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Lr Gupta - One of the best experts on this subject based on the ideXlab platform.
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Simultaneous Spectrophotometric Estimation of Diacerein and Aceclofenac by Vierodt's Method and First Derivative Method
Asian Journal of Research in Chemistry, 2010Co-Authors: Sb Bhalerao, Tambe, Pareek, Rh Shinde, Lr GuptaAbstract:Two novel Spectrophotometric methods, simultaneous equation method (Vierodt's Method) and first derivative method were developed, validated and compared for the simultaneous estimation of Diacerein and aceclofenac in their combined tablet dosage form. In Vierodt's method, λ max of Diacerein and aceclofenac, 257.6 nm and 274.0 nm respectively were selected for estimation. In first derivative spectrophotometric method the zero crossing technique was applied for the estimation of Diacerein and aceclofenac in which 250.0 nm and 298.40 nm were selected respectively. The Diacerein and aceclofenac follow Beer-Lambert's law in the concentration ranges from 2.5 to 15μg/mL and 5.0 to 30μg/mL respectively. The correlation coefficient was found to be 0.9998 for Diacerein and 0.9998 for aceclofenac by Vierodt's method. By First Derivative method, correlation coefficient was found to be 0.9999 for Diacerein and 0.9985 for aceclofenac. Mean recoveries were found satisfactory. These procedures do not involve any separation step. Proposed methods were successfully applied for the simultaneous estimation of Diacerein and aceclofenac in the combined tablet dosage forms.
Fabiana Piovesan - One of the best experts on this subject based on the ideXlab platform.
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effect of Diacerein on metabolic control and inflammatory markers in patients with type 2 diabetes using antidiabetic agents a randomized controlled trial
Experimental Diabetes Research, 2018Co-Authors: Glaucia Sarturi Tres, Sandra C Fuchs, Fabiana Piovesan, Patricia Koehlersantos, Fernanda Dos Santos Pereira, Suzi Alves Camey, Hugo Roberto Kurtz Lisboa, Leila Beltrami MoreiraAbstract:Introduction. Studies have shown that T2DM is an inflammatory disease. Thus, the present study was aimed at evaluating whether Diacerein could improve the metabolic and inflammatory profile among patients with T2DM under long-term treatment with glucose-lowering agents. Methods. This is a double-blind, parallel, placebo-controlled trial with 72 participants randomly assigned to Diacerein 50 mg or placebo for 12 weeks. The primary endpoint was the between-group difference in change in HbA1c. Secondary endpoints included the proportion of patients achieving metabolic control [ (53 mmol/mol)] and change in inflammatory mediators. Results. Participants in the Diacerein group had greater reductions in mean HbA1c level in comparison to placebo (−0.98; 95% CI: −2.02 to 0.05, ), independently of confounding factors. The difference in HbA1c level was −1.3 (95% CI: −2.3 to −0.4) in favor of Diacerein ( ) in those with ) in those with longer duration. The Diacerein group had a 50% increase in the number of participants at the lowest TNF-α level (≤1.46 pg/mL). Conclusions. In patients with long-established T2DM under long-term treatment with glucose-lowering agents, Diacerein improves metabolic control as measured by HbA1c level and has a favorable impact on inflammatory profile. Clinical Trial Registry. This trial is registered with Brazilian Clinical Trials Registry (ReBEC) number RBR-29j956 .
