Characteristic | Kahn 2006 | Ko 2006 | Lebovitz 2001 | Ovalle 2004 | Philipps 2001 | Raskin 2004 |
I1: rosiglitazone max. 8 mg C1: metformin max. 2 g C2: glyburide max. 15 mg | I1: rosiglitazone max. 8 mg + (sulfonylurea +/‐ metformin) C1: "bedtime insulin" + (sulfonylurea +/‐ metformin) | I1: rosiglitazone 4 mg I2: rosiglitazone 8 mg C1: placebo | I1: rosiglitazone 8 mg C1: insulin 70/30 | I1: rosiglitazone 4 mg I2: rosiglitazone 2 x 2 mg I3: rosigllitazone 8 mg I4: rosiglitazone 2 x 4 mg C1: placebo | I1: rosiglitazone 8 mg C1: repaglinide 12 mg C2: rosiglitazone 4 mg + repaglinide 6 mg | |
[n] of participants who died | I1: 34 C1: 31 C2: 31 | ? | ? | ? | ? | ? |
[%] adverse events | I1: 91.9 (1338/1456) C1: 92.2 (1341/1454) C2: 91.7 (1321/1441) | I1: 7.1 C1: 10.7 | I1: 73.1 (121/166) I2: 74.3 (126/169) C1: 69.9 (110/158) | ? | I1+ I2+ I3+I4: 75 (551/ 735) C1: 71 (123/173) | I1: 24 (15/62) C1:37 (23/63) C2: 64 (81/127) |
[%] serious adverse events | I1: 23.8 (346/1456) C1: 22.8 (331/1454) C2: 21.4 (308/1441) | I1: 5.4 C1: 0 | ? | ? | ? | ? |
[%] drop‐outs due to adverse events | I1: 11.6 C1: 12.2 C2: 14.9 | I1: 7.1 C1: 0 | ? | ? | I1+I2 +I3 +I4: 5.6 (41/735) C1: 10.8 (19/173) | I1: 9.7 (6/62) C1: 6.3 (4/63) C2: 3.1 (4/127) |
[%] oedema | I1: 14.1 (205/1456) C1: 7.2 (104/1454) C2: 8.5 (123/1441) | I1: 3.6 C1: 0 | I1: 6 (10/166) I2: 10.7(18/169) C1:1.9 (3/158) | ? | I1: 5.2 (10/181) I2: 4.1 (8/ 186) I3: 6.4 (12/181) I4: 6.6 (13/187) C1: 1.6 (3/173) | I1: 3 (2/62) C1: 0 C2: 4 (5/125) |
haemoglobin [g/dl] | ? | ? | I1: ‐0.6 I2: ‐1.0 C1: ? | ? | I1+ I2+ I3+ I4 : ‐0.5 to ‐ 0.9 (dosage dependent) C: ? | I1: ‐ 0.7 C1: 0 C2: ‐ 0.8 |
body weight [kg] | ? | ? | I1: 1.6 I2: 3.5 C1: ‐1 | ? | I1: 1.2 I2: 1.5 I3: 2.6 I4: 3.3 C1: ‐ 0.9 | I1: + 2.3 C1: +1.6 C2: + 4.4 |
body mass index (BMI) [kg/m2] (SD) | ? | I1: 0.9 (1.3 ) C1: 0.8 (0.9) change data after one year | ? | ? | ? | ? |
[%] hypoglycaemic episodes | I1: 9.8 (142/1456) C1: 11.6 (168/1454) C2: 38.7 (557/1441) | I1: 0 C1: 8.9 | ? | ? | ? | I1: 2 (1/62) C1: 6 (4/63) C2: 9 (11/127) |
[%] severe hypoglycaemic episodes | I1: 0.1 (2/1456) C1: 0.1 (1/1454) C2: 0.6 (8/1441) | I1: 0 C1: 0 | ? | ? | ? | I1: 0 C1: 0 C2: <1 (1 episode) |
Notes | ./. | ./. | ./. | ./. | ITT population | C1: one patient with elevated liver transaminase (>3X normal limit) |
[n] fractures (%) | Men I1: 32 (3.95) C1: 29 (3.36) C2: 28 (3.35) Women I1: 60 (9.30) C1: 30 (5.08) C2: 21 (3.47) Lower limb I1: 36 (5.58) C1: 18 (3.05) C2: 8 (1.32) Upper limb I1: 22 (3.41) C1: 10 (1.69) C2: 9 (1.49) Spinal I1: 1 (0.16) C1: 1 (0.17) C2: 1 (0.17) | |||||
[%] hospitalization for any cause | I1: 11.6 (169/1456) C1: 11.8 (172/1454) C2: 10.4 (150/1441) | |||||
[%] cardiovascular disease, total events | I1: 4.3 (62/1456) C1: 4.0 (58/1454) C2: 2.8 (41/1441) | |||||
[%] congestive heart failure, investigator‐reported, total events | I1: 1.5 (22/1456) C1: 1.3 (19/1454) C2: 0.6 (9/1441) | |||||
[%] peripheral vascular disease, total events | I1: 2.5 (36/1456) C1: 1.9 (27/1456) C2: 2.2 (31/1441) | |||||
[%] gastrointestinal events, total events | I1: 23.0 (335/1456) C1: 38.3 (557/1456) C2: 21.9 (316/1441) | |||||
[%] weight gain, total events | I1: 6.9 (100/1456) C1: 1.2 (18/1456) C2: 7.2 (104/1441) | |||||
[%] haematocrit >= 5 percentage points below the reference range | I1: 2.8 (41/1456) C1: 1.5 (22/1456) C2: 1.0 (14/1441) | |||||
Footnotes ? = unclear; I = intervention; C = control |