US Patients Research Articles

Utilization of Telemedicine for Patients Receiving In-center Hemodialysis in the United States

Background: In March 2020, responding to the COVID-19 pandemic, federal emergency waivers in the United States enabled kidney care providers (nephrologists and advanced practice providers) to substitute face-to-face in-center hemodialysis visits with telemedicine encounters. We examined whether the frequency of kidney care provider visits and hospitalizations were associated with telemedicine use in hemodialysis care. Methods: We used Medicare claims to identify US patients receiving in-center hemodialysis during the first 16 months of the COVID-19 pandemic. We examined the association between telemedicine use during in-center hemodialysis, the frequency with which kidney care providers visited patients at dialysis four-or-more times per month, and hospitalizations. We also examined whether the association between telemedicine use and visit frequency varied at facilities located in more remote areas. Multivariable regression models adjusted for patient, physician, geographic and dialysis facility characteristics along with the frequency with which kidney care providers saw patients at each facility before the pandemic. We focused on kidney care providers who demonstrated knowledge of how to bill for telemedicine visits by using the telemedicine modifier on prior claims Results: We identified 1,881 providers who saw patients between 3/2020-6/2021 and were definitively using telemedicine. In the adjusted model, a 35% absolute higher use of telemedicine at a facility (representing one standard deviation difference) was associated with a 1.4% higher rate of four-or-more visits (Incidence Rate Ratio (IRR) 1.014; 95% Confidence Interval 1.007-1.022). The association between telemedicine use and visit frequency was stronger where travel distances to facilities were farther (interaction p=0.01). There was no significant association between telemedicine use and hospitalizations. Conclusions: The use of telemedicine to care for patients receiving in-center hemodialysis was associated with a slightly higher frequency of four-or-more visits per month but not with hospitalizations; the association with visit frequency was more pronounced in areas where providers had to travel longer distances to see patients in-person.

Defining and Measuring Financial Toxicity in Low- and Middle-Income Countries.

Financial toxicity (FT) of cancer treatment likely affects more patients in low- and middle-income countries (LMICs); however, most of the research on FT comes from high-income countries, which may not apply to LMICs. The causes and consequences of FT in patients with cancer in LMICs remain understudied. Following PRISMA guidelines, we searched MEDLINE, Web of Science, and CINAHL for FT literature in cancer originating from LMICs from inception until the end of 2023, and documented the different definitions used to define FT in LMICs, and the magnitude of FT documented using those definitions. LMIC was defined using the World Bank Country and Lending Group classification. Sixty-eight studies met the inclusion criteria. Studies on FT in cancer originating from LMICs have increased in recent years (>75% studies published 2020 onward) and used varying criteria to define FT, broadly categorized into five themes. Majority of the studies defined FT in terms of catastrophic health expenditure (45%) or household impoverishment (10%), while 26% of the studies used the Comprehensive Score for Financial Toxicity tool, developed and validated in US patients, to measure FT in LMIC settings. Twenty-six percent of the studies defined FT in terms of coping mechanisms and 10% in terms of subjective financial burden. The magnitude of FT in patients with cancer was substantial irrespective of the definitions used. This review synthesizes the different definitions of FT for LMICs that have been used in the literature so far. We conclude that the definitions that capture the coping mechanisms or hardships might reflect the magnitude of FT better than absolute dollar values or relative percentages of expenditures. Future studies can use our results to devise locally tailored definitions of FT.

Comparative Effectiveness of Fluticasone Furoate/Umeclidinium/Vilanterol and Budesonide/Glycopyrrolate/Formoterol Fumarate among US Patients with Chronic Obstructive Pulmonary Disease.

