Effects of empagliflozin on day-to-day variability of home blood pressure and heart rate in patients with type 2 diabetes

Tatsuo Misawa  Yamagata Prefectural Kahoku Hospital

Background and aims: Recent evidence suggests that day-to-day variability of self-measured home blood pressure is strongly associated with cardiovascular and stroke mortality, and the EMPA-REG OUTCOM study documented impressive benefits with empagliflozin on cardiovascular and all-cause mortality and hospitalization for heart failure. However, the effects of empagliflozin in addition to standard care, on day-to-day variability of self-measured home blood pressure (BP) and heart rate (HR) at home in patients with type 2 diabetes (T2DM) at high cardiovascular risk are not known.
Materials and methods: We followed twenty-three consecutive T2DM patients (mean age: 69 years old, 12 men, mean BMI: 29.0 kg/m2) with cardiovascular risk (coronary artery disease: 13 patients(pts), hypertension: 17 pts, atrial fibrillation: 5 pts, cardiac failure: 5 pts, stroke: 1 pt) to add 10 mg of empagliflozin once daily for three months. Home BP and HR were measured once every morning at home, using an oscillometric device. The variability of BP and HR were defined as the standard deviations (SD) of measurements which were performed on seven consecutive days.
Results: For home BP, empagliflozin significantly reduced systolic blood pressure (SBP) from 130±11 mmHg at baseline to 126±11 mmHg at the first week(1W) of the administration (P<0.05). SBP achieved the target home BP goal (125±11 mmHg) at the second week(2W) and was maintained during the study (4W: 124±10 mmHg, 8W: 125±8 mmHg, 12W: 124±10 mmHg, P<0.01). As regards day-to-day variability of SBP, SD mmHg and coefficient of variation (CV) % : SD/mean SBP decreased from 7.3±3.5 mmHg and 5.6±2.7 % at baseline to 6.7±2.5 mmHg and 5.4±1.9 %, respectively, at 1W (4W: 5.8±2.3 mmHg and 4.6±1.9 %, 8W: 5.2±2.3 mmHg and 4.2±1.9 %, P<0.05), but increased at 11W and 12 W (11W:6.6±2.3 mmHg and 5.3±1.8 %, 12W: 6.8±2.0 mmHg and 5.5±1.6 %). In diastolic blood pressure (DBP), there was a significant reduction of SD and CV compared with that at baseline (4.9±1.6 mmHg and 6.9±2.3 % at baseline, 4W: 4.3±1.6 mmHg and 6.3±2.3 %, 8W: 3.9±1.8 mmHg and 5.5±2.5 %, 12W: 4.4±1.6 mmHg and 6.2±2.3 %, P<0.05); however, there was no change of DPB (71±10 mmHg at baseline, 4W: 68±8 mmHg, 8W: 71±9 mmHg, 12W: 71±8 mmHg). Similarly, there was a decreasing trend in SD and CV of HR (3.9±1.2 beats per minute (bpm) and 6.3±1.9 % at baseline, 1W: 4.3±2.6 bpm and 6.9±4.1%, 4W: 3.3±1.3 bpm and 5.4±2.1 %, 8W:3.5±1.8 bpm and 5.7±3.0 %, 12W: 3.1±1.3 bpm and 5.0±2.2 %, P<0.1), although there was no significant change in HR (62±13 bpm at baseline, 1W: 63±11 bpm, 4W: 61±11 bpm, 8W: 61±11 bpm, 12W: 61±12 bpm).
Conclusion: 1, Empagliflozin significantly reduced systolic home BP, without increasing HR in T2DM patients. 2, Empagliflozin tended to reduce the day-to-day variability of self-measured morning home BP and HR in T2DM patients.

Effects of empagliflozin on day-to-day variability of home blood pressure and heart rate in patients with T2DM