| Trial | control | p<0.05 | harm | NS |
|---|
| RALES, 1998 | spironolactone vs placebo | death from any cause 0.75 [0.67; 0.85] death from cardiovascular causes 0.74 [0.65; 0.85] Sudden death 0.76 [0.58; 1.00] hospitalisation for cardiovascular causes 0.79 [0.70; 0.90] worsening heart failure, 0.79 [0.71; 0.88] | Discontinuation because of adverse event 1.59 [1.08; 2.33] NYHA functional class improvement 1.24 [1.09; 1.41] | Adverse events 1.03 [0.99; 1.08] serious hyperkalemia (¡Ý6.0 mmol per liter) 2.05 [0.19; 22.52] |
| Agostoni, 2005 | spironolactone vs placebo | | | |
| Mottram, 2004 | spironolactone vs placebo | | | |
| Macdonald, 2004 | spironolactone vs placebo | | | |
| Cicoira, 2004 | spironolactone vs control | | | |
| Cicoira, 2002 | spironolactone vs control | | | |
| Yee, 2001 | spironolactone vs placebo | | | |
| Tsutamoto, 2001 | spironolactone vs placebo | | | |
| Ramires, 2000 | spironolactone vs control | | | |
| Farquharson, 2000 | spironolactone vs placebo | | | |
| MacFadyen, 1997 | spironolactone vs placebo | | | |
| Barr, 1995 | spironolactone vs placebo | | | |
| Trial | Treatments | Patients | Method |
|---|
| RALES, 1998 | spironolactone (25 to 50 mg daily) (n=822) vs. placebo (n=841) | patients with severeheart failure | Open Parallel groups Sample size: 822/841 Primary endpoint: death from any cause FU duration: 24 mo |
| Agostoni, 2005 | spironolactone 25mg/d (n=14) vs. placebo (n=15) | stable chronic heart failure patients with reduced influences lung diffusion (DLCO) | open Parallel groups Sample size: 14/15 Primary endpoint: FU duration: 6 months |
| Mottram, 2004 | spironolactone 25 mg/d (n=30) vs. placebo (n=0) | hypertensive patients with diastolic heart failure | double blind Sample size: 30/0 Primary endpoint: myocardial function FU duration: 6 months |
| Macdonald, 2004 | spironolactone 12.5-50 mg/d (n=43) vs. placebo (n=43) | patients with New York Heart Association class I-II congestive heart failure taking optimal treatment (including beta blockers) | double blind Cross over Sample size: 43/43 Primary endpoint: none FU duration: 3 months |
| Cicoira, 2004 | spironolactone (n=47) vs. control (n=46) | chronic heart failure patients | open Sample size: 47/46 Primary endpoint: ACE gene insertion/deletion polymorphism FU duration: 12 months |
| Cicoira, 2002 | spironolactone 12.5 to 50 mg/day (n=54) vs. control (n=52) | patients with chronic heart failure | open Parallel groups Sample size: 54/52 Primary endpoint: Ventricular Function and Exercise tolerance FU duration: 12 months |
| Yee, 2001 | spironolactone 50mg/d (n=28) vs. placebo (n=28) | patients with New York Heart Association class II to IV congestive heart failure | double blind Sample size: 28/28 Primary endpoint: FU duration: 4 weeks |
| Tsutamoto, 2001 | spironolactone 25 mg daily (n=20) vs. placebo (n=17) | patients with mild-to-moderate nonischemic congestive heart failure | double blind Parallel groups Sample size: 20/17 Primary endpoint: neurohumoral factors FU duration: 12 weeks |
| Ramires, 2000 | spironolactone (n=19) vs. standard medical treatment (n=16) | patients with systolic dysfunction and NYHA class III CHF secondary to dilated or ischemic cardiomyopathy | open Parallel groups Sample size: 19/16 Primary endpoint: none FU duration: 20 weeks |
| Farquharson, 2000 | spironolactone 50 mg/d (n=10) vs. placebo (n=10) | patients with NYHA class II to III chronic heart failure on standard diuretic/ACE inhibitor therapy | double blind Sample size: 10/10 Primary endpoint: none FU duration: 4 weeks |
| MacFadyen, 1997 | spironolactone (50-100 mg/day) (n=21) vs. placebo (n=16) | patients with stable chronic heart failure | double blind Parallel groups Sample size: 21/16 Primary endpoint: none FU duration: 8 weeks |
| Barr, 1995 | spironolactone 50 to 100 mg/day, titrated to blood pressure and plasma potassium (added to an angiotensin-converting enzyme inhibitor) (n=28) vs. placebo (n=14) | patients with New York Heart Association II to III congestive heart failure | double blind Parallel groups Sample size: 28/14 Primary endpoint: none FU duration: 8 weeks |
