| pathology | treatment | patient | Demonstrated benefit and harm | k | | | |
|---|
| diabetic kidney disease | amlodipine | not classified | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| IDNT (amlodipine vs PBO), 2001 | amlodipine vs placebo | | | All deaths 0.88 [0.66; 1.18] Cardiovascular events 0.88 [0.69; 1.12] microvascular events 1.04 [0.86; 1.25] |
| Trial | Treatments | Patients | Method |
|---|
| IDNT (amlodipine vs PBO), 2001 | Amlodipine 10 mg daily (n=567) vs. placebo (n=569) | hypertensive patients with nephropathy due to type 2 diabetes | double-blind Parallel groups Sample size: 567/569 Primary endpoint: renal death FU duration: 2.6 years |
|
| diabetic kidney disease | irbesartan | not classified | versus placebo or control No demonstrated result for efficacy | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| IPDM (150mg), 2001 | irbesartan vs placebo | microvascular events 0.30 [0.14; 0.64] | | | | IDNT (irbesartan vs pbo), 2001 | irbesartan vs placebo | microvascular events 0.80 [0.66; 0.97] | | All deaths 0.92 [0.69; 1.23] Cardiovascular events 0.91 [0.72; 1.15] |
| Trial | Treatments | Patients | Method |
|---|
| IPDM (150mg), 2001 | irbesartan 150 mg daily (n=195) vs. placebo (n=201) 3 arms trial: irbesartan 150 and 300 mg daily, placebo | hypertensive patients with type 2 diabetes and microalbuminuria | double-blind Parallel groups Sample size: 195/201 Primary endpoint: diabetic nephropathy FU duration: 2 years | | IDNT (irbesartan vs pbo), 2001 | Irbesartan 300 mg daily (n=579) vs. placebo (n=569)
| hypertensive patients with nephropathy due to type 2 diabetes
| double blind Parallel groups Sample size: 579/569 Primary endpoint: renal death FU duration: 2.6 years
|
|
| diabetic kidney disease | irbesartan | not classified | versus calcium-channel blockers No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| IDNT (irbesartan vs amlodipine), 2001 | irbesartan vs amlodipine | microvascular events 0.77 [0.63; 0.94] | | All deaths 1.04 [0.77; 1.40] Cardiovascular events 1.03 [0.81; 1.31] |
| Trial | Treatments | Patients | Method |
|---|
| IDNT (irbesartan vs amlodipine), 2001 | Irbesartan 300 mg daily (n=579) vs. amlodipine 10 mg daily (n=567)
| hypertensive patients with nephropathy due to type 2 diabetes
| double blind Parallel groups Sample size: 579/567 Primary endpoint: renal death FU duration: 2.6 years
|
|
| diabetic kidney disease | losartan | not classified | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| RENAAL, 2001 | losartan vs placebo | microvascular events 0.79 [0.66; 0.95] | | All deaths 1.02 [0.80; 1.30] |
| Trial | Treatments | Patients | Method |
|---|
| RENAAL, 2001 | losartan 50 to 100 mg once daily (n=751) vs. placebo (n=762) | patients with type 2 diabetes and nephropathy | double-blind Parallel groups Sample size: 751/762 Primary endpoint: doubling of the creatinine, end-stage renal disease, death FU duration: 3.4 y |
|
| diabetic kidney disease | olmesartan | not classified | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| ORIENT | olmesartan vs placebo | | | all cause death 0.96 [0.52; 1.75] CV death 3.36 [0.93; 12.07] non fatal stroke 0.73 [0.30; 1.79] non fatal MI 0.43 [0.11; 1.65] |
| Trial | Treatments | Patients | Method |
|---|
| ORIENT | olmesartan (n=282) vs. placebo (n=284) | patients with diabetic Nephropathy and overt proteinuria secondary to type 2 diabetes mellitus | double-blind Parallel groups Sample size: 282/284 Primary endpoint: FU duration: |
|
| diabetic kidney disease | ramipril | not classified | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| DIABHYCAR, 2004 | ramipril vs placebo | | | All deaths 1.04 [0.90; 1.20] Cardiovascular death 1.07 [0.85; 1.35] non fatal stroke 1.07 [0.80; 1.44] non fatal MI 0.89 [0.62; 1.29] Stroke 1.03 [0.80; 1.32] Fatal and nonfatal MI 0.79 [0.57; 1.10] Cardiovascular events 0.97 [0.85; 1.11] |
