pathology | treatment | patient | Demonstrated benefit and harm | k | | | |
---|
acute heart failure | rolofylline | not classified | versus No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
PROTECT, 2010 | rolofylline vs placebo | | | treatment success 0.92 [0.78; 1.09] |
Trial | Treatments | Patients | Method |
---|
PROTECT, 2010 | daily intravenous rolofylline (30 mg) for up to 3 days (n=-9) vs. placebo (n=-9) | patients hospitalized for acute heart failure with impaired renal function | double-blind Parallel groups Sample size: -9/-9 Primary endpoint: treatment success FU duration: 3 days (60 days) |
|
heart failure | amiloride | not classified | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Cheitlin, 1991 | amiloride vs placebo | | | |
Trial | Treatments | Patients | Method |
---|
Cheitlin, 1991 | amiloride (n=12) vs. placebo (n=12) | men with a history of congestive heart failure | double blind Cross over Sample size: 12/12 Primary endpoint: haemodynamic FU duration: 12 weeks |
|
heart failure | eplerenone | not classified | versus placebo or control No demonstrated result for efficacy eplerenone inferior to placebo in terms of serious hyperkalemia (¡Ý6.0 mmol per liter) in EPHESUS, 2003 eplerenone inferior to placebo in terms of serious hyperkalemia (¡Ý6.0 mmol per liter) in EMPHASIS-HF, 2010 | 2 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
EPHESUS, 2003 | eplerenone vs placebo | death from any cause 0.86 [0.77; 0.96] death from cardiovascular causes 0.84 [0.74; 0.95] Sudden death 0.80 [0.66; 0.98] death from cardiovascular causes or hospitalization for cardiovascular causes 0.89 [0.82; 0.96] | serious hyperkalemia (¡Ý6.0 mmol per liter) 1.43 [1.14; 1.78] | Adverse events 0.99 [0.97; 1.02] hospitalisation for cardiovascular causes 0.93 [0.84; 1.03] | EMPHASIS-HF, 2010 | eplerenone vs placebo | death from any cause 0.81 [0.67; 0.97] death from cardiovascular causes 0.80 [0.65; 0.98] Death from any cause or hospitalization for
any reason 0.82 [0.74; 0.90] Hospitalization for heart failure 0.65 [0.54; 0.78] Hospitalization for any reason 0.84 [0.75; 0.93] Death from any cause or hospitalization for
heart failure 0.72 [0.63; 0.83] | serious hyperkalemia (¡Ý6.0 mmol per liter) 2.19 [1.58; 3.04] | Death from worsening heart failure 0.74 [0.51; 1.08] Adverse events 0.98 [0.93; 1.02] Sudden death 0.79 [0.57; 1.11] |
Trial | Treatments | Patients | Method |
---|
EPHESUS, 2003 | eplerenone 25 mg per day initially, titrated to amaximum of 50 mg per day (n=3319) vs. placebo (n=3313) | patients with acute myocardial infarction complicated by left ventricular dysfunction and heart failure | Double blind Parallel groups Sample size: 3319/3313 Primary endpoint: all cause death AND cardiovascular death or hospitalization for a CV event FU duration: 16 mo (mean, range 0 to 33) | EMPHASIS-HF, 2010 | eplerenone (n=1364) vs. placebo (n=1373) | patients with
New York Heart Association class II heart failure and an ejection fraction of no
more than 35% | double blind Parallel groups Sample size: 1364/1373 Primary endpoint: CV death, hospitalization for HF FU duration: 21 months |
|
heart failure | furosemide | not classified | versus active treatment No demonstrated result for efficacy | 2 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Boccanelli, 1986 | furosemide vs captopril | | | NYHA functional class improvement 0.71 [0.45; 1.14] worsening heart failure, ∞ [NaN; ∞] | Cowley, 1986 | furosemide vs captopril | | | |
Trial | Treatments | Patients | Method |
---|
