Table 3.
PA (n=448)a
|
Non-PA (n=969)a
|
|||
---|---|---|---|---|
PMI arm (n=247) | UC arm (n=201) | PMI arm (n=513) | UC arm (n=456) | |
Number of AEs, n | 354 | 266 | 365 | 327 |
Patients with AEs, n (%) | 137 (55.5) | 124 (61.7) | 23 (45.2) | 172 (37.7) |
Serious AEs,b n (%) | 19 (7.7) | 8 (4.0) | 31 (6.0) | 13 (2.9) |
Severe AEs,c n (%) | 13 (5.3) | 6 (3.0) | 27 (5.3) | 10 (2.2) |
Discontinued due to AEs, n (%) | 7 (2.8) | 0 (0.0) | 38 (7.4) | 4 (0.9) |
Dose reduced or temporarily discontinued, n (%) | 8 (3.2) | 0 (0.0) | 16 (3.1) | 6 (1.3) |
Most frequent AEsd | ||||
Edema peripheral, n (%) | 15 (6.1) | 1 (0.5) | 36 (7.0) | 10 (2.2) |
Hypercholesterolemia, n (%) | 0 (0.0) | 11 (5.5) | 1 (0.2) | 1 (0.2) |
Headache, n (%) | 10 (4.0) | 7 (3.5) | 13 (2.5) | 8 (1.8) |
Dyslipidemia, n (%) | 0 (0.0) | 8 (4.0) | 0 (0.0) | 3 (0.7) |
Nasopharyngitis, n (%) | 12 (4.9) | 4 (2.0) | 10 (1.9) | 6 (1.3) |
Chest pain, n (%) | 13 (5.3) | 7 (3.5) | 4 (0.8) | 3 (0.7) |
Increase in TG, n (%) | 2 (0.8) | 5 (2.5) | 9 (1.8) | 9 (2.0) |
Bronchitis, n (%) | 3 (1.2) | 0 (0.0) | 9 (1.8) | 15 (3.3) |
Dizziness, n (%) | 10 (4.0) | 7 (3.5) | 6 (1.2) | 2 (0.4) |
Upper respiratory tract infection, n (%) | 16 (6.5) | 10 (5.0) | 0 (0.0) | 4 (0.9) |
Increase in creatine phosphokinase, n (%) | 4 (1.6) | 3 (1.5) | 11 (2.1) | 2 (0.4) |
Dyspepsia, n (%) | 3 (1.2) | 5 (2.5) | 2 (0.4) | 5 (1.1) |
Constipation, n (%) | 6 (2.4) | 3 (1.5) | 3 (0.6) | 1 (0.2) |
Arthralgia, n (%) | 6 (2.4) | 4 (2.0) | 3 (0.6) | 4 (0.9) |
Hyperlipidemia, n (%) | 0 (0.0) | 9 (4.5) | 0 (0.0) | 1 (0.2) |
Insomnia, n (%) | 6 (2.4) | 7 (3.5) | 2 (0.4) | 4 (0.9) |
Hypertension, n (%) | 2 (0.8) | 2 (1.0) | 2 (0.4) | 10 (2.2) |
Pharyngitis, n (%) | 2 (0.8) | 1 (0.5) | 4 (0.8) | 12 (2.6) |
Palpitations, n (%) | 7 (2.8) | 3 (1.5) | 1 (0.2) | 2 (0.4) |
Abdominal pain upper, n (%) | 6 (2.4) | 4 (2.0) | 1 (0.2) | 3 (0.7) |
Chest discomfort, n (%) | 5 (2.0) | 4 (2.0) | 0 (0.0) | 0 (0.0) |
Osteoarthritis, n (%) | 7 (2.8) | 3 (1.5) | 3 (0.6) | 5 (1.1) |
Back pain, n (%) | 5 (2.0) | 5 (2.5) | 6 (1.2) | 1 (0.2) |
Cough, n (%) | 7 (2.8) | 6 (3.0) | 2 (0.4) | 2 (0.4) |
Hypoesthesia, n (%) | 6 (2.4) | 0 (0.0) | 1 (0.2) | 0 (0.0) |
Hyperuricemia, n (%) | 0 (0.0) | 4 (2.0) | 0 (0.0) | 0 (0.0) |
Myalgia, n (%) | 2 (0.8) | 4 (2.0) | 4 (0.8) | 1 (0.2) |
Notes:
Safety population: all randomized patients who received at least one dose of study medication
serious AEs are defined as meeting one of the following criteria: AE resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability or incapacity, or in congenital anomaly or birth defect
severe AEs are defined as AEs that interfere significantly with a patient’s usual function
all observed or self-reported AEs that occurred at a rate of ≥2%.
Abbreviations: AEs, adverse events; PA, Pacific Asian; PMI, proactive multifactorial intervention; TG, triglycerides; UC, usual care.