Calcium dobesilate may improve hemorheology in patients undergoing coronary artery bypass grafting

Beşirli, Kazım; Aydemir, Birsen; Arslan, Caner; Kiziler, Ali Rıza; Cantürk, Emir; Kayhan, Bekir

doi:10.5935/1678-9741.20120057

Cited by 2 publications

(3 citation statements)

References 22 publications

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“…No other medicines were taken within 14 days before the trial. Any of the following conditions precluded subjects from participating: (1) physicians determined that some subjects did not meet the requirements for the physical examination; (2) individuals who were pregnant, nursing, or had a positive blood pregnancy test before the study's commencement; (3) a history of acute gastrointestinal disease or were currently experiencing such episodes or had chronic gastritis; (4) donated blood within the past 30 days; (5) a history and/or existing psychological renal, nervous, respiratory, hematological, cardiovascular, hepatic, or gastrointestinal disease; (6) allergy to any component of the test or reference drugs; (7) excessive cigarette use (more than 5 cigarettes each day), history of alcohol or drug abuse within the 3 months leading to the study or currently involved in such activities; (8) consumption of cytochrome P450 3A4/5-affecting medications and foods over the previous 30 days; or (9) involvement in another research experiment 3 months prior to this research.…”

Section: Subjectsmentioning

confidence: 99%

“…4 The ability of calcium dobesilate to lessen oxidative stress by reducing the stimulation of the nuclear factor kappa-light-chain enhancer of activated B cells and p38 mitogen-activated protein kinase pathways has led to its long-standing use in the treatment of DR. 1,5 Recently, researchers have paid great interest to calcium dobesilate's efficacy in kidney illness, 6 thrombotic disorders, 7 chronic venous insufficiency, 8 and various types of cardiac disease. 9 Calcium dobesilate has a significant impact on diabetic kidney disease by reducing the rate of urine albumin excretion 10 has undergone significant research in clinical studies. 11 Considering the small sample numbers and inconsistent results of the currently published randomized controlled trials on calcium dobesilate, it is difficult to draw definitive conclusions about the benefits and possible adverse effects.…”

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confidence: 99%

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Pharmacokinetics, Bioequivalence, and Safety Evaluation of Two Oral Formulations of Calcium Dobesilate Capsules in Healthy Chinese Volunteers Under Fasting and Fed Conditions

Wang,

Liu,

Tang

et al. 2024

Clinical Pharm in Drug Dev

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To determine the pharmacokinetics (PK), safety, and bioequivalence profiles of 0.5‐g calcium dobesilate capsules in both fasting and fed states for the test drug and reference drug. A randomized‐sequence, single‐dose, open‐label, 2‐period crossover study was conducted in fasted and fed healthy Chinese volunteers (Chinese Clinical Trials Registry identifier: CTR202000268‐01). The fasting and fed studies, both involving 24 subjects, were conducted. A single dosage of either the reference or the test preparation was given to each eligible subject in a 1:1 ratio, followed by a 7‐day rest interval before the administration of the alternative formulation. After taking the capsules, plasma samples were taken for 48 hours, and using liquid chromatography‐tandem mass spectrometry, the calcium dobesilate level was determined. The PK parameters evaluated in the study included the maximum serum concentration (Cmax), area under the plasma concentration‐time curve (AUC) from time 0 to the last quantifiable concentration, AUC from time 0 to infinity, half‐life, time to Cmax, and terminal elimination rate constant. In addition, the safety evaluation encompassed monitoring fluctuations in vitals (temperature, pulse, and blood pressure) and laboratory tests (urinalysis, hepatic function, blood biochemistry, and hematology), as well as recording the emergence of adverse events (AEs). The geometric mean ratio (GMR) of the test/reference medications was used to assess bioequivalence by determining if the 90% confidence intervals of the GMR fell within the predefined range of 80%‐125%. AEs were assessed as safety end points. The study included 48 healthy Chinese volunteers (with n = 24 each for the fasting and the fed conditions), and no subjects dropped out for any reason. The differences in the PK metrics for the test and reference drugs for both conditions were insignificant (P > .05). For bioequivalence, irrespective of whether the food was consumed or not, the range of the 90% confidence intervals of the GMR for Cmax, AUC from time 0 to the last quantifiable concentration, and AUC from time 0 to infinity was between 80% and 125%. In the experiment, no serious AEs were recorded. Our findings revealed that the calcium dobesilate capsules used as the reference and the test drugs were both bioequivalent. Irrespective of whether the healthy Chinese volunteers consumed food or not, the PK and safety profiles were comparable.

