TY - JOUR
T1 - Eligibility and Preventive Potential for New Evidence-Based Cardiovascular Drugs in Secondary Prevention
AU - Mortensen, Martin Bødtker
AU - Blaha, Michael Joseph
AU - Nordestgaard, Børge Grønne
N1 - Funding Information:
grants from the National Institutes of Health, US Food and Drug Administration, American Heart Association, and Aetna Foundation; grants and personal fees from Amgen; and personal fees from Sanofi, Regeneron, Novartis, Bayer, and Novo Nordisk outside the submitted work. Dr Nordestgaard reported personal fees from AstraZeneca, Sanofi, Regeneron, Akcea, Amgen, Kowa, Amarin, Novo Nordisk, and Silence Therapeutics during the conduct of the study. No other disclosures were reported.
Funding Information:
Funding/Support: This study was funded in part by Copenhagen University Hospital and the
Publisher Copyright:
© 2019 American Medical Association. All rights reserved.
PY - 2020/2
Y1 - 2020/2
N2 - Importance: Recently, 12 randomized clinical trials (RCTs) have demonstrated the efficacy of novel therapies for mainly secondary prevention of atherosclerotic cardiovascular disease. However, given the potential overlapping eligibility of the RCTs, along with the cost of the new therapies, there are uncertainty and questions about implementing these RCT findings in real-world clinical practice. Objective: To determine the eligibility and preventive potential for these new preventive therapies in a contemporary population. Design, Setting, and Participants: This population-based contemporary cohort study included 6292 patients with known ischemic heart disease (IHD) and 2277 with a previous myocardial infarction (MI) enrolled between November 2003 and February 2015. Analyses were performed in the Copenhagen General Population Study with a mean (SD) of 7.7 (3.5) years of follow-up. The data were analyzed between January and October 2019. Main Outcomes and Measures: We determined the drug eligibility and evidence-based potential for preventing major cardiovascular events of the 12 cardiovascular drugs tested in the following recent RCTs: IMPROVE-IT, PEGASUS, EMPA-REG, LEADER, SUSTAIN-6, FOURIER, CANVAS, REVEAL, CANTOS, COMPASS, ODYSSEY-OUTCOMES, and REDUCE-IT. The analyses were performed in patients with known IHD or with a previous MI at baseline. Results: Of 6292 participants, 3861 (61%) were men and the mean (interquartile range) age was 69 (62-76) years. In patients with IHD or MI at baseline, eligibility for 1 or more new medications was 80% (n = 5036) and 99% (n = 2273), respectively, by meeting RCT enrollment criteria. Dividing the new therapies into 4 drug classes (lipid-modifying, antithrombotic, anti-inflammatory, and antidiabetic drugs), 2594 and 1834 patients with IHD or MI (41% and 81%, respectively) were eligible for 2 or more drug classes simultaneously. The 5-year estimated percentage of major cardiovascular events that could be prevented for each new therapy was 1% to 20% in patients with IHD or MI at baseline. Conclusions and Relevance: Most patients with known IHD or previous MI are eligible for additional new secondary prevention therapies. This raises questions for the cardiovascular community and health care authorities about access to these potentially expensive therapies, including strategies for prioritizing their use.
AB - Importance: Recently, 12 randomized clinical trials (RCTs) have demonstrated the efficacy of novel therapies for mainly secondary prevention of atherosclerotic cardiovascular disease. However, given the potential overlapping eligibility of the RCTs, along with the cost of the new therapies, there are uncertainty and questions about implementing these RCT findings in real-world clinical practice. Objective: To determine the eligibility and preventive potential for these new preventive therapies in a contemporary population. Design, Setting, and Participants: This population-based contemporary cohort study included 6292 patients with known ischemic heart disease (IHD) and 2277 with a previous myocardial infarction (MI) enrolled between November 2003 and February 2015. Analyses were performed in the Copenhagen General Population Study with a mean (SD) of 7.7 (3.5) years of follow-up. The data were analyzed between January and October 2019. Main Outcomes and Measures: We determined the drug eligibility and evidence-based potential for preventing major cardiovascular events of the 12 cardiovascular drugs tested in the following recent RCTs: IMPROVE-IT, PEGASUS, EMPA-REG, LEADER, SUSTAIN-6, FOURIER, CANVAS, REVEAL, CANTOS, COMPASS, ODYSSEY-OUTCOMES, and REDUCE-IT. The analyses were performed in patients with known IHD or with a previous MI at baseline. Results: Of 6292 participants, 3861 (61%) were men and the mean (interquartile range) age was 69 (62-76) years. In patients with IHD or MI at baseline, eligibility for 1 or more new medications was 80% (n = 5036) and 99% (n = 2273), respectively, by meeting RCT enrollment criteria. Dividing the new therapies into 4 drug classes (lipid-modifying, antithrombotic, anti-inflammatory, and antidiabetic drugs), 2594 and 1834 patients with IHD or MI (41% and 81%, respectively) were eligible for 2 or more drug classes simultaneously. The 5-year estimated percentage of major cardiovascular events that could be prevented for each new therapy was 1% to 20% in patients with IHD or MI at baseline. Conclusions and Relevance: Most patients with known IHD or previous MI are eligible for additional new secondary prevention therapies. This raises questions for the cardiovascular community and health care authorities about access to these potentially expensive therapies, including strategies for prioritizing their use.
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U2 - 10.1001/jamacardio.2019.4759
DO - 10.1001/jamacardio.2019.4759
M3 - Review article
C2 - 31895459
AN - SCOPUS:85077560912
SN - 2380-6583
VL - 5
SP - 209
EP - 215
JO - JAMA cardiology
JF - JAMA cardiology
IS - 2
ER -