Citations

Introduction Glycemic targets and glucose-lowering regimens should be individualized based on multiple factors, including the presence of comorbidities. We examined contemporary patterns of glycemic control and use of medications known to cause hypoglycemia among adults with diabetes across age and multimorbidity. Research design and methods We retrospectively examined glycosylated hemoglobin (HbA1c) levels and rates of insulin/sulfonylurea use as a function of age and multimorbidity using administrative claims and laboratory data for adults with type 2 diabetes included in OptumLabs Data Warehouse, 1 January 2014 to 31 December 2016. Comorbidity burden was assessed by counts of any of 16 comorbidities specified by guidelines as warranting relaxation of HbA1c targets, classified as being diabetes concordant (diabetes complications or risk factors), discordant (unrelated to diabetes), or advanced (life limiting). Results Among 194 157 patients with type 2 diabetes included in the study, 45.2% had only concordant comorbidities, 30.6% concordant and discordant, 2.7% only discordant, and 13.0% had ≥1 advanced comorbidity. Mean HbA1c was 7.7% among 18–44 year-olds versus 6.9% among ≥75 year-olds, and was higher among patients with comorbidities: 7.3% with concordant only, 7.1% with discordant only, 7.1% with concordant and discordant, and 7.0% with advanced comorbidities compared with 7.4% among patients without comorbidities. The odds of insulin use decreased with age (OR 0.51 (95% CI 0.48 to 0.54) for age ≥75 vs 18–44 years) but increased with accumulation of concordant (OR 5.50 (95% CI 5.22 to 5.79) for ≥3 vs none), discordant (OR 1.72 (95% CI 1.60 to 1.86) for ≥3 vs none), and advanced (OR 1.45 (95% CI 1.25 to 1.68) for ≥2 vs none) comorbidities. Conversely, sulfonylurea use increased with age (OR 1.36 (95% CI 1.29 to 1.44) for age ≥75 vs 18–44 years) but decreased with accumulation of concordant (OR 0.76 (95% CI 0.73 to 0.79) for ≥3 vs none), discordant (OR 0.70 (95% CI 0.64 to 0.76) for ≥3 vs none), but not advanced (OR 0.86 (95% CI 0.74 to 1.01) for ≥2 vs none) comorbidities. Conclusions The proportion of patients achieving low HbA1c levels was highest among older and multimorbid patients. Older patients and patients with higher comorbidity burden were more likely to be treated with insulin to achieve these HbA1c levels despite potential for hypoglycemia and uncertain long-term benefit.

Background: The authors compared long-term health care use and cost in women undergoing immediate autologous breast reconstruction and implant-based breast reconstruction. Methods: This study was conducted using the OptumLabs Data Warehouse, which contains deidentified retrospective administrative claims data, including medical claims and eligibility information from a large U.S. health insurance plan. Women who underwent autologous or implant-based breast reconstruction between January of 2004 and December of 2014 were included. The authors compared 2-year use rates and predicted costs of care. Comparisons were tested using the t test. Results: Overall, 12,296 women with immediate breast reconstruction were identified; 4257 with autologous (35 percent) and 8039 with implant-based (65 percent) breast reconstruction. The proportion of autologous breast reconstruction decreased from 47.2 percent in 2004 to 32.7 percent in 2014. The mean predicted reconstruction cost of autologous reconstruction was higher than that of implant-based reconstruction in both unilateral and bilateral surgery. Similar results for mean predicted 2-year cost of care were seen in bilateral procedures. However, in unilateral procedures, the 2-year total costs were higher for implant-based than for autologous reconstruction. Two-year health care use rates were higher for implant-based reconstruction than for autologous reconstruction for both unilateral and bilateral procedures. Women undergoing unilateral implant-based reconstruction had higher rates of hospital admissions (30.3 versus 23.1 per 100; p < 0.01) and office visits (2445.1 versus 2283.6 per 100; p < 0.01) than those who underwent autologous reconstruction. Emergency room visit rates were similar between the two methods. Bilateral procedures yielded similar results. Conclusion: Although implant-based breast reconstruction is a less expensive index operation than autologous breast reconstruction, it was associated with higher health care use, resulting in similar total cost of care over 2 years.

