Table 1.
Summary of phase III studies investigating efficacy and safety of mirabegron in a male OAB population.
| Study |
|||||
|---|---|---|---|---|---|
| SCORPIO (046) | ARIES (047) | CAPRICORN (074) | TAURUS (049) | BEYOND | |
| Study duration | 12 weeks | 12 weeks | 12 weeks | 52 weeks | 12 weeks |
| Study design | Phase III, randomized, placebo-controlled, double-blind | Phase III, randomized, placebo-controlled, double-blind | Phase III, randomized, placebo-controlled, double-blind | Phase III, randomized, active-controlled, double-blind | Phase IIIb, non-inferiority, randomized, double-blind |
| Patient population | Adults with OAB ⩾ 3 months | Adults with OAB ⩾ 3 months | Adults with OAB ⩾ 3 months | Adults with OAB ⩾ 3 months | Adult OAB patients dissatisfied with their previous antimuscarinic due to lack of efficacy |
| Treatment arms/daily dose | Placebo; mirabegron 50 mg, mirabegron 100 mg,† tolterodine ER 4 mg‡ | Placebo, mirabegron 50 mg, mirabegron 100 mg† | Placebo, mirabegron 25 mg,* mirabegron 50 mg | Mirabegron 50 mg, mirabegron 100 mg,† tolterodine ER 4 mg | Mirabegron 50 mg, solifenacin 5 mg |
| Total proportion of males in the overall SAF | 549/1978 (27.8%) | 341/1328 (25.7%) | 408/1305 (31.3%) | 634/2444 (25.9%) | 449/1870 (24.0%) |
| Total proportion of males in the overall FAS | 534/1906 (28.0%) | 320/1270 (25.2%) | 394/1251 (31.5%) | 615/2382 (25.8%) | 443/1833 (24.2%) |
| Treatment arms included in efficacy analysis (FAS) | Placebo (n = 362), mirabegron 50 mg (n = 382) | Not applicable | Mirabegron 50 mg (n = 222), solifenacin 5 mg (n = 221) | ||
| Treatment arms included in SAF | Placebo (n = 378), mirabegron 50 mg (n = 393) | Mirabegron 50 mg (n = 210), tolterodine ER 4 mg (n = 212) | Mirabegron 50 mg (n = 224), solifenacin 5 mg (n = 225) | ||
| Efficacy data available by sex | Change from baseline to EoT: • Mean number of micturitions/24 h • Mean number of incontinence episodes/24 h • Mean number of urgency episodes (grade 3 or 4)/24 h |
No post hoc efficacy analysis in males was conducted as this study was designed primarily to assess 12-month safety | Change from baseline to EoT: • Mean number of micturitions/24 h • Mean number of incontinence episodes/24 h • Mean urgency episodes (grade 3 or 4)/24 h |
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| Safety data available by sex | • Incidence of TEAEs • Change from baseline in vital signs (blood pressure and pulse rate) • AEs of special interest (antimuscarinic AEs, urinary retention) • Change from baseline in PVR |
• Incidence of TEAEs • Change from baseline in vital signs (blood pressure and pulse rate) • AEs of special interest (antimuscarinic AEs, urinary retention) |
• Incidence of TEAEs • AEs of special interest (antimuscarinic AEs, urinary retention) |
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*
Mirabegron 25 mg results excluded as this dose was restricted to a single study (074); †Mirabegron 100 mg results not shown as this is not a licensed dose; ‡Tolterodine ER 4 mg active-control excluded from pooled analysis.
The efficacy and safety endpoints only reflect those included in this publication and do not represent all endpoints investigated in the total population in ARIES, SCORPIO, CAPRICORN, BEYOND, and TAURUS.
AE, adverse event; EoT, end of treatment; ER, extended release; FAS, full analysis set; OAB, overactive bladder; PVR, post-void residual; SAF, safety analysis set; TEAE, treatment-emergent adverse event.