Heien, Herbert C.

Abstract Background Recent studies suggested that treating obesity and its comorbidities with glucagon-like peptide-1 (GLP-1) receptor agonists may improve outcomes in patients with heart failure with preserved ejection fraction (HFpEF). The randomized SUMMIT trial found that tirzepatide use was associated with a lower risk of heart failure (HF) events or cardiovascular death in adults with HFpEF and obesity compared with placebo. Purpose We aimed to examine whether tirzepatide use in clinical practice was associated with risks of HF events and all-cause mortality among adults with HFpEF and obesity. Methods This was a retrospective cohort study leveraging the Optum Labs Data Warehouse (OLDW), a de-identified administrative claims database of commercial and Medicare Advantage enrollees across the United States. We identified all adults with HFpEF and obesity from January 1, 2022, to December 31, 2024. Our primary exposure was tirzepatide use, and our primary outcome was a composite of a HF event (ED visits or hospitalization for HF) or mortality. Secondary outcomes included hospitalization for angina, atrial fibrillation or atrial flutter (AF/AFL), acute myocardial infarction (MI), cardiac arrest, and cardiogenic shock. Patients were followed from the index date, defined as the tirzepatide treatment start date after HFpEF diagnosis or pseudo-index date in tirzepatide non-users, to the end of enrollment or death using the intention-to-treat framework. Inverse probability of treatment weighting (IPTW) was used to balance groups. Fracture, conjunctivitis, ear infection, and fungal skin infection were used as falsification endpoints. Cox-proportional and Fine-Gray subdistribution hazard models were used to estimate a hazard ratio (HR) and subdistribution hazard ratio (SHR), respectively. Results Among our total cohort of 99,270 patients, the mean age was 73 years, 58,616 (59.1%) were female, 8,839 (8.9%) used tirzepatide, and the mean follow-up time was about 385 days. Patients using tirzepatide had a significantly lower risk of a HF event or mortality (HR=0.73; 95% confidence interval [CI]=0.66–0.80; p<0.001) compared to patients not using tirzepatide. Patients using tirzepatide had a lower risk of a HF event (SHR=0.80; 95% CI=0.73–0.88; p<0.001) and all-cause mortality (HR=0.48; 95% CI=0.38–0.60; p<0.001). Tirzepatide use was associated with lower risks of hospitalization for acute MI (SHR=0.67; 95% CI=0.52–0.85; p=0.001) and cardiogenic shock (SHR=0.56; 95% CI=0.38–0.83; p=0.003), but not angina, AF/AFL, or cardiac arrest (Figure 1). Conclusion Among adults with HFpEF and obesity, tirzepatide use in real-world clinical practice was associated with a lower risk of HF events, hospitalizations for acute cardiovascular disease, and all-cause mortality.For image description, please refer to the figure legend and surrounding text.

Background Previous studies have demonstrated disparities in the utilization of diabetes technology among youth with type 1 diabetes (T1D) based on race and socioeconomic status (SES). Few studies have examined these differences on a national scale or among youth with commercial health insurance. Aim To investigate differences in the fill rates of insulin pumps and continuous glucose monitors (CGMs) among commercially insured children with T1D across diverse racial and SES groups. Methods Using medical and pharmacy claims included in the OptumLabs Data Warehouse, we calculated the proportion of youth <18 years with T1D who had a fill for an insulin pump or a CGM, overall and stratified by race/ethnicity and annual household income, between 2011 and 2021. Results Among 13,246 youth with T1D, 36.1% had CGM and 30.9% had pump fills. White youth had higher CGM and pump fills than black (CGMs: 35.8% vs 22.5%; pumps: 31.9% vs 21.2%, p<0.001) and Hispanic (CGMs: 35.8% vs 32.6%, p=0.047; pumps: 31.9% vs 25.0%, p<0.001). Youth from households with income <US$40,000 had lower CGM and pump fills than those with income ≥US$200,000 (CGM 25.4% vs 43.8%; pumps: 22.4% vs 38.8%, p<0.001). Within similar incomes <US$40,000, black youth had fewer CGM and pump fills than white youth (CGM: 15.2% vs 27.9%, p=0.006; pumps: 12.9% vs 25.5%, p=0.004). This racial difference disappeared with income ≥US$200,000 (CGMs: 47.5% for black vs 43.1% for white; pumps: 45.9% for black vs 38.3% for white, p=0.45 and p=0.57, respectively). Conclusions In a cohort of commercially insured youth with T1D, both race and income are important factors that can independently influence the use of diabetes technology. Racial disparities decrease with higher income and disappear at incomes ≥US$200,000. Black youth with income <US$40,000 are at the highest exclusion risk from essential technologies. Greater effort is needed at both the system and individual levels to mitigate these disparities.

