Treatment-emergent adverse events in AF patients with CHD treated with dronedarone or placebo
| . | Placebo (n = 733) . | Dronedarone (n = 666) . | P value . |
|---|---|---|---|
| Any TEAE | 538 (73.4%) | 510 (76.6%) | |
| Any cardiac events | 92 (12.6%) | 83 (12.5%) | NS |
| Bradycardia | 13 (1.8%) | 29 (4.4%) | 0.007 |
| QT interval prolongation | 5 (0.7%) | 21 (3.2%) | <0.001 |
| Any respiratory events | 129 (17.6%) | 117 (17.6%) | NS |
| Any gastrointestinal events | 183 (25.0%) | 203 (30.5%) | 0.023 |
| Diarrhea | 52 (7.1%) | 78 (11.7%) | 0.003 |
| Any serious TEAE | 190 (25.9%) | 151 (22.7%) | |
| Cardiac events | 6 (0.8%) | 6 (0.9%) | NS |
| Other events of interest | |||
| Hepatic events | 14 (1.9%) | 11 (1.7%) | NS |
| Serum creatinine increase | 10 (1.4%) | 34 (5.1%) | <0.001 |
| INR increase | 15 (2.0%) | 18 (2.7%) | NS |
| . | Placebo (n = 733) . | Dronedarone (n = 666) . | P value . |
|---|---|---|---|
| Any TEAE | 538 (73.4%) | 510 (76.6%) | |
| Any cardiac events | 92 (12.6%) | 83 (12.5%) | NS |
| Bradycardia | 13 (1.8%) | 29 (4.4%) | 0.007 |
| QT interval prolongation | 5 (0.7%) | 21 (3.2%) | <0.001 |
| Any respiratory events | 129 (17.6%) | 117 (17.6%) | NS |
| Any gastrointestinal events | 183 (25.0%) | 203 (30.5%) | 0.023 |
| Diarrhea | 52 (7.1%) | 78 (11.7%) | 0.003 |
| Any serious TEAE | 190 (25.9%) | 151 (22.7%) | |
| Cardiac events | 6 (0.8%) | 6 (0.9%) | NS |
| Other events of interest | |||
| Hepatic events | 14 (1.9%) | 11 (1.7%) | NS |
| Serum creatinine increase | 10 (1.4%) | 34 (5.1%) | <0.001 |
| INR increase | 15 (2.0%) | 18 (2.7%) | NS |
TEAE, treatment-emergent adverse event; INR, international normalized ratio.
Treatment-emergent adverse events in AF patients with CHD treated with dronedarone or placebo
| . | Placebo (n = 733) . | Dronedarone (n = 666) . | P value . |
|---|---|---|---|
| Any TEAE | 538 (73.4%) | 510 (76.6%) | |
| Any cardiac events | 92 (12.6%) | 83 (12.5%) | NS |
| Bradycardia | 13 (1.8%) | 29 (4.4%) | 0.007 |
| QT interval prolongation | 5 (0.7%) | 21 (3.2%) | <0.001 |
| Any respiratory events | 129 (17.6%) | 117 (17.6%) | NS |
| Any gastrointestinal events | 183 (25.0%) | 203 (30.5%) | 0.023 |
| Diarrhea | 52 (7.1%) | 78 (11.7%) | 0.003 |
| Any serious TEAE | 190 (25.9%) | 151 (22.7%) | |
| Cardiac events | 6 (0.8%) | 6 (0.9%) | NS |
| Other events of interest | |||
| Hepatic events | 14 (1.9%) | 11 (1.7%) | NS |
| Serum creatinine increase | 10 (1.4%) | 34 (5.1%) | <0.001 |
| INR increase | 15 (2.0%) | 18 (2.7%) | NS |
| . | Placebo (n = 733) . | Dronedarone (n = 666) . | P value . |
|---|---|---|---|
| Any TEAE | 538 (73.4%) | 510 (76.6%) | |
| Any cardiac events | 92 (12.6%) | 83 (12.5%) | NS |
| Bradycardia | 13 (1.8%) | 29 (4.4%) | 0.007 |
| QT interval prolongation | 5 (0.7%) | 21 (3.2%) | <0.001 |
| Any respiratory events | 129 (17.6%) | 117 (17.6%) | NS |
| Any gastrointestinal events | 183 (25.0%) | 203 (30.5%) | 0.023 |
| Diarrhea | 52 (7.1%) | 78 (11.7%) | 0.003 |
| Any serious TEAE | 190 (25.9%) | 151 (22.7%) | |
| Cardiac events | 6 (0.8%) | 6 (0.9%) | NS |
| Other events of interest | |||
| Hepatic events | 14 (1.9%) | 11 (1.7%) | NS |
| Serum creatinine increase | 10 (1.4%) | 34 (5.1%) | <0.001 |
| INR increase | 15 (2.0%) | 18 (2.7%) | NS |
TEAE, treatment-emergent adverse event; INR, international normalized ratio.
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