Table 6.
Rosiglitazone meta-analyses for cardiovascular related deaths
| Method (fixed or random effects), and data sources | Single zero event trials | Zero total event trials | Continuity correction | Effect estimate (95% CI) | No of trials |
|---|---|---|---|---|---|
| Peto (fixed) | |||||
| IPD only | Included | Excluded | None | OR 1.34 (0.60 to 2.98) | 15 |
| IPD+RECORD | Included | Excluded | OR 1.11 (0.76 to 1.62) | 16 | |
| IPD+summary | Included | Excluded | OR 1.23 (0.77 to 1.98) | 33 | |
| IPD+summary+RECORD | Included | Excluded | OR 1.13 (0.82 to 1.55) | 34 | |
| Mantel-Haenszel (fixed) | |||||
| IPD only | Included | Excluded | Constant continuity correction of 0.5 | OR 1.13 (0.58 to 2.21) | 15 |
| RR 1.13 (0.58 to 2.20) | 15 | ||||
| IPD+RECORD | Included | Excluded | OR 1.07 (0.75 to 1.54) | 16 | |
| RR 1.07 (0.75 to 1.53) | 16 | ||||
| IPD+summary | Included | Excluded | OR 1.10 (0.73 to 1.65) | 33 | |
| RR 1.09 (0.73 to 1.64) | 33 | ||||
| IPD+summary+RECORD | Included | Excluded | OR 1.08 (0.80 to 1.44) | 34 | |
| RR 1.07 (0.80 to 1.44) | 34 | ||||
| IPD only | Included | Included | OR 0.97 (0.56 to 1.66) | 33 | |
| RR 0.97 (0.57 to 1.65) | 33 | ||||
| IPD+RECORD | Included | Included | OR 1.02 (0.73 to 1.42) | 34 | |
| RR 1.02 (0.73 to 1.41) | 34 | ||||
| IPD+summary | Included | Included | OR 1.00 (0.75 to 1.32) | 136 | |
| RR 1.00 (0.76 to 1.32) | 136 | ||||
| IPD+summary+RECORD | Included | Included | OR 1.01 (0.80 to 1.28) | 137 | |
| RR 1.01 (0.80 to 1.27) | 137 | ||||
| Dersimonian and Laird (random) | |||||
| IPD only | Included | Excluded | Constant continuity correction of 0.5 | OR 1.15 (0.55 to 2.41) | 15 |
| RR 1.15 (0.55 to 2.39) | 15 | ||||
| IPD+RECORD | Included | Excluded | OR 1.08 (0.64 to 1.56) | 16 | |
| RR 1.08 (0.75 to 1.55) | 16 | ||||
| IPD+summary | Included | Excluded | OR 1.12 (0.72 to 1.74) | 33 | |
| RR 1.12 (0.72 to 1.73) | 33 | ||||
| IPD+summary+RECORD | Included | Excluded | OR 1.08 (0.80 to 1.47) | 34 | |
| RR 1.08 (0.80 to 1.46) | 34 | ||||
| IPD only | Included | Included | OR 0.95 (0.53 to 1.69) | 33 | |
| RR 0.95 (0.54 to 1.68) | 33 | ||||
| IPD+RECORD | Included | Included | OR 1.01 (0.72 to 1.43) | 34 | |
| RR 1.01 (0.72 to 1.42) | 34 | ||||
| IPD+summary | Included | Included | OR 1.00 (0.74 to 1.33) | 136 | |
| RR 1.00 (0.74 to 1.32) | 136 | ||||
| IPD+summary+RECORD | Included | Included | OR 1.01 (0.79 to 1.29) | 137 | |
| RR 1.01 (0.80 to 1.28) | 137 | ||||
| Mantel-Haenszel (fixed) | |||||
| IPD only | Included | Excluded | Treatment arm correction | OR 1.23 (0.62 to 2.42) | 15 |
| RR 1.22 (0.62 to 2.42) | 15 | ||||
| IPD+RECORD | Included | Excluded | OR 1.10 (0.77 to 1.58) | 16 | |
| RR 1.10 (0.77 to 1.57) | 16 | ||||
| IPD+summary | Included | Excluded | OR 1.17 (0.77 to 1.77) | 33 | |
| RR 1.17 (0.77 to 1.77) | 33 | ||||
| IPD+summary+RECORD | Included | Excluded | OR 1.11 (0.83 to 1.50) | 34 | |
| RR 1.11 (0.83 to 1.49) | 34 | ||||
| IPD only | Included | Included | OR 1.15 (0.66 to 1.99) | 33 | |
| RR 1.14 (0.66 to 1.99) | 33 | ||||
| IPD+RECORD | Included | Included | OR 1.09 (0.77 to 1.52) | 34 | |
| RR 1.08 (0.78 to 1.52) | 34 | ||||
| IPD+summary | Included | Included | OR 1.08 (0.81 to 1.44) | 136 | |
| RR 1.08 (0.81 to 1.43) | 136 | ||||
| IPD+summary+RECORD | Included | Included | OR 1.07 (0.84 to 1.36) | 137 | |
| RR 1.07 (0.85 to 1.35) | 137 | ||||
| Dersimonian and Laird (random) | |||||
| IPD only | Included | Excluded | Treatment arm correction | OR 1.26 (0.58 to 2.72) | 15 |
| RR 1.26 (0.59 to 2.70) | 15 | ||||
| IPD+RECORD | Included | Excluded | OR 1.10 (0.76 to 1.59) | 16 | |
| RR 1.10 (0.76 to 1.58) | 16 | ||||
| IPD+summary | Included | Excluded | OR 1.19 (0.75 to 1.88) | 33 | |
| RR 1.18 (0.75 to 1.86) | 33 | ||||
| IPD+summary+RECORD | Included | Excluded | OR 1.11 (0.82 to 1.52) | 34 | |
| RR 1.11 (0.82 to 1.51) | 34 | ||||
| IPD only | Included | Included | OR 1.15 (0.63 to 2.10) | 33 | |
| RR 1.15 (0.63 to 2.09) | 33 | ||||
| IPD+RECORD | Included | Included | OR 1.08 (0.77 to 1.54) | 34 | |
| RR 1.08 (0.77 to 1.53) | 34 | ||||
| IPD+summary | Included | Included | OR 1.08 (0.80 to 1.45) | 136 | |
| RR 1.08 (0.80 to 1.45) | 136 | ||||
| IPD+summary+RECORD | Included | Included | OR 1.07 (0.84 to 1.37) | 137 | |
| RR 1.07 (0.84 to 1.36) | 137 | ||||
IPD=individual patient level data; OR=odds ratio; RECORD=Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes study; RR=relative risk.
For all analyses, numbers of cardiovascular related deaths observed among total population of patients was as follows: IPD only, rosiglitazone population: 15 events among 11 837 patients; IPD only, control population: 10 events among 9319 patients; RECORD, rosiglitazone population: 44 events among 2226 patients; RECORD, control population: 42 events among 2232 patients; summary, rosiglitazone population: 26 events among 12 183 patients; summary, control population: 20 events among 10 589 patients.