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Advances in Therapy Sep 2023Pharmacological asthma management focuses on the use of inhaled corticosteroid (ICS)-containing therapies, which reduce airway inflammation and provide... (Review)
Review
INTRODUCTION
Pharmacological asthma management focuses on the use of inhaled corticosteroid (ICS)-containing therapies, which reduce airway inflammation and provide bronchoprotection, improving symptom control and reducing exacerbation risk. ICS underuse due to poor adherence is common, leading to poor clinical outcomes including increased risk of mortality. This article reviews efficacy versus systemic activity profiles for various adherence patterns and dosing regimens of fluticasone furoate (FF)-containing and budesonide (BUD)-containing asthma therapies in clinical trials and real-world studies.
METHODS
We performed a structured literature review (1 January 2000-3 March 2022) and mathematical modelling analysis of FF-containing and BUD-containing regular daily dosing in patients with mild-to-severe asthma, as-needed BUD/formoterol (FOR) in mild asthma, and BUD/FOR maintenance and reliever therapy (MART) dosing in moderate-to-severe asthma, to assess efficacy (bronchoprotection) and systemic activity (cortisol suppression) profiles of dosing patterns of ICS use in multiple adherence scenarios.
RESULTS
A total of 22 manuscripts were included in full-text review and 18 in the model simulations. Focusing on FF-containing or BUD-containing treatments at comparable adherence rates, regular daily FF or FF/vilanterol (VI) dosing provided more prolonged bronchoprotection and fewer systemic effects than daily BUD, daily BUD/FOR, or BUD/FOR MART dosing, especially in low adherence scenarios. In model simulations and the real-world setting, FF/VI generally provided longer bronchoprotection, lower systemic activity, and greater clinical benefits over BUD/FOR as well as consistently higher adherence.
CONCLUSION
In this literature review and modelling analysis, FF/VI was found to show clinical advantages on asthma control over BUD/FOR. These findings have implications for helping clinicians select the most suitable inhaled therapy for their patients with asthma.
Topics: Humans; Budesonide; Drug Combinations; Administration, Inhalation; Adrenal Cortex Hormones; Asthma; Budesonide, Formoterol Fumarate Drug Combination; Fluticasone
PubMed: 37438554
DOI: 10.1007/s12325-023-02585-z -
Annals of Medicine Dec 2022Eosinophilic esophagitis (EoE) is a chronic, local immune-mediated inflammatory oesophageal disease. Although Budesonide is recommended as one of the first-line drugs... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
Eosinophilic esophagitis (EoE) is a chronic, local immune-mediated inflammatory oesophageal disease. Although Budesonide is recommended as one of the first-line drugs for EoE treatment, its efficacy is still controversial in multiple studies. Due to the continuous emergence of new and reliable research evidence in recent years, we updated the meta-analysis using RCT trial results to evaluate the efficacy and safety of budesonide.
MATERIALS AND METHOD
Retrieve the data of the randomised controlled trial literature from 2000 to June 20, 2021, on using Budesonide in the treatment of eosinophilic esophagitis from the three major databases. Based on the results achieved with the Cochrane risk assessment tool, evaluate the quality of the included literature to extract the data, and perform the Meta-analysis with RevMan5.4 and Stata15.0.
RESULTS
A total of 958 articles were retrieved, with 10 articles finally included, thus forming a sample size of 712 cases. The main outcome indicators of the meta-analysis are as follows: (1) Histological remission: the Budesonide group performs better than the placebo control group when it comes to histological remission of injuries [RR = 23.82, 95%CI = (13.46, 42.21), < .001]; (2) Eosinophil count: the Budesonide group is superior to the control group in terms of reduced eosinophil count [SMD = -1.34, 95%CI = (-1.52, -1.15), < .001].
