| heart failure | taspoglutide | not classified | 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: |
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