Chronic obstructive pulmonary disease (COPD) is associated with exacerbations which can reduce quality of life and increase mortality. Single-inhaler triple therapy (SITT) is recommended for maintenance treatment of COPD among patients experiencing exacerbations despite dual-therapy use. This real-world comparative effectiveness study compared the impact of SITTs, fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI), and budesonide/glycopyrrolate/formoterol fumarate (BUD/GLY/FORM), on COPD exacerbations and mortality. Medicare Fee-for-Service (FFS) patients with COPD initiated on FF/UMEC/VI or BUD/GLY/FORM were identified from the Komodo Research healthcare claims dataset (01/01/2016-12/31/2023). Overlap weighting based on high-dimensional propensity scores evaluated from patient characteristics was used to adjust for baseline confounding. Primary outcome was annualized rate of moderate-severe COPD exacerbations (per patient-year; PPY) compared using rate ratios (RRs) with 95% confidence intervals (CIs) from weighted Poisson regression models. Secondary and exploratory outcomes were risk of moderate-severe COPD exacerbations and all-cause mortality, respectively, evaluated using Kaplan-Meier analysis and hazard ratios (HR) with 95% CIs from Cox proportional hazard models. A secondary analysis was conducted among a mutually exclusive population with Medicare Advantage, Medicaid, or commercial insurance. Overall, 32,312 FF/UMEC/VI and 12,230 BUD/GLY/FORM Medicare FFS patients were included. After weighting, median follow-up was 9months. Compared with BUD/GLY/FORM, FF/UMEC/VI users had a 12% lower rate of annualized moderate-severe COPD exacerbations [0.80 and 0.91 PPY; RR (95% CI): 0.88 (0.85-0.92); P<0.001] and a 10% lower risk of moderate-severe exacerbations at 12months post-initiation [HR (95% CI): 0.90 (0.87-0.93); P<0.001], driven by moderate exacerbations. FF/UMEC/VI compared with BUD/GLY/FORM users had 11% lower risk of all-cause mortality at 12months post-initiation [5.6% vs. 6.4%; HR (95% CI): 0.89 (0.80-0.98); P=0.020]. Results were consistent among patients with Medicare Advantage, Medicaid, or commercial insurance. In this real-world comparative effectiveness study, FF/UMEC/VI was associated with significantly lower rate and risk of COPD exacerbations than BUD/GLY/FORM.

Lisocabtagene Maraleucel for Relapsed/Refractory Large B-Cell Lymphoma: A Cell Therapy Consortium Real-World Analysis.

Lisocabtagene maraleucel (liso-cel) is an autologous CD19-directed CAR T cell therapy approved for the treatment of relapsed/refractory large B-cell lymphoma (LBCL). We present a multicenter retrospective study evaluating safety, efficacy, and resource utilization of liso-cel in the standard-of-care setting. Patients received commercial liso-cel at 7 US medical centers and patient selection, toxicity management, and disease assessment followed institutional practices. Among 101 infused patients, the median age was 71 years (35% ≥75 years), 68% had a Charlson Comorbidity score ≥3, and 10% had secondary CNS involvement. Median number of prior therapies was 3, and due to comorbidities, 33% would have been ineligible for the TRANSCEND study. Bridging therapy was used in 60% (43% received polatuzumab-based treatment). Any Grade CRS occurred in 49% (3% Grade ≥3) with any Grade ICANS in 26% (10% Grade ≥3). The overall response rate (ORR) to bridging therapy was 45% with 18% achieving a complete response (CR). Following liso-cel infusion, the day 90 ORR was 66% (60% CR), and with a median follow-up of 15.5 months, 12-month progression-free survival (PFS) and overall survival were 55% and 68%, respectively. A normal lactate dehydrogenase pre-lymphodepletion was associated with improved PFS and OS. These analyses confirm similar efficacy and safety of commercial liso-cel compared to pivotal trial results. Notably, these outcomes were achieved in patients predominantly of advanced age and with significant comorbidities. Results also likely reflect advancements in patient selection, toxicity management, and the use of novel bridging strategies.

