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Efficacy and safety of solifenacin plus tamsulosin OCAS in men with voiding and storage lower urinary tract symptoms: results from a phase 2, dose-finding study (SATURN).
Eur Urol. 2013 Sep; 64(3):398-407.EU

Abstract

BACKGROUND

Storage symptoms are often undertreated in men with lower urinary tract symptoms (LUTS).

OBJECTIVE

To evaluate the combination of an antimuscarinic (solifenacin) with an α-blocker (tamsulosin) versus tamsulosin alone in the treatment of men with LUTS.

DESIGN, SETTING, AND PARTICIPANTS

A double-blind, 12-wk, phase 2 study in 937 men with LUTS (≥ 3 mo, total International Prostate Symptom Score [IPSS] ≥ 13, and maximum urinary flow rate 4.0-15.0 ml/s).

INTERVENTION

Eight treatment groups: tamsulosin oral controlled absorption system (OCAS) 0.4 mg; solifenacin 3, 6, or 9 mg; solifenacin 3, 6 or 9 mg plus tamsulosin OCAS 0.4 mg; or placebo.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS

The primary efficacy end point was change from baseline in total IPSS. Secondary end points included micturition diary and quality-of-life (QoL) parameters. Post hoc subgroup analyses were performed by severity of baseline storage symptoms, with statistical comparisons presented only for tamsulosin OCAS alone versus combination therapy, due to the small sample size of the solifenacin monotherapy and placebo subgroups.

RESULTS AND LIMITATIONS

Combination therapy was associated with significant improvements in micturition frequency and voided volume versus tamsulosin OCAS alone in the total study population; improvements in total IPSS were not significant. Statistically significant improvements in urgency episodes, micturition frequency, total urgency score, voided volume, IPSS storage subscore, IPSS-QoL index, and Patient Perception of Bladder Condition were observed in a subpopulation of men with two or more urgency episodes per 24h (Patient Perception of Intensity of Urgency Scale grade 3 or 4) and eight or more micturitions per 24h at baseline (storage symptoms subgroup) with combination therapy versus tamsulosin OCAS alone (p ≤ 0.05 for the dose-response slope, all variables). Combination therapy was well tolerated, and adverse events were consistent with the safety profiles of both compounds.

CONCLUSIONS

Solifenacin plus tamsulosin OCAS did not significantly improve IPSS in the total study population but offered significant efficacy and QoL benefits over tamsulosin OCAS monotherapy in men with both voiding and storage symptoms at baseline. Combination therapy was well tolerated.

TRIAL REGISTRATION

Clinical Trials.gov Identifier: NCT00510406.

Authors+Show Affiliations

Maastricht University Medical Centre, Maastricht, The Netherlands. p.vankerrebroeck@mumc.nlNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase II
Controlled Clinical Trial
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23537687

