1 min

The investigational sodium-glucose cotransporter (SGLT) 1/2 inhibitor sotagliflozin is the first agent clearly shown in a prespecified analysis of randomized trials to improve clinical outcomes in patients with heart failure with reduced ejection fraction (HFpEF).

Researchers who ran the SCORED and SOLOIST–WHF pivotal trials for sotagliflozin first made that claim in November 2020 when reporting top-line results from a prespecified meta-analysis of the two trials during the American Heart Association annual scientific sessions.

Source: Medscape

In the HARP-2 trial of simvastatin in acute respiratory distress syndrome (ARDS), published a few years ago, the main results were neutral, but in the subgroup of patients with hyperinflammatory ARDS, there was a reduction in mortality with simvastatin in comparison with placebo.

Moreover, in a series of observational studies of patients with COVID-19, use of statins was associated with a reduction in mortality among hospitalized patients. However, there are limited high-quality data to guide clinical practice.

Source: Medscape

An experimental varenicline nasal spray can reduce signs and symptoms of dry eye disease, the results of a phase 3 trial suggest. That’s because Oyster Point’s OC-01 works by stimulating the trigeminal nerve through the nasal passage, causing the eyes to tear. By contrast, most current treatments are either anti-inflammatories or artificial tears that don’t include all the components of natural ones.

OC-01 also improves symptoms relatively fast — in as few as 14 days, rather than the 3-6 months needed for some other dry eye treatments.

Source: Medscape

A new drug combination containing rifapentine and moxifloxacin has finally broken the 6-month treatment barrier for drug-susceptible pulmonary tuberculosis, requiring only 4 months to produce a disease-free state at 1 year in most patients.

In open-label, phase 3, multinational trial, Doctors pitted 4-month regimens containing 1200 mg of rifapentine taken once daily with or without 400 mg of moxifloxacin taken daily against a standard 6-month regimen of rifampin, isoniazid, pyrazinamide, and ethambutol. For both 4-month treatments, rifapentine replaced rifampin, and for one of them, moxifloxacin also replaced ethambutol.

Source: The New England Journal of Medicine

A plant-based fusion protein is safe and effective for inducing favorable immune modulation in patients with mild to moderate ulcerative colitis with no immune suppression–side effects reported.

OPRX-106, an orally administered BY2 plant cell–expressing recombinant TNF fusion protein, has demonstrated effectiveness as an anti–TNF-alpha therapy.

After 8 weeks, 67% of the patients demonstrated clinical response and 28% showed clinical remission. 89% of the patients experienced some degree of improvement in their Mayo scores, 61% had mucosal improvement, and 33% achieved mucosal healing.

Source: Medscape

None of the 43 antibiotics currently in development as well as recently approved medicines are enough to combat the increasing emergence and spread of antimicrobial resistance, the World Health Organization cautioned.

Drug resistance is driven by the misuse and overuse of antibiotics and other antimicrobials, which encourages bacteria to evolve into “superbugs” and find new ways to beat the medicines. Previous studies have estimated AMR will kill tens of millions of people every year after 2050.

Out of the 43 antibiotics in development, the WHO said 26 drugs target the 13 most dangerous “superbugs”. But the health agency said most of these antibiotics are derivatives of existing classes, which could result in “rapid emergence of drug-resistance.”

Source: WHO

HCC is the fourth-leading cause of cancer mortality worldwide, and is driven mostly by viral hepatitis B (HBV) and viral hepatitis C (HCV) infection. The risk of hepatocellular carcinoma (HCC) was reduced by 31% compared with no aspirin use, and liver-related mortality dropped by 27%, as long as aspirin use continued. The analysis showed that in aspirin users, the 10-year cumulative incidence of HCC was 4% compared with 8.3% in nonusers. After multivariable adjustment, aspirin users had a risk of HCC that was 31% lower compared with nonusers (adjusted subhazard ratio, 0.69; 95% confidence interval.

Source: New England Journal of Medicine

Chronic immune-related adverse events (irAEs) associated with anti-programmed cell death-1 (PD-1) therapy for melanoma were more common than previously thought in a retrospective multicenter study.

As reported in JAMA Oncology, Dr. Johnson and colleagues analyzed data on 387 melanoma patients treated at eight academic medical centers between 2015-2020. The median age was 63, 61% were men, and all received adjuvant anti-PD-1 for stage III-IV melanomas.

Sixty-nine percent of patients had any acute irAE, defined as arising during anti-PD-1 treatment, including 19.5% with grades 3-5 events. One patient had neurotoxicity and one had fatal myocarditis.

Chronic irAEs – those that persisted beyond 12 weeks after anti-PD-1 discontinuation – developed in 43.2% of patients; most (96.4%) were grade 1 or 2 and only 14% had resolved by the last available follow-up.

Source: Medscape

When esophageal or gastroesophageal-junction cancer remains a threat after chemoradiotherapy and surgery because of residual pathological disease, treatment with the checkpoint inhibitor nivolumab doubles disease-free survival, according to the results of the large international CheckMate 577 trial.

The treatment, also used for kidney, liver, lung and a host of other cancers, is designed to block the cancer’s defense mechanism against the immune system. It costs about $165,000, sells under the brand name Opdivo.

Source: The New England Journal of Medicine

Women with a BRCA1 or BRCA2 mutation have an increased risk for endometrial cancer (EC), and the greatest risk is for the rare subgroup of serous-like and p53-abnormal endometrial cancers in BRCA1 mutation carriers, according to a Dutch study.

BRCA1 and BRCA2 mutation carriers had a significant two- to three-fold increase in EC risk, with the highest risk increases found for two EC subgroups with “unfavorable” clinical outcomes: serous-like histology (8-10 fold) and p53-abnormal EC (11-12 fold), the researchers report in the Journal of the National Cancer Institute.

Source: Journal of the National Cancer Institute.