Background: The purpose of the present study was to identify trends in management and to compare the outcomes and complications following nonoperative and operative management (including external fixation, closed reduction and percutaneous pinning, and open reduction and internal fixation) for distal radial fractures in patients ≥65 years of age. Methods: We performed a retrospective analysis, with use of the OptumLabs Data Warehouse database, of patients ≥65 years of age who had been managed for a distal radial fracture between 2009 and 2014 (as indicated by diagnosis codes according to the International Classification of Diseases, Ninth Revision, Clinical Modification). Ninety-day and 1-year complication rates per 1,000 fractures were analyzed overall and by treatment modality. Results: Thirteen thousand, seven hundred and thirteen distal radial fractures were analyzed. The overall 90-day complication rate was 36.5 per 1,000 fractures, and the 1-year upper-extremity-specific complication rate was 236.2 and 307.5 per 1,000 fractures for nonoperative and operative management, respectively. Overall, post-injury stiffness was the most common 1-year upper-extremity-specific complication (incidence, 11.5%). There was no significant difference between operative and nonoperative management in terms of 90-day complication rates. However, operative management had a higher 1-year complication rate than nonoperative management (307.5 versus 236.2 per 1,000 fractures). Overall, the 5 most common upper-extremity-specific complications following operative treatment of distal radial fracture were stiffness (16.0%), chronic regional pain syndrome (9.9%), median neuropathy (8.0%), implant-related complications (3.8%), and tendon-related complications (2.8%). Stiffness was significantly more frequent following operative management (16.0% versus 9.8%; p < 0.01). Conclusions: Operative management of a distal radial fracture should be carefully considered when discussing treatment options with patients ≥65 years of age. Level of Evidence: Therapeutic Level III . See Instructions for Authors for a complete description of levels of evidence.

Abstract Background: Proteasome inhibitors and immunomodulatory drugs are currently an integral part of the management of multiple myeloma. Pre-clinical and clinical studies suggest that bortezomib, the first approved proteasome inhibitor for the management of multiple myeloma, may be associated with an increased risk of cardiac events such as heart failure (HF), acute myocardial infarction (MI), and arrhythmia. The goal of this study was to evaluate the rate of adverse cardiac events in patients treated with bortezomib compared to lenalidomide. Methods: This retrospective, propensity-matched study using a large, national administrative claims database included multiple myeloma patients who initiated bortezomib and a comparison group (matched on age, sex, year of drug initiation, baseline HF, hyperlipidemia, hypertension, history of MI, arrhythmia and Charlson comorbidity index) who initiated lenalidomide between January 2008 and December 2014. Those who received both bortezomib and lenalidomide were excluded from the analysis. The primary endpoints were time to hospitalization for HF, acute MI and arrhythmia. Rates of hospitalizations were computed per 100 patient years (PY). Cox proportional hazard models were used to obtain hazard ratios (HR) and 95% confidence intervals (CI). Results: A total of 1,128 patients (564 bortezomib users and 564 lenalidomide users, mean age of 69, 47% female, and average follow-up time of 438 days) were included in the analysis. The rate of hospitalization for HF, acute MI, and arrhythmia was 5.76/100 PY, 2.57/100 PY, and 3.10/100 PY respectively among bortezomib users and 2.45/100 PY, 1.47/100 PY, and 2.85/100 PY respectively among lenalidomide users. In the propensity score matched models, the risk of hospitalization for acute MI and arrhythmia with bortezomib was similar to lenalidomide (HR 1.60 [95% CI 0.73-3.49] and HR 1.01 [95% CI 0.54-1.90] respectively). The risk of hospitalization for HF with bortezomib use was significantly higher compared to lenalidomide (HR 2.10 [95% CI 1.18-3.74], Figure 1). Further stratification of the patient population by baseline HF status showed that those with baseline HF (n=212) were significantly more likely to be hospitalized for HF following treatment with bortezomib compared to lenalidomide. The rate of hospitalization for HF in the population with baseline HF was 24.12/100 PY among bortezomib users and 8.77/100 PY among lenalidomide users (HR 2.24 [95% CI 1.04-4.83]). Those without baseline HF (n=916) had similar rates of hospitalization for HF when treated with bortezomib and lenalidomide (2.83/100 PY and 1.29/100 PY respectively, HR 2.05 [95% CI 0.86-4.91]). Conclusion: The current study shows that bortezomib use in patients treated for multiple myeloma is associated with an increased risk of hospitalization for heart failure, but not acute MI or arrhythmia. Those with HF prior to initiating therapy with bortezomib had a significantly increased risk of hospitalization for HF when compared to those treated with lenalidomide. There was no significant difference in the rate of hospitalization for HF in those without a baseline diagnosis of HF. Collectively, these data have important implications for the management of patients with multiple myeloma, especially those with a history of HF at the time of therapy initiation. Figure 1. Kaplan Meier plot for HF hospitalizations. Figure 1. Kaplan Meier plot for HF hospitalizations. Disclosures No relevant conflicts of interest to declare.

