Table 3.
Net benefit-harm index for treatment of COPD with roflumilast
| Net benefit-harm index* per 10,000 patients treated over 1 year by patient profiles | ||||||||||||
| Type of analysis | Patients' projected 1-year risk of having ≥1 moderate or severe COPD exacerbation | |||||||||||
| 30% | 60% | 90% | ||||||||||
| Men | Women | Men | Women | Men | Women | |||||||
|
Age <65 |
Age ≥65 |
Age <65 |
Age ≥65 |
Age <65 |
Age ≥65 |
Age <65 |
Age ≥65 |
Age <65 |
Age ≥65 |
Age <65 |
Age ≥65 |
|
|
Analysis I: Equal weights |
−3221 (0.0%)† |
−3192 (0.0%) |
−3246 (0.0%) |
−3225 (0.0%) |
−3125 (0.0%) |
−3097 (0.0%) |
−3150 (0.0%) |
−3129 (0.0%) |
−3088 (0.0%) |
−3059 (0.0%) |
−3112 (0.0%) |
−3092 (0.0%) |
|
Analysis II: Weights based on importance of outcomes |
−477 (0.0%) |
−473 (0.0%) |
−481 (0.0%) |
−478 (0.0%) |
−430 (0.0%) |
−426 (0.0%) |
−433 (0.0%) |
−430 (0.0%) |
−411 (0.0%) |
−407 (0.0%) |
−414 (0.0%) |
−411 (0.0%) |
|
Analysis III (main analysis): Weights based on importance and co-occurrence of harm outcomes |
−195 (0.0%) |
−194 (0.0%) |
−197 (0.0%) |
−196 (0.0%) |
−148 (0.0%) |
−146 (0.0%) |
−149 (0.0%) |
−148 (0.0%) |
−129 (0.0%) |
−127 (0.0%) |
−130 (0.0%) |
−129 (0.0%) |
| Patients' projected 1-year risk of having ≥1 severe COPD exacerbation | ||||||||||||
| 10% | 20% | 30% | ||||||||||
| Men | Women | Men | Women | Men | Women | |||||||
|
Age <65 |
Age ≥65 |
Age <65 |
Age ≥65 |
Age <65 |
Age ≥65 |
Age <65 |
Age ≥65 |
Age <65 |
Age ≥65 |
Age <65 |
Age ≥65 |
|
|
Sensitivity analysis focusing on severe exacerbations |
−140 (0.0%) |
−139 (0.0%) |
−141 (0.0%) |
−140 (0.0%) |
−16 (37.6%) |
−16 (37.5%) |
−16 (37.0%) |
−16 (37.1%) |
85 (86.9%) |
85 (87.0%) |
86 (86.9%) |
85 (87.0%) |
Abbreviations: COPD = chronic obstructive pulmonary disease
Negative values of the index = roflumilast is harmful (harms outweigh benefits); positive values of the index = roflumilast is beneficial (benefits outweigh harms).
The numbers in parentheses is the probability that the index is positive (the probability that roflumilast is beneficial).