mirabegron
Fuentes regulatorias consultadas
Indicaciones aprobadas
- Tratamiento sintomático de urgencia, frecuencia e incontinencia de urgencia en adultos con vejiga hiperactiva.
Contraindicaciones
Absolutas
- Hipertensión grave no controlada, definida como presión sistólica ≥180 mmHg o diastólica ≥110 mmHg; hipersensibilidad.
Advertencias clínicas
- Advertencia mayor · Puede aumentar la presión arterial; medirla antes y periódicamente durante el tratamiento. — CIMA/AEMPS, ficha técnica 112809010
- Advertencia mayor · Vigilar retención urinaria, especialmente con obstrucción de salida vesical o antimuscarínicos, y suspender ante angioedema. — CIMA/AEMPS, ficha técnica 112809010
Interacciones medicamentosas
- SeveraSustratos de CYP2D6 de margen estrecho
Mecanismo: Mirabegrón inhibe CYP2D6 y puede aumentar su exposición.
Recomendación: Monitorizar y ajustar el sustrato cuando sea necesario.
CIMA/AEMPS, ficha técnica 112809010https://cima.aemps.es/cima/dochtml/ft/112809010/FT_112809010.html
- ModeradaDigoxina
Mecanismo: Puede aumentar la exposición a digoxina por interacción con P-gp.
Recomendación: Iniciar digoxina con la menor dosis, monitorizar niveles y ajustar.
CIMA/AEMPS, ficha técnica 112809010https://cima.aemps.es/cima/dochtml/ft/112809010/FT_112809010.html
- SeveraInhibidores potentes de CYP3A4
Mecanismo: Aumentan la exposición a mirabegrón; el efecto es mayor con insuficiencia renal o hepática.
Recomendación: Limitar a 25 mg/día en insuficiencia renal leve-moderada o hepática leve; evitar en insuficiencia renal grave o hepática moderada.
CIMA/AEMPS, ficha técnica 112809010https://cima.aemps.es/cima/dochtml/ft/112809010/FT_112809010.html
Eventos adversos
Comunes (≥1%)
Taquicardia · Infección urinaria · Cefalea · Mareo · Estreñimiento o náuseas
Raros pero graves
Fibrilación auricular · Crisis hipertensiva · Retención urinaria · Angioedema
Embarazo y lactancia
No se recomienda durante el embarazo ni en mujeres con potencial fértil sin anticoncepción; no debe utilizarse durante la lactancia.
Bibliografía reciente (PubMed)
Up to 40% of men older than 50 years have lower urinary tract symptoms, including urinary urgency, nocturia, and weak urinary stream, due to disorders of the bladder and prostate. These symptoms negatively affect quality of life and may be associated with urinary retention, which can cause kidney insufficiency, bladder calculi, hematuria, and urinary tract infections. In men, lower urinary tract symptoms can be caused by bladder outlet obstruction secondary to benign prostatic hyperplasia (BPH), an overactive bladder detrusor (a syndrome of urinary urgency and frequency), or both. Behavioral therapy, including pelvic floor physical therapy, timed voiding (voiding at specific intervals), and fluid restriction, can improve symptoms. Medications including α-blockers (such as tamsulosin), 5α-reductase inhibitors (such as finasteride), and phosphodiesterase 5 inhibitors (such as tadalafil) improve lower urinary tract symptoms (mean improvement, 3-10 points on the International Prostate Symptom Score [IPSS], which ranges from 0-35, with higher scores indicating greater severity) and can prevent symptom worsening measured by increased IPSS greater than or equal to 4 points or development of secondary sequelae, such as urinary retention. Combination therapies are more effective than monotherapy. For example, α-blockade (eg, tamsulosin) combined with 5α-reductase inhibition (eg, finasteride) lowers progression risk to less than 10% compared with 10% to 15% with monotherapy. Treatment for overactive bladder detrusor muscle, including anticholinergics (eg, trospium) and β3 agonists (eg, mirabegron), reduces voiding frequency by 2 to 4 times per day and reduces episodes of urinary incontinence by 10 to 20 times per week. Surgery (eg, transurethral resection of the prostate, holmium laser enucleation of the prostate) and minimally invasive surgery are highly effective for refractory or complicated cases of BPH, defined as persistent symptoms despite behavioral and pharmacologic
