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United European Gastroenterology Journal Dec 2020
Topics: Budesonide; Colitis, Ulcerative; Humans; Mesalamine
PubMed: 33276714
DOI: 10.1177/2050640620962329 -
Medicine Apr 2022Among the most prevalent allergic conditions that affect children is anaphylactic rhinitis (AR). It is capable of leading to physical as well as mental health issues....
BACKGROUND
Among the most prevalent allergic conditions that affect children is anaphylactic rhinitis (AR). It is capable of leading to physical as well as mental health issues. Concomitant use of loratadine and budesonide may improve symptoms of AR more than treatment with either drug alone. To assess the efficacy and safety of combined loratadine and budesonide for patients experiencing AR is the aim of this study.
METHODS
We will apply 2 independent authors in six databases, including EMBASE, Pub Med, Web of Science, China National Knowledge Infrastructure, WanFang Database, Chinese Scientific Journal Database (VIP database). Studies evaluating the efficacy and safety of combined loratadine and budesonide in patients with AR will include studies published between inception and Dec 2021. Accordingly, the data will have to be in English and Chinese. For the selection of data extraction, the studies and risk of bias assessment will be completed by 2 independent authors. Accordingly, data synthesis will be conducted through RevMan 5.3 software. The study will establish heterogeneity using the I2 test. Without correct data or information, there is a need for Publication bias, which is assessed by performing the Begg and Egger test and generating a funnel plot.
RESULTS
The study provides a trustable clinical foundation for loratadine and budesonide for AR treatment.OSF registration number: DOI 10.17605/OSF.IO/M2RFGEthics and dissemination: Because the present study is founded on existing studies, it does not require ethics approval.
Topics: Anaphylaxis; Budesonide; Child; Humans; Loratadine; Meta-Analysis as Topic; Research Design; Rhinitis; Systematic Reviews as Topic
PubMed: 35512063
DOI: 10.1097/MD.0000000000028851 -
The Cochrane Database of Systematic... Aug 2016Reduction of lung inflammation is one of the goals of cystic fibrosis therapy. Inhaled corticosteroids are often used to treat children and adults with cystic fibrosis.... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Reduction of lung inflammation is one of the goals of cystic fibrosis therapy. Inhaled corticosteroids are often used to treat children and adults with cystic fibrosis. The rationale for this is their potential to reduce lung damage arising from inflammation, as well as their effect on symptomatic wheezing. It is important to establish the current level of evidence for the risks and benefits of inhaled corticosteroids, especially in the light of their known adverse effects on growth. This is an update of a previously published review.
OBJECTIVES
To assess the effectiveness of taking regular inhaled corticosteroids, compared to not taking them, in children and adults with cystic fibrosis.
SEARCH METHODS
We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register, comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. We requested information from pharmaceutical companies manufacturing inhaled corticosteroids and authors of identified trials.Date of most recent search of the Group's Trials Register: 15 August 2016.
SELECTION CRITERIA
Randomised or quasi-randomised trials, published and unpublished, comparing inhaled corticosteroids to placebo or standard treatment in individuals with cystic fibrosis.
DATA COLLECTION AND ANALYSIS
Two independent authors assessed methodological quality and risk of bias in trials using established criteria and extracted data using standard pro formas.
MAIN RESULTS
The searches identified 34 citations, of which 26 (representing 13 trials) were eligible for inclusion. These 13 trials reported the use of inhaled corticosteroids in 506 people with cystic fibrosis aged between six and 55 years. One was a withdrawal trial in individuals who were already taking inhaled corticosteroids. Methodological quality and risk of bias were difficult to assess from published information. Many of the risk of bias judgements were unclear due to a lack of available information. Only two trials specified how participants were randomised and less than half of the included trials gave details on how allocation was concealed. Trials were generally judged to have a low risk of bias from blinding, except for two which were open label or did not use a placebo. There were some concerns that a number of trials had not been published in peer-reviewed journals, but the risk of bias from this was unclear. Inclusion criteria varied between trials, as did type and duration of treatment and timing of outcome assessments. Objective measures of airway function were reported in most trials but were often incomplete. Significant benefit has not been conclusively demonstrated. Four trials systematically documented adverse effects and growth was significantly affected in one study using high doses.
AUTHORS' CONCLUSIONS
Evidence from these trials is insufficient to establish whether inhaled corticosteroids are beneficial in cystic fibrosis, but withdrawal in those already taking them has been shown to be safe. There is some evidence they may cause harm in terms of growth. It has not been established whether long-term use is beneficial in reducing lung inflammation, which should improve survival, but it is unlikely this will be proven conclusively in a randomised controlled trial.
