pathology | treatment | patient | Demonstrated benefit and harm | k | | | |
---|
atrial fibrillation | atorvastatin | not classified | versus placebo No demonstrated result for efficacy | 3 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
ARMYDA-3 (AF ancillary study), 2006 | atorvastatin vs placebo | AF 0.61 [0.45; 0.84] | | | Chello, 2006 | atorvastatin vs placebo | | | AF 0.40 [0.09; 1.83] | MIRACL (AF ancillary study), 2001 | atorvastatin vs placebo | | | AF 1.10 [0.63; 1.93] |
Trial | Treatments | Patients | Method |
---|
ARMYDA-3 (AF ancillary study), 2006 | atorvastatin 40mg daily (n=101) vs. placebo (n=99) | patients with scheduled cardiac surgery without history of AF | Sample size: 101/99 Primary endpoint: post-operative AF 5 min FU duration: 30 days | Chello, 2006 | atorvastatin 20mg daily (n=20) vs. placebo (n=20) | patients with scheduled coronary bypass surgery | double-blind Parallel groups Sample size: 20/20 Primary endpoint: FU duration: 3 weeks | MIRACL (AF ancillary study), 2001 | atorvastatin 80mg daily (n=1421) vs. placebo (n=1440) | Acute coronary syndrome; subgroup without history of AF | double-blind Parallel groups Sample size: 1421/1440 Primary endpoint: FU duration: 16 weeks |
|
atrial fibrillation | atorvastatin | not classified | versus placebo or control No demonstrated result for efficacy | 4 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Almroth, 2009 | atorvastatin vs placebo | AF recurrence 0.62 [0.47; 0.81] | | | MIRACL (sub-group) (Schwartz), 2004 | atorvastatin vs placebo | AF recurrence 0.73 [0.58; 0.91] | | | Ozaydin, 2006 | atorvastatin vs control | AF recurrence 0.27 [0.09; 0.86] | | | Dernellis, 2006 | atorvastatin vs placebo | AF recurrence 0.39 [0.25; 0.60] | | |
Trial | Treatments | Patients | Method |
---|
Almroth, 2009 | atorvastatin 80 mg daily (n=118) vs. placebo (n=116) | patients with persistent atrial fibrillation undergoing electrical cardioversion | double blind Parallel groups Sample size: 118/116 Primary endpoint: FU duration: 12 patients were excluded after randomization | MIRACL (sub-group) (Schwartz), 2004 | atorvastatin 80 mg (n=118) vs. placebo (n=108) | Acute coronary syndrome | double blind Sample size: 118/108 Primary endpoint: FU duration: 16 weeks | Ozaydin, 2006 | atorvastatin 10 mg (n=24) vs. standard therapy (n=24) | Persistent AF and scheduled EC | open Sample size: 24/24 Primary endpoint: recurrence of AF FU duration: 3 months | Dernellis, 2006 | atorvastatin 20–40 mg (n=40) vs. placebo (n=40) | Paroxysmal AF with CRP between 0.8 and 13 mg/L | NA Sample size: 40/40 Primary endpoint: FU duration: 4–6 months |
|
atrial fibrillation | candesartan | not classified | versus placebo No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
CHARM (AF ancillary study), 2005 | candesartan vs placebo | AF 0.82 [0.68; 1.00] | | |
Trial | Treatments | Patients | Method |
---|
CHARM (AF ancillary study), 2005 | candesartan (n=3225) vs. placebo (n=3221) | Heart failure | Sample size: 3225/3221 Primary endpoint: FU duration: 3.17 y |
|
atrial fibrillation | candesartan | not classified | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
CAPRAF (Tveit), 2007 | candesartan vs placebo | | | |
Trial | Treatments | Patients | Method |
---|
CAPRAF (Tveit), 2007 | candesartan 8 mg once daily for 3-6 weeks before and candesartan 16 mg once daily for 6 months after electrical cardioversion (n=86) vs. placebo (n=85) | patients undergoing electrical cardioversion for persistent AF | double blind Parallel groups Sample size: 86/85 Primary endpoint: Recurrence of atrial fibrillation FU duration: 6 months |
|
atrial fibrillation | enalapril | not classified | versus placebo No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
SOLVD (AF ancillary study), 2003 | enalapril vs placebo | AF 0.22 [0.12; 0.43] | | |
Trial | Treatments | Patients | Method |
---|
SOLVD (AF ancillary study), 2003 | enalapril (n=186) vs. placebo (n=188) | Heart failure | Sample size: 186/188 Primary endpoint: FU duration: 2.9 y |
|