Boccanelli, 1986 | furosemide 25 to 100 mg od (n=8) vs. captopril 12.5 to 50 mg bid +furosemide 25mg od (n=7) | patients with moderate congestive heart failure not completely controlled on digoxin (0.25 mg o.d.) and frusemide (25 mg o.d.), | double blind Parallel groups Sample size: 8/7 Primary endpoint: exercise FU duration: 13 weeks | Cowley, 1986 | furosemide (increased doses of frusemide) (n=10) vs. captopril (addition) (n=10) introduction | patients with moderate heart failure who still had symptoms despite 40 mg frusemide daily | double blind Cross over Sample size: 10/10 Primary endpoint: exercise tolerance FU duration: |
|
heart failure | hydrochlorothiazide | not classified | versus active treatment No demonstrated result for efficacy | 2 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Nordrehaug, 1992 | hydrochlorothiazide vs benazepril | NYHA functional class improvement 0.06 [0.01; 0.41] | | | Sievert, 1989 | hydrochlorothiazide+triamterene vs digoxin | | | |
Trial | Treatments | Patients | Method |
---|
Nordrehaug, 1992 | hydrochlorothiazide 50 mg daily (n=29) vs. benazepril 20 mg daily (n=29) | patients with symptomatic (NYHA functional class 2) mild heart failure | double blind Cross over Sample size: 29/29 Primary endpoint: none FU duration: 8 weeks | Sievert, 1989 | hydrochlorothiazide+triamterene (n=16) vs. digoxin (n=16) | patients in heart failure and sinus rhythm | double blind Cross over Sample size: 16/16 Primary endpoint: haemodynamic response FU duration: 5 weeks |
|
heart failure | rolofylline | not classified | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
PROTECT-1 | rolofylline vs placebo | | | |
Trial | Treatments | Patients | Method |
---|
PROTECT-1 | (n=-9) vs. (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: |
|
heart failure | spironolactone | not classified | versus placebo or control No demonstrated result for efficacy spironolactone inferior to placebo in terms of Discontinuation because of adverse event in RALES, 1998 spironolactone inferior to placebo in terms of NYHA functional class improvement in RALES, 1998 | 12 trials | meta-analysis | | 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 |
|
heart failure | spironolactone | not classified | versus active treatment No demonstrated result for efficacy | 4 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Bednarz, 2000 | aldactone vs furosemide | | | | Han, 1994 | spironolactone+captopril vs captopril | | | | Mauersberger, 1985 | spironolactone+furosemide vs spironolactone+butizide | | | | Dalhstrom, 1986 | furosemide + spironolactone vs prenalterol | | | NYHA functional class improvement 0.75 [0.41; 1.36] |
Trial | Treatments | Patients | Method |
---|
Bednarz, 2000 | Aldactone 200 mg i.v (n=11) vs. furosemide 20 mg i.v (n=10) | patients with NYHA class III to IV congestive heart failure | open Sample size: 11/10 Primary endpoint: FU duration: | Han, 1994 | captopril plus spironolactone (n=19) vs. captopril alone (n=16) | patients with refractory CHF and New York Heart Association functional class IV without renal dysfunction, hypotension and hyperkalemia | open Sample size: 19/16 Primary endpoint: none FU duration: 4 weeks | Mauersberger, 1985 | spironolactone 50mg + furosemide 20 mg (n=22) vs. spironolactone 50mg + butizide 5mg (n=0) | patients with congestive heart failure | open Sample size: 22/0 Primary endpoint: none FU duration: | Dalhstrom, 1986 | intensified treatment with diuretics (furosemide- spironolactone) (n=10) vs. prenalterol 100-200 mg daily in addition to their basal treatment (n=10) | patients with severe chronic congestive heart failure (CHF) due to ischaemic heart disease treated with digitalis and diuretics | double blind Cross over Sample size: 10/10 Primary endpoint: exercise tolerance FU duration: 12 weeks |
|