Abigail Brooks, MA

The July 2024 gastroenterology month in review highlights FDA news, GI pipeline updates, and a new clinical practice update from the American Gastroenterological Assocation.

Findings support the use of mineralocorticoid receptor antagonists for the short-term reduction of proteinuria in patients with IgAN.

This July 2024 month in review highlights renal pipeline updates, new patient-focused CKD guidelines, and other top nephrology news and research.

Grady explains the significance of the recent FDA approval of the first blood-based test for primary CRC screening and his hope for its impact on overall screening rates and compliance.

This July 2024 month in review highlights pipeline movement in hepatology as well as research about novel diagnostic/prognostic approaches and factors impacting hepatic health outcomes.

Findings support the safety and efficacy of using HBsAg-positive donor kidneys in HBsAg-negative recipients, noting a lack of impact on posttransplant outcomes.

The acellular tissue engineered vessel met co-primary endpoints for function and patency at 6 and 12 months compared to autogenous fistula in patients on hemodialysis.

Results showed significant reductions in mean HbA1c, fasting glucose, and insulin resistance in patients with chronic HCV infection and type 2 diabetes who achieved SVR with DAAs.

Greater circulating Z-polymer levels were associated with an increased risk of adverse clinical outcomes in adults with AATD and the PiZZ genotype.

Results suggest cholesterol absorption inhibitors are linked to a lower risk of liver cancer, but no association was observed for other nonstatins like fibrates, omega-3 fatty acids, and niacin.

The phase 2 trial did not meet its primary endpoint for mean change in Crohn’s disease activity index in either VTX958 dosing group.

The approval of Guardant Health’s Shield test makes it the first blood test to be approved as a primary screening option for CRC and the first to meet Medicare coverage requirements.

Patients with MASH and cirrhosis had a greater prevalence of comorbidities and faced increased annual total health care costs compared to those without cirrhosis.

Findings suggest the current emphasis on targeting inflammation to mitigate fibrosis in MASLD may be incorrect, citing the minimal impact of LBP function loss on fibrosis.

Using NHANES data, researchers calculated AGILE 3 + and AGILE 4 scores to determine the prevalence of advanced fibrosis and cirrhosis in patients with MASLD in the US.

New research suggests combined treatment with fecal microbiota transplant and anti-PD-1 inhibitors may help overcome immune checkpoint inhibitor resistance in gastrointestinal cancers.

Positive topline results from the phase 2 SPRING trial highlight CM-101’s anti-fibrotic, anti-inflammatory, and anti-cholestatic effects in primary sclerosing cholangitis.

The sNDA for furosemide seeks to expand the indication to include the treatment of edema due to fluid overload in patients with CKD, with a PDUFA date of March 6, 2025.

The expanded label includes use in patients with PFIC 12 months of age and older as well as a higher concentration formulation.

The nomogram was constructed using independent risk factors for early cirrhosis and demonstrated greater diagnostic accuracy than current noninvasive fibrosis tests.

The homogenous genotyping test combines allele-specific tailed primers with SYBR-Green to facilitate fast and accurate detection of PI*S and PI*Z alleles of SERPINA1.

Integrating serum C3 and C4 levels into existing prognostic scores led to better prediction accuracy and may help optimize risk stratification in patients with IgAN.

Primary care patients with MASLD who received a prescription for moderate- and high-intensity statins had a lower risk of progressing to a high-risk FIB-4 score.

Spigler provides insight into the development of new patient-focused guidelines for managing hyperkalemia in CKD and the importance of providing patients with such resources.

Data from INSPIRE and COMMAND were used to support risankizumab’s FDA approval for ulcerative colitis, demonstrating the IL-23 inhibitor’s impact on clinical remission.

The analysis of NHANES data found individuals with viral hepatitis and NAFLD as well as lower income and no college education were at a greater risk of mortality.

The novel potassium-competitive acid blocker now boasts 3 FDA approvals across erosive and non-erosive GERD, expanding the treatment armamentarium for patients and clinicians.

Vonoprazan (Voquezna), the first major innovation in GERD treatment in more than 30 years, is now FDA-approved for both erosive and non-erosive GERD.

Announced on July 18, 2024, the FDA approval for heartburn relief associated with non-erosive GERD is based on the phase 3 PHALCON-NERD-301 trial.

The cross-sectional analysis found Medicaid nonexpansion status, fibrosis, and sobriety restrictions negatively impacted annual rates of DAA prescription fills.