| Trial | control | p<0.05 | harm | NS |
|---|
| PROactive, 2005 | vs placebo | Death, Myocardial infarction, stroke 0.85 [0.74; 0.98] | serious heart failure 1.39 [1.10; 1.78] | death 0.96 [0.79; 1.17] stroke 0.81 [0.61; 1.07] myocardial infarction 0.82 [0.63; 1.06] CV events 0.90 [0.80; 1.02] |
| PERISCOPE, 2008 | vs placebo | | | CV death 2.99 [0.31; 28.56] serious heart failure 0.80 [0.22; 2.94] stroke 0.00 [0.00; NaN] myocardial infarction 0.50 [0.09; 2.70] CV events 0.84 [0.38; 1.85] Death, Myocardial infarction, stroke 0.83 [0.26; 2.69] |
| PNFP-010 | vs placebo | | | death 0.25 [0.02; 2.75] serious heart failure 0.00 [0.00; NaN] stroke NaN [NaN; NaN] myocardial infarction 0.50 [0.07; 3.53] Death, Myocardial infarction, stroke 0.33 [0.06; 1.98] |
| PNFP-014 | vs placebo | | | death NaN [NaN; NaN] serious heart failure ∞ [NaN; ∞] stroke NaN [NaN; NaN] myocardial infarction ∞ [NaN; ∞] Death, Myocardial infarction, stroke ∞ [NaN; ∞] |
| PNFP-027 | vs placebo | | | death NaN [NaN; NaN] serious heart failure ∞ [NaN; ∞] stroke NaN [NaN; NaN] myocardial infarction NaN [NaN; NaN] Death, Myocardial infarction, stroke NaN [NaN; NaN] |
| PNFP-026 | vs placebo | | | death NaN [NaN; NaN] serious heart failure NaN [NaN; NaN] stroke NaN [NaN; NaN] myocardial infarction 0.00 [0.00; NaN] Death, Myocardial infarction, stroke 0.00 [0.00; NaN] |
| OPI-502 | vs placebo | | | death NaN [NaN; NaN] serious heart failure NaN [NaN; NaN] stroke NaN [NaN; NaN] myocardial infarction 0.00 [0.00; NaN] Death, Myocardial infarction, stroke 0.00 [0.00; NaN] |
| PNFP-012 | vs placebo | | | death 0.00 [0.00; NaN] serious heart failure NaN [NaN; NaN] stroke NaN [NaN; NaN] myocardial infarction 0.00 [0.00; NaN] Death, Myocardial infarction, stroke 0.00 [0.00; NaN] |
| OPI-504 | vs placebo | | serious heart failure 2.61 [1.24; 5.50] | death 1.59 [0.67; 3.77] stroke ∞ [NaN; ∞] myocardial infarction 2.44 [0.48; 12.48] Death, Myocardial infarction, stroke 1.47 [0.67; 3.20] |
| GLAI | vs placebo | | | death 0.50 [0.05; 5.45] serious heart failure NaN [NaN; NaN] stroke 0.00 [0.00; NaN] myocardial infarction 0.50 [0.05; 5.45] Death, Myocardial infarction, stroke 0.40 [0.08; 2.03] |
| PNFP-001 | vs placebo | | | death NaN [NaN; NaN] serious heart failure NaN [NaN; NaN] stroke NaN [NaN; NaN] myocardial infarction 0.24 [0.02; 3.80] Death, Myocardial infarction, stroke 0.24 [0.02; 3.80] |
| EC405 | vs placebo | | | death 0.80 [0.16; 3.99] serious heart failure 0.00 [0.00; NaN] stroke 3.01 [0.31; 28.86] myocardial infarction 1.00 [0.14; 7.10] Death, Myocardial infarction, stroke 1.14 [0.29; 4.51] |
| OPI-501 | vs placebo | | | death 0.00 [0.00; NaN] serious heart failure NaN [NaN; NaN] stroke NaN [NaN; NaN] myocardial infarction 1.00 [0.14; 7.04] Death, Myocardial infarction, stroke 0.50 [0.07; 3.45] |
| EC404 | vs placebo | | | death 1.50 [0.20; 11.24] serious heart failure 1.50 [0.20; 11.24] stroke 0.50 [0.05; 5.50] myocardial infarction 0.75 [0.17; 3.34] Death, Myocardial infarction, stroke 0.75 [0.18; 3.06] |
| EC409 | vs placebo | | | death 0.75 [0.13; 4.36] serious heart failure 2.00 [0.15; 26.19] stroke 0.14 [0.02; 1.16] myocardial infarction 0.80 [0.22; 2.96] Death, Myocardial infarction, stroke 0.50 [0.14; 1.83] |
| EC410 | vs placebo | | | death 1.00 [0.11; 8.73] serious heart failure 0.50 [0.04; 6.55] stroke 0.66 [0.11; 3.91] myocardial infarction 4.94 [0.58; 42.02] Death, Myocardial infarction, stroke 1.33 [0.33; 5.43] |
| OPI-520 | vs placebo | | | death 1.00 [0.11; 8.73] serious heart failure ∞ [NaN; ∞] stroke NaN [NaN; NaN] myocardial infarction 0.99 [0.14; 6.91] Death, Myocardial infarction, stroke 1.00 [0.19; 5.29] |
| OPI-506 | vs placebo | | | death 0.17 [0.02; 1.38] serious heart failure 1.09 [0.48; 2.45] stroke 1.11 [0.45; 2.71] myocardial infarction 0.58 [0.23; 1.47] Death, Myocardial infarction, stroke 0.72 [0.38; 1.37] |
| Bolli, 2008 | vs placebo | | | all hypoglycemia ∞ [NaN; ∞] |
| PROACTIVE | vs placebo | | | |
| IRIS, 2016 | vs placebo | | | |
| Trial | Treatments | Patients | Method |
