Introduction
Methods
Results
Parameter | Placebo | Dronedarone | Total | ||
---|---|---|---|---|---|
400 mg | 800 mg | 1,200 mg | |||
n = 40 | n = 29 | n = 30 | n = 25 | N = 124 | |
Age, y | 57.1 (9.5) | 56.3 (9.0) | 57.5 (9.8) | 57.3 (10.5) | 57.0 (9.5) |
Weight, kg | 87.04 (17.44) | 83.60 (12.62) | 91.56 (18.15) | 88.98 (20.58) | 87.72 (17.35) |
Race, n (%) | |||||
Caucasian | 22 (55) | 20 (69) | 21 (70) | 16 (64) | 79 (64) |
Black | 18 (45) | 7 (24) | 9 (30) | 9 (36) | 43 (35) |
Other | – | 2 (7) | – | – | 2 (2) |
Sex, n (%) | |||||
Male | 33 (83) | 27 (93) | 26 (87) | 24 (96) | 110 (89) |
Female | 7 (18) | 2 (7) | 4 (13) | 1 (4) | 14 (11) |
Walking distance during 6 min exercise test, meters | 393.4 (115.7) | 417.0 (114.7) | 398.9 (62.2) | 415.3 (142.8) | 404.6 (110.7) |
LVEF, % | 23.4 (5.2) | 24.5 (4.7) | 24.4 (4.2) | 23.4 (6.1) | 23.9 (5.0) |
Cardiothoracic ratio, % | 54.3 (7.0) | 53.1 (7.5) | 55.6 (6.8) | 53.3 (4.7) | 54.1 (6.7) |
NYHA status, n (%) | |||||
I | 10 (25) | 15 (52) | 6 (20) | 3 (12) | 34 (27) |
II | 30 (75) | 14 (48) | 24 (80) | 22 (88) | 90 (73) |
Concomitant medication, n (%) | |||||
ACE inhibitors or ARBs | 37 (92.5) | 28 (96.6) | 29 (96.7) | 22 (88.0) | 116 (93.5) |
Diuretics | 37 (92.5) | 26 (89.7) | 25 (83.3) | 22 (88.0) | 110 (88.7) |
Digitalis | 30 (75.0) | 23 (79.3) | 23 (76.7) | 22 (88.0) | 98 (79.0) |
Chronic antiplatelet therapy | 24 (60.0) | 15 (51.7) | 15 (50.0) | 11 (44.0) | 65 (52.4) |
Oral anticoagulant | 12 (30.0) | 11 (37.9) | 8 (26.7) | 11 (44.0) | 42 (33.9) |
Statins | 11 (27.5) | 10 (34.5) | 9 (30.0) | 8 (32.0) | 38 (30.6) |
NSAIDs | 3 (7.5) | 1 (3.4) | 1 (3.3) | 1 (4.0) | 6 (4.8) |
Beta-blockers | 1 (2.5)a
| 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.8) |
Visit | Treatment group | Mean (SD) | Difference vs. placebo | 90% CI of difference | ANOVAa
|
---|---|---|---|---|---|
Mean walking distance (meters) | |||||
Day 0 (n = 124) | Placebo | 393.4 (115.7) | NA | NA | 0.7842 |
Dronedarone 400 mg | 417.0 (114.7) | NA | NA | ||
Dronedarone 800 mg | 398.9 (62.2) | NA | NA | ||
Dronedarone 1,200 mg | 415.3 (142.8) | NA | NA | ||
All | 404.6 (110.7) | NA | NA | ||
Day 8 (n = 118) | Placebo | 411.0 (123.4) | NA | NA | 0.8705 |
Dronedarone 400 mg | 414.9 (102.3) | 3.92 | −41.55/49.39 | ||
Dronedarone 800 mg | 408.0 (59.2) | −2.94 | −40.30/34.42 | ||
Dronedarone 1,200 mg | 431.5 (128.8) | 20.50 | −34.34/75.35 | ||
Day 30 (n = 113) | Placebo | 421.6 (113.8) | NA | NA | 0.8502 |
Dronedarone 400 mg | 445.1 (120.9) | 23.51 | −25.35/72.36 | ||
Dronedarone 800 mg | 421.0 (55.5) | −0.64 | −35.71, 34.43 | ||
Dronedarone 1,200 mg | 430.0 (165.0) | 8.44 | −58.11, 74.99 |
LVEF and cardiothoracic ratio
Serious adverse events | No. of subjects with at least one adverse event (no. of adverse events), % | |||
---|---|---|---|---|
Placebo | Dronedarone | |||
400 mg | 800 mg | 1,200 mg | ||
n = 40 | n = 29 | n = 30 | n = 25 | |
Any class, any event | 3 (4) 7.5 | 3 (5) 10.3 | 4 (4) 13.3 | 3 (9) 12.0 |
Body as a whole | ||||
Chest pain | 1 (1) 2.5 | – | 1 (1) 3.3 | 2 (2) 8.0 |
Sudden death | – | – | 1 (1) 3.3a
| 1 (1) 4.0b
|
Chest pain substernal | – | 1 (1) 3.4 | – | – |
Fatigue | – | – | – | 1 (1) 4.0 |
Alcohol intolerance | 1 (1) 2.5 | – | – | – |
Cardiovascular disorders | ||||
Cardiac failure | – | 1 (1) 3.4a
| 1 (1) 3.3 | – |
Cardiac failure left | 1 (1) 2.5 | – | – | – |
Hypertension | 1 (1) 2.5 | – | – | – |
Gastrointestinal system | ||||
Abdominal pain | – | – | – | 1 (1) 4.0 |
Diarrhea | – | – | – | 1 (1) 4.0 |
Heart rate and rhythm disorders | ||||
Extrasystoles | – | 1 (1) 3.4 | – | – |
Musculoskeletal system disorders | ||||
Arthropathy | – | – | 1 (1) 3.3 | – |
Myo-, endo-, and pericardial and valve disorders | ||||
Angina pectoris | – | – | – | 1 (1) 4.0 |
Platelet, bleeding, and clotting disorders | ||||
Gastrointestinal hemorrhage | – | 1 (1) 3.4 | – | – |
Respiratory system disorders | ||||
Dyspnea | – | – | – | 2 (2) 8.0 |
Pulmonary carcinoma | – | 1 (1) 3.4 | – | – |