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Latest & greatest articles for budesonide
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The Use of Budesonide MMX to Induce Remission in Active, Moderate to Mild Ulcerative Colitis: A Systematic Review "The Use of Budesonide MMX to Induce Remission in Active, Moderate to M" by Terence Potter < > > > > > Title Author Date of Graduation Fall 8-10-2013 Degree Type Capstone Project Degree Name Master of Science in Physician Assistant Studies First Advisor Robert Rosenow, Pharm.D., OD Second Advisor Annjanette Sommers, PA-C, MS Rights . Abstract Background: Ulcerative colitis (UC (...) severe side effects. Budesonide, a second-generation glucocorticoid already used topically for UC, has less systemic effects, but needs an effective delivery mechanism as an oral form to treat areas unreachable via topical solutions. Budesonide multi-matrix (MMX) was just approved January 2013 for treatment. Will it be effective in inducing remission in patients with active, mild to moderate UC? Methods: An exhaustive literature search using Medline-OVID, CINAHL, EBMR Multifile, and Web of Science
Labazenit - budesonide / salmeterol 27 June 2013 EMA/465765/2013 Committee for Medicinal Products for Human Use (CHMP) CHMP assessment report Labazenit International non-proprietary names: budesonide/salmeterol Procedure No. EMEA/H/C/002201/0000 Assessment Report as adopted by the CHMP with all information of a commercially confidential nature deleted 7 Westferry Circus ? Canary Wharf ? London E14 4HB ? United Kingdom An agency of the European Union Telephone +44 (0)20 7418 8400 Facsimile +44 (...) needed. In patients with a history of multiple exacerbations there is a risk of long-term progressive decline in lung function. For all these reasons, additional treatment options are desirable. CHMP assessment report EMA/465765/2013 Page 7/181 Labazenit is a new fixed combination medicinal product containing two known components, salmeterol xinafoate and budesonide. Salmeterol and budesonide have different modes of action. Corticosteroid therapy, principally inhaled glucocorticosteroid (ICS
Clinical efficacy and safety of budesonide-formoterol in non-cystic fibrosis bronchiectasis The aim of this study is to evaluate the efficacy and safety of medium-dose formoterol-budesonide combined inhaled treatment in a single inhaler compared with high-dose budesonide treatment in patients with non-cystic fibrosis (non-CF) bronchiectasis.This is a 12-month randomized, double-blind, parallel-groups clinical trial, to run in 40 patients with non-CF bronchiectasis diagnosed by high-resolution (...) CT scan of the chest, receiving formoterol-budesonide combined treatment (18/640 μg daily) or budesonide treatment (1,600 μg daily). Variables concerning clinical condition, health-related quality of life (HRQL), lung function, β(2)-adrenergic agonist use, potentially pathogenic microorganism (PPM) isolates, and medication side effects were analyzed by intention-to-treat analysis.The study group receiving a formoterol-budesonide combined treatment showed a significant improvement, both clinically
Once-daily budesonide MMX(R) extended-release tablets induce remission in patients with mild to moderate ulcerative colitis: results from the CORE I study Budesonide is a corticosteroid with minimal systemic corticosteroid activity due to first-pass hepatic metabolism. Budesonide MMX® is a once-daily oral formulation of budesonide that extends budesonide release throughout the colon using multi-matrix system (MMX) technology.We performed a randomized, double-blind, double-dummy, placebo (...) -controlled trial to evaluate the efficacy of budesonide MMX for induction of remission in 509 patients with active, mild to moderate ulcerative colitis (UC). Patients were randomly assigned to groups that were given budesonide MMX (9 mg or 6 mg), mesalamine (2.4 g, as reference), or placebo for 8 weeks. The primary end point was remission at week 8.The rates of remission at week 8 among subjects given 9 mg or 6 mg budesonide MMX or mesalamine were 17.9%, 13.2%, and 12.1%, respectively, compared with 7.4
Budesonide/formoterol vs. salmeterol/fluticasone in COPD: a systematic review and adjusted indirect comparison of pneumonia in randomised controlled trials This analysis was designed to provide a comparison between budesonide/formoterol and salmeterol/fluticasone for the relative incidence of pneumonia adverse events, pneumonia serious adverse events and pneumonia-related mortality in patients being treated for chronic obstructive pulmonary disease.An initial literature search revealed (...) no suitable head-to-head trials between budesonide/formoterol and salmeterol/fluticasone and therefore a systematic review was conducted to find randomised controlled trials providing data for input into an adjusted indirect comparison of the two combination treatments using placebo as a common comparator. The Bucher adjusted indirect comparison method was used to calculate odds ratios and 95% confidence intervals.Eight salmeterol/fluticasone trials and four budesonide/formoterol trials were identified
