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Systematic review and meta-analysis of randomized controlled trials evaluating silodosin in the treatment of non-neurogenic male lower urinary tract symptoms suggestive of benign prostatic enlargement

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An Erratum to this article was published on 04 July 2013

Abstract

Purpose

To perform a systematic review and meta-analysis of randomized clinical trials (RCTs) reporting the efficacy and safety of silodosin in the treatment of non-neurogenic male LUTS suggestive of benign prostatic enlargement.

Patients and methods

A systematic review searching multiple dataset for the term “silodosin”. A meta-analysis was conducted using Review Manager software (Cochrane Collaboration, Oxford, UK).

Results

Our systematic search retrieved four studies summarizing the data of five RCTs. Silodosin was more effective than placebo with regard to mean change in all the parameters related to the IPSS and Qmax (all p values <0.0003). Adverse events (AE), abnormal ejaculation (AEj), and withdrawal due to AE were all more common with silodosin (all p values <0.001). The prevalence of dizziness and adverse events other than AEj was similar with silodosin and placebo. Silodosin was more effective than tamsulosin 0.2 mg with regard to some IPSS-related parameters and Qmax (p ≤ 0.05). Silodosin and tamsulosin 0.4 mg were similarly effective in all the efficacy analyses. AEj was less common with tamsulosin 0.2 and 0.4 mg (p values <0.00001); adverse events other than AEj were more common with tamsulosin 0.2 and 0.4 mg (p values ≤0.05).

Conclusions

Silodosin was significantly more effective than placebo and tamsulosin 0.2 mg in improving symptoms and as effective as tamsulosin 0.4 mg. With regard to adverse events, AEj was more common with silodosin. All the adverse events other than AEj were significantly more common with tamsulosin 0.2 and 0.4 mg and as frequent with silodosin and placebo.

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Conflict of interest

W. Artibani: speaker for Astellas, Ipsen, Zambon; C.R. Chapple: Consultant to AMS and Lilly, Consultant and Researcher to ONO; Consultant, Researcher and Speaker to Allergan, Astellas, Pfizer and Recordati; F. Montorsi: consultant Recordati, Eli Lilly, GSK, Astellas, Pierre Fabre, Takeda; G. Novara: advisory board member/consultant/researcher/speaker for Astellas, GSK, Lilly, Pierre Fabre, Recordati, Takeda; R. Sanseverino: consultant/speaker for GSK, Takeda, Pierre Fabre. Financial support from IPSEN, J&J, Olympus, Storz, Angelini, Bayer; S. Spatafora: consultant/advisory board member for Takeda, GSK, Astellas; speaker for Sanofi Aventis, Recordati; A. Tubaro: advisory board member/consultant/researcher/speaker for Allergan, Amgen, AMS, Astellas, GSK, Novartis, Takeda and F. Zattoni: nothing to disclose.

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Authors and Affiliations

  1. Department of Oncological, Surgical, and Gastroenterological Sciences, Urology Clinic, University of Padua, Via Giustiniani 2, 35100, Padua, Italy

    Giacomo Novara & Filiberto Zattoni

  2. Department of Urology, Sant’Andrea Hospital, La Sapienza University, Rome, Italy

    Andrea Tubaro

  3. Ospedale Umberto I, Salerno, Italy

    Roberto Sanseverino

  4. Azienda Ospedaliera Santa Maria Nuova, Reggio Emilia, Italy

    Sebastiano Spatafora

  5. University of Verona, Verona, Italy

    Walter Artibani

  6. Urologic Research Institute, Vita Salute San Raffaele University, Milan, Italy

    Francesco Montorsi

  7. Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital, Glossop Road, Sheffield, S10 2JF, UK

    Christopher R. Chapple

Authors
  1. Giacomo Novara
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  2. Andrea Tubaro
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  3. Roberto Sanseverino
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  4. Sebastiano Spatafora
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  5. Walter Artibani
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  6. Filiberto Zattoni
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  7. Francesco Montorsi
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  8. Christopher R. Chapple
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Corresponding author

Correspondence to Giacomo Novara.

Additional information

The idea of the paper arose during advisory board held by Takeda and Recordati on Silodosin. Members of the advisory board received a fee by the sponsor for participation.

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Novara, G., Tubaro, A., Sanseverino, R. et al. Systematic review and meta-analysis of randomized controlled trials evaluating silodosin in the treatment of non-neurogenic male lower urinary tract symptoms suggestive of benign prostatic enlargement. World J Urol 31, 997–1008 (2013). https://doi.org/10.1007/s00345-012-0944-8

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  • DOI: https://doi.org/10.1007/s00345-012-0944-8

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