Effects of Sarpogrelate Versus Aspirin on Whole Blood Viscosity in Patients With Type 2 Diabetes and Peripheral Artery Disease.

BACKGROUND: Whole blood viscosity (WBV) is associated with impaired microvascular circulation and cardiovascular risk in patients with Type 2 diabetes mellitus (T2DM) and peripheral artery disease (PAD). This study investigated the efficacy and safety of sarpogrelate compared with aspirin on WBV in patients with T2DM and PAD. METHODS: This randomised, open-label clinical trial enrolled adults with T2DM and PAD. A total of 66 participants were randomised to aspirin (n = 33) or sarpogrelate (n = 33) for 24 weeks. The primary endpoint was change in diastolic WBV at a shear rate of 1 s-1 from baseline to week 24. Secondary endpoints included tissue oxygen delivery index, pain visual analogue scale (VAS) and cold sensation scores. RESULTS: After 24 weeks, diastolic WBV did not decrease significantly in both groups (sarpogrelate group: 31.91 ± 7.83 to 30.76 ± 7.08, mean change, -1.15 ± 9.25; p = 0.509; aspirin group: 33.32 ± 8.86 to 32.12 ± 9.60, mean change, -1.20 ± 8.36; p = 0.432). VAS scores improved significantly in both groups (mean change, -9.09 ± 18.09; p = 0.007 for sarpogrelate; -6.13 ± 16.47; p = 0.047 for aspirin), with no between-group difference. Cold sensation scores improved only in the sarpogrelate group (mean change, -0.21 ± 0.55; p = 0.033 vs. -0.23 ± 0.85; p = 0.147 for aspirin group), with no between-group difference. CONCLUSION: In patients with T2DM and PAD, sarpogrelate did not significantly improve WBV compared with aspirin. VAS scores and cold sensation improved significantly within the sarpogrelate group with no between-group difference.