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Randomized Controlled Trial
. 2025 Sep 1;48(9):1512-1516.
doi: 10.2337/dc25-0942.

Cardiovascular Outcomes and Efficacy of the PCSK9 Inhibitor Evolocumab in Individuals With Type 1 Diabetes: Insights From the FOURIER Trial

Yu Mi Kang  1   2 , Robert P Giugliano  1 , Xinhui Ran  1 , Prakash Deedwania  3 , Gaetano M De Ferrari  4 , Jyothis T George  5 , Ioanna Gouni-Berthold  6 , Gabriel Paiva da Silva Lima  5 , Yehuda Handelsman  7 , Basil S Lewis  8 , E Magnus Ohman  5 , Huei Wang  5 , J Antonio G López  5 , Maria Laura Monsalvo  5 , Marc S Sabatine  1 , Lawrence A Leiter  9
Affiliations
Randomized Controlled Trial

Cardiovascular Outcomes and Efficacy of the PCSK9 Inhibitor Evolocumab in Individuals With Type 1 Diabetes: Insights From the FOURIER Trial

Yu Mi Kang et al. Diabetes Care. .

Abstract

Objective: To evaluate the clinical efficacy of intensive LDL cholesterol (LDL-C) lowering in type 1 diabetes mellitus (T1DM).

Research design and methods: Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk (FOURIER) randomized participants with atherosclerotic cardiovascular disease (ASCVD) on statins to evolocumab or placebo (median follow-up 2.2 years). The primary end point (PEP) was cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization.

Results: Of 27,564 participants, 10,834 (39.3%) had type 2 diabetes mellitus (T2DM), and 197 (0.7%) had T1DM. In the placebo arm, there was a stepwise increase in the 2.5-year PEP Kaplan-Meier rate from 11.0% to 15.2% to 20.4% in participants with no diabetes, T2DM, and T1DM, respectively (P < 0.0001). Hazard ratios for PEP with evolocumab were 0.87 (95% CI 0.79-0.96), 0.84 (0.75-0.93), and 0.66 (0.32-1.38) in the no diabetes, T2DM, and T1DM groups, and absolute risk reduction was 1.3%, 2.5%, and 7.3%, respectively.

Conclusions: Intensive LDL-C lowering may provide substantial clinical benefit in individuals with T1DM and ASCVD. Additional randomized controlled cardiovascular outcomes trials are needed in this population.

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Conflict of interest statement

Duality of Interest. R.P.G. reports research support from Amgen, Daiichi Sankyo, and Ionis Pharmaceuticals, Inc.; honoraria for lectures from Amgen, Daiichi Sankyo, Dr. Reddy’s Laboratories, Medical Education Resources, and Summeet; and consulting fees from Daiichi Sankyo and Sanofi. G.M.D.F. reports consulting fees from Amgen, Merck, and Novartis and lecture or advisory board honoraria from Daiichi Sankyo, Merck, and Novatis. I.G.-B. reports consulting fees from Daiichi Sankyo, Novartis, Sanofi and Regeneron, and Ultragenyx, and honoraria for lectures from Sanofi and Regeneron, Daiichi Sankyo, Novartis, and Amgen. Y.H. reports research grants from Applied Therapeutics, Corcept Therapeutics, Ionis Pharmaceuticals, Inc., Eli Lilly, Merck, and Regeneron. Y.H. served as an advisor or consultant for Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Corcept Therapeutics, Regeneron, Sanofi, and Verdiva Bio and on the speaker’s bureau for Novo Nordisk. B.S.L. reports consulting fees from Janssen R&D and Idorsia. J.T.G., G.P.d.S.L., E.M.O., H.W., J.A.G.L., and M.L.M. are full-time employees and shareholders of Amgen. M.S.S. reports research grant support through Brigham and Women’s Hospital from Abbott Laboratories, Amgen, Anthos Therapeutics, Inc., AstraZeneca, Boehringer Ingelheim, Daiichi Sankyo, Ionis Pharmaceuticals, Inc., Marea Therapeutics, Merck, Novartis, Pfizer, Saghmos Therapeutics, and Verve Therapeutics and consulting for Amgen, AMPEL BioSolutions, Anthos Therapeutics, Inc., AstraZeneca, Beren Therapeutics, Boehringer Ingelheim, Dr. Reddy’s Laboratories, General Medicines, Merck, Novo Nordisk, and Precision BioSciences. L.A.L. reports research grant support from Amgen, Eli Lilly, HLS, Merck, and Novartis and has provided continuing medical education on behalf of and/or has acted as an advisor to Abbott Laboratories, Amgen, Boehringer Ingelheim, Eli Lilly, GlaxoSmithKline, HLS Therapeutics, Inc., Merck, Novartis, Novo Nordisk, and Regeneron. M.S.S., R.P.G., and X.R. are members of the Thrombolysis in Myocardial Infarction (TIMI) Study Group, which has received institutional research grant support through Brigham and Women’s Hospital from Abbott Laboratories, Abiomed, Inc., Amgen, Anthos Therapeutics, ARCA biopharma, Inc., AstraZeneca, Boehringer Ingelheim, Cleerly, Inc., Daiichi Sankyo, Ionis Pharmaceuticals, Inc., Janssen Research and Development, LLC, MedImmune, Merck, Novartis, Pfizer, Softcell Medical Limited, and The Medicines Company. No other potential conflicts of interest relevant to this article were reported.

Comment in

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