Phase III Study to Assess Long ‐Term (52‐Week) Safety and Efficacy of Mirabegron, a β3‐Adrenoceptor Agonist, in Japanese Patients with Overactive Bladder

ConclusionsThere were no safety or tolerability concerns associated with mirabegron 50 mg (with an optional dose increase to 100 mg) over 52 weeks. Improvement in micturition variables was maintained with mirabegron 50 mg from weeks 8 to 52.
Source: LUTS: Lower Urinary Tract Symptoms - Category: Urology & Nephrology Authors: Tags: ORIGINAL ARTICLE Source Type: research

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Wrapping up this year and looking back on the particularly interesting developments in medical technology, we at Medgadget are impressed and very excited about the future. We’re lucky to cover one of the most innovative fields of research and o...
Source: Medgadget - Category: Medical Devices Authors: Tags: Exclusive Source Type: blogs
ConclusionA favorable CV safety profile was observed following long ‐term combination treatment with mirabegron and an antimuscarinic in patients with OAB symptoms.
Source: LUTS: Lower Urinary Tract Symptoms - Category: Urology & Nephrology Authors: Tags: ORIGINAL ARTICLE Source Type: research
Cardiovascular Safety of the β3 -Adrenoceptor Agonist Mirabegron and the Antimuscarinic Agent Solifenacin in the SYNERGY Trial. J Clin Pharmacol. 2018 Apr 12;: Authors: White WB, Chapple C, Gratzke C, Herschorn S, Robinson D, Frankel J, Ridder A, Stoelzel M, Paireddy A, van Maanen R, Weber MA Abstract There have been concerns that treatment of overactive bladder with β3 -adrenoceptor agonists may potentially have detrimental cardiovascular (CV) side effects. We evaluated the CV safety of mirabegron, a β3 -adrenoceptor agonist, alone and in combination therapy with the antimuscarinic age...
Source: The Journal of Clinical Pharmacology - Category: Drugs & Pharmacology Authors: Tags: J Clin Pharmacol Source Type: research
ConclusionThe comparable frequency of CV‐related TEAEs, changes in vital signs and ECG parameters indicates no synergistic effect on CV safety outcomes when mirabegron and solifenacin are combined.
Source: International Journal of Clinical Practice - Category: Internal Medicine Authors: Tags: ORIGINAL PAPER Source Type: research
Conclusions Once-daily solifenacin oral suspension in children with OAB was superior to placebo for MVV (primary efficacy endpoint) and was well tolerated. Patient summary In this 12-wk study, a once-daily oral suspension of solifenacin in children aged 5–<12 yr with overactive bladder was superior to placebo in increasing mean volume voided/micturition, the primary efficacy variable in the study. Solifenacin was well tolerated, with a low incidence of dry mouth and constipation. This study is registered at ClinicalTrials.gov as NCT01565707. A once-daily oral suspension of solifenacin in children aged 5–<...
Source: European Urology - Category: Urology & Nephrology Source Type: research
ConclusionsMirabegron was well tolerated in real‐world Japanese patients with overactive bladder and coexisting cardiovascular disease. No unexpected cardiovascular safety concerns were observed.
Source: International Journal of Urology - Category: Urology & Nephrology Authors: Tags: Original Article Source Type: research
Conclusions Mirabegron treatment is associated with a satisfactory cardiovascular safety profile, as well as, significant symptomatic improvement also in a heterogeneous population of non-selected women with overactive bladder presenting in everyday clinical practice.
Source: European Journal of Obstetrics and Gynecology and Reproductive Biology - Category: OBGYN Source Type: research
Conclusions Mirabegron, a novel first-in-class therapy, appeared as a safe and effective alternative for children with idiopathic OAB refractory to antimuscarinics. Patient summary We evaluated the efficacy and safety of mirabegron to treat incontinence in pediatric patients. Continence, median voided volumes, and quality of life were improved after the introduction of mirabegron, and few side effects were reported. Mirabegron, a β3-adrenoreceptor agonist, is of interest for the treatment of overactive bladder in pediatrics because it improves median voided volume, quality of life, and number of incontinence episodes...
Source: European Urology - Category: Urology & Nephrology Source Type: research
ConclusionsPropiverine ER 30 mg was confirmed to be an effective and well‐tolerated treatment option for patients with OAB symptoms. This first head‐to‐head study showed non‐inferiority of propiverine ER 30 mg compared with tolterodine ER 4 mg.
Source: BJU International - Category: Urology & Nephrology Authors: Tags: Original Article Source Type: research
ConclusionsPropiverine ER 30 mg was confirmed to be an effective and well‐tolerated treatment option for patients with OAB symptoms. This first head‐to‐head study showed non‐inferiority of propiverine ER 30 mg compared with tolterodine ER 4 mg.
Source: BJU International - Category: Urology & Nephrology Authors: Tags: Original Article Source Type: research
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