calcium dobesilate monohydrate / Generic mfg. - LARVOL DELTA

Minimizing serum creatinine interference in automated laboratory analyses through the implementation of urea/creatinine ratio alerting mechanisms. (PubMed, Clin Chim Acta) - "The implementation of an automated UCR-based screening protocol has been shown to efficiently pinpoint samples with drug-related interference. This strategic approach not only decreases clinical risk but also guarantees the fidelity of serum Cr measurements without undermining the overall productivity of the laboratory's automated workflow."

Journal

Fasting/postprandial, single oral, randomized, open, two-formulation, two-cycle, cross-over bioequivalence study of calcium dobesilate capsules in healthy subjects (ChiCTR) - P=N/A | N=52 | Completed | Sponsor: Affiliated Hospital of Traditional Chinese Medicine of Southwest Medical University; Affiliated Hospital of Traditional Chinese Medicine of Southwest

New trial • Cardiovascular

Efficacy of Calcium Dobesilate Versus Tranexamic Acid for Treating Heavy Menstrual Bleeding (clinicaltrials.gov) - P=N/A | N=100 | Not yet recruiting | Sponsor: University of Health Sciences Lahore

New trial • Gynecology • Women's Health

TXA: Effect of Tranexamic Acid and Calcium Dobesilate for Bleeding of Endometrial Origin (clinicaltrials.gov) - P2/3 | N=100 | Completed | Sponsor: District Headquarters Teaching Hospital Sahiwal

New P2/3 trial • Agranulocytosis • Granulocytopenia • Immunology

Discovery of a potent, Kv7.3-selective potassium channel opener from a Polynesian traditional botanical anticonvulsant. (PubMed, Commun Chem) - "GA is, uniquely to our knowledge, 100% selective for Kv7.3 versus other Kv7 homomers; it requires S5 residue Kv7.3-W265 for Kv7.2/3 activation, and it ameliorates pentylenetetrazole-induced seizures in mice. Structure-activity studies revealed that the FDA-approved vasoprotective drug calcium dobesilate, a GA analog, is a previously unrecognized Kv7.2/3 channel opener. Also an active aspirin metabolite, GA provides a molecular rationale for the use of T. populnea as an anticonvulsant in Polynesian indigenous medicine and presents novel pharmacological prospects for potent, isoform-selective, therapeutic Kv7 channel activation."

Journal • CNS Disorders • Epilepsy

Which dose of calcium dobesilate is more effective and safe in chronic venous insufficiency? Multicenter retrospective clinical trial. (PubMed, Phlebology) - "Higher doses of calcium dobesilate markedly enhance the management of CVI symptoms and reduce edema more effectively than lower doses, particularly in patients with advanced CVI. These findings support the use of higher dosages for optimal treatment, though further research is needed to fully evaluate long-term safety."

Journal • Retrospective data • Cardiovascular

Correction of negative-interference from calcium dobesilate in the Roche sarcosine oxidase creatinine assay using CuO. (PubMed, Clin Chem Lab Med) - No abstract available

Journal

Effect of HMP on Diabetic Microangiopaemia in T2DM (clinicaltrials.gov) - P4 | N=40 | Completed | Sponsor: Affiliated Hospital of Nantong University | Recruiting ➔ Completed | N=60 ➔ 40

Enrollment change • Trial completion • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus • CRP • CST3 • FABP4 • TNFA • VEGFA

Effect of HMP on Diabetic Microangiopaemia in T2DM (clinicaltrials.gov) - P4 | N=60 | Recruiting | Sponsor: Affiliated Hospital of Nantong University | Trial completion date: Nov 2023 ➔ May 2024 | Trial primary completion date: Nov 2023 ➔ May 2024

Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus • CRP • CST3 • FABP4 • TNFA • VEGFA

Study protocol for assessment of the efficacy of calcium dobesilate versus placebo on SARS-CoV-2 viral load in outpatients with COVID-19 (CADOVID study): a randomised, placebo-controlled, double-blind, monocentric phase II trial. (PubMed, BMJ Open) - P2 | "Dissemination of results will be through presentations at scientific conferences and publication in scientific journals. NCT05305508; Clinicaltrials.gov; Swiss National Clinical Portal Registry (SNCTP 000004938)."