atrial fibrillation | enalapril | not classified | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Ueng, 2003 | enalapril vs control | AF recurrence 0.60 [0.37; 0.97] | | |
Trial | Treatments | Patients | Method |
---|
Ueng, 2003 | enalapril (n=70) vs. control (n=75) | atrial fibrillation | open Parallel groups Sample size: 70/75 Primary endpoint: FU duration: 270 days (range 61-575d) |
|
atrial fibrillation | gemfibrozil | not classified | versus No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
VA HIT (AF ancillary study), 1999 | gemfibrozil vs placebo | | | AF 1.07 [0.76; 1.51] |
Trial | Treatments | Patients | Method |
---|
VA HIT (AF ancillary study), 1999 | gemfibrozil (n=1070) vs. placebo (n=1060) | men with coronary heart disease, an HDL cholesterol level of 40 mg per deciliter (1.0 mmol per liter) or less, and an LDL cholesterol level of 140 mg per deciliter (3.6 mmol per liter) or less | double blind Parallel groups Sample size: 1070/1060 Primary endpoint: FU duration: 4.4 y |
|
atrial fibrillation | irbesartan | not classified | versus No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
ACTIVE I, 2009 | irbesartan vs placebo | hospitalization for HF 0.87 [0.78; 0.98] | | cardiovascular events + HF hospitalization 0.95 [0.89; 1.02] vascular death 1.03 [0.93; 1.13] stroke/MI/vascular death 1.00 [0.92; 1.08] stroke 0.92 [0.81; 1.05] MI 1.05 [0.84; 1.33] |
Trial | Treatments | Patients | Method |
---|
ACTIVE I, 2009 | irbesartan 300mg once daily (n=4518) vs. placebo (n=4498) | patients with atrial fibrillation and with a systolic blood pressure of at least 110 mmHg associated with at least one major risk of vascular events these patients were drawn from two parallel trials (ACTIVE-A and ACTIVE-W) utilizing a partial factorial design | double blind Factorial plan Sample size: 4518/4498 Primary endpoint: coprimary MACE, HF events FU duration: 4.1 years |
|
atrial fibrillation | irbesartan | not classified | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Madrid, 2002 | irbesartan vs control | AF recurrence 0.39 [0.19; 0.79] | | |
Trial | Treatments | Patients | Method |
---|
Madrid, 2002 | irbesartan (n=79) vs. control (n=75) | atrial fibrillation | open Parallel groups Sample size: 79/75 Primary endpoint: FU duration: 254 d (range 60-710) |
|
atrial fibrillation | lisinopril | not classified | versus placebo No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
GISSI-3 (AF ancillary study), 2003 | lisinopril vs placebo | | | AF 0.92 [0.83; 1.01] |
Trial | Treatments | Patients | Method |
---|
GISSI-3 (AF ancillary study), 2003 | lisinopril (n=8902) vs. placebo (n=8846) | Post–myocardial infarction | Sample size: 8902/8846 Primary endpoint: FU duration: 0.5 y |
|
atrial fibrillation | lisinopril | not classified | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Van den Burg, 1995 | lisinopril vs placebo | | | AF recurrence 0.45 [0.13; 1.57] |
Trial | Treatments | Patients | Method |
---|
Van den Burg, 1995 | lisinopril (n=7) vs. placebo (n=11) | atrial fibrillation, congestive heart failure | double blind Parallel groups Sample size: 7/11 Primary endpoint: FU duration: 84 days |
|
atrial fibrillation | losartan | not classified | versus beta-blockers No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
LIFE (AF ancillary study), 2005 | losartan vs atenolol | AF 0.66 [0.54; 0.81] | | |
Trial | Treatments | Patients | Method |
---|
LIFE (AF ancillary study), 2005 | losartan (n=4298) vs. atenolol (n=4182) | hypertension | Sample size: 4298/4182 Primary endpoint: FU duration: 4.8 y |
|
atrial fibrillation | pravastatin | not classified | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Tveit, 2004 | pravastatin vs control | | | AF recurrence 1.06 [0.62; 1.81] |
Trial | Treatments | Patients | Method |
---|
Tveit, 2004 | pravastatin 40 mg (n=51) vs. standard therapy (n=51) | AF >48 h and scheduled EC | Sample size: 51/51 Primary endpoint: FU duration: 6 weeks |
|
atrial fibrillation | rosuvastatin | not classified | versus No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
GISSI HF (subgroup and ancillary study), 2009 | rosuvastatin vs placebo | | | AF 0.00 [NaN; NaN] |
