Safety and tolerability of once-daily tiotropium Respimat® as add-on to at least inhaled corticosteroids in adult patients with symptomatic asthma: A pooled safety analysis. (September 2016)

• Record Type: Journal Article
• Authors: Dahl, Ronald; Engel, Michael; Dusser, Daniel; Halpin, David; Kerstjens, Huib A.M.; Zaremba-Pechmann, Liliana; Moroni-Zentgraf, Petra; Busse, William W.; Bateman, Eric D.
• Is Part Of: Respiratory medicine. Volume 118(2016)
• Page Start: 102
• Page End: 111
• Publication Date: 2016-09
• Subjects: Asthma -- Respimat® -- Safety -- Tiotropium -- Tolerability; Chest -- Diseases -- Periodicals; Chest -- Diseases -- Great Britain -- Periodicals; Respiratory organs -- Diseases -- Periodicals; Respiratory Tract Diseases -- Periodicals; Appareil respiratoire -- Maladies -- Périodiques; Thorax -- Maladies -- Périodiques; Appareil respiratoire -- Maladies -- Traitement -- Périodiques; Electronic journals; 616.2
• DOI: 10.1016/j.rmed.2016.07.001
• Languages: English
• ISSNs: 0954-6111

Abstract

Abstract: Background: Tiotropium, a long-acting anticholinergic bronchodilator, has demonstrated efficacy and safety as add-on therapy to inhaled corticosteroids (ICS), with or without other maintenance therapies, in patients with symptomatic asthma. Objective: To evaluate safety and tolerability of tiotropium delivered via the Respimat ® device, compared with placebo, each as add-on to at least ICS therapy, in a pooled sample of adults with symptomatic asthma at different treatment steps. Methods: Data were pooled from seven Phase II and III, randomised, double-blind, parallel-group trials of 12–52 weeks' treatment duration, which investigated once-daily tiotropium Respimat ® (5 μg, 2.5 μg) versus placebo as add-on to different background maintenance therapy including at least ICS. Adverse events (AEs) including serious AEs were assessed throughout treatment + 30 days after the last dose of trial medication. Results: Of 3474 patients analysed, 2157 received tiotropium. The percentage of patients with AEs was comparable between treatment groups: tiotropium 5 μg, 60.8%; placebo 5 μg pool, 62.5%; tiotropium 2.5 μg, 57.1%; placebo 2.5 μg pool, 55.1%. Consistent with the disease profile, the most frequent AEs overall were asthma, decreased peak expiratory flow rate (both less frequent with tiotropium) and nasopharyngitis. Overall incidence of dry mouth, commonly associated with use of anticholinergics, was low: tiotropium 5 μg, 1.0%; placebo 5 μg pool, 0.5%; tiotropium 2.5 μg, 0.4%; placebo 2.5 μg pool, 0.5%. The percentage of cardiac disorder AEs was comparable between tiotropium and placebo: tiotropium 5 μg, 1.4%; placebo 5 μg pool, 1.4%; tiotropium 2.5 μg, 1.4%; placebo 2.5 μg pool, 1.1%. The proportions of patients with serious AEs were balanced across groups: tiotropium 5 μg, 4.0%; placebo 5 μg pool, 4.9%; tiotropium 2.5 μg, 2.0%; placebo 2.5 μg pool, 3.3%. Conclusion: Tiotropium Respimat ® demonstrated safety and tolerability comparable with those of placebo, as add-on to at least ICS therapy, at different treatment steps in adults with symptomatic asthma. Highlights: Tiotropium Respimat ® demonstrated safety and tolerability comparable with placebo. Incidence of adverse events and serious adverse events was similar between groups. Overall incidence of dry mouth, common with anticholinergic use, was low. Low number of cardiac disorder adverse events, comparable between groups. No deaths occurred during any of the trials.