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Open-label, 9-month extension study investigating the uro-selective alpha-blocker silodosin in men with LUTS associated with BPH

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Abstract

Objectives

To evaluate the long-term safety (primary objective) and efficacy/impact on quality of life (QoL, secondary objectives) of silodosin 8 mg once daily in men with LUTS/BPH.

Patients and Methods

Men who completed the 12-week double-blind study with silodosin 8 mg, tamsulosin 0.4 mg, or placebo were offered to continue with the 9-month open-label study during which all patients received silodosin 8 mg once daily. Safety was assessed by analysing vital signs, electrocardiograms, laboratory tests, and adverse events. Efficacy was evaluated with the International Prostate Symptom Score (IPSS), IPSS voiding and storage sub-scores, IPSS–QoL, and maximum urinary flow rate (Q max).

Results

A total of 500 patients (mean age 66 years) entered the 9-month open-label study. Treatment-emergent adverse events (TEAE) were experienced by 33.4 % patients. Ejaculation dysfunction was the most common TEAE (9.0 %) but led to study discontinuations in only 1.6 % of patients. Dizziness without orthostatic hypotension occurred in 0.8 %. A marked reduction in total IPSS (−2.7 ± 3.8) was documented at the first visit of this extension phase in patients having de novo silodosin compared with lesser improvement in patients previously treated with silodosin (−0.82 ± 4.2) or tamsulosin (−0.83 ± 3.8). Improvements were maintained throughout the open-label phase. QoL also improved, with the greatest improvement in de novo silodosin patients. No relevant changes in Q max occurred.

Conclusions

Long-term treatment with silodosin was safe and efficacious. Abnormal ejaculation was the most common TEAE, but led to treatment discontinuation in only 1.6 % of patients. Orthostatic hypotension was not seen, and only a few patients experienced dizziness.

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Acknowledgments

This study was initiated and supported by Recordati Industria Chimica e Farmaceutica SpA, Milan, Italy. The authors would like to thank Mr. Alessandro Antonellini and Mr. Massimo Casi for their valuable support with regard to study monitoring, data summary, and proof reading.

Conflicts of interest

Nadir I. Osman has no conflict of interest. Christopher R. Chapple is a consultant and researcher for Allergan, Astellas, Pfizer, and Recordati. Teuvo L. Tammela is a consultant and researcher for Astellas, Pfizer, and Recordati. Andreas Eisenhardt is speaker, advisor and/or trial participant of Berlin-Chemie, Ipsen, Janssen-Cilag, Lilly, Recordati, and Takeda. Matthias Oelke is speaker, advisor and/or trial participant of Apogepha, Astellas, GlaxoSmithKline, Lilly, Mundipharma, Pfizer, Recordati, and Sophiris.

Ethical standard

The trial was registered under clinical trials registration number NCT00359905. Ethics committee approval was obtained for each centre, and written informed consent was obtained from all study participants. The study was designed and performed according to the GCP recommendations and the 1964 Declaration of Helsinki.

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Authors and Affiliations

  1. Department of Urology, The Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Foundation Trust, Glossop Road, Sheffield, S10 2JF, UK

    Nadir I. Osman & Christopher R. Chapple

  2. Department of Urology, Tampere University Hospital, Tampere, Finland

    Teuvo L. Tammela

  3. School of Medicine, University of Tampere, Tampere, Finland

    Teuvo L. Tammela

  4. PUR/R Practiceclinic Urology Rhein-Ruhr, Mülheim, Germany

    Andreas Eisenhardt

  5. Department of Urology, Hannover Medical School, Hannover, Germany

    Matthias Oelke

Authors
  1. Nadir I. Osman
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  2. Christopher R. Chapple
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  3. Teuvo L. Tammela
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  4. Andreas Eisenhardt
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  5. Matthias Oelke
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Corresponding author

Correspondence to Christopher R. Chapple.

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Osman, N.I., Chapple, C.R., Tammela, T.L. et al. Open-label, 9-month extension study investigating the uro-selective alpha-blocker silodosin in men with LUTS associated with BPH. World J Urol 33, 697–706 (2015). https://doi.org/10.1007/s00345-015-1519-2

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  • DOI: https://doi.org/10.1007/s00345-015-1519-2

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