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Triglyceride Lowering with Pemafibrate to Reduce Cardiovascular Risk.

Aruna Das Pradhan1, Robert J Glynn1, Jean-Charles Fruchart1

  • 1From the Center for Cardiovascular Disease Prevention, Division of Preventive Medicine (A.D.P., R.J.G., J.G.M., E.S.Z., B.M.E., N.P.P., J.E.B., P.M.R) and the Division of Cardiovascular Medicine (B.M.E.,P.L., P.M.R.), Brigham and Women's Hospital, the Division of Cardiovascular Medicine, Veteran Affairs Boston Health Care System (A.D.P., J.J.), and Kowa Pharma Development (R.O.) - all in Boston; University of Lille, Lille (J.-C.F.) and the Department of Neurology and Stroke Center, Paris Cité University, Paris (P.A.) - both in France; Kowa Research Institute, Morrisville, NC (S.E.C.); the Division of Lipidology, Department of Medicine, University of Cape Town, Cape Town, South Africa (D.J.B.); Utah Lipid Center, Salt Lake City (E.A.B.); the University of Colorado School of Medicine, Aurora (R.H.E.); the University of Tennessee Health Science Center, Memphis (M.B.E.); the Division of Endocrinology, Universitário Hospital João de Barros Barreto, Belém (J.S.F.), and the Heart Institute (InCor), University of São Paulo Medical School Hospital, and Hospital Israelita Albert Einstein (R.D.S.), São Paulo - all in Brazil; Columbia University Vagelos College of Physicians and Surgeons, New York (H.N.G.); Queen Giovanna University Hospital, Sofia, Bulgaria (A.G.); Jichi Medical University, Shimotsuke (S.I.), the Research Center for Advanced Science and Technology, University of Tokyo, Tokyo (T.K.), and Chiba University Graduate School of Medicine, Chiba (K.Y.) - all in Japan; Deutsches Herzzentrum München, Technische Universität München and German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich (W.K.), Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm (W.K.), and Rheinisch-Westfälische Technische Hochschule Aachen, University Hospital Aachen, Aachen (N.M.) - all in Germany; McMaster University and Population Health Research Institute, Hamilton, ON (P.A.) and the Division of Endocrinology and Metabolism, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.) - both in Canada; Docencia, Asistencia Médica e Investigación Clínica Medical Institute-Rusculleda Foundation for Research, Córdoba, Argentina (A.J.L.); Shupyk National Healthcare University of Ukraine, Kyiv (B.M.); Copenhagen University Hospital-Herlev Gentofte, University of Copenhagen, Copenhagen (B.G.N.); the Department of Medical Clinical Pharmacology, University of Debrecen, Debrecen, Hungary (D.P.); the Department of Primary Care and Public Health, Imperial College London, London (K.K.R.), and the Department of Endocrinology, Diabetes, and Metabolism, Manchester University Hospital NHS Foundation Trust, Manchester (H.S.) - both in the United Kingdom; the Russian Academy of Postgraduate Medical Education, Moscow (A.S.); and the Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland (M.T.).

The New England Journal of Medicine
|November 7, 2022
PubMed
Summary
This summary is machine-generated.

Pemafibrate did not reduce cardiovascular events in patients with type 2 diabetes and hypertriglyceridemia. While it improved lipid profiles by lowering triglycerides and other markers, the primary endpoint showed no significant benefit compared to placebo.

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Area of Science:

  • Cardiology
  • Endocrinology
  • Metabolic Diseases

Background:

  • High triglyceride levels are a known cardiovascular risk factor.
  • The efficacy of triglyceride-lowering therapies in reducing cardiovascular events remains under investigation.
  • Pemafibrate is a selective peroxisome proliferator-activated receptor α modulator with lipid-lowering properties.

Purpose of the Study:

  • To evaluate the effect of pemafibrate on cardiovascular events in patients with type 2 diabetes and hypertriglyceridemia.
  • To assess pemafibrate's impact on lipid profiles and other cardiovascular risk markers.

Main Methods:

  • A multinational, double-blind, randomized, placebo-controlled trial (PROMINENT) involving 10,497 patients.
  • Patients had type 2 diabetes, mild-to-moderate hypertriglyceridemia, and low HDL and LDL cholesterol levels.
  • The primary endpoint was a composite of major adverse cardiovascular events.

Main Results:

  • Pemafibrate significantly reduced triglyceride, VLDL cholesterol, remnant cholesterol, and apolipoprotein C-III levels compared to placebo.
  • No significant difference in the primary endpoint (cardiovascular events) was observed between the pemafibrate and placebo groups (HR, 1.03; 95% CI, 0.91 to 1.15).
  • Pemafibrate was associated with increased risks of adverse renal events and venous thromboembolism but a decreased incidence of nonalcoholic fatty liver disease.

Conclusions:

  • Pemafibrate effectively lowers triglyceride and related lipid levels in patients with type 2 diabetes and hypertriglyceridemia.
  • The study did not demonstrate a reduction in cardiovascular events with pemafibrate treatment in this patient population.
  • Further research may be needed to clarify the role of pemafibrate in cardiovascular risk management.