CONCLUSION
More and more high-quality randomised controlled trials show that oral budesonide in the treatment of eosinophils esophagitis was better than the placebo group. Mounting high-quality RCTs have confirmed the efficacy of oral budesonide in the treatment of eosinophilic esophagitis and that the effects of this drug may not be so dose-dependent. It is safe to take budesonide for a long time, and this drug is a relatively ideal option for drug treatment of eosinophilic esophagitis at present, so it is worthy of clinical application.Key MessagesWe used high-quality randomised controlled trials to meta-update the previous results to further confirm the clinical efficacy and safety of budesonide.Oral budesonide in the treatment of eosinophilic esophagitis is significantly better than the placebo control group. We have confirmed the value of its clinical application and promotion by including more high-quality randomised controlled trials.We also found that the efficacy of budesonide in patients is not dose-dependent, and more research is needed to confirm this.
Topics: Budesonide; Eosinophilic Esophagitis; Humans; Leukocyte Count; Randomized Controlled Trials as Topic
PubMed: 35862288
DOI: 10.1080/07853890.2022.2101689 -
Journal of Pediatric Gastroenterology... Nov 2022Non-responsive celiac disease (NRCD) is defined as patients having persistent symptoms and enteropathy (Marsh 3 histology) suggestive of active celiac disease (CeD),...
OBJECTIVES
Non-responsive celiac disease (NRCD) is defined as patients having persistent symptoms and enteropathy (Marsh 3 histology) suggestive of active celiac disease (CeD), after following a gluten-free diet (GFD) for at least 12 months. NRCD is suggested to affect 15% of children with CeD but data are limited and there is no research to date describing treatment of children with this condition. The aim of this study was to describe our center's approach to identifying and treating NRCD with budesonide and the Gluten Containing Elimination Diet (GCED).
METHODS
We performed a retrospective, single center analysis over a 5-year period of patients with CD less than 18 years of age (inclusive) who underwent treatment for persistent symptoms and enteropathy despite following a GFD.
RESULTS
We identified 22 patients with NRCD. Thirteen were treated with the GCED for 3 months with 46% achieving both histological and symptomatic resolution. Nine patients were treated with budesonide (6-9 mg), with 89% achieving both symptomatic and histologic resolution after a median 3-month treatment course. Further, 67% of patients who responded to the GCED and 100% of patients who responded to budesonide remained in remission for at least 6 months following treatment transition back to exclusive GFD.
CONCLUSIONS
The GCED and budesonide can provide benefit for NRCD. Most patients with NRCD can return to a GFD after 3 months of treatment.
Topics: Child; Humans; Celiac Disease; Glutens; Retrospective Studies; Budesonide; Diet, Gluten-Free
PubMed: 36305882
DOI: 10.1097/MPG.0000000000003596 -
BMJ Case Reports Mar 2016A 57-year-old man, diagnosed with colon cancer stage III in July/2010, underwent surgery and received adjuvant chemotherapy with FOLFOX 4 (5-fluorouracil; calcium...
A 57-year-old man, diagnosed with colon cancer stage III in July/2010, underwent surgery and received adjuvant chemotherapy with FOLFOX 4 (5-fluorouracil; calcium folinate and oxaliplatin), which ended in March/2011 after 12-cycles. It was then decided to maintain periodical surveillance. About 1 year later, the patient developed several episodes of diarrhoea, mainly during the night, and presented persistent peripheral eosinophilia in the blood count (range 585-1300 eosinophils/µL). Colonoscopy was performed, with the histological result showing eosinophilic infiltration of the colon, compatible with eosinophilic colitis. The patient was treated with a short course of budesonide, achieving resolution of symptoms, and has remained asymptomatic.
Topics: Budesonide; Colitis; Colonoscopy; Eosinophilia; Glucocorticoids; Humans; Male; Middle Aged; Treatment Outcome
PubMed: 26957036
DOI: 10.1136/bcr-2016-214496 -
Molecules (Basel, Switzerland) Mar 2022The authors developed four variants of the qNMR technique (H or C nucleus, DMSO-d6 or CDCl solvent) for identification and quantification by NMR of 22 and 22 epimers in...