Medicare Enrollment and Spending Among Patients Initiating Dialysis After the Affordable Care Act

Medicare finances health care for most US patients with end-stage kidney disease (ESKD), regardless of age. Medicare enrollment may have slowed for patients with incident ESKD who gained access to new private insurance options with the 2014 passage of the Affordable Care Act (ACA) and introduction of the ACA Marketplace. To describe trends in public and private insurance coverage and dialysis spending among patients with incident ESKD from 2012 to 2017. This serial cross-sectional study included patients 18 to 64 years old in Colorado who were not enrolled in Medicare at dialysis initiation. Data analysis was conducted from May to August 2023. Introduction of the ACA Marketplace in 2014. Medicare, Medicaid, or private insurance enrollment in the first year after dialysis initiation, and dialysis spending by insurance type. Of 2005 patients included in the sample, 1416 (70.6%) were 45 to 64 years old, and 1259 (62.8%) were male. A lower proportion of patients with incident ESKD starting dialysis were newly enrolled in Medicare in the years following the ACA (361 of 713 [50.6%]) compared to 2 years prior (420 of 595 [70.6%]). Unadjusted rates of switching from Medicaid to Medicare 1 year after dialysis initiation decreased 14.3 percentage points over time (68.9% in 2012-2013 vs 58.3% and 54.6% in 2014-2015 and 2016-2017, respectively). Unadjusted rates of switching from private insurance to Medicare 1 year after dialysis initiation decreased by 22.3 percentage points (68.1% in 2012-2013 vs 52.2% and 45.8% in 2014-2015 and 2016-2017, respectively). Over the entire 2012 to 2017 period, quarterly dialysis spending in the first year of dialysis among patients with private insurance was higher than among those with Medicare coverage ($26 351-$29 781 vs $10 039-$12 741). This cross-sectional study demonstrates that lower Medicare enrollment rates over time among those initiating dialysis may be inducing higher social spending. This finding raises concerns about the effectiveness of Medicare policies and federal leverage to improve access, outcomes, and value of dialysis care.

Real-world impact of the platinum chemotherapy shortage on US patients with advanced cancer.

The recent cisplatin and carboplatin ("platinum") chemotherapy shortage, first announced on February 10, 2023, has impacted cancer patients nationwide. Here, we quantify the extent to which the shortage affected platinum chemotherapy prescribing and short-term mortality. This cohort study included 11 797 adults with advanced solid cancers who initiated first-line therapy during the 1-year period before (February 1, 2022-February 9, 2023) or during (February 10, 2023-January 31, 2024) the platinum shortage. During the shortage, there was a 2.7% absolute reduction in platinum use (95% CI = -4.4% to -0.9%) compared to the previous year. At the peak of the shortage, there was a 15.1% absolute reduction in platinum prescribing (June 2023: 57.8% [95% CI = 53.6% to 62.0%]) compared to 1 year prior (June 2022: 72.9% [95% CI = 70.7% to 75.2%]). There was no difference in mortality before vs during the shortage (adjusted hazard ratio 1.00; 95% CI = 0.94 to 1.07) with median follow-up time of 7.6 months. Further research is required to study shortage impacts on long-term mortality.

S19 Real-World Efficacy and Safety of Ozanimod in US Patients With Moderately to Severely Active Ulcerative Colitis: Initial Results from POLARIS, an Ongoing Phase 4 Open-Label Study

S19 Real-World Efficacy and Safety of Ozanimod in US Patients With Moderately to Severely Active Ulcerative Colitis: Initial Results from POLARIS, an Ongoing Phase 4 Open-Label Study

Real-world survival and economic burden among patients with locally advanced or metastatic urothelial carcinoma in the United States