Clinical • Clinical protocol • Journal • P2 data • P2 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Assessment of the Tolerance of Dobenox Forte® in Patients with Chronic Venous Disease. (PubMed, Life (Basel)) - "This prospective, observational, multicenter study assessed the tolerance of Dobenox Forte®, the first approved over-the-counter product containing calcium dobesilate, in 1795 outpatients with chronic venous disease (CVD) in daily clinical practice...The percentages of patients reporting moderate to very severe lower limb heaviness decreased from 96.6% to 56.0%, calf cramps decreased from 91.0% to 41.0%, calf pain decreased from 89.2% to 43.7%, swelling decreased from 86.1% to 38.8%, and burning sensation that worsens when standing decreased from 79.0% to 33.7%. The medicinal product Dobenox Forte® is well tolerated by patients and seems to effectively reduce the symptoms of CVD."

Clinical • Journal • Pain

CADOVID: Assessment of the Efficacy of Calcium Dobesilate vs. Placebo on SARS-CoV-2 Viral Load Amongst Outpatients With COVID-19. (clinicaltrials.gov) - P2 | N=74 | Completed | Sponsor: Hervé SPECHBACH | Not yet recruiting ➔ Completed | Trial completion date: Mar 2023 ➔ Feb 2024 | Trial primary completion date: Jan 2023 ➔ Nov 2023

Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

The effectiveness and safety of Chinese patent medicines plus calcium dobesilate for the treatment of diabetic retinopathy: A network meta-analysis. (PubMed, Heliyon) - "As for safety profile that CPMs plus CD did not increase the incidence of adverse events. The results of this study might support DS as a relatively prior adjuvant therapy option for patients with DR."

Journal • Retrospective data • Diabetic Retinopathy • Retinal Disorders

Pharmacokinetics, Bioequivalence, and Safety Evaluation of Two Oral Formulations of Calcium Dobesilate Capsules in Healthy Chinese Volunteers Under Fasting and Fed Conditions. (PubMed, Clin Pharmacol Drug Dev) - "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."

Journal • PK/PD data • Hematological Disorders

Calcium Dobesilate Ameliorates Cisplatin-induced Hepatotoxicity by Inhibiting Liver Oxidative Stress in Mice. (PubMed, Iran J Pharm Res) - "Moreover, CD (100 mg/kg) elevated the SOD and GPx activity in the liver tissue of cisplatin-treated mice. The findings showed that CD has a protective effect against cisplatin-induced hepatotoxicity, at least by improving the antioxidant parameters."

Journal • Preclinical • Hepatology • Oncology • ICAM3

The effect of calcium dobesilate combined with hypoglycemic drugs in the treatment of cataract NPDR and its effect on fundus microcirculation and blood ICAM-1, MCP-1 and MIF levels. (PubMed, J Med Biochem) - "ICAM-1, MCP-1, MIF, vascular endothelial growth factor (VEGF) and insulin-like growth factor-1 (IGF1) in the observation after treatment were reduced vs. the control, but pigment epithelium-derived factor (PEDF) were higher vs. the control (P 0.05). Calcium dobesilate combined with hypoglycemic drugs has good clinical efficacy in the treatment of cataract complicated with NPDR, which can effectively reduce the level of blood glucose and blood lipids, reduce inflammation, and mitigate the microcirculation of branch retinal vein occlusion lesions."

Journal • Age-related Macular Degeneration • Cataract • Diabetic Retinopathy • Dyslipidemia • Gastrointestinal Disorder • Hematological Disorders • Inflammation • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion • ICAM1 • IGF1 • MIF

Calcium dobesilate-induced hyperpyrexia: A case report. (PubMed, Medicine (Baltimore)) - "Moreover, misdiagnosis and mistreatment of this condition can deteriorate the patient's condition. Herein, we report a case of calcium dobesilate-induced hyperpyrexia that occurred during the treatment of chronic renal insufficiency. Subsequently, a systematic analysis of the patient's diagnosis and treatment was reviewed. If unexplained high fever develops during the use of calcium dobesilate, calcium dobesilate-induced hyperpyrexia should be considered. Accordingly, calcium dobesilate should be discontinued."

