Real-life effectiveness and safety of the inhalation suspension budesonide comparator vs the originator product for the treatment of patients with asthma: a historical cohort study using a US health claims database

Abstract

Objective: The objective of this study was to determine whether the effectiveness of budesonide comparator is non-inferior to budesonide reference in the prevention of asthma exacerbations. Asthma-related hospitalizations and safety were also examined. Methods: This study used a matched, historic cohort design. Data were drawn from the Clinformatics ™ Data Mart US claims database and included a 1-year baseline, starting 1 year before the index prescription date, and a 1-year outcome period. Patients received budesonide comparator or reference treatment. The primary outcome was the rate of asthma exacerbations. Non-inferiority for budesonide comparator vs budesonide reference was established if the 95% confidence interval (CI) upper limit of mean difference in proportions between treatments was <15%. Secondary outcomes examined rate of asthma-related hospitalizations and adverse events (AEs). Results:The budesonide comparator and reference-matched cohorts each included 3109 patients. The adjusted upper 95% CI for the difference in proportions of patients experiencing asthma exacerbations was 0.035 (3.5%), demonstrating non-inferiority. Cohorts did not significantly differ in the rate of asthma exacerbations (adjusted rate ratio [RR]=1.04, 95% CI: 0.95-1.14) or rate of asthma-related hospitalizations (adjusted RR=1.10, 95% CI: 0.99-1.24) after adjusting for baseline confounders. No asthma exacerbations occurred during the outcome period in 72.9% of budesonide comparator patients and 71.8% of budesonide reference patients. No asthma-related hospitalizations occurred in 77.9% of patients in the budesonide comparator cohort and 79.0% of patients in the budesonide reference cohort. The most frequent AEs were throat irritation (≤0.4% of patients) and hoarseness/dysphonia (0.02% of patients). AEs did not significantly differ between treatment cohorts. Conclusion:In this real-life study, non-inferiority of the budesonide comparator vs reference was met for the primary end point of asthma exacerbation rates. Asthma-related hospitalization and AE rates did not differ between the two treatment cohorts. The budesonide comparator is an effective and safe treatment alternative for asthma exacerbations.

Comparison of Corticosteroids by 3 Approaches to the Treatment of Chronic Rhinosinusitis With Nasal Polyps

“…Consistent with previous studies investigating the use of BIS nebulization in asthmatics,424344 the current study also showed no effect of treatment on hypothalamic-pituitary-adrenal (HPA) axis suppression as evidenced by lack of significant changes in morning serum cortisol over the treatment period. Serum cortisol levels of the treated patients did not differ from the reference values of the laboratory; however, serum cortisol was reduced by 18.7% in the BIS-treated group, 2.2% in the nasal spray-treated group and 87.9% in the oral methylprednisolone-treated group.…”

Current and recommended practices for evaluating adverse drug events using electronic health records: A systematic review

“…The remaining were a prospective cohort study 36 and a genome-wide association study. 37 All studies utilized EHR data, of which 18 (69.2%) [14][15][16]18,19,22,23,[25][26][27][28][29][30][31][32][34][35][36] analyzed claims databases as well. The sample sizes ranged from 100 to 1000 (n = 4, 15.4%), 1001 to 10 000 (n = 7, 26.9%), and > 10 000 (n = 15, 57.7%).…”

Using Inhaled Corticosteroids in Children with Bronchial Obstruction and Respiratory Viral Infections

“…Будесонид суспензия отличается высоким профилем безопасности, что доказано многочисленными исследованиями [18][19][20][21]. Длительная терапия будесонид суспензией детей с БА не оказывала влияния на их конечный рост [19].…”

“…Кроме того, не было значимой разницы в минеральной плотности и уровне кальция в костях между получавшими будесонид и детьми контрольной группой [20]. Благодаря этим данным препарат разрешен детям раннего возраста, начиная с 6 месяцев, беременным женщинам и кормящим матерям [18].…”

“…В ходе рандомизированного плацебо-контролируемого двойного слепого мультицентрового исследования также изучалась безопасность небулизированной суспензии будесонида у детей 6-12 месяцев (n = 141) с персистирующей среднетяжелой БА или рецидивирующими свистящими хрипами [18]. Профиль безопасности ингаляционного будесонида был сопоставим с таковым у плацебо.…”