Table 2. Number of patients with at least 1 SAE according to treatment group.
| Patients with SAEs, n | Benazepril (n = 209) | Valsartan (n = 201) | Combination (n = 202) |
|---|---|---|---|
| Fatal | |||
| MACEs* | |||
| -Myocardial infarction | 1 | 1 | 0 |
| -Stroke | 0 | 1 | 0 |
| -Sudden cardiac death | 1 | 0 | 3 |
| Neoplasia‡ | 2 | 4 | 1 |
| Traffic accident | 1 | 0 | 0 |
| Suicide | 0 | 1 | 0 |
| Respiratory failure | 1 | 0 | 0 |
| Nonfatal | |||
| Cardiovascular | |||
| MACEs* | |||
| -Myocardial infarction | 2 | 3 | 4 |
| -Stroke | 1 | 3 | 2 |
| Minor cardiovascular events† | |||
| -Transitory ischemic attack | 0 | 0 | 1 |
| Other cardiovascular events | |||
| -Peripheral artery disease/revascularization | 2 | 4 | 5 |
| -Peripheral artery disease/amputation | 1 | 0 | 1 |
| -Coronary revascularization | 6 | 7 | 6 |
| -Atrial fibrillation | 3 | 1 | 0 |
| -Atrial flutter | 1 | 1 | 0 |
| -Other electrocardiographic anomalies | 3 | 0 | 3 |
| -Syncope | 1 | 2 | 1 |
| -Heart failure | 1 | 3 | 2 |
| -Unstable angina | 1 | 0 | 1 |
| -Aortic valve insufficiency | 0 | 0 | 1 |
| -Pericardial effusion | 0 | 0 | 1 |
| -Peripheral venous insufficiency | 0 | 1 | 1 |
| -Pulmonary embolism | 0 | 1 | 0 |
| Renal | |||
| -Acute kidney injury | 4 | 0 | 2 |
| -Chronic kidney disease | 2 | 0 | 0 |
| -Nephrotic syndrome | 0 | 0 | 1 |
| Urological | |||
| -Urolithiasis | 5 | 2 | 1 |
| -Benign prostatic hyperplasia | 3 | 2 | 1 |
| -Prostatitis | 0 | 1 | 0 |
| -Urethritis | 1 | 0 | 0 |
| -Other urological events | 5 | 2 | 0 |
| Cancer and benign tumors | |||
| -Prostate cancer | 2 | 2 | 1 |
| -Skin cancer | 2 | 1 | 1 |
| -Colorectal cancer | 1 | 2 | 0 |
| -Pancreatic cancer | 2 | 0 | 0 |
| -Bladder cancer | 1 | 0 | 0 |
| -Hepatocellular carcinoma | 0 | 1 | 0 |
| -Breast cancer | 0 | 1 | 0 |
| -Gastric cancer | 0 | 0 | 1 |
| -Non-Hodgkin lymphoma | 0 | 0 | 1 |
| -Keratoacanthoma | 1 | 0 | 0 |
| -Colon adenoma | 1 | 0 | 0 |
| -Schwannoma | 1 | 0 | 0 |
| -Lung cancer | 0 | 2 | 0 |
| Gastrointestinal | |||
| -Cholelithiasis/cholecystitis | 2 | 1 | 5 |
| -Acute pancreatitis | 1 | 0 | 1 |
| -Acute diverticulitis | 2 | 1 | 2 |
| -Intestinal obstruction | 0 | 2 | 1 |
| -Diarrhea | 0 | 1 | 1 |
| -Other gastrointestinal events | 1 | 1 | 1 |
| Respiratory | |||
| -Pneumonia | 0 | 1 | 1 |
| -Acute bronchitis | 0 | 0 | 1 |
| -Sleep apnea syndrome | 1 | 0 | 0 |
| -Dyspnea | 0 | 1 | 0 |
| Neurological | |||
| -Vertigo | 1 | 1 | 1 |
| -Epilepsy | 0 | 0 | 1 |
| -Subdural hematoma | 0 | 0 | 2 |
| -Other neurological events | 0 | 2 | 3 |
| Metabolic | |||
| -Decompensated diabetes | 2 | 0 | 3 |
| -Hyperkalemia | 1 | 0 | 0 |
| -Anemia | 0 | 1 | 2 |
| -Other metabolic events | 2 | 0 | 1 |
| Musculoskeletal and trauma | |||
| -Musculoskeletal pain | 0 | 1 | 2 |
| -Repetitive muscular strain injury | 1 | 1 | 3 |
| -Osteoarthritis | 4 | 5 | 6 |
| -Intravertebral disc hernia | 0 | 0 | 3 |
| -Abdominal hernia | 1 | 1 | 1 |
| -Bone fracture | 3 | 1 | 3 |
| -Traumatic amputation | 0 | 0 | 1 |
| -Head injury | 2 | 0 | 2 |
| Gynecological | |||
| -Benign uterine or adnexal mass | 1 | 0 | 1 |
| -Vaginal prolapse | 1 | 0 | 0 |
| Infections | |||
| -Sepsis | 1 | 1 | 0 |
| -Herpes zoster | 0 | 1 | 0 |
| -Staphylococcal meningitis | 1 | 0 | 0 |
| -Subhepatic abscess | 0 | 0 | 1 |
| -Appendicitis | 0 | 0 | 1 |
| -Knee prosthetic joint infection | 1 | 0 | 0 |
| -Foot gangrene | 0 | 0 | 1 |
| -Amputation | 0 | 0 | 1 |
| Other SAEs | 1 | 1 | 2 |
No statistically significant difference observed across treatments.
*Major CV events: Sudden cardiac death, fatal and nonfatal acute myocardial infarction, or stroke.
†Minor CV events: Transient ischemic attack and coronary artery disease without revascularization.
‡Neoplasia: Hodgkin lymphoma (n = 1), lung cancer (n = 2), colorectal cancer (n = 1), pancreatic cancer (n = 1), malignant neoplasm of retroperitoneum (n = 1), and metastases to the central nervous system of colorectal cancer (n = 1).
CV, cardiovascular; MACE, major cardiovascular event; SAE, serious adverse event.