Table 3

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 armMean (SD), intervention armMean difference (95% CI)‡P value
Proportion with at least one moderate or severe COPD exacerbation469 (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 FVC400 (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 cause469 (3)72/234 (30.8)79/235 (33.6)1.16 (0.76 to 1.75)0.50
Death due to any cause469 (3)8/234 (3.4)15/235 (6.4)2.25 (0.82 to 6.19)0.12
Death due to COPD exacerbation/respiratory failure469 (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 hypercalcaemia469 (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 stones469 (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.