Given the changing treatment landscape for locally advanced or metastatic urothelial carcinoma (la/mUC), this study aimed to describe real-world treatments, overall survival (OS), health care resource utilization (HCRU), and costs among US patients with la/mUC receiving first-line therapy. This retrospective study was conducted using 100% Medicare claims data (2015-2020). Patients with la/mUC were selected; initiation of first-line therapy was the index date. Treatments and OS were assessed during follow-up (index date to the earliest of end of data availability, health plan coverage, or death). All-cause HCRU and costs (2021 USD) were assessed during the first-line treatment period (index date to the earliest of first-line discontinuation, switch to second-line therapy, end of follow-up, or death). Outpatient pharmacy costs were not included. All-cause OS from start of first-line therapy was estimated using the Kaplan-Meier approach. The HCRU, cost, and OS analyses were stratified by 3 index treatment groups-platinum-based chemotherapy, non-platinum-based chemotherapy, and programmed cell death protein 1/ligand 1 (PD-1/L1) inhibitor monotherapy-and adjusted for baseline characteristics. Of 9,939 patients included, 77.1% were men and mean age was 76 years. In total, 5,050 (50.8%) received platinum-based chemotherapy, 1,361 (13.7%) received non-platinum-based chemotherapy, and 3,242 (32.6%) received PD-1/L1 inhibitor monotherapy for first-line la/mUC. Median OS was 12.9, 12.9 (P = 0.960), and 9.0 months (P < 0.001) with platinum-based chemotherapy (reference), non-platinum-based chemotherapy, and PD-1/L1 inhibitor monotherapy, respectively. Most (> 99%) patients had ≥ 1 outpatient visit during the treatment period; mean number of visits per patient was 13.1 with platinum-based chemotherapy, 10.5 with non-platinum-based chemotherapy, and 18.3 with PD-1/L1 inhibitor monotherapy. In general, HCRU was significantly lower for patients receiving PD-1/L1 inhibitor monotherapy versus platinum-based chemotherapy. However, costs were significantly higher with PD-1/L1 inhibitor monotherapy versus platinum-based chemotherapy. Mean total monthly cost per patient was $10,285 for platinum-based chemotherapy, $8,982 for non-platinum-based chemotherapy, and $18,147 for PD-1/L1 inhibitor monotherapy. From 2015 to 2020, patients with la/mUC had substantial HCRU and costs and short survival, regardless of first-line treatment. More effective therapies were needed to prolong survival and reduce the economic burden of la/mUC.

Evaluating transportability of overall survival estimates from US to UK populations receiving first-line treatment for advanced non-small cell lung cancer: a retrospective cohort study

ObjectivesThe objective of this study is to explore how the UK versus the USA compare in patient characteristics, treatment patterns and overall survival (OS) of patients with advanced non-small cell...

Regulatory landscape with U.S. patient requirements and Clinical Trial Diversity expectations

The Food and Drug Administration (FDA) has an expectation that products filed for marketing authorization have to include data that are representative of the US patient population. Any foreign clinical data that is submitted has to represent an ethnically diverse population that is generated utilizing qualified Principal Investigators (PIs) and conducted according to Good Clinical Practices (GCP) requirements outlined in 21 CFR 312.120, Foreign clinical studies not conducted under an IND. With the recent passing of the Omnibus Legislation, FDA now also has the authority to require Diversity Plans for all Phase 3 clinical trials of new drugs or “as appropriate, another pivotal study of a new drug.” The FDA has released a guidance document, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials” (April 2022), for the industry with expectations to update the document in 2023 now that legislation is passed. This whitepaper discusses the FDA guidance and expectations of sponsors with regards to foreign clinical data and the intersection with enrolling ethnically diverse populations in clinical studies.

Serum protein risk stratification score for diagnostic evaluation of metabolic dysfunction–associated steatohepatitis

Background: Reliable, noninvasive tools to diagnose at-risk metabolic dysfunction–associated steatohepatitis (MASH) are urgently needed to improve management. We developed a risk stratification score incorporating proteomics-derived serum markers with clinical variables to identify high-risk patients with MASH (NAFLD activity score &gt;4 and fibrosis score &gt;2). Methods: In this 3-phase proteomic study of biopsy-proven metabolic dysfunction–associated steatotic fatty liver disease, we first developed a multi-protein predictor for discriminating NAFLD activity score &gt;4 based on SOMAscan proteomics quantifying 1305 serum proteins from 57 US patients. Four key predictor proteins were verified by ELISA in the expanded US cohort (N = 168) and enhanced by adding clinical variables to create the 9-feature MASH Dx score, which predicted MASH and also high-risk MASH (F2+). The MASH Dx score was validated in 2 independent, external cohorts from Germany (N = 139) and Brazil (N = 177). Results: The discovery phase identified a 6-protein classifier that achieved an AUC of 0.93 for identifying MASH. Significant elevation of 4 proteins (THBS2, GDF15, SELE, and IGFBP7) was verified by ELISA in the expanded discovery and independently in the 2 external cohorts. MASH Dx score incorporated these proteins with established MASH risk factors (age, body mass index, ALT, diabetes, and hypertension) to achieve good discrimination between MASH and metabolic dysfunction–associated steatotic fatty liver disease without MASH (AUC: 0.87—discovery; 0.83—pooled external validation cohorts), with similar performance when evaluating high-risk MASH F2-4 (vs. MASH F0-1 and metabolic dysfunction–associated steatotic fatty liver disease without MASH). Conclusions: The MASH Dx score offers the first reliable noninvasive approach combining novel, biologically plausible ELISA-based fibrosis markers and clinical parameters to detect high-risk MASH in patient cohorts from the United States, Brazil, and Europe.

