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Response to Kim et al "Legislative Efforts to Expand Insurance Coverage of Wigs for Individuals with Medical Causes of Alopecia." [Letter]

Sadeghian, Sabrina; Gupta, Radhika; Shapiro, Jerry; Lacouture, Mario; Tattersall, Ian W; Lo Sicco, Kristen I
PMID: 41391632
ISSN: 1097-6787
CID: 5978972

Seven-year Safety and Efficacy of Somapacitan in Children With GH Deficiency: Final Results From REAL 3

Sävendahl, Lars; Battelino, Tadej; Højby, Michael; Leunbach, Tina; Saenger, Paul; Silverman, Lawrence; Horikawa, Reiko
BACKGROUND/UNASSIGNED:Somapacitan is a once-weekly GH treatment that has shown efficacy and safety profiles equivalent to daily GH in children with GH deficiency (GHD). OBJECTIVE/UNASSIGNED:To investigate long-term safety, efficacy, and treatment burden associated with somapacitan after 7 years (364 weeks) of treatment. METHODS/UNASSIGNED:REAL 3 (NCT02616562) was a phase 2, randomized, open-label trial investigating the efficacy and safety of somapacitan vs daily GH in children with GHD. After 156 weeks, participants entered a 208-week safety extension. Children in cohort I (age 2.5-10.0 years) previously completed 3 years in the trial; cohort II (age <2.5 years) and cohort III (age 9.0-17.0 years) entered the trial at week 156 for safety-only assessment. All participants received somapacitan 0.16 mg/kg/week. Height velocity (HV), HV SD score (SDS), height SDS, IGF-I SDS, incidence of adverse events (AEs), and treatment burden were assessed. RESULTS/UNASSIGNED:Overall, 43 participants (73%) in cohort I, 1 participant (100%) in cohort II, and 11 participants (69%) in cohort III completed the 208-week safety extension. Consistent increments in HV and HV SDS were seen in cohort I, and height SDSs at week 364 were close to 0. The incidence of AEs was aligned with previous investigations across all cohorts; 3 serious AEs in cohort I were considered probably/possibly related to treatment. Treatment burden was reduced in children who switched from daily GH to somapacitan. CONCLUSION/UNASSIGNED:After 7 years of treatment, children with GHD receiving somapacitan experienced consistent increases in height SDS and reduced treatment burden. No new safety concerns were identified.
PMCID:12699150
PMID: 41394116
ISSN: 2472-1972
CID: 5979012

A Target Trial Emulation Study of SGLT2 Inhibitors, GLP-1 Receptor Agonists, and Combination Therapy in Preventing Kidney Failure in Type 2 Diabetes

Blum, Matthew F; Mehta, Sneha; Surapaneni, Aditya; Carrero, Juan J; Zhang, Donglan; Inker, Lesley; Horwitz, Leora I; Blecker, Saul; Shin, Jung-Im; Grams, Morgan E
PMID: 41400456
ISSN: 1555-905x
CID: 5979212

Overscreening of patients on glucagon-like peptide-1 receptor agonists: A second "epidemic" of thyroid cancer overdiagnosis?

Raghunathan, Rajam; Jacobs, Anna; Gajic, Zoran; Castiglioni, Sofia; Dawood, Nardeen; Arthurs, Likolani; Ranjbar, Suedeh; Rothberger, Gary D; Seib, Carolyn D; Prescott, Jason; Allendorf, John; Liou, Rachel; Suh, Insoo; Patel, Kepal N
BACKGROUND:Guidelines do not recommend routine screening for thyroid nodules when starting a glucagon-like peptide-1 receptor agonist. Patients, however, increasingly present with incidental nodules from imaging ordered at glucagon-like peptide-1 receptor agonist initiation. METHODS:This retrospective case-control study examined patients in a single academic health system from 1 January 2019 to 31 December, 2024 who underwent thyroid ultrasound, fine-needle aspiration biopsy, molecular testing, and/or surgery with glucagon-like peptide-1 receptor agonist initiation compared with patients not prescribed a glucagon-like peptide-1 receptor agonist. Patient, prescription, and intervention data were collected. Chart review was also performed for a subset of patients. RESULTS:From 2019 to 2024, 2,523 patients prescribed a glucagon-like peptide-1 receptor agonist underwent thyroid ultrasound; from 2020 to 2023, there was a higher growth rate of ultrasound scans ordered for them. A random sample of 415 patients prescribed a glucagon-like peptide-1 receptor agonist showed that most ultrasounds were ordered for "thyroid nodules" by the endocrinologist who prescribed glucagon-like peptide-1 receptor agonist. In this subset, 757 nodules were detected on ultrasound; 10.6% (80/757) had fine-needle aspiration biopsy. Cytology showed 3.8% were Bethesda I (3/80), 72.5% Bethesda II (58/80), 15% Bethesda III (12/80), 0% Bethesda IV (0/80), 2.5% Bethesda V (2/80), and 6.6% Bethesda VI (5/80). Of 15 indeterminate nodules, 11 had molecular testing: 5 were positive or suspicious, including fusions, alterations, RAS and BRAF mutations. Sixteen patients had thyroid surgery after glucagon-like peptide-1 receptor agonist initiation (8 total thyroidectomies, 8 hemithyroidectomies, 1 completion). Final pathology demonstrated 6 benign, 10 malignant, 1 NIFTP. The rate of malignancy in the subset was 2.4% (10/415). CONCLUSION/CONCLUSIONS:The malignancy rate in patients prescribed a glucagon-like peptide-1 receptor agonist remains low, but ultrasound screening rates increased for a period. Strong clinical suspicion should govern screening.
PMID: 41371825
ISSN: 1532-7361
CID: 5977492

