Safety of tiotropium Respimat® in black or African-American patients with symptomatic asthma

Abstract

Background: Black patients with asthma have a higher disease burden and greater morbidity compared with other racial/ethnic groups. Tiotropium Respimat ® , as add-on to at least inhaled corticosteroids (ICS), improves lung function and asthma control and reduces asthma exacerbation risk in patients, with a safety profile comparable with placebo. This study aimed to assess the safety of tiotropium Respimat ® , compared with placebo, in black or African-American patients. Methods: Data were pooled from 12 randomized, placebo-controlled, parallel-group, Phase II or III trials from the global Boehringer Ingelheim program with once-daily tiotropium Respimat ® (5 μg or 2.5 μg). Trial participants had symptomatic persistent asthma with a broad range of severities and were aged 1-75 years. The safety results of black or African-American patients were compared with the overall trial population. Results: Of the 5165 patients treated with tiotropium or placebo, 3.2% were black or African American. For both doses of tiotropium, the proportion of patients reporting adverse events (AEs) was approximately 10% lower compared with placebo and was generally comparable with the proportion of patients reporting AEs in all groups of the overall population. The number of investigator-assessed drug-related AEs, AEs leading to trial drug discontinuation or serious AEs reported by patients was low and comparable between treatment groups and with the overall population. Conclusion: Tiotropium Respimat ® appears to be a generally safe add-on bronchodilator treatment option to ICS with or without other controllers in pediatric and adult black or African-American patients with asthma.

Maintenance Therapy for Children and Adolescents with Asthma: Guidelines and Recommendations from the Emilia-Romagna Asthma (ERA) Study Group

“…In particular, a pooled analysis of 5 RCTs supports the favorable risk-benefit profile of once-daily tiotropium as an add-on to maintenance ICS with or without additional controllers in pediatric patients with symptomatic asthma [116]. The safety of tiotropium was extensively proven in a pooled analysis of 12 RCTs (aged 1 to 75 years) [119].…”

Optimizing asthma management: Role of long-acting muscarinic antagonists

“…54 This study did not indicate the superiority of LABA plus ICS compared with tiotropium (Handihaler; 18 mg tiotropium) plus ICS in Black patients with asthma. 54 Graham et al 65 compared the safety of TioR (5 mg or 2.5 mg) 1 time each day in Black or African-American patients aged 1 to 75 years with persistent symptomatic asthma of varying severities with that in the overall population by analyzing the pooled data from 12 randomized, placebocontrolled, parallel-group, phase II or III trials. TioR was found to be a generally safe add-on bronchodilator to ICS with or without other controllers in this population.…”

“…TioR was found to be a generally safe add-on bronchodilator to ICS with or without other controllers in this population. 65 According to the most current NAEPP recommendations, the Expert Panel conditionally recommends that, in patients aged 12 years or more with uncontrolled persistent asthma, ICS plus LAMA should generally not be chosen over ICS plus LABA unless LABAs are not available to the patient or not appropriate due to concerns about lack of efficacy or safety concerns. 7 The Expert Panel conditionally recommends adding a LAMA to ICS controller therapy versus continuing the same dose of ICS alone.…”