Rosiglitazone antidiabetic drugs

Description Results

diabetes 0.47 [0.42; 0.54]

cardiovasculaire events 1.52 [1.08; 2.14]

normoglycemia 2.10 [1.92; 2.29]

death 1.01 [0.62; 1.65]

CV death 1.34 [0.58; 3.09]

CV death, MI, stroke 1.55 [0.91; 2.64]

serious heart failure 1.25 [0.91; 1.70]

stroke 0.89 [0.46; 1.71]

myocardial infarction 1.40 [0.84; 2.36]

CV events 1.35 [0.95; 1.93]

Bone fractures 1.57 [1.26; 1.97]

HF death or hospitalization 2.10 [1.35; 3.27]

heart failure 2.11 [1.36; 3.27]

serious heart failure 2.11 [1.36; 3.27]

death 0.87 [0.70; 1.08]

CV death 0.85 [0.60; 1.19]

stroke 0.73 [0.50; 1.07]

myocardial infarction 1.15 [0.80; 1.63]

CV events 1.00 [0.86; 1.15]

rosiglitazone 4 mg/d (n=-9)

vs.

control (n=-9)

open

Parallel groups

Sample size: -9/-9

Primary endpoint: not defined

FU duration: 6 months

rosiglitazone 8 mg daily (n=2365)

vs.

placebo (n=2634)

factorial design with ramipril

double blind

Parallel groups

Sample size: 2365/2634

Primary endpoint: diabetes, death

FU duration: 3 years (median)

Rosiglitazone (n=357)

vs.

Placebo (n=176)

Parallel groups

Sample size: 357/176

Primary endpoint:

FU duration: 24 wk

Rosiglitazone (n=391)

vs.

Glyburide (n=207)

Parallel groups

Sample size: 391/207

Primary endpoint:

FU duration: 52 wk

Rosiglitazone with or without metformin (n=213)

vs.

Metformin (n=109)

Parallel groups

Sample size: 213/109

Primary endpoint:

FU duration: 26 wk

Rosiglitazone and metformin (n=232)

vs.

Metformin (n=116)

Parallel groups

Sample size: 232/116

Primary endpoint:

FU duration: 26 wk

Rosiglitazone and glyburide (n=43)

vs.

Glyburide (n=47)

Parallel groups

Sample size: 43/47

Primary endpoint:

FU duration: 52 wk

Rosiglitazone and glyburide (n=121)

vs.

Glyburide (n=124)

Parallel groups

Sample size: 121/124

Primary endpoint:

FU duration: 24 wk

Rosiglitazone and usual care (n=110)

vs.

Usual care (n=114)

Parallel groups

Sample size: 110/114

Primary endpoint:

FU duration: 52 wk

Rosiglitazone and metformin (n=382)

vs.

Metformin (n=384)

Parallel groups

Sample size: 382/384

Primary endpoint:

FU duration: 24 wk

Rosiglitazone and metformin (n=284)

vs.

Metformin (n=135)

Parallel groups

Sample size: 284/135

Primary endpoint:

FU duration: 48 wk

Rosiglitazone and metformin (n=294)

vs.

Metformin and sulfonylurea (n=302)

Parallel groups

Sample size: 294/302

Primary endpoint:

FU duration: 52 wk

Rosiglitazone with or without metformin (n=563)

vs.

Usual care with or without metformin (n=142)

Parallel groups

Sample size: 563/142

Primary endpoint:

FU duration: 32 wk

Rosiglitazone (n=278)

vs.

Placebo (n=279)

Parallel groups

Sample size: 278/279

Primary endpoint:

FU duration: 52 wk

Rosiglitazone and insulin (n=418)

vs.

Insulin (n=212)

Parallel groups

Sample size: 418/212

Primary endpoint:

FU duration: 24 wk

Rosiglitazone and sulfonylurea (n=395)

vs.

Sulfonylurea (n=198)

Parallel groups

Sample size: 395/198

Primary endpoint:

FU duration: 24 wk

Rosiglitazone with or without glyburide (n=203)

vs.

Glyburide (n=106)

Parallel groups

Sample size: 203/106

Primary endpoint:

FU duration: 26 wk

Rosiglitazone (n=104)

vs.

Glyburide (n=99)

Parallel groups

Sample size: 104/99

Primary endpoint:

FU duration: 156 wk

Rosiglitazone and insulin (n=138)

vs.

Insulin (n=139)

Parallel groups

Sample size: 138/139

Primary endpoint:

FU duration: 26 wk

Rosiglitazone and insulin (n=196)

vs.

Insulin (n=96)

Parallel groups

Sample size: 196/96

Primary endpoint:

FU duration: 26 wk

Rosiglitazone (n=122)

vs.

Glyburide (n=120)

Parallel groups

Sample size: 122/120

Primary endpoint:

FU duration: 156 wk

Rosiglitazone and sulfonylurea (n=175)

vs.

