ORal anticoaGulants in diAbetic and Nondiabetic patients with nOn-valvular atrial fibrillatioN (ORGANON)

Giuseppe Derosa; Manfredi Rizzo; Natale Daniele Brunetti; Riccardo Raddino; Mara Gavazzoni; Gianfranco Pasini; Giovanni Gaudio; Antonio Maggi; Angela D'Angelo; Luisa De Gennaro; Pamela Maffioli

doi:10.1016/j.jdiacomp.2023.108512

ORal anticoaGulants in diAbetic and Nondiabetic patients with nOn-valvular atrial fibrillatioN (ORGANON)

J Diabetes Complications. 2023 Aug;37(8):108512. doi: 10.1016/j.jdiacomp.2023.108512. Epub 2023 May 20.

Authors

Affiliations

¹ Centre of Diabetes and Metabolic Diseases, Department of Internal Medicine and Therapeutics, University of Pavia and Fondazione IRCCS Policlinico San Matteo, Pavia, Italy; Laboratory of Molecular Medicine, University of Pavia, Pavia, Italy. Electronic address: giuseppe.derosa@unipv.it.
² Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties, University of Palermo, Palermo, Italy.
³ Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy.
⁴ Cardiology Department, University of Brescia, Spedali Civili of Brescia, Brescia, Italy.
⁵ Cardiologic Unit, Presidio Ospedaliero di Gavardo, Gavardo, Brescia, Italy.
⁶ Internal Medicine Division, Ospedale Angelo Bellini, Somma Lombardo, Varese, Italy.
⁷ Cardiologic Unit, Poliambulanza Foundation, Brescia, Italy.
⁸ Centre of Diabetes and Metabolic Diseases, Department of Internal Medicine and Therapeutics, University of Pavia and Fondazione IRCCS Policlinico San Matteo, Pavia, Italy; Laboratory of Molecular Medicine, University of Pavia, Pavia, Italy.
⁹ Cardiology Unit, St. Paolo Hospital, Bari, Italy.
¹⁰ Centre of Diabetes and Metabolic Diseases, Department of Internal Medicine and Therapeutics, University of Pavia and Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.

PMID: 37390799
DOI: 10.1016/j.jdiacomp.2023.108512

Abstract

Background: Diabetes represents a pro-thrombotic condition.

Objectives: The primary objective was to evaluate the effects of Vitamin K Antagonist (VKA) compared to direct oral anticoagulants (DOACs) in diabetic and nondiabetic patients with non-valvular atrial fibrillation, newly diagnosed. The secondary objective was to evaluate the effects on the risk of bleeding.

Methods: We enrolled 300 patients with newly diagnosed atrial fibrillation. One hundred and sixteen patients were taking warfarin, 31 acenocumarol, 22 dabigatran, 80 rivaroxaban, 34 apixaban, and 17 edoxaban. We evaluated: anthropometric parameters, glycated hemoglobin (HbA_1c), fasting and post-prandial glucose (FPG, and PPG), lipid profile, Lp(a), small and dense low-density lipoprotein (SD-LDL), oxidized LDL (Ox-LDL), I-troponin (I-Tn), creatinine, transaminases, iron, red blood cells (RBC); hemoglobin (Hb), platelets (PLT), fibrinogen, D-dimer, anti-thrombin III, C-reactive protein (Hs-CRP), Metalloproteinases-2 (MMP-2), Metalloproteinases-9 (MMP-9), and incidence of bleeding.

Results: We did not record any differences among nondiabetic patients between VKA and DOACs. However, when we considered diabetic patients, we found a slight, but significant improvement of triglycerides and SD-LDL. As regards incidence of bleeding, minor bleeding was more frequent in VKA diabetic group compared to DOACs diabetic group; furthermore, the incidence of major bleeding was higher with VKA in nondiabetic and diabetic group, compared to patients with DOACs. Among DOACs, we recorded a higher incidence of bleeding (minor and major) with dabigatran compared to rivaroxaban, apixaban and edoxaban in nondiabetic and diabetic patients.

Conclusion: DOACs seem to be metabolically favourable in diabetic patients. Regarding incidence of bleeding, DOACs with the exception of dabigatran, seem better than VKA in diabetic patients.

Trial registration: ClinicalTrials.gov NCT02935855.

Keywords: Atrial fibrillation; DOACs; Diabetes; Metabolic parameters; Warfarin.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Administration, Oral
Anticoagulants / adverse effects
Atrial Fibrillation* / complications
Atrial Fibrillation* / drug therapy
Atrial Fibrillation* / epidemiology
Dabigatran / adverse effects
Diabetes Mellitus* / drug therapy
Diabetes Mellitus* / epidemiology
Hemorrhage / chemically induced
Hemorrhage / epidemiology
Humans
Rivaroxaban / adverse effects
Stroke* / epidemiology

Substances

Anticoagulants
Dabigatran
edoxaban
Rivaroxaban

Associated data

ClinicalTrials.gov/NCT02935855