Abstract

Abstract Background and purpose The optimal choice of antidiabetic medication in patients that need combined therapy is under debate. The aim of this study was to analyze whether beyond glucose control the combination of empagliflozin (E) and linagliptin (L) improves blood pressure (BP) and vascular function in patients with type 2 diabetes (T2DM) as opposed to the combination of metformin (M) and insulin glargine (I). Methods This was a prospective, randomized, controlled, single center study including 101 patients with T2DM, who were randomized 1:1 to E 10–25mg combined with L 5mg once daily or M 850 or 1000mg twice daily combined with I once daily. All patients underwent BP measurement and vascular function analysis by validated systems at baseline and after 12 weeks of treatment. Results In comparison to baseline, office, 24-hour ambulatory BP as well as central blood and pulse pressure (PP) values decreased significantly after 12 weeks of treatment with E+L, whereas there was no change in the M+I group (see table). Twenty-four-hour peripheral systolic (mean difference: −5.2±1.5mmHg, p=0.004) and diastolic BP (−1.9±1.0mmHg, p=0.036), central clinical systolic BP (−5.56±1.9mmHg, p=0.009), forward pressure pulse height (−2.0±0.9mmHg, p=0.028), 24-h central systolic BP (−3.6±1.4mmHg, p=0.045) and 24-h pulse wave velocity (−0.14±0.05m/s, p=0.043) were reduced to a greater extent in the E+L than in the M+I group. Empagliflozin+Linagliptin Metformin+Insulin Baseline 12 weeks p value Baseline 12 weeks p value Peripheral ambulatory BP values 24-h SBP [mmHg] 131.0±10.9 127.0±8.8 <0.001 131.0±9.7 131.0±8.6 0.438 24-h DBP [mmHg] 81.5±7.1 79.7±7.0 0.013 81.0±7.1 81.0±7.5 0.976 Clinical (laboratory) central vascular parameters Central SBP [mmHg] 123.0±9.6 117.0±10.4 <0.001 121.0±9.9 121.0±8.3 0.944 Central PP [mmHg] 44.4±8.0 41.4±6.6 0.004 43.5±8.6 42.8±7.5 0.471 Forward pressure pulse height [mmHg] 33.0±5.7 30.2±4.6 <0.001 32.5±5.6 31.8±4.5 0.216 Central office PWV [m/s] 8.2±1.6 8.0±1.5 0.039 8.4±1.3 8.3±1.2 0.400 24-h ambulatory central vascular parameters Central 24-h SBP [mmHg] 120.5±9.3 117.3±7.9 0.007 121.0±9.1 121.0±8.0 0.608 Central 24-h DBP [mmHg] 83.2±7.3 81.1±6.9 0.016 82.4±7.1 82.4±7.7 0.928 Central 24-h PWV [m/s] 8.9±1.3 8.8±1.3 0.010 9.0±1.4 9.0±1.3 0.349 SBP, systolic blood pressure; DBP, diastolic blood pressure; PP, pulse pressure; PWV, pulse wave velocity. Conclusion The combination of E+L significantly improves BP and vascular function in contrast to the combination of M+I. Acknowledgement/Funding This IIS was supported by a research grant from Boehringer Ingelheim International GmBH

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