Glibenclamide You need to be logged in to see the full monograph.LoginUSE OF GLIBENCLAMIDE IN PREGNANCYDate of issue: December 2021, Version: 3Glibenclamide (glyburide) is an oral sulfonylurea hypoglycaemic agent indicated in the treatment of non-insulin-dependent diabetes in patients who fail to respond to dietary measures alone.Data on the use of glibenclamide in pregnancy consist of >9,500 exposures; however, glibenclamide is used in the management of gestational diabetes, which most commonly occurs in the second or third trimester; therefore, first trimester exposure data are lacking and an increased risk of congenital malformation or miscarriage cannot be excluded. Data regarding risk of large for gestational age (LGA) or macrosomia in the infant and neonatal hypoglycaemia following
Intravenous glibenclamide for cerebral oedema after large hemispheric stroke (CHARM): a phase 3, double-blind, placebo-controlled, randomised trial No treatment is available to prevent brain oedema, which can occur after a large hemispheric infarction. Glibenclamide has previously been shown to improve functional outcome and reduce neurological or oedema-related death in patients younger than 70 years who were at risk of brain oedema after an acute ischaemic stroke. We aimed to assess whether intravenous glibenclamide could improve functional outcome at 90 days in patients with large hemispheric infarction. CHARM was a phase 3, double-blind, placebo-controlled, randomised trial conducted across 143 acute stroke centres in 21 countries. We included patients aged 18-85 years with a large stroke
Safety and efficacy of glibenclamide on cerebral oedema following aneurysmal subarachnoid haemorrhage: a randomised, double-blind, placebo-controlled clinical trial. Glibenclamide has garnered attention due to its multifaceted neuroprotective effects in cases of acute central nervous system injury. We initiated a trial to explore the effectiveness and safety of a high dose of glibenclamide in the management of cerebral oedema following aneurysmal subarachnoid haemorrhage (aSAH). This trial constituted a single-centre, randomised clinical study. Half of the 56 patients assigned to the glibenclamide group received 15 mg of glibenclamide tablets daily for 10 days (5 mg, three times/day). The primary outcome was the proportion of patients achieving the subarachnoid haemorrhage early brain oedema score
Efficacy and Safety of Early Treatment with Glibenclamide in Patients with Aneurysmal Subarachnoid Hemorrhage: A Randomized Controlled Trial. This study aims to investigate the efficacy and safety of glibenclamide treatment in patients with acute aneurysmal subarachnoid hemorrhage (aSAH). The randomized controlled trial was conducted from October 2021 to May 2023 at two university-affiliated hospitals in Beijing, China. The study included patients with aSAH within 48 h of onset, of whom were divided into the intervention group and the control group according to the random number table method. Patients in the intervention group received glibenclamide tablet 3.75 mg/day for 7 days. The primary end points were the levels of serum neuron-specific enolase (NSE) and soluble protein 100B (S100B
The Effects of Glibenclamide on Cognitive Performance, Quality of Life, and Emotional Aspects Among Patients With Aneurysmal Subarachnoid Hemorrhage: A Randomized Controlled Trial. Aneurysmal subarachnoid hemorrhage (aSAH) is associated with a high incidence of long-term cognitive impairment, decreased quality of life (QoL), and psychiatric disorders. The effects of glibenclamide on such outcomes in the setting of aSAH are unknown. To assess the impact of glibenclamide in patients with aSAH on cognitive performance, QoL, and emotional aspects. Patients identified with aSAH were randomly allocated to receive 5 mg of glibenclamide for 21 days or placebo, starting within 96 hours of the ictus. After 6 months, patients were evaluated with Montreal Cognitive Assessment test (cognitive
Glibenclamide (Amglidia) - neonatal diabetes mellitus Published 07 October 2019 6 September 2019 ADVICE: in the absence of a submission from the holder of the marketing authorisation glibenclamide (Amglidia®) is not recommended for use within NHSScotland. Indication under review: Treatment of neonatal diabetes mellitus, for use in newborns, infants and children. The holder , in consultation with the patient and/or guardian or carer. Chairman Scottish Medicines Consortium Statement of advice SMC 2237 glibenclamide 0.6mg/mL , 6mg/mL oral suspension ( Amglidia ®) Amring Pharma www.scottishmedicines.org.uk
