pathology | Demonstrated benefit and harm | k | | | |
---|
acute myocardial infarction | versus placebo No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
HEBE III, 2010 | epoetin alfa vs placebo | | | MACE 0.48 [0.22; 1.04] Cardiovascular death 0.51 [0.05; 5.54] Emergency PCI for in-stent thrombosis/reinfarction/unstable angina 0.56 [0.19; 1.65] Stroke 1.01 [0.06; 16.09] Heart failure 0.14 [0.02; 1.17] |
Trial | Treatments | Patients | Method |
---|
HEBE III, 2010 | single bolus of 60,000 IU epoetin alfa administered intravenously within three hours after a successful PCI (n=263) vs. control (n=266) | patients with a first ST-elevation MI and a successful PCI | open Parallel groups Sample size: 263/266 Primary endpoint: left ventricular ejection fraction FU duration: 6 weeks |
|
diabetes type 2 | versus No demonstrated result for efficacy | 2 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Nauck 20 once weekly vs PBO, 2009 | taspoglutide 20mg once weekly vs placebo | | | | Nauck 20 every 2 weeks vs PBO, 2009 | taspoglutide 20mg once every 2 weeks vs placebo | | | |
Trial | Treatments | Patients | Method |
---|
Nauck 20 once weekly vs PBO, 2009 | (n=-9) vs. (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: | Nauck 20 every 2 weeks vs PBO, 2009 | (n=-9) vs. (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: |
|
diabetes type 2 | versus add on oral therapy No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Ratner (20mg once weekly), 2010 | taspoglutide vs placebo (add on MET) | | | |
Trial | Treatments | Patients | Method |
---|
Ratner (20mg once weekly), 2010 | taspoglutide s.c. 20mg once weekly for 8 weeks (n=97) vs. placebo s.c. once
weekly on top metformin (n=32) 3 different regimens : 20 mg taspoglutide s.c. once weekly
for 4 weeks, followed by 4 weeks of 20 mg once weekly
(20/20), or titration up to 30 mg once-weekly (20/30) or
40 mg once-weekly (20/40) taspoglutide | subjects with Type 2 diabetes inadequately controlled on metformin alone | double-blind Parallel groups Sample size: 97/32 Primary endpoint: GI adverse events FU duration: 8 weeks (+4wk) phase 2 |
|
diabetes type 2 | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Nauck 10 once weekly vs PBO, 2009 | taspoglutide 10mg once weekly vs placebo | | | |
Trial | Treatments | Patients | Method |
---|
Nauck 10 once weekly vs PBO, 2009 | taspoglutide, either 5, 10, or 20 mg once weekly or 10 or 20 mg once every 2 weeks for 8 weeks (n=257) vs. placebo (n=49) | patients with type 2 diabetes inadequately controlled with metformin | double-blind Parallel groups Sample size: 257/49 Primary endpoint: change in A1C FU duration: 12 weeks phase 2b, dose ranging |
|
heart failure | versus placebo or control No demonstrated result for efficacy darbepoetin alfa inferior to placebo in terms of Patient’s Global Assessment (reported improvement) in Ponikowski, 2007 | 6 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
