Characteristic | Garber 2006 | Goldberg 2005 | Hällsten 2002 | Hanefeld 2007 | Jung 2005 |
I1: rosiglitazone 4 mg + metformin 2000 C1: glibenclamide 5 mg +metformin 1000 mg | I1: rosiglitazone 8 mg + diet C1: pioglitazone 45 mg+diet | I1: rosiglitazone 8 mg C1: metformin 2 g C2: placebo | I1: rosiglitazone (2 mg bid) + placebo I2: rosiglitazone (4 mg bid) + placebo C1: glibenclamide up to 15 mg + placebo | I1: rosiglitazone 4 mg+ glimepiride 4mg C1: metformin 1000 mg + glimepiride 4mg | |
[n] of participants who died | ? | I1: 2 C1: 1 | I1:0 C2:0 C1:0 | I1: 0 I2: 0 C1: 0 | ? |
[%] adverse events | I1: 63 (98/155) C1: 68 (108/160) | ? | ? | I1: 75.0 (150/200) I2: 75.4 (144/191) C1: 69.6 (144/207) | ? |
[%] serious adverse events | I1: 6 (9/155) C1: 4 (7/159) | ? | ? | ? | ? |
[%] drop‐outs due to adverse events | I1: 4.4 (7/158) C1: 10 (16/160) | I1: 2.7 (10/366) C1: 2.7 (10/369) | I1:0 C2:0 C1:0 | I1: 6 I2: 4.7 C1: 6.3 | I1:? C1: 3.3 (1/30) |
[%] oedema | ? | ? | ? | I1: 3.5 (7/200) I2: 8.9 (17/191) C1: 1.9 (4/207) | ? |
haemoglobin [g/dl] | ? | ? | ? | I1: ‐0.48 I2: ‐0.98 C1: 0 | ? |
body weight [kg] | I1: +1.4 C1: +3 | I1: 1.6 C1: 2.0 | I1: + 0.6 C1: ‐ 2.0 C2: + 0.1 | I1: 1.75 I2: 2.95 C1: 1.9 | ? |
body mass index (BMI) [kg/m2] | ? | ? | ? | ? | ? |
[%] hypoglycaemic episodes | I1: 26 (41/155) C1: 73 (116/159) | ? | ? | I1: 0.5 (1/200) I2: 1.6 (3/191) C1: 12.1 (25/207) | ? |
[%] severe hypoglycaemic episodes | ? | ? | ? | I1: I2: C1: 0.01 | ? |
Notes | elevated levels of ALT ( > 3x pretreatment levels and > upper normal limit): I1: 2 patients C1: 3 patients | I1 + C1: no significant differences observed for: ‐ liver functions tests ‐ haemoglobin ans haematocrit ‐ hypoglycemic episodes ‐ adverse events (oedema, congestive heart failure) | body weight change data calculated | two hypoglycaemic events were severe and one required hospitalization; unclear in which medication group these events happened | ./. |
Footnotes ? = unclear; I = intervention; C = control; AE = adverse event; ALT = alanine aminotransferase |