Objective To characterise the changing trends in the pharmacological management of SLE in the USA between 2007 and 2023 as new treatment options emerged. Methods In a retrospective cohort study using data from OptumLabs Data Warehouse, we characterised the annual prevalent (ie, all) and incident (ie, new) use of antimalarials, glucocorticoids and immunosuppressive medications among patients with SLE from 2007 to 2023 and assessed for changing trends over time. Results We identified 19 122 adults with SLE; they were 51.2 (SD 16.1) years of age, 89% were female, 61.3% were White, 18.5% were Black and 13.1% were Hispanic. The proportion of prevalent users of antimalarials has decreased from 79.4% in 2007 to 77.2% in 2023 (p=0.0055), while the proportion of incident users fluctuated between a lowest 5.8% in 2021 and a highest 8.1% in 2008 (p=0.008). The proportion of prevalent users of glucocorticoids increased from 64.6% in 2007 to 66.7% in 2023 (p=0.0132), as did the proportion of incident users (12.4% in 2007 to 21.7% in 2023; p<0.0001). The use of cyclophosphamide (2.0% in 2007 to 0.4% in 2023, p<0.0001) has decreased; the use of mycophenolate mofetil (7.7% in 2007 to 10.3% in 2023, p<0.0001), rituximab (1.4% in 2007 to 2.1% in 2023, p<0.0001) and belimumab (0.8% in 2011 to 6.1% in 2023, p=0.0001) has increased. Conclusions Despite increasing availability of alternative treatment options, patients with SLE in the USA increasingly rely on glucocorticoid-based therapy. Efforts to improve the use of antimalarials and steroid-sparing immunosuppressants are needed.

ObjectivesRacial disparities are pervasive in access to pediatric surgery. The goal of this study was to test the hypotheses that, compared with White children, non‐White and Hispanic children: (1) were less likely to attend evaluations by otolaryngologists after a diagnosis of otitis media (OM) eligible for surgical referral, and (2) these children were less likely to receive tympanostomy tube (TT) after surgical consultation.MethodsThe OptumLabs Data Warehouse is a de‐identified claims database of privately insured enrollees. Guidelines on the management of OMs suggest that children should be evaluated for surgery if they have recurrent acute OM or chronic OM with effusion. A cohort of children who were diagnosed with OM were constructed. For Hypothesis 1, the primary outcome was otolaryngology office visit within 6 months of a diagnosis of recurrent or chronic OM. For Hypothesis 2, the outcome was TT placement within 6 months following the otolaryngology office visit. Cox regression models were used to determine the relationship between race/ethnicity and the primary outcomes.ResultsAmong 187,776 children with OMs, 72,774 (38.8%) had otolaryngology visits. In a multivariate Cox model, the hazard ratios of attending otolaryngology visit for Black, Hispanic, and Asian children were 0.93 (95% CI,0.90, 0.96), 0.86 (0.83, 0.88), and 0.74 (0.71, 0.77), compared with White children. Among the children evaluated by otolaryngologists, 46,554 (63.97%) received TT. Black, Hispanic, and Asian children with recurrent acute OM had lower likelihood of receiving TT.ConclusionsRacial disparities in attending otolaryngology office visit contributed to the disparities in receiving TT.Quality of EvidenceLevel 3 Laryngoscope, 134:3846–3852, 2024

OBJECTIVETo characterize contemporary trends in glucagon fill rates and expenditures in a nationwide cohort of adults with diabetes overall and by key demographic and clinical characteristics.RESEARCH DESIGN AND METHODSIn this retrospective cohort study, we examined 1) glucagon fill rates per 1,000 person-years and 2) patient out-of-pocket and health plan costs per filled glucagon dose among adults with diabetes included in OptumLabs Data Warehouse between 1 January 2011 and 31 March 2021.RESULTSThe study population comprised 2,814,464 adults with diabetes with a mean age of 62.8 (SD 13.2) years. The overall glucagon fill rate decreased from 2.91 to 2.28 per 1,000 person-years (−22%) over the study period. In groups at high risk for severe hypoglycemia, glucagon fill rates increased from 22.46 to 36.76 per 1,000 person-years (64%) among patients with type 1 diabetes, 11.64 to 16.63 per 1,000 person-years (43%) among those treated with short-acting insulin, and 16.08 to 20.12 per 1,000 person-years (25%) among those with a history of severe hypoglycemia. White patients, women, individuals with high income, and commercially insured patients had higher glucagon fill rates compared with minority patients, males, individuals with low income, and Medicare Advantage patients, respectively. Total cost per dosing unit increased from $157.97 to $275.32 (74%) among commercial insurance beneficiaries and from $150.37 to $293.57 (95%) among Medicare Advantage beneficiaries.CONCLUSIONSGlucagon fill rates are concerningly low and declined between 2011 and 2021 but increased in appropriate subgroups with type 1 diabetes, using short-acting insulin, or with a history of severe hypoglycemia. Fill rates were disproportionately low among minority patients and individuals with low income.

