684 Efficacy of mirabegron in patients with and without prior antimuscarinic therapy for overactive bladder (OAB): Post-hoc analysis of a prospective, randomised European-Australian phase III trial

Khullar, Vikram; Cambronero, J.; Angulo, Javier; Wooning, M.; Blauwet, Mary Beth; Dorrepaal, Caroline; Martin, Neil E.

doi:10.1016/s1569-9056(12)60681-2

Cited by 5 publications

(7 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In addition, in a post‐hoc analysis of SCORPIO, mirabegron at a dose of 50 or 100 mg QD demonstrated improvements in the frequency of micturitions or incontinence episodes in OAB patients who had discontinued prior antimuscarinic therapy due to insufficient efficacy (66.9% of patients). In such patients, the response to tolterodine was similar to placebo …”

Section: Introductionmentioning

confidence: 80%

“…The response in treatment‐naïve patients and those who had previously discontinued antimuscarinic treatment was also examined for the pooled data . Approximately, 50% of the patients included in the pooled full analysis set (FAS) population (n = 3,542) and the patients in the FAS‐I population (n = 2,317) had previously used antimuscarinics (tolterodine, solifenacin, oxybutynin, trospium, darifenacin, propiverine, fesoterodine, or emepronium).…”

Section: Introductionmentioning

confidence: 99%

“…36 The response in treatment-na€ ıve patients and those who had previously discontinued antimuscarinic treatment was also examined for the pooled data. 37 Approximately, 50% of the patients included in the pooled full analysis set (FAS) population (n ¼ 3,542) and the patients in the FAS-I population (n ¼ 2,317) had previously used antimuscarinics (tolterodine, solifenacin, oxybutynin, trospium, darifenacin, propiverine, fesoterodine, or emepronium). Mirabegron 50 and 100 mg demonstrated improvements from baseline to final visit versus placebo in the co-primary endpoints in patients who had received prior OAB medication, as well as in those who were treatment-na€ ıve ( Table V).…”

Section: Introductionmentioning

confidence: 99%

“…In such patients, the response to tolterodine was similar to placebo. 38 A 12-month, multinational, randomized, double-blind, parallel-group, active-controlled, Phase III trial (TAURUS [Study 178-CL-049; NCT00688688]), assessed mirabegron 50 and 100 mg and tolterodine ER 4 mg QD. 39 Although the study was not designed to demonstrate a statistically significant difference in efficacy between treatment groups, mirabegron 50 and 100 mg and tolterodine ER 4 mg showed numerical improvements from months 1-12 in mean number of micturitions/24 hr, incontinence episodes/24 hr, and mean volume voided/micturition.…”

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Mirabegron in overactive bladder: A review of efficacy, safety, and tolerability