Budesonide 9 mg is at least as effective as mesalamine 4.5 g in patients with mildly to moderately active Crohn`s disease Comparative data on budesonide vs mesalamine for the treatment of mild-to-moderately active Crohn's disease (CD) are sparse. We assessed the efficacy and safety of each therapy in patients with mildly to moderately active CD.We performed a randomized, double-blind, double-dummy, 8-week, multicenter study in which 309 patients with mildly to moderately active CD received pH (...) -modified-release oral budesonide (9 mg/day once daily or 3 mg/day 3 times daily) or Eudragit-L-coated oral mesalamine (4.5 g/day).The primary efficacy variable, clinical remission (defined as Crohn's Disease Activity Index ≤150), at the final visit occurred in 69.5% (107 of 154) of patients given budesonide vs 62.1% (95 of 153) of patients given mesalamine (difference, 7.4%; 95% repeated confidence interval, -4.6% to 18.0%; P = .001 for noninferiority). Clinical remission rates did not differ
Daily or intermittent budesonide in preschool children with recurrent wheezing. Daily inhaled glucocorticoids are recommended for young children at risk for asthma exacerbations, as indicated by a positive value on the modified asthma predictive index (API) and an exacerbation in the preceding year, but concern remains about daily adherence and effects on growth. We compared daily therapy with intermittent therapy.We studied 278 children between the ages of 12 and 53 months who had positive (...) values on the modified API, recurrent wheezing episodes, and at least one exacerbation in the previous year but a low degree of impairment. Children were randomly assigned to receive a budesonide inhalation suspension for 1 year as either an intermittent high-dose regimen (1 mg twice daily for 7 days, starting early during a predefined respiratory tract illness) or a daily low-dose regimen (0.5 mg nightly) with corresponding placebos. The primary outcome was the frequency of exacerbations requiring
Budesonide/formoterol vs. salmeterol/fluticasone in COPD: a systematic review and adjusted indirect comparison of pneumonia in randomised controlled trials Budesonide/formoterol vs salmeterol/fluticasone in COPD: a systematic review and adjusted indirect comparison of pneumonia in randomised controlled trials Budesonide/formoterol vs salmeterol/fluticasone in COPD: a systematic review and adjusted indirect comparison of pneumonia in randomised controlled trials Halpin DM, Gray J, Edwards SJ (...) , Morais J, Singh D CRD summary The review of indirect comparisons concluded that budesonide/formoterol was associated with fewer pneumonia events than salmeterol/fluticasone in patients with chronic obstructive pulmonary disease. The authors' conclusions seem reasonable but reporting limitations mean that cautious interpretation is warranted. Authors' objectives To compare the efficacy of budesonide/formoterol with salmeterol/fluticasone on the incidence of pneumonia adverse events, pneumonia serious
Comparative efficacy of indacaterol 150mug and 300mug versus fixed-dose combinations of formoterol + budesonide or salmeterol + fluticasone for the treatment of chronic obstructive pulmonary disease: a network meta-analysis Untitled Document The CRD Databases will not be available from 08:00 BST on Friday 4th October until 08:00 BST on Monday 7th October for essential maintenance. We apologise for any inconvenience.
Budesonide is effective in adolescent and adult patients with active eosinophilic esophagitis Eosinophilic esophagitis (EoE) is a chronic inflammatory disease of the esophagus characterized by dense tissue eosinophilia; it is refractory to proton pump inhibitor therapy. EoE affects all age groups but most frequently individuals between 20 and 50 years of age. Topical corticosteroids are effective in pediatric patients with EoE, but no controlled studies of corticosteroids have been reported (...) in adult patients.We performed a randomized, double-blind, placebo-controlled trial to evaluate the effect of oral budesonide (1 mg twice daily for 15 days) in adolescent and adult patients with active EoE. Pretreatment and posttreatment disease activity was assessed clinically, endoscopically, and histologically. The primary end point was reduced mean numbers of eosinophils in the esophageal epithelium (number per high-power field [hpf] = esophageal eosinophil load). Esophageal biopsy and blood
Oral budesonide for induction of remission in ulcerative colitis. Corticosteroids remain one of the most popular medication choices for the induction of remission in ulcerative colitis and Crohn's disease. While corticosteroids may improve symptoms, they do not always result in mucosal healing and have significant adverse effects. Steroids which act topically, with less systemic side-effects may be more desirable. Oral budesonide, a topically acting corticosteroid with extensive first pass (...) hepatic metabolism, is effective in Crohn's disease and in enema formulation for left-sided ulcerative colitis. Data are limited regarding the role of oral budesonide in ulcerative colitis.To systematically review the safety and efficacy of oral budesonide for induction of remission in ulcerative colitis.Electronic searching of the MEDLINE and EMBASE databases was performed. Two authors independently reviewed all identified titles and abstracts. Full text articles of all potentially relevant studies
Budesonide is effective in treating lymphocytic colitis: a randomized double-blind placebo-controlled study Budesonide is effective in treating collagenous colitis, but no treatment is established for lymphocytic colitis. We performed a randomized, double-blind, placebo-controlled study to evaluate the effects of budesonide in patients with lymphocytic colitis.Forty-two patients (median age, 61 years) with lymphocytic colitis and chronic diarrhea were randomly assigned to groups that were given (...) oral doses of budesonide (9 mg/d) or placebo for 6 weeks. Nonresponders at week 6 were given open-label budesonide (9 mg/d) for 6 additional weeks. A complete colonoscopy and histologic and quality-of-life analyses were performed at baseline and at week 6. The primary end point was clinical remission at 6 weeks, with last observation carried forward (LOCF). All patients who left the study in clinical remission were followed for relapse.At week 6, 86% of patients given budesonide were in clinical
