| pathology | Demonstrated benefit and harm | k | | | |
|---|
| acute myocardial infarction | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| DIAMOND MI, 1997 | dofetilide vs placebo | | | |
| Trial | Treatments | Patients | Method |
|---|
| DIAMOND MI, 1997 | dofetilide (n=-9) vs. placebo (n=-9) | patients with acute myocardial infarction within 7 days and left ventricular systolic dysfunction (EF <= 35%) | double blind Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: >12 months |
|
| atrial fibrillation | versus placebo or control No demonstrated result for efficacy | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| DIAMOND, 2001 | dofetilide vs placebo | Atrial fibrillation recurrence 0.62 [0.54; 0.70] | | all cause mortality 0.99 [0.77; 1.29] Pro-arrhythmia ∞ [NaN; ∞] | | SAFIRE-D, 2000 | dofetilide vs placebo | Atrial fibrillation recurrence 0.85 [0.72; 1.00] | | all cause mortality 0.75 [0.19; 2.90] Withdrawals due to adverse effects 1.68 [0.37; 7.59] Pro-arrhythmia 4.48 [0.59; 33.83] |
| Trial | Treatments | Patients | Method |
|---|
| DIAMOND, 2001 | Dofetilide 500 mcg/d5 (n=249) vs. placebo (n=257) | Persistent AF in patients with heart failure or recent myocardial infarction and reduced LVEF | double blind Parallel groups Sample size: 249/257 Primary endpoint: FU duration: 24 months | | SAFIRE-D, 2000 | Dofetilide various doses (250, 500, 1000 mcg/d) (n=182) vs. placebo (n=68) | Persistent AF or AFl lasting 2 weeks to 6 months | double blind Parallel groups Sample size: 182/68 Primary endpoint: FU duration: 12 months |
|
| post myocardial infarction | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| DIAMOND MI, 1997 | dofetilide vs placebo | | | |
| Trial | Treatments | Patients | Method |
|---|
| DIAMOND MI, 1997 | dofetilide (n=-9) vs. placebo (n=-9) | patients with acute myocardial infarction within 7 days and left ventricular systolic dysfunction (EF <= 35%) | double blind Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: >12 months |
|
