TABLE 1.
Overview of the studies identified for the proposed model‐based meta‐analysis
| Study no. | Informed consent for data reuse | Study description | Dose and administration* | Number of patients | Visits (months or weeks) | ||
|---|---|---|---|---|---|---|---|
| ARIA3001 | Yes | A multicentre randomised double‐blind, placebo‐controlled, 2‐year parallel group study with a 2‐year open label phase | 0.5 mg dutasteride for 2 years | 720 |
AUA‐SI/IPSS: 0, 1, 3, 6, 12, 18, 24, 30, 36, 42 and 48 Prostate volume: 0, 1, 6, 12, 24 and 48 Max. urinary flow: 0, 1, 3, 6, 12, 18, 24, 30, 36, 42 and 48 PSA: 0, 1, 3, 6, 12, 18, 24, 36 and 48 AUR and BPH‐related surgery monitored throughout study and censored at 4 years |
||
| placebo for 2 years | 720 | ||||||
| ARIA3002 | Yes | A multicentre randomised double‐blind, placebo‐controlled, 2‐year parallel group study with a 2‐year open label phase | 0.5 mg dutasteride for 2 years | 677 |
AUA‐SI/IPSS: 0, 1, 3, 6, 12, 18, 24, 30, 36, 42 and 48 Prostate volume: 0, 3, 6, 12, 24, 36 and 48 Max. urinary flow: 0, 1, 3, 6, 12, 18, 24, 30, 36, 42 and 48 PSA: 0, 1, 3, 6, 12, 18, 24, 36 and 48 AUR and BPH‐related surgery monitored throughout study and censored at 4 years |
||
| placebo for 2 years | 685 | ||||||
| ARI40002 | Yes | A pilot, multicentre, double‐blind, parallel group, 36 weeks randomised study | 0.5 mg dutasteride and 0.4 mg tamsulosin for 36 weeks | 164 |
AUA‐SI/IPSS: 0, 4, 12, 24, 30, 36 and 37 weeksPSA: 0 and 36 weeks AUR and BPH‐related surgery monitored throughout study and censored at 36 weeks |
||
| 0.5 mg dutasteride for 12 weeks after 24 weeks. combination therapy | 163 | ||||||
| CombAT | Yes | A multicentre, randomised, double‐blind, 4‐year parallel‐group study | 0.4 mg tamsulosin for 4 years | 1611 |
AUA‐SI/IPSS: 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45 and 48Prostate volume: 0, 12, 24, 36 and 48 Max. urinary flow: 0, 6, 12, 18, 24, 30, 36, 42 and 48PSA: 0, 12, 24, 36 and 48 AUR and BPH‐related surgery monitored throughout study and censored at 4 years |
||
| 0.5 mg dutasteride for 4 years | 1623 | ||||||
| 0.5 mg dutasteride and 0.4 mg tamsulosin therapy for 4 years | 1610 | ||||||
| CONDUCT | Yes | A multicentre, randomised, open‐label, 2‐year parallel‐group study | Watchful waiting with protocol‐defined initiation of 0.4 mg tamsulosin | 373 |
AUA‐SI/IPSS: 0, 1, 3, 6, 9, 12, 15, 18, 21 and 24 PSA: 0, 6, 12 and 24 AUR and BPH‐related surgery monitored throughout study and censored at 2 years |
||
| 0.5 mg dutasteride and 0.4 mg tamsulosin therapy for 2 years | 369 | ||||||
| ARIB3003 | Yes | A multicentre randomised double‐blind, placebo‐controlled, 2‐year parallel group study with a 2‐year open label phase | 0.5 mg dutasteride for 2 years | 770 |
AUA‐SI/IPSS: 0, 1, 3, 6, 12, 18, 24, 30, 36, 42 and 48 Prostate volume: 0, 6, 12, 18, 24 and 48Max. urinary flow: 0, 1, 3, 6, 12, 18 24, 30, 36, 42 and 48PSA: 0, 1, 3, 6, 12, 18, 24, 36 and 48 AUR and BPH‐related surgery monitored throughout study and censored at 4 years |
||
| placebo for 2 years | 753 | ||||||
Protocol title is shown along with details regarding treatment type, duration and the purpose of the study data during model building and validation procedures.
Abbreviations: AUA‐SI, American Urological Association‐Symptom Index; IPSS, International Prostate Symptom Score.
*All treatments were given as a once daily dosing regimen.