OBJECTIVE To characterize trends in clinical complexity, treatment burden, health care use, and diabetes-related outcomes among adults with diabetes. RESEARCH DESIGN AND METHODS We used a nationwide claims database to identify enrollees in commercial and Medicare Advantage plans who met claims criteria for diabetes between 1 January 2006 and 31 March 2019 and to quantify annual trends in clinical complexity (e.g., active health conditions), treatment burden (e.g., medications), health care use (e.g., ambulatory, emergency department [ED], and hospital visits), and diabetes-related outcomes (e.g., hemoglobin A1c [HbA1c] levels) between 2006 and 2018. RESULTS Among 1,470,799 commercially insured patients, the proportion with ≥10 active health conditions increased from 33.3% (95% CI 33.1–33.4) in 2006 to 38.9% (38.8–39.1) in 2018 (P = 0.001) and the proportion taking three or more glucose-lowering medications increased from 11.6% (11.5–11.7) to 23.1% (22.9–23.2) (P = 0.007). The proportion with HbA1c ≥8.0% (≥64 mmol/mol) increased from 28.0% (27.7–28.3) in 2006 to 30.5% (30.2–30.7) in 2015, decreasing to 27.8% (27.5–28.0) in 2018 (overall trend P = 0.04). Number of ambulatory visits per patient per year decreased from 6.86 (6.84–6.88) to 6.19 (6.17–6.21), (P = 0.001) while ED visits increased from 0.26 (0.257–0.263) to 0.29 (0.287–0.293) (P = 0.001). Among 1,311,903 Medicare Advantage enrollees, the proportion with ≥10 active conditions increased from 51.6% (51.2–52.0) to 65.1% (65.0–65.2) (P &lt; 0.001); the proportion taking three or more glucose-lowering medications was stable at 16.6% (16.3–16.9) and 18.1% (18.0–18.2) (P = 0.98), and the proportion with HbA1c ≥8.0% increased from 17.4% (16.7–18.1) to 18.6% (18.4–18.7) (P = 0.008). Ambulatory visits per patient per year remained stable at 8.01 (7.96–8.06) and 8.17 (8.16–8.19) (P = 0.23), but ED visits increased from 0.41 (0.40–0.42) to 0.66 (0.66–0.66) (P &lt; 0.001). CONCLUSIONS Among patients with diabetes, clinical complexity and treatment burden have increased over time. ED utilization has also increased, and patients may be using ED services for low-acuity conditions.

INTRODUCTION: Obesity has been associated with adverse disease-related outcomes and inferior treatment response to biologic agents in patients with inflammatory bowel diseases (IBDs), but its impact on the risk of treatment-related complications is unknown. We performed a cohort study examining the association between obesity and risk of serious infections in biologic-treated patients with IBD. METHODS: Using an administrative claims database, in a cohort of biologic-treated patients with IBD between 2014 and 2018 with follow-up 1 year before and after treatment initiation, we compared the risk of serious infections (infections requiring hospitalization) between obese vs nonobese patients (based on validated administrative claims) using Cox proportional hazard analysis. RESULTS: We included 5,987 biologic-treated patients with IBD (4,881 on tumor necrosis factor-α antagonists and 1,106 on vedolizumab), of whom 524 (8.8%) were classified as obese. Of the 7,115 person-year follow-up, 520 patients developed serious infection. Risk of serious infection was comparable in obese vs nonobese patients (8.8% vs 8.5%; unadjusted hazard ratio, 1.15; 95% confidence interval, 0.86–1.54). After adjusting for age, comorbidities, disease characteristics, health care utilization, use of corticosteroids, immunomodulators, and opiates, obesity was not associated with an increased risk of serious infection (adjusted hazard ratio, 0.74 [95% confidence interval, 0.55–1.01]). Similar results were seen on stratified analysis by disease phenotype (Crohn's disease and ulcerative colitis) and index biologic therapy (tumor necrosis factor-α antagonists and vedolizumab). DISCUSSION: After adjusting for comorbid conditions and disease characteristics, obesity is not independently associated with an increased risk of serious infections in biologic-treated patients with IBD.

AbstractBackgroundTo evaluate the economic burden of locally advanced rectal cancer (LARC) treatment from a society perspective through analysis of health insurance‐derived data of commercially insured and Medicare Advantage (MA) patients.MethodsRetrospective cost analysis of patients undergoing rectal resection within a multimodal (neoadjuvant chemoradiation + adjuvant chemotherapy) treatment strategy between January 1, 2010 and October 31, 2018, using the claims OptumLabs Data Warehouse database.ResultsIn total, 1738 (935 commercial and 803 MA) patients were included. Overall treatment costs totaled $230,881,746 (on average $183 653 ± 82 384 per commercially insured and $73 681 ± 32 917 per MA patient). Cost distribution according to category (commercially insured patients) was: 29.92% related to outpatient care (follow‐up visits/diagnostics), radiotherapy: 21.83%, index resection: 20.62%, chemotherapy: 17.44%, surgical inpatient: 6.32%, medical inpatient: 3.28%, emergency room: 0.58%. Relative cost distribution of the index resection itself differed marginally between the three approaches and was 21.49% for open, 19.30% for laparoscopic, and 20.93% for robotic surgery. Relative cost distributions of neoadjuvant, adjuvant, and outpatient treatments remained unchanged, independently of the surgical approach. This representation was similar in MA patients.ConclusionIndex‐surgery related costs were outweighed by costs related to oncological and outpatient workup/follow‐up treatments independently of both surgical approach and insurance type.