| Trial | Treatments | Patients | Method |
|---|
| DIABHYCAR, 2004 | ramipril 1.25 mg/day (n=2443) vs. placebo (n=2469) | patients with type 2 diabetes who have microalbuminuria or proteinuria | double-blind Parallel groups Sample size: 2443/2469 Primary endpoint: cardiovascular death, non-fatal MI, stroke, HF, end-stage renal failure FU duration: median 4 years conducted mostly
by general practitioners in 16 countries |
|
| heart failure with preserved LVEF | candesartan | not classified | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| CHARM preserved, 2003 | candesartan vs placebo | | | |
| Trial | Treatments | Patients | Method |
|---|
| CHARM preserved, 2003 | candesartan target dose 32 mg once daily (n=1514) vs. placebo (n=1509) | patients with NYHA II-IV heart failure and LVEF higher than 40% | double blind Parallel groups Sample size: 1514/1509 Primary endpoint: cardiovascular death or admission to FU duration: 36.6 months |
|
| heart failure with preserved LVEF | irbesartan | not classified | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| I-PRESERVE (McMurray), 2008 | ibesartan vs placebo | | | Death from Any Cause, Cardiac Arrest with Resuscitation, Hospitalization for Worsening Heart Failure, or Therapy with Intravenous Inotropes or Vasodilators 0.97 [0.89; 1.05] all cause death 1.02 [0.91; 1.14] Cardiovascular death 1.03 [0.89; 1.19] hospital admission for heart failure 0.96 [0.84; 1.11] hospital admission for any reason 1.02 [0.97; 1.08] death or CV hospitalization 0.97 [0.89; 1.05] Cardiovascular death or hospital admission for CHF 0.97 [0.87; 1.10] |
| Trial | Treatments | Patients | Method |
|---|
| I-PRESERVE (McMurray), 2008 | ibersatan 300mg daily (n=2067) vs. placebo (n=2061) | patients with NYHA
II, III, or IV heart failure and an ejection fraction of at least 45% | double blind Parallel groups Sample size: 2067/2061 Primary endpoint: FU duration: 49.5 months |
|
| heart failure with preserved LVEF | perindopril | not classified | versus placebo or no treatment No demonstrated result for efficacy perindopril inferior to placebo in terms of Hospitalisation in PEP CHF, 2006 | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| PEP CHF, 2006 | perindopril vs placebo | | Hospitalisation 0.64 [0.43; 0.97] | Death 0.90 [0.47; 1.71] Long term death (1 year) 0.90 [0.47; 1.71] all cause death or hospitalisation 0.69 [0.47; 1.02] |
| Trial | Treatments | Patients | Method |
|---|
| PEP CHF, 2006 | perindopril, 4 mg/day (n=424) vs. placebo (n=426) | patients aged >=70 years with a diagnosis of heart failure, treated with diuretics and an echocardiogram
suggesting diastolic dysfunction and excluding substantial LV systolic dysfunction or valve disease | double blind Parallel groups Sample size: 424/426 Primary endpoint: all-cause mortality and unplanned heart failure related hospitalization FU duration: 26.2 months (range 12-54.2m) |
|
| melanoma | Interferon alpha | adjuvant | versus placebo or control No demonstrated result for efficacy | 4 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| EORTC18871/DKG 80-1 (Kleeberg), 2004 | rIFN alpha-2b vs observation | | | OS 0.96 [0.76; 1.21] PFS 1.04 [0.84; 1.29] | | EORTC18952 (Eggermont), 2005 | ID IFN alpha-2b (I M) vs observation | | | OS 0.84 [0.66; 1.07] PFS 0.84 [0.67; 1.06] DMFS 0.84 [0.66; 1.07] | | EORTC18991 (Eggermont), 2008 | PEG IFN alpha-2b (I M) vs observation | PFS 0.87 [0.76; 1.00] | | OS 0.96 [0.83; 1.12] DMFS 0.93 [0.81; 1.07] | | Nordic IFN Trial, 2011 | ID IFN alpha-2b (I M) vs observation | PFS 0.77 [0.62; 0.95] | | OS 0.91 [0.72; 1.15] |
