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. 2007 Jul 18;2007(3):CD006063. doi: 10.1002/14651858.CD006063.pub2
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