Table 2.
Reported treatment-related adverse events of mirabegron ≥ 2%
| Adverse events | Khullar et al39,§
|
Nitti et al41,§
|
Van Kerrebroeck et al40,#
|
||||||
|---|---|---|---|---|---|---|---|---|---|
| Placebo | Mirabegron 50 mg | Mirabegron 100 mg | Placebo | Mirabegron 50 mg | Mirabegron 100 mg | Placebo | Mirabegron 25 mg | Mirabegron 50 mg | |
| Hypertension | 7.7% | 5.9% | 5.4% | 6.6% | 6.1% | 4.9% | 8.5% | 11.3% | 10.7% |
| Nasopharyngitis | 1.6% | 2.8% | 2.8% | 2.9% | 3.4% | 2.5% | 3.2% | 3.5% | 5.7% |
| Dry mouth | 2.6% | 2.8% | 2.8% | 1.5% | 0.5% | 2.1% | * | * | * |
| Headache | 2.8% | 3.7% | 1.8% | 2.0% | 3.2% | 3.0% | 4.4% | 2.1% | 2.7% |
| Influenza | 1.6% | 2.2% | 2.0% | NR | NR | NR | NR | NR | NR |
| Sinusitis | NR | NR | NR | 2.2% | 2.0% | 2.1% | NR | NR | NR |
| Upper respiratory tract infection | * | * | * | 2.5% | 2.7% | 2.1% | 1.3% | 2.1% | 1.6% |
| Urinary tract infection | * | * | * | 1.8% | 2.7% | 3.7% | 3.3% | 4.2% | 4.8% |
| Diarrhea | NR | NR | NR | 1.3% | 2.7% | 2.1% | NR | NR | NR |
Notes:
*
Reported but < 2% for treatment groups
§
includes events reported from first dose of double-blind treatment until 30 days after the last dose of double-blind study drug
#
includes events reported from first dose of double-blind treatment until 14 days after the last dose of double-blind study drug.
Abbreviation: NR, not reported.