| Trial | Treatments | Patients | Method |
|---|
| EORTC18871/DKG 80-1 (Kleeberg), 2004 | rIFN-alpha2b (n=-9) vs. observation (n=-9) 4 arms: IFN-alpha2b versus rIFN-gamma versus ISCADOR M versus observation | High-risk stage II patients (thickness >3 mm) and stage III patients (positivelymph nodes) without distant metastasis | Sample size: -9/-9 Primary endpoint: FU duration: 8.2 years (median) | | EORTC18952 (Eggermont), 2005 | (n=-9) vs. (n=-9) | patients who had had a thick primary tumour (thickness4 mm) resected (stage IIb) or regional lymph node metastases dissected (stage III) | Sample size: -9/-9 Primary endpoint: FU duration: 4.65 years | | EORTC18991 (Eggermont), 2008 | pegylated interferon alfa-2b 6 mug/kg per week for 8 weeks (induction) then 3 mug/kg per week (maintenance) for an intended duration of 5 years (n=627) vs. (n=629) | patients with resected stage III melanoma | Sample size: 627/629 Primary endpoint: recurrence-free survival FU duration: 3.8 years | | Nordic IFN Trial, 2011 | intermediate-dose interferon alfa-2b duration 1 (n=-9) vs. duration 2 (n=-9) | patients with stage IIB-IIC or III resected cutaneous melanoma. | Sample size: -9/-9 Primary endpoint: FU duration: 72·4 months |
|
| melanoma | ipilimumab | adjuvant | versus placebo or control ipilimumab superior to placebo in terms of recurrence free survival in EORTC 18071 (Eggermont), 2015 (adjuvant patients) ipilimumab inferior to placebo in terms of grade 3-4 in EORTC 18071 (Eggermont), 2015 (adjuvant patients) | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| EORTC 18071 (Eggermont), 2015 | ipilimumab vs placebo | recurrence free survival 0.76 [0.64; 0.90] Demonstrated OS 0.72 [0.58; 0.89] PFS 0.76 [0.64; 0.90] distant metastasis free survival 0.76 [0.63; 0.91] | grade 3-4 2.07 [1.74; 2.46] | |
| Trial | Treatments | Patients | Method |
|---|
| EORTC 18071 (Eggermont), 2015 | ipilimumab at a dose of 10 mg per kilogram every 3 weeks for four doses, then every 3 months for up to 3 years or until disease recurrence or an unacceptable level of toxic effects occurred (n=475) vs. placebo (n=476) | high risk patients who had undergone complete resection of stage III melanoma | double-blind Parallel groups Sample size: 475/476 Primary endpoint: RFS FU duration: 5.3 years phase 3 |
|
| melanoma | nivolumab | adjuvant | versus anti-CTLA-4 nivolumab superior to ipilimumab in terms of recurrence free survival in CheckMate 238, 2017 (adjuvant patients) | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| CheckMate 238, 2017 | nivolumab vs ipilimumab | recurrence free survival 0.65 [0.51; 0.83] Demonstrated PFS 0.65 [0.51; 0.83] Adverse events leading to discontinuation of drug 0.23 [0.17; 0.31] Grade 3 or 4 drug-related adverse events 0.31 [0.24; 0.40] | | |
| Trial | Treatments | Patients | Method |
|---|
| CheckMate 238, 2017 | nivolumab at a dose of 3 mg per kilogram of body weight every 2 weeks (n=453) vs. ipilimumab at a dose of 10 mg per kilogram every 3 weeks for four doses and then every 12 weeks (n=453) | patients with Complete Resection of Stage IIIb/c or Stage IV Melanoma | double-blind Parallel groups Sample size: 453/453 Primary endpoint: Recurrence free survival FU duration: 18 months (median) |
|
| melanoma | pembrolizumab | adjuvant | versus placebo or control pembrolizumab superior to placebo in terms of recurrence free survival in KEYNOTE-054, 2018 (adjuvant patients) pembrolizumab inferior to placebo in terms of Grade 3 or 4 drug-related adverse events in KEYNOTE-054, 2018 (adjuvant patients) pembrolizumab inferior to placebo in terms of Vitiligo any grade in KEYNOTE-054, 2018 (adjuvant patients) | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| KEYNOTE-054, 2018 | pembrolizumab vs placebo | recurrence free survival 0.57 [0.43; 0.75] Demonstrated PFS LP-D1 positif 0.54 [0.42; 0.69] PFS PD-L1 negatif 0.47 [0.26; 0.85] PFS 0.57 [0.43; 0.75] | Grade 3 or 4 drug-related adverse events 4.35 [2.61; 7.26] Vitiligo any grade 2.96 [1.34; 6.52] | Vitiligo grade 3-4 NaN [NaN; NaN] |
