Nevin Manimala

JAMA Netw Open. 2025 May 1;8(5):e2510781. doi: 10.1001/jamanetworkopen.2025.10781.

ABSTRACT

IMPORTANCE: The extent of mother’s milk provision by race and ethnicity and its change over time is poorly understood in the US preterm population.

OBJECTIVE: To examine US prevalence and trends over time of mother’s milk initiation and continuation at 12 weeks after birth (2009-2019) by maternal race and ethnicity and to examine associations of maternal race and ethnicity and mother’s milk initiation and continuation among mothers of preterm infants.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study used data from the nationally representative Pregnancy Risk Assessment Monitoring System database. Participants included mothers of preterm infants identifying as non-Hispanic Asian, non-Hispanic Black, Hispanic any race, or non-Hispanic White, with survey completion 12 or more weeks post partum from 2009 to 2019. Data were analyzed from February 2022 to June 2024.

EXPOSURE: Maternal race and ethnicity obtained from birth certificate data.

MAIN OUTCOMES AND MEASURES: Mother’s milk initiation and continuation at 12 weeks were assessed using survey questions. The overall prevalence and trends over time by maternal race and ethnicity were determined. Multivariable regression was used to analyze independent associations between maternal race and ethnicity and mother’s milk initiation and continuation.

RESULTS: Among 1 523 131 (weighted) mother-preterm infant dyads, mother’s milk initiation increased significantly from 2009 to 2019 for White and Black mothers but not for Asian or Hispanic mothers. Mother’s milk provision at 12 weeks increased significantly among all groups. There were significant differences in mother’s milk outcomes between groups. Initiation was highest for Asian mothers (92.8%; 95% CI, 91.1%-94.4%), followed by Hispanic (88.1%; 95% CI, 86.5%-89.8%), White (84.1%; 95% CI, 83.3%-84.9%), and Black (75.3%; 95% CI, 73.4%-76.6%) mothers. After adjusting for covariates of interest, compared with White mothers, initiation remained higher for Asian (adjusted relative risk [aRR], 1.09; 95% CI, 1.06-1.12) and Hispanic (aRR, 1.10; 95% CI, 1.08-1.12) mothers. Continuation at 12 weeks was highest for Asian mothers (65.4%; 95% CI, 62.7%-68.0%), followed by Hispanic (48.2%; 95% CI, 46.1%-50.3%), White (47.7%; 95% CI, 46.7%-48.7%), and Black (34.3%; 95% CI, 32.9%-35.7%) mothers. After adjustment, continuation was higher for Asian (aRR, 1.37; 95% CI, 1.24-1.47) and Hispanic (aRR, 1.33; 95% CI, 1.27-1.41) mothers compared with White mothers.

CONCLUSIONS AND RELEVANCE: In this cross-sectional study, mother’s milk provision among preterm infants increased from 2009 to 2019, but notable racial and ethnic disparities persist. Future work should address barriers to continued provision of mother’s milk for preterm infants.

PMID:40377941 | DOI:10.1001/jamanetworkopen.2025.10781

JAMA Netw Open. 2025 May 1;8(5):e2510790. doi: 10.1001/jamanetworkopen.2025.10790.

ABSTRACT

IMPORTANCE: Most of the 2.3 million annual neonatal deaths occur in sub-Saharan Africa and South Asia, with perinatal asphyxia and neonatal sepsis being the leading causes of neonatal mortality. Most neonatal deaths are considered preventable through high-quality clinical care, which includes adherence to clinical care guidelines.

OBJECTIVE: To assess adherence to World Health Organization clinical care guidelines for management of perinatal asphyxia and neonatal sepsis and to identify patient-level factors in adherence among neonates who died from these conditions.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study obtained data from December 2015 through October 2023 from the Child Health and Mortality Prevention Surveillance (CHAMPS) catchment areas in 7 low- and middle-income countries in sub-Saharan Africa (Ethiopia, Kenya, Mali, Mozambique, Sierra Leone, and South Africa) and South Asia (Bangladesh). Participants were neonates who were born alive and were aged 0 to 28 days at the time of death and had either perinatal asphyxia or neonatal sepsis.

EXPOSURE: Medical records of neonates who died from perinatal asphyxia or neonatal sepsis determined by postmortem diagnostics.

MAIN OUTCOMES AND MEASURES: The main outcome was the proportion of deceased neonates who received guideline-adherent treatments before they died. Mixed-effect multivariable logistic regression analyses were performed to identify factors associated with administration of at least bag-valve-mask (BVM) ventilation for perinatal asphyxia.