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Effect of Diacerein on Metabolic Control and Inflammatory Markers in Patients with Type 2 Diabetes Using Antidiabetic Agents: A Randomized Controlled Trial
Hindawi Limited, 2018Co-Authors: Glaucia Sarturi Tres, Sandra C Fuchs, Fabiana Piovesan, Suzi Alves Camey, Patricia Koehler-santos, Fernanda Dos S. Pereira, Hugo K. Lisboa, Leila Beltrami MoreiraAbstract:Introduction. Studies have shown that T2DM is an inflammatory disease. Thus, the present study was aimed at evaluating whether Diacerein could improve the metabolic and inflammatory profile among patients with T2DM under long-term treatment with glucose-lowering agents. Methods. This is a double-blind, parallel, placebo-controlled trial with 72 participants randomly assigned to Diacerein 50 mg or placebo for 12 weeks. The primary endpoint was the between-group difference in change in HbA1c. Secondary endpoints included the proportion of patients achieving metabolic control [HbA1c≤7.0% (53 mmol/mol)] and change in inflammatory mediators. Results. Participants in the Diacerein group had greater reductions in mean HbA1c level in comparison to placebo (−0.98; 95% CI: −2.02 to 0.05, P=0.06), independently of confounding factors. The difference in HbA1c level was −1.3 (95% CI: −2.3 to −0.4) in favor of Diacerein (P=0.007) in those with
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effect of Diacerein on renal function and inflammatory cytokines in participants with type 2 diabetes mellitus and chronic kidney disease a randomized controlled trial
PLOS ONE, 2017Co-Authors: Glaucia Sarturi Tres, Fabiana Piovesan, Hugo Roberto Kurtz Lisboa, Leila Beltrami Moreira, Michael Everton Andrades, Sandra C FuchsAbstract:Diacerein seems to improve metabolic control and reduce inflammatory marker levels in individuals with type 2 diabetes mellitus (Type 2 DM), but for participants with chronic kidney disease (CKD) its effect is unknown. This study aimed to evaluate the effect of Diacerein vs. placebo on urinary albumin/creatinine ratio (ACR), glomerular filtration rate (GFR), and inflammatory cytokines in type 2 DM participants with CKD. Blood pressure (BP) and metabolic control were secondary outcomes. This randomized, placebo-controlled, parallel trial of adjuvant treatment of type 2 DM with Diacerein enrolled seventy-two participants with CKD, aged 30-80 years, with glycated hemoglobin levels from 53-97 mmol/mol (7.0-11.0%), receiving angiotensin-converting enzyme inhibitors or angiotensin receptor blockers and antidiabetic agents. Participants randomized to Diacerein or placebo were followed-up up to 90 days. Both groups had a marked reduction in ACR, but there was no effect on glomerular filtration rate. While the Diacerein group had reduced TNF-α levels at the 75th percentile with a borderline significance (P = 0.05), there were no changes in the IL levels at the 75th percentile. Diacerein prevented the increase in blood glucose to the level observed in the placebo group (P = 0.04), improving metabolic control by 74%, reducing 24-hour diastolic BP, nighttime systolic and diastolic BP compared to the placebo group. In conclusion, among patients with type 2 DM and CKD, Diacerein does not have an effect on ACR or GFR, but slows metabolic control deterioration and is associated with lower nighttime systolic and diastolic blood pressure. Trial registration Brazilian Clinical Trials Registry (Registro Brasileiro de Ensaios Clinicos; ReBeC) U1111-1156-0255.
Glaucia Sarturi Tres - One of the best experts on this subject based on the ideXlab platform.