STAMINA-HeFT (Ghali), 2008 | darbepoetin alfa vs placebo | | | Patient’s Global Assessment (reported improvement) 1.00 [0.87; 1.14] All-cause mortality 0.59 [0.29; 1.21] Adverse effect: hypertension 1.26 [0.57; 2.79] Adverse effect: stroke 0.97 [0.20; 4.73] Adverse effect: myocardial infarction 0.78 [0.21; 2.83] Adverse effect: other thromboembolic effects 1.29 [0.29; 5.68] | van Veldhuisen, 2007 | darbepoetin alfa vs placebo | | | Patient’s Global Assessment (reported improvement) 1.33 [0.99; 1.80] All-cause mortality ∞ [NaN; ∞] Adverse effect: hypertension 0.51 [0.07; 3.52] Adverse effect: stroke NaN [NaN; NaN] Adverse effect: myocardial infarction ∞ [NaN; ∞] Adverse effect: other thromboembolic effects 0.00 [0.00; NaN] | Ponikowski, 2007 | darbepoetin alfa vs placebo | | Patient’s Global Assessment (reported improvement) 1.93 [1.11; 3.36] | All-cause mortality 1.16 [0.08; 17.28] Adverse effect: hypertension ∞ [NaN; ∞] Adverse effect: stroke ∞ [NaN; ∞] Adverse effect: myocardial infarction 0.00 [0.00; NaN] Adverse effect: other thromboembolic effects NaN [NaN; NaN] | Parissis, 2008 | darbepoetin alfa vs placebo | | | All-cause mortality 0.00 [0.00; NaN] Adverse effect: hypertension ∞ [NaN; ∞] Adverse effect: myocardial infarction NaN [NaN; NaN] Adverse effect: other thromboembolic effects 0.00 [0.00; NaN] | Parissis, 2009 | darbepoetin alfa vs placebo | | | | Kourea, 2008 | darbepoetin alfa vs placebo | | | All-cause mortality 0.32 [0.04; 2.80] Adverse effect: hypertension ∞ [NaN; ∞] Adverse effect: stroke NaN [NaN; NaN] Adverse effect: myocardial infarction 0.00 [0.00; NaN] Adverse effect: other thromboembolic effects 0.00 [0.00; NaN] |
Trial | Treatments | Patients | Method |
---|
STAMINA-HeFT (Ghali), 2008 | darbepoetin alfa SC every 2 weeks for 1 year (target hemoglobin, 14.0+/-1.0 g/dL). (n=162) vs. placebo (n=157) | Patients with symptomatic HF, left ventricular ejection fraction < or = 40%, and hemoglobin > or = 9.0 g/dL and < or = 12.5 g/dL | double blind Parallel groups Sample size: 162/157 Primary endpoint: treadmill exercise time FU duration: 27 weeks | van Veldhuisen, 2007 | darbepoetin alfa subcutaneously every 2 weeks for 26 weeks at a starting weight-adjusted dose of 0.75 mcg/kg or a fixed dose of 50 mcg (n=110) vs. placebo (n=55) | Patients with chronic heart failure (>=3 months), left ventricular ejection fraction <= 40%, and Hb 9.0 to 12.5 g/dL | double blind Parallel groups Sample size: 110/55 Primary endpoint: node defined FU duration: 27 weeks | Ponikowski, 2007 | Subcutaneous (SC) Darbepoetin Alfa (n=19) vs. subcutaneous placebo (n=22) | patients with Symptomatic Congestive Heart Failure (CHF) and Anemia | double blind Parallel groups Sample size: 19/22 Primary endpoint: Exercise tolerance FU duration: 27 weeks | Parissis, 2008 | 3-month darbepoetin alpha regimen at 1.5 microg/kg every 20 days plus oral iron (n=21) vs. placebo plus oral iron (n=11) | CHF patients NYHA II-III, LV ejection fraction [EF] <40%, hemoglobin level <12.5 g/dL, serum creatinine level <2.5 mg/dL | Sample size: 21/11 Primary endpoint: none defined FU duration: | Parissis, 2009 | 3-month darbepoetin alfa regimen at 1.5 microg/kg every 20 days plus oral iron (n=30) vs. placebo plus oral iron (n=0) | patients with CHF (LV ejection fraction [LVEF] <40%, hemoglobin <12.5 g/dl, and serum creatinine <2.5 mg/dl | Sample size: 30/0 Primary endpoint: FU duration: | Kourea, 2008 | 3-month darbepoietin-alpha at 1.5 microg/Kg every 20 days plus iron orally (n=21) vs. placebo plus iron orally (n=20) | CHF patients NYHA II-III; left ventricular ejection fraction <40%; hemoglobin<12.5 g/dl; serum creatinine<2.5 mg/dl | double blind Sample size: 21/20 Primary endpoint: FU duration: |
|