Citation

Van Kerrebroeck, Philip, et al. "Efficacy and Safety of Solifenacin Plus Tamsulosin OCAS in Men With Voiding and Storage Lower Urinary Tract Symptoms: Results From a Phase 2, Dose-finding Study (SATURN)." European Urology, vol. 64, no. 3, 2013, pp. 398-407.
Van Kerrebroeck P, Haab F, Angulo JC, et al. Efficacy and safety of solifenacin plus tamsulosin OCAS in men with voiding and storage lower urinary tract symptoms: results from a phase 2, dose-finding study (SATURN). Eur Urol. 2013;64(3):398-407.
Van Kerrebroeck, P., Haab, F., Angulo, J. C., Vik, V., Katona, F., Garcia-Hernandez, A., Klaver, M., Traudtner, K., & Oelke, M. (2013). Efficacy and safety of solifenacin plus tamsulosin OCAS in men with voiding and storage lower urinary tract symptoms: results from a phase 2, dose-finding study (SATURN). European Urology, 64(3), 398-407. https://doi.org/10.1016/j.eururo.2013.03.031
Van Kerrebroeck P, et al. Efficacy and Safety of Solifenacin Plus Tamsulosin OCAS in Men With Voiding and Storage Lower Urinary Tract Symptoms: Results From a Phase 2, Dose-finding Study (SATURN). Eur Urol. 2013;64(3):398-407. PubMed PMID: 23537687.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of solifenacin plus tamsulosin OCAS in men with voiding and storage lower urinary tract symptoms: results from a phase 2, dose-finding study (SATURN). AU - Van Kerrebroeck,Philip, AU - Haab,François, AU - Angulo,Javier C, AU - Vik,Viktor, AU - Katona,Ferenc, AU - Garcia-Hernandez,Alberto, AU - Klaver,Monique, AU - Traudtner,Klaudia, AU - Oelke,Matthias, Y1 - 2013/03/19/ PY - 2012/12/10/received PY - 2013/03/08/accepted PY - 2013/3/30/entrez PY - 2013/3/30/pubmed PY - 2014/4/1/medline KW - Lower urinary tract symptoms KW - Overactive bladder KW - Solifenacin KW - Storage symptoms KW - Tamsulosin OCAS KW - Voiding symptoms SP - 398 EP - 407 JF - European urology JO - Eur Urol VL - 64 IS - 3 N2 - BACKGROUND: Storage symptoms are often undertreated in men with lower urinary tract symptoms (LUTS). OBJECTIVE: To evaluate the combination of an antimuscarinic (solifenacin) with an α-blocker (tamsulosin) versus tamsulosin alone in the treatment of men with LUTS. DESIGN, SETTING, AND PARTICIPANTS: A double-blind, 12-wk, phase 2 study in 937 men with LUTS (≥ 3 mo, total International Prostate Symptom Score [IPSS] ≥ 13, and maximum urinary flow rate 4.0-15.0 ml/s). INTERVENTION: Eight treatment groups: tamsulosin oral controlled absorption system (OCAS) 0.4 mg; solifenacin 3, 6, or 9 mg; solifenacin 3, 6 or 9 mg plus tamsulosin OCAS 0.4 mg; or placebo. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary efficacy end point was change from baseline in total IPSS. Secondary end points included micturition diary and quality-of-life (QoL) parameters. Post hoc subgroup analyses were performed by severity of baseline storage symptoms, with statistical comparisons presented only for tamsulosin OCAS alone versus combination therapy, due to the small sample size of the solifenacin monotherapy and placebo subgroups. RESULTS AND LIMITATIONS: Combination therapy was associated with significant improvements in micturition frequency and voided volume versus tamsulosin OCAS alone in the total study population; improvements in total IPSS were not significant. Statistically significant improvements in urgency episodes, micturition frequency, total urgency score, voided volume, IPSS storage subscore, IPSS-QoL index, and Patient Perception of Bladder Condition were observed in a subpopulation of men with two or more urgency episodes per 24h (Patient Perception of Intensity of Urgency Scale grade 3 or 4) and eight or more micturitions per 24h at baseline (storage symptoms subgroup) with combination therapy versus tamsulosin OCAS alone (p ≤ 0.05 for the dose-response slope, all variables). Combination therapy was well tolerated, and adverse events were consistent with the safety profiles of both compounds. CONCLUSIONS: Solifenacin plus tamsulosin OCAS did not significantly improve IPSS in the total study population but offered significant efficacy and QoL benefits over tamsulosin OCAS monotherapy in men with both voiding and storage symptoms at baseline. Combination therapy was well tolerated. TRIAL REGISTRATION: Clinical Trials.gov Identifier: NCT00510406. SN - 1873-7560 UR - https://www.unboundmedicine.com/medline/citation/23537687/Efficacy_and_safety_of_solifenacin_plus_tamsulosin_OCAS_in_men_with_voiding_and_storage_lower_urinary_tract_symptoms:_results_from_a_phase_2_dose_finding_study__SATURN__ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0302-2838(13)00255-8 DB - PRIME DP - Unbound Medicine ER -