Table 2.
Statin-related event category | Patients (%) |
---|---|
Myalgia or myopathy | 5075 (4.7) |
Rhabdomyolysis | 7 (0.006) |
CK 3-10 ULN | 992 (0.9) |
Musculoskeletal and connective tissue disorders other than myalgia or myopathy | 2742 (2.5) |
Muscle spasms | 882 (0.8) |
Pain in extremity | 537 (0.5) |
Arthralgia | 356 (0.3) |
Other | 967 (0.9) |
General disorders and administration site conditions | 2493 (2.3) |
Pain | 1222 (1.1) |
Fatigue | 313 (0.3) |
Asthenia | 208 (0.2) |
Other | 750 (0.7) |
Hepatobiliary disorders | 2308 (2.1) |
Drug intolerant | 1827 (1.7) |
Gastrointestinal disorders | 1681 (1.6) |
Nervous system disorders | 564 (0.5) |
Memory problems | 70 (0.06) |
Immune system disorders | 399 (0.4) |
Vascular disorders | 399 (0.4) |
Psychiatric disorders | 333 (0.3) |
Unknown | 246 (0.2) |
Cardiac disorders | 133 (0.1) |
Injury, poisoning and procedural complications | 112 (0.1) |
Skin and subcutaneous tissue disorders | 107 (0.1) |
Reproductive system and breast disorders | 99 (0.09) |
Respiratory, thoracic and mediastinal disorders | 82 (0.08) |
Drug ineffective | 50 (0.05) |
Ear and labyrinth disorders | 35 (0.03) |
Blood and lymphatic system disorders | 34 (0.03) |
Renal and urinary disorders | 23 (0.02) |
Eye disorders | 20 (0.02) |
Metabolism and nutrition disorders | 16 (0.01) |
Number of patients with statin-related events among all 107,835 patients included in the study. Statin-related events were classified according to the Medical Dictionary for Regulatory Activities (MedDRA).
Abbreviations: CK, creatine kinase; ULN, upper limit of normal.