Bariatric surgery vs. GLP-1 receptor agonists among primarily medicare and medicaid patients with diabetes: a 3-year analysis

Brown, Avery; Patel, Suhani S; Li, Elizabeth; Vu, Alexander Hien; Somoza, Eduardo; Chen, Jialin; Zhang, Donglan; Massie, Allan B; Orandi, Babak J; Segev, Dorry; Parikh, Manish; Chhabra, Karan
BACKGROUND:Bariatric surgery has long been established as an effective treatment option for obesity and diabetes [Kalainov et al. in J Am Acad Orthop Surg [32(10):427-438, 2025] and Ogden et al. in JAMA 311(8):806-806, 2025. 10.1001/jama.2014.732]. Recently, GLP-1 Receptor Agonists' (GLP-1RAs) use has expanded as an alternative therapy for weight loss and diabetes management. While GLP1RAs are known to be safe and effective, few have compared long term outcomes of GLP-1RAs versus the "gold standard" of bariatric surgery among Medicare/Medicaid patients, who make up the largest payer group in the U.S. [Kalainov et al. in J Am Acad Orthop Surg [32(10):427-438, 2025]. METHODS:This was a retrospective, multicenter study of obese, type-2 diabetic patients (T2D) ≥ 18 years old, who initiated weekly injectable semaglutide or tirzepatide or underwent bariatric surgery between January 1st, 2018 to July 31st, 2024. Patients with a baseline BMI ≤ 35, those with prior GLP1-RA use, or any prior bariatric procedure were excluded from analysis. The primary outcome of interest was % total body weight loss 3 months to 3 years post intervention among bariatrics surgery patients vs. GLP1-RA patients (any GLP1-RA prescription and 12 months continuous GLP1-RA prescription). RESULTS:7667 patients were included for analysis (7200 GLP1-RA, 467 bariatric surgery). Bariatric surgery patients were younger (median (IQR): 43 (34, 53) vs. 65 (54, 72); p < 0.001) and more likely to be female (67.5% vs. 60.8%; p < 0.01) and Hispanic (58.7% vs. 19.4%; p < 0.001) while GLP1-RA users were more likely to be white (58.5% vs. 10.7%; p < 0.001). In models adjusting for demographic and clinical characteristics, bariatric surgery was associated with a 22.9% total weight loss 3 years following surgery compared to 2.3% for patients with any GLP1-RA use, and 15.9% vs 2.4% for patients with 12 months consecutive GLP1-RA use (22.9 [21.0-24.8] vs 2.3 [0.5-4.1], 15.9 [6.9-24.9] vs. 2.4 [6.7-11.5]. CONCLUSIONS:Among obese, T2D, publicly insured patients, bariatric surgery was associated with greater weight loss than GLP1-RAs at all measured periods from 3 months to 3 years post op.
PMID: 41326727
ISSN: 1432-2218
CID: 5974752

