The Effect of Dapagliflozin on Platelet Function Testing Profiles in Diabetic Patients: The EDGE Pilot Study

Abstract

Introduction: This prospective pharmacodynamic (PD) study assessed the effect of the sodium-glucose co-transporter-2 inhibitor (SGLT2i), dapagliflozin, on platelet reactivity. Methods: Patients with stable coronary artery disease (CAD) and type 2 diabetes mellitus (T2DM) (n = 27) who were on maintenance dual antiplatelet therapy (DAPT) of aspirin 81 mg daily, and clopidogrel 75 mg daily were recruited. Platelet function was evaluated with the VerifyNow TM P2Y 12 assay (Werfen, Bedford, MA, USA) and assessed prior to initiation of and after 10 days of treatment with dapagliflozin 10 mg once-daily dose regimen. Results were compared with a paired t test. Results: Treatment with dapagliflozin significantly decreased P2Y12 reaction units (PRU) by 20%, (95% confidence interval (CI) 8.5-32.6%, p value 0.002). The mean difference in PRU was . No patients experienced any serious adverse events (SAEs). Conclusions: Significantly diminished platelet reactivity was observed on dapagliflozin as compared to without dapagliflozin. This dedicated pharmacodynamic study could be potentially informative and applicable for Trinidadian stable CAD patients with T2DM on DAPT. Further studies are required to confirm these exploratory findings. Clinical Trial Registration: EDGE ClinicalTrials.gov number NCT04400760.

Efficacy of Dapagliflozin in Patients with Diabetes Mellitus Complicated with Coronary Artery Disease and Its Impact on the Vascular Endothelial Function

“…Dapagliflozin is a class of hypoglycemic agents that has received considerable attention in recent years [3,4]. It lowers blood glucose and blood pressure, ameliorates blood lipids, and provides cardioprotective effects [5].…”

Effect of cocoa (Theobroma cacaoL.) on platelet function testing profiles in patients with coronary artery disease: ECLAIR pilot study

“…Despite this study being sufficiently powered for prospective pharmacodynamic outcomes with respect to PRUs and ARUs, it was not designed for prespecified clinical outcomes, and thus no definitive conclusions on clinical efficacy and safety can be ascertained. As with previous studies conducted by this group in Trinidad, there was a preponderance of South Asian patients, alluding to a selection bias during study enrolment 14 43. A double-blind, randomised controlled trial would have been the gold standard for ascertaining the antiplatelet effect of this cocoa intervention; however, there are logistical challenges in executing such methodology in our limited resource setting without a dedicated clinical research organisation 44…”

Drug Safety Evaluation of Sodium-Glucose Cotransporter 2 Inhibitors in Diabetic Comorbid Patients by Review of Systemic Extraglycemic Effects

“…Since platelet hyperactivity in diabetic patients is directly related to the onset of atherosclerosis, 115 , 116 two clinical studies conducted in type 2 diabetes patients showed that dapagliflozin and empagliflozin suppress platelets activity and prevent the development of ischemic heart diseases. 117 , 118 …”