Treatment Outcomes in the STAR Study: A Subanalysis of Solifenacin 5 mg and Tolterodine ER 4 mg - Abstract Show Comments
  
Tuesday, 21 August 2007
Urology Research Office, Royal Hallamshire Hospital, Sheffield, UK.

To compare OAB symptom outcomes following initial randomised treatment with solifenacin 5mg or tolterodine ER 4mg at the 4-week clinic-visit and again at 12 weeks for patients choosing to remain on this treatment dose from 4 weeks.

A prospective, double blind, double-dummy, two-arm, parallel-group, 12-week study (The STAR study) was conducted to compare the efficacy and safety of solifenacin 5/10mg and tolterodine extended release (ER) 4mg in OAB patients.

At 4 weeks mean improvements in OAB symptoms, including urgency, frequency (primary variable), incontinence and nocturia, were larger in patients randomised to solifenacin 5mg; with the difference for incontinence being statistically significant (mean reduction in incontinence episodes/24hrs in the solifenacin group of -1.30 vs. -0.90 (p=0.0181); the mean result for solifenacin 5mg amounted to a 44% additional improvement.) There was an associated significant reduction in pad use (reduced by -1.21 vs. -0.80; p=0.0089); the mean result for solifenacin 5mg amounted to a 51% additional improvement over that of tolterodine ER 4mg. For patients choosing to remain on these treatments improvements in favour of solifenacin were maintained at study end (12-weeks). Treatments were well tolerated.

Within 4 weeks solifenacin 5mg was statistically significantly better than tolterodine ER 4mg in improving incontinence and reducing incontinence pad use. Differences in efficacy in favour of solifenacin 5mg were maintained from 4 weeks for the duration of the study for patients choosing to remain on their starting dose.

Written by Chapple CR, Fianu-Jonsson A, Indig M, Khullar V, Rosa J, Scarpa RM, Mistry A, Wright DM, Bolodeoku J; for the STAR study group.

Reference

Eur Urol. 2007 Jun 6; [Epub ahead of print]

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