Topics: Administration, Inhalation; Adolescent; Adult; Anti-Inflammatory Agents; Budesonide; Child; Cystic Fibrosis; Fluticasone; Glucocorticoids; Humans; Middle Aged; Randomized Controlled Trials as Topic; Young Adult
PubMed: 27552284
DOI: 10.1002/14651858.CD001915.pub5 -
Alimentary Pharmacology & Therapeutics Jun 2015Budesonide and mesalazine (mesalamine) are commonly used in the medical management of patients with mild to moderate Crohn's disease. (Comparative Study)
Comparative Study Meta-Analysis Review
BACKGROUND
Budesonide and mesalazine (mesalamine) are commonly used in the medical management of patients with mild to moderate Crohn's disease.
AIM
To assess their comparative efficacy and harm using the methodology of network meta-analysis.
METHODS
A comprehensive search of Medline, Embase, the Cochrane Library and ClinicalTrials.gov, through October 2014, was performed to identify randomised controlled trials (RCTs) that recruited adult patients with active or quiescent Crohn's disease, and compared budesonide or mesalazine with placebo, or against each other, or different dosing strategies of one drug.
RESULTS
Twenty-five RCTs were combined using Bayesian network meta-analysis. Budesonide 9 mg/day, or at higher doses (15 or 18 mg/day), was shown superior to placebo for induction of remission [odds ratio (OR), 2.93; 95% credible interval (CrI), 1.52-5.39, and OR, 3.28; CrI, 1.46-7.55 respectively] and ranks at the top of the hierarchy of the competing treatments. For maintenance of remission, budesonide 6 mg/day demonstrated superiority over placebo (OR, 1.69; CrI, 1.05-2.75), being also at the best ranking position among all compared treatment strategies. No other comparisons (i.e. different doses of mesalazine vs. placebo or budesonide, for induction or maintenance of remission) reached significance. The occurrence of withdrawals due to adverse events was not shown different between budesonide, mesalazine and placebo, in both the induction and maintenance phases.
CONCLUSIONS
Budesonide, at the doses of 9 mg/day, or higher, for induction of remission in active mild or moderate Crohn's disease, and at 6 mg/day for maintenance of remission, appears to be the best treatment choice.
Topics: Adult; Bayes Theorem; Budesonide; Crohn Disease; Humans; Mesalamine; Odds Ratio; Randomized Controlled Trials as Topic
PubMed: 25864873
DOI: 10.1111/apt.13190 -
Respiratory Medicine Jul 1998The physicochemical and pharmacokinetic characteristics of BDP and budesonide are somewhat different, but the overall result is that both are well suited for use as... (Comparative Study)
Comparative Study Review
The physicochemical and pharmacokinetic characteristics of BDP and budesonide are somewhat different, but the overall result is that both are well suited for use as inhaled corticosteroids. Both BDP and budesonide are metabolized primarily by the liver, with one of the metabolites of BDP, 17-BMP, having greater receptor affinity than either the parent compound or budesonide, which has no active metabolites. BDP has a lower water solubility than either 17-BMP or budesonide, which have similar water solubilities. Budesonide has lower oral bioavailability than BDP; however, it is generally reported to have a longer plasma half-life than either BDP or 17-BMP. The physicochemical and pharmacokinetic profiles of inhaled BDP and budesonide provide both compounds with a favourable ratio of topical to systemic effects and support their well-established role in the treatment of asthma. The device used to deliver an inhaled corticosteroid influences the lung deposition of the drug and selection of the device should be made with an understanding of the particular advantages and disadvantages of the device for each individual patient.
Topics: Absorption; Administration, Inhalation; Anti-Asthmatic Agents; Asthma; Beclomethasone; Budesonide; Drug Delivery Systems; Humans; Liver; Lung; Nebulizers and Vaporizers; Structure-Activity Relationship
PubMed: 10193529
DOI: 10.1016/s0954-6111(98)90434-6 -
Respirology (Carlton, Vic.) Aug 2020Despite improvements in medications, devices and understanding of the disease, about half of all asthma patients worldwide remain inadequately controlled, suggesting the... (Review)
Review
Despite improvements in medications, devices and understanding of the disease, about half of all asthma patients worldwide remain inadequately controlled, suggesting the need for a new approach to asthma management. Poor adherence to prescribed maintenance therapy and over-reliance on SABA reliever medication is a common cause of inadequate control. This article reviews published data from 6- to 12-month, double-blind, RCT and open-label real-world studies involving budesonide/formoterol maintenance and reliever therapy (MART) and relevant comparator approaches to asthma management, and considers how these compare in achieving the treatment goals described in guidelines. The data confirm that patients with asthma treated with budesonide/formoterol MART achieved the same or better asthma symptom control compared with ICS/LABA plus SABA regimens at similar or higher ICS doses, with consistently lower rates of exacerbations and considerably lower annual requirement for oral corticosteroids. These findings have been confirmed across a range of severities of persistent asthma. With the MART approach, maintenance dosing ensures coverage for day-to-day control, and the use of a reliever with anti-inflammatory properties (budesonide/formoterol) provides extra doses of ICS as soon as symptoms prompt the use of reliever, resulting in a 40-50% reduction of exacerbations compared with an ICS-based treatment approach plus as-needed SABA as reliever. As-needed, budesonide/formoterol has also recently been shown to be more effective as a reliever in mild asthma than SABA alone, reducing exacerbations by up to 64% in the SYGMA studies.
