Rivaroxaban May Improve Outcomes in Cirrhosis
Rivaroxaban improved portal hypertension-related complication-free survival in patients with cirrhosis and moderate liver dysfunction, without significantly increasing the risk for major bleeding events.
METHODOLOGY:
Researchers conducted a randomised trial of 90 patients with cirrhosis, portal hypertension, and moderate liver dysfunction (on the basis of the Child-Pugh score) who were enrolled at 14 hospitals in Spain between May 2016 and October 2020 to assess the improvement in outcomes with rivaroxaban.
Patients were randomly assigned to receive either 10 mg rivaroxaban daily (n = 41; median age, 58 years; 85.4% men) or matched placebo (n = 49; median age, 59 years; 79.6% men) for up to 24 months.
The primary combined endpoint was the time to the first occurrence of any portal hypertension-related complication (including new-onset ascites, portal hypertensive gastrointestinal bleeding, and overt hepatic encephalopathy), death, portal vein thrombosis, hepatocellular carcinoma, or liver transplantation.
The safety of rivaroxaban and the incidence of non-portal hypertension-related bleeding events were also assessed. The mean follow-up duration was 10.1 months.
TAKEAWAY:
The primary combined endpoint occurred in 26.8% of patients in the rivaroxaban group vs 46.9% of those in the placebo group, with 1-year survival probabilities of 78.7% vs 54.4% and 2-year survival probabilities of 67.1% vs 43.0%.
The risk of reaching the main endpoint was reduced in the rivaroxaban group (adjusted hazard ratio [HR], 0.418; 95% CI, 0.204-0.858).
In a subgroup analysis, a significant effect of rivaroxaban vs placebo was observed in patients with a Child-Pugh B score of 7 points (n = 55; HR, 0.258; 95% CI, 0.074-0.900).
The rivaroxaban group experienced bleeding events related to non-portal hypertension more frequently than the placebo group (relative risk, 2.56; 95% CI, 1.16-5.67); no differences in first or recurrent portal hypertension-related bleeding or other adverse events were observed between the two groups.
IN PRACTICE:
"Unfortunately, there was no clinical or biochemical parameter able to predict rivaroxaban levels obtained after 10 mg rivaroxaban and, if our data on the beneficial effects of rivaroxaban are confirmed, monitoring of rivaroxaban plasma levels would be required to reduce bleeding risk," the authors of the study wrote.
SOURCE:
This study was led by Ángela Puente, PhD, Valdecilla Research Institute (IDIVAL), Marqués de Valdecilla University Hospital, Santander, Spain. It was published online on July 19, 2025, in the Journal of Hepatology.
LIMITATIONS:
The trial was underpowered to show statistical significance. The direct effect of rivaroxaban on portal pressure was not assessed. Alcohol consumption was tracked during follow-up visits through direct questioning, without using scales or biochemical markers.
DISCLOSURES:
This study was supported by grants from Instituto de Salud Carlos III and co-funded by the European Union. Support was also received from "Commissioner for Universities and Research from the Department of Economy and Knowledge" of the "Generalitat de Catalunya." Some authors reported receiving grants from Instituto de Salud Carlos III. The authors declared having no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Bloomberg
a day ago
- Bloomberg
FDA Investigates Death of Boy Who Got Sarepta's Gene Therapy
US regulators said they are investigating the death of an 8-year-old boy who received a gene therapy from Sarepta Therapeutics Inc. The death occurred on June 7, according to a statement from the US Food and Drug Administration.
