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Table 1 Quantitative summary of the safety outcomes with different statins

From: A systematic review on pharmacokinetics, cardiovascular outcomes and safety profiles of statins in cirrhosis

Statin/dose

Authors/publication year

Composite of rhabdomyolysis and muscle injury

Rhabdomyolysis

Muscle injury not fulfilling criteria of Rhabdomyolysis

Myalgia

Drug induced liver injury

Simvastatin 40 mg

Abraldes 2009 [48]

2/30

0/30

2/30 ↑CK > 2x

Muscle weakness or myalgias 1/30

1/30 ↑AST > 2x

 

Abraldes 2016 [51]

2/70

2/70 (one Child B the other in Child C)

0/70

0/70

1/70 ↑3 × liver transaminases

 

Elwan 2018 [63]

0/20

0/20

0/20

2/20

0/20

 

Pollo-Flores 2015 [49]

0/14

0/14

0/14

1/14

0/14

ALT decreased in simvastatin group, no values provided, and did not reach significance

 

Pose 2019 [59]

3/16

3/16 (2 Child Pugh C, 1 Child Pugh B)

0/16

CK—mean difference vs. placebo: 1009 IU/L (208 to 1809) p = 0·014

(muscle symptoms) 5/16

3/16 ↑AST or ALT > 3 × ULN

AST—mean difference vs. placebo: 130 IU/L (54 to 205) p = 0.0009

ALT -mean difference vs. placebo: 61 IU/L (22 to 100) p = 0·0025

 

Vijayaraghavan 2020 [50]

3/81

n = 3/81 (all Child Pugh C)

0/81

0/81

n = 3/81 AST/ALT > 20 × ULN (same patients as Rhabdomyolysis)

 

*Jha 2019 [33] (n = 65 in simvastatin group)

0/65

0/65

0/65

0/65

0/65

 

*Munoz 2019 [32] (n = 9 in simvastatin group)

0/9

0/9

0/9

0/9

0/9

 

Munoz 2018 [44] (abstract)

(Munoz 2020 [45] full article published after initial search)

4/30

0/30

4/30 (13%) myalgia plus CK increase

7/30 (23%)

0/30

  

Total: 14/335 (14/261 excluding*)

Total: 8/335 (8/261 excluding*)

Total: 6/335 (6/261 excluding*)

Total: 16/335 (16/261 excluding*)

Total: 8/335 (8/261 excluding*)

Simvastatin 20 mg

Pose 2019 [59]

N/A

0/14

0/14

(muscle symptoms) 6/14

1/14 ↑AST and ALT > 3 × ULN

 

Wani 2017 [64]

N/A

0/38

1/38—muscle weakness, CPK > 5X ULN with normal ALT (after 15 days of simvastatin 20 mg daily before dose titration)

0/38

0/38

  

N/A

Total: 0/52

Total: 1/52

Total: 6/52

Total: 1/52

Atorvastatin 20 mg

Bishnu 2018 [42] (n = 11 for atorvastatin group)

N/A

0/11

0/11

0/11

0/11

 

Ghadir 2019 [53]

(both intervention and control group has atorvastatin)

N/A

0/40

0/40

0/40

7/40 (3/20 + 4/20) ↑ liver transaminases > 3 xULN or noncompliance were excluded from final analysis

  

N/A

Total: 0/51

Total: 0/51

Total: 0/51

Total: 7/51

Pravastatin 40 mg

Jouve 2019 [52]

(84.8% of participants with cirrhosis) All patients received Sorafenib

N/A

0/155

CK increase

Grade 1–2

29/155 in Sorafenib + Pravastatin vs (30/157 in Sorafenib alone)

Grade 3–4

1/155 in Sorafenib + Pravastatin

vs. 0/157 in sorafenib alone

Grade 1–2

24/155 in Sorafenib + Pravastatin vs (19/157 in Sorafenib alone)

Grade 3–4

3/155 in Sorafenib + Pravastatin

vs. 0/157 in sorafenib alone

0/155

 

Riaño 2020 [31]

(90.3% of participants with cirrhosis) All patients received Sorafenib

N/A

0/15

0/15

0/15

0/15

 

Blanc 2018 [43] (Abstract)

N/A

N/A

N/A

N/A

N/A

  

N/A

Total: 0/170

Total: 30/170

Total: 27/170

Total: 0/170

  1. *Published in journals not indexed in the studied databases