Cardiovascular safety of mirabegron add-on therapy to tamsulosin for the treatment of overactive bladder in men with lower urinary tract symptoms : A post hoc analysis from the MATCH study
© 2020 Astellas Pharma Inc. LUTS: Lower Urinary Tract Symptoms published by John Wiley & Sons Australia, Ltd..
OBJECTIVES: To investigate the cardiovascular safety of mirabegron add-on treatment to tamsulosin in male patients with residual overactive bladder symptoms.
METHODS: This was a post hoc analysis of MATCH, the first double-blind, placebo-controlled study comparing mirabegron and placebo as add-on therapy to tamsulosin for treatment of overactive bladder in men with lower urinary tract symptoms. The analysis focused on treatment-emergent adverse events relating to the cardiovascular system or blood pressure, and changes in vital signs during 12 weeks of follow-up.
RESULTS: Cardiovascular-related treatment-emergent adverse events were reported by 6/566 patients, although only one serious treatment-emergent adverse event was related to treatment (unstable angina in the tamsulosin + placebo group). Hypertension (two patients) and increased blood pressure (one patient) were reported in the tamsulosin + placebo group, but there were no blood pressure-related treatment-emergent adverse events among tamsulosin + mirabegron patients. There were no clinically meaningful changes from baseline in blood pressure, and changes in pulse rate were small (+1.2 bpm in the tamsulosin + mirabegron group). Increased pulse rate was more frequent with tamsulosin + mirabegron than with tamsulosin + placebo in older patients, although within the normal range.
CONCLUSIONS: Cardiovascular-related adverse events were uncommon in both treatment groups. Mirabegron is a well-tolerated add-on therapy to tamsulosin in Japanese and Korean males with residual overactive bladder symptoms.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:13 |
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| Enthalten in: |
Lower urinary tract symptoms - 13(2021), 1 vom: 18. Jan., Seite 98-107 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Katoh, Takao [VerfasserIn] |
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| Links: |
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| Themen: |
Acetanilides |
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| Anmerkungen: |
Date Completed 06.10.2021 Date Revised 06.10.2021 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1111/luts.12339 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM315458070 |
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| 100 | 1 | |a Katoh, Takao |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Cardiovascular safety of mirabegron add-on therapy to tamsulosin for the treatment of overactive bladder in men with lower urinary tract symptoms |b A post hoc analysis from the MATCH study |
| 264 | 1 | |c 2021 | |
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| 500 | |a Date Completed 06.10.2021 | ||
| 500 | |a Date Revised 06.10.2021 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2020 Astellas Pharma Inc. LUTS: Lower Urinary Tract Symptoms published by John Wiley & Sons Australia, Ltd. | ||
| 520 | |a OBJECTIVES: To investigate the cardiovascular safety of mirabegron add-on treatment to tamsulosin in male patients with residual overactive bladder symptoms | ||
| 520 | |a METHODS: This was a post hoc analysis of MATCH, the first double-blind, placebo-controlled study comparing mirabegron and placebo as add-on therapy to tamsulosin for treatment of overactive bladder in men with lower urinary tract symptoms. The analysis focused on treatment-emergent adverse events relating to the cardiovascular system or blood pressure, and changes in vital signs during 12 weeks of follow-up | ||
| 520 | |a RESULTS: Cardiovascular-related treatment-emergent adverse events were reported by 6/566 patients, although only one serious treatment-emergent adverse event was related to treatment (unstable angina in the tamsulosin + placebo group). Hypertension (two patients) and increased blood pressure (one patient) were reported in the tamsulosin + placebo group, but there were no blood pressure-related treatment-emergent adverse events among tamsulosin + mirabegron patients. There were no clinically meaningful changes from baseline in blood pressure, and changes in pulse rate were small (+1.2 bpm in the tamsulosin + mirabegron group). Increased pulse rate was more frequent with tamsulosin + mirabegron than with tamsulosin + placebo in older patients, although within the normal range | ||
| 520 | |a CONCLUSIONS: Cardiovascular-related adverse events were uncommon in both treatment groups. Mirabegron is a well-tolerated add-on therapy to tamsulosin in Japanese and Korean males with residual overactive bladder symptoms | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a benign prostatic hyperplasia | |
| 650 | 4 | |a cardiovascular | |
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| 700 | 1 | |a Lee, Kyu-Sung |e verfasserin |4 aut | |
| 700 | 1 | |a Ishida, Kota |e verfasserin |4 aut | |
| 700 | 1 | |a Katou, Daisuke |e verfasserin |4 aut | |
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| 700 | 1 | |a Uno, Satoshi |e verfasserin |4 aut | |
| 700 | 1 | |a Yamaguchi, Osamu |e verfasserin |4 aut | |
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