Medscape
a day ago
- Medscape
Rivaroxaban May Improve Outcomes in Cirrhosis
TOPLINE: Rivaroxaban improved portal hypertension-related complication-free survival in patients with cirrhosis and moderate liver dysfunction, without significantly increasing the risk for major bleeding events. METHODOLOGY: Researchers conducted a randomised trial of 90 patients with cirrhosis, portal hypertension, and moderate liver dysfunction (on the basis of the Child-Pugh score) who were enrolled at 14 hospitals in Spain between May 2016 and October 2020 to assess the improvement in outcomes with rivaroxaban. Patients were randomly assigned to receive either 10 mg rivaroxaban daily (n = 41; median age, 58 years; 85.4% men) or matched placebo (n = 49; median age, 59 years; 79.6% men) for up to 24 months. The primary combined endpoint was the time to the first occurrence of any portal hypertension-related complication (including new-onset ascites, portal hypertensive gastrointestinal bleeding, and overt hepatic encephalopathy), death, portal vein thrombosis, hepatocellular carcinoma, or liver transplantation. The safety of rivaroxaban and the incidence of non-portal hypertension-related bleeding events were also assessed. The mean follow-up duration was 10.1 months. TAKEAWAY: The primary combined endpoint occurred in 26.8% of patients in the rivaroxaban group vs 46.9% of those in the placebo group, with 1-year survival probabilities of 78.7% vs 54.4% and 2-year survival probabilities of 67.1% vs 43.0%. The risk of reaching the main endpoint was reduced in the rivaroxaban group (adjusted hazard ratio [HR], 0.418; 95% CI, 0.204-0.858). In a subgroup analysis, a significant effect of rivaroxaban vs placebo was observed in patients with a Child-Pugh B score of 7 points (n = 55; HR, 0.258; 95% CI, 0.074-0.900). The rivaroxaban group experienced bleeding events related to non-portal hypertension more frequently than the placebo group (relative risk, 2.56; 95% CI, 1.16-5.67); no differences in first or recurrent portal hypertension-related bleeding or other adverse events were observed between the two groups. IN PRACTICE: "Unfortunately, there was no clinical or biochemical parameter able to predict rivaroxaban levels obtained after 10 mg rivaroxaban and, if our data on the beneficial effects of rivaroxaban are confirmed, monitoring of rivaroxaban plasma levels would be required to reduce bleeding risk," the authors of the study wrote. SOURCE: This study was led by Ángela Puente, PhD, Valdecilla Research Institute (IDIVAL), Marqués de Valdecilla University Hospital, Santander, Spain. It was published online on July 19, 2025, in the Journal of Hepatology. LIMITATIONS: The trial was underpowered to show statistical significance. The direct effect of rivaroxaban on portal pressure was not assessed. Alcohol consumption was tracked during follow-up visits through direct questioning, without using scales or biochemical markers. DISCLOSURES: This study was supported by grants from Instituto de Salud Carlos III and co-funded by the European Union. Support was also received from "Commissioner for Universities and Research from the Department of Economy and Knowledge" of the "Generalitat de Catalunya." Some authors reported receiving grants from Instituto de Salud Carlos III. The authors declared having no conflicts of interest. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
New York Times
4 days ago
- New York Times
Mountain Lion Is Euthanized After Attacking a Child in Olympic National Park
A mountain lion that bit a 4-year-old child on a popular trail at Olympic National Park in Washington State was euthanized on Monday, park officials said. The child was treated at a hospital in Seattle and released on Monday, officials said. The child had been walking with family at the national park on Sunday when the mountain lion, which was wearing a tracking collar for research purposes, attacked, according to park officials. The child's identity and extent of their injuries were not released. Mountain lion attacks on humans are exceedingly rare, according to wildlife experts. There have only been a couple dozen fatal attacks in the U.S. and Canada in the last 150 years, according to data. Mountain lions are mostly solitary cats, tending to keep a low profile among people, which makes sightings of them unusual. The child was attacked while on a popular trail near the Victoria Overlook area on Hurricane Ridge in Olympic National Park, officials said. Rangers were notified of the attack about 3:15 p.m. on Sunday, and paramedics and park staff quickly transferred the child by an air ambulance to Harborview Medical Center in Seattle. Rangers, and later a canine team, searched for the animal and found it on Sunday. It was not euthanized until Monday morning, park officials said. Mountain lions are known by more than 40 common names, including puma, cougar, panther, red tiger and catamount. They are most active at dusk and dawn, and their favorite prey are deer and elk. No details were released about the animal, or its contribution to research. In 2022, another collared mountain lion, known as P-22, was euthanized in Los Angeles after wildlife officials determined that he had serious health issues. That one had become a celebrity in the city, after helping to inspire the construction of a wildlife crossing bridge on the 101 Freeway. P-22 lived most of his life in Griffith Park and gained a social media following, with more than 10,000 followers on Instagram. But despite the crossing bridge, he was hit by a car in 2022. Soon afterward, he attacked two dogs, one of which died. Olympic National Park, which covers more than 920,000 acres on a thumb of land known as the Olympic Peninsula, is one of the largest, most remote, and least-developed protected areas in the United States.