Abstract Direct-acting antivirals (DAA) are now the mainstay of treatment for patients with chronic hepatitis C virus (HCV); however, there is some controversy over whether use of DAAs for HCV, as compared with IFN-based regimens, leads to an increased risk for hepatocellular carcinoma (HCC) development. We investigated the association between use of DAAs and subsequent development of HCC in longitudinal data from patients with HCV from diverse backgrounds (various ages, ethnicities, and geographic regions) across the United States. The design was a retrospective study performed using medical and pharmacy claims from OptumLabs. HCV treatment exposure was categorized as DAA-only, DAA + IFN, any-DAA, or IFN-only. To account for confounding by indication, inverse probability of treatment weighting was performed. Cox proportional hazard models were used to calculate hazard ratios (HR) and 95% confidence intervals (CI). We identified 5,781 patients with HCV with no history of HCC at baseline. Compared with IFN-only regimen, no significant increase in HCC risk was found for use of DAA-only (HR, 1.53; 95% CI, 0.73–3.23), DAA + IFN (HR, 1.02; 95% CI, 0.51–2.06), or any-DAA (HR, 1.04; 95% CI, 0.65–1.65). When stratified by sustained virological response (SVR), we noted a higher HCC risk for DAA-only among patients who achieved SVR post-treatment (HR, 7.53; 95% CI, 1.48–38.34), but the CIs were wide, which might be due to the small sample size of the subgroups. Among those who did not achieve SVR, no association was found for use of DAA-only (HR, 0.59; 95% CI, 0.19–1.91). These findings do not provide compelling evidence for the conception that use of DAAs for HCV is associated with increased risk of HCC development.

