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Gastroenterologia Y Hepatologia 2018Oral budesonide is a glucocorticoid of primarily local action. In the field of digestive diseases, it is used mainly in inflammatory bowel disease, but also in other... (Review)
Review
Oral budesonide is a glucocorticoid of primarily local action. In the field of digestive diseases, it is used mainly in inflammatory bowel disease, but also in other indications. This review addresses the pharmacology, pharmacodynamics and therapeutic use of budesonide. Its approved indications are reviewed, as well as other clinical scenarios in which it could play a role, in order to facilitate its use and improve the accuracy of its prescription.
Topics: Anti-Inflammatory Agents; Budesonide; Colitis, Ulcerative; Controlled Clinical Trials as Topic; Crohn Disease; Humans; Ileostomy; Postoperative Complications; Practice Guidelines as Topic
PubMed: 30007787
DOI: 10.1016/j.gastrohep.2018.05.013 -
Canadian Family Physician Medecin de... May 2022
Topics: Bronchodilator Agents; Budesonide; COVID-19; Humans; SARS-CoV-2
PubMed: 35552214
DOI: 10.46747/cfp.6805355 -
Reviews in Gastroenterological Disorders 2001Budesonide modified-release capsule is an effective form of therapy for the treatment of Crohn's disease located in the distal ileum, ileocecal region, and ascending... (Review)
Review
Budesonide modified-release capsule is an effective form of therapy for the treatment of Crohn's disease located in the distal ileum, ileocecal region, and ascending colon. Because some of the benefit of budesonide therapy results from local effects, this agent will not be very effective in the treatment of patients with extensive colitis or left-side colitis. Budesonide is equal to less effective than prednisolone or prednisone therapy in the treatment of active Crohn's disease, but is associated with fewer glucocorticoids adverse reactions.
Topics: Administration, Oral; Administration, Topical; Anti-Inflammatory Agents; Budesonide; Capsules; Crohn Disease; Glucocorticoids; Humans
PubMed: 12120182
DOI: No ID Found -
Digestive Diseases and Sciences Feb 2016Ulcerative colitis (UC) is a chronic idiopathic inflammatory disorder in which patients cycle between active disease and remission. Budesonide multi-matrix (MMX) is an... (Review)
Review
Ulcerative colitis (UC) is a chronic idiopathic inflammatory disorder in which patients cycle between active disease and remission. Budesonide multi-matrix (MMX) is an oral second-generation corticosteroid designed to deliver active drug throughout the colon. In pharmacokinetic studies, the mean relative absorption of budesonide in the region between the ascending colon and the descending/sigmoid colon was 95.9 %. In 2 identically designed, phase 3 studies (CORE I and II), budesonide MMX 9 mg once daily was efficacious and well tolerated for induction of remission of mild to moderate UC. Clinical and endoscopic remission rates were 17.9 % (CORE I) and 17.4 % (CORE II) for budesonide MMX 9 mg compared with 7.4 and 4.5 %, respectively, with placebo (p < 0.05, budesonide MMX 9 mg vs. placebo in both studies), 12.1 % with mesalamine 2.4 g, and 12.6 % with budesonide controlled ileal release capsules 9 mg. A 12-month maintenance therapy study suggested that budesonide MMX 6 mg may prolong time to clinical relapse: Median time was >1 year with budesonide MMX 6 mg versus 181 days (p = 0.02) with placebo; however, further studies are needed. In the CORE studies, budesonide MMX exhibited a favorable safety profile; the majority of adverse events were mild or moderate in intensity, and serious adverse events were uncommon. Furthermore, rates of potential glucocorticoid-related adverse events were comparable across treatment groups. The long-term (12-month) safety of budesonide MMX appears to be comparable with placebo. Data support budesonide MMX in the management algorithm of UC.
Topics: Anti-Inflammatory Agents; Budesonide; Colitis, Ulcerative; Delayed-Action Preparations; Dosage Forms; Humans
PubMed: 26541989
DOI: 10.1007/s10620-015-3897-0 -
The Lancet. Respiratory Medicine Feb 2018The peripheral blood eosinophil count might help identify those patients with chronic obstructive pulmonary disease (COPD) who will experience fewer exacerbations when... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
The peripheral blood eosinophil count might help identify those patients with chronic obstructive pulmonary disease (COPD) who will experience fewer exacerbations when taking inhaled corticosteroids (ICS). Previous post-hoc analyses have proposed eosinophil cutoffs that are both arbitrary and limited in evaluating complex interactions of treatment response. We modelled eosinophil count as a continuous variable to determine the characteristics that determine both exacerbation risk and clinical response to ICS in patients with COPD.
METHODS
We analysed data from three AstraZeneca randomised controlled trials of budesonide-formoterol in patients with COPD with a history of exacerbations and available blood eosinophil counts. Patients with any history of asthma were excluded. Negative binomial regression analysis was done using splines for modelling of continuous variables to study the primary outcome of annual exacerbation rate adjusted for exposure time and study design. The trials are registered with ClinicalTrials.gov, NCT00206167, NCT00206154, and NCT00419744.