Brodalumab: Six-Year US Pharmacovigilance Report.

Brodalumab is a human interleukin-17 receptorA antagonist indicated for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies. In the USA, brodalumab has a boxed warning regarding suicidal ideation and behavior and is only available under a Risk Evaluation and Mitigation Strategy, but no causal association has been established. To assess long-term safety of brodalumab, we summarize pharmacovigilance data from 6years of real-world clinical practice. Crude adverse event (AE) reporting rates per 100 patients were calculated for common AEs and AEs of special interest reported to Ortho Dermatologics by US patients and healthcare providers from August 15, 2017 through August 14, 2023. Brodalumab exposure was estimated as time from the first to last prescription-dispensing authorization dates. Adverse events were defined by Medical Dictionary for Regulatory Activities v26.0 Preferred Terms and standardized MedDRA queries. Data were collected from 5138 US patients (estimated exposure of 6900 patient-years). Over 6years, 13 cases of adjudicated major adverse cardiovascular events were reported (0.25 events/100 patients). The rate of serious infections was 2.20 events/100 patients. Since the 5-year report, there was one new case of Candida infection and a serious fungal infection of the elbow. Among 57 reported malignancies affecting 49 patients, 4 were deemed possibly related to brodalumab. One new case of indeterminate inflammatory bowel disease unrelated to brodalumab was reported. No new suicide attempts were reported in year6, and there were no completed suicides throughout 6years. Pharmacovigilance data throughout 6years are consistent with the safety profile of brodalumab established in clinical trials and previous US pharmacovigilance reports, with no completed suicides and a low fungal infection rate.

Use of Biologic or Targeted Synthetic Disease-Modifying Antirheumatic Drugs and Cancer Risk

The Oral Rheumatoid Arthritis Trial Surveillance demonstrated an increased cancer risk among patients with rheumatoid arthritis (RA) taking tofacitinib compared with those taking tumor necrosis factor inhibitors (TNFis). Although international cohort studies have compared cancer outcomes between TNFis, non-TNFi drugs, and Janus kinase inhibitor (JAKis), their generalizability to US patients with RA is limited. To assess the comparative safety of TNFis, non-TNFi drugs, and JAKis among US patients with RA (ie, the cancer risk associated with the use of these drugs among these patients). This retrospective cohort study used US administrative claims data from Merative Marketscan Research Databases from November 1, 2012, to December 31, 2021. Follow-up occurred up to 2 years after initiation of biologic or targeted synthetic disease-modifying antirheumatic drugs (DMARDs). Participants included individuals aged 18 to 64 years with RA, identified using at least 2 RA International Classification of Diseases, Ninth Revision or International Statistical Classification of Diseases and Related Health Problems, Tenth Revision diagnostic codes on or before the date of TNFi, non-TNFi, or JAKi initiation ("index date"). Statistical analysis took place from June 2022 to September 2024. New initiations of TNFis, abatacept, interleukin 6 inhibitors (IL-6is), rituximab, or JAKis. Individuals could contribute person-time to more than 1 treatment exposure if treatment escalation mimicked typical clinical practice but were censored if they switched to a previously trialed medication class. Incident cancer, excluding nonmelanoma skin cancer, after at least 90 days and within 2 years of initiation of biologic or targeted synthetic DMARDs. Outcomes were associated with the most recent drug exposure. Of the 25 305 individuals who initiated treatment and who met the inclusion criteria, most were female (19 869 [79%]), had a median age of 50 years (IQR, 42-56 years), and were from the South US (12 516 [49%]). Of a total 27 661 drug exposures, drug initiations consisted of 20 586 TNFi exposures (74%), 2570 JAKi exposures (9%), 2255 abatacept exposures (8%), 1182 rituximab exposures (4%), and 1068 IL-6i exposures (4%). Multivariable Cox proportional hazards regression analysis showed that rituximab was associated with a higher risk of incident cancer compared with TNFis (hazard ratio [HR], 1.91; 95% CI, 1.17-3.14), followed by abatacept (HR, 1.47; 95% CI, 1.03-2.11), and JAKis (HR, 1.36; 95% CI, 0.94-1.96). In this cohort study of individuals with RA and new biologic or targeted synthetic DMARD exposures, individuals initiating rituximab, abatacept, and JAKis demonstrated higher incidence rates and statistically significantly increased risks of incident cancers compared with those initiating TNFis in the first 2 years after initiation of biologic or targeted synthetic DMARDs. Given the limitations of administrative claims data and confounding by indication, it is likely that these patients may have a higher disease burden, resulting in channeling bias. To better understand these associations, larger studies with longer follow-up time are needed.

