. We estimated a 3-year counterfactual cumulative risk and risk difference (RD) for 10 negative control outcomes using the clone-censor-weight approach to address time-varying confounding and immortal person-time. RESULTS: PCSK9 mAb initiation within 1-year post-MI was low (0.7% in MarketScan and 0.4% in both CDM and Medicare databases). In CDM, there was a lower risk for cancer (RD = -3.6% [95% CI: -4.3%, -2.9%]), decubitus ulcer (RD = -7.7% [95% CI: -11.8%, -3.7%]), fracture (RD = -8.1% [95% CI: -9.6%, -6.6%]), influenza vaccine (RD = -9.3% [95% CI: -17.5%, -1.1%]), and visual test (RD = -0.6% [95% CI: -0.7%, -0.6%]) under the PCSK9 mAb initiation versus no initiation strategy. Similar differences persisted in the MarketScan and Medicare databases. In each database, ezetimibe and low-density lipoprotein testing were unbalanced between treatment strategies. CONCLUSION: A comparative effectiveness study of these treatments using the current approach would likely bias results due to the low number of PCSK9 mAb initiators.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Comparing PCSK9 Monoclonal Antibody Treatment Strategies Following Myocardial Infarction Using Negative Control Outcomes: A Target Trial Emulation Study
- Date Crossref
- 12/04/2024
- Éditeur
- Ovid Technologies (Wolters Kluwer Health)
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Amgen (United Kingdom) pays non établi dans la noticeEntreprise
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University of North Carolina at Chapel Hill Department of Epidemiology pays non établi dans la noticeUniversité ou école supérieure
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Target (United States) pays non établi dans la noticeEntreprise
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Inc. (United States) Target PharmaSolutions pays non établi dans la noticeEntreprise
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Amgen (United States) pays non établi dans la noticeEntreprise
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AbbVie (United States) pays non établi dans la noticeEntreprise
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University of Alabama at Birmingham Department of Epidemiology pays non établi dans la noticeUniversité ou école supérieure
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Duke University Department of Population Health Sciences pays non établi dans la noticeUniversité ou école supérieure
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Amgen Ltd. pays non établi dans la noticeEntreprise
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Acknowledgments: We thank Shannon Rao for her support with creating all the figures in this article pays non établi dans la noticeInstitution
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Conflicts of Interest: R.S. was an employee of Amgen at the time of completion of the study. A.B. was an employee of Target RWE at the time of the study completion. L.D.C. receives research support from Amgen. A.G.A. and Y.Y. are employees of Target RWE. S.S. and N.D. are employees of Amgen. P.M. re pays non établi dans la noticeInstitution
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Source of Funding: Amgen Inc. funded this study Center for Observational Research pays non établi dans la noticeEntreprise
Amgen (United Kingdom), Department of Epidemiology — University of North Carolina at Chapel Hill et Target (United States), avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.