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Dapagliflozin Does Not Affect Short-Term Blood Pressure Variability in Patients With Type 2 Diabetes Mellitus
Eirini Papadopoulou1,2, Marieta P Theodorakopoulou1, Charalampos Loutradis1
1Department of Nephrology, Aristotle University of Thessaloniki, Hippokration Hospital, Thessaloniki, Greece.
Background:
Increased blood pressure variability (BPV) is associated with increased cardiovascular and all-cause mortality in patients with type-2 diabetes mellitus (T2DM). Sodium-glucose co-transporter 2 (SGLT-2) inhibitors decrease the incidence of cardiovascular events, renal events, and death in this population. This study aimed to evaluate the effect of dapagliflozin on short-term BPV in patients with T2DM.
Methods:
This is a secondary analysis of a double-blind, randomized, placebo-controlled trial in 85 patients with T2DM. Subjects were randomized to dapagliflozin 10 mg/day or placebo for 12 weeks. All participants underwent 24-hour ambulatory blood pressure (BP) monitoring with Mobil-O-Graph-NG device at baseline and study-end. SD, weighted SD (wSD), coefficient of variation, average real variability (ARV), and variation independent of mean were calculated for the 24-hour, daytime and nighttime periods.
Results:
Dapagliflozin reduced 24-hour brachial BP compared with placebo. From baseline to study-end 24-hour brachial BPV indexes did not change with dapagliflozin (SBP-ARV: 11.51 ± 3.45 vs. 11.05 ± 3.35; P = 0.326, SBP-wSD: 13.59 ± 3.60 vs. 13.48 ± 3.33; P = 0.811) or placebo (SBP-ARV: 11.47 ± 3.63 vs. 11.05 ± 3.00; P = 0.388, SBP-wSD: 13.85 ± 4.38 vs. 13.97 ± 3.87; P = 0.308). Similarly, no significant changes in BPV indexes for daytime and nighttime were observed in any group. At study-end, no between-group differences were observed for any BPV index. Deltas (Δ) of all indexes during follow-up were minimal and not different between groups (SBP-wSD: dapagliflozin: -0.11 ± 3.05 vs. placebo: 0.12 ± 4.20; P = 0.227).
Conclusions:
This study is the first to evaluate the effects of an SGLT-2 inhibitor on short-term BPV in T2DM, showing no effect of dapagliflozin on all BPV indexes studied.
Clinical Trials Registration:
Trial Number NCT02887677.
Insights
Dapagliflozin did not alter short-term blood pressure variability (BPV) in patients with type-2 diabetes mellitus (T2DM). This study found no significant changes in BPV indexes with dapagliflozin compared to placebo over 12 weeks.
Area of Science:
- Cardiology
- Endocrinology
- Pharmacology
Background:
- Increased blood pressure variability (BPV) is linked to higher mortality in type-2 diabetes mellitus (T2DM).
- Sodium-glucose co-transporter 2 (SGLT-2) inhibitors are known to reduce cardiovascular events in T2DM patients.
Purpose of the Study:
- To investigate the impact of dapagliflozin on short-term BPV in patients with T2DM.
- To determine if SGLT-2 inhibition influences BP fluctuations in this population.
Main Methods:
- Secondary analysis of a 12-week randomized, placebo-controlled trial involving 85 T2DM patients.
- 24-hour ambulatory BP monitoring was performed at baseline and study-end.
- Multiple BPV indices, including SD, wSD, and ARV, were calculated for different time periods.
Main Results:
- Dapagliflozin did not significantly alter any measured 24-hour, daytime, or nighttime BPV indices compared to placebo.
- No significant differences in BPV index changes were observed between the dapagliflozin and placebo groups.
- Brachial BP was reduced by dapagliflozin, but BPV remained unchanged.
Conclusions:
- Dapagliflozin demonstrated no effect on short-term blood pressure variability in T2DM patients.
- This is the first study to report on the effects of an SGLT-2 inhibitor on BPV in T2DM.
- Further research may be needed to explore long-term BPV effects or effects in different patient subgroups.
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