Journal • Chronic Kidney Disease • Infectious Disease • Nephrology • Renal Disease

Calcium dobesilate prevents PLD-induced hand-foot syndrome by alleviating capillary endothelial tight junction injury via the HA/CD44 pathway. (PubMed, Am J Cancer Res) - "Pegylated liposomal doxorubicin (PLD) has excellent therapeutic efficacy in the treatment of cancers, but can cause serious adverse reactions such as hand-foot syndrome (HFS). In summary, our data suggest that PLD may promote the destruction of TJs via the HA/CD44 pathway, thereby leading to HFS through increased skin permeability and exacerbated doxorubicin extravasation. Moreover, CaD can inhibit this pathway, offering a potential therapeutic avenue to alleviate HFS."

Journal • Dermatology • Oncology • CD44 • CLDN5 • TJP1

Novel holistic pharmacokinetic model applied to plasma and urine concentrations of 2,5-dihydroxybenzene sulphonate following administrations of calcium dobesilate and etamsylate to exercised horses. (PubMed, J Vet Pharmacol Ther) - "Using the parameters obtained from this PK model, in conjunction with methodology developed by Toutain, afforded a possible screening limit (SL) that can regulate for a DT of 3 days in urine; however, a corresponding SL in plasma would be below current levels of detection. However, it is the responsibility of the individual racing authorities to apply their own risk management with regard to SLs and DTs."

Journal • PK/PD data

Calcium dobesilate attenuates renal ischemia-reperfusion injury in a mouse model. (PubMed, Curr Mol Med) - "Overall, CaD effectively ameliorated renal injury by eliminating ROS and demonstrated in vivo and in vitro for I/R-induced AKI. CaD has been shown to be a promising therapeutic agent for the treatment of I/R-induced AKI."

Journal • Preclinical • Acute Kidney Injury • Cardiovascular • Nephrology • Renal Disease • Reperfusion Injury

Tangningtongluo Tablet in the Treatment of Non-proliferative Diabetic Retinopathy (clinicaltrials.gov) - P2 | N=240 | Active, not recruiting | Sponsor: Guizhou Bailing Group Pharmaceutical Co Ltd | Recruiting ➔ Active, not recruiting | Trial completion date: Mar 2023 ➔ Dec 2023 | Trial primary completion date: Dec 2022 ➔ Oct 2023

Enrollment closed • Trial completion date • Trial primary completion date • Diabetes • Diabetic Retinopathy • Metabolic Disorders • Retinal Disorders • Type 2 Diabetes Mellitus

A single-dose, randomized crossover study in healthy Chinese subjects to evaluate pharmacokinetics and bioequivalence of two capsules of calcium dobesilate 0.5 g under fasting and fed conditions. (PubMed, PLoS One) - "In this study, the T calcium dobesilate 0.5 g capsule was bioequivalent to the reference product under both fasting and fed conditions. Taking food would slow down its rate and reduce its amount of absorption. Both formulations were generally well tolerated."

Clinical • Journal • PK/PD data

The comparative effects of oral Chinese patent medicines in non-proliferative diabetic retinopathy: A Bayesian network meta-analysis of randomized controlled trials. (PubMed, Front Endocrinol (Lausanne)) - "The Compound Danshen Dripping Pill (CDDP) combined with calcium dobesilate (CD) had the most improvement in clinical efficacy rate (SUCRA, 88.58%)...The current findings need to be confirmed by more large-sample, double-blind, multi-center RCTs of rigorous design and robust methods in the future. https://www.crd.york.ac.uk/prospero/, identifier CRD42022367867."

Clinical • Retrospective data • Review • Cardiovascular • Diabetes • Diabetic Retinopathy • Hematological Disorders • Retinal Disorders

"Calcium dobesilate, defibrotide and Aminaphtone. All drugs knowingly to improve endothelial function, reduce platelet aggregation and more. https://t.co/cX69ORyktq" (@Fangorn17)

Clinical study on prescription used for invigorating spleen, reinforcing kidney and warming yang combined with calcium dobesilate in treatment of senile diabetic nephropathy. (PubMed, Biotechnol Genet Eng Rev) - "The prescription used for invigorating spleen, reinforcing kidney and warming yang combined with calcium dobesilate is a reliable method to improve the hemorheology indexes and renal function of DN patients, which benefits patients, and further studies are helpful to establish a better solution for such patients."

Journal • Diabetic Nephropathy • Nephrology • Renal Disease