Table 5.
Symptomatic responses and adverse event rates in men on placebo, tamsulosin oral-controlled absorption system (OCAS) or modified release (MR) drug delivery systems (derived from data of Chapple et al 2005b)
| Placebo | OCAS 0.4 mg | OCAS 0.8 mg | MR 0.4 mg | |
|---|---|---|---|---|
| Number | 350 | 354 | 707 | 700 |
| Percent with reduction in IPSS ≥25% | 60.9% | 71.2% | 75.4% | 73.8% |
| Change from baseline IPSS | −3.7 | −4.7 | −5.0 | −5.0 |
| P value (treatment vs placebo) | <0.001 | <0.001 | ||
| P value (treatment vs MR 0.4 mg) | NSa | |||
| Change in IPSS QoL score | −2.2 | −3.0 | −3.0 | −3.0 |
| P value (treatment vs placebo) | <0.001 | <0.001 | ||
| P value (treatment vs MR 0.4 mg) | NS | |||
| Adverse events | 3.7% | 6.9% | 11.1% | 7.8% |
a
not significant.
Abbreviations: ICSS, International Prostate Symptom Score.