RESULTS: Of the 1194 neonates (median [IQR] age at the time of death, 2 [1-6] days; 692 males [58.0%]) who died and were enrolled in CHAMPS with available clinical data, 476 (39.9%) died from perinatal asphyxia, 562 (47.0%) died from neonatal sepsis, and 156 (13.1%) from both conditions. These neonates had a median (IQR) birth weight of 2130 (1266-2988) g. For cases with perinatal asphyxia, guideline adherence ranged from 12.2% (n = 77) for adrenaline administration to 85.4% (540) for supplemental oxygen administration. Only 4.4% of neonates (28) with perinatal asphyxia received all recommended treatments. Among cases with neonatal sepsis, antibiotics were administered to 86.8% (623), although the recommended treatment was administered to only 61.0% (438). In multivariable analyses, neonates in whom clinicians accurately identified perinatal asphyxia were more likely to receive BVM ventilation than those who had received discordant antemortem and postmortem diagnoses (adjusted odds ratio, 2.00; 95% CI, 1.29-3.12).

CONCLUSIONS AND RELEVANCE: In this cross-sectional study, clinical care guideline adherence was suboptimal among neonates who died from perinatal asphyxia or neonatal sepsis. This finding underscores the critical need to increase adherence in regions with high rates of neonatal mortality and may inform strategies for strengthening health systems to support compliance with clinical care guidelines.

PMID:40377940 | DOI:10.1001/jamanetworkopen.2025.10790

JAMA Netw Open. 2025 May 1;8(5):e2510799. doi: 10.1001/jamanetworkopen.2025.10799.

ABSTRACT

IMPORTANCE: Children are disproportionately exposed to sexual orientation-based discrimination and ethnic or racial discrimination due to intersections of sexual orientation, ethnicity, race, and assigned sex at birth. Yet, there is sparse evidence in clinical settings.

OBJECTIVE: To investigate how social strata of sexual orientation, ethnicity, race, and assigned sex at birth intersect and are associated with experiences of sexual orientation-based discrimination and ethnic or racial discrimination.

DESIGN, SETTING, AND PARTICIPANTS: This survey study included data retrieved from children enrolled in the Adolescent Brain Cognitive Development Study between 2016 and 2020. Children were recruited from 21 study sites across 17 states. Eligible participants were between ages 9 and 11 years at recruitment. Baseline data (2016-2018), first-year follow-up data (2017-2019), and second-year follow-up data (2018-2020) were included. Analyses were conducted between June and October 2024.

MAIN OUTCOMES AND MEASURES: Logistic regressions were conducted to test the association between children’s social strata indicated by intersections of sexual orientation, ethnicity, race, and assigned sex at birth and discrimination based on sexual orientation and ethnic or racial discrimination.

RESULTS: Among 9854 children (mean [SD] age at baseline, 9.5 [0.5] years; 4582 girls [46.5%]; 202 Asian [2.0%], 1488 Black [15.1%], 2030 Latinx [20.6%], 906 multiple races [9.2%], 4921 White [49.9%]), White sexual minority girls reported the highest percentage of sexual orientation-based discrimination (113 of 312 [36.2%]). Ethnically or racially minoritized boys reported the highest percentage of ethnic or racial discrimination (41 of 174 [23.7%]). After accounting for covariates, ethnically or racially minoritized sexual minority girls were less likely to report sexual orientation-based discrimination compared with ethnically or racially minoritized heterosexual boys (odds ratio [OR], 0.60; 95% CI, 0.43-0.85). Ethnically or racially minoritized sexual minority boys (OR, 3.17; 95% CI, 1.71-5.88) and girls (OR, 2.09; 95% CI, 1.47-2.97) were more likely to report ethnic or racial discrimination compared with ethnically or racially minoritized heterosexual boys. Moreover, ethnically or racially minoritized sexual minority boys (OR, 3.39; 95% CI, 1.81-6.34) and girls (OR, 2.24; 95% CI, 1.56-3.21) were more likely to report ethnic or racial discrimination compared with ethnically or racially minoritized heterosexual girls.

CONCLUSIONS: In this survey study investigating experience of sexual orientation-based discrimination alongside ethnic or racial discrimination during late childhood, findings highlighted that intersections of sexual orientation, ethnicity, race, and assigned sex at birth contributed to disproportionate exposures to sexual orientation-based discrimination and ethnic or racial discrimination among children. These findings provide valuable insight into intersectional experiences of discrimination among children.

