Cardiovascular safety in refractory incontinent patients with overactive bladder receiving add-on mirabegron therapy to solifenacin (BESIDE)
| Autor: | Marcus J. Drake, Stavros Athanasiou, Scott MacDiarmid, Sender Herschorn, Christopher R. Chapple, Javier Cambronero Santos, Moses Huang, Matthias Stoelzel, Emad Siddiqui, David Mitcheson, Ahmet Adil Esen |
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| Jazyk: | angličtina |
| Rok vydání: | 2017 |
| Předmět: |
Solifenacin Succinate
Adult Male medicine.medical_specialty Combination therapy medicine.drug_class Urology 030232 urology & nephrology Adrenergic beta-3 Receptor Agonists Muscarinic Antagonists urologic and male genital diseases QT interval Drug Administration Schedule 03 medical and health sciences 0302 clinical medicine Double-Blind Method medicine Anticholinergic Humans Single-Blind Method Aged Aged 80 and over Original Paper Solifenacin business.industry Urinary Bladder Overactive General Medicine Middle Aged medicine.disease Thiazoles Blood pressure Treatment Outcome Overactive bladder Centre for Surgical Research Cardiovascular Diseases 030220 oncology & carcinogenesis Anesthesia Acetanilides Drug Therapy Combination Female Mirabegron business medicine.drug Follow-Up Studies |
| Zdroj: | International Journal of Clinical Practice Drake, M J, MacDiarmid, S, Chapple, C R, Esen, A, Athanasiou, S, Cambronero Santos, J, Mitcheson, D, Herschorn, S, Siddiqui, E, Huang, M & Stoelzel, M 2017, ' Cardiovascular safety in refractory incontinent patients with overactive bladder receiving add-on mirabegron therapy to solifenacin (BESIDE) ', International Journal of Clinical Practice, vol. 71, no. 5, e12944 . https://doi.org/10.1111/ijcp.12944 Repositorio Institucional de la Consejería de Sanidad de la Comunidad de Madrid Consejería de Sanidad de la Comunidad de Madrid |
| ISSN: | 1368-5031 |
| Popis: | Aims/objectives: In the BESIDE study, combination therapy (antimuscarinic [solifenacin] and β3-adrenoceptor agonist [mirabegron]) improved efficacy over solifenacin monotherapy without exacerbating anticholinergic side effects in overactive bladder (OAB) patients; however, a potential synergistic effect on the cardiovascular (CV) system requires investigation. Methods: OAB patients remaining incontinent despite daily solifenacin 5 mg during 4-week single-blind run-in, were randomised 1:1:1 to double-blind daily combination (solifenacin 5 mg/mirabegron 25 mg, increasing to 50 mg after week 4), solifenacin 5 or 10 mg for 12 weeks. CV safety assessments included frequency of CV-related treatment-emergent adverse events (TEAEs), change from baseline in vital signs (systolic blood pressure [SBP], diastolic blood pressure [DBP], pulse rate) and electrocardiogram (ECG) parameters. Results: The frequency of hypertension, tachycardia and ECG QT prolongation, respectively, was low and comparable across combination (1.1%, 0.3%, 0.1%), solifenacin 5 mg (0.7%, 0.1%, 0.1%), and solifenacin 10 mg groups (0.8%, 0%, 0.1%). Adjusted mean (SE) change from baseline to end of treatment (EoT) in SBP, DBP, and pulse rate with combination (0.07 mm Hg [0.38], −0.35 mm Hg [0.26], 0.47 bpm [0.28]), solifenacin 5 mg (−0.93 mm Hg [0.38], −0.45 mm Hg [0.26], 0.43 bpm [0.28]) and solifenacin 10 mg (−1.28 mm Hg [0.38], −0.48 mm Hg [0.26], 0.27 bpm [0.28]) was generally comparable, with the exception of a mean treatment difference of ~1 mm Hg in SBP between combination and solifenacin monotherapy; SBP was unchanged with combination and decreased with solifenacin monotherapy. Mean changes from baseline to EoT in ECG parameters were generally similar across treatment groups, except for QT interval corrected using Fridericia's formula, which was higher with solifenacin 10 mg (3.30 mseconds) vs. combination (0.49 mseconds) and solifenacin 5 mg (0.77 mseconds). Conclusion: The comparable frequency of CV-related TEAEs, changes in vital signs and ECG parameters indicates no synergistic effect on CV safety outcomes when mirabegron and solifenacin are combined. |
| Databáze: | OpenAIRE |
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