Subject: In-Practice Usage and Performance (IPUP) Study of Tamdura® for the treatment of signs and symptoms of benign prostatic hyperplasia (BPH) in adult men with an enlarged prostate
Male lower urinary tract symptoms (LUTS) are one of the most common causes for consultation with a health care provider, and one of the most common causes of male LUTS is benign prostatic hyperplasia (BPH). Male LUTS is commonly divided into 3 different symptom categories: voiding or obstructive (hesitancy, slow stream, intermittency, incomplete emptying), storage or irritative (frequency, urgency, nocturia, urge urinary incontinence), and postmicturition (postvoid dribbling). Medical treatments of symptomatic BPH include: 5α-reductase inhibitors (5ARIs), α1-adrenergic antagonists, and the combination of a 5ARI and a α1-adrenergic antagonist. Tamsuloisn is a a selective α1A- and α1D-adrenoceptor antagonist indicated for the treatment of the signs and symptoms of BPH. Tamsulosin is effective in patients with mild to severe LUTS, patients with diabetes mellitus or those aged ≥65 years and does not interfere with the antihypertensive action of nifedipine, enalapril or atenolol. It has a tolerability profile similar to that of placebo (apart from a higher incidence of abnormal ejaculation, dizziness and rhinitis). Dutasteride is a potent, selective, irreversible inhibitor of type 1 and type 2 5α-reductase isoenzymes approved for the treatment of moderate to severe symptomatic BPH in men with an enlarged prostate.
The combination of an alpha-blocker and a 5ARI is an effective treatment for patients with LUTS associated with demonstrable prostatic enlargement. The rationale for this therapy is that a rapid relief of symptoms will be provided by α-blocker, and a more sustained relief of symptoms will be provided by the 5ARI. In addition, the 5-ARI will reduce the risk of serious complications such as acute urinary retention and/or the need for BPH-related surgery.
FDC of tamsulosin and dutasteride is marketed by the Amphion team of Sun Pharma as ‘TAMDURA’. It is is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate.
Although every product is marketed only after regulatory approval, it is important to know how it performs in day-to-day practice of individual medical practitioners. For this purpose, we have planed to conduct a prospective study to assess the real-life performance of ‘TAMDURA’ in treatment of the signs and symptoms of BPH.
We invite you to participate in this study. All you need to do is to report on a standard form your experience with ‘TAMDURA’ in patients in whom you prescribe this product in the normal course of your practice. Thus, this is not an experimental study because the product will be prescribed and purchased as you and your patients normally do.
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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