A Phase III, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicentre Study to Assess the Efficacy and Safety of the ?3 Adrenoceptor Agonist, Mirabegron, in Patients With Symptoms of Overactive Bladder - 28/07/13
Abstract |
Objective |
To assess the efficacy and tolerability of mirabegron 25 mg and 50 mg once-daily vs placebo in patients with overactive bladder (OAB).
Materials and Methods |
Patients ≥18 years with OAB symptoms were recruited to a 2-week, single-blind, placebo run-in. Those with ≥8 micturitions per 24 hours and ≥3 urgency episodes were randomized 1:1:1 to once-daily mirabegron 25 mg or 50 mg, or placebo for 12 weeks. Primary endpoints were changes to final visit in mean number of incontinence episodes and micturitions per 24 hours. Key secondary endpoints were changes to final visit in mean volume voided or micturition, change to week 4 in mean number of incontinence episodes and micturitions per 24 hours, changes to final visit in mean level of urgency, number of urgency incontinence episodes, and urgency (grade 3 or 4) episodes per 24 hours. Patient-reported outcomes were assessed using the OAB-questionnaire, Patient Perception of Bladder Condition, and Treatment-Satisfaction-Visual Analog Scale.
Results |
Both mirabegron groups demonstrated statistically significant improvements in coprimary endpoints vs placebo. Mirabegron 50 mg demonstrated significantly greater improvements vs placebo in the following: change to final visit in mean volume voided per micturition and change to week 4 in mean number of incontinence episodes per 24 hours. Statistically significant improvements vs placebo were demonstrated by mirabegron 50 mg in all patient-reported outcome scales with no increase in the incidence of treatment-emergent adverse events vs placebo.
Conclusion |
Mirabegron 25 mg and 50 mg were associated with significant improvements in efficacy measures of incontinence episodes and micturition frequency. Mirabegron was well tolerated vs placebo.
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| ClinicalTrials.gov identifier: NCT00912964. |
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| Financial Disclosure: Sender Herschorn is a Consultant and Speaker for Astellas, Pfizer, Allergan and Eli Lilly, and an Advisor and Clinical Trial Investigator for Astellas, Pfizer, and Allergan. Jack Barkin is a Consultant/Investigator/Lecturer/on the Medical Advisory Board for Astellas, Merck, GSK, Astra Zeneca, Ferring, Eli Lilly, and Pfizer. David Castro-Diaz is a Consultant/Speaker and participates in trials for Astellas, is a Consultant for Pfizer and Takeda, and participates in trials for Allergan. Jeffrey Frankel is a Consultant/Advisor/Lecturer/Investigator for Astellas, a Lecturer/Investigator for Ferring, a Lecturer for GSK and Eli Lilly, and on the Speaker's bureau for Amgen. Montserrat Espuna-Pons is a speaker for Astellas and Pfizer. Angelo Gousse is an investigator for Astellas and Allergan. Matthias Stölzel and Adrie Gunther are employees of Astellas Pharma Europe B.V. Nancy Martin is an employee of Astellas Pharma Global Development. Philip Van Kerrebroeck is a Consultant for Astellas, Allergan, and Ferring and a speaker for Astellas, Medtronic, and Ferring. |
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| Funding Support: The study and medical writing support were funded by Astellas. |
Vol 82 - N° 2
P. 313-320 - août 2013 Retour au numéro
Article précédent
- Endoscopic Management of Intraluminal Ureteral Endometriosis
- Crystal V. Castaneda, Edan Y. Shapiro, Jennifer J. Ahn, Jason P. Van Batavia, Mark V. Silva, Yungkhan Tan, Mantu Gupta
- Editorial Comment
- Andrea Tubaro, Cosimo De Nunzio, Federica Puccini
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