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 analysisPatients’ projected 1-year risk of having ≥1 moderate or severe COPD exacerbations
30%60%90%
MenWomenMenWomenMenWomen
Age <65Age ≥65Age <65Age ≥65Age <65Age ≥65Age <65Age ≥65Age <65Age ≥65Age <65Age ≥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 exacerbations
10%20%30%
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%)
  • *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 are the probability that the index is positive (the probability that roflumilast is beneficial).