Referencia

SPRINGER – Alemania.

Resumen general

Background Simvastatin administration to decompensated cirrhosis patients improved Child-Pugh (CP) at the end of a safety trial (EST). Aim To evaluate whether simvastatin reduces cirrhosis severity through a secondary analysis of the safety trial. Methods Thirty patients CP class (CPc) CPc A (n=6), CPc B (n=22), and CPc C (n=2) received simvastatin for one year. Primary endpoint: cirrhosis severity. Secondary endpoints: health-related quality of life (HRQoL) and hospitalizations for cirrhosis complications. Results Cirrhosis severity decreased baseline versus EST only across CP score (7.3±1.3 versus 6.7±1.7, P=0.041), and CPc: 12 patients lessened from CPc B to CPc A, and three patients increased from CPc A to CPc B (P=0.029). Due to cirrhosis severity changes and diferences in clinical outcomes, 15 patients completed the trial as CPc AEST and another 15 as CPc B/C. At baseline, CPc AEST showed greater albumin and high-density lipoprotein cholesterol concentrations than CPc B/C (P=0.036 and P=0.028, respectively). Comparing EST versus baseline, only in CPc AEST, there was a reduction in white-cell blood (P=0.012), neutrophils (P=0.029), monocytes (P=0.035), and C-reactive protein (P=0.046); an increase in albumin (P=0.011); and a recovery in HRQoL (P<0.030). Finally, admissions for cirrhosis complications decreased in CPc AEST versus CPc B/C (P=0.017). Conclusions Simvastatin would reduce cirrhosis severity only in CPc B at baseline in a suitable protein and lipid milieu, possibly due to its anti-infammatory efects. Furthermore, only in CPc AEST would improve HRQoL and reduce admissions by cirrhosis complications. However, as these outcomes were not primary endpoints, they require validation.