Abstract Background: Direct acting antiviral medications (DAA) have become the mainstay for treatment of chronic hepatitis C virus (HCV) infection. However, some studies have suggested an increased risk of HCC development following use of DAAs for HCV compared with use of interferon-based medications (IFN), while other studies, mostly in Veterans Administration population in the United States, did not show an increase in HCC risk after the use of DAA in patients with HCV. To address these conflicting reports, we investigated the association between use of DAA for HCV and subsequent development of HCC in a large, longitudinal data with broad representation of individuals from various ages, ethnicities, and geographic regions across the United States. Methods: A retrospective cohort study was performed using medical and pharmacy claims from the OptumLabs® Data Warehouse. The study included 9,532 incident HCV cases (2010-2016) of ages 18 years or older treated with DAA or IFN and did not have a prior diagnosis of HCC before initiation of the antiviral therapy. The participants were categorized into DAA-only or IFN-only groups. To account for confounding by indication, inverse probability of treatment weighting (IPTW) was performed to ensure balance in sociodemographic and treatment related factors between treatment groups. Cox proportional hazard models were used to calculate hazard ratios (HRs) and 95% confidence intervals (CIs) for HCC risk, comparing DAA-only regimen with IFN-only regimen (reference). Results: Median follow-up for the entire study cohort was 1.4 years, with a slightly longer follow-up for individuals in the IFN-only group (1.8 years) than for those in the DAA-only group (1.4 years). One hundred and seventy-one incident HCC cases developed during follow-up, with a higher occurrence of HCC in the DAA-only group (n=155; 11.9 cases per 1,000 person-years) than in the IFN-only group (n=16; 8.3 cases per 1,000 person-years). Compared with IFN-only treatment, use of DAA-only for HCV was not associated with an increase in HCC risk (HR=1.47, 95% CI: 0.89-2.42). Similarly, no association was found between use of DAA-only regimen and HCC risk among individuals with cirrhosis (HR=1.28, 95% CI: 0.71-2.31) or those without cirrhosis (HR =1.80, 95% CI: 0.64-5.03). When stratified by sustained virologic response (SVR), a measure of complete viral clearance, we noted a higher HCC risk associated with DAA-only regimen among individuals with SVR (HR=7.83, 95% CI: 1.54-39.88) and a lower risk for DAA-only regimen among those without SVR (HR=0.12, 95% CI: 0.02-0.95); however, the CIs are substantially wide, reflecting the small numbers in these subgroup analyses. Conclusion: Despite some prior reports of increased risk of HCC development following use of DAA for HCV, this ethnically and geographically diverse study did not find compelling evidence indicating an increased HCC risk associated with use of DAA in patients with HCV when compared with use of IFN. Citation Format: Samuel O. Antwi, Holly K. Van Houten, Lindsey R. Sangaralingham, Tushar Patel. Risk of de novo hepatocellular carcinoma development following use of direct acting antiviral medications for treatment of chronic hepatitis C virus infection [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2019; 2019 Mar 29-Apr 3; Atlanta, GA. Philadelphia (PA): AACR; Cancer Res 2019;79(13 Suppl):Abstract nr LB-150.

Objective The aim of this study was to evaluate national patterns of care for women with overactive bladder (OAB) in an administrative data set and identify potential areas for improvement. Methods We performed an analysis using the OptumLabs Data Warehouse, which contains deidentified administrative claims data from a large national US health insurance plan. The study included women, older than 18 years, with a new OAB diagnosis from January 1, 2007, to June 30, 2017. We excluded those with an underlying neurologic etiology, with interstitial cystitis/painful bladder syndrome, were pregnant, or did not have continuous enrollment for 12 months before and after OAB diagnosis. Trends in management were assessed via the Cochran-Armitage test. Time to discontinuation among medications was compared using t test. Results Of 1.4 million women in the database during the study time frame, 60,246 (4%) were included in the study. Median age was 61 years [interquartile range (IQR), 50–73], and median follow-up was 2.6 years (IQR, 1.6–4.2). Overall, 37% were treated with anticholinergics, 5% with beta-3 agonists, 7% with topical estrogen, and 2% with pelvic floor physical therapy; 26% saw a specialist; and 2% underwent third-line therapy. Median time to cessation of prescription filling was longer for beta-3 agonists versus anticholinergics [median, 4.1 months (IQR, 1–15) vs 3.6 months (IQR, 1–10); P < 0.0001]. Use of third-line therapies significantly increased over the study time frame, from 1.1% to 2.2% ( P < 0.0001). Conclusions Most of the patients do not continue filling prescriptions for OAB medications, and a minority of patients were referred for specialty evaluation. Although third-line therapy use is increasing, it is used in a small proportion of women with OAB. Given these patterns, there may be underutilization of specialist referral and other OAB therapies.