Introduction
Methods
Study Design and Patients
Statistical Analysis
Results
Patient Disposition and Baseline Characteristics
Total | Landiolol | Digoxin |
p value | |
---|---|---|---|---|
Age (n) | 93 | 107 | ||
20 to <65 years | 59 (29.5%) | 32 (34.4%) | 27 (25.2%) | |
≥65 years | 141 (70.5%) | 61 (65.6%) | 80 (74.8%) | |
Mean ± SD | 71.6 ± 11.5 | 70.5 ± 12.0 | 72.5 ± 11.0 | 0.221 |
Sex (n) | 93 | 107 | ||
Male | 106 (53.0%) | 50 (53.8%) | 56 (52.3%) | 0.840 |
Female | 94 (47.0%) | 43 (46.2%) | 51 (47.7%) | |
NYHA (n) | 93 | 107 | ||
Class III | 163 (81.9%) | 71 (77.2%) | 92 (86.0%) | 0.108 |
Class IV | 36 (18.1%) | 21 (22.8%) | 15 (14.0%) | |
Baseline HR (n) | 90 | 107 | ||
<140 bpm | 115 (58.4%) | 55 (61.1%) | 60 (56.1%) | |
≥140 bpm | 82 (41.6%) | 35 (38.9%) | 47 (43.9%) | |
Mean ± SD | 138.1 ± 15.3 | 138.2 ± 15.7 | 138.0 ± 15.0 | 0.934 |
Baseline SBP (n) | 92 | 107 | ||
<120 mmHg | 88 (44.2%) | 39 (42.4%) | 49 (45.8%) | |
≥120 mmHg | 111 (55.8%) | 53 (57.6%) | 58 (54.2%) | |
Mean ± SD | 125.7 ± 21.8 | 124.6 ± 19.8 | 126.6 + 23.5 | 0.523 |
LVEF (n) | 92 | 107 | ||
25.0 to <35.0% | 90 (45.2%) | 41 (44.6%) | 49 (45.8%) | |
35.0 to 50.0% | 109 (54.8%) | 51 (55.4%) | 58 (54.2%) | |
Mean ± SD | 36.6 ± 7.6 | 36.4 ± 7.9 | 36.7 ± 7.3 | 0.753 |
Beta blocker (oral) (n) | 93 | 107 | ||
No beta-blockers intake | 159 (79.5%) | 75 (80.6%) | 84 (78.5%) | |
Beta-blockers intake | 41 (20.5%) | 18 (19.4%) | 23 (21.5%) | 0.708 |
eGFR (n) | 92 | 107 | ||
90 ≤ eGFR | 18 (9.1%) | 8 (8.7%) | 10 (9.4%) | |
60 ≤ eGFR < 90 | 58 (29.1%) | 26 (28.3%) | 32 (29.9%) | |
30 ≤ eGFR < 60 | 109 (54.8%) | 51 (55.4%) | 58 (54.2%) | |
15 ≤ eGFR < 30 | 14 (7.0%) | 7 (7.6%) | 7 (6.5%) | |
Mean ± SD | 57.3 ± 19.7 | 57.6 ± 19.7 | 57.0 ± 19.8 | 0.845 |
Efficacy
Safety
Group | Baseline SBP (mmHg) | Subject | Adverse events | Time to events from the administration of the study drug (h) | Severity | Relationship to the study drug | Outcomea
|
---|---|---|---|---|---|---|---|
Landiolol | <120 | L-1 | Blood pressure increased | 21 | Mild | Not related | Recovered |
L-2 | Blood pressure decreased | 29.2 | Mild | Not related | Recovered | ||
L-3 | Serum creatinine increased | 62.8 | Mild | Not related | Recovered | ||
Blood pressure systolic decreased | 2 | Mild | Related | Recovered | |||
Blood urea nitrogen increased | 62.8 | Mild | Not related | Recovered | |||
Brain natriuretic peptide increased | 71.9 | Moderate | Not related | Recovered | |||
Dehydration | 56.8 | Mild | Not related | Recovered | |||
L-4 | Blood pressure decreased | 0.9 | Moderate | Related | Recovered | ||
L-5 | Palpitations | 11 | Mild | Not related | Ongoing | ||
Serum creatinine increased | 18 | Mild | Not related | Ongoing | |||
≥120 | L-6 | Blood pressure decreased | 5.6 | Moderate | Not related | Recovered | |
Blood pressure decreased | 33.1 | Moderate | Not related | Recovered | |||
L-7 | Hypotension | 3.2 | Moderate | Related | Recovered | ||
L-8 | Serum potassium decreased | 47.8 | Mild | Not related | Recovered | ||
Blood pressure decreased | 90.2 | Moderate | Not related | Recovered | |||
L-9 | Serum creatinine increased | 46.7 | Mild | Not related | Recovered | ||
Blood urea nitrogen increased | 46.7 | Mild | Not related | Lost to follow-up | |||
Dehydration | 32.8 | Mild | Not related | Recovered | |||
L-10 | Tachycardia | 17.3 | Mild | Not related | Recovered | ||
L-11 | Blood pressure decreased | 1 | Mild | Related | Recovered | ||
L-12 | Congestive heart failure | 14.3 | Severe | Not related | Lost to follow-up | ||
Blood urea nitrogen increased | 4.2 | Mild | Not related | Lost to follow-up | |||
Digoxin | <120 | D-1 | Serum creatinine increased | 4.6 | Mild | Not related | Recovered |
Serum potassium increased | 44.1 | Moderate | Not related | Recovered | |||
Blood pressure decreased | 4.6 | Mild | Not related | Recovered | |||
D-2 | Serum potassium decreased | 31.6 | Mild | Not related | Recovered | ||
D-3 | Blood pressure decreased | 21.5 | Moderate | Not related | Recovered | ||
Blood pressure decreased | 41.5 | Moderate | Not related | Recovered | |||
D-4 | Serum creatinine increased | 36 | Mild | Not related | Recovered | ||
D-5 | Hypokalemia | 39 | Mild | Not related | Recovered | ||
D-6 | Serum creatinine increased | 46.1 | Mild | Not related | Recovered | ||
Blood urea nitrogen increased | 46.1 | Mild | Not related | Recovered | |||
D-7 | Tachycardia | 21 | Mild | Not related | Recovered | ||
D-8 | Blood pressure increased | 12.1 | Mild | Not related | Recovered | ||
D-9 | Hypokalemia | 17.3 | Mild | Not related | Recovered | ||
D-10 | Blood pressure decreased | 31.2 | Mild | Not related | Recovered | ||
D-11 | Sinus arrest | 21.5 | Mild | Not related | Recovered | ||
D-12 | Blood pressure increased | 0.3 | Mild | Related | Recovered | ||
≥120 | D-13 | Blood pressure decreased | 12.6 | Moderate | Not related | Recovered | |
Blood pressure decreased | 27.6 | Moderate | Not related | Recovered | |||
D-14 | Tachycardia | 6.6 | Moderate | Not related | Recovered | ||
Serum potassium decreased | 15.9 | Mild | Not related | Recovered | |||
D-15 | Tachycardia | 45.1 | Mild | Not related | Recovered | ||
D-16 | Dehydration | 40.2 | Mild | Not related | Recovered |