Adrian Wagg1, Daniel Arumi2, Sender Herschorn3, Javier Angulo Cuesta4, Francois Haab5, Fady Ntanios6, Martin Carlsson7, Matthias Oelke8. 1. Geriatric Medicine, University of Alberta, Alberta, Canada. 2. Pfizer Europe-Pfizer Global Innovative Pharma Business, Madrid, Spain. 3. Urology, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada. 4. Urology, Hospital Universitario de Getafe, Getafe, Madrid, Spain. 5. Groupe Hospitalier Diaconess Croix Saint Simon - Urology, Paris, France. 6. Pfizer Inc, New York, NY, USA. 7. Pfizer European Service Center BVBA, Brussels, Belgium. 8. Urology, University of Hannover, Hannover, Bavaria, Germany.
Abstract
Background: overactive bladder (OAB) is a common condition in older persons. Antimuscarinic treatment remains the mainstay of treatment of OAB but clinicians have been reluctant to prescribe this to older patients. This study examined efficacy and safety information from patients >65 in fesoterodine trials to reaffirm efficacy and to explore the relationships between treatment emergent adverse events (TEAEs), coexisting medication and co-morbidity. Methods: data from 10 double-blind, placebo-controlled studies were analysed. A logistic regression analysis, where TEAE incidence was predicted by treatment, prior antimuscarinic treatment, number of coexisting medications, number of concomitant diseases and all possible combinations of two-way interaction terms with treatment was conducted. Results: of 4,040 patients who participated in trials; fesoterodine treatment was associated with statistically significant reductions in all disease-related and patient-reported outcomes compared to placebo. There was a significant increase in the likelihood of reporting a TEAE in association with the number of coexistent medications (odds ratio (OR) = 1.028, 95% CI: 1.0143-1.044, P < 0.003). The OR of having a TEAE with increase in the number of concomitant diseases was 1.058 (95% CI: 1.044-1.072, P < 0.0001). Central nervous system (CNS) events were few. Discussion: fesoterodine treatment led to clinically meaningful improvements across all included patient reported outcomes. The number of concomitant conditions had the greatest influence on the likelihood of an adverse event being reported. CNS TEAE were not associated with fesoterodine dose and were low across all categories of concomitant disease and coexisting medication.
Background: overactive bladder (OAB) is a common condition in older persons. Antimuscarinic treatment remains the mainstay of treatment of OAB but clinicians have been reluctant to prescribe this to older patients. This study examined efficacy and safety information from patients >65 in fesoterodine trials to reaffirm efficacy and to explore the relationships between treatment emergent adverse events (TEAEs), coexisting medication and co-morbidity. Methods: data from 10 double-blind, placebo-controlled studies were analysed. A logistic regression analysis, where TEAE incidence was predicted by treatment, prior antimuscarinic treatment, number of coexisting medications, number of concomitant diseases and all possible combinations of two-way interaction terms with treatment was conducted. Results: of 4,040 patients who participated in trials; fesoterodine treatment was associated with statistically significant reductions in all disease-related and patient-reported outcomes compared to placebo. There was a significant increase in the likelihood of reporting a TEAE in association with the number of coexistent medications (odds ratio (OR) = 1.028, 95% CI: 1.0143-1.044, P < 0.003). The OR of having a TEAE with increase in the number of concomitant diseases was 1.058 (95% CI: 1.044-1.072, P < 0.0001). Central nervous system (CNS) events were few. Discussion: fesoterodine treatment led to clinically meaningful improvements across all included patient reported outcomes. The number of concomitant conditions had the greatest influence on the likelihood of an adverse event being reported. CNS TEAE were not associated with fesoterodine dose and were low across all categories of concomitant disease and coexisting medication.
Authors: Greta Lozano-Ortega; David R Walker; Karissa Johnston; Alexis Mickle; Sean Harrigan; Basia Rogula; Rita M Kristy; John C Hairston; Carol R Schermer Journal: Drugs Aging Date: 2020-11 Impact factor: 3.923