Chapple

Cardozo

Νitti

et al. 2013

Neurourology and Urodynamics

248

218

View full text Add to dashboard Cite

Aims: Mirabegron, the first b 3 -adrenoceptor agonist to enter clinical practice, has a different mechanism of action from antimuscarinic agents. This review presents data on the efficacy, safety, and tolerability of mirabegron in studies conducted to date. Methods: All clinical data on mirabegron that are currently in the public domain are included, including some in-press manuscripts. Results: In Phase III clinical trials in patients with overactive bladder (OAB), mirabegron at daily doses of 25, 50, and 100 mg demonstrated significant efficacy in treating the symptoms of OAB, including micturition frequency, urgency incontinence, and urgency. Significant improvements in micturition frequency, urgency incontinence, and mean volume voided/micturition were seen as early as the first assessment (week 4) for mirabegron 50 and 100 mg, and were maintained throughout treatment. Responder analyses showed a significant improvement with mirabegron 50 and 100 mg in terms of dry rates, !50% reduction in mean number of incontinence episodes/24 hr, and the proportion of patients with 8 micturitions/24 hr at final visit. The benefit of mirabegron 50 and 100 mg was also evident in patients !65 years of age, and in both treatment-na€ ıve patients and those who previously discontinued antimuscarinic therapy. These data therefore demonstrate a clinically meaningful benefit with mirabegron in the objective endpoints of OAB. Assessment of measures of health-related quality of life and treatment satisfaction showed that patients perceived treatment with mirabegron as meaningful. In OAB clinical trials of up to 12 months mirabegron appeared to be well tolerated. The most common adverse events (AEs) observed with mirabegron in clinical trials of up to 12 months were hypertension, nasopharyngitis, and urinary tract infection. The incidence of dry mouth was similar to placebo, and was between three and fivefold less than for tolterodine extended release 4 mg. Since dry mouth is the most bothersome AE associated with antimuscarinic drugs and often a reason for treatment discontinuation, mirabegron may be a valuable treatment option for these patients. Conclusions: In Phase III clinical trials, mirabegron at daily doses of 25, 50, and 100 mg demonstrated significant efficacy in treating symptoms of OAB and, at doses of 50 and 100 mg, demonstrated significant improvements versus placebo on key secondary endpoints, as early as the first assessment (week 4), and these were maintained throughout treatment. In OAB clinical trials of up to 12 months, mirabegron appeared to be well tolerated.

show abstract

Section: Introductionmentioning

confidence: 80%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Mirabegron in overactive bladder: A review of efficacy, safety, and tolerability

Chapple

Cardozo

Νitti

et al. 2013

Neurourology and Urodynamics

248

218

View full text Add to dashboard Cite

show abstract

“…A post hoc analysis of the SORPIO trial [Khullar et al 2011] showed that both mirabegron doses (50 mg and 100 mg once daily) were effective in improving coprimary efficacy endpoints versus placebo in antimuscarinic treatment-naïve patients and in patients whose condition failed to respond to previous antimuscarinic therapy, regardless of the reason for discontinuation [Khullar et al 2012].…”

Section: Clinical Efficacymentioning

confidence: 99%

Mirabegron: a review of recent data and its prospects in the management of overactive bladder

Sacco

Bientinesi

2012

Therapeutic Advances in Urology

112

View full text Add to dashboard Cite

Recent advances in the understanding of the physiopathology of OAB have driven a huge amount of basic and clinical research into novel pharmacological compounds. Among potential novel peripherally acting drugs, β3-adrenoceptor (AR) agonists appear very promising [Sacco et al. 2008]. Mirabegron (also known as YM178) is a novel, once-daily orally active, first-in-class, potent β 3-AR agonist [Takasu et al. 2007]. Regulatory applications for mirabegron are under review in several countries. In July 2011, mirabegron was granted marketing approval in Japan and was launched in September 2011. In June 2012 FDA also approved mirabegron (Myrbetriq, Astellas Pharma US, Inc.). Thereafter we reviewed clinical data on the safety and efficacy of mirabegron by searching English language full papers and abstracts in MEDLINE, ClinicalTrials.gov, controlled-trials.

show abstract

Evidencia disponible acerca del uso del agonista β3-adrenoceptor selectivo mirabegrón para el tratamiento de la vejiga hiperactiva

Angulo

Khullar

Νitti

et al. 2013

Actas Urológicas Españolas

View full text Add to dashboard Cite

684 Efficacy of mirabegron in patients with and without prior antimuscarinic therapy for overactive bladder (OAB): Post-hoc analysis of a prospective, randomised European-Australian phase III trial

Cited by 5 publications

References 0 publications

Mirabegron in overactive bladder: A review of efficacy, safety, and tolerability

Mirabegron in overactive bladder: A review of efficacy, safety, and tolerability

Mirabegron: a review of recent data and its prospects in the management of overactive bladder

Evidencia disponible acerca del uso del agonista β3-adrenoceptor selectivo mirabegrón para el tratamiento de la vejiga hiperactiva

Contact Info

Product

Resources

About