scholarly journals Effects of treatment with SGLT-2 inhibitors on arginine-related cardiovascular and renal biomarkers

2022 ◽  
Vol 21 (1) ◽  
Author(s):  
Arne Gessner ◽  
Anna Gemeinhardt ◽  
Agnes Bosch ◽  
Dennis Kannenkeril ◽  
Christian Staerk ◽  
...  
Keyword(s):  
Renal Clearance ◽  
Risk Markers ◽  
Therapeutic Approaches ◽  
Symmetric Dimethylarginine ◽  
Double Blind ◽  
New Therapeutic Approaches ◽  
Sodium Glucose Cotransporter ◽  
Related Risk ◽  
Before And After

Abstract Background In patients with type 2 diabetes (T2D) sodium-glucose cotransporter 2 (SGLT-2) inhibitors improve glycaemic control as well as cardiovascular and renal outcomes. Their effects on l-arginine (Arg) related risk markers asymmetric and symmetric dimethylarginine (ADMA and SDMA) and the protective biomarker L-homoarginine (hArg) linking T2D to cardiovascular and renal disease have not yet been reported. Methods Plasma and 24-h urine samples taken before and after 6 weeks of treatment were available from two prospective, randomized, double-blind, placebo-controlled, cross-over trials with empagliflozin (71 patients analyzed, NCT02471963) and dapagliflozin (59 patients analyzed, NCT02383238). In these samples, concentrations of hArg, Arg, ADMA, SDMA, and creatinine were determined by liquid-chromatography coupled to tandem mass-spectrometry. Additionally, intraindividual changes of the biomarkers in plasma were correlated with intraindividual changes of clinical parameters. Results Treatment with empagliflozin and dapagliflozin was associated with a reduction of plasma hArg by 17.5% and 13.7% (both p < 0.001), respectively, and increase in plasma SDMA concentration of 6.7% and 3.6%, respectively (p < 0.001 and p < 0.05), while plasma Arg and ADMA concentrations were not significantly altered. 24-h urinary excretion of ADMA was reduced by 15.2% after treatment with empagliflozin (p < 0.001) but not after dapagliflozin treatment, while excretion of the other markers was not significantly altered. Renal clearance of SDMA was reduced by 9.1% and 3.9% for both drugs (both p < 0.05). A reduction in ADMA clearance was observable after empagliflozin treatment only (− 15.5%, p < 0.001), but not after dapagliflozin. Renal clearance of hArg and Arg was not significantly altered. Treatment effects on l-arginine related biomarkers were not constantly correlated with effects on glycated hemoglobin, fasting plasma glucose, body mass index, and systolic blood pressure. Conclusions Treatment with SGLT-2 inhibitors has divergent effects on Arg-related biomarkers and could affect risk estimates associated with these markers. The observed effects are unlikely to explain the known cardiovascular and renal benefits of treatment with empagliflozin or dapagliflozin but still may indicate new therapeutic approaches in patients treated with SGLT-2 inhibitors. Trial registrationhttp://www.clinicaltrials.gov: NCT02471963 (registered 15th June 2015, retrospectively registered) and NCT02383238.

SYMPHYTUM OFFICINALE IN THE TREATMENT OF PLANTAR KERATOSIS IN DIABETIC PATIENTS: DOUBLE BLIND RANDOMIZED CLINICAL TRIAL

2021 ◽  
pp. 62-64
Author(s):  
Beatriz Bertolaccini Martínez ◽  
Elisa Coutinho Moura
Keyword(s):  
Clinical Trial ◽  
Salicylic Acid ◽  
Statistical Analysis ◽  
Diabetic Patients ◽  
Type 2 Diabetic Patients ◽  
Double Blind ◽  
Double Blind Clinical Trial ◽  
Before And After ◽  
Type 2 Diabetic

PURPOSE: To compare the efcacy between SO and salicylic acid SA in the treatment of plantar keratosis of diabetic patients. METHODS: Randomized, double-blind clinical trial, with 47 type 2 diabetic patients, both sexes and with plantar keratosis. Patients were randomized into 2 groups: G1 (n = 48; treated with 15% SO extract) and G2 (n = 46; treated with 10% AS). The feet were photographed before (D0) and after the treatment (D30) and keratosis areas were measured using the Image J software. For each patient, a lesion in each foot was analyzed. The results were expressed by median. In the statistical analysis, the Wilcoxin test was used to compare the lesion areas before and after treatments and the Mann-Whitney test was used to compare the regression of the lesion areas between the two groups. P <0.05 was adopted. RESULTS: G1 (D0 = 2 8.156 vs D30 = 2.226; p <0.0001) and G2 (D0 = 4.835 vs D30 = 2.059; p <0.0001) showed a difference between the areas (cm ) of the keratosis, 2 before and after the treatment. There was a difference in the regression of the areas (cm ) of keratosis, between G1 and G2, respectively (4.540 vs 1.171, p <0.0001). CONCLUSION: Symphytum ofcinale proved to be more effective than Salicylic Acid in the treatment of plantar keratosis in diabetic patients.

scholarly journals Effects of canagliflozin on serum potassium in the CANagliflozin cardioVascular Assessment Study (CANVAS) Program

2020 ◽  
Author(s):  
Matthew R Weir ◽  
April Slee ◽  
Tao Sun ◽  
Dainius Balis ◽  
Richard Oh ◽  
...  
Keyword(s):  
Adverse Events ◽  
Serum Potassium ◽  
Filtration Rate ◽  
Estimated Glomerular Filtration Rate ◽  
High Serum ◽  
Double Blind ◽  
Assessment Study ◽  
Sodium Glucose Cotransporter ◽  
Cardiovascular Assessment

