TY - JOUR
T1 - Real-world use and modeled impact of glucose-lowering therapies evaluated in recent cardiovascular outcomes trials
T2 - An NCDR® Research to Practice project
AU - Arnold, Suzanne V.
AU - Inzucchi, Silvio E.
AU - Tang, Fengming
AU - McGuire, Darren K
AU - Mehta, Sanjeev N.
AU - Maddox, Thomas M.
AU - Goyal, Abhinav
AU - Sperling, Laurence S.
AU - Einhorn, Daniel
AU - Wong, Nathan D.
AU - Khunti, Kamlesh
AU - Lam, Carolyn S.P.
AU - Kosiborod, Mikhail
N1 - Funding Information:
The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article. SEI: honoraria for trial leadership from AstraZeneca, Boehringer Ingelheim, Daichii Sankyo, Janssen, Lexicon, Merck and Sanofi and data monitoring committees for Novo Nordisk and Intarci; he also served on the steering committees for the EMPA-REG OUTCOME trial; DKM: honoraria for trial leadership from Boehringer Ingelheim, Janssen Research and Development LLC, Merck Sharp and Dohme Corp, Lilly USA, Novo Nordisk, GlaxoSmithKline, Takeda Pharmaceuticals North America, AstraZeneca and Lexicon; honoraria for consultancy from Janssen Research and Development LLC, Sanofi Aventis Group, Merck Sharp and Dohme Corp., Novo Nordisk and Regeneron; DE: honoraria for consultancy from Eli Lilly, Novo Nordisk, Sanofi, AstraZeneca, Janssen, Takeda and Halozyme; clinical research honoraria from Novartis, Eli Lilly, Novo Nordisk, Mylan, Janssen, Bristol-Myers Squibb and Eisai; speaker for Takeda; equity in Halozyme; CSPL: supported by a Clinician Scientist Award from the National Medical Research Council of Singapore; has received research support from Boston Scientific, Bayer, Thermo Fisher, Medtronic and Vifor Pharma; and has consulted for Bayer, Novartis, Takeda, Merck, AstraZeneca, Janssen Research and Development LLC, Menarini, Boehringer Ingelheim and Abbott Diagnostics; MK: research grants from AstraZeneca and Boehringer Ingelheim; other research support from AstraZeneca, Amgen and ZS Pharma; consulting honoraria from AstraZeneca, Sanofi, Amgen, GSK, Boehringer Ingelheim, Merck (Diabetes), Novo Nordisk, Eisai, Janseen, Intarcia, Glytec and ZS Pharma. The remaining authors report no relevant disclosures to the current manuscript.
Funding Information:
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The Diabetes Collaborative Registry is funded by AstraZeneca (founding sponsor) and Boehringer Ingelheim. Corporate sponsors had no role in data analysis or interpretation, manuscript development or in publication review or approval for this study.
Publisher Copyright:
© European Society of Cardiology.
PY - 2017/10/1
Y1 - 2017/10/1
N2 - Aims Recent trials (EMPA-REG OUTCOME and Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results [LEADER]) have shown improved cardiovascular (CV) mortality with specific currently available glucose-lowering medications (empagliflozin and liraglutide, respectively), but were limited to selected patient populations. We sought to evaluate the current use and potential real-world impact of empagliflozin (and other sodium-glucose co-transporter 2 inhibitors [SGLT2is]) and liraglutide (and other glucagonlike peptide-1 receptor agonist [GLP-1 RAs]) among patients in the Diabetes Collaborative Registry (DCR). Methods and results We evaluated 182,525 patients from the DCR - a large, US-based outpatient registry of individuals with type 2 diabetes from 313 sites that included cardiology, endocrinology and primary care practices. Among these patients, 26.2% met major eligibility criteria for EMPA-REG OUTCOME and 48.0% met major eligibility criteria for LEADER. Of these potentially eligible patients, only a small minority were actually prescribed these agents: 5.2% on an SGLT2i and 6.0% on a GLP-1 RA, respectively. Patients receiving these studied medications or medication classes, in general, had lower CV disease burden compared with those not on these agents. Assuming similar risk reductions as in the clinical trials, if all potentially trial-eligible patients in the DCR were treated for 1 year with empagliflozin (or other SGLT2is, assuming a class effect) or liraglutide (or other GLP-1 RAs, assuming a class effect), this may have prevented 354 CV deaths, 231 heart failure hospitalizations, 329 CV deaths and 247 myocardial infarctions, respectively. Conclusion In a large, US-based outpatient registry, we found a significant number of patients would have been potentially eligible for glucose-lowering agents that demonstrated CV benefit in recent clinical trials. In view of these findings, a broader and better-targeted use of these medications in evidence-based patient populations should be considered.
AB - Aims Recent trials (EMPA-REG OUTCOME and Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results [LEADER]) have shown improved cardiovascular (CV) mortality with specific currently available glucose-lowering medications (empagliflozin and liraglutide, respectively), but were limited to selected patient populations. We sought to evaluate the current use and potential real-world impact of empagliflozin (and other sodium-glucose co-transporter 2 inhibitors [SGLT2is]) and liraglutide (and other glucagonlike peptide-1 receptor agonist [GLP-1 RAs]) among patients in the Diabetes Collaborative Registry (DCR). Methods and results We evaluated 182,525 patients from the DCR - a large, US-based outpatient registry of individuals with type 2 diabetes from 313 sites that included cardiology, endocrinology and primary care practices. Among these patients, 26.2% met major eligibility criteria for EMPA-REG OUTCOME and 48.0% met major eligibility criteria for LEADER. Of these potentially eligible patients, only a small minority were actually prescribed these agents: 5.2% on an SGLT2i and 6.0% on a GLP-1 RA, respectively. Patients receiving these studied medications or medication classes, in general, had lower CV disease burden compared with those not on these agents. Assuming similar risk reductions as in the clinical trials, if all potentially trial-eligible patients in the DCR were treated for 1 year with empagliflozin (or other SGLT2is, assuming a class effect) or liraglutide (or other GLP-1 RAs, assuming a class effect), this may have prevented 354 CV deaths, 231 heart failure hospitalizations, 329 CV deaths and 247 myocardial infarctions, respectively. Conclusion In a large, US-based outpatient registry, we found a significant number of patients would have been potentially eligible for glucose-lowering agents that demonstrated CV benefit in recent clinical trials. In view of these findings, a broader and better-targeted use of these medications in evidence-based patient populations should be considered.
KW - Diabetes mellitus
KW - cardiovascular outcomes
KW - registries
UR - http://www.scopus.com/inward/record.url?scp=85031666948&partnerID=8YFLogxK
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U2 - 10.1177/2047487317729252
DO - 10.1177/2047487317729252
M3 - Article
C2 - 28870145
AN - SCOPUS:85031666948
SN - 2047-4873
VL - 24
SP - 1637
EP - 1645
JO - European Journal of Preventive Cardiology
JF - European Journal of Preventive Cardiology
IS - 15
ER -