Trial | Treatments | Patients | Method |
---|
GISSI HF (subgroup and ancillary study), 2009 | rosuvastatin 10mg daily (n=1855) vs. placebo (n=1835) | patients with chronic heart failure who were not in AF at study entry sub groups | double-blind Factorial plan Sample size: 1855/1835 Primary endpoint: FU duration: 3.7y (median) inclusion questionnable |
|
atrial fibrillation | valsartan | not classified | versus placebo No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Val-HeFT (AF ancillary study), 2003 | valsartan vs placebo | AF 0.67 [0.54; 0.83] | | |
Trial | Treatments | Patients | Method |
---|
Val-HeFT (AF ancillary study), 2003 | valsartan (n=2506) vs. placebo (n=2494) | Heart failure | Sample size: 2506/2494 Primary endpoint: FU duration: 1.92 y |
|
atrial fibrillation | valsartan | not classified | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
GISSI-AF (Disertori), 2009 | valsartan vs placebo | | | AF recurrence 0.99 [0.89; 1.09] more than 1 recurrence 0.96 [0.81; 1.14] |
Trial | Treatments | Patients | Method |
---|
GISSI-AF (Disertori), 2009 | valsartan (n=722) vs. placebo (n=720) | patients in sinus rhythm but with either two or more documented episodes of atrial fibrillation in the previous 6 months or successful cardioversion for atrial fibrillation in the previous 2 weeks
and with underlying cardiovascular disease, diabetes, or left atrial enlargement | double blind Parallel groups Sample size: 722/720 Primary endpoint: AF recurrence FU duration: 1 year |
|
diabetes type 2 | diet | not classified | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Liao, 2002 | AHA 2 diet vs AHA 1 diet | | | diabetes 0.52 [0.06; 4.50] |
Trial | Treatments | Patients | Method |
---|
Liao, 2002 | American Heart Association (AHA) step 2 diet (<30% of total calories as fat, <7% saturated fat, 55% carbohydrate, and < 200 mg cholesterol daily) plus endurance exercise for 1 h three times a week (n=70) vs. AHA step 1 diet (30% of total calories as fat, 10% saturated fat, 50% carbohydrate, and <300 mg cholesterol) plus stretching exercise three times a week (n=0) | Japanese American subjects with impaired glucose tolerance (WHO criteria 1998) | open Parallel groups Sample size: 70/0 Primary endpoint: not defined FU duration: 22 months |
|
diabetes type 2 | glargine | not classified | versus No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
GRACE - ORIGIN (glargine), 2012 | insulin glargine vs placebo | | | |
Trial | Treatments | Patients | Method |
---|
GRACE - ORIGIN (glargine), 2012 | insulin glargine (with a target fasting blood glucose level of <=95 mg per deciliter [5.3 mmol per liter]) (n=1184) vs. standard glycemic care alone (n=0) | subject with known CV disease and/or CV risk factors plus impaired fasting glucose, impaired glucose tolerance, or type 2 diabetes | open-label Factorial plan Sample size: 1184/0 Primary endpoint: change in maximum CIMT FU duration: |
|
diabetes type 2 | glipizide | not classified | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Eriksson, 2006 | glipizide vs placebo | | | diabetes 0.18 [0.02; 1.37] |
Trial | Treatments | Patients | Method |
---|
Eriksson, 2006 | glipizide 2.5 mg daily (n=34) vs. placebo (n=0) | first-degree relatives of patients with type 2 diabetes fulfilling WHO criteria for IGT (WHO criteria in 2006) | double blind Parallel groups Sample size: 34/0 Primary endpoint: not defined FU duration: 18 months |
|
diabetes type 2 | metformin | not classified | versus placebo or control No demonstrated result for efficacy | 35 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
