One-step individual participant data meta-analysis, secondary outcomes.
| No. of participants (no. of trials) | Proportion with ≥1 event, control group (%) | Proportion with≥1 event, intervention group (%) | aOR (95% CI)* | Median time to event, control group (IQR) | Median time to event, intervention group (IQR) | aHR (95% CI)† | Mean (SD), control arm | Mean (SD), intervention arm | Mean difference (95% CI)‡ | P value | |
| Proportion with at least one moderate or severe COPD exacerbation | 469 (3) | 153/234 (65.4) | 143/235 (60.9) | 0.79 (0.53 to 1.19) | – | – | – | – | – | – | 0.27 |
| Time to first moderate or severe COPD exacerbation‡ | 469 (3) | – | – | – | 144 (38, –)§ | 125 (43, –)§ | 0.93 (0.74 to 1.17) | – | – | – | 0.53 |
| Proportion with at least one severe COPD exacerbation¶ | 469 (3) | 35/234 (15.0) | 47/235 (20.0) | 1.45 (0.85 to 2.46) | – | – | – | – | – | – | 0.17 |
| End-study % predicted FEV1 | 400 (3) | – | – | – | – | – | – | 54.9 (21.9) | 54.9 (21.0) | −1.20 (−2.87 to 0.46) | 0.16 |
| End-study % predicted FVC | 400 (3) | – | – | – | – | – | – | 89.9 (21.8) | 88.8 (20.0) | −0.83 (−3.17 to 1.51) | 0.49 |
| End-study BMI, kg/m2 | 381 (3) | – | – | – | – | – | – | 26.1 (6.2) | 27.4 (6.3) | 0.01 (−0.38 to 0.41) | 0.94 |
| Proportion with at least one serious adverse event of any cause | 469 (3) | 72/234 (30.8) | 79/235 (33.6) | 1.16 (0.76 to 1.75) | – | – | – | – | – | – | 0.50 |
| Death due to any cause | 469 (3) | 8/234 (3.4) | 15/235 (6.4) | 2.25 (0.82 to 6.19) | – | – | – | – | – | – | 0.12 |
| Death due to COPD exacerbation/respiratory failure | 469 (3) | 4/234 (1.7) | 5/235 (2.1) | 2.17 (0.27 to 17.70) | – | – | – | – | – | – | 0.47 |
| Proportion with at least one episode of hypercalcaemia | 469 (3) | 6/234 (2.6) | 3/235 (1.3) | 0.48 (0.12 to 2.00) | – | – | – | – | – | – | 0.32 |
| Proportion with at least one episode of renal stones | 469 (3) | 0/234 (0.0) | 0/235 (0.0) | – | – | – | – | – | – | – | – |
*Adjusted for trial, age, sex, GOLD spirometric grade and follow-up duration.
†Adjusted for trial, age, sex and GOLD spirometric grade.
‡Adjusted for trial, age, sex, GOLD spirometric grade, follow-up duration and baseline value.
§75th centiles for time to first event in these groups cannot be defined.
¶Severe exacerbation defined as one requiring emergency department attendance or hospitalisation; moderate exacerbation defined as one requiring treatment with systemic corticosteroids or antibiotics, or both, but not precipitating emergency department attendance or hospitalisation.
aHR, adjusted Hazard Ratio; aOR, adjusted OR; BMI, body mass index; GOLD, Global Initiative for Chronic Obstructive Lung Disease.