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effect of Diacerein on metabolic control and inflammatory markers in patients with type 2 diabetes using antidiabetic agents a randomized controlled trial
Experimental Diabetes Research, 2018Co-Authors: Glaucia Sarturi Tres, Sandra C Fuchs, Fabiana Piovesan, Patricia Koehlersantos, Fernanda Dos Santos Pereira, Suzi Alves Camey, Hugo Roberto Kurtz Lisboa, Leila Beltrami MoreiraAbstract:Introduction. Studies have shown that T2DM is an inflammatory disease. Thus, the present study was aimed at evaluating whether Diacerein could improve the metabolic and inflammatory profile among patients with T2DM under long-term treatment with glucose-lowering agents. Methods. This is a double-blind, parallel, placebo-controlled trial with 72 participants randomly assigned to Diacerein 50 mg or placebo for 12 weeks. The primary endpoint was the between-group difference in change in HbA1c. Secondary endpoints included the proportion of patients achieving metabolic control [ (53 mmol/mol)] and change in inflammatory mediators. Results. Participants in the Diacerein group had greater reductions in mean HbA1c level in comparison to placebo (−0.98; 95% CI: −2.02 to 0.05, ), independently of confounding factors. The difference in HbA1c level was −1.3 (95% CI: −2.3 to −0.4) in favor of Diacerein ( ) in those with ) in those with longer duration. The Diacerein group had a 50% increase in the number of participants at the lowest TNF-α level (≤1.46 pg/mL). Conclusions. In patients with long-established T2DM under long-term treatment with glucose-lowering agents, Diacerein improves metabolic control as measured by HbA1c level and has a favorable impact on inflammatory profile. Clinical Trial Registry. This trial is registered with Brazilian Clinical Trials Registry (ReBEC) number RBR-29j956 .
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Effect of Diacerein on Metabolic Control and Inflammatory Markers in Patients with Type 2 Diabetes Using Antidiabetic Agents: A Randomized Controlled Trial
Hindawi Limited, 2018Co-Authors: Glaucia Sarturi Tres, Sandra C Fuchs, Fabiana Piovesan, Suzi Alves Camey, Patricia Koehler-santos, Fernanda Dos S. Pereira, Hugo K. Lisboa, Leila Beltrami MoreiraAbstract:Introduction. Studies have shown that T2DM is an inflammatory disease. Thus, the present study was aimed at evaluating whether Diacerein could improve the metabolic and inflammatory profile among patients with T2DM under long-term treatment with glucose-lowering agents. Methods. This is a double-blind, parallel, placebo-controlled trial with 72 participants randomly assigned to Diacerein 50 mg or placebo for 12 weeks. The primary endpoint was the between-group difference in change in HbA1c. Secondary endpoints included the proportion of patients achieving metabolic control [HbA1c≤7.0% (53 mmol/mol)] and change in inflammatory mediators. Results. Participants in the Diacerein group had greater reductions in mean HbA1c level in comparison to placebo (−0.98; 95% CI: −2.02 to 0.05, P=0.06), independently of confounding factors. The difference in HbA1c level was −1.3 (95% CI: −2.3 to −0.4) in favor of Diacerein (P=0.007) in those with
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effect of Diacerein on renal function and inflammatory cytokines in participants with type 2 diabetes mellitus and chronic kidney disease a randomized controlled trial
PLOS ONE, 2017Co-Authors: Glaucia Sarturi Tres, Fabiana Piovesan, Hugo Roberto Kurtz Lisboa, Leila Beltrami Moreira, Michael Everton Andrades, Sandra C FuchsAbstract:Diacerein seems to improve metabolic control and reduce inflammatory marker levels in individuals with type 2 diabetes mellitus (Type 2 DM), but for participants with chronic kidney disease (CKD) its effect is unknown. This study aimed to evaluate the effect of Diacerein vs. placebo on urinary albumin/creatinine ratio (ACR), glomerular filtration rate (GFR), and inflammatory cytokines in type 2 DM participants with CKD. Blood pressure (BP) and metabolic control were secondary outcomes. This randomized, placebo-controlled, parallel trial of adjuvant treatment of type 2 DM with Diacerein enrolled seventy-two participants with CKD, aged 30-80 years, with glycated hemoglobin levels from 53-97 mmol/mol (7.0-11.0%), receiving angiotensin-converting enzyme inhibitors or angiotensin receptor blockers and antidiabetic agents. Participants randomized to Diacerein or placebo were followed-up up to 90 days. Both groups had a marked reduction in ACR, but there was no effect on glomerular filtration rate. While the Diacerein group had reduced TNF-α levels at the 75th percentile with a borderline significance (P = 0.05), there were no changes in the IL levels at the 75th percentile. Diacerein prevented the increase in blood glucose to the level observed in the placebo group (P = 0.04), improving metabolic control by 74%, reducing 24-hour diastolic BP, nighttime systolic and diastolic BP compared to the placebo group. In conclusion, among patients with type 2 DM and CKD, Diacerein does not have an effect on ACR or GFR, but slows metabolic control deterioration and is associated with lower nighttime systolic and diastolic blood pressure. Trial registration Brazilian Clinical Trials Registry (Registro Brasileiro de Ensaios Clinicos; ReBeC) U1111-1156-0255.
