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Randomized Controlled Trial
, 14, 225-232
eCollection

Effects of Sarpogrelate, Eicosapentaenoic Acid and Pitavastatin on Arterioslcerosis Obliterans-Related Biomarkers in Patients With Type 2 Diabetes (SAREPITASO Study)

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Randomized Controlled Trial

Effects of Sarpogrelate, Eicosapentaenoic Acid and Pitavastatin on Arterioslcerosis Obliterans-Related Biomarkers in Patients With Type 2 Diabetes (SAREPITASO Study)

Shosaku Nomura et al. Vasc Health Risk Manag.

Abstract

Background: The aim was to evaluate the significance of arteriosclerosis obliterans-related biomarkers in patients with type 2 diabetes mellitus (T2DM), and to compare the effects of sarpogrelate, eicosapentaenoic acid (EPA) and pitavastatin on these markers.

Patients and methods: Seventy-two arteriosclerosis obliterans patients with T2DM were classified into two groups, pitavastatin with either sarpogrelate (PS) or EPA (PE). We observed no differences in all biomarkers between the PS and PE groups before treatments.

Results: The levels of body mass index, hemoglobin A1c, soluble E-selectin, soluble vascular cell adhesion molecule 1, plasminogen activator inhibitor-1 and platelet-derived microparticle in the PE group decreased significantly after treatment. The ankle branchial pressure index and adiponectin levels significantly increased in the PE group after treatment compared with the PS group.

Conclusion: These results suggest that combination therapy using pitavastatin and EPA possesses an antiatherosclerotic effect and may be beneficial for prevention of vascular complications in patients with T2DM.

Keywords: EPA; PDMP; T2DM; adiponectin; eicosapentaenoic acid; pitavastatin; platelet-derived microparticle; sarpogrelate.

Conflict of interest statement

Disclosure The authors report no conflicts of interest in this work.

Figures

Figure 1
Figure 1
Schema of study protocol. Abbreviations: ABI, ankle branchial pressure index; BT, blood test; EPA, eicosapentaenoic acid; IC, informed consent; M, months; ST, special test.
Figure 2
Figure 2
Changes in ABI, BMI, HbA1c, IL-6 and MCP-1 in response to treatment with PS or PE in T2DM patients. Notes: Bars show the mean±SD. 0: before; M: months (after). P-values are for comparison with each baseline parameter (0 vs 6 and 12 months). ANOVA (PS vs PE). Abbreviations: ABI, ankle brachial pressure index; ANOVA, analysis of variance; BMI, body mass index; HbA1c, hemoglobin A1c; IL-6, interleukin-6; MCP-1, monocyte chemoattractant protein-1; NS, nonsignificant; PE, pitavastatin with eicosapentaenoic acid; PS, pitavastatin with sarpogrelate; T2DM, type 2 diabetes mellitus.
Figure 3
Figure 3
Changes in sE-selectin, sVCAM-1, PAI-1, PDMP and adiponectin in response to treatment with PS or PE of T2DM patients. Notes: Bars show the mean±SD. 0: before M: months (after). P-values are for comparison with each baseline parameter (0 vs 6 and 12 months). ANOVA (PS vs PE). Abbreviations: ANOVA, analysis of variance; NS, nonsignificant; PAI-1, plasminogen activator inhibitor-1; PDMP, platelet-derived microparticle; sE-selectin, soluble E-selectin; sVCAM-1, soluble vascular cell adhesion molecule 1; PE, pitavastatin with eicosapentaenoic acid; PS, pitavastatin with sarpogrelate; T2DM, type 2 diabetes mellitus.

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