US-DPP (metformin) (Knowler), 2002 | metformin vs placebo | | | diabetes 0.69 [0.37; 1.28] | EDIT (Holman), 2003 | metformin vs placebo | | | | Li, 1999 | metformin vs placebo | | | diabetes 0.49 [0.09; 2.54] | IDDP (Ramachandran), 2006 | lifestyle modification + metformin vs control | | | diabetes 0.65 [0.27; 1.56] | Jarret, 1979 | lifestyle modification + metformin vs control | | | diabetes 0.84 [0.25; 2.87] | Baillargeon, 2004 | metformin vs placebo | | | | Bridger, 2006 | metformin vs placebo | | | | Charles, 1998 | metformin vs placebo | | | diabetes 0.00 [0.00; NaN] | Charles, 2000 | metformin vs placebo | | | | Choux, 2003 | metformin vs placebo | | | | Crave, 1995 | metformin vs placebo | | | | Fleming, 2002 | metformin vs placebo | | | | Freemark, 2001 | metformin vs placebo | | | | Gambineri, 2004 | metformin vs placebo | | | | Giugliano, 1993 | metformin vs placebo | | | | Hoeger, 2004 | metformin vs placebo | | | | James, 2005 | metformin vs control | | | | Kay, 2001 | metformin vs placebo | | | | Kelly, 2002 | metformin vs placebo | | | | Kocak, 2002 | metformin vs placebo | | | | Lehtovirta, 2001 | metformin vs placebo | | | diabetes 1.00 [0.07; 14.90] | Moghetti, 2000 | metformin vs placebo | | | | Morel, 1999 | metformin vs placebo | | | | Ng, 2001 | metformin vs placebo | | | | Orchard, 2005 | metformin vs placebo | diabetes 0.71 [0.61; 0.82] | | | Pasquali, 2000 | metformin vs placebo | | | | Rodriguez, 2004 | metformin vs placebo | | | | Rodriguez-Moctezuma, 2004 | metformin vs placebo | | | diabetes 0.00 [0.00; NaN] | Sirtori, 1984 | metformin vs placebo | | | | Srinivasan, 2006 | metformin vs placebo | | | | Stakos, 2005 | metformin vs placebo | | | | Sturrock, 2002 | metformin vs placebo | | | | Tang, 2006 | metformin vs placebo | | | | Vitale, 2005 | metformin vs placebo | | | | CANOE, 2010 | rosiglitazone and metformin vs placebo | diabetes 0.25 [0.16; 0.41] | | normoglycemia 1.00 [1.00; 1.00] |
Trial | Treatments | Patients | Method |
---|
US-DPP (metformin) (Knowler), 2002 | metformin 850mg twice daily (n=3234) vs. placebo (n=0) | nondiabetic patients with elevated glucose and high risk for diabetes | double blind Parallel groups Sample size: 3234/0 Primary endpoint: not defined FU duration: 2.8 years | EDIT (Holman), 2003 | metformin 500 mg three times/day, (n=631) vs. placebo (n=0) | (WHO 1985 criteria) | Sample size: 631/0 Primary endpoint: FU duration: | Li, 1999 | metformin 250 mg three times/day (n=33) vs. placebo (n=37) | patients with impaired glucose tolerance (WHO 1985 criteria) | double blind Parallel groups Sample size: 33/37 Primary endpoint: not defined FU duration: 12 months | IDDP (Ramachandran), 2006 | advice on lifestyle modification, metformin, or both (n=531) vs. given standard health care advice (control) (n=0) 4 arms: advice on lifestyle modification, metformin, or both and standard health care advice (control) | native Asian Indians with impaired glucose tolerance | open Parallel groups Sample size: 531/0 Primary endpoint: development of diabetes FU duration: 2.5 y | Jarret, 1979 | carbohydrate restriction with phenformin 50 mg daily (n=204) vs. carbohydrate restriction alone (n=0) | men with impaired glucose toleranc | open Parallel groups Sample size: 204/0 Primary endpoint: FU duration: 4.3 y | Baillargeon, 2004 | metformin 850 mg BID (n=32) vs. placebo (n=32) | Non obese women with PCOS | Sample size: 32/32 Primary endpoint: FU duration: 26 weeks | Bridger, 2006 | metformin 750 mg BID (n=11) vs. placebo (n=11) | Adolescents with PCOS and insulin resistance | Sample size: 11/11 Primary endpoint: FU duration: 12 weeks | Charles, 1998 | metformin 850 mg BID (n=227) vs. placebo (n=230) | Abdominal obesity | Sample size: 227/230 Primary endpoint: FU duration: 52 weeks | Charles, 2000 | metformin 850 mg BID (n=83) vs. placebo (n=85) | Abdominal obesity, hypertension, and elevated triglycerides | Sample size: 83/85 Primary endpoint: FU duration: 13 weeks | Choux, 2003 | metformin 500 mg TID (n=15) vs. placebo (n=17) | PCO | Sample size: 15/17 Primary endpoint: FU duration: 13 weeks | Crave, 1995 | metformin 850 mg BID (n=12) vs. placebo (n=12) | Overweight with PCO | Sample size: 12/12 Primary endpoint: FU duration: 17 weeks | Fleming, 2002 | metformin 850 mg BID (n=45) vs. placebo (n=47) | PCO | Sample size: 45/47 Primary endpoint: FU duration: 17 weeks | Freemark, 2001 | metformin 500 mg BID (n=16) vs. placebo (n=16) | Insulin resistance and family history of diabetes | Sample size: 16/16 Primary endpoint: FU duration: 26 weeks | Gambineri, 2004 | metformin 850 mg BID (n=10) vs. placebo (n=10) | Obesity and PCOS | Sample size: 10/10 Primary endpoint: FU duration: 26 weeks | Giugliano, 1993 | metformin 850 mg BID (n=12) vs. placebo (n=12) | Hypertension with normal glucose tolerance | Sample size: 12/12 Primary endpoint: FU duration: 12 weeks | Hoeger, 2004 | metformin 850 mg BID + lifestyle modification (n=18) vs. placebo + lifestyle modification (n=20) | Overweight with PCOSo[ | Sample size: 18/20 Primary endpoint: FU duration: 48 weeks | James, 2005 | metformin 1 g BID (n=10) vs. no treatment (n=10) | Abdominal obesity with insulin resistance[ | Sample size: 10/10 Primary endpoint: FU duration: 8 weeks | Kay, 2001 | metformin 850 mg BID (n=12) vs. placebo (n=12) | Adolescents with morbid obesity | Sample size: 12/12 Primary endpoint: FU duration: 8 weeks | Kelly, 2002 | metformin 500 mg TID (n=16) vs. placebo (n=16) | PCO | Sample size: 16/16 Primary endpoint: FU duration: 26 weeks | Kocak, 2002 | metformin 850 mg BID (n=28) vs. placebo (n=28) | PCO | Sample size: 28/28 Primary endpoint: FU duration: 8 weeks | Lehtovirta, 2001 | metformin 500 mg BID (n=20) vs. placebo (n=20) | Overweight with impaired glucose tolerance and family history of diabetes | Sample size: 20/20 Primary endpoint: FU duration: 26 weeks | Moghetti, 2000 | metformin 500 mg TID (n=12) vs. placebo (n=11) | PCOS with normal glucose tolerance | Sample size: 12/11 Primary endpoint: FU duration: 26 weeks | Morel, 1999 | metformin 850 mg BID (n=19) vs. placebo (n=19) | Impaired glucose tolerancee | Sample size: 19/19 Primary endpoint: FU duration: 8 weeks | Ng, 2001 | metformin 500 mg TID (n=10) vs. placebo (n=10) | PCO | Sample size: 10/10 Primary endpoint: FU duration: 12 weeks | Orchard, 2005 | metformin 850 mg BID (n=1073) vs. placebo (n=1082) | Impaired glucose tolerance | Sample size: 1073/1082 Primary endpoint: FU duration: 156 weeks | Pasquali, 2000 | metformin 850 mg BID (n=20) vs. placebo (n=20) | Abdominal obesity with and without PCO | Sample size: 20/20 Primary endpoint: FU duration: 26 weeks | Rodriguez, 2004 | metformin 1.7 g/d (n=10) vs. placebo (n=11) | Obesity with insulin resistance | Sample size: 10/11 Primary endpoint: FU duration: 20 weeks | Rodriguez-Moctezuma, 2004 | metformin 850 mg BID (n=12) vs. placebo (n=11) | Family history of diabetes | Sample size: 12/11 Primary endpoint: FU duration: 8 weeks | Sirtori, 1984 | metformin 850 mg BID (n=15) vs. placebo (n=15) | Peripheral vascular disease | Sample size: 15/15 Primary endpoint: FU duration: 26 weeks | Srinivasan, 2006 | metformin 1 g BID (n=28) vs. placebo (n=28) | Children and adolescents with obesity and insulin resistance | Sample size: 28/28 Primary endpoint: FU duration: 26 weeks | Stakos, 2005 | metformin 500 mg/d (n=59) vs. placebo (n=97) | African-Americans with insulin resistance and family history of diabetes | Sample size: 59/97 Primary endpoint: FU duration: 104 weeks | Sturrock, 2002 | metformin 1500 mg/d (n=17) vs. placebo (n=17) | PCO | Sample size: 17/17 Primary endpoint: FU duration: 13 weeks | Tang, 2006 | metformin 850 mg BID (n=69) vs. placebo (n=74) | Obesity with PCO | Sample size: 69/74 Primary endpoint: FU duration: 26 weeks | Vitale, 2005 | metformin 500 mg BID (n=32) vs. placebo (n=33) | Metabolic syndrome | Sample size: 32/33 Primary endpoint: FU duration: 13 weeks | CANOE, 2010 | rosiglitazone (2 mg) and metformin (500 mg) twice-daily (n=103) vs. placebo (n=104) | patients with impaired glucose tolerance | double-blind Parallel groups Sample size: 103/104 Primary endpoint: incident diabetes FU duration: 3.9y (median) |
|
diabetes type 2 | nateglinide | not classified | versus placebo or control No demonstrated result for efficacy nateglinide inferior to placebo in terms of diabetes in NAVIGATOR nateglinide, 2010 | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
NAVIGATOR nateglinide, 2010 | nateglinide vs placebo | | diabetes 1.06 [1.01; 1.12] | death 1.00 [0.86; 1.16] CV death 1.07 [0.84; 1.37] fatal and non fatal stroke 0.88 [0.69; 1.14] fatal and non fatal MI 0.95 [0.75; 1.19] hospitalization for heart failure 0.85 [0.64; 1.14] cardiovasculaire events 0.95 [0.83; 1.09] |