The authors developed four variants of the qNMR technique (H or C nucleus, DMSO-d6 or CDCl solvent) for identification and quantification by NMR of 22 and 22 epimers in budesonide active pharmaceutical ingredient and budesonide drugs (sprays, capsules, tablets). The choice of the qNMR technique version depends on the drug excipients. The correlation of H and C spectra signals to molecules of different budesonide epimers was carried out on the basis of a comprehensive analysis of experimental spectral NMR data (H-H gCOSY, H-C gHSQC, H-C gHMBC, H-H ROESY). This technique makes it possible to identify budesonide epimers and determine their weight ratio directly, without constructing a calibration curve and using any standards. The results of measuring the 22 epimer content by qNMR are comparable with the results of measurements using the reference HPLC method.
Topics: Budesonide; Glucocorticoids; Magnetic Resonance Spectroscopy; Pharmaceutical Preparations; Stereoisomerism
PubMed: 35408662
DOI: 10.3390/molecules27072262 -
Frontiers in Immunology 2022Collagenous colitis (CC) is an inflammatory bowel disease, which usually responds to budesonide treatment. Our aim was to study the immunological background of the...
INTRODUCTION
Collagenous colitis (CC) is an inflammatory bowel disease, which usually responds to budesonide treatment. Our aim was to study the immunological background of the disease.
METHODS
Analyses of peripheral and mucosal MAIT (mucosa associated invariant T cells) and NK (natural killer) cells were performed with flow cytometry. Numbers of mucosal cells were calculated using immunohistochemistry. We studied the same patients with active untreated CC (au-CC) and again while in remission on budesonide treatment. Budesonide refractory patients and healthy controls were also included. The memory marker CD45R0 and activation marker CD154 and CD69 were used to further study the cells. Finally B cells, CD4 and CD8 T cells were also analysed.
RESULTS
The percentages of circulating CD56CD16 NK cells as well as MAIT cells (CD3TCRVa7.2CD161) were decreased in au-CC compared to healthy controls. This difference was not seen in the mucosa; where we instead found increased numbers of mucosal CD4 T cells and CD8 T cells in au-CC. Mucosal immune cell numbers were not affected by budesonide treatment. In refractory CC we found increased mucosal numbers of MAIT cells, CD4 and CD8 T cells compared to au-CC.
DISCUSSION
Patients with active collagenous colitis have lower percentages of circulating MAIT and NK cells. However, there was no change of these cells in the colonic mucosa. Most mucosal cell populations were increased in budesonide refractory as compared to au-CC patients, particularly the number of MAIT cells. This may indicate that T cell targeting therapy could be an alternative in budesonide refractory CC.
Topics: Humans; Budesonide; CD8-Positive T-Lymphocytes; Colitis, Collagenous; Intestinal Mucosa; Killer Cells, Natural
PubMed: 36591297
DOI: 10.3389/fimmu.2022.981740 -
Digestion 2012Due to misunderstandings about their effectiveness and feasibility, topical (or rectal) therapies with aminosalicylates (5-aminosalicylic acid, 5-ASA) and steroids are... (Review)
Review
Due to misunderstandings about their effectiveness and feasibility, topical (or rectal) therapies with aminosalicylates (5-aminosalicylic acid, 5-ASA) and steroids are often underused in patients with ulcerative colitis (UC). However, many of these patients could be treated solely with rectal/topical therapies, or could benefit from them in combination with oral therapies. We review the evidence for topical therapies containing 5-ASA and budesonide in UC and discuss how these therapies can be optimized in daily practice, thereby improving compliance. Finally, we provide a brief summary of studies on the use of other topical treatments in UC, the results of which were both promising and negative.
