📃 Paper Title: Long-term safety and efficacy of single-tablet combinations of solifenacin and tamsulosin oral controlled absorption system in men with storage and voiding lower urinary tract symptoms: results from the NEPTUNE Study and NEPTUNE II open-label extension
🧍 Author: Marcus J Drake
🕒 Year: 2015
📚 Journal: European Urology
🌎 Country: United Kingdom
ㅤContext to the study:
Can you tell me about a study that demonstrated the safety of combined antimuscarinic and alpha-blocker treatment for mixed lower urinary tract symptoms (LUTS)?
ㅤ✅ Take-home message of study:
This was the first long-term study evaluating the efficacy and safety of a combined alpha blocker and antimuscarinic. There was significant improvement in symptoms as measured by the International Prostate Symptom Score as well as urinary frequency over 12 months. The authors report a urinary retention rate of 1.1% that ranged from 6 to 347 days (median 77) after medication was started. Long-term treatment with fixed-dose combination (FDC) Solifenacin and Tamsulosin was well tolerated and efficacious in men with storage and voiding LUTS, with a low incidence of AUR.
ㅤ NEPTUNE II was a 40-week, multicentre, open-label, flexible-dosing, phase 3 extension study following the 12-week, double-blind NEPTUNE study.
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Study participants:
NEPTUNE enrolled men aged 45 yr, with International Prostate Symptom Score (IPSS) 13, a maximum urinary flow rate (Qmax) of 4.0-12.0 ml/s, ultrasound-estimated prostate size <75 ml, two or more urgency episodes per 24 hours and eight or more micturitions per 24 hours. 1066 men completed NEPTUNE and received one dose or more of study medication in NEPTUNE II.
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Key study outcomes:
The NEPTUNE study researched the safety and efficacy of FDC therapy for mixed LUTS, using tamsulosin 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. These positive effects on symptomatology endured throughout the NEPTUNE II study, an open-label extension of the original research. Notably, the occurrence of acute urinary retention, an adverse event of particular interest, was observed only in a minor subset of treated men.
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Study Limitations:
There was no placebo arm in the NEPTUNE II study. The percentage of patients reaching a clinically relevant improvement on FDC treatment could not therefore be compared with a control arm. However, the preceding 12-week NEPTUNE study demonstrated significant benefit with FDC for all key efficacy parameters over placebo and for storage and QoL parameters over tamsulosin. The combined analysis of NEPTUNE allowed prospective comparison of the 6 mg and 9 mg FDCs, whereas NEPTUNE II patients were allowed to switch doses based on their experience in the study. The combined analyses, therefore, covered data from two dose groups.
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