Trial | Treatments | Patients | Method |
---|
NAVIGATOR nateglinide, 2010 | nateglinide 60mg 3 times daily (n=4645) vs. placebo (n=4661) factorial design: patuents were also randomized between nateglinide or placebo
| subjects with impaired glucose tolerance and either CV disease or CV risk factors
| double-blind Factorial plan Sample size: 4645/4661 Primary endpoint: 3 coprimary: diabetes, CV events FU duration: 5 years
|
|
diabetes type 2 | orlistat | not classified | versus placebo or control No demonstrated result for efficacy | 2 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Heymsfield, 2000 | orlistat vs placebo | | | diabetes 0.39 [0.12; 1.23] | XENDOS (Chiasson), 2002 | orlistat vs placebo | | | diabetes 0.48 [0.16; 1.44] |
Trial | Treatments | Patients | Method |
---|
Heymsfield, 2000 | orlistat 120 mg three times/day (n=359) vs. placebo (n=316) | obese (body mass index, 30-43 kg/m2) adults (WHO 1985 criteria) | double blind Parallel groups Sample size: 359/316 Primary endpoint: glucose tolerance status FU duration: 4 weeks | XENDOS (Chiasson), 2002 | orlistat 120 mg three times/day (n=714) vs. placebo (n=715) | patients with impaired glucose tolerance (WHO 1994) | double blind Parallel groups Sample size: 714/715 Primary endpoint: diabetes FU duration: 3 months |
|
diabetes type 2 | ramipril | not classified | versus placebo or control No demonstrated result for efficacy ramipril inferior to placebo in terms of normoglycemia in DREAM ramipril, 2006 | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
DREAM ramipril, 2006 | ramipril vs placebo | | normoglycemia 1.11 [1.04; 1.19] | death 0.98 [0.60; 1.60] CV death 1.21 [0.52; 2.80] cardiovasculaire events 1.07 [0.76; 1.51] diabetes 0.93 [0.82; 1.04] |
Trial | Treatments | Patients | Method |
---|
DREAM ramipril, 2006 | ramipril up to 15 mg daily (n=2623) vs. placebo (n=2646) factorial design with rosiglitazone | patients with impaired fasting glucose or impaired glucose tolerance, or both, and no previous cardiovascular disease | double blind Parallel groups Sample size: 2623/2646 Primary endpoint: diabetes or death FU duration: 3 y (median) |
|
diabetes type 2 | rosiglitazone | not classified | versus placebo or control No demonstrated result for efficacy rosiglitazone inferior to placebo in terms of cardiovasculaire events in DREAM rosiglitazone, 2006 rosiglitazone inferior to placebo in terms of normoglycemia in DREAM rosiglitazone, 2006 | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
DREAM rosiglitazone, 2006 | rosiglitazone vs placebo | 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] |
Trial | Treatments | Patients | Method |
---|
DREAM rosiglitazone, 2006 | rosiglitazone 8 mg daily (n=2365) vs. placebo (n=2634) factorial design with ramipril | patients with impaired fasting glucose or impaired glucose tolerance, or both | double blind Parallel groups Sample size: 2365/2634 Primary endpoint: diabetes, death FU duration: 3 years (median) |
|
diabetes type 2 | troglitazone | not classified | versus placebo or control No demonstrated result for efficacy | 2 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
TRIPOD (Buchanan), 2002 | troglitazone vs placebo | | | | US DDP troglitazone (Knowler), 2005 | troglitazone vs placebo | | | |
Trial | Treatments | Patients | Method |
---|
TRIPOD (Buchanan), 2002 | troglitazone 400 mg once daily (n=133) vs. placebo (n=133) | Hispanic women with previous gestational diabetes | double blind Parallel groups Sample size: 133/133 Primary endpoint: not defined FU duration: 30 months (median) | US DDP troglitazone (Knowler), 2005 | troglitazone (n=585) vs. double placebo (n=582) | nondiabetic patients with elevated glucose and high risk for diabetes | double blind Parallel groups Sample size: 585/582 Primary endpoint: not defined FU duration: 0.9 year |
|
diabetes type 2 | valsartan | not classified | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