Bimekizumab Efficacy and Safety Over 48 Weeks in US and Canadian Patients with Psoriasis who had a Treatment Interruption After 3 Years of Treatment: Results from BE RADIANT

Bimekizumab Efficacy and Safety Over 48 Weeks in US and Canadian Patients with Psoriasis who had a Treatment Interruption After 3 Years of Treatment: Results from BE RADIANT

Association between homocysteine levels and mortality in CVD: a cohort study based on NHANES database

BackgroundCardiovascular disease (CVD) is a major global health concern with increasing incident cases and deaths. Homocysteine (Hcy) has been investigated for its potential association with CVD, researchers have debated the extent to which Hcy should be considered a risk factor for cardiovascular diseases, as only 50% of CVD can be explained by classical risk factors.MethodsWe conducted a prospective cohort study using NHANES 1999–2006 data, analyzing 1,739 US patients aged at least 30 with CVD. Cox proportional hazards regression and restricted cubic splines were used to examine the relationship between Hcy levels and mortality, adjusting for covariates.ResultA total of 1,739 participants with cardiovascular disease (CVD) were enrolled, with a median follow-up period of 126 months. Among them, 1,194 participants died, including 501 deaths due to cardiovascular causes. After adjusting for covariates, the hazard ratios (HR) and 95% confidence intervals (CI) for CVD mortality at different levels of homocysteine (Hcy) (T1 (< 9.3), T2 (9.3–12.5), T3 (> 12.5)) were 1.26 (0.92, 1.73) (T2), and 1.69 (1.14, 2.51) (T3) (P for trend = 0.0086). The HR and 95% CI for all-cause mortality at different levels of Hcy were 1.22 (1.05, 1.42) (T2) and 1.64 (1.29, 2.09) (T3) (P for trend < 0.0001). Elevated Hcy levels were associated with increased risks of all-cause mortality and CVD deaths, even at levels below the conventional threshold. The nonlinear relationship was observed, with inflection points at 14.5 µmol/L for all-cause mortality and 14.6 µmol/L for CVD mortality. Subgroup analyses revealed interactions with age, serum vitamin B12, and smoking.ConclusionOur study supports the notion that elevated Hcy levels are associated with higher all-cause and CVD mortality risks in CVD participants. The impact of Hcy on health outcomes can be observed at lower concentrations than previously thought.

Lefamulin for Mycoplasma genitalium treatment failure in Australia and the USA: a case series and pilot open-label parallel arm randomised trial

ObjectivesMycoplasma genitalium (MG) causes urethritis and is associated with cervicitis, pelvic inflammatory disease and preterm delivery. Antimicrobial resistance is widespread and cure rates are declining. Lefamulin, a novel pleuromutilin, may...

