title: Tamsulosin/solifenacin fixed-dose combination tablet for the treatment of male lower urinary tract symptoms.
abstract: Men reporting mixed storage and voiding lower urinary tract symptoms (LUTS) often experience persisting storage LUTS after initial treatment. Combination therapy of an alpha-adrenergic antagonist and an antimuscarinic is increasingly recognized as a therapy option. Clinical trials have combined tamsulosin (0.4 mg) with different doses of solifenacin. In the SATURN study, greater efficacy benefits were observed for moderate to severe storage symptoms. Single tablet administration may offer improved compliance. Accordingly, the NEPTUNE study researched fixed-dose combination (FDC) therapy for mixed LUTS, using tamsulosin (oral controlled administration system formulation), with solifenacin (6 or 9 mg). The FDC containing tamsulosin and solifenacin 6 mg improved storage and voiding LUTS, with no additional benefit from the higher solifenacin dose. During the open-label extension study, symptom improvement was maintained. Adverse events reflected the known effects of the component therapies. Acute urinary retention, an adverse event of special interest, was seen in only a small number of treated men.
authors.affiliation: Department of Urology, St. Cyril and Method University Hospital, Bratislava, Slovakia.
authors.forename: M
authors.initials: M
authors.lastname: Romancik
authors.affiliation: University of Bristol and Bristol Urological Institute, Southmead Hospital, Bristol, UK.
authors.forename: S
authors.initials: S
authors.lastname: Pandian
authors.affiliation: University of Bristol and Bristol Urological Institute, Southmead Hospital, Bristol, UK. marcus.drake@nbt.nhs.uk.
authors.forename: M J
authors.initials: MJ
authors.lastname: Drake
mesh_terms: D002986:Clinical Trials as Topic; D004338:Drug Combinations; D006801:Humans; D059411:Lower Urinary Tract Symptoms / Q000188:drug therapy*; D008297:Male; D000069464:Solifenacin Succinate / Q000008:administration & dosage*; D013449:Sulfonamides / Q000008:administration & dosage*; D013607:Tablets; D000077409:Tamsulosin; D064804:Urological Agents / Q000008:administration & dosage*
chemical_list: D004338:Drug Combinations; D013449:Sulfonamides; D013607:Tablets; D064804:Urological Agents; D000077409:Tamsulosin; D000069464:Solifenacin Succinate
keywords: LUTS; Muscarinic M3 receptor antagonists; Solifenacin; Tamsulosin; alpha1-Adrenoceptor antagonists