FINDINGS
4528 patients were studied. A non-linear increase in exacerbations occurred with increasing eosinophil count in patients who received formoterol alone. At eosinophil counts of 0·10 × 10 cells per L or more, a significant treatment effect was recorded for exacerbation reduction with budesonide-formoterol compared with formoterol alone (rate ratio 0·75, 95% CI 0·57-0·99; p=0·015). Interactions were observed between eosinophil count and the treatment effects of budesonide-formoterol over formoterol on St George's Respiratory Questionnaire (p=0·0043) and pre-bronchodilator FEV (linear effect p<0·0001, p=0·067). Only eosinophil count and smoking history were independent predictors of response to budesonide-formoterol in reducing exacerbations (eosinophil count, p=0·013; smoking history, p=0·015).
INTERPRETATION
In patients with COPD treated with formoterol, blood eosinophil count predicts exacerbation risk and the clinical response to ICS.
FUNDING
AstraZeneca.
Topics: Adult; Aged; Aged, 80 and over; Bronchodilator Agents; Budesonide; Double-Blind Method; Eosinophils; Female; Humans; Male; Middle Aged; Pulmonary Disease, Chronic Obstructive; Risk; Therapeutics
PubMed: 29331313
DOI: 10.1016/S2213-2600(18)30006-7 -
Drugs Nov 2019Airway inflammation is a major contributing factor in both asthma and chronic obstructive pulmonary disease (COPD) and represents an important target for treatment.... (Review)
Review
Airway inflammation is a major contributing factor in both asthma and chronic obstructive pulmonary disease (COPD) and represents an important target for treatment. Inhaled corticosteroids (ICS) as monotherapy or in combination therapy with long-acting β-agonists or long-acting muscarinic antagonists are used extensively in the treatment of asthma and COPD. The development of ICS for their anti-inflammatory properties progressed through efforts to increase topical potency and minimise systemic potency and through advances in inhaled delivery technology. Budesonide is a potent, non-halogenated ICS that was developed in the early 1970s and is now one of the most widely used lung medicines worldwide. Inhaled budesonide's physiochemical and pharmacokinetic/pharmacodynamic properties allow it to reach a rapid and high airway efficacy due to its more balanced relationship between water solubility and lipophilicity. When absorbed from the airways and lung tissue, its moderate lipophilicity shortens systemic exposure, and its unique property of intracellular esterification acts like a sustained release mechanism within airway tissues, contributing to its airway selectivity and a low risk of adverse events. There is a large volume of clinical evidence supporting the efficacy and safety of budesonide, both alone and in combination with the fast- and long-acting β-agonist formoterol, as maintenance therapy in patients with asthma and with COPD. The combination of budesonide/formoterol can also be used as an as-needed reliever with anti-inflammatory properties, with or without regular maintenance for asthma, a novel approach that is already approved by some country-specific regulatory authorities and currently recommended in the Global Initiative for Asthma (GINA) guidelines. Budesonide remains one of the most well-established and versatile of the inhaled anti-inflammatory drugs. This narrative review provides a clinical reappraisal of the benefit:risk profile of budesonide in the management of asthma and COPD.
Topics: Anti-Inflammatory Agents; Asthma; Budesonide; Humans; Pulmonary Disease, Chronic Obstructive
PubMed: 31549299
DOI: 10.1007/s40265-019-01198-7 -
Drugs 2004Budesonide and formoterol have been combined in a single dry powder device, Symbicort Turbuhaler (budesonide/formoterol 160/9-640/18 microg/day), in an effort to... (Review)
Review
Budesonide and formoterol have been combined in a single dry powder device, Symbicort Turbuhaler (budesonide/formoterol 160/9-640/18 microg/day), in an effort to simplify asthma management. The efficacy of budesonide/formoterol as maintenance therapy in patients with asthma has been examined in several randomised studies.Twice-daily budesonide/formoterol was significantly more effective than an equivalent or higher daily dose of budesonide alone or high-dose fluticasone propionate alone at improving peak expiratory flow (PEF) in adults with predominantly moderate persistent asthma. Symptom control and the risk of mild exacerbations were significantly improved versus budesonide alone. Moreover, budesonide/formoterol appeared to be as effective as concurrent therapy with equivalent dosages of budesonide and formoterol administered via separate inhalers in adults with moderate persistent asthma. Budesonide/formoterol administered once daily was as effective as twice-daily administration (equivalent daily doses) and more effective than once-daily budesonide in adults with moderate persistent asthma. Twice-daily budesonide/formoterol significantly improved PEF compared with budesonide in paediatric patients with asthma. Adjustable maintenance dosing with budesonide/formoterol was associated with significantly less study drug use than fixed dosing with budesonide/formoterol in adults with predominantly mild or moderate persistent asthma. In two of three studies (all longer than 4 months' duration), the risk of exacerbations was significantly lower with adjustable than with fixed dosing, but no difference was detected in four short-term studies. Symptom severity was maintained or improved in most patients receiving either treatment regimen. In adults with moderate-to-severe persistent asthma, adjustable maintenance dosing with budesonide/formoterol reduced the rate of exacerbations and reliever medication use compared with fixed dosing with salmeterol/fluticasone propionate. Budesonide/formoterol was well tolerated in both fixed and adjustable dosing regimens. In conclusion, in patients with persistent asthma symptoms despite treatment with inhaled corticosteroids, budesonide/formoterol administered via a single dry powder Turbuhaler device is an effective, well tolerated, convenient treatment option, which may have the potential for improved compliance. It appears to be as effective as treatment with budesonide and formoterol administered via separate inhalers and is more effective than budesonide monotherapy in improving PEF, controlling symptoms and preventing mild exacerbations. Adjustable maintenance dosing with budesonide/formoterol is associated with a lower overall dosage and appears to maintain control as effectively as fixed dosing.