PMID:40377939 | DOI:10.1001/jamanetworkopen.2025.10799

JAMA Netw Open. 2025 May 1;8(5):e2510933. doi: 10.1001/jamanetworkopen.2025.10933.

ABSTRACT

IMPORTANCE: A growing number of people with dementia are opting to live at home and receive care in the community rather than enter a nursing home. Adequately supporting their care at home can be challenging, and Medicare-funded home health care is one common source of care.

OBJECTIVE: To examine trends in the use of home-based care among traditional Medicare beneficiaries with dementia compared with those without dementia.

DESIGN, SETTING, AND PARTICIPANTS: A cross-sectional study of home health care use from January 1, 2010, to June 30, 2022, was conducted among 13 604 086 traditional Medicare beneficiaries aged 68 years or older who were receiving home health care during the study period. Statistical analysis took place from February 2024 to March 2025.

MAIN OUTCOMES AND MEASURES: Receipt of Medicare-funded home health care, as home health “spells” (the initial Medicare-certified home health episode and all subsequent recertifications were considered 1 home health spell for analysis).

RESULTS: Among the 13 604 086 traditional Medicare beneficiaries included in the study (mean [SD] age, 79.4 [7.7] years; 60.4% women), 27.7% had a diagnosis of dementia. Compared with beneficiaries using home health care without a diagnosis of dementia, those with a diagnosis of dementia were older (mean [SD] age, 82.2 [7.5] vs 78.4 [7.5] years), and a higher percentage were female (61.9% vs 59.9%) and dually eligible for Medicare and Medicaid (17.0% vs 11.1%). There were 30 549 666 new home health spells during the study. Individuals with dementia more commonly used community-initiated home health care than postacute care (53.8% vs 46.2%). Among individuals with a diagnosis of dementia, the initiation of home health spells increased between 2010 and 2019 by 16.8% (from 35.4 to 40.2 spells per 1000 beneficiaries) for community-initiated care and by 21.4% (from 28.9 to 35.1 spells per 1000 beneficiaries) for postacute care. Between 2020 and 2022, home health care use decreased among individuals with dementia; community-initiated spells decreased from 40.2 to 33.6 spells per 1000 beneficiaries, and postacute spells decreased from 35.1 to 28.5 spells per 1000 beneficiaries. In comparison, home health use among individuals without a diagnosis of dementia was relatively low and gradually decreased over the study period: between 2010 and 2019, home health spells decreased by 20.1% (from 8.9 to 7.1 spells per 1000 beneficiaries) for community-initiated care and by 20.7% (from 12.8 to 10.1 spells per 1000 beneficiaries) for postacute care. Home health spells were longer for people with dementia compared with people without dementia (community-initiated care: median, 47 days [IQR, 27-80 days] to 52 days [IQR, 29-89 days] vs 44 days [IQR, 25-76 days] to 50 days [IQR, 27-91 days]; postacute care: median, 40 days [IQR, 23-59 days] to 43 days [IQR, 25-59 days] vs 32 days [IQR, 19-56 days] to 34 days [IQR, 20-56 days]) and increased after 2020 (community-initiated care: median, 55 days [IQR, 33-111 days] vs 53 days [IQR, 27-98 days]; postacute care: median, 48 days [IQR, 27-59 days] vs 42 days [IQR, 24-58 days]).

CONCLUSIONS: This study suggests that home health use is high and has increased among people with dementia. Decreasing rates of home health use since 2020 in this high-need population suggest a need for ongoing monitoring of service use and outcomes for people with dementia.

PMID:40377938 | DOI:10.1001/jamanetworkopen.2025.10933

JAMA Netw Open. 2025 May 1;8(5):e2511009. doi: 10.1001/jamanetworkopen.2025.11009.

ABSTRACT

IMPORTANCE: Ocular point-of-care ultrasonography (POCUS) may be a clinically useful method to evaluate shunt dysfunction for children with hydrocephalus presenting to the emergency department (ED).

OBJECTIVE: To evaluate whether a change in the optic nerve sheath diameter (ONSD) from prior asymptomatic baseline was associated with shunt failure.