NAVIGATOR valsartan, 2010 | valsartan vs placebo | diabetes 0.90 [0.85; 0.95] | | death 0.91 [0.78; 1.06] CV death 1.11 [0.87; 1.43] fatal and non fatal stroke 0.80 [0.62; 1.03] fatal and non fatal MI 1.00 [0.79; 1.25] hospitalization for heart failure 0.98 [0.73; 1.30] cardiovasculaire events 0.98 [0.89; 1.08] |
Trial | Treatments | Patients | Method |
---|
NAVIGATOR valsartan, 2010 | valsartan up to 160 mg daily (n=4631) vs. placebo (n=4675) factorial design: patuents were also randomized between nateglinide or placebo | subjects with impaired glucose tolerance and either CV disease or CV risk factors | double-blind Factorial plan Sample size: 4631/4675 Primary endpoint: 3 coprimary: diabetes, CV events FU duration: 5 years |
|
diabetes type 2 | voglibose | not classified | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Voglibose Ph-3, 2009 | voglibose vs placebo | diabetes 0.46 [0.34; 0.64] | | |
Trial | Treatments | Patients | Method |
---|
Voglibose Ph-3, 2009 | voglibose 0.2 mg three times daily (n=897) vs. placebo (n=881) | patients with impaired fasting glucose | double blind Parallel groups Sample size: 897/881 Primary endpoint: type 2 diabetes mellitus FU duration: 4.01 years |
|
impaired fasting glucose | glargine | not classified | versus No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
GRACE - ORIGIN (glargine), 2012 | insulin glargine vs placebo | | | |
Trial | Treatments | Patients | Method |
---|
GRACE - ORIGIN (glargine), 2012 | insulin glargine (with a target fasting blood glucose level of <=95 mg per deciliter [5.3 mmol per liter]) (n=1184) vs. standard glycemic care alone (n=0) | subject with known CV disease and/or CV risk factors plus impaired fasting glucose, impaired glucose tolerance, or type 2 diabetes | open-label Factorial plan Sample size: 1184/0 Primary endpoint: change in maximum CIMT FU duration: |
|
impaired fasting glucose | metformin | not classified | versus placebo or control No demonstrated result for efficacy | 2 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
US-DPP (metformin) (Knowler), 2002 | metformin vs placebo | | | diabetes 0.69 [0.37; 1.28] | CANOE, 2010 | rosiglitazone and metformin vs placebo | diabetes 0.25 [0.16; 0.41] | | normoglycemia 1.00 [1.00; 1.00] |
Trial | Treatments | Patients | Method |
---|
US-DPP (metformin) (Knowler), 2002 | metformin 850mg twice daily (n=3234) vs. placebo (n=0) | nondiabetic patients with elevated glucose and high risk for diabetes | double blind Parallel groups Sample size: 3234/0 Primary endpoint: not defined FU duration: 2.8 years | CANOE, 2010 | rosiglitazone (2 mg) and metformin (500 mg) twice-daily (n=103) vs. placebo (n=104) | patients with impaired glucose tolerance | double-blind Parallel groups Sample size: 103/104 Primary endpoint: incident diabetes FU duration: 3.9y (median) |
|
impaired fasting glucose | nateglinide | not classified | versus placebo or control No demonstrated result for efficacy nateglinide inferior to placebo in terms of diabetes in NAVIGATOR nateglinide, 2010 | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
NAVIGATOR nateglinide, 2010 | nateglinide vs placebo | | diabetes 1.06 [1.01; 1.12] | death 1.00 [0.86; 1.16] CV death 1.07 [0.84; 1.37] fatal and non fatal stroke 0.88 [0.69; 1.14] fatal and non fatal MI 0.95 [0.75; 1.19] hospitalization for heart failure 0.85 [0.64; 1.14] cardiovasculaire events 0.95 [0.83; 1.09] |
Trial | Treatments | Patients | Method |
---|
NAVIGATOR nateglinide, 2010 | nateglinide 60mg 3 times daily (n=4645) vs. placebo (n=4661) factorial design: patuents were also randomized between nateglinide or placebo
| subjects with impaired glucose tolerance and either CV disease or CV risk factors
| double-blind Factorial plan Sample size: 4645/4661 Primary endpoint: 3 coprimary: diabetes, CV events FU duration: 5 years
|
|
impaired fasting glucose | ramipril | not classified | versus placebo or control No demonstrated result for efficacy ramipril inferior to placebo in terms of normoglycemia in DREAM ramipril, 2006 | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
DREAM ramipril, 2006 | ramipril vs placebo | | normoglycemia 1.11 [1.04; 1.19] | death 0.98 [0.60; 1.60] CV death 1.21 [0.52; 2.80] cardiovasculaire events 1.07 [0.76; 1.51] diabetes 0.93 [0.82; 1.04] |