|---|
| PROactive, 2005 | pioglitazone titrated from 15 mg to 45 mg (n=2605) vs. placebo (n=2633) | Inadequately controlled patients with type 2 diabetes who had evidence of macrovascular disease | double blind Parallel groups Sample size: 2605/2633 Primary endpoint: cardiovascular events FU duration: 34.5 mo |
| PERISCOPE, 2008 | pioglitazone 15 to 45 mg (n=274) vs. glimepiride, 1 to 4 mg (n=273) | patients with coronary disease and type 2 diabetes | double blind Parallel groups Sample size: 274/273 Primary endpoint: percent atheroma volume FU duration: 18 months |
| PNFP-010 | Pioglitazone + sulfonylurea (n=373) vs. Sulfonylurea (n=187) | patients with type 2 diabetes | Parallel groups Sample size: 373/187 Primary endpoint: FU duration: 16 wk |
| PNFP-014 | Pioglitazone insulin (n=379) vs. Placebo + insulin (n=187) | patients with type 2 diabetes | Parallel groups Sample size: 379/187 Primary endpoint: FU duration: 16 wk |
| PNFP-027 | Pioglitazone + metforminrea (n=168) vs. Placebo +metformin (n=160) | patients with type 2 diabetes | Parallel groups Sample size: 168/160 Primary endpoint: FU duration: 16 wk |
| PNFP-026 | Pioglitazone (n=101) vs. Placebo (n=96) | patients with type 2 diabetes | Parallel groups Sample size: 101/96 Primary endpoint: FU duration: 16 wk |
| OPI-502 | Pioglitazone + insulin (n=110) vs. Placebo + insulin (n=112) | Insulin-dependent DM-2 | Parallel groups Sample size: 110/112 Primary endpoint: FU duration: 20 wk |
| PNFP-012 | Pioglitazone (n=176) vs. Placebo (n=84) | patients with type 2 diabetes | Parallel groups Sample size: 176/84 Primary endpoint: FU duration: 24 wk |
| OPI-504 | Pioglitazone (n=262) vs. Sulfonylurea (n=256) | patients with type 2 diabetes andmild to moderate congestive heart failure | Parallel groups Sample size: 262/256 Primary endpoint: FU duration: 24 wk |
| GLAI | Pioglitazone (n=369) vs. Rosiglitazone (n=366) | patients with type 2 diabetes and dyslipidemia | Parallel groups Sample size: 369/366 Primary endpoint: FU duration: 24 wk |
| PNFP-001 | Pioglitazone (n=329) vs. Placebo (n=79) | patients with type 2 diabetes | Parallel groups Sample size: 329/79 Primary endpoint: FU duration: 26 wk |
| EC405 | Pioglitazone (n=624) vs. Sulfonylurea (n=626) | patients with type 2 diabetes | Parallel groups Sample size: 624/626 Primary endpoint: FU duration: 52 wk |
| OPI-501 | Pioglitazone (n=251) vs. Sulfonylurea (n=251) | Recently diagnosed DM-2 | Parallel groups Sample size: 251/251 Primary endpoint: FU duration: 56 wk |
| EC404 | Pioglitazone (n=597) vs. Metformin (n=597) | patients with type 2 diabetes | Parallel groups Sample size: 597/597 Primary endpoint: FU duration: 52 wk |
| EC409 | Pioglitazone + sulfonylurea (n=319) vs. Metformin + sulfonylurea (n=320) | patients with type 2 diabetes | Parallel groups Sample size: 319/320 Primary endpoint: FU duration: 104 wk |
| EC410 | Pioglitazone + metformin (n=317) vs. Sulfonylurea + metformin (n=313) | patients with type 2 diabetes | Parallel groups Sample size: 317/313 Primary endpoint: FU duration: 104 wk |
| OPI-520 | Pioglitazone (n=151) vs. Sulfonylurea (n=149) | Inadequately controlled DM-2 with mild cardiac disease(New York HeartAssociation Class I) | Parallel groups Sample size: 151/149 Primary endpoint: FU duration: 52 wk |
| OPI-506 | Pioglitazone (n=1051) vs. Sulfonylurea (n=1046) | Inadequately controlled DM-2 | Parallel groups Sample size: 1051/1046 Primary endpoint: FU duration: 156 wk |
| Bolli, 2008 | vildagliptin (50 mg b.i.d. (n=295) vs. pioglitazone (30 mg daily (n=295) | | Sample size: 295/295 Primary endpoint: FU duration: 52 weeks |
| PROACTIVE | oral pioglitazone titrated from 15 mg to 45 mg (n=2605) vs. placebo (n=2633) | patients with type 2 diabetes who had evidence of macrovascular disease. | Sample size: 2605/2633 Primary endpoint: all cause death, MI, stroke, ACS, revascularization, amputation (above ankle) FU duration: 34.5 months |
| IRIS, 2016 | (n=-9) vs. (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: |