DESIGN, SETTING, AND PARTICIPANTS: Participants in this prospective single-center observational cohort study at a tertiary care children’s hospital were enrolled from January 5, 2018, to March 2, 2022. Children 18 years or younger with cerebrospinal fluid (CSF) shunts were consecutively recruited during routine asymptomatic visits in the outpatient neurosurgery clinic. The institution sees approximately 1000 children with shunts. Children with comorbid eye pathologic conditions known to increase the ONSD were excluded, as were those with shunt interventions between baseline and symptomatic ocular POCUS. Data analysis was completed in May 2024.

EXPOSURES: Baseline ocular POCUS was performed on asymptomatic children with CSF shunts recruited in the outpatient neurosurgery clinic; a second ocular POCUS was performed if the patient subsequently presented to the ED with symptoms of shunt failure. Change in ONSD from prior asymptomatic baseline to symptomatic presentation was the main study exposure.

MAIN OUTCOMES AND MEASURES: Shunt failure was defined as intraoperative confirmation of inadequate CSF flow through the shunt system associated with identifiable shunt complications, including catheter or valve obstruction, shunt tubing fracture or disconnection, or proximal catheter migration out of the ventricle within 96 hours from presentation to the ED.

RESULTS: Seventy-six pairs of baseline and symptomatic ultrasonograms from 58 patients (mean [SD] age, 6.6 [4.7] years; 36 of 58 boys [62%]) were included. Twenty patients (35%) had 2 or more prior shunt revisions, and 29 (50%) had communicating hydrocephalus. The primary outcome of intraoperatively confirmed shunt failure was observed in 14 of 76 ED patient presentations (18%). The mean (SD) change in ONSD among patients with shunt failure was 0.89 (0.66) mm vs 0.16 (0.40) mm among patients without shunt failure (mean difference, 0.73 mm [95% CI, 0.47-0.99 mm]; P < .001). The odds of full shunt failure were 1.4 times higher (95% CI, 1.21-1.78; P < .001) for every 0.1-mm increase in ONSD. The area under the receiver operating characteristic curve was 0.86, with an optimal cutoff of 0.4 mm or more, yielding a sensitivity of 0.93, specificity of 0.73, positive predictive value of 0.43, and negative predictive value of 0.98, for a disease prevalence of 15%, with a positive likelihood ratio of 3.39 and negative likelihood ratio of 0.10.

CONCLUSIONS AND RELEVANCE: In this single-center, prospective cohort study of symptomatic children with CSF shunts, a change in ONSD measured by ocular POCUS was associated with shunt failure. A change in ONSD from prior asymptomatic baseline to symptomatic presentation of less than 0.4 mm identified a population at low risk of true shunt failure. Further research is warranted to validate these findings, the presented change in ONSD threshold, and to risk stratify low-risk patients for cross-sectional neuroimaging.

PMID:40377937 | DOI:10.1001/jamanetworkopen.2025.11009

JAMA Netw Open. 2025 May 1;8(5):e2511063. doi: 10.1001/jamanetworkopen.2025.11063.

ABSTRACT

IMPORTANCE: Personal and professional development are integral to students’ professional identity formation.

OBJECTIVES: To examine the association between race, ethnicity, family income, and growing up in an underresourced neighborhood with perception of medical school support of professional and personal development.

DESIGN, SETTING, AND PARTICIPANTS: Retrospective cross-sectional study using deidentified data of medical graduates who completed the Association of American Medical Colleges Graduation Questionnaire in 2018 to 2022. Statistical analysis was performed from October 1 to November 1, 2024.

MAIN OUTCOMES AND MEASURES: Perception of medical school support of professional and personal development. Multivariate logistic regression models to assess the association of family income, race, ethnicity, and underresourced neighborhood status with perception of medical school support of professional and personal development during medical school, adjusting for students’ sex, age at graduation in quartiles, and clustered by school to account for school-to-school variability.

