Thai Princess Being Treated for Low Blood Pressure, Palace Says
The 46-year-old princess, the oldest of King Maha Vajiralongkorn's seven children, is being administered medications to increase her blood pressure along with antibiotics, the bureau said in a statement on Tuesday. It was the second health update on the princess issued by the palace in less than a week.
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Medscape
2 hours ago
- Medscape
Stapokibart Improves Rhinosinusitis With Nasal Polyps
Addition of the monoclonal antibody stapokibart significantly improved nasal polyps and nasal congestion in adults with uncontrolled chronic rhinosinusitis with nasal polyps, based on new data from 179 individuals. Biologics are now more commonly used as treatments for chronic rhinosinusitis with nasal polyps (CRSwNP), and monoclonal antibodies have emerged as significantly more effective than other biologics for these patients, wrote Shen Shen, MS, of Capital Medical University, Beijing, China, and colleagues. In a study known as CROWNS-2 published in JAMA , the researchers randomly assigned 180 adults with CRSwNP to stapokibart (300 mg subcutaneously) or a placebo injection every 2 weeks for 24 weeks. All participants also received 100 μg of mometasone furoate per nostril once a day as background treatment before and during the study. The co-primary endpoints were changes in nasal polyp score and nasal congestion score from baseline to 24 weeks in the study population overall and in the subgroup with eosinophilic chronic rhinosinusitis with nasal polyps. The 24-week double-blind period was followed by an open-label extension to 52 weeks. Key secondary endpoints included the percentage of patients who achieved improvement of 1 point or more on nasal polyp scores and 2 points or more on nasal polyp scores. The final analysis included 90 individuals in the stapokibart group and 89 in the placebo group. The mean age of the study population was 45 years, and approximately one third were women. The mean duration of CRSwNP was 6.0 years, and 139 patients (77.7%) had eosinophilic CRSwNP. Study Outcomes Compared with placebo patients at 24 weeks, patients in the stapokibart group had a significant reduction in polyp size, with least-squares mean (LSM) changes in nasal polyp score from baseline of -2.6 and -0.3 points, respectively ( P < .001). Similarly, patients in the stapokibart group had a significantly greater LSM change in nasal congestion score from baseline to week 24 than those in the placebo group (-1.2 points vs -0.5 points, respectively; P < .001). Nearly all of the patients treated with stapokibart (96.5%) had a reduction in nasal polyp score of at least 1 point, and 89.5% had a reduction of at least 2 points after 52 weeks. The improvements in both primary endpoints were even greater among patients with eosinophilia, with an LSM change of -3.0 vs -0.04 for nasal polyp scores and -1.3 vs -0.5 for nasal congestion scores in stapokibart vs placebo patients, respectively. The overall incidence of adverse events in the first 24 weeks of the study was similar for the stapokibart and placebo groups. The most common adverse events were upper respiratory tract infections, COVID-19, and unconfirmed but suspected COVID-19. Serious adverse events were rare and similar between the stapokibart and placebo groups (2.2% vs 1.1%). However, higher rates of arthralgia and hyperuricemia were reported with stapokibart than with placebo (7.8% vs 0% and 5.6% vs 1.1%, respectively). The findings were limited by several factors, including the lack of data on aspirin-exacerbated respiratory disease, the small numbers of patients, and the inclusion only of patients in China, the researchers noted. However, the results support the potential of stapokibart to reduce nasal polyp size and symptom severity in adults with severe CRSwNP, they concluded. Emergence of Endotyping The significant reduction in polyp score was the study's most notable finding, according to an accompanying editorial. 'The emergence of biologic therapies for chronic rhinosinusitis with nasal polyps has brought the concept of inflammatory endotyping to the forefront of this condition,' wrote Michael P. Platt, MD, of Boston University Chobanian & Avedisian School of Medicine, Boston; Stacey T. Gray, MD, of Harvard Medical School, Boston; and Anju T. Peters, MD, of Northwestern University Feinberg School of Medicine, Chicago. The current study included a majority of individuals with eosinophilic CRSwNP, and the successful reduction in polyp size was based on correct identification of this T2 endotype, as stapokibart targeted T2 inflammation, they said. However, choosing the appropriate biologic therapy for uncontrolled CRSwNP with nasal polyps also requires consideration of other comorbid atopic diseases and disease pathogenesis, with shared decision-making, they added. Tuning in to Eosinophilia 'Currently, three biologics are approved for CRSwNP in the US, with additional agents likely to follow,' said Michael S. Blaiss, MD, an allergist and clinical professor at the Medical College of Georgia at Augusta University, Augusta, Georgia, in an interview. 'What distinguishes this trial is that the investigators specifically defined and studied eosinophilic CRSwNP,' said Blaiss, who was not involved in the study. 'In this subgroup, the biologic demonstrated significant efficacy, providing important data for this population of CRSwNP sufferers,' he said. The study findings were not unexpected, as stapokibart has a similar mechanism of action to dupilumab, said Blaiss. 'Both target the IL-4Rα [interleukin-4 receptor subunit alpha] receptor, albeit at different binding sites and affinities, and dupilumab is already FDA-approved for CRSwNP, so efficacy was expected,' he said. 'However, safety findings warrant attention,' he emphasized. The significantly greater occurrence of arthralgia and hyperuricemia in stapokibart vs placebo patients deserves further evaluation in larger and longer studies, Blaiss said. 'If approved, this biologic would provide an additional treatment option for patients with moderate to severe CRSwNP,' Blaiss told Medscape Medical News . However, its advantages over currently available biologics remain unknown, as the dosing schedule of every 2 weeks does not improve convenience, he noted. 'Head-to-head comparative studies are needed, similar to the recent dupilumab vs omalizumab trial in CRSwNP, to determine whether one biologic is clinically superior,' said Blaiss. 'Furthermore, evaluation in noneosinophilic CRSwNP is necessary, as the present study included too few patients in this subgroup for meaningful statistical analysis,' he added.
