A strategy utilizing ambulatory monitoring and home and clinic blood pressure measurements to optimize the safety evaluation of noncardiovascular drugs with potential for hemodynamic effects

Weber, Michael A.; Chapple, Christopher R.; Gratzke, Christian; Herschorn, Sender; Robinson, Dudley; Frankel, Jeffrey; Ridder, Arwin; Stoelzel, Matthias; Paireddy, Asha; Maanen, Rob van; White, William Β.

doi:10.1097/mbp.0000000000000320

Cited by 11 publications

(7 citation statements)

References 31 publications

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“…Slightly higher increases in pulse rate were observed in the combination and mirabegron groups compared with the solifenacin group (1.0, 1.2, and 0.3 bpm, respectively). This finding was expected given the known effect of mirabegron on heart rate [14][15][16].…”

Section: Discussionmentioning

confidence: 53%

Long-term Safety and Efficacy of Mirabegron and Solifenacin in Combination Compared with Monotherapy in Patients with Overactive Bladder: A Randomised, Multicentre Phase 3 Study (SYNERGY II)

Gratzke¹,

Maanen

Chapple

et al. 2018

European Urology

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This study looked at the safety and efficacy of a combination of solifenacin succinate 5mg plus mirabegron 50mg tablets over 12 mo in patients with the overactive bladder (OAB) symptoms of increased urination frequency, heightened urgency to urinate, and unintentional passing of urine. We compared this treatment with solifenacin succinate 5mg or mirabegron 50mg alone, and found that the combination treatment was well tolerated by patients and led to greater improvements in symptoms. This novel combination could be an improved treatment option in the clinical setting for patients with OAB. This study is registered at ClinicalTrials.gov as NCT02045862.

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Section: Discussionmentioning

confidence: 53%

Long-term Safety and Efficacy of Mirabegron and Solifenacin in Combination Compared with Monotherapy in Patients with Overactive Bladder: A Randomised, Multicentre Phase 3 Study (SYNERGY II)

Gratzke¹,

Maanen

Chapple

et al. 2018

European Urology

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“…A paper published last month in the journal Blood Pressure Monitoring by Weber and colleagues 18 is of note here. It discussed the employment of ABPM as part of a comprehensive blood pressure safety evaluation in patients with an overactive bladder (OAB) receiving solifenacin, mirabegron, or a combination of both compared with placebo.…”

Section: A Recent Study Employing Abpm Is Of Notementioning

confidence: 97%

“Assessment of Pressor Effects of Drugs”—A New US FDA Draft Guidance for Industry

Turner

2018

Ther Innov Regul Sci

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On May 31, 2018, the US Food and Drug Administration (FDA) released a draft Guidance for Industry titled "Assessment of Pressor Effects of Drugs." 1 The purpose of the guidance is to advise sponsors with regard to premarketing assessment of a drug's off-target effect on blood pressure. Given that elevated blood pressure is known to increase the risk of stroke, heart attack, and death, a drug's effect on blood pressure can be an important consideration in benefit-risk assessment. As is typical in such documents, the guidance notes that it does not establish legally enforceable responsibilities, and that the use of the word "should" means that something is suggested or recommended, but not required. 1 That said, it can reasonably be assumed that sponsors will give this guidance considerable attention.

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“…All statistical analyses were performed using the JMP 15 software (SAS Institute, Cary, NC, USA). The number of samples was determined on the basis of previous reports [14][15][16]. Hence, we set a probability of 0.05 (two-sided), a power of 80%, and an effect size of 0.5.…”

Section: Statistical Analysesmentioning

confidence: 99%

Impact of Mirabegron Administration on the Blood Pressure and Pulse Rate in Patients with Overactive Bladder

et al. 2022

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Background and Objectives: To determine changes in the blood pressure (BP) and pulse rate (PR) before and after the administration of mirabegron in real-world clinical practice for patients with overactive bladder (OAB). Materials and Methods: This study was conducted in patients newly diagnosed with OAB. Before and 12 weeks after mirabegron treatment, we evaluated the effects on BP and PR. An overall examination was conducted, and the patients were divided into two groups according to their age: a young group (<65 years old) and an old group (≥65 years old). Results: A total of 263 patients were enrolled in this study. In the overall and intragroup comparisons, the systolic BP (SBP) did not change significantly after mirabegron administration. However, an increase in SBP of ≥10 mmHg was observed in 53 (20.2%), 4 (7.4%), and 49 (23.4%) in the entire group, young group, and old group, respectively (p = 0.009). Regarding diastolic BP, a significant decrease after the treatment was detected in entire (71.2 ± 11.4 versus 69.8 ± 10.7 mmHg; p = 0.041) and old patients (71.5 ± 10.6 versus 69.5 ± 10.2 mmHg; p = 0.012). There was no significant change in PR in our study population. Further examination using a propensity match score revealed that age was the risk factor for the increase in SBP after mirabegron administration. Conclusions: Mirabegron does not have any adverse effects on BP and PR. However, since some patients in this study had elevated SBP after administration, we suggest regular BP monitoring during mirabegron treatment.

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A strategy utilizing ambulatory monitoring and home and clinic blood pressure measurements to optimize the safety evaluation of noncardiovascular drugs with potential for hemodynamic effects

Abstract: Supplemental Digital Content is available in the text.

Cited by 11 publications

References 31 publications

Long-term Safety and Efficacy of Mirabegron and Solifenacin in Combination Compared with Monotherapy in Patients with Overactive Bladder: A Randomised, Multicentre Phase 3 Study (SYNERGY II)

Long-term Safety and Efficacy of Mirabegron and Solifenacin in Combination Compared with Monotherapy in Patients with Overactive Bladder: A Randomised, Multicentre Phase 3 Study (SYNERGY II)

“Assessment of Pressor Effects of Drugs”—A New US FDA Draft Guidance for Industry

Impact of Mirabegron Administration on the Blood Pressure and Pulse Rate in Patients with Overactive Bladder

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