Safety and efficacy of mirabegron in daily clinical practice: a prospective observational study.
OBJECTIVE
To determine risks associated with prescribing mirabegron, the first-in-class β3-adrenoreceptor agonist, to non-selected female patients with overactive bladder.


METHODS
Routine female patients seeking treatment for overactive bladder (n=221) in a urology/gynecology outpatient clinic. Data on adverse events, cardiovascular outcomes, condition specific symptoms and drug discontinuation was collected at two months follow-up (FU). Non-parametric statistics was used as appropriate. Odds ratios (ORs) with 95% confidence intervals (CIs) for outcome association analyses using logistic regression.


RESULTS
16 patients (7.2%) discontinued treatment because of side effects. There were no significant associations between cardiovascular adverse events and pre-existing cardiovascular disease (OR 0.3, 95% CI 0.3-2.6), or pre-existing ECG abnormalities (OR 2.3, 95% CI 0.3-16.3). At FU ECGs there were no de novo cases of tachyarrhythmias and no significant difference in mean QTc between baseline (403ms, SD 21.7) and the 2 months follow-up ECG (403ms, SD 20.3) (p=0.75). There was a significant decrease in the mean systolic blood pressure (p=0.03) but no significant change in mean diastolic pressure (p=0.8) or heart rates (p=0.2) from baseline to FU. Overactive bladder specific symptoms and quality of life improved significantly (p<0.001 respectively).


CONCLUSIONS
Mirabegron treatment is associated with a satisfactory cardiovascular safety profile, as well as, significant symptomatic improvement also in a heterogeneous population of non-selected women with overactive bladder presenting in everyday clinical practice.
Department of Women's and Children's Health, Karolinska Institutet, Solna, Stockholm, Sweden; Department of Clinical Sciences, Karolinska Institutet, Danderyd Hospital, Solna, Stockholm, Sweden.
Helena Kopp
HK
Kallner
GynStockholm, St Göran Hospital, Solna, Stockholm, Sweden.
Anna Almén
AA
Christensson
Stockholm Urogynecological Clinic, Solna, Stockholm, Sweden.
Caroline
C
Elmér
Department of Anesthesiology, Surgical Services and Intensive Care Medicine, Karolinska University Hospital, Solna, Stockholm, Sweden.
Benjamin
B
Flam
Department of Clinical Sciences, Karolinska Institutet, Danderyd Hospital, Solna, Stockholm, Sweden; Stockholm Urogynecological Clinic, Solna, Stockholm, Sweden; Department of Statistics and Quantitative Methods, University of Milano-Bicocca, Milano, Italy. Electronic address: daniel.altman@ki.se.
Daniel
D
Altman
D000083:Acetanilides / Q000009:adverse effects / Q000627:therapeutic use*; D058667:Adrenergic beta-3 Receptor Agonists / Q000009:adverse effects / Q000627:therapeutic use*; D000368:Aged; D002318:Cardiovascular Diseases / Q000139:chemically induced / Q000453:epidemiology; D015331:Cohort Studies; D016903:Drug Monitoring; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D055118:Medication Adherence; D008875:Middle Aged; D010044:Outpatient Clinics, Hospital; D011446:Prospective Studies; D011788:Quality of Life; D012306:Risk; D057566:Self Report; D012720:Severity of Illness Index; D013548:Sweden / Q000453:epidemiology; D013844:Thiazoles / Q000009:adverse effects / Q000627:therapeutic use*; D053201:Urinary Bladder, Overactive / Q000188:drug therapy* / Q000503:physiopathology; D064804:Urological Agents / Q000009:adverse effects / Q000627:therapeutic use*
D000083:Acetanilides; D058667:Adrenergic beta-3 Receptor Agonists; D013844:Thiazoles; D064804:Urological Agents; C520025:mirabegron
Cardiovascular; Drug; Mirabegron; Overactive bladder