Characteristic | Rosenstock 2006b | Stocker 2007 | Sutton 2002 | Yang 2002 |
I1: rosiglitazone max. 8 mg + sulfonyurea + metformin until 2000 mg C1: insulin glargine max. 10 U + sulfonylurea + metformin max. 2000 mg | I1: rosiglitazone 4 mg C1: metformin 1.7 g | I1: rosiglitazone 8 mg C1: glyburide less than 20 mg | I1: rosiglitazone 4 mg C1: placebo | |
[n] of participants who died | ? | I1: 0 C1: 0 | ? | I1: none C1: none |
[%] adverse events | I1: 28.6 (32/112) C1: 6.7 (7/105) | ? | ? | ? |
[%] serious adverse events | I1: 9.8 (11/112) C1: 4.8 (5/105) | ? | ? | ? |
[%] drop‐outs due to adverse events | I1: 8 (9/112) C1: 2 (2/105) | I1: 8.9 (4/45) C1: 14.9 (7/47) | I1: 8 (8/104) C1: 4 (4/99) | ? |
[%] oedema | I1: 12.5 (14/112) C1: 0 | I1: 24.4 (11/45) C1: 0 | I1: 6.7 (7/104) C1: 1 (1/99) | ? |
haemoglobin [g/dl] | ? | ? | ? | ? |
body weight [kg] | I1: + 3 C1: + 1.7 | I1: 1.6 C1: ‐2.0 | I1: + 5 C1: + 3.4 | I1: + 3.0 C1: ‐ 0.4 |
body mass index (BMI) [kg/m2] | ? | ? | ? | I1: + 1.2 C1: ‐0.4 |
[%] hypoglycaemic episodes | I1: 42 (47/112) C1: 55 (57/104) | ? | I1: 1.9 (2/104) C1: 7.1 (7/99) | ? |
[%] severe hypoglycaemic episodes | I1: 5.4 (6/112) C1: 2.9 (3/104) | ? | I1: 0 C1: 3 (3/99) | ? |
Notes | severe hypoglycemia = plasma glucose < 36 mg/dl or prompt recovery after oral carbohydrate, intravenous glucose or glucagon adminstration nocturnal hypoglycemia = < 50 mg/dl: I1: 3 events C1: 10 events safety was assessed in the intent‐to‐treat (ITT) population | ./. | cardiac related adverse events: I1: 15.4%; C1: 12.1% heart disorder: I1: 9/104.; C1:5/99 cardiomegaly: I1: 5/104.; C1:2/99 I1: 1/104 clinical heart failure I1:2/104 initiated diuretic therapy as a result of a fluid related event C1: severe hypoglycaemia: 3 of 7 total hypoglycaemic episodes | |
Footnotes ? = unclear; I = intervention; C = control; AE = adverse events |