Volume 150, Issue 5, Pages e3 (May 2016)

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Transcripción de la presentación:

Volume 150, Issue 5, Pages 1160-1170.e3 (May 2016) Addition of Simvastatin to Standard Therapy for the Prevention of Variceal Rebleeding Does Not Reduce Rebleeding but Increases Survival in Patients With Cirrhosis Juan G. Abraldes, Candid Villanueva, Carles Aracil, Juan Turnes, Manuel Hernandez-Guerra, Joan Genesca, Manuel Rodriguez, Jose Castellote, Juan Carlos García-Pagán, Ferran Torres, Jose Luis Calleja, Agustin Albillos, Jaime Bosch Salvador Augustin, Elba Llop, Dalia Morales Arraez, Goretti Hernández Mesa, Javier Martinez, Enric Reverter, Susana Seijo, Fanny Turon, Josep Miñana, Juan Buenestado, Josep M. Reñe, Carmen A. Navacués, Ramon Planas, Rosa M. Morillas, Pau Bellot, Jose Such, Mercedes Vergara, Angela Puente, Joaquin de la Pena, José Mera Calviño, Laura Rivas Moral, Oana Pavel, Edilmar Alvarado, Alba Ardevol, Anna Girbau, Alba Cachero, Joan Albert Arnaiz, Annalisa Berzigotti, Judit Pich, Jose Rios, Rosa Saenz, Laura Millan, Helena Beleta, Núria Ramos Juan G. Abraldes, Candid Villanueva, Carles Aracil, Juan Turnes, Manuel Hernandez-Guerra, Joan Genesca, Manuel Rodriguez, Jose Castellote, Juan Carlos García-Pagán, Ferran Torres, Jose Luis Calleja, Agustin Albillos, Jaime Bosch Salvador Augustin, Elba Llop, Dalia Morales Arraez, Goretti Hernández Mesa, Javier Martinez, Enric Reverter, Susana Seijo, Fanny Turon, Josep Miñana, Juan Buenestado, Josep M. Reñe, Carmen A. Navacués, Ramon Planas, Rosa M. Morillas, Pau Bellot, Jose Such, Mercedes Vergara, Angela Puente, Joaquin de la Pena, José Mera Calviño, Laura Rivas Moral, Oana Pavel, Edilmar Alvarado, Alba Ardevol, Anna Girbau, Alba Cachero, Joan Albert Arnaiz, Annalisa Berzigotti, Judit Pich, Jose Rios, Rosa Saenz, Laura Millan, Helena Beleta, Núria Ramos Gastroenterology Volume 150, Issue 5, Pages 1160-1170.e3 (May 2016) DOI: 10.1053/j.gastro.2016.01.004 Copyright © 2016 AGA Institute Terms and Conditions

Figure 1 Kaplan-Meier curve showing the probability of developing the primary end point (rebleeding or death) in patients from simvastatin (red) and placebo (blue) groups. There were no differences between the study groups. Gastroenterology 2016 150, 1160-1170.e3DOI: (10.1053/j.gastro.2016.01.004) Copyright © 2016 AGA Institute Terms and Conditions

Figure 2 (A) Kaplan-Meier curve showing that patients in simvastatin arm (red) had a significantly greater survival than patients in the placebo arm (blue). (B) Kaplan-Meier curve showing the rate of rebleeding. There were no differences between the treatment arms. Gastroenterology 2016 150, 1160-1170.e3DOI: (10.1053/j.gastro.2016.01.004) Copyright © 2016 AGA Institute Terms and Conditions

Supplementary Figure 1 Flowchart showing the disposition of the patients. DBR, data blind review; EBL, endoscopic banding ligation; FAS, full analysis set; HCC, hepatocellular carcinoma; ITT, intention to treat; TIPS, transjugular intrahepatic portosystemic shunt. Gastroenterology 2016 150, 1160-1170.e3DOI: (10.1053/j.gastro.2016.01.004) Copyright © 2016 AGA Institute Terms and Conditions

Supplementary Figure 2 MELD trajectory during the study period in the placebo and simvastatin group (least square means and 95% CI from the mixed models for repeated measurements analysis). Gastroenterology 2016 150, 1160-1170.e3DOI: (10.1053/j.gastro.2016.01.004) Copyright © 2016 AGA Institute Terms and Conditions

Supplementary Figure 3 Forest plot showing the effects of simvastatin on the primary and main secondary end points, according to the predefined Child-Pugh class strata (A/B vs C). Statistics are rate differences (95% CI) and P values from the log-binomial regression model. There was no statistical heterogeneity in the effects of simvastatin across the strata. However, in Child-Pugh A/B patients there was a significant decrease in mortality with simvastatin, which was not observed in Child-Pugh C patients. Gastroenterology 2016 150, 1160-1170.e3DOI: (10.1053/j.gastro.2016.01.004) Copyright © 2016 AGA Institute Terms and Conditions