Table 2.
Characteristics and results of studies on tamsulosin/solifenacin FDC
| Author | Type of study | Number of participants | Trial design | Outcome measures | Efficacy | Changes in primary efficacy variables from baseline to EoT | Safety |
|---|---|---|---|---|---|---|---|
| van Kerrebroeck et al13 (NEPTUNE) | 12-week, double-blind, randomized, placebo controlled | 1,328 | 2-week placebo run-in period, 12-week treatment period with placebo (341 pts), TAM 0.4 mg (327 pts), TAM 0.4 mg + SOL 6 mg (339 pts) and TAM 0.4 mg + SOL 9 mg (327 pts) | IPSS, TUFS, Qmax, Qave, PVR, voided volume/micturition, daily micturition frequency, urgency episodes, nocturia, use of pads, QoL, OAB-q, HRQoL, PGI, CGI | Significant improvements versus placebo for both TAM + SOL combinations in total and storage IPSS, TUFS, QoL, PGI, CGI, OAB-q, HRQoL, frequency, voided volume and urgency episodes. TAM + SOL 6 mg was superior to TAM for total IPSS, TUFS, andFrequency improvement. Both combinations were superior to TAM for storage IPSS, voided volume, and several QoL variables |
Total IPSS: Pbo: −5.4±0.41 TAM: −6.2±0.42 TAM + SOL 6 mg: −7.0±0.41 TAM + SOL 9 mg: −6.5±0.42 TUFS: Pbo: −4.4±0.68 TAM: −6.7±0.69 TAM + SOL 6 mg: −8.1±0.67 TAM + SOL 9 mg: −7.6±0.69 |
AUR: 0.3% in TAM + SOL 6 mg, 0.9% in TAM + SOL 9 mg PVR increases with both combinations were clinically insignificant |
| Drake et al14 (NEPTUNE II) | 40-week, open-label, flexible-dosing | 1,066 | 40 weeks of treatment with TAM 0.4 mg plus SOL 6 or 9 mg | IPSS, TUFS, Qmax, Qave, PVR, voided volume/micturition, daily micturition frequency, urgency episodes, QoL, OAB-q | Qmax and Qave were increased at EoT. Total, storage and voiding IPSS and TUFS, as well as frequency, urgency, and incontinence episodes were improved at the EoT. QoL parameters were reported improved at EoT | Total IPSS: −9.0±5.70 TUFS: −10.1±9.20 |
Small PVR increase was observed; however, AUR rate was 0.7% in total |
Abbreviations: EoT, end of treatment; pts, patients; TAM, tamsulosin; SOL, solifenacin; pbo, placebo; PVR, post-void residual; Qmax, maximum urinary flow rate; Qave, average flow rate; OAB-q, overactive bladder questionnaire; HRQoL, health-related quality-of-life questionnaire; PGI, Patient Global Impression scale; CGI, Clinician Global Impression scale; IPSS, International Prostate Symptom Score; AUR, acute urinary retention; QoL, quality of life; TUFS, Total Urgency and Frequency Score; FDC, fixed dose combination.