Table 1.
Model inputs
| Total | |
|---|---|
| N=800a | |
| Patient demographics (ITT population Study 207626) | |
| Age, years, meana (SE)b | 66.2a (0.3) |
| Sex, female, % | 32.1 |
| BMIc, % | |
| Low | 10.9 |
| Medium | 60.1 |
| High | 29.0 |
| Any CVD comorbidity, % | 54.8 |
| Any other comorbidity, % | 23.9 |
| History of ≥1 exacerbationd, % | 79.3 |
| mMRC score ≥2e, % | 48.1 |
| Current smoker, %a | 47.6a |
| Height, cm, mean (SE)b | 169.7 (0.3) |
| Exacerbationsd in previous year, mean | 1.4 |
| Moderate exacerbations, mean | 1.2 |
| Severe exacerbations, mean | 0.2 |
| Baseline SGRQ, mean (SE)b | 48.9 (0.6) |
| Baseline FEV1% predicted, meana (SE)b | 50.0a (0.5) |
| Treatment effects (Study 207626) | |
| Endpoint (12 weeks) | FF/UMEC/VI versus TIO |
| FEV1 increment, mean (95% CI) mL difference | 95.0 (62, 128) |
| SGRQ change, mean (95% CI) score difference | −3.2 (−5.0, −1.4) |
| Exacerbation reduction, relative risk | No differencef |
Notes: a19 bCalculated as SD/√(N). cLow: <21, medium: ≥21 to ≤30, high: >30. dModerate or severe. eAssumed the same as CAT ≥21. fTreatment effect input on exacerbation reduction was set to “no difference” as the relative risk reduction of exacerbations was not included as an endpoint in Study 207626.
Abbreviations: BMI, body mass index; CAT, COPD Assessment Test; CI, confidence interval; COPD, chronic obstructive pulmonary disease; CVD, cardiovascular disease; FEV1, forced expiratory volume in 1 second; FF, fluticasone furoate; ITT, intent-to-treat; mMRC, modified Medical Research Council; SD, standard deviation; SE, standard error; SGRQ, St George’s Respiratory Questionnaire; TIO, tiotropium; UMEC, umeclidinium; VI, vilanterol.