Subject: : To understand the usage and performance of Mirago 25 and 50 mg extended release tablets in real-life clinical practice.
Individuals are diagnosed with overactive bladder (OAB) if they experience urinary urgency, usually with increased daytime frequency and nocturia, that is not caused by a proven infection or other obvious pathology. Pharmacotherapy options principally include antimuscarinics, including solifenacin, and the b3-adrenoreceptor agonist mirabegron.
The first-in-class b3-adrenoceptor agonist mirabegron is indicated for the management of OAB syndrome. Evidence for its use in this setting includes several large phase 3 trials. Compared with placebo, oral mirabegron for 12 weeks reduced the frequency of micturition and generally also that of incontinence, with other benefits including reduced urgency, increased void volume and improved health related quality-of-life (HR-QOL). In a 12-week powered comparison versus solifenacin in patients dissatisfied with antimuscarinic efficacy, mirabegron did not demonstrate noninferiority in reducing micturition frequency or significantly differ in terms of improving other urinary symptoms. Urinary and HR-QOL benefits of mirabegron were sustained over up to 52 weeks of treatment and the drug was generally well tolerated, with a numerically lower incidence of dry mouth than antimuscarinics. Real-world data support the trial findings and indicate possible persistence and adherence benefits for mirabegron over antimuscarinics. Current clinical evidence indicates that mirabegron provides an alternative to antimuscarinics for the management of OAB in adults, including those for whom antimuscarinics have proven unsuitable.
Mirabegron 25 mg and 50mg extended-release tablets are marketed by the Amphion team of Sun Pharma as ‘Mirago 25’ and ‘Mirago 50’. It is indicated for the treatment of overactive bladder (OAB).
Post marketing of a product, it is important to know how it performs in day-to-day practice of individual medical practitioners. For this purpose, we have planned to conduct a surveillance to assess the in-practice usage and performance of ‘Mirago’ in real-life clinical practice.
We invite you to participate in this surveillance and share your experience of 25 patients in your routine clinical practice. Thus, this is not an experimental study because data of patients already receiving the product will be captured.
If you agree to participate, we request you to provide us a copy of relevant information from the patient’s case papers, and investigational reports if any (which we call source documents), in the standard data collection forms (which we call DCF). You will be responsible for seeking patient consent and for verifying the DCF with the source documents to ensure that the DCF signed by you are free from errors or omissions. The DCF will not contain the patient’s names so as to ensure confidentiality.
We trust you and we are partners in ensuring safe and effective drug therapy. In that spirit we hope you will consent to participate in this surveillance. If you do, please sign and return the enclosed reply document along with your visiting card for accuracy of records.
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