Glibenclamide Posttreatment Does Not Inhibit Levcromakalim Induced Headache in Healthy Participants: A Randomized Clinical Trial. Intravenous infusion of ATP-sensitive potassium channel (K) opener levcromakalim causes headache in humans and implicates K channels in headache pathophysiology. Whether K channel blocker glibenclamide inhibits levcromakalim-induced headache has not yet been elucidated. We aimed to investigate the effect of posttreatment with glibenclamide on levcromakalim-induced headache in healthy participants. In a double blind, randomized, three-arm, placebo-controlled, crossover study, 20 healthy participants were randomized to receive 20 mL of levcromakalim (0.05 mg/min (50 mg/mL)) or 20 mL placebo (isotonic saline) intravenously over 20 min followed by oral
Effects of oral glibenclamide versus subcutaneous insulin on perinatal outcome of patients with gestational diabetes mellitus: A randomized clinical trial. The first-line treatment for gestational diabetes mellitus remains insulin, but oral hypoglycemic agents are easier and cheaper to use. The aim of the current study was to compare the efficacy and safety of oral glibenclamide and subcutaneous glibenclamide ( = 44) or subcutaneous insulin ( = 40) according to a standard protocol and followed until delivery. The primary endpoint was to compare the glycemic level of patients, and the secondary outcomes included pregnancy adverse events and neonatal complications such as preeclampsia, preterm and premature rupture of membranes, preterm labor, placental abruption, maternal hypoglycemia, birth weight
Pharmacokinetic and Bioequivalence Studies of 2 Metformin Glibenclamide Tablets in Healthy Chinese Subjects Under Fasting and Fed Conditions. The rational combination of oral antidiabetic agents is more likely to provide better glycemic control than monotherapy. Metformin glibenclamide tablets can be used as second-line therapy for patients with type 2 diabetes mellitus who cannot successfully control their blood glucose levels by diet and exercise plus metformin or sulfonylureas. The aim of this study was to evaluate the bioequivalence and safety of metformin hydrochloride and glibenclamide tablets (500 mg/5 mg) prepared by 2 different vendors in healthy Chinese subjects under fasting and fed conditions. This is an open-label, single-center, randomized, 2-formulation, 2-period crossover
The aggressiveness of SDHB deficient chromaffin cells is reduced when their bioelectrical properties are restored by glibenclamide. Pheochromocytomas/paragangliomas (PPGLs) are neuroendocrine tumours, mostly resulting from mutations in predisposing genes. Mutations of succinate dehydrogenase (SDH) subunit B (SDHB) are associated with high probability of metastatic disease. Since bioelectrical to glibenclamide, a specific KATP inhibitor, or to ATP caused normalization of potassium current features. In this work, we show for the first time that reduced intracellular ATP levels in SDHB deficient chromaffin cells impaired cell bioelectrical properties, which in turn, increased cell aggressiveness. Moreover, we first ever demonstrated that glibenclamide, not only reduced the outward potassium currents
Safety and efficacy of glibenclamide combined with rtPA in acute cerebral ischemia with occlusion/stenosis of anterior circulation (SE-GRACE): a randomized, double-blind, placebo-controlled trial.
Precision Effects of Glibenclamide on MRI Endophenotypes in Clinically Relevant Murine Traumatic Brain Injury. Addressing traumatic brain injury (TBI) heterogeneity is increasingly recognized as essential for therapy translation given the long history of failed clinical trials. We evaluated differential effects of a promising treatment (glibenclamide) based on dose, TBI type (patient selection ), and imaging endophenotype (outcome selection). Our goal to inform TBI precision medicine is contextually timely given ongoing phase 2/planned phase 3 trials of glibenclamide in brain contusion. Blinded randomized controlled preclinical trial of glibenclamide on MRI endophenotypes in two established severe TBI models: controlled cortical impact (CCI, isolated brain contusion) and CCI+hemorrhagic shock (HS
Glibenclamide for Brain Contusions: Contextualizing a Promising Clinical Trial Design that Leverages an Imaging-Based TBI Endotype. TBI heterogeneity is recognized as a major impediment to successful translation of therapies that could improve morbidity and mortality after injury. This heterogeneity exists on multiple levels including primary injury, secondary injury/host-response, and recovery drivers of death and disability after TBI. Over the past decade, there has been increasing evidence of the role of the sulfonylurea-receptor 1-transient receptor potential melastatin 4 (SUR1-TRPM4) channel in secondary injury after TBI, including progression of both cerebral edema and intraparenchymal hemorrhage. Inhibition of SUR1-TRPM4 with glibenclamide has shown promising results in preclinical
