A Prospective Single-Blind Randomized Trial of Ramipril, Eplerenone and Their Combination in Type 2 Diabetic Nephropathy

2020 ◽  
Vol 10 (6) ◽  
pp. 392-401
Author(s):  
Mostafa El Mokadem ◽  
Yasser Abd El Hady ◽  
Ashraf Aziz

<b><i>Introduction:</i></b> Angiotensin-converting enzyme inhibitors (ACEI) combined with mineralocorticoid receptor antagonists were found to have a beneficial effect on patients with chronic kidney disease. <b><i>Objective:</i></b> The aim of our clinical trial was to compare the antialbuminuric effect of ramipril monotherapy, eplerenone monotherapy and eplerenone/ramipril combination therapy in patients with stage 1 hypertension and type 2 diabetes mellitus. <b><i>Methods:</i></b> In a single-blind, randomized clinical trial, 75 hypertensive patients (stage 1 hypertension) with type 2 diabetes mellitus and microalbuminuria were randomized in a 1:1:1 ratio to 1 of 3 groups: ramipril 10 mg monotherapy (25 patients), eplerenone 50 mg monotherapy (25 patients) and combination therapy of eplerenone/ramipril 50/10 mg (25 patients) through a randomized clinical trial. Blood pressure, urinary albumin/creatinine ratio (UACR), serum creatinine, estimated glomerular filtration rate (eGFR) and serum K level were measured before randomization and after 24 weeks. <b><i>Results:</i></b> Ramipril and eplerenone monotherapy showed a significant lowering of UACR compared with baseline levels (<i>p</i> ≤ 0.0001). The eplerenone/ramipril combination group showed a more significant reduction of UACR compared with the ramipril and eplerenone monotherapy groups (<i>p</i> = 0.0001). There was a more significant lowering of systolic blood pressure in the combination group (<i>p</i> &#x3c; 0.0001). A nonsignificant change of serum potassium level, serum creatinine and eGFR was found among the 3 groups. <b><i>Conclusion:</i></b> Addition of eplerenone to ACEI shows an added antialbuminuric effect without significant change of the serum K level compared with eplerenone or ACEI.

2020 ◽  
Vol 2020 ◽  
pp. 1-7
Author(s):  
Yoshiro Fushimi ◽  
Atsushi Obata ◽  
Junpei Sanada ◽  
Yuichiro Iwamoto ◽  
Akiko Mashiko ◽  
...  

Recently, dipeptidyl peptidase-4 (DPP-4) inhibitors and sodium-glucose cotransporter 2 (SGLT2) inhibitors have been very often used in subjects with type 2 diabetes mellitus (T2DM). In addition, combination drugs of both inhibitors have attracted much attention in aspects of its cost-effectiveness and improvement of patients’ adherence. However, it is still poorly understood which factors are related to the efficacy of SGLT2 inhibitors as add-on therapy to DPP-4 inhibitors. Therefore, we aimed to elucidate in which type of individuals and/or under which conditions canagliflozin as add-on therapy to teneligliptin could exert more beneficial effects on glycemic control and/or renal protection. We retrospectively analyzed 56 Japanese subjects with T2DM in the real-world clinical practice. Three months after starting the combination therapy, the change of HbA1c (ΔHbA1c) was strongly related to HbA1c levels at baseline. As expected, serum glucagon level was increased after starting the combination therapy. Interestingly, however, the change of glucagon levels (Δglucagon) was not related to HbA1c levels at baseline, ΔHbA1c, and other parameters, which indicated that the increase of glucagon did not clinically affect the effectiveness of combination therapy. In addition, the change of urinary albumin excretion (ΔUAE) was negatively correlated with systolic blood pressure and HbA1c levels at baseline and positively correlated with the change of systolic blood pressure (ΔsBP) in univariate analysis. Furthermore, in multivariate analysis, only ΔsBP was the independent factor associated with ΔUAE. Taken together, canagliflozin as add-on therapy to teneligliptin improves glycemic control in a Δglucagon-independent manner and reduces UAE in a ΔsBP-dependent manner in Japanese subjects with T2DM.


2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Eirini Papadopoulou ◽  
Charalampos Loutradis ◽  
Kalliopi Kotsa ◽  
Spiros Karras ◽  
Christos Sambanis ◽  
...  

Abstract Background and Aims Arterial stiffness is a prominent risk factor for heart failure and overall mortality in patients with type-2 diabetes mellitus (DM). Sodium-glucose co-transporter 2 (SGLT-2) inhibitors reduce the incidence of heart failure and death in these patients. The aim of this study is to evaluate the effects of dapagliflozin on ambulatory central blood pressure (BP) levels and arterial stiffness parameters in patients with type-2 DM. Method This is a double-blind, randomized, placebo-controlled clinical trial including 85 adult patients with type-2 DM on monotherapy or combination therapy with two of: metformin, sulphonylurea, DDP-4 inhibitor, or insulin. Patients were randomized in a 1:1 ratio to oral dapagliflozin 10 mg per day or placebo for 12 weeks. Study participants underwent 24-h ambulatory BP monitoring with the Mobil-O-Graph NG monitor at baseline and study-end. Results Baseline demographic, clinical and laboratory parameters were similar in the two groups (age 61.74±6.73 vs 60.64±9.35; p=0.534). During follow-up, 24-hour central SBP/DBP significantly decreased in dapagliflozin (117.41±10.52/78.88±7.25 vs 113.30±8.75/77.25±6.54; p=0.002/p=0.047), but not in the placebo group. Corresponding reductions of 24-hour central SBP (-4.12±8.00 vs -0.65±7.77; p=0.046) were greater with dapagliflozin than placebo. Aortic pulse pressure (PP) decreased only in the dapagliflozin group (38.53±7.44 vs 36.05±6.59 mmHg; p=0.004). 24-hour heart-rate adjusted augmentation-index significantly decreased with dapagliflozin. Importantly, there was a significant difference in the change of 24-hour PWV (-0.16±0.32 vs 0.02±0.27; p=0.007) favoring dapagliflozin. Conclusion Treatment with dapagliflozin significantly reduces ambulatory central BP and PWV levels in type-2 diabetics. Improvement in these parameters may substantially contribute to the cardiovascular benefits of SGLT-2 inhibitors.


2021 ◽  
Vol 39 (Supplement 1) ◽  
pp. e25
Author(s):  
Eirini Papadopoulou ◽  
Charalampos Loutradis ◽  
Glyceria Tzatzagou ◽  
Kalliopi Kotsa ◽  
Ioanna Zografou ◽  
...  

2017 ◽  
Vol 38 (02) ◽  
pp. 72-72
Author(s):  
Bernhard Uehleke

Referiert Azimi P, Ghiasvand R, Feizi A et al. Effect of cinnamon, cardamom, saffron and ginger consumption on blood pressure and a marker of endothelial function in patients with type 2 diabetes mellitus: A randomized controlled clinical trial. Blood Press 2016; 25: 133–140


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