| Trial | Treatments | Patients | Method |
|---|
| KEYNOTE-054, 2018 | Pembrolizumab (Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 1 year)
(n=514) vs. placebo (n=505) | patients with complete Resection of High-Risk Stage III Melanoma | double-blind Parallel groups Sample size: 514/505 Primary endpoint: Recurrence-free survival , FU duration: 15 months (median) |
|
| melanoma | trametinib + dabrafenib | adjuvant | versus placebo or control No demonstrated result for efficacy | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| COMBI-AD, 2017 | trametinib and dabrafenib vs placebo | OS 0.57 [0.42; 0.78] PFS 0.47 [0.39; 0.57] distant metastasis free survival 0.51 [0.40; 0.65] | | | | COMBI neo, 2018 | trametinib and dabrafenib vs SOC | | | |
| Trial | Treatments | Patients | Method |
|---|
| COMBI-AD, 2017 | dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for 12 months (n=-9) vs. placebo (n=-9) | Patients with completely resected, histologically confirmed, BRAF V600E/K mutation-positive, high-risk [Stage IIIa (lymph node metastasis >1 mm), IIIb or IIIc] cutaneous melanoma | double-blind Sample size: -9/-9 Primary endpoint: Relapse-free survival FU duration: | | COMBI neo, 2018 | (n=-9) vs. (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: |
|
| melanoma | vemurafenib | adjuvant | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| BRIM 8, 2018 | vemurafenib vs placebo | PFS 0.65 [0.50; 0.85] | | OS 0.72 [0.49; 1.08] |
| Trial | Treatments | Patients | Method |
|---|
| BRIM 8, 2018 | e twice-daily adjuvant oral vemurafenib 960 mg tablets for52 weeks (13×28-day cycles) (n=-9) vs. placebo (n=-9) | patients with resected,BRAFV600 mutation-positive melanoma: IC–IIIA–IIIB (cohort 1) or stage IIIC (cohort 2) | Sample size: -9/-9 Primary endpoint: FU duration: |
|
| obesity and overweight | Bupropion | not classified | versus placebo or control No demonstrated result for efficacy | 3 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Anderson, 2002 | Bupropion vs placebo | | | | | Croft, 2002 | Bupropion vs placebo | | | | | Jain, 2002 | Bupropion vs placebo | | | |
| Trial | Treatments | Patients | Method |
|---|
| Anderson, 2002 | bupropion SR 300, or 400 mg/d. (n=105) vs. placebo (n=112) | obese adults | double-blind Sample size: 105/112 Primary endpoint: FU duration: 24 weeks | | Croft, 2002 | Bupropion, 300 mg for 44 wk (n=210) vs. Placebo (n=213) | patients with major depression responder to open-label treatment with bupropion SR | double-blind Sample size: 210/213 Primary endpoint: FU duration: 44 weeks | | Jain, 2002 | bupropion SR 300 mg/d (n=213) vs. Placebo (n=209) | Obese adults (body mass index, 30 to 44 kg/m(2)) not currently meeting criteria for major depression but with depressive symptoms (Beck Depression Inventory score 10-30) | double-blind Sample size: 213/209 Primary endpoint: FU duration: 26 weeks |
|
| obesity and overweight | liraglutide | not classified | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Astrup (NN8022-1807 ), 2009 | liraglutide vs placebo | | | |
| Trial | Treatments | Patients | Method |
|---|
| Astrup (NN8022-1807 ), 2009 | 4 liraglutide doses (1.2 mg, 1.8 mg, 2.4 mg, or 3.0 mg daily) (n=-9) vs. placebo (n=-9) 3rd arms with orlistat 120 mg three times a day orally (n = 95) | obese individuals without type 2 diabetes | double blind Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: 20 weeks |