The shortcoming of using glibenclamide in exploratory clinical headache provocation studies. Preclinical and clinical studies implicate the vascular ATP-sensitive potassium (K) channel in the signaling cascades underlying headache and migraine. However, attempts to demonstrate that the K channel inhibitor glibenclamide would attenuate triggered headache in healthy volunteers have proven unsuccessful. It is questionable, however, whether target engagement was achieved in these clinical studies. Literature data for human glibenclamide pharmacokinetics, plasma protein binding and functional IC values were used to predict the K receptor occupancy (RO) levels obtained after glibenclamide dosing in the published exploratory clinical headache provocation studies. RO vs. time profiles
Effect of KATP channel blocker glibenclamide on PACAP38-induced headache and hemodynamic. To determine whether glibenclamide, a non-selective adenosine 5'-triphosphate-sensitive K (K) channel blocker, attenuates pituitary adenylate cyclase-activating polypeptide-38 (PACAP38)-induced headache and vascular changes in healthy volunteers. In a double-blind, randomized, placebo controlled and crossover design, 22 healthy volunteers were assigned to receive an intravenous infusion of 10 picomole/kg/min pituitary adenylate cyclase-activating polypeptide-38 over 20 minutes followed by oral administration of 10 mg glibenclamide or placebo. The primary endpoint was the difference in incidence of headache (0-12 hours) between glibenclamide and placebo. The secondary endpoints were a difference
Effect of Sitagliptin Versus Glibenclamide on Glycemic Markers, Lipid Profile Inflammatory and Oxidative Stress Factors in Type 2 Diabetes Patients: a Double-Blinded Randomized Controlled Trial. Diabetes mellitus is leading to chronic complications, including cardiovascular diseases. The aim of this study was to compare the effect of Sitagliptin and Glibenclamide on glycemic markers, lipid profile inflammatory, and oxidative stress factors in type 2 diabetes patients. This double-blinded randomized controlled trial was performed on patients with type 2 diabetes mellitus (n=54). The treatment group (27 patients) received 100 mg of Sitagliptin once daily + 500 mg Metformin twice daily, orally, for 12 weeks, and the control group (27 patients) was given 5 mg of Glibenclamide once daily
The effects of metformin monotherapy and combination of metformin and glibenclamide therapy on the expression of RAGE, Sirt1, and Nrf2 genes in peripheral blood mononuclear cells of type 2 diabetic patients. Although metformin is the first-line treatment of type 2 diabetes mellitus (T2DM), a few studies have evaluated the benefits of monotherapies (metformin) versus combination therapy (metformin and glibenclamide) for treatment of T2DM patients. The present study aimed to evaluate the effect of monotherapy with metformin compared to combination therapy with metformin and glibenclamide on the expression of , , and genes. EightyT2DM patients and 40 healthy individuals participated in this case-control study. The patients in the treatment group were divided into two groups who received
Efficacy and safety of glibenclamide therapy after intracerebral haemorrhage (GATE-ICH): A multicentre, prospective, randomised, controlled, open-label, blinded-endpoint, phase 2 clinical trial. Glibenclamide is a promising agent for treating brain oedema, but whether it improves clinical outcomes in patients with intracerebral haemorrhage (ICH) remains unclear. In this study, we aimed to explore the efficacy and safety of glibenclamide treatment in patients with acute ICH. The Glibenclamide Advantage in Treating Oedema after Intracerebral Haemorrhage (GATE-ICH) study was a randomised controlled phase 2 clinical trial conducted in 26 hospitals in the northwest of China, recruiting patients with acute ganglia ICH no more than 72 h after onset from Dec 12, 2018 to Sept 23, 2020. During
Glibenclamide Advantage in Treating Edema After Intracerebral Hemorrhage (GATE-ICH): Study Protocol for a Multicenter Randomized, Controlled, Assessor-Blinded Trial. Brain edema after acute intracerebral hemorrhage (ICH) plays a critical role in the secondary injury of ICH and may heighten the potential for a poor outcome. This trial aims to explore the efficacy of small doses of oral glibenclamide in perihematomal edema (PHE) and the prognosis of patients with ICH. The GATE-ICH trial is a multicenter randomized, controlled, assessor-blinded trial. A total of 220 adult patients with acute primary ICH in 28 study centers in China will be randomized to the glibenclamide group (glibenclamide plus guideline-recommended ICH management) or the control group (guideline-recommended ICH management