RESULTS: Among 66 898 respondents in the study cohort, 34 731 identified as female (51.9%), 14 100 as Asian (21.1%), 3594 as Black or African American (5.4%), 3419 as Hispanic (5.1%), and 38 483 as White (57.5%). The mean (SD) age of respondents was 27.5 (2.6) years and 10 088 were from households with incomes less than $50 000 a year (15.1%). Students from families with incomes in the lowest 2 quintiles were significantly less likely to report medical school support of professional and personal development than students from household incomes of more than $200 000 (less than $50 000: 69.5% vs 75.1%; relative risk [RR], 0.96; 95% CI, 0.94-0.98; $50 000-$74 999: 71.0% vs 75.1%; RR, 0.96; 95% CI, 0.94-0.98). Compared with White students, Asian students (aRR, 0.97; 95% CI, 0.96-0.98) and Black students (adjusted relative risk [aRR], 0.97; 95% CI, 0.95-0.99) were less likely to report medical school support of professional development, and Black students were less likely to report medical school support of personal development (aRR, 0.93; 95% CI, 0.89-0.97). Compared with their peers, students who reported growing up in an underresourced neighborhood were significantly less likely to report medical school support of professional and personal development. Intersectionality analysis of family income, race, ethnicity, and underresourced neighborhood status suggested that perception of medical school support of professional and personal development decreased with increasing number of minoritized identities, with students who were URIM, from a low-income family, and reported growing up in underresourced neighborhoods the least likely to report medical school support of professional and personal development.

CONCLUSION AND RELEVANCE: In this cross-sectional study of medical graduates, students who were URIM, low-income, and students who reported growing up in underresourced neighborhood were significantly less likely to report medical school support of professional and personal development. It is therefore critical for medical schools and accreditation bodies to evaluate current curriculum and practices to foster professional and personal development that are equitable for all students.

PMID:40377935 | DOI:10.1001/jamanetworkopen.2025.11063

JAMA Health Forum. 2025 May 2;6(5):e250756. doi: 10.1001/jamahealthforum.2025.0756.

ABSTRACT

IMPORTANCE: Advances in diabetes detection and treatment have mitigated the risks of serious complications and death, but little is known about whether economic outcomes for people with diabetes have similarly improved.

OBJECTIVE: To assess whether associations between diagnosed diabetes and labor market outcomes have changed over time.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study analyzed data from the National Health Interview Survey from 1998 to 2018. The sample was nationally representative of the US population aged 40 to 64 years. Average marginal effects, the regression-adjusted difference in probability of outcomes between people with and without diabetes, pooled by 3-year periods (1998-2000 to 2016-2018), were estimated with controls for demographics, education, and comorbid health risks. Behavioral Risk Factor Surveillance (BRFSS) data from 1993 to 2023 were included in robustness analyses. Data were analyzed from September 2023 to November 2024.

EXPOSURE: Diagnosed diabetes, defined based on respondents’ self-report that they have ever been diagnosed by a medical professional.

MAIN OUTCOMES AND MEASURES: The main outcomes were labor force participation and any Supplemental Security Income or Social Security Disability Insurance income receipt. Secondary outcomes included reporting health limitations for any activities, health limitations for work, any nights in hospital, and receiving health care 10 or more times in the past year.

RESULTS: The study included 249 712 individuals, 25 177 with diabetes. The weighted population was 50% female, 12% Hispanic, 11% non-Hispanic Black, 72% non-Hispanic White, and 5% multiracial or other race (Alaska Native or American Indian, Asian, or nonspecified). In the weighted population from 1998 to 2000, 46% of people with diabetes were 55 years and older, while 27% of people without diabetes were 55 years and older. In the weighted population from 2016 to 2018, 56% of people with diabetes were 55 years and older, while 38% of people without diabetes were 55 years and older. The average marginal effect of diabetes on probability of labor force participation was -10.9 percentage points (95% CI, -13.0 to -8.9) from 1998 to 2000 and -11.0 percentage points (95% CI, -13.0 to -9.1) from 2016 to 2018; for people who received Supplemental Security Income or Social Security Disability Insurance income, it was 4.4 percentage points (95% CI, 3.3-5.5) and 4.9 percentage points (95% CI, 3.7-6.0) from 1998 to 2000 and 2016 to 2018, respectively. During the same period, average marginal effects for all examined health outcomes significantly improved. Similar patterns were observed using BRFSS data, but with a slight improvement in labor force participation between 2017 to 2019 and 2021 to 2023.

CONCLUSIONS AND RELEVANCE: This cross-sectional study demonstrated that while people with diabetes experienced meaningful health improvements, they saw little progress in economic performance. Changing patient selection appears to play a role. Future research is needed to disentangle the paradox.

PMID:40377930 | DOI:10.1001/jamahealthforum.2025.0756

Gen Thorac Cardiovasc Surg. 2025 May 16. doi: 10.1007/s11748-025-02157-8. Online ahead of print.

ABSTRACT

PURPOSE: This study aimed to evaluate the effectiveness of a cadaver surgical training program at the Clinical Anatomy Laboratory Nagoya (CALNA), focusing on its impact on procedural skills, confidence, and anatomical understanding among young and mid-career thoracic surgeons.

