Subject: Understanding In-practice usage of ‘SILODAL - M’ (Silodosin 8 mg capsule + Mirabegron 25/50 mg extended release tablet) in BPH with OAB patients.
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. Silodosin is a highly selective α1A-adrenoceptor antagonist indicated for the treatment of the signs and symptoms of BPH.
Most elderly men have at least one LUTS. Prevalence of LUTS increases with increasing age and reaches 30% in the age group older than 50 years. In India, 6.7–14% prevalence of BPH was reported in hospital and community studies. In elderly patients with BPO, about 50% of patients have OAB.
In the EpiLUTS study, 47% of men had LUTS from more than one symptom category, with voiding+ storage+ postmicturition symptoms as the largest subgroup (24.3%).
In general, α1-blockers are usually used as first line pharmacotherapy for male LUTS regardless of prostate size. However, pharmacotherapy using an α1-blocker alone often fails to improve storage symptoms, including OAB, and therefore, combination therapy of an α1-blocker plus antimuscarinic has been recommended. A number of studies have reported efficacy of antimuscarinics as add-on therapy to α blockers (tamsulosin) for the treatment of OAB symptoms in men. Mirabegron, a beta3-adrenoreceptor agonist, is an alternative treatment option to antimuscarinics for OAB symptoms, with proven efficacy in both men and women.
Oral silodosin had a rapid onset of effect in men with LUTS associated with BPH, with improvements seen in voiding and storage symptoms, maximum urinary flow rate and health-related quality of life. Clinical studies of silodosin in BPH patients shown that silodosin improved Qmax (maximum flow rate of urine) within 2 to 6 hours of first dose and IPSS (International Prostate Symptom Score) within 3 to 4 days. Also, the improvement in Qmax and IPSS was sustained in 6 years long term study. It was safe in elderly BPH patients taking antihypertensive medicines and shown lesser risk of cardiovascular adverse events. Silodosin also shown significantly better improvement in nocturia as compared to placebo and numerically better improvement in IPSS and Qmax as compared to tamsulosin in a study comparing effect of silodosin and tamsulosin in BPH patients.
Mirabegron is a potent selective agonist of the β3-adrenoceptor. β3-adrenergic receptors are the predominant β-adrenergic receptor type present in the human bladder. By stimulating β3-adrenoceptors in the bladder, mirabegron likely results in bladder relaxation and thus enhanced urine storage, reductions in bladder contraction and, consequently, fewer unwanted urinations. The study showed that mirabegron did not adversely affecting voiding parameters such as the bladder contractility index versus placebo compared with placebo after 12 weeks of treatment
Combi-pack of Silodosin 8 mg capsule and Mirabegron 25/50 mg extended release tablet is marketed by the Auriel team of Sun Pharma as ‘SILODAL-M 25/50’. It is indicated for the treatment of the signs and symptoms of Benign Prostatic Hyperplasia (BPH) with Overactive bladder (OAB).
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