Topics: Administration, Rectal; Anti-Inflammatory Agents; Budesonide; Colitis, Ulcerative; Drug Therapy, Combination; Enema; Guideline Adherence; Humans; Induction Chemotherapy; Maintenance Chemotherapy; Mesalamine; Patient Compliance; Practice Guidelines as Topic; Suppositories
PubMed: 23051725
DOI: 10.1159/000341947 -
Journal of Hepatology Apr 2015
Review
Topics: Budesonide; Hepatitis, Autoimmune; Humans; Liver; Liver Transplantation; Standard of Care; Treatment Failure
PubMed: 25920079
DOI: 10.1016/j.jhep.2015.03.005 -
Revista Espanola de Enfermedades... May 2006In this review, we examined studies published on oral and topical formulations of budesonide (Entocort and Budenofalk, in Spain: Entocord and Intestifalk) for the... (Review)
Review
In this review, we examined studies published on oral and topical formulations of budesonide (Entocort and Budenofalk, in Spain: Entocord and Intestifalk) for the treatment of ulcerative colitis. This glycocorticosteroid has a potent local action and an important first-pass liver metabolism. It has proven successful over the last years as a controlled-release formulation. It obtained results similar to prednisolone, without the latter s significant suppression of plasma cortisol. Many publications exist on the effects of oral budesonide for the treatment of Crohn s disease (CD). These have led to the registration of this drug for the treatment of CD. Studies on oral formulations of budesonide for the treatment of ulcerative colitis (UC) are scarce. After reviewing published evidence, we suggest the conduction of controlled trials for the treatment of UC to obtain evidence-based efficacy and safety results in order to benefit patients with this form of inflammatory bowel disease (IBD).
Topics: Animals; Anti-Inflammatory Agents; Anti-Ulcer Agents; Budesonide; Colitis, Ulcerative; Humans
PubMed: 16944997
DOI: 10.4321/s1130-01082006000500007 -
Annals of Internal Medicine May 2023Previous trials have demonstrated the effects of fluvoxamine alone and inhaled budesonide alone for prevention of disease progression among outpatients with COVID-19. (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Previous trials have demonstrated the effects of fluvoxamine alone and inhaled budesonide alone for prevention of disease progression among outpatients with COVID-19.
OBJECTIVE
To determine whether the combination of fluvoxamine and inhaled budesonide would increase treatment effects in a highly vaccinated population.
DESIGN
Randomized, placebo-controlled, adaptive platform trial. (ClinicalTrials.gov: NCT04727424).
SETTING
12 clinical sites in Brazil.
PARTICIPANTS
Symptomatic adults with confirmed SARS-CoV-2 infection and a known risk factor for progression to severe disease.
INTERVENTION
Patients were randomly assigned to either fluvoxamine (100 mg twice daily for 10 days) plus inhaled budesonide (800 mcg twice daily for 10 days) or matching placebos.
MEASUREMENTS
The primary outcome was a composite of emergency setting retention for COVID-19 for more than 6 hours, hospitalization, and/or suspected complications due to clinical progression of COVID-19 within 28 days of randomization. Secondary outcomes included health care attendance (defined as hospitalization for any cause or emergency department visit lasting >6 hours), time to hospitalization, mortality, patient-reported outcomes, and adverse drug reactions.
RESULTS
Randomization occurred from 15 January to 6 July 2022. A total of 738 participants were allocated to oral fluvoxamine plus inhaled budesonide, and 738 received placebo. The proportion of patients observed in an emergency setting for COVID-19 for more than 6 hours or hospitalized due to COVID-19 was lower in the treatment group than the placebo group (1.8% [95% credible interval {CrI}, 1.1% to 3.0%] vs. 3.7% [95% CrI, 2.5% to 5.3%]; relative risk, 0.50 [95% CrI, 0.25 to 0.92]), with a probability of superiority of 98.7%. No relative effects were found between groups for any of the secondary outcomes. More adverse events occurred in the intervention group than the placebo group, but no important differences between the groups were detected.
LIMITATION
Low event rate overall, consistent with contemporary trials in vaccinated populations.
CONCLUSION
Treatment with oral fluvoxamine plus inhaled budesonide among high-risk outpatients with early COVID-19 reduced the incidence of severe disease requiring advanced care.
PRIMARY FUNDING SOURCE
Latona Foundation, FastGrants, and Rainwater Charitable Foundation.
Topics: Adult; Humans; COVID-19; Budesonide; Fluvoxamine; SARS-CoV-2; COVID-19 Drug Treatment; Treatment Outcome
PubMed: 37068273
DOI: 10.7326/M22-3305