Topics: Adult; Anti-Asthmatic Agents; Asthma; Bronchodilator Agents; Budesonide; Clinical Trials as Topic; Female; Formoterol Fumarate; Humans; Maintenance Chemotherapy; Male
PubMed: 32237004
DOI: 10.1111/resp.13804 -
Alimentary Pharmacology & Therapeutics May 20145-Aminosalicylates (5-ASA) are first-line treatment for mild-moderately active ulcerative colitis (UC). When 5-ASAs fail, systemic corticosteroids have been the standard... (Review)
Review
BACKGROUND
5-Aminosalicylates (5-ASA) are first-line treatment for mild-moderately active ulcerative colitis (UC). When 5-ASAs fail, systemic corticosteroids have been the standard next step. Due to the significant side effect profile of systemic corticosteroids, alternative options in the treatment algorithm after 5-ASA failures are needed. Budesonide-Multi-Matrix System (MMX) is a novel oral formulation of budesonide that uses colonic release MMX technology to extend release of the drug to the colon. Now that budesonide-MMX has been approved for use in some countries, and pending in others we need to understand its position in the treatment algorithm for UC.
AIM
To review the available literature for budesonide-MMX and incorporate it into the treatment algorithm for mild-moderate UC.
METHODS
The available efficacy and safety literature regarding budesonide-MMX was reviewed, and compared to 5-ASAs and systemic corticosteroids.
RESULTS
In two large studies referred to as CORE (Colonic Release Budesonide trial), budesonide-MMX 9 mg daily was significantly more effective in achieving a combined end point of clinical and endoscopic remission than placebo in patients with mild-moderately active UC. Safety data are reassuring, with no clinically relevant differences between budesonide-MMX and placebo, including steroid-related side effects.
CONCLUSIONS
Budesonide-MMX 9 mg daily is an effective and safe treatment for induction in patients with mild-moderately active UC. At the current time, it should be considered in patients after 5-ASA failure and before systemic corticosteroids. Data are still needed to understand its role and dose beyond 8 weeks, and if it should be considered first line before 5-ASAs.
Topics: Algorithms; Anti-Inflammatory Agents; Budesonide; Chemistry, Pharmaceutical; Colitis, Ulcerative; Delayed-Action Preparations; Glucocorticoids; Humans; Mesalamine; Severity of Illness Index
PubMed: 24641622
DOI: 10.1111/apt.12712 -
Gastroenterology Nov 2020Eosinophilic esophagitis (EoE) is a chronic inflammatory disorder. Swallowed topical-acting corticosteroids are effective in bringing active EoE into remission. However,... (Comparative Study)
Comparative Study Randomized Controlled Trial
BACKGROUND & AIMS
Eosinophilic esophagitis (EoE) is a chronic inflammatory disorder. Swallowed topical-acting corticosteroids are effective in bringing active EoE into remission. However, it is not clear whether these drugs are effective for long-term maintenance of remission.
METHODS
We performed a double-blind trial to compare the efficacy and safety of 2 dosages of a budesonide orodispersible tablet (BOT) vs placebo in maintaining remission of EoE. Maintenance of remission was defined as absence of clinical and histologic relapse and no premature withdrawal for any reason. Two hundred and four adults with EoE in clinical and histologic remission, from 29 European study sites, were randomly assigned to groups given BOT 0.5 mg twice daily (n = 68), BOT 1.0 mg twice daily (n = 68), or placebo twice daily (n = 68) for up to 48 weeks.
RESULTS
At end of treatment, 73.5% of patients receiving BOT 0.5 mg twice daily and 75% receiving BOT 1.0 mg twice daily were in persistent remission compared with 4.4% of patients in the placebo group (P < .001 for both comparisons of BOT with placebo). Median time to relapse in the placebo group was 87 days. The frequency of adverse events was similar in the BOT and placebo groups. Morning serum levels of cortisol were in the normal range at baseline and did not significantly change during treatment. Four patients receiving BOT developed asymptomatic, low serum levels of cortisol. Clinically manifested candidiasis was suspected in 16.2% of patients in the BOT 0.5 mg group and in 11.8% of patients in the BOT 1.0 mg group; all infections resolved with treatment.