|
| obesity and overweight | lorcaserin | not classified | versus placebo or control No demonstrated result for efficacy lorcaserin inferior to placebo in terms of 10% Weight Loss Responders in BLOSSOM (10mg bid), 2009 lorcaserin inferior to placebo in terms of 5% Weight Loss Responders in BLOSSOM (10mg bid), 2009 lorcaserin inferior to placebo in terms of 10% Weight Loss Responders in BLOOM, 2010 lorcaserin inferior to placebo in terms of 5% Weight Loss Responders in BLOOM, 2010 lorcaserin inferior to placebo in terms of 10% Weight Loss Responders in BLOOM-DM (10mg bid) lorcaserin inferior to placebo in terms of 5% Weight Loss Responders in BLOOM-DM (10mg bid) | 3 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| BLOSSOM (10mg bid), 2009 | lorcaserin vs placebo | | 10% Weight Loss Responders 2.32 [1.94; 2.77] 5% Weight Loss Responders 1.89 [1.71; 2.09] | | | BLOOM, 2010 | lorcaserin vs placebo | | 10% Weight Loss Responders 2.94 [2.41; 3.59] 5% Weight Loss Responders 2.34 [2.09; 2.62] | | | BLOOM-DM (10mg bid) | lorcaserin vs placebo | | 10% Weight Loss Responders 3.68 [1.94; 7.00] 5% Weight Loss Responders 2.32 [1.68; 3.22] | |
| Trial | Treatments | Patients | Method |
|---|
| BLOSSOM (10mg bid), 2009 | lorcaserin 10 mg twice daily (n=1603) vs. placebo (n=1603) 3 arms trial with lorcaserin 10 mg twice daily, 10 mg once daily, and placebo | obese and overweight patients | double blind Parallel groups Sample size: 1603/1603 Primary endpoint: hierarchical testing procedure FU duration: 1 year | | BLOOM, 2010 | lorcaserin 10mg bid (n=-9) vs. placebo (n=-9) | | double-blind Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: 52 weeks | | BLOOM-DM (10mg bid) | lorcaserin 10 mg BID (n=253) vs. placebo (n=56) the lorcaserin 10mg QD was interrupted prematurely due to slow enrollment | overweight and obese patients with type 2 diabetes mellitus managed with oral hypoglycemic agents | double-blind Parallel groups Sample size: 253/56 Primary endpoint: FU duration: 52 weeks |
|
| obesity and overweight | orlistat | not classified | versus placebo or control No demonstrated result for efficacy | 28 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Bakris, 2002 | Orlistat vs placebo | | | | | Broom, 2002 | Orlistat vs placebo | | | | | Broom,, 2001 | Orlistat vs placebo | | | | | Davidson, 1999 | Orlistat vs placebo | | | | | Deerochanawong,, 2001 | Orlistat vs placebo | | | | | Derosa, 2003 | Orlistat vs placebo | | | | | Gotfredsen, 2001 | Orlistat vs placebo | | | | | Halpern, 2003 | Orlistat vs placebo | | | | | Hanefeld, 2002 | Orlistat vs placebo | | | | | Hauptman, 2000 | Orlistat vs placebo | | | | | Hill, 1999 | Orlistat vs placebo | | | | | Hollander, 1998 | Orlistat vs placebo | | | | | Karhunen, 2000 | Orlistat vs placebo | | | | | Kelley, 2002 | Orlistat vs placebo | | | | | Krempf, 2005 | Orlistat vs placebo | | | | | Lindgarde, 2000 | Orlistat vs placebo | | | | | Lucas, 2003 | Orlistat vs placebo | | | | | Micic, 1999 | Orlistat vs placebo | | | | | Miles, 2002 | Orlistat vs placebo | | | | | Muls, 2001 | Orlistat vs placebo | | | | | Naumov, 2002 | Orlistat vs placebo | | | | | Reaven, 2001 | Orlistat vs placebo | | | | | Rissanen, 2001 | Orlistat vs placebo | | | | | Rosenfalck, 2002 | Orlistat vs placebo | | | | | Rossner, 2000 | Orlistat vs placebo | | | | | Shi Yi, 2001 | Orlistat vs placebo | | | | | Sjostrom, 1998 | Orlistat vs placebo | | | | | Vidgren, 1999 | Orlistat vs placebo | | | |
| Trial | Treatments | Patients | Method |
|---|
| Bakris, 2002 | orlistat (n=278) vs. placebo (n=276) | obese individuals with inadequately controlled hypertension.
