Drake Marcus J, Oelke Matthias, Snijder Robert, Klaver Monique, Traudtner Klaudia, van Charldorp Karin, Bongaerts Dominique, Van Kerrebroeck Philip
University of Bristol, Bristol, United Kingdom.
Bristol Urological Institute, Bristol, United Kingdom.
PLoS One. 2017 Feb 6;12(2):e0170726. doi: 10.1371/journal.pone.0170726. eCollection 2017.
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.
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.
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.
FDC Soli and TOCAS was associated with a low rate of UR and AUR in men with LUTS.
在使用抗毒蕈碱药物治疗下尿路症状（LUTS）的男性患者时，尿潴留（UR）尤其是急性尿潴留（AUR）的出现一直是个令人担忧的问题。
在NEPTUNE研究（为期12周的双盲研究）中，患有LUTS的男性（≥45岁）被随机分配接受坦索罗辛口服控释系统（TOCAS）0.4毫克、索利那新（Soli）6毫克+TOCAS 0.4毫克的固定剂量组合（FDC）、索利那新9毫克+TOCAS 0.4毫克的FDC或安慰剂。在NEPTUNE II研究（为期40周，NEPTUNE的开放标签扩展研究）中，继续参与研究的患者先接受4周的索利那新6毫克+TOCAS的FDC治疗，然后在研究的剩余时间接受索利那新6毫克或9毫克+TOCAS的FDC治疗，每3个月可切换一次。
在两项研究中，1208名男性接受了长达52周的索利那新6毫克或9毫克+TOCAS的FDC至少1剂治疗；1199名男性完成了NEPTUNE研究，1066名在NEPTUNE II研究中接受了至少1剂治疗。总共有13名男性（1.1%；95%置信区间，0.6%-1.8%）在接受FDC治疗时报告了尿潴留事件，其中8例为急性尿潴留（0.7%；95%置信区间，0.3%-1.3%，发病率为7/1000人年）。6名男性在服用索利那新6毫克+TOCAS时报告了尿潴留事件（3例急性尿潴留），7名男性在服用索利那新9毫克+TOCAS时报告了尿潴留事件（5例急性尿潴留）。1名男性在单独服用TOCAS时发生了急性尿潴留，4名在安慰剂导入期报告了尿潴留（3例急性尿潴留）。大多数急性尿潴留/尿潴留事件发生在治疗开始后的4个月内。
索利那新与TOCAS的FDC在患有LUTS的男性中与低尿潴留和急性尿潴留发生率相关。