Overactive bladder (OAB) symptoms of frequency, urgency and urge incontinence are frequently associated with known neurological diseases like multiple sclerosis (MS), spinal cord injury (SCI), Parkinson's disease (PD), stroke. The aim of our study was to review the efficacy of pharmacological and non-pharmacological treatments for neurogenic overactive bladder. We searched two electronic databases (PubMed and EMBASE) for randomized controlled trials focusing on pharmacological and non-pharmacological medical treatments for overactive bladder symptoms associated with neurological diseases published up to 30 April 2022. A total of 157 articles were retrieved; 94 were selected by title and abstract screening; after removal of 17 duplicates, 77 records were evaluated by full-text examination. Sixty-two studies were finally selected. The articles selected for review focused on the following interventions: anticholinergics (n = 9), mirabegron (n = 5), comparison of different drugs (n = 3), cannabinoids (n = 2), intravesical instillations (n = 3), botulinum toxin (n = 16), transcutaneous tibial nerve stimulation (TTNS) (n = 6), acupuncture (n = 2), transcutaneous electrical nerve stimulation TENS (n = 4), pelvic floor muscle training (PFMT) (n = 10), others (n = 2). Anticholinergics were more effective than placebo in decreasing the number of daily voids in patients with PD (mean difference [MD]- 1.16, 95 % CI - 1.80 to - 0.52, 2 trials, 86 patients, p < 0.004), but no significant difference from baseline was found for incontinence episodes and nocturia. Mirabegron was more effective than placebo in increasing the cystometric capacity in patients with MS (mean difference [MD] 89.89 mL, 95 % CI 29.76 to 150.01, 2 trials, 98 patients, p < 0.003) but no significant difference was observed for symptom scores and bladder diary parameters. TTNS was more effective than its sham-control in decreasing the number of nocturia episodes (MD -1.40, 95 % CI -2.39 to -0.42, 2 trials, 53 p
The aim of this study was to indirectly compare the efficacy and safety of mirabegron and vibegron in patients with overactive bladder. A systematic search was performed on Pubmed, Web of Science, Embase, and the Cochrane Central Register of Controlled Trials databases to identify studies from the date of database inception to January 1, 2022. All randomized controlled trials comparing mirabegron or vibegron with tolterodine, imidafenacin, or placebo were eligible. One reviewer extracted data, and a second reviewer checked. Included trials were assessed for similarity, and networks were developed using Stata 16.0 software. Mean differences for continuous variables and odds ratios for dichotomous variables together with their 95% confidence intervals (CIs) were used to rank treatments and compare the differences, respectively. A total of 11 randomized controlled trials and 10 806 patients were included. For each outcome, results for all licensed treatment doses were included. Both vibegron and mirabegron were more efficacious than placebo at reducing the frequency of micturition, incontinence, urgency, urgency incontinence, and nocturia. Vibegron was more efficacious than mirabegron in reducing mean voided volume/micturition (95% CI [5.15, 14.98]). Safety outcomes for vibegron and mirabegron were similar to those in the placebo group, except for mirabegron, which had a higher risk of nasopharyngitis and cardiovascular adverse events than placebo. Both drugs seem to be comparable and well tolerated, particularly as direct comparisons are not available. However, vibegron may be more effective than mirabegron in reducing mean voided volume.
bladder based on a systematic review and network meta-analysis approach. Pubmed, Embase, Web of Science, and the Cochrane Register of Clinical Trials databases were systematically searched. The search time frame was from database creation to June 2, 2022. Randomized controlled double-blind trials of oral medication for overactive bladder were screened against the protocol's entry criteria. Trials were evaluated for quality using the Cochrane Risk of Bias Assessment Tool, and data were statistically analyzed using Stata 16.0 software. A total of 60 randomized controlled double-blind clinical trials were included involving 50,333 subjects. Solifenacin 10mg was the most effective in mean daily micturitions and incontinence episodes, solifenacin 5/10mg in mean daily urinary urgency episodes and nocturia episodes, fesoterodine 8mg in urgency incontinence episodes/d and oxybutynin 5mg in voided volume/micturition. In terms of safety, solifenacin 5mg, ER-tolterodine 4mg, mirabegron, vibegron and ER-oxybutynin 10mg all showed a better incidence of dry mouth, fesoterodine 4mg, ER-oxybutynin 10mg, tolterodine 2mg, and vibegron in the incidence of constipation. Compared to placebo, imidafenacin 0.1mg showed a significantly increased incidence in hypertension, solifenacin 10mg in urinary tract infection, fesoterodine 4/8mg and darifenacin 15mg in headache. Solifenacin showed better efficacy. For safety, most anticholinergic drugs were more likely to cause dry mouth and constipation, lower doses were better tolerated. The choice of drugs should be tailored to the patient's specific situation to find the best balance between efficacy and safety.