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Section: Subjectsmentioning

confidence: 99%

mentioning

confidence: 99%

Pharmacokinetics, Bioequivalence, and Safety Evaluation of Two Oral Formulations of Calcium Dobesilate Capsules in Healthy Chinese Volunteers Under Fasting and Fed Conditions

Wang,

Liu,

Tang

et al. 2024

Clinical Pharm in Drug Dev

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“…CaD has long been utilized to treat diabetic retinopathy (DR) due to its potential to reduce oxidative stress by decreasing the activation of the p38MAPK and NF-B pathways ( Liu et al, 2019 ; Ashraf et al, 2021 ). CaD’s efficacy in kidney illness ( Zhang et al, 2021 ), chronic venous insufficiency ( Ciapponi et al, 2004 ), thrombotic disorders ( Michal and Giessinger, 1985 ), and various types of cardiac disease ( Besirli et al, 2012 ) has received great attention recently. CaD considerably affects DKD in lowering the urine albumin excretion rate ( Qin et al, 2017 ) and has been studied extensively in clinical trials ( Zhou et al, 2018 ).…”

Section: Introductionmentioning

confidence: 99%

Calcium dobesilate efficiency in the treatment of diabetic kidney disease through suppressing MAPK and chemokine signaling pathways based on clinical evaluation and network pharmacology

Yin

Wang

et al. 2022

Front. Pharmacol.

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Aims: To evaluate the effectiveness and potential mechanism of calcium dobesilate (CaD) in diabetic kidney disease (DKD) patients.Methods: We searched for available randomized controlled studies on DKD patients’ treatment with CaD through open databases. Continuous variables were expressed as standardized mean difference (SMD) with a 95% confidence interval (CI). The putative targets and possible pathways of CaD on DKD were analyzed by network pharmacology. Molecular docking was employed to verify the match between CaD and the target genes.Results: In the meta-analysis, 42 trials were included, involving 3,671 DKD patients, of which 1,839 received CaD treatment in addition to conventional treatment, while 1,832 received conventional treatment. Compared with routine therapy, the levels of serum creatinine (Scr) and blood urea nitrogen (BUN) significantly decreased in the CaD treatment (early stage of DKD, Scr: p < 0.00001; BUN: p < 0.0001; clinical stage of DKD, Scr: p < 0.00001; BUN: p < 0.00001; kidney failure stage, Scr: p = 0.001; BUN: p = 0.004). The levels of serum cystatin C (Cys-C), urine levels of molecules reflecting kidney function (urinary albumin excretion rate (UAER) and micro glycoprotein), and inflammatory factors [hypersensitive c-reactive protein (hs-CRP)] were reduced compared with control groups, while glomerular filtration rate (GFR) was increased in patients treated with CaD for 12 weeks. CaD also showed a better effect on improving endothelial function. Network pharmacology results showed that the interaction pathway between CaD and DKD was mainly enriched in MAPK and chemokine signaling pathways. AKT1, CASP3, IGF1, MAPK8, and CCL5 might be the key targets for CaD in treating DKD.Conclusion: Combination with CaD is effective and safe in patients with DKD. Inhibition of MAPK and chemokine signaling pathways might be vital in treating CaD in DKD patients.

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Calcium dobesilate may improve hemorheology in patients undergoing coronary artery bypass grafting

Cited by 2 publications

References 22 publications

Pharmacokinetics, Bioequivalence, and Safety Evaluation of Two Oral Formulations of Calcium Dobesilate Capsules in Healthy Chinese Volunteers Under Fasting and Fed Conditions

Pharmacokinetics, Bioequivalence, and Safety Evaluation of Two Oral Formulations of Calcium Dobesilate Capsules in Healthy Chinese Volunteers Under Fasting and Fed Conditions

Calcium dobesilate efficiency in the treatment of diabetic kidney disease through suppressing MAPK and chemokine signaling pathways based on clinical evaluation and network pharmacology

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