Contemporary comparative surgical outcomes of type A aortic dissection in US and China: an analysis of the national inpatient sample database and a Chinese multi-institutional registry

BackgroundTo investigate the contemporary comparative inpatient prognosis among US and Chinese patients with type A aortic dissection (TAAD).MethodsData from Chinese multi-institutional TAAD registry and the US National Inpatient Sample databases were analyzed. We used multivariable logistic regression models to compare in-hospital mortality and perioperative complication rates between the US and China. Length of stay and overall costs were fitted with quantile regression models. Independent prognostic factors associated with post-operative survival were assessed via Cox proportional hazards models.ResultsAmong 3,121 eligible TAAD patients, 1,073 were from China (25.0% female; mean ± SD age, 53.9 ± 12.4) and 2,048 were from the US (31.2% female; mean ± SE age, 59.8 ± 0.3). During the study period, the in-hospital mortality rates in China and the US were 15.5% and 13.3%, yet the difference was insignificant after adjustment (aOR, 1.16; 95% CI, 0.69–1.97). While there was no significant difference in overall perioperative complications (aOR, 1.07; 95% CI, 0.52–2.18), the patterns of complications differed between two cohorts. While Chinese TAAD patients experienced significantly longer duration of hospitalization (median difference, + 10.4 days; 95% CI, 9.2–11.5), the US TAAD cohort had significantly greater overall hospitalization costs (49.9; 95% CI, 55.4–44.5, in 1000 USD).ConclusionsNotwithstanding significant differences in demographic and clinical characteristics, TAAD patients from China and the US demonstrated comparable in-hospital mortality and overall perioperative complication rates. Future initiatives should focus on expanding surgical eligibility to the elderly Chinese TAAD patients and optimizing the duration of hospitalization without undermining meaningful clinical outcomes.Trial registrationKY20220425-05, April 5th 25 2022.

Healthcare costs and resource utilization of patients with chronic post-traumatic stress disorder: a retrospective US claims analysis of commercially insured patients.

Aim: Exploring the healthcare costs and resource use among privately insured US patients with post-traumatic stress disorder (PTSD). Methods: This study used Merative MarketScan data. The index date was defined as the first PTSD claim. Study period included a 1-year pre-index and 2-year post-index follow-up. Cases with only acute PTSD, cancer, or insurance gap during the study period were excluded. The PTSD with (PwC) and PTSD without comorbidities (PwoC) cohorts were defined by the presence/absence of comorbid mental health conditions (schizophrenia, bipolar and major depressive disorder). Baseline PTSD (BP) cohort included PwoC cases with only index PTSD event and without FDA-approved PTSD medications or psychotherapy. Sub-analysis is conducted among patients with PTSD and substance/alcohol use disorder. Study cohorts were matched in a 1:1:1 ratio. Results: The matched sample included 5076 patients (1681 PwC, 1681 PwoC, 1714 BP). PwC patients had higher 2-year PTSD-related costs than PwoC and BP patients ($3762 vs $1750 and $841; all p<0.001). The same trend was noted among all-cause and anxiety-related costs. PwC patients had higher 2-year PTSD-related inpatient and emergency department (ED) rates than PwoC (10.2% vs 1.7% and 6.8% vs 2.6%, all p<0.001) and inpatient and outpatient rates than BP (10.2% vs 2.1% and 98.0% vs 93.1%; all p≤0.004). The sub-analysis had 3776 patients (3154 PwC, 537 PwoC, 85 BP). PwC had higher 2-year PTSD-related costs than PwoC and BP ($7668 vs $2919 and $1,483; all p<0.001). The same trend was noted in all-cause and anxiety-related costs. PwC also had higher 2-year PTSD-related inpatient and ED rates than PwoC (25.6% vs 10.4% and 12.7% vs 5.2%; all p<0.001) and inpatient and outpatient rates than BP (25.6% vs 8.2% and 95.5% vs 84.7%; all p<0.001). Conclusion: PTSD is associated with high healthcare costs and resource use. The highest economic burden was observed in patients with PTSD and mental health comorbidities.