Topics: Animals; Asthma; Budesonide; Clinical Trials as Topic; Drug Combinations; Ethanolamines; Formoterol Fumarate; Humans
PubMed: 15233594
DOI: 10.2165/00003495-200464140-00006 -
Drugs 2008*The corticosteroid budesonide and the long-acting [beta]2-adrenoceptor agonist formoterol have been combined into a single pressurized metered-dose inhaler (pMDI) for... (Review)
Review
*The corticosteroid budesonide and the long-acting [beta]2-adrenoceptor agonist formoterol have been combined into a single pressurized metered-dose inhaler (pMDI) for use in patients aged > or =12 years with asthma. *In well designed 12-week clinical trials in patients with mild to moderate or moderate to severe persistent asthma, lung function improved to a significantly greater extent with twice-daily budesonide/formoterol pMDI 160 [micro]g/9 [micro]g or 320 [micro]g/9 [micro]g than with placebo or the same nominal dosage of either of the components alone. *Budesonide/formoterol pMDI was also associated with improvements from baseline in patient-reported asthma control, asthma symptom and asthma-related quality of life outcomes that were significantly greater than those with placebo and, for many endpoints, monotherapy with the individual components. *In a 52-week safety study, treatment with twice-daily budesonide/formoterol pMDI 320 [micro]g/9 [micro]g was associated with rapid and durable improvements in lung function and asthma control that were significantly greater than those with twice-daily budesonide pMDI 640 [micro]g monotherapy. *Budesonide/formoterol pMDI was well tolerated in clinical trials. Its overall adverse event profile is consistent with the known tolerability profiles of long-acting [beta]2-adrenoceptor agonist and inhaled corticosteroid therapy, and is similar to that shown with placebo.
Topics: Administration, Inhalation; Adrenal Cortex Hormones; Asthma; Budesonide; Drug Combinations; Ethanolamines; Formoterol Fumarate; Humans; Metered Dose Inhalers; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 18729536
DOI: 10.2165/00003495-200868130-00005 -
Expert Opinion on Pharmacotherapy Aug 2003Budesonide/formoterol (Symbicort), AstraZeneca plc) is a novel treatment for asthma, combining an inhaled corticosteroid - budesonide, and a long-acting beta(2)-agonist... (Review)
Review
Budesonide/formoterol (Symbicort), AstraZeneca plc) is a novel treatment for asthma, combining an inhaled corticosteroid - budesonide, and a long-acting beta(2)-agonist - formoterol, in a single inhaler, the Turbuhaler. Randomised, clinical studies in patients with asthma have demonstrated that budesonide/formoterol is more effective than the inhaled corticosteroids, budesonide and fluticasone alone, and at least as effective as both monocomponents in separate inhalers. Results from clinical studies suggest a synergistic effect when both drugs are administered via one inhaler, although the mechanisms for this are not fully understood. Budesonide/formoterol has a rapid onset of effect, apparent within 1 min of treatment, which is largely because of the properties of formoterol. Once- and twice-daily dosing with budesonide/formoterol are effective treatment options for patients with mild or moderate asthma. Studies have also shown that the beneficial safety profiles and dose relationships of both budesonide and formoterol allow dose adjustments of budesonide/formoterol in response to variations in the patient's asthma. Findings from the budesonide/formoterol adjustable maintenance dosing programme, comparing fixed and adjustable, symptom-guided dosing regimens, demonstrate that patients achieve equally good asthma control with adjustable dosing (from one inhalation twice-daily to more than four inhalations twice-daily), but at a significantly lower overall drug load. Adverse events, mainly expected inhaled corticosteroid and long-acting beta(2)agonist class effects, have been few in number and mild in nature. In addition, there is growing evidence that budesonide/formoterol is also effective in patients with chronic obstructive pulmonary disease. The future for treatment with budesonide/formoterol may include as-needed administration in addition to maintenance therapy.
Topics: Anti-Asthmatic Agents; Asthma; Budesonide; Child; Drug Combinations; Drug Synergism; Ethanolamines; Formoterol Fumarate; Humans
PubMed: 12877646
DOI: 10.1517/14656566.4.8.1393 -
Journal of the American Academy of... Feb 2022
Topics: Budesonide; Capsules; Humans; Ileostomy; Pyoderma Gangrenosum; Wound Healing
PubMed: 34097997
DOI: 10.1016/j.jaad.2021.05.053