Details | Patient 17 | Patient 28 | Patient 312 | Patient 416 | Patient 521 | Current Patient |
---|---|---|---|---|---|---|
Age/sex | 72/male | 63/male | 77/male | 68/female | 56/male | 72/male |
Simvastatin dose* | 80 mg | 40 mg | 80 mg | 40 mg | 40 mg | 80 mg |
Amiodarone dose* | 200 mg | 200 mg | 100 mg | Not reported | 600 mg | 200 mg |
Other risk factors† | Chronic renal insufficiency, age, diabetes, recent surgery | Age, diabetes, recent surgery | Chronic renal insufficiency, age, hypo-thyroidism | Age, verapamil | Recent surgery, clarithromycin | Age, atazanavir, delviradine |
Reported adverse event | Rhabdomyolysis | Rhabdomyolysis | Rhabdomyolysis | Myopathy | Myositis | Rhabdomyolysis |
Time to adverse event‡ | 39 days | 14 days | 21 days | 2 years | 1 to 9 days | 19 days |
Peak creatine kinase (U/L) | 19,620 | 40,392 | 28,523 | 48,000 | >20,000 | >70,000 |
Dialysis required | No | No | No | No | No | Yes |
Outcome | Resolved | Resolved | Resolved | Resolved | Resolved | Resolved after 1 month of dialysis |
* Dose at time of adverse event.
† Other risk factors include advanced age, chronic renal insufficiency, metabolic disorders such as diabetes or hypothyroidism, major surgery, alcohol abuse, and the use of concomitant medications (azole antifungals, macrolide antibiotics, HIV protease inhibitors, nefazodone, cyclosporine, danazol, verapamil, and amiodarone).
‡ Time to adverse event from the time that amiodarone and simvastatin were being administered concomitantly.