METHODS: From 2016 to 2024, 13 cadaver surgical training sessions were conducted, divided into basic, advanced, and specialized courses. The program included hands-on practice using cadavers preserved with Thiel or hypertonic saline methods. The surveys were administered post-training to assess confidence, satisfaction, and practical applicability. Statistical analysis was performed on the survey results.

RESULTS: A total of 100 participants attended the training sessions (mean: 12.5/session). The survey responses indicated that 92% of participants rated the training content as “good” or “excellent,” and 88% found the training “applicable” or “highly applicable” to clinical practice. Reflective discussions following each session facilitated iterative program refinement. The key improvements included enhanced surgical instrument availability and optimized trainee-to-instructor ratios.

CONCLUSIONS: Our cadaver surgical training program was shown to significantly enhance surgical skills, boost confidence, and deepen thoracic anatomical understanding, demonstrating its value in advancing thoracic surgical education. Further development of standardized programs across institutions is needed to enable novice surgeons to acquire advanced skills efficiently.

PMID:40377896 | DOI:10.1007/s11748-025-02157-8

Environ Geochem Health. 2025 May 16;47(6):208. doi: 10.1007/s10653-025-02517-6.

ABSTRACT

Groundwater in Wadi Ranyah, the main water source for local communities, was analyzed using 77 samples to evaluate physicochemical properties, major ions, and heavy metal concentrations. While most parameters met World Health Organization (WHO) standards, levels of arsenic, lead, cadmium, chromium, and nickel exceeded permissible limits. Hydrochemical analyses were conducted using Piper and Durov diagrams, alongside health risk assessments based on statistical ratios established by the United States Environmental Protection Agency (US EPA). The analysis identified two dominant water types (SO₄·Cl-Ca·Mg and HCO₃-Ca·Mg), influenced by ion exchange, evaporite dissolution, and silicate weathering. Health risk assessment, based on US EPA models, revealed significant non-carcinogenic and carcinogenic risks, particularly for children. Oral ingestion accounted for the majority of exposure, with arsenic and lead being the most hazardous. Dermal exposure risks were comparatively lower. The identified health threats include potential dermatological, cardiovascular, and neurological effects, and an increased cancer risk. Based on these findings, groundwater in Wadi Ranyah is unsuitable for drinking without treatment. Mitigation strategies such as reverse osmosis, ion exchange filtration, and continuous monitoring are recommended to reduce heavy metal contamination and protect public health.

PMID:40377859 | DOI:10.1007/s10653-025-02517-6

Pain Ther. 2025 May 16. doi: 10.1007/s40122-025-00745-3. Online ahead of print.

ABSTRACT

INTRODUCTION: This study aims to evaluate the efficacy and safety of Crisugabalin in patients with diabetic peripheral neuropathic pain (DPNP), with a focus on its rapid onset of action.

METHODS: All the analyses in this study were based on data from a phase 2/3 adaptive randomized clinical trial that enrolled 596 patients. Participants were categorized into four treatment groups according to the intervention received: Crisugabalin 40 mg/day, Crisugabalin 80 mg/day, placebo, and Pregabalin 300 mg/day. The primary endpoint was the change in the average daily pain score (ADPS) over a 13-week treatment period. Secondary endpoints included changes in the Numeric Rating Scale (NRS) and the daily sleep interference score (DSIS) during the first two weeks of treatment.

RESULTS: Both Crisugabalin treatment groups (40 mg/day and 80 mg/day) demonstrated statistically significant reductions in ADPS compared to the placebo group starting from week 1 and continuing through week 13 (P < 0.05). Significant differences in pain relief for the Pregabalin group were observed only from week 6. Improvements in NRS and DSIS scores were also noted in both Crisugabalin groups, with statistically significant enhancements evident as early as day 2 of administration. Safety assessments indicated that Crisugabalin was well-tolerated, with a low incidence of serious adverse events and no significant increase in dropout rates among participants.

CONCLUSION: The findings suggest that Crisugabalin offers effective pain relief with an acceptable safety profile, highlighting its rapid onset in patients with DPNP.

CLINICAL TRIAL REGISTRATION: Clinical trial registration number derived from our parent project, we have retained the original registration identifier: NCT04647773.

PMID:40377855 | DOI:10.1007/s40122-025-00745-3