Subject: To understand the usage and performance of Mirago-S tablets ER 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.
Mirabegron and solifenacin have different mechanisms of action and co-administration appears to have no noticeable effect on their pharmacokinetics. Studies have demonstrated that combination treatment for 12 week leads to improved efficacy without a substantial impact on the safety profile when compared with monotherapy. Mirabegron and solifenacin combination treatment for OAB symptoms was well tolerated over 12 months and led to efficacy improvements over each monotherapy.
Fixed dose combination of Mirabegron 50mg extended release and Solifenacin 5 mg is marketed by the Amphion team of Sun Pharma as ‘Mirago-S’. 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-S’ 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 & other details 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.
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