Sb Bhalerao - One of the best experts on this subject based on the ideXlab platform.
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Simultaneous Spectrophotometric Estimation of Diacerein and Aceclofenac by Vierodt's Method and First Derivative Method
Asian Journal of Research in Chemistry, 2010Co-Authors: Sb Bhalerao, Tambe, Pareek, Rh Shinde, Lr GuptaAbstract:Two novel Spectrophotometric methods, simultaneous equation method (Vierodt's Method) and first derivative method were developed, validated and compared for the simultaneous estimation of Diacerein and aceclofenac in their combined tablet dosage form. In Vierodt's method, λ max of Diacerein and aceclofenac, 257.6 nm and 274.0 nm respectively were selected for estimation. In first derivative spectrophotometric method the zero crossing technique was applied for the estimation of Diacerein and aceclofenac in which 250.0 nm and 298.40 nm were selected respectively. The Diacerein and aceclofenac follow Beer-Lambert's law in the concentration ranges from 2.5 to 15μg/mL and 5.0 to 30μg/mL respectively. The correlation coefficient was found to be 0.9998 for Diacerein and 0.9998 for aceclofenac by Vierodt's method. By First Derivative method, correlation coefficient was found to be 0.9999 for Diacerein and 0.9985 for aceclofenac. Mean recoveries were found satisfactory. These procedures do not involve any separation step. Proposed methods were successfully applied for the simultaneous estimation of Diacerein and aceclofenac in the combined tablet dosage forms.
Martin Wolkersdorfer - One of the best experts on this subject based on the ideXlab platform.
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Basal pharmacokinetic parameters of topically applied Diacerein in pediatric patients with generalized severe epidermolysis bullosa simplex.
Orphanet journal of rare diseases, 2018Co-Authors: Michael Ablinger, Florian B. Lagler, Martin Wolkersdorfer, Peter Hofbauer, Thomas K. Felder, Anja Diem, M. Wimmer, R. Zauner, Thomas Lettner, Johann W. BauerAbstract:Generalized severe epidermolysis bullosa simplex (EBS-gen sev) is caused by mutations within either the KRT5 or KRT14 gene, phenotypically resulting in blistering and wounding of the skin and mucous membranes after minor mechanical friction. In a clinical phase 2/3 trial, Diacerein has recently been shown to significantly reduce blister numbers upon topical application. In this study we addressed basic pharmacokinetic parameters of locally applied Diacerein in vitro and in vivo. Ex vivo experiments using a Franz diffusion cell confirmed the uptake and bio-transformation of Diacerein to rhein in a porcine skin model. Rhein, the active metabolite of Diacerein, was also detected in both urine and serum samples of two EBS-gen sev patients who topically applied a 1% Diacerein ointment over a period of 4 weeks. The accumulated systemic levels of rhein in EBS-gen sev patients were lower than reported levels after oral application. These preliminary findings point towards the uptake and prolonged persistance of Diacerein / rhein within the intended target organ - the skin. Further, they imply an acceptable safety profile at the systemic level. DRKS. DRKS00005412 . Registered 6 November 2013.
