Effectiveness of statin intensive therapy in type 2 diabetes mellitus with high visit-to-visit blood pressure variability

2021 ◽  
Vol Publish Ahead of Print ◽  
Author(s):  
Shota Ikeda ◽  
Keisuke Shinohara ◽  
Nobuyuki Enzan ◽  
Shouji Matsushima ◽  
Takeshi Tohyama ◽  
...  
Author(s):  
Eirini Papadopoulou ◽  
Marieta P Theodorakopoulou ◽  
Charalampos Loutradis ◽  
Georgios Tzanis ◽  
Glykeria Tzatzagou ◽  
...  

Abstract 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 (NCT02887677). Subjects were randomized to oral dapagliflozin 10mg once daily or placebo for 12 weeks. All participants underwent 24-h ambulatory blood pressure (BP) monitoring with the Mobil-O-Graph NG device at baseline and study-end. Standard-deviation (SD), weighted-SD (wSD), coefficient-of-variation (CV), average-real-variability (ARV) and variation-independent-of-mean (VIM) were calculated with validated formulae for the 24-h and the daytime and nighttime periods. Results Dapagliflozin reduced 24-h brachial BP compared to placebo. From baseline to study-end 24-h 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 differences between the groups 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 patients with T2DM, showing no effect on dapagliflozin on all BPV indexes studied.


Hypertension ◽  
2020 ◽  
Vol 76 (Suppl_1) ◽  
Author(s):  
Shota Ikeda ◽  
Keisuke Shinohara ◽  
Nobuyuki Enzan ◽  
Shouji Matsushima ◽  
Takeshi Tohyama ◽  
...  

Introduction: Control of blood pressure (BP) is associated with decreased risk of cardiovascular (CV) events in patients with type 2 diabetes mellitus (T2DM). Lowering the level of low-density lipoprotein cholesterol (LDL-C) by statins is also effective to reduce CV events in T2DM patients with hyperlipidemia. In this study, we examined whether the effectiveness of statin lipid-lowering therapy was affected by baseline BP level in T2DM patients in a primary prevention setting. Methods: The EMPATHY study was a randomized controlled trial investigating the effects of statin intensive therapy targeting LDL-C <70 mg/dL compared to standard therapy targeting LDL-C ≥100 to <120 mg/dL in T2DM patients with diabetic retinopathy and hyperlipidemia without known CV diseases. In this post-hoc subgroup analysis, a total of 4980 patients were divided into two groups based on baseline BP: high BP (systolic BP ≥130 mmHg and/or diastolic BP ≥80 mmHg) and non-high BP (systolic BP <130 mmHg and diastolic BP <80 mmHg) groups. CV events were defined as composite of cardiac, cerebral, renal, and vascular events. Results: At baseline, mean systolic and diastolic BP values were 141.7 and 78.3 mmHg in high BP group (n=3335) and 120.2 and 67.9 mmHg in non-high BP group (n=1645). Compared to non-high BP group, the proportion of patients with diabetic nephropathy (55.5 % vs 46.6 %), body mass index (26.1 kg/m 2 vs 24.8 kg/m 2 ), HbA1c (7.82 % vs 7.67 %), and LDL-C (131.3 mg/dL vs 129.6 mg/dL) were significantly higher in high BP group. During a median follow-up of 36.8 months, 281 CV events were observed. In high BP group, statin intensive therapy was associated with low risk of CV events (HR 0.70, 95% CI 0.54-0.92, p=0.011) compared to standard therapy after adjustment. In non-high BP group, no such association was observed. Interaction between BP group and statin therapy was significant in CV events (p=0.036). Conclusion: Compared to statin standard therapy, statin intensive therapy targeting LDL-C <70 mg/dL significantly reduced CV events in the primary prevention setting among T2DM patients with BP ≥130/80 mmHg, but not among those with BP <130/80 mmHg.


2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
Eirini Papadopoulou ◽  
Marieta Theodorakopoulou ◽  
Charalampos Loutradis ◽  
Georgios Tzanis ◽  
Glyceria Tzatzagou ◽  
...  

Abstract Background and Aims 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. Method This is a secondary analysis of a double-blind, randomized, placebo-controlled trial in 85 patients with T2DM (NCT02887677). Subjects were randomized to oral dapagliflozin 10mg once daily or placebo for 12 weeks. All participants underwent 24-h ambulatory blood pressure (BP) monitoring with the Mobil-O-Graph NG device at baseline and study-end. Standard deviation (SD), weighted SD (wSD), coefficient of variation (CV), average real variability (ARV) and variation independent of mean (VIM) were calculated with validated formulae for the 24-h and the daytime and nighttime periods. Results Dapagliflozin reduced 24-h brachial BP compared to placebo. From baseline to study-end 24-h 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 differences between the groups 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). Conclusion This study is the first to evaluate the effects of an SGLT-2 inhibitor on short-term BPV in patients with T2DM, showing no effect on dapagliflozin on all BPV indexes studied.


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