Safety of Chronic Simvastatin Treatment in Patients with Decompensated Cirrhosis: Many Adverse Events but No Liver Injur
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ORIGINAL ARTICLE
Safety of Chronic Simvastatin Treatment in Patients with Decompensated Cirrhosis: Many Adverse Events but No Liver Injury Alberto E. Muñoz1,4 · Florencia Pollarsky1 · Mónica Marino1 · Mariano Cartier1 · Carlos Míguez1 · Horacio Vázquez2 · Daniel Álvarez3 · Pablo Salgado4 · Gustavo Romero1 Received: 11 June 2020 / Accepted: 20 September 2020 © Springer Science+Business Media, LLC, part of Springer Nature 2020
Abstract Background The high mortality rate of decompensated cirrhosis underlines the need for new treatments. Experimental models of cirrhosis and its reported relationship with atherosclerotic cardiovascular disease have provided data supporting the rational use of statins in these patients. However, little is known about the safety of statins in this setting. Aim We evaluate the safety of chronic simvastatin treatment in patients with decompensated cirrhosis. Methods We conducted a prospective, open, uncontrolled, phase 2a trial in 30 patients with Child–Pugh class A (n = 6), B (n = 22), and C (n = 2) decompensated cirrhosis. The patients received standard treatment throughout the trial plus simvastatin 20 mg/day for 2 weeks and thereafter simvastatin 40 mg/day up to 1 year. Results Sixteen out of 30 patients (53.3%) showed adverse events, including gastrointestinal toxicity (36.7%), muscle injury (MI) (36.7%), and headache (13.3%). No liver injury was registered. Due to MI alone, simvastatin dosage was reduced in 23.4% of cases and transiently interrupted in 13.3%. Once these adverse events were overcome, simvastatin was resumed until the end of the trial. MI was associated with baseline MELD score > 12 (p = 0.035) and with baseline Child–Pugh class C. No MI was associated with final Child–Pugh score ≤ 6 (p = 0.030) or final Child–Pugh class A (p = 0.020). Conclusions Chronic treatment with simvastatin 40 mg/day in patients with decompensated cirrhosis was associated with several adverse events, being MI the only clinically significant one, which appears to be related to the simvastatin dosage and the degree of cirrhosis severity. Noticeably, no liver injury was recorded. Keywords Fibrosis · Liver disease · Statins · Safety * Alberto E. Muñoz [email protected] Florencia Pollarsky [email protected] Mónica Marino [email protected]
1
Sección de Hepatología, Hospital de Gastroenterología Dr. Carlos Bonorino Udaondo, Facultad de Medicina, Universidad de Buenos Aires, Av. Caseros 2061 (1264), Ciudad Autónoma de Buenos Aires, Argentina
2
Unidad Clínica, Hospital de Gastroenterología Dr. Carlos Bonorino Udaondo, Facultad de Medicina, Universidad de Buenos Aires, Av. Caseros 2061 (1264), Investigador Asociado del Gobierno de La Ciudad de Buenos Aires, Ciudad Autónoma de Buenos Aires, Argentina
3
Servicio de Ecografía, Fundación Favaloro, Facultad de Medicina, Universidad Favaloro, Av. Belgrano 1782 (1093), Ciudad Autónoma de Buenos Aires, Argentina
4
Instituto de Investigaciones en Salud Pública, Facultad de Odontología, Universidad de Buenos Air
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