Bloomberg
5 hours ago
- Bloomberg
FDA Warns Against Eating Shrimp Brand, Citing Radioactive Matter
The US Food and Drug Administration has advised the public not to eat a brand of shrimp sold at Walmart Inc. over concerns about radioactive contamination. The agency told Walmart to pull three lots of raw frozen shrimp sourced from Indonesia after officials detected radioactive Cesium-137 in a shipment that did not enter the US, the FDA said in a statement on Tuesday. The isotope can lead to an elevated risk of cancer through repeated exposure to low doses, though the detected levels were not high enough to cause an acute risk, the FDA said.
Medscape
6 hours ago
- Medscape
Rivaroxaban or Combo Therapy: A Winner for All Ages?
TOPLINE: In patients with atrial fibrillation (AF) and stable coronary artery disease (CAD), rivaroxaban monotherapy reduced the risks for major cardiovascular events (MACE) and major bleeding across all adult age groups. METHODOLOGY: Researchers performed a post hoc analysis of data from the AFIRE trial, conducted in Japan, to assess the age-stratified effects of rivaroxaban monotherapy vs treatment with rivaroxaban plus an antiplatelet agent. The analysis included 2215 patients (mean age, 74.3 years; 79.1% men) with AF and stable CAD more than 1 year after revascularization or angiographically confirmed CAD that did not need revascularization. Patients were randomly assigned to 10 mg or 15 mg of rivaroxaban monotherapy, depending on creatinine clearance, or combination therapy involving rivaroxaban plus aspirin or a P2Y12 inhibitor (at the physician's discretion). The patients were stratified into four age groups: younger than 70 years, 70-74 years, 75-79 years, and 80 years or older. The primary efficacy endpoint was MACE, defined as a composite of stroke, myocardial infarction, systemic embolism, unstable angina requiring revascularization, or death; the primary safety endpoint was major bleeding. The patients were followed for up to 45 months. TAKEAWAY: Across the age spectrum, rivaroxaban alone matched combination therapy for reducing the risks for MACE and major bleeding. However, rivaroxaban monotherapy, compared with combination therapy, was associated with a more pronounced reduction in the risk for MACE among patients aged 80 years or older (hazard ratio [HR], 0.61; 95% CI, 0.40-0.93) and a more pronounced reduction in the risk for major bleeding among those younger than 70 years (HR, 0.23; 95% CI, 0.06-0.79). IN PRACTICE: 'Although the present study did not clarify the factors involved, it is important to reaffirm that rivaroxaban monotherapy effectively reduces net adverse clinical events, which comprehensively include both thrombotic and hemorrhagic events, across a wide age range, even in older patients,' the researchers reported. SOURCE: This study was led by Junichi Yamaguchi, MD, PhD, of the Department of Cardiology at Tokyo Women's Medical University in Tokyo, Japan. It was published online on August 13, 2025, in JAMA Cardiology. LIMITATIONS: The open-label design of the trial may have introduced bias. As a post hoc analysis, this study was underpowered, and differences between the two arms may have been missed due to small sample size. The antiplatelet agent was chosen by the treating physician and was not standardized. DISCLOSURES: This study received support from the Japan Cardiovascular Research Foundation through a contract with Bayer Yakuhin, Ltd. Several authors reported receiving grants, personal fees, and endowments from multiple sources, including Bayer, the Ministry of Education, Culture, Sports, Science and Technology of Japan, and Abbott, among others. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
