📃 Paper Title: Combination therapy with solifenacin and tamsulosin oral controlled absorption system in a single tablet for lower urinary tract symptoms in men: efficacy and safety results from the randomised controlled NEPTUNE trial
🧍 Author: Philip van Kerrebroeck
🕒 Year: 2013
📚 Journal: European Urology
🌎 Country: The Netherlands
ㅤContext to the study:
Can you cite a clinical trial comparing Tamsulosin & Solifenacin combination therapy with Tamsulosin alone for the management of lower urinary tract symptoms in men?
ㅤ✅ Take-home message of study:
Combination tamsulosin 0.4 mg + solifenacin 6 mg was non-inferior to tamsulosin 0.4 mg alone in the improvement of voiding lower urinary tract symptoms and superior for storage lower urinary tract symptoms in men presenting with mixed symptoms, when compared to placebo.
The combination treatment was safe and well tolerated by most men.
Increasing the dose of solifenacin to 9mg was not of additional benefit
ㅤ Randomised controlled trial (multi-centre, international)
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Study participants:
Inclusion Criteria:
Men ≥45 years old
Presenting with mixed storage and voiding LUTS of >3 months duration
International Prostate Symptom Severity Score (IPSS) ≥13
Maximum flow rate 4-12 mls/s on a voided volume >120mls
2 or more urgency episodes in a 24 hour period
8 voids in a 24 hours period
Prostate volume <75 g
Post void residual <150 mls
Randomisation:
The study enrolled 1334 men who were randomised 1:1:1:1 to receive placebo, tamsulosin 0.4 mg alone, tamsulosin 0.4 mg + solifenacin 6mg or tamsulosin 0.4 mg + solifenacin 9 mg for 12 weeks.
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Key study outcomes:
IPSS: Similar improvements seen in IPSS score for all treatment groups compared to placebo (-6.2 to -7)
Total urgency and frequency score (TUFS): Improvements seen across all groups (tamsulosin alone -6.7, tamsulosin + solifenacin 6mg -8.1, or tamsulosin + solifenacin 9 mg -7.6). Tamsulosin + solifenacin 6mg was statistically superior to tamsulosin alone, but tamsulosin + solifenacin 9mg was not.
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Study Limitations:
The study did not assess long-term safety or efficacy of the combination treatment.
99% of the study population was of white ethnicity and it is therefore not clear if the results would be applicable to non-white populations
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