Table 2. Treatment-Emergent Adverse Events.
| Event | Patients, No. (%) | P value | |
|---|---|---|---|
| Bempedoic acid (n = 2424) | Placebo (n = 1197) | ||
| Overview of TEAEs | |||
| Any | 1771 (73.1) | 868 (72.5) | .75 |
| Serious | 341 (14.1) | 159 (13.3) | .54 |
| Associated with study drug | 583 (24.1) | 243 (20.3) | .01 |
| Drug discontinued due to a TEAE | 273 (11.3) | 93 (7.8) | .001 |
| With a fatal outcomea | 19 (0.8) | 4 (0.3) | .12 |
| SOC cardiac disorders | 8 (0.3) | 2 (0.2) | .51 |
| Other | 11 (0.5) | 2 (0.2) | .24 |
| Most common TEAEsb | |||
| Nasopharyngitis | 180 (7.4) | 106 (8.9) | .15 |
| Urinary tract infection | 110 (4.5) | 66 (5.5) | .22 |
| Arthralgia | 100 (4.1) | 57 (4.8) | .39 |
| Upper respiratory tract infection | 94 (3.9) | 44 (3.7) | .85 |
| Dizziness | 83 (3.4) | 41 (3.4) | >.99 |
| Diarrhea | 82 (3.4) | 39 (3.3) | .92 |
| Back pain | 75 (3.1) | 27 (2.3) | .17 |
| Headache | 68 (2.8) | 37 (3.1) | .67 |
| Fatigue | 54 (2.2) | 42 (3.5) | .03 |
| TEAEs of special interestc | |||
| Myalgia | 118 (4.9) | 63 (5.3) | .63 |
| Muscle spasms | 89 (3.7) | 31 (2.6) | .09 |
| Pain in extremity | 75 (3.1) | 21 (1.8) | .02 |
| Muscular weakness | 13 (0.5) | 7 (0.6) | .82 |
| New-onset or worsening diabetes | 96 (4.0) | 67 (5.6) | .03 |
| Blood uric acid level increase | 51 (2.1) | 6 (0.5) | <.001 |
| Hyperuricemia | 40 (1.7) | 7 (0.6) | .007 |
| Gout | 33 (1.4) | 5 (0.4) | .008 |
| Blood creatinine level increase | 19 (0.8) | 4 (0.3) | .12 |
| Glomerular filtration rate decrease | 16 (0.7) | 1 (<0.1) | .02 |
| Hepatic enzyme (ALT or AST) level increase | 67 (2.8) | 15 (1.3) | .004 |
| >3 Times the upper reference limit | 18 (0.7) | 3 (0.3) | .10 |
| >5 Times the upper reference limit | 6 (0.2) | 2 (0.2) | >.99 |
| Neurocognitive disorder | 16 (0.7) | 9 (0.8) | .83 |
| Hemoglobin decrease | 69 (2.8) | 22 (1.8) | .07 |
| Anemia | 60 (2.5) | 19 (1.6) | .09 |
| Hemoglobin level decrease | 9 (0.4) | 3 (0.3) | .76 |
| Hematocrit decrease | 2 (<0.1) | 3 (0.3) | .34 |
| Tendon ruptured | 6 (0.2) | 0 | .19 |
| Most common TEAEs leading to discontinuatione | |||
| Myalgia | 31 (1.3) | 21 (1.8) | .30 |
| Muscle spasm | 18 (0.7) | 3 (0.3) | .10 |
| Headache | 11 (0.5) | 3 (0.3) | .57 |
| Diarrhea | 11 (0.5) | 1 (<0.1) | .12 |
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; SOC, System Organ Class; TEAEs, treatment-emergent adverse events.
All fatal TEAEs were judged by the investigator and medical monitor as unrelated to treatment.
Occurring in 3% or more of patients in either treatment group, excluding TEAEs of special interest.
TEAEs of special interest were identified a priori (except for tendon rupture) and were derived from nonclinical findings or clinical data for bempedoic acid, adverse events associated with other lipid-lowering therapies, and anticipated adverse events among patients requiring lipid-lowering therapy.
Not prespecified as a TEAE of special interest.
Occurring in 0.5% or more of patients in either treatment group.