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“Bites” from Clinical Research – 2026/4
29. 1. 2026
In selecting this edition of “bites,” we explored new findings published in leading medical journals — ranging from the prevention of ventricular arrhythmias and early detection of pancreatic cancer to current results on oral pharmacotherapy for obesity and the treatment of migraine in children and adolescents.
Earlier Detection of Pancreatic Cancer on CT Using AI
Pancreatic ductal adenocarcinoma (PDAC) has a very poor prognosis, primarily due to late diagnosis. The new PANORAMA study investigated the ability of artificial intelligence (AI) to detect PDAC on routine CT scans and compared its performance with standard radiologist assessment.
The AI system was trained on a cohort of 2,310 patients and externally validated on a test cohort of 1,130 individuals. CT scans of 391 patients from the test cohort were also evaluated by 68 experienced radiologists (6–14.5 years of experience) from 12 countries. The reference standard consisted of histopathological verification combined with 3 years of clinical follow-up. The primary endpoint was the area under the ROC curve (AUROC) for PDAC detection by AI and by radiologists.
In the test cohort, 32% of patients had histologically confirmed PDAC; in the subgroup assessed by radiologists, this proportion was 37%. AI demonstrated both non-inferiority (p < 0.0001) and superiority compared with radiologists. The AUROC for PDAC detection was 0.92 for AI and 0.88 for radiologists. The use of AI thus offers the potential for earlier detection of this disease and improved treatment outcomes.
Source: Alves N., Schuurmans M., Rutkowski D. et al. Artificial intelligence and radiologists in pancreatic cancer detection using standard of care CT scans (PANORAMA): an international, paired, non-inferiority, confirmatory, observational study. Lancet Oncol 2026; 27 (1): 116–124, doi: 10.1016/S1470-2045(25)00567-4.
Oral Semaglutide 25 mg/day Demonstrated Efficacy in the Treatment of Overweight and Obesity
Oral semaglutide is approved for the treatment of type 2 diabetes mellitus. In its subcutaneous form, it is also registered for the treatment of obesity or overweight. The OASIS 1 study showed that oral semaglutide at a dose of 50 mg/day reduced body weight by 15.1% compared with 2.4% with placebo. The subsequent randomized, double-blind, placebo-controlled OASIS 4 study evaluated the efficacy of a lower oral dose — 25 mg/day.
The study enrolled 307 adults without diabetes with a BMI ≥ 30 kg/m2 or ≥ 27 kg/m2 plus at least one complication (hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease). Treatment was added to lifestyle modification.
The mean baseline body weight was 106.4 kg and 104.8 kg, respectively, and the mean BMI was 37.5 kg/m2 and 37.8 kg/m2. After 71 weeks, semaglutide led to a mean body weight reduction of 13.6%, compared with 2.2% with placebo (p < 0.001). At least a 10% weight loss was achieved by 63.0% vs. 14.4%, and at least a 20% weight loss by 29.7% vs. 3.3%. The semaglutide group showed significantly greater reductions in waist circumference, triglycerides, VLDL cholesterol, and C-reactive protein.
The most common adverse events were gastrointestinal (nausea, vomiting, constipation, dyspepsia, diarrhea) and occurred in 74.0% of patients receiving semaglutide and 42.2% receiving placebo. Treatment discontinuation occurred in 3.4% vs. 2.0% of participants.
Source: Wharton S., Lingvay I., Bogdanski P. et al.; OASIS 4 Study Group. Oral semaglutide at a dose of 25 mg in adults with overweight or obesity. N Engl J Med 2025 Sep 18; 393 (11): 1077–1087, doi: 10.1056/NEJMoa2500969.
Therapeutic Increase of Potassium Levels in Patients at Risk of Ventricular Arrhythmias
According to the results of the POTCAST study, a therapeutically induced increase in serum potassium to the high-normal range in patients with cardiovascular disease (CVD) and a high risk of ventricular arrhythmias (VA) is associated with a significant reduction in the risk of implantable cardioverter-defibrillator (ICD) implantation, unplanned hospitalizations for arrhythmias or heart failure, or all-cause mortality.
This multicenter, open-label, randomized study enrolled 1,200 patients with CVD and increased VA risk defined by ICD therapy, with baseline potassium levels ≤ 4.3 mmol/l. Participants were randomized either to a strategy targeting potassium levels of 4.5–5.0 mmol/l via supplementation or mineralocorticoid receptor antagonists (MRA), or to standard care.
The composite primary endpoint included sustained VA or need for ICD therapy, unplanned hospitalization > 24 hours for arrhythmia or heart failure, and all-cause mortality.
During a median follow-up of 40 months, mean potassium levels increased from 4.01 mmol/l to 4.36 mmol/l in the intervention group and to 4.05 mmol/l with standard care. The target potassium range was achieved in 249 of 600 patients in the intervention group. The primary endpoint occurred in 22.7% of patients with targeted potassium increase compared with 29.2% receiving standard care (hazard ratio [HR] 0.76; 95% CI 0.61–0.95; p = 0.01). The incidence of hospitalizations for hyperkalemia or hypokalemia was comparable between groups.
Source: Jøns C., Zheng C., Winsløw U. C. G. et al.; POTCAST Study Group. Increasing the potassium level in patients at high risk for ventricular arrhythmias. N Engl J Med 2025 Nov 20; 393 (20): 1979–1989, doi: 10.1056/NEJMoa2509542. Epub 2025 Aug 29.
Fremanezumab Demonstrated Safety and Efficacy in Children and Adolescents with Episodic Migraine
Fremanezumab is a humanized anti-CGRP monoclonal antibody approved for migraine prophylaxis in adults. The study cited below has now demonstrated its benefit in pediatric patients.
The trial enrolled 237 individuals aged 6–17 years with episodic migraine (≤ 14 migraine days per month [MMD] over ≥ 6 months), randomized to receive subcutaneous fremanezumab (120 mg for body weight < 45 kg and 225 mg for ≥ 45 kg) or placebo once monthly for 3 months. Patients were allowed to use specific acute migraine treatments during attacks. The primary endpoint was the change in the number of MMD.
Fremanezumab reduced the mean number of MMD by 2.5 compared with a reduction of 1.4 MMD in the placebo group (p = 0.02). At least a 50% reduction in MMD was achieved by 47.2% of patients receiving fremanezumab versus 27.0% receiving placebo (p = 0.002). The most common adverse event was injection-site erythema, occurring in 9.8% of patients treated with fremanezumab (vs. 5.4% with placebo). Longer-term follow-up is planned.
Source: Hershey A. D., Szperka C. L., Barbanti P. et al. Fremanezumab in children and adolescents with episodic migraine. N Engl J Med 2026 Jan 15; 394 (3): 243–252, doi: 10.1056/NEJMoa2504546.
Editorial Team, Medscope.pro
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