A proof-of-concept study: mirabegron, a new therapy for overactive bladder.

AIMS: To evaluate the potential of mirabegron, a selective ß3-adrenoceptor agonist, for treatment of overactive bladder (OAB) symptoms. METHODS: A multicenter, randomized, double-blind, double-dummy, parallel group, placebo and active-controlled, Phase 2, proof-of-concept study was conducted. Eligible patients (n = 314) were enrolled into a single-blind, 2-week placebo run-in period followed by a randomized, double-blind, placebo-controlled treatment period. Patients received mirabegron 100 or 150 mg twice-daily (BID), placebo or tolterodine 4 mg extended release (ER) once-daily for 4 weeks. Primary endpoint was change from baseline to end-of-treatment in mean number of micturition episodes per 24 hr. Secondary endpoints included changes in mean volume voided per micturition; mean number of urinary incontinence, urgency urinary incontinence, and urgency episodes per 24 hr; severity of urgency; nocturia, and quality of life measures. Safety parameters included adverse events, laboratory tests, electrocardiogram parameters and post-void residual volume. RESULTS: Mirabegron 100 and 150 mg BID resulted in a statistically significant improvement versus placebo in mean change from baseline to end-of-treatment in the primary endpoint of micturition frequency (2.2 micturitions/24 hr vs. 1.2 micturitions/24 hr for both doses, adjusted P ≤ 0.01 for both comparisons). Mirabegron had a statistically significant effect versus placebo for most secondary endpoints, including quality of life variables. Despite a small increase in pulse rate, mirabegron demonstrated good safety and tolerability. CONCLUSIONS: Mirabegron was efficacious and well tolerated in patients with OAB symptoms and heralds the first of a new class of oral pharmacological therapy for OAB for more than 30 years.

[Penile metastasis like first sign of esophagus carcinoma]. / Metástasis peneana como primera manifestación de un carcinoma esofágico.

We present a new case of penile metastatic disease. The original tumour has been situated in the esophagus, which is a rare clinical situation. But what becomes exceptional in our clinical case is that the penile metastasis was the first disease symptom, since until this moment the original tumour has been silent. Like the majority of these cases the prognosis was gloomy and the patient died in few months after the clinical beginning of the disease.

Metástasis peneana como primera manifestación de un carcinoma esofágico / Penile metastasis like first sign of esophagus carcinoma

Presentamos un nuevo caso de enfermedad metastásica en pene. El tumor primitivo se originó en el esófago, lo que es una rareza clínica. Pero lo que hace excepcional a nuestro caso clínico es que fue la metástasis peneana el primer síntoma de la enfermedad, ya que hasta entonces el tumor primitivo permanencia silente. Como en la mayoría de casos similares el pronóstico fue pésimo y el paciente falleció a los pocos meses del inicio clínico de la enfermedad metastásica peneana (AU)

We present a new case of penile metastatic disease. The original tumour has been situated in the esophagus, which is a rare clinical situation. But what becomes exceptional in our clinical case is that the penile metastasis was the first disease symptom, since until this moment the original tumour has been silent. Like the majority of these cases the prognosis was gloomy and the patient died in few months after the clinical beginning of the disease (AU)