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Unilateral APAs are potentially treatable causes of hypertension but often necessitate adrenal vein sampling (AVS) and laparoscopic adrenalectomy, both invasive procedures that are not appealing to many patients. Because the left adrenal gland is close to the stomach anatomically, investigators sought to determine whether EUS-RFA a method that uses a fine-needle catheter under the guidance of endoscopic ultrasound could provide localized thermal ablation without damaging surrounding organs or the remainder of the adrenal gland. The objective was to assess this adrenal-sparing strategy for safety and possible efficacy in lowering hormone overproduction and blood pressure levels.

This feasibility study enrolled 28 participants between February 2018 and February 2023 in three UK centers. Patients eligible were 18 years or older, diagnosed with primary aldosteronism according to Endocrine Society criteria, and had PET-CT or AVS-documented left-sided APAs. Molecular imaging was obtained twice—diagnosis once, and post-treatment to evaluate ablation once. With a 19G radiofrequency ablation catheter, all APAs were ablated in short bursts of 10–20 seconds under ultrasound guidance in real time. Safety, in the form of serious complications 24–48 hours following the intervention, was the main outcome. Secondary outcomes comprised decreased PET-CT uptake, improved aldosterone-to-renin ratios, and improvement in blood pressure after 6 months.

Results

• Of the 44 screened individuals, 28 were enrolled—21 men (75%) and seven women (25%), with a mean age of 57.7 years.

• Racial distribution included 16 White (57%), 11 Black (39%), and one Asian (4%) participant.

• A total of 35 ablations were performed, with seven patients requiring two sessions.

• All APA nodules seen on PET-CT were identified and treated. Critically, none of the serious adverse events listed prior to the procedure (e.g., hemorrhage, infarction, or organ perforation) were seen after the procedure, suggesting a high degree of procedural safety.

• By 3 months after treatment, localized decrease in radiotracer uptake in the treated adrenal nodules was observed.

• Biochemical cure or partial cure—defined by normalization or improvement in aldosterone-to-renin ratio—was observed in 21 of 28 subjects (75%, 95% CI 55–91).

• Clinically, 12 patients (43%, 95% CI 24–61) had complete or partial remission of hypertension.

• In four instances, the APA entirely resolved on imaging, and these patients had blood pressure less than 135/85 mmHg without any antihypertensive medication.

EUS-RFA was a safe, adrenal-sparing alternative to the conventional adrenalectomy for the treatment of left-sided aldosterone-producing adenomas. With a large majority of patients obtaining biochemical and clinical improvement and even some of them being fully cured this new technique can transform the treatment of primary aldosteronism.

Reference:

Argentesi, G., Wu, X., Ney, A., Goodchild, E., Laycock, K., Lee, Y.-N., Senanayake, R., MacFarlane, J., Ng, E., Kearney, J., O’Toole, S., Salsbury, J., Carroll, N., Gillett, D., Tadross, J. A., Marker, A., Godfrey, E. M., Goodchild, G., Bestwick, J. P., … FABULAS study group. (2025). Endoscopic, ultrasound-guided, radiofrequency ablation of aldosterone-producing adenomas (FABULAS): a UK, multicentre, prospective, proof-of-concept trial. Lancet, 405(10479), 637–647. https://doi.org/10.1016/S0140-6736(24)02755-7

“The submission provides evidence of TrenibotE’s differentiated clinical profile to offer patients an opportunity to experience a faster onset and shorter treatment duration as an introduction to a neurotoxin,” said Darin Messina, Ph.D., senior vice president, aesthetics R&D, AbbVie. “TrenibotE has the potential to transform the aesthetic toxin treatment landscape for new patients interested in the facial aesthetics category.”

“New patients wanting to experience the aesthetic benefits of a neurotoxin cite “fear of looking unnatural” as a barrier to initiating neurotoxin use for aesthetic indications. If approved, TrenibotE will be the first serotype E neurotoxin offering patients the opportunity to experience a neurotoxin with rapid clinical effect for a shorter duration of time as a trial before getting treatment with BOTOX Cosmetic,” the Cmpany stated in a recent releae.

The BLA submission is supported by data from over 2,100 patients treated with TrenibotE in the clinical program, which included two pivotal Phase 3 clinical studies evaluating TrenibotE for the treatment of moderate to severe glabellar lines (M21-500 and M21-508) and a Phase 3 open-label safety study (M21-509). All primary and secondary endpoints of the Phase 3 studies were met, with a rapid onset of action as early as 8 hours after drug administration (the earliest assessment time) and observed efficacy duration for 2-3 weeks. Treatment-emergent adverse events for TrenibotE were similar to placebo, both as a single treatment and up to three consecutive treatments. Topline data from the Phase 3 pivotal studies were previously shared.

“Concern about an unnatural outcome remains a significant barrier for many patients considering medical aesthetics treatment,” said Cheryl Burgess, MD, FAAD, lead clinical investigator for one of the Phase 3 studies. “Treatment with a product offering rapid onset of effect and short duration of action could help address this barrier and empower confidence for patients exploring their aesthetics treatment journey with innovation from the makers of BOTOX Cosmetic.”

As per the letters, the Undergraduate Medical Education Board (UGMEB) is requested to submit the additional information regarding cadavers/major and minor OTs in the annual declaration form for annual renewal by 28 April 2025.

The uploading of Annual Declaration details/data by respective medical colleges/institutions on the NMC Portal, as mandated under the NMC Act, 2019 and relevant regulations issued by the Commission from time to time.

To view the letter, click the link below

https://medicaldialogues.in/pdf_upload/nmc-to-close-submission-of-additional-information-in-annual-medical-declarations-facility-284356.pdf