Airway inflammation in patients with asthma with high-fixed or low-fixed plus as-needed budesonide/formoterol Budesonide/formoterol maintenance and reliever therapy maintains asthma control and reduces exacerbation frequency compared with higher fixed-dose combination regimens. Its effects on eosinophilic airway inflammation and structure are unknown.We sought to compare the effects of budesonide/formoterol 200/6 microg twice daily plus as-needed with budesonide/formoterol 800/12 microg twice (...) daily on airway eosinophils and remodeling.This 52-week, parallel-group, randomized, double-blind study of 127 asthma patients who were symptomatic despite therapy compared (1) the change between induced sputum percent eosinophils at baseline and the geometric mean of 4 on-treatment values and (2) the change in endobronchial biopsy eosinophil counts pre- and post-treatment.Mean daily doses of budesonide/formoterol were 604/18 microg in the maintenance and reliever therapy group and 1,600/24 microg
Oral budesonide for maintenance of remission of Crohn`s disease: a pooled safety analysis Budesonide exhibits similar efficacy to systemic glucocorticosteroids (GCSs) in Crohn's disease (CD), but with fewer adverse events (AEs). Aim To evaluate budesonide's safety profile in CD patients, in particular, incidences of clinically important AEs known to be associated with systemic GCSs.Five 1-year, double-blind, placebo-controlled trials evaluating budesonide for mild-to-moderate CD were pooled (...) for analysis.The highest incidence rates of AEs were gastrointestinal- and endocrine systems-related in both groups (budesonide 6 mg/day, n = 208; placebo, n = 209). Incidence rates were similar, except for higher incidence of endocrine disorders in budesonide versus placebo patients (P = 0.0042) caused by a higher overall occurrence of cutaneous GCS symptoms (P = 0.0036) in the budesonide group; differences in individual symptoms were nonsignificant. Percentage of patients with normal adrenal function
Long-term budesonide treatment of collagenous colitis: a randomised, double-blind, placebo-controlled trial To evaluate the efficacy and safety of long-term budesonide therapy for the maintenance of clinical remission in patients with collagenous colitis.Randomised, placebo-controlled study with a 24-week, blinded follow-up period without any treatment.Three gastroenterology clinics in Denmark.Forty-two patients with histologically confirmed collagenous colitis and diarrhoea (more than three (...) stools/day).Patients in clinical remission after 6 weeks' open-label therapy with oral budesonide (Entocort CIR capsules, 9 mg/day) received 24 weeks' double-blind maintenance therapy with budesonide 6 mg/day or placebo. Thereafter, patients entered the 24-week, blinded follow-up period.The proportion of patients in clinical remission (three or fewer stools/day) at the end of maintenance therapy.A total of 34 patients in remission at week 6 were randomly assigned to budesonide 6 mg/day (n = 17
Budesonide for maintenance of remission in Crohn's disease. Corticosteroids have been shown to be effective for induction, but not maintenance of remission in Crohn's disease. However, significant concerns exist regarding their risk for adverse events, particularly when used for long treatment courses. Budesonide is a glucocorticoid with limited systemic bioavailability due to extensive first-pass hepatic metabolism. Budesonide has been shown to be effective for induction of remission (...) in Crohn's disease.To evaluate the efficacy and safety of oral budesonide for maintenance of remission in Crohn's disease.The following electronic databases were searched: MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, the Cochrane IBD/FBD Group Specialised Trial Register, and ClinicalTrials.gov. Reference lists of articles, as well as conference proceedings were manually searched. Study authors, study sponsors and pharmaceutical companies were also contacted.Randomized controlled
Budesonide and the risk of pneumonia: a meta-analysis of individual patient data. Concern is continuing about increased risk of pneumonia in patients with chronic obstructive pulmonary disease (COPD) who use inhaled corticosteroids. We aimed to establish the effects of inhaled budesonide on the risk of pneumonia in such patients.We pooled patient data from seven large clinical trials of inhaled budesonide (320-1280 mug/day), with or without formoterol, versus control regimen (placebo (...) )).We analysed data from 7042 patients, of whom 3801 were on inhaled budesonide and 3241 were on control treatment, with 5212 patient-years of exposure to treatment. We recorded no significant difference between treatment groups for the occurrence of pneumonia as an adverse event (3% [n=122 patients] vs 3% [n=103]; adjusted hazard ratio 1.05, 95% CI 0.81-1.37) or a serious adverse event (1% [n=53] vs 2% [n=50]; 0.92, 0.62-1.35), or for time to pneumonia as an adverse event (log-rank test 0.94
Budesonide and the risk of pneumonia: a meta-analysis of individual patient data Untitled Document The CRD Databases will not be available from 08:00 BST on Friday 4th October until 08:00 BST on Monday 7th October for essential maintenance. We apologise for any inconvenience.