Incidence of urinary retention during treatment with single tablet combinations of solifenacin+tamsulosin OCAS™ for up to 1 year in adult men with both storage and voiding LUTS: A subanalysis of the NEPTUNE/NEPTUNE II randomized controlled studies.
BACKGROUND
The emergence of urinary retention (UR), specifically acute urinary retention (AUR), has been a concern when treating men with lower urinary tract symptoms (LUTS) with antimuscarinic drugs.


METHODS
In NEPTUNE (12-week, double-blind), men (≥45 years) with LUTS were randomized to receive tamsulosin oral-controlled absorption system (TOCAS) 0.4 mg, fixed-dose combination (FDC) of solifenacin (Soli) 6 mg + TOCAS 0.4 mg, FDC Soli 9 mg + TOCAS 0.4 mg, or placebo. In NEPTUNE II (40-week, open-label extension of NEPTUNE), continuing patients received 4-week FDC Soli 6 mg + TOCAS, then FDC Soli 6 mg or 9 mg + TOCAS for the remainder of the study, switchable every 3 months.


RESULTS
Across both studies, 1208 men received ≥1 dose of FDC Soli 6 mg or 9 mg + TOCAS for up to 52 weeks; 1199 men completed NEPTUNE and 1066 received ≥1 dose in NEPTUNE II. In total, 13 men (1.1%; 95% CI, 0.6%-1.8%) reported a UR event while receiving FDC, eight of which were AUR (0.7%; 95% CI, 0.3%-1.3%, incidence 7/1000 man-years). Six men reported UR events while taking Soli 6 mg + TOCAS (three AUR), and seven men reported a UR event while taking Soli 9 mg + TOCAS (five AUR). One man developed AUR while taking TOCAS alone and four reported UR (three AUR) during placebo run-in. Most AUR/UR events occurred within 4 months of treatment initiation.


CONCLUSIONS
FDC Soli and TOCAS was associated with a low rate of UR and AUR in men with LUTS.
University of Bristol, Bristol, United Kingdom.|Bristol Urological Institute, Bristol, United Kingdom.
Marcus J
MJ
Drake
Hannover Medical School, Hannover, Germany.
Matthias
M
Oelke
Astellas Pharma Europe B.V., Leiden, The Netherlands.
Robert
R
Snijder
Astellas Pharma Europe B.V., Leiden, The Netherlands.
Monique
M
Klaver
Astellas Pharma Europe B.V., Leiden, The Netherlands.
Klaudia
K
Traudtner
Astellas Pharma Europe B.V., Leiden, The Netherlands.
Karin
K
van Charldorp
Astellas Pharma Europe B.V., Leiden, The Netherlands.
Dominique
D
Bongaerts
Maastricht University Medical Center, Maastricht, The Netherlands.
Philip
P
Van Kerrebroeck
D004338:Drug Combinations; D006801:Humans; D015994:Incidence; D059411:Lower Urinary Tract Symptoms / Q000150:complications* / Q000188:drug therapy; D008297:Male; D012307:Risk Factors; D000069464:Solifenacin Succinate / Q000008:administration & dosage / Q000009:adverse effects*; D013449:Sulfonamides / Q000008:administration & dosage / Q000009:adverse effects*; D013607:Tablets; D000077409:Tamsulosin; D013997:Time Factors; D016055:Urinary Retention / Q000175:diagnosis / Q000453:epidemiology* / Q000209:etiology*; D064804:Urological Agents / Q000008:administration & dosage / Q000009:adverse effects*
D004338:Drug Combinations; D013449:Sulfonamides; D013607:Tablets; D064804:Urological Agents; D000077409:Tamsulosin; D000069464:Solifenacin Succinate