Trial | Treatments | Patients | Method |
---|
DREAM ramipril, 2006 | ramipril up to 15 mg daily (n=2623) vs. placebo (n=2646) factorial design with rosiglitazone | patients with impaired fasting glucose or impaired glucose tolerance, or both, and no previous cardiovascular disease | double blind Parallel groups Sample size: 2623/2646 Primary endpoint: diabetes or death FU duration: 3 y (median) |
|
impaired fasting glucose | rosiglitazone | not classified | versus placebo or control No demonstrated result for efficacy rosiglitazone inferior to placebo in terms of cardiovasculaire events in DREAM rosiglitazone, 2006 rosiglitazone inferior to placebo in terms of normoglycemia in DREAM rosiglitazone, 2006 | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
DREAM rosiglitazone, 2006 | rosiglitazone vs placebo | 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] |
Trial | Treatments | Patients | Method |
---|
DREAM rosiglitazone, 2006 | rosiglitazone 8 mg daily (n=2365) vs. placebo (n=2634) factorial design with ramipril | patients with impaired fasting glucose or impaired glucose tolerance, or both | double blind Parallel groups Sample size: 2365/2634 Primary endpoint: diabetes, death FU duration: 3 years (median) |
|
impaired fasting glucose | valsartan | not classified | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
NAVIGATOR valsartan, 2010 | valsartan vs placebo | diabetes 0.90 [0.85; 0.95] | | death 0.91 [0.78; 1.06] CV death 1.11 [0.87; 1.43] fatal and non fatal stroke 0.80 [0.62; 1.03] fatal and non fatal MI 1.00 [0.79; 1.25] hospitalization for heart failure 0.98 [0.73; 1.30] cardiovasculaire events 0.98 [0.89; 1.08] |
Trial | Treatments | Patients | Method |
---|
NAVIGATOR valsartan, 2010 | valsartan up to 160 mg daily (n=4631) vs. placebo (n=4675) factorial design: patuents were also randomized between nateglinide or placebo | subjects with impaired glucose tolerance and either CV disease or CV risk factors | double-blind Factorial plan Sample size: 4631/4675 Primary endpoint: 3 coprimary: diabetes, CV events FU duration: 5 years |
|
impaired fasting glucose | voglibose | not classified | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Voglibose Ph-3, 2009 | voglibose vs placebo | diabetes 0.46 [0.34; 0.64] | | |
Trial | Treatments | Patients | Method |
---|
Voglibose Ph-3, 2009 | voglibose 0.2 mg three times daily (n=897) vs. placebo (n=881) | patients with impaired fasting glucose | double blind Parallel groups Sample size: 897/881 Primary endpoint: type 2 diabetes mellitus FU duration: 4.01 years |
|
post stroke | folic acid | not classified | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
VITATOPS, 2010 | folic acid, vit B12 and vit B6 vs placebo | vascular death 0.86 [0.75; 0.99] | | cardiovascular event 0.91 [0.82; 1.00] |
Trial | Treatments | Patients | Method |
---|
VITATOPS, 2010 | folic acid and vitamins B12 and B6 in a single tablet (n=4089) vs. placebo (n=4075) | patients with recent stroke or TIA (within the past seven months) | double-blind Parallel groups Sample size: 4089/4075 Primary endpoint: nonfatal stroke, nonfatal MI, vascular death FU duration: 3.4 y |
|
post stroke | folic acid | not classified | versus folic acid, vit B12 and vit B6 No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
VISP (Toole), 2004 | high dose - folic acid, vit B12 and vit B6 vs low dose - folic acid, vit B12 and vit B6 | | | Death from any cause 0.86 [0.66; 1.11] Myocardial infarction 0.90 [0.66; 1.23] stroke (fatal & non fatal) 1.04 [0.84; 1.29] cardiovascular event (fatal and non fatal) 0.97 [0.84; 1.12] |
Trial | Treatments | Patients | Method |
---|
VISP (Toole), 2004 | high-dose of folic acid, pyridoxine (vitamin B6),
and cobalamin (vitamin B12) (n=1827) vs. low-dose of folic acid, pyridoxine (vitamin B6),
and cobalamin (vitamin B12) (n=1853) | adults with nondisabling cerebral infarction | double blind Parallel groups Sample size: 1827/1853 Primary endpoint: Recurrent cerebral infarction FU duration: 2 y |
|