Abstract 4138757: Lipid-Lowering Therapy Intensification and Low-Density Lipoprotein Cholesterol Testing Following a Major Cardiovascular Event or Procedure in Adult Patients in the United States

Background: Optimizing lipid-lowering therapy (LLT) use is foundational to reduce atherosclerotic cardiovascular disease (ASCVD) risk, especially among patients who have already experienced an ASCVD event. This study aimed to evaluate the patterns of LLT intensification and LDL-C testing within 12 months following an ASCVD event in US patients. Methods: Adults who experienced an ASCVD event (acute coronary syndrome, coronary revascularization, stable angina, ischemic stroke, transient ischemic attack, or peripheral arterial disease) between January 1, 2016 and December 31, 2022 in the IQVIA Longitudinal Access and Adjudication Data were included. The first instance of LLT intensification after the event was defined as an increase from a low-moderate to high intensity statin, or the initiation of statins, ezetimibe, PCSK9i, or bempedoic acid in addition to a baseline LLT regimen that did not include these medications. Baseline medication use was defined during 6 months before the ASCVD event. Results: Among 6,028,573 patients who had an eligible ASCVD event (mean age: 63.6 years, 51.5% male), 53.9% were not taking any LLT and 43.2% were taking statins only (low-moderate intensity: 26.7%; high intensity: 16.4%) during baseline. Within 1, 3, and 12 months after the event, 16.3%, 21.3%, and 30.0% of patients intensified LLT, respectively. Among patients who intensified LLT within 12 months (n= 1,820,246), the most commonly observed intensification was from no LLT use at baseline to low-moderate (29.0%) or high-intensity statins (43.5%), followed by intensification from low-moderate to high-intensity statins (20.3%). LDL-C values at baseline were available in a subset of 10.7% of patients, with the median being 95 mg/dL (78.9% ≥70 mg/dL). LDL-C values were observed in 17.7% of patients within 12 months after the ASCVD event, with the median being 84 mg/dL (68.3% ≥70 mg/dL). Conclusions: Within 12 months after an ASCVD event, only about one-third of patients intensified LLT and two-thirds did not achieve guideline-recommended LDL-C levels. The results highlight a missed opportunity to reduce recurrent ASCVD events. Future effort is warranted to address the clinical inertia that may be contributing to this unmet need.

We Are on the Verge of Breakthrough Cures for Type 1 Diabetes, but Who Are the 2 Million Americans Who Have It?

Background: Two million Americans have type 1 diabetes (T1DM). Innovative treatments have standardized insulin delivery and improved outcomes for patients, but patients' access to such technologies depends on social determinants of health, including insurance coverage, proper diagnosis, and appropriate patient supports. Prior estimates of US prevalence, incidence, and patient characteristics have relied on data from select regions and younger ages and miss important determinants. Objectives: This study sought to use large, nationally representative healthcare claims data sets to holistically estimate the size of the current US population with T1DM and investigate geographic nuances in prevalence and incidence, patient demographics, insurance coverage, and device use. This work also aimed to project T1DM population growth over the next 10 years. Methods: We used administrative claims from 4 sources to identify prevalent and incident T1DM patients in the US, as well as various demographic and insurance characteristics of the patient population. We combined this data with information from national population growth projections and literature to construct an actuarial model to project growth of the T1DM population based on current trends and scenarios for 2024, 2029, and 2033. Results: We estimated 2.07 million T1DM patients nationally across all insurance coverages in our 2024 baseline model year: 1.79 million adults (≥20 years) and 0.28 million children. This represents a US T1DM prevalence rate of 617 per 100 000 and an incidence rate of 0.016%. By 2033, we project the US population with T1DM will grow by about 10%, reaching approximately 2.29 million patients. Discussion: Our results showed important differences in T1DM prevalence and incidence across regions, payers, and ethnic groups. This suggests studies based on more geographically concentrated data may miss important variation in prevalence and incidence across regions. It also indicates T1DM prevalence tends to vary by income, consistent with several international studies. Conclusions: Accurate projections of T1DM population growth are critical to ensure appropriate healthcare coverage and reimbursement for treatments. Our work supports future policy and research efforts with 2024, 2029, and 2033 projections of demographics and insurance coverage for people with T1DM.