| double-blind Sample size: 278/276 Primary endpoint: FU duration: 1-year | | Broom, 2002 | orlistat (n=265) vs. placebo (n=261) | obese patients with cardiovascular risk | double-blind parallel group Sample size: 265/261 Primary endpoint: FU duration: 54-week | | Broom,, 2001 | (n=71) vs. (n=71) | | Sample size: 71/71 Primary endpoint: FU duration: | | Davidson, 1999 | orlistat, 120 mg 3 times a day, for 52 weeks (n=668) vs. placebo (n=224) | Obese adults (BMI 30-43 kg/m2) | double-blind Sample size: 668/224 Primary endpoint: FU duration: 52 weeks | | Deerochanawong,, 2001 | (n=126) vs. (n=126) | | Sample size: 126/126 Primary endpoint: FU duration: | | Derosa, 2003 | orlistat 120 mg TID (n=27) vs. placebo (n=23) | obese patients with hypercholesterolemia | double-blind Sample size: 27/23 Primary endpoint: FU duration: 1-year | | Gotfredsen, 2001 | (n=16) vs. (n=14) sous groupe | | Sample size: 16/14 Primary endpoint: FU duration: | | Halpern, 2003 | orlistat (120 mg t.i.d.), (n=169) vs. placebo (n=174) | Obese, non-insulin-dependent diabetic patients, aged 18-70 years old, with BMI > 27 kg/m2 | Double-blind parallel Sample size: 169/174 Primary endpoint: FU duration: 24 weeks | | Hanefeld, 2002 | orlistat 120 mg t.i.d. (n=195) vs. placebo (n=188) | Overweight or obese adults (BMI >or= 28 kg/m2) with HbA1c of 6.5-11% and clinical type 2 diabetes | double-blind Sample size: 195/188 Primary endpoint: FU duration: 48-week | | Hauptman, 2000 | 60 mg of orlistat TID or 120 mg of orlistat TID, (n=210) vs. placebo (n=212) | obese patients (BMI 30-44 kg/m2) | double-blind Sample size: 210/212 Primary endpoint: FU duration: 1 year | | Hill, 1999 | 30 mg orlistat, 60 mg orlistat, or 120 mg orlistat 3 times daily for 1 y (n=181) vs. placebo (n=188) | Obese subjects who lost > or = 8% of their initial body weight during a 6-mo lead-in of a prescribed hypoenergetic diet (4180-kJ/d deficit) with no adjunctive pharmacotherapy | double-blind Sample size: 181/188 Primary endpoint: FU duration: 1 year | | Hollander, 1998 | 120 mg orlistat orally three times a day (n=163) vs. placebo (n=159) | obese men and women with type 2 diabetes who were aged > 18 years, had a BMI of 28-40 kg/m2, and were clinically stable on oral sulfonylureas | double-blind Sample size: 163/159 Primary endpoint: FU duration: 57-week | | Karhunen, 2000 | orlistat 120 mg t.i.d.