CONCLUSIONS
In a phase 3 trial, up to 48 weeks of treatment with BOT (0.5 mg or 1.0 mg twice daily) was superior to placebo in maintaining remission of EoE. Both dosages were equally effective and well tolerated. EudraCT number; 2014-001485-99; ClinicalTrials.gov number, NCT02434029.
Topics: Administration, Oral; Adrenal Cortex Hormones; Adult; Budesonide; Double-Blind Method; Eosinophilic Esophagitis; Europe; Female; Humans; Male; Middle Aged; Remission Induction; Tablets; Time Factors; Treatment Outcome
PubMed: 32721437
DOI: 10.1053/j.gastro.2020.07.039 -
Annals of Allergy, Asthma & Immunology... Apr 2017The efficacy and safety of budesonide/formoterol pressurized metered-dose inhaler (pMDI) have been demonstrated in patients with asthma at least 12 years old. (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
The efficacy and safety of budesonide/formoterol pressurized metered-dose inhaler (pMDI) have been demonstrated in patients with asthma at least 12 years old.
OBJECTIVE
To evaluate the efficacy of 2 formoterol doses added to budesonide as fixed combinations vs budesonide alone in children 6 to younger than 12 years with asthma.
METHODS
This randomized, double-blinded, parallel-group, multicenter study (NCT02091986; CHASE 3) included children 6 to younger than 12 years with asthma previously receiving a medium-dose inhaled corticosteroid (ICS) or an ICS plus a long-acting β-agonist. Children symptomatic during a 7-28-day run-in on low-dose ICS, 1 inhalation of budesonide dry powder inhaler 90 μg twice daily (BID), were randomized to receive 2 inhalations of budesonide/formoterol pMDI 80/4.5 μg (160/9 μg) BID (n = 92), budesonide/formoterol pMDI 80/2.25 μg (160/4.5 μg) BID (n = 95), or budesonide pMDI 80 μg (160 μg) BID (n = 92) for 12 weeks.
RESULTS
Change in forced expiratory volume in 1 second from baseline to 1 hour after dosing (primary end point), change in forced expiratory volume in 1 second 15 minutes after dosing, and peak expiratory flow 1 hour after dosing at week 12 were statistically significantly greater for budesonide/formoterol 160/9 μg vs budesonide (P ≤ .015 for all comparisons), but not for budesonide/formoterol 160/4.5 μg vs budesonide. Bronchodilator effects, evident 15 minutes after the dose on day 1, were maintained at week 12. Incidence of protocol-defined asthma exacerbations and improvements in asthma symptom-related and quality-of-life outcomes were similar across treatments. There were no notable safety differences among treatments.
CONCLUSION
Budesonide/formoterol pMDI 160/9 μg showed statistically significant and clinically meaningful lung function improvements vs budesonide pMDI 160 μg, demonstrating appropriateness as a therapeutic option for children 6 to younger than 12 years with asthma symptomatic on ICS alone.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT02091986.
Topics: Anti-Asthmatic Agents; Asthma; Budesonide; Child; Drug Therapy, Combination; Ethanolamines; Female; Forced Expiratory Volume; Formoterol Fumarate; Humans; Male; Metered Dose Inhalers; Quality of Life; Treatment Outcome
PubMed: 28256307
DOI: 10.1016/j.anai.2017.01.020 -
World Journal of Gastroenterology Sep 2020Eosinophilic esophagitis (EoE) is an emerging chronic local immune-mediated disease of the esophagus. Beside proton pump inhibitors and food-restriction-diets swallowed... (Review)
Review
Eosinophilic esophagitis (EoE) is an emerging chronic local immune-mediated disease of the esophagus. Beside proton pump inhibitors and food-restriction-diets swallowed topical corticosteroids (STC) can be offered as a first line therapy according to current guidelines. This review describes the background and practical management of STCs in EoE. So far, mainly asthma inhalers containing either budesonide or fluticasone have been administered to the esophagus by swallowing these medications "off label". Recently esophagus-targeted formulations of topical steroids have been developed showing clinicopathological response rates up to 85% - an orodispersible tablet of budesonide has been approved as the first "in label" medication for EoE in Europe in June 2018. Whereas it was shown that disease remission induction of EoE by STCs is highly effective, there is still a lack of data regarding long-term and maintenance therapy. However, current studies on STC maintenance therapy add some movement into the game.
Topics: Adrenal Cortex Hormones; Budesonide; Deglutition; Eosinophilic Esophagitis; Europe; Humans
PubMed: 33024392
DOI: 10.3748/wjg.v26.i36.5395