Sulfonylurea (n=173)

Parallel groups

Sample size: 175/173

Primary endpoint:

FU duration: 26 wk

Rosiglitazone and glyburide (n=56)

vs.

Glyburide (n=58)

Parallel groups

Sample size: 56/58

Primary endpoint:

FU duration: 26 wk

Rosiglitazone (n=39)

vs.

Placebo (n=38)

Parallel groups

Sample size: 39/38

Primary endpoint:

FU duration: 28 wk

Rosiglitazone (n=561)

vs.

Placebo (n=276)

Parallel groups

Sample size: 561/276

Primary endpoint:

FU duration: 28 wk

Rosiglitazone and glipizide (n=116)

vs.

Glipizide (n=111)

Parallel groups

Sample size: 116/111

Primary endpoint:

FU duration: 104 wk

Rosiglitazone (n=148)

vs.

Placebo (n=143)

Parallel groups

Sample size: 148/143

Primary endpoint:

FU duration: 26 wk

Rosiglitazone and gliclazide (n=231)

vs.

Gliclazide (n=242)

Parallel groups

Sample size: 231/242

Primary endpoint:

FU duration: 26 wk

Rosiglitazone and sufonylurea (n=89)

vs.

Sulfonylurea (n=88)

Parallel groups

Sample size: 89/88

Primary endpoint:

FU duration: 26 wk

Rosiglitazone and glyburide (n=168)

vs.

Glyburide (n=172)

Parallel groups

Sample size: 168/172

Primary endpoint:

FU duration: 26 wk

Rosiglitazone and glimepiride (n=116)

vs.

Glimepiride (n=61)

Parallel groups

Sample size: 116/61

Primary endpoint:

FU duration: 26 wk

Rosiglitazone (n=1)

vs.

Placebo (n=382)

Parallel groups

Sample size: 1/382

Primary endpoint:

FU duration: 52 wk

Rosiglitazone (n=706)

vs.

Placebo (n=325)

Parallel groups

Sample size: 706/325

Primary endpoint:

FU duration: 52 wk

Rosiglitazone and metformin (n=204)

vs.

Glyburide and metformin (n=185)

Parallel groups

Sample size: 204/185

Primary endpoint:

FU duration: 32 wk

Rosiglitazone and metformin (n=288)

vs.

Metformin (n=280)

Parallel groups

Sample size: 288/280

Primary endpoint:

FU duration: 24 wk

Rosiglitazone and metformin (n=254)

vs.

Metformin (n=272)

Parallel groups

Sample size: 254/272

Primary endpoint:

FU duration: 32 wk

Rosiglitazone with or without metformin (n=314)

vs.

Metformin (n=154)

Parallel groups

Sample size: 314/154

Primary endpoint:

FU duration: 32 wk

Rosiglitazone, metformin, and insulin (n=162)

vs.

Insulin (n=160)

Parallel groups

Sample size: 162/160

Primary endpoint:

FU duration: 24 wk

Rosiglitazone and sulfonylurea (n=442)

vs.

Sulfonylurea (n=112)

Parallel groups

Sample size: 442/112

Primary endpoint:

FU duration: 24 wk

Rosiglitazone (n=394)

vs.

Placebo (n=124)

Parallel groups

Sample size: 394/124

Primary endpoint:

FU duration: 24 wk

Rosiglitazone 4mg twice daily (n=1456)

vs.

Metformin 1000mg twice daily or glyburide 7.5mg twice daily (n=2895)

double blind

Parallel groups

Sample size: 1456/2895

Primary endpoint: monotherapy failure

FU duration: 4y (median)

addition of rosiglitazone (4-8 mg daily titrated) to metformin or sulfonylurea, target HbA1c<=7·0% (n=2220)

vs.

combination of metformin and sulfonylurea, target HbA1c<=7·0% (n=2227)

rescue therapy by addition of a third oral agent (if in the rosiglitazone group) or transfer to insulin (in the metformin plus sulfonylurea group) if confirmed HbA1c>8·5%

open

Parallel groups

Sample size: 2220/2227

Primary endpoint: CV hospitalization or death

FU duration: 5.5 y

rosiglitazone at up to 8 mg/day (n=333)

vs.

glipizide at 15 mg/day (n=339)

double blind

Parallel groups

Sample size: 333/339

Primary endpoint: percent atheroma volume by IVUS

FU duration: 18 months

diabetes 0.47 [0.42; 0.54]

cardiovasculaire events 1.52 [1.08; 2.14]

normoglycemia 2.10 [1.92; 2.29]

death 1.01 [0.62; 1.65]

CV death 1.34 [0.58; 3.09]

CV death, MI, stroke 1.55 [0.91; 2.64]

rosiglitazone 8 mg daily (n=2365)

vs.

placebo (n=2634)

factorial design with ramipril

double blind

Parallel groups

Sample size: 2365/2634

Primary endpoint: diabetes, death

FU duration: 3 years (median)