(n=36) vs. placebo (n=36) | obese subjects | double-blind Sample size: 36/36 Primary endpoint: FU duration: 1 y. | | Kelley, 2002 | orlistat 120 mg three times a day (n=274) vs. placebo (n=276) | overweight or obese adults (BMI 28-40 kg/m(2)) with type 2 diabetes treated with insulin alone or combined with oral agents, but with suboptimal metabolic control (HbA(1c) 7.5-12.0%) | double-blind Sample size: 274/276 Primary endpoint: FU duration: 1-year | | Krempf, 2005 | orlistat 120 mg three times daily (n=346) vs. placebo (n=350) | otherwise healthy, overweight patients aged 18-65 y (BMI >or=28 kg/m2 | double-blind Sample size: 346/350 Primary endpoint: FU duration: 18-month | | Lindgarde, 2000 | orlistat 120 mg three times daily (n=190) vs. placebo (n=186) | obese adults (body mass index 28-38 kg m-2) with type 2 diabetes, hypercholesterolaemia and/or hypertension | double-blind Sample size: 190/186 Primary endpoint: FU duration: 1 year | | Lucas, 2003 | (n=256) vs. (n=188) | | Sample size: 256/188 Primary endpoint: FU duration: | | Micic, 1999 | orlistat 120 mg three times daily (n=60) vs. placebo (n=59) | obese patients (BMI > or = 30 kg/m2) with hyperlipidemia (LDL-cholesterol > or = 4, 2 mmol/l) | double-blind Sample size: 60/59 Primary endpoint: FU duration: 24 weeks | | Miles, 2002 | 120 mg orlistat t.i.d. (n=255) vs. placebo (n=261) | overweight and obese patients with suboptimal control of type 2 diabetes | double-blind Sample size: 255/261 Primary endpoint: FU duration: 1 year | | Muls, 2001 | orlistat 120 mg three times daily (n=147) vs. placebo (n=147) | obese hypercholesterolemic patients, BMI between 27-40 kg/m2 and low-density-lipoprotein cholesterol, LDL-C, between 4.1-6.7 mmol/l | double-blind Sample size: 147/147 Primary endpoint: FU duration: 24 week | | Naumov, 2002 | orlistat (n=15) vs. diet alone (n=15) | patients with stable angina pectoris concomitant with obesity and hyperlipemia | open Sample size: 15/15 Primary endpoint: FU duration: | | Reaven, 2001 | (n=156) vs. (n=91) | | Sample size: 156/91 Primary endpoint: FU duration: | | Rissanen, 2001 | orlistat 120 mg three times daily (n=25) vs. placebo (n=26) | healthy obese women | double-blind Sample size: 25/26 Primary endpoint: FU duration: 12-month | | Rosenfalck, 2002 | (n=3) vs. (n=1) | obese patients | Sample size: 3/1 Primary endpoint: FU duration: | | Rossner, 2000 | orlistat (60 or 120 mg) three times a day (n=244) vs. Obese patients (body mass index 28 to 43 kg/m2) (n=243) | Obese patients (body mass index 28 to 43 kg/m2) | double-blind Sample size: 244/243 Primary endpoint: FU duration: 2-year | | Shi Yi, 2001 | (n=986) vs. (n=142) | | Sample size: 986/142 Primary endpoint: FU duration: | | Sjostrom, 1998 | orlistat 120 mg (three times a day) (n=345) vs. (n=343) | | double-blind Sample size: 345/343 Primary endpoint: FU duration: 1 year | | Vidgren, 1999 | 120 mg of orlistat three times a day (n=37) vs. placebo (n=38) | obese subjects | Sample size: 37/38 Primary endpoint: FU duration: 1 year |
|
| obesity and overweight | phentermine and topiramate | not classified | versus placebo or control No demonstrated result for efficacy | 6 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| OB 301 (mid-dose) | PHEN/TPM mid-dose vs placebo | | | | | OB 302 (low-dose) | PHEN/TPM low-dose vs placebo | | | | | CONQUER (mid-dose) (OB 303) | PHEN/TPM mid-dose vs placebo | | | | | CONQUER (high-dose) (OB 303) | PHEN/TPM high dose vs placebo | | | | | OB 302 (high-dose) | PHEN/TPM high dose vs placebo | | | | | OB 301 (high-dose) | PHEN/TPM high dose vs placebo | | | |