A review of NRC medical event reports related to brachytherapy, 2005-2024

Sillanpaa, Jussi; Santoro, Joseph
METHODS:We analyzed the Nuclear Regulatory Commission event notifications related to brachytherapy events that occurred between January 1, 2005, and December 31, 2024. The events were categorized and their distribution and time evolution analyzed. RESULTS:A total of 818 events (227 LDR, 203 HDR, 21 intravascular, 367 microsphere) were identified, excluding events that related purely to shipping. We analyzed the events for the whole period and in consecutive 5-year intervals. The total number of events rose by 27% from the first to the last interval (2005-09:179, 2020-24:227), with the LDR events decreasing by 81% (2005-2009:98, 2020-24: 19) and microsphere events increasing by 588% (2005-09:25, 2020-24:172). HDR events decreased by 15% (2005-09:53, 2020-24:45), while intravascular events increased (2005-09:3, 2020-2024:7) but stayed very rare. . For HDR, the three most frequent categories were treatment planning error (26%), transfer tube issues (13%) and other/unknown issues (13%); the frequency of treatment planning events decreased with time (2005-09: 38%, 2020-24: 18%). For LDR, the three most frequent categories were lost or leaking source (39%), other/unknown issues (24%) and permanent implant sources implanted into wrong tissue (18%). For microspheres, most events were related to the sphere remaining in the delivery apparatus and for intravascular brachytherapy, to the source not retracting. The radioisotopes of LDR events were I-125 (72%), Pd-103 (11%), Cs-137 (8%), Ir-192 (4%), Cs-131 (3%) and Sr-90 (2%); no events relating to Ir-192 or Cs-137 occurred in 2020-24. CONCLUSION/CONCLUSIONS:The reduction in the LDR events is probably explained by the decreased frequency of prostate implants and LDR gynecological procedures. Microspheres now account for most event reports.
PMID: 41242923
ISSN: 1873-1449
CID: 5975542

CRISPR-Cas-associated SCCmec variants in methicillin-resistant Staphylococcus aureus evade rapid diagnostic detection

Podkowik, Magdalena; Tillman, Alice; Takats, Courtney; Carion, Heloise; Putzel, Gregory; McWilliams, Julian; See, Benjamin; Wang, Guiqing; Munoz-Gomez, Sigridh; Otto, Caitlin; Drlica, Karl; Marraffini, Luciano; Pironti, Alejandro; Hochman, Sarah; Kerantzas, Christopher; Shopsin, Bo
Rapid molecular assays guiding treatment of methicillin-resistant Staphylococcus aureus (MRSA) detect SCCmec (Xpert) or the SCCmec-orfX junction (BCID2). Sequence variation in this region can disrupt primer binding, yielding false-negative results. Investigation of a missed bloodstream infection linked escape to a CRISPR-Cas-associated SCCmec variant, leading to identification of 64 variants from 45 patients-2% of 2,432 screened. Misdiagnosis was restricted to clonal complex 5, a hospital-associated lineage; 11 of 40 SCCmec/junctions evaded detection by BCID2 or Xpert. Variants had mecA instability and circulated in healthcare settings. Our findings reveal a unique escape mechanism and underscore a threat to diagnostic accuracy.
PMID: 41254867
ISSN: 1537-6613
CID: 5975822

Value Bias and Ethnocentrism and its Effect on Advance Care Planning: Mind the Gap [Editorial]

Berger, Jeffrey T; Miller, Dana Ribeiro
After decades of efforts by academic and professional organizations and by governmental agencies to promote advance care planning, less than half of adults in the USA have formally executed advance directives. For patients who have completed these documents, studies find limited impact on end-of-life care. In this paper, we discussed ways in which bias towards certain values in the health care enterprise including ethnocentrism, the centering of one set of cultural norms, may contribute to the public's ambivalence and the relative inefficacy of advance directives. We offer a more expansive perspective on this aspect of clinical care with the goal of serving all patients more effectively.
PMID: 41249655
ISSN: 1525-1497
CID: 5975682

No serum estradiol changes with 5-alpha reductase inhibitors for late alopecia in cancer survivors: a retrospective cohort study

Ong, Michael M; Mittal, Lavanya; Lacouture, Mario; Dusza, Stephen; Gordon, Allison; Bromberg, Jacqueline F; Goldfarb, Shari B; Iyengar, Neil M; Long Roche, Kara; Markova, Alina
PMID: 41314426
ISSN: 1097-6787
CID: 5968842

Infected products of conception in obstructed hemivagina after medical management of early pregnancy loss: A case report [Case Report]

Dinelli, John; Espino, Kevin; Casey, Frances
Obstructed hemivagina and ipsilateral renal anomaly is a Mullerian anomaly with variable presentations. A patient with this syndrome had a superinfected fluid collection in an obstructed hemivagina after mifepristone and misoprostol administration for an embryonic demise, identifying a potential complication in this population.
PMID: 40998078
ISSN: 1879-0518
CID: 5967652