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Diacerein orphan drug development for epidermolysis bullosa simplex a phase 2 3 randomized placebo controlled double blind clinical trial
Journal of The American Academy of Dermatology, 2018Co-Authors: Verena Wally, Peter Hofbauer, Thomas K. Felder, Michael Ablinger, Thomas Lettner, Alain Hovnanian, Hana Buckova, Victoria Brunner, Martin WolkersdorferAbstract:Background Epidermolysis bullosa simplex (EBS) is a rare genetic, blistering skin disease for which there is no cure. Treatments that address the pathophysiology of EBS are needed. Objective Compare the impact of 1% Diacerein cream with placebo in reducing the number of blisters in EBS. Methods In a randomized, placebo-controlled, phase 2/3 trial we used a 1% Diacerein topical formulation to treat defined skin areas in 17 patients. In a 2-period crossover trial, patients were randomized to either placebo or Diacerein for a 4-week treatment and a 3-month follow-up in period 1. After a washout, patients were crossed over during period 2. The prespecified primary end point was the proportion of patients with a reduction of number of blisters by more than 40% from baseline in selected areas over the treatment episode. Results Of the patients receiving Diacerein, 86% in episode 1 and 37.5% in episode 2 met the primary end point (vs 14% and 17% with placebo, respectively). This effect was still significant after the follow-up. Changes in absolute blister numbers were significant for the Diacerein group only. No adverse effects were observed. Limitations Low patient numbers and no invasive data acquisition because of clinical burden in children. Conclusion This trial provides evidence of the impact of 1% Diacerein cream in the treatment of EBS.
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Basal pharmacokinetic parameters of topically applied Diacerein in pediatric patients with generalized severe epidermolysis bullosa simplex
BMC, 2018Co-Authors: Michael Ablinger, Florian B. Lagler, Martin Wolkersdorfer, Peter Hofbauer, Thomas K. Felder, Anja Diem, M. Wimmer, R. Zauner, Thomas Lettner, Johann W. BauerAbstract:Abstract Generalized severe epidermolysis bullosa simplex (EBS-gen sev) is caused by mutations within either the KRT5 or KRT14 gene, phenotypically resulting in blistering and wounding of the skin and mucous membranes after minor mechanical friction. In a clinical phase 2/3 trial, Diacerein has recently been shown to significantly reduce blister numbers upon topical application. In this study we addressed basic pharmacokinetic parameters of locally applied Diacerein in vitro and in vivo. Ex vivo experiments using a Franz diffusion cell confirmed the uptake and bio-transformation of Diacerein to rhein in a porcine skin model. Rhein, the active metabolite of Diacerein, was also detected in both urine and serum samples of two EBS-gen sev patients who topically applied a 1% Diacerein ointment over a period of 4 weeks. The accumulated systemic levels of rhein in EBS-gen sev patients were lower than reported levels after oral application. These preliminary findings point towards the uptake and prolonged persistance of Diacerein / rhein within the intended target organ - the skin. Further, they imply an acceptable safety profile at the systemic level. Trial registration DRKS. DRKS00005412. Registered 6 November 2013
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Topical Diacerein for epidermolysis bullosa: a randomized controlled pilot study.
Orphanet journal of rare diseases, 2013Co-Authors: Verena Wally, Sophie Kitzmueller, Florian B. Lagler, Angelika Moder, Wolfgang Hitzl, Martin Wolkersdorfer, Peter Hofbauer, Thomas K. Felder, Michael Dornauer, Anja DiemAbstract:Blistering in epidermolysis bullosa simplex type Dowling-Meara (EBS-DM) is associated with an inflammatory phenotype, which can be disrupted by Diacerein in vitro. In this pilot study we hypothesized, that a topical formulation of Diacerein 1% reduces blistering. Five patients initially applied Diacerein underneath both armpits. Then, each participant received 1% Diacerein-cream for one armpit, and placebo for the other (randomized withdrawal). The number of blisters was reduced significantly (left: -78%; right: -66% of baseline) within two weeks and remained significantly below the initial level even during withdrawal in four patients. These findings point to a relevant effect of Diacerein and provide important information for a confirmative study.