| Trial | Treatments | Patients | Method |
|---|
| OB 301 (mid-dose) | PHEN/TPM 7.5/46 mg (n=107) vs. placebo (n=109) 3 arms: PHEN/TPM 3.75/23 mg, PHEN/TPM
15/92 mg and placebo | | Parallel groups Sample size: 107/109 Primary endpoint: Weight loss at 28 weeks FU duration: 28 weeks | | OB 302 (low-dose) | PHEN/TPM 3.75/23 mg (n=241) vs. placebo (n=514) | | Sample size: 241/514 Primary endpoint: Weight loss at 56 weeks FU duration: 56 weeks | | CONQUER (mid-dose) (OB 303) | PHEN/TPM 7.5/46 mg (n=498) vs. placebo (n=994) | | Sample size: 498/994 Primary endpoint: Weight loss at 56 weeks FU duration: 56 weeks | | CONQUER (high-dose) (OB 303) | PHEN/TPM 15/92 mg (n=995) vs. placebo (n=994)
|
| Sample size: 995/994 Primary endpoint: Weight loss at 56 weeks FU duration: 56 weeks
| | OB 302 (high-dose) | PHEN/TPM 15/92 mg (n=512) vs. placebo (n=514)
|
| Sample size: 512/514 Primary endpoint: Weight loss at 56 weeks FU duration: 56 weeks
| | OB 301 (high-dose) | PHEN/TPM 15/92 mg (n=108) vs. placebo (n=109) 3 arms: PHEN/TPM 3.75/23 mg, PHEN/TPM
15/92 mg and placebo
|
| Sample size: 108/109 Primary endpoint: Weight loss at 28 weeks FU duration: 28 weeks
|
|
| obesity and overweight | Sibutramine | not classified | versus placebo or control No demonstrated result for efficacy sibutramine inferior to placebo in terms of cardiovascular events in SCOUT, 2010 | 4 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| McMahon, 2000 | Sibutramine vs placebo | | | | | McMahon, 2002 | Sibutramine vs placebo | | | | | Smith, 2001 | Sibutramine vs placebo | | | | | SCOUT, 2010 | sibutramine vs placebo | | cardiovascular events 1.16 [1.03; 1.31] | |
| Trial | Treatments | Patients | Method |
|---|
| McMahon, 2000 | (n=142) vs. (n=157) | | Sample size: 142/157 Primary endpoint: FU duration: | | McMahon, 2002 | (n=145) vs. (n=72) | | Sample size: 145/72 Primary endpoint: FU duration: | | Smith, 2001 | (n=142) vs. (n=69) | | Sample size: 142/69 Primary endpoint: FU duration: | | SCOUT, 2010 | sibutramine (n=4906) vs. placebo (n=4898) | overweight or obese patients with diabetes or a history of coronary or peripheral vascular disease or stroke, along with other CV risk factors | double blind Parallel groups Sample size: 4906/4898 Primary endpoint: death, MI, stroke FU duration: 3.4 year |
|
| obesity and overweight | topiramate | not classified | versus placebo or control No demonstrated result for efficacy | 6 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Bray, 2003 | Topiramate vs placebo | | | | | Caterson, 2003 | Topiramate vs placebo | | | | | Pud’homme, 2003 | Topiramate vs placebo | | | | | Rissanen, 2003 | Topiramate vs placebo | | | | | Stenlof, 2003 | Topiramate vs placebo | | | | | Tonstad, 2003 | Topiramate vs placebo | | | |
| Trial | Treatments | Patients | Method |
|---|
| Bray, 2003 | (n=75) vs. (n=75) | | Sample size: 75/75 Primary endpoint: FU duration: | | Caterson, 2003 | (n=93) vs. (n=97) | | Sample size: 93/97 Primary endpoint: FU duration: | | Pud’homme, 2003 | (n=33) vs. (n=33) | | Sample size: 33/33 Primary endpoint: FU duration: | | Rissanen, 2003 | (n=123) vs. (n=103) | | Sample size: 123/103 Primary endpoint: FU duration: | | Stenlof, 2003 | (n=135) vs. (n=137) | | Sample size: 135/137 Primary endpoint: FU duration: | | Tonstad, 2003 | (n=178) vs. (n=177) | | Sample size: 178/177 Primary endpoint: FU duration: |
|
