Table 1.
Summary of case reports.
| Study | Year | Age (Years) |
SARM | Dose (mg) | Duration (Weeks) | Time from Stopping to Symptoms (days) | Presenting Symptoms | Imaging | Biopsy | R Factor | Treatment and Outcome |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Baliss et al. [24] | 2020 | 31 | RAD-140 | 12 | 3 days of epigastric pain, jaundice and pruritis, scleral icterus | MRI abdomen normal | Labs down-trended after 1 month | ||||
| Barbara et al. [11] | 2020 |
32 | LGD-4033 | 10 | 2 | 1–7 | diffuse itching, jaundice, acholic stool, intermittent abdominal pain, nausea, 40 lbs. weight loss, scleral icterus |
US and CT-hepatomegaly MRCP, small hepatic cyst and splenomegaly, otherwise normal |
Cholestatic hepatitis with mild portal, periportal, perisinusoidal fibrosis |
||
| Barbara et al. [18] | 2020 | 52 | RAD-140, LGD-4033 | 17.86, 10 | 7 | 1–7 | Right upper quadrant pain, pruritus, and greasy diarrhea, scleral icterus, jaundice | MRI abdomen normal | Diffuse centrilobular canalicular cholestasis, mild portal and periportal fibrosis |
0.2 | Stop alcohol consumption, improvement in labs at 3 months |
| Bittner et al. [25] | 2020 | 34 | LGD-4033 | 7.5 | 4 | 7 | Decreased appetite, worsening pruritus, dark amber urine, and cognitive ‘clouding’, jaundice, scleral icterus |
US normal. CT abdomen–mild splenomegaly | Inflammation and diffuse cholestasis | ||
| Flores et al. [26] | 2020 | 24 | LGD-4033 | 9 | 7 | jaundice, anorexia, nausea, lethargy, 5 kg weight loss |
US normal | 8.22 | Labs normalized after 4 months | ||
| Flores et al. [26] | 2020 | 49 | RAD-140 | 4 | 20–30 | Jaundice and itching |
Moderate cholestasis with ductopenia and minimal fibrosis and inflammation, |
5 | Ursodiol and cholestyramine, labs normalized after 12 months | ||
| Bedi et al. [12] | 2021 |
40 | Enobosarm | 8 | Jaundice, anorexia, weight loss, lethargy, and diarrhea, scleral icterus | US, CT abdomen, and MRCP normal | centrilobular cholestasis with yellow-green bile in hepatocytes and canaliculi |
0.8 | Improvement in labs over several months of follow up | ||
| Gould et al. [14] | 2021 | 36 | Ostarine and Carderine | 8 | 35 | Asynchronous bilateral Achilles tendon rupture after two 4-week cycles of SARM compounds | |||||
| Kintz et al. [9] | 2021 | 43 | MK-2866, Carderine | 20, 20 | 0.7 | 10 | Patient presented with severe rhabdomyolysis after cycling 74.6 miles with extreme elevations of ALT, AST, and CK | ||||
| Koller et al. [16] | 2021 | 19 | LGD-4033 | 7 | 0 | Patient cycled 4 weeks on, 4 weeks off. Restarted the cycle for 3 weeks and stopped after noticing dark urine, yellow sclera, and thinner light-colored stools |
US abdomen-normal | Mild septal fibrosis, canalicular cholestasis in the hepatocytes with numerous biliary plugs |
3.9 | 1000 mg ursodeoxycholic acid (UDCA) daily for 2 mo. Labs normalized after 3 months |
|
| Koller et al. [16] | 2021 | 28 | LGD-4033, Ostarine | 0 | For 3 months took unknown amount of SARM. After 3-week break, a formulation of SARM bought on internet was taken for 4 doses, reasons for seeking medical care unclear | MRI abdomen hepatomegaly without biliary pathology | Mild bridging fibrosis, destruction of bile ducts, centrilobular canalicular cholestasis with numerous bile plugs |
3.3 | 300 mg intravenous N-acetyl cysteine 4 times daily, 1000 mg oral UDCA daily, and 450 mg silymarin daily. Labs significantly improved at 3 months |
||
| Cardaci et al. [27] | 2022 | 25 | LGD-4033, MK-677 | 10, 15 | 5 | This was an efficacy case report, no SAE’s reported, however, ALT increased from 20 IU/L to 61 IU/L after 5 weeks. The ALT returned to baseline after 4 weeks off SARM | |||||
| Khan et al. [28] | 2022 | 29 | 4 | Jaundice, pruritus, fatigue, scleral icterus, light-colored stools, dark urine | CT abdomen-normal | Centrilobular bile stasis with lipofuscin pigment along with collection of neutrophils within lobular parenchyma |
Labs normalized by 6 months | ||||
| Lee et al. [29] | 2022 | 23 | LGD-4033, RAD-140, YK11 | 12 | 7 | Jaundice, scleral icterus, decrease in appetite, and worsening pruritis |
MRI and MRCP normal | 0.8 | Ursodeoxycholic acid and hydroxyzine, labs normalized within a year |
||
| Peranathan et al. [30] | 2022 | 30 | RAD-140 | Jaundice and fatigue | Unspecified image normal | Acute cholestasis with canalicular bile plugs, without evidence of ductopenia |
1.8 | ursodeoxycholic acid and cholestyramine down-trending within 60–80 days | |||
| Peranathan et al. [30] | 2022 | 43 | RAD-140 | Jaundice and fatigue | Unspecified image normal | Acute cholestasis with canalicular bile plugs, without evidence of ductopenia |
2.3 | ursodeoxycholic acid and cholestyramine down-trending within 60–80 days | |||
| Weinblatt et al. [13] | 2022 | 31 | Enobosarm | 2 | 0 | Itch and dark-colored urine | US abdomen, fatty liver, otherwise normal | 7.5 | Cyproheptadine, labs significantly improved after 7 days and normalized at 10 month follow up | ||
| Wallstab et al. [31] | 2022 | 37 | Ligandrol (LGD-4033) | 4 mg | 8 | 60 | Jaundice, pruritus, anorexia, fatigue, 12 kg weight loss, dark urine | U/S abdomen ruled out extrahepatic cholestasis and cholecystolithiasis Fibroscan showed fibrosis 10.7 ± 2.3 kPa |
Canalicular cholestasis, ductopenia, Acute portal hepatitis with early periportal fibrosis |
2.7 | Ursodeoxycholic acid and cholestyramine, Linimentum Aquosum ointment |