Abstract Background The sodium-glucose cotransporter 2 inhibitor canagliflozin has been shown to reduce the risk of cardiovascular and renal events in patients with Type 2 diabetes mellitus and high risk. Pooled analyses of data from early studies and interim data from the CANagliflozin cardioVascular Assessment Study (CANVAS) suggested that canagliflozin might lead to increases in serum potassium, particularly the 300 mg dose in patients with renal impairment, which is important because high serum potassium is associated with increased cardiovascular and renal risk. We examined the effect of canagliflozin on serum potassium levels and hyperkalemia rates in the completed CANVAS Program. Methods The CANVAS Program (n = 10,142) was comprised of two comparable double-blind, randomized, placebo-controlled trials (CANVAS and CANVAS-Renal). Participants received canagliflozin 100 or 300 mg or placebo. Serum potassium measurements were performed in a central laboratory0 and assessed at ∼6-month intervals. Results In the CANVAS Program, mean potassium levels were generally consistent with canagliflozin and placebo, overall and by baseline estimated glomerular filtration rate (eGFR; ≥60, 45 to&lt;60 and &lt;45 mL/min/1.73 m2). The risk of increased or decreased potassium was similar with canagliflozin and placebo overall and by baseline eGFR (all P-heterogeneity ≥0.56) or use of renin–angiotensin–aldosterone system inhibitors (all P-heterogeneity ≥0.71); levels did not appear different by canagliflozin dose. Hyperkalemia {hazard ratio (HR) [95% confidence interval (CI)] 1.60 (0.92–2.81)} and serious hyperkalemia [HR (95% CI) 0.75 (0.27–2.11)] adverse events were not different across groups. Conclusions In the CANVAS Program, there were no meaningful effects of canagliflozin on serum potassium in the overall population or key subgroups. Hyperkalemia adverse events were uncommon and occurred at comparable rates with canagliflozin and placebo.

scholarly journals Efficacy of clindamycin compared with amoxicillin-metronidazole after a 7-day regimen in the treatment of periodontitis in patients with diabetes: a randomized clinical trial

2020 ◽  
Vol 8 (1) ◽  
pp. e000665
Author(s):  
Juan Ramón Gómez-Sandoval ◽  
José Antonio Robles-Cervantes ◽  
Sandra Ofelia Hernández-González ◽  
María Claudia Espinel-Bermudez ◽  
Rocío Mariaud-Schmidt ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Plaque Index ◽  
Double Blind ◽  
Bleeding On Probing ◽  
Probing Depth ◽  
Before And After ◽  
Patients With Diabetes

ObjectiveTo determine the efficacy of clindamycin compared with amoxicillin-metronidazole after a 7-day regimen during nonsurgical treatment of periodontitis in patients with type 2 diabetes mellitus.Research design and methodsIn this double-blind, randomized clinical trial, a total of 42 patients with chronic periodontitis and type 2 diabetes were included. Patients were randomly assigned to treatment with either clindamycin or amoxicillin-metronidazole three times a day during 7 days. Clinical determinations (probing depth, bleeding on probe, and plaque index) were performed to determine the extent and severity of periodontitis before and after the pharmacological treatment.ResultsAfter 7 days of administration of clindamycin or amoxicillin-metronidazole, no differences were observed between the clinical determinations, probing depth (0.44 vs 0.50 mm, p=0.624), plaque index (17.62 vs 15.88%, p=0.910), and bleeding on probing (16.12 vs 22.17%, p=0.163), respectively. There were no adverse events in either group.ConclusionThe administration during 7 days of clindamycin or amoxicillin/metronidazole showed the same efficacy for the reduction of probing depth, plaque index, and bleeding on probing in patients with periodontitis and type 2 diabetes.

scholarly journals The effect of liraglutide on endothelial function in patients with type 2 diabetes

2014 ◽  
Vol 11 (6) ◽  
pp. 419-430 ◽  
Author(s):  
Debashis Nandy ◽  
Christopher Johnson ◽  
Rita Basu ◽  
Michael Joyner ◽  
Jason Brett ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Endothelial Function ◽  
Controlled Trial ◽  
Venous Occlusion ◽  
Double Blind ◽  
Postprandial Period ◽  
Treatment Difference ◽  
Before And After ◽  
Glucagon Like Peptide 1

This single-centre, 12-week, double-blind, placebo-controlled trial assessed how the human glucagon-like-peptide 1 analogue liraglutide impacted endothelial function in adult patients (n = 49) with type 2 diabetes and no overt cardiovascular disease. Patients were randomized to liraglutide, placebo or glimepiride. At baseline and Week 12, venous occlusion plethysmography was used to measure forearm blood flow (FBF) in response to acetylcholine (ACh) and sodium nitroprusside (SNP) before and after l-NG-monomethyl arginine (L-NMMA) infusion. At Week 12, ACh-mediated FBF increased with liraglutide and decreased with placebo; however, the between-treatment difference was not significant ( p = 0.055). Inhibition of ACh-mediated FBF after L-NMMA infusion increased with liraglutide and decreased with placebo; this between-treatment difference was also not significant ( p = 0.149). No change in FBF was observed with SNP. Liraglutide did not significantly impact endothelium-dependent vasodilation after 12 weeks; however, additional investigations looking at the effect of liraglutide on endothelial function in alternative vasculature and during the postprandial period are warranted.

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