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BACKGROUND This study sought to examine the real-world impact of multimodality cyclical-pressure topical wound oxygen therapy (TWO2) on hospitalizations and amputations in patients with diabetic foot ulcer (DFU) compared to patients without TWO2. METHODS We conducted a retrospective review of deidentified patient medical records at 2 US Veterans Affairs hospitals between January 2012 and January 2020. DFU patients were assigned to TWO2 or NO TWO2 cohorts based on their treatment records. Patients received appropriate standard of care and may have received other advanced wound treatments, including skin substitutes, negative pressure wound therapy, and growth factors. Primary study outcomes were patients requiring hospitalization and/or amputation within 360 days of initial wound documentation. FINDINGS Among unmatched cohorts of 202 patients with DFU (91 TWO2, 111 NO TWO2), 66% and 121% of TWO2 patients had hospitalizations and amputations, respectively, compared to 541% and 414% of NO TWO2 patients within 360 days (P < 00001, P < 00001), representing 88% and 71% reductions. Among propensity score matched cohorts of 140 DFU patients (70 TWO2, 70 NO TWO2), compared to NO TWO2, 82% fewer TWO2 patients were hospitalized (71% vs 400%, P < 00001) and 73% fewer TWO2 patients had amputations (86% vs. 314%, P = 00007). Logistic regression among matched cohorts demonstrated nearly 9-fold and 5-fold higher risk of hospitalization and amputation, respectively, for NO TWO2 vs. TWO2. INTERPRETATION This retrospective cohort study demonstrates that treating patients with DFU with TWO2 is associated with significant reductions in hospitalizations and amputations in the real-world setting.

Background Lymphedema (LE) has been called the forgotten vascular disease, given such scant knowledge about LE-associated comorbidities or causes. Such knowledge of the comorbidities and treatment of LE may assist in diagnostic decisions and health care planning. Methods To determine the proportion of LE patients with various LE-associated comorbidities as well as the rate of associated treatment, deidentified Health Insurance Portability and Accountability Act-compliant commercial administrative claims from the Blue Health Intelligence (BHI) research database (165 million Blue Cross Blue Shield members) were queried. We analyzed a BHI study sample of 26,902 patients with LE who had been enrolled with continuous medical benefits for 12 months before and after the index date for the complete years 2012 through 2016. Patients were first identified by comorbidity and then grouped into those receiving no treatment for LE and those receiving any treatment for LE. Any treatment was defined as receiving manual lymphatic drainage, physical therapy, compression garments, or a pneumatic compression device. The purpose of this study was to determine the proportion of LE patients comorbid with various known LE-associated conditions and the treatment rates of LE patients with each comorbidity. Results Among the 84,579,269 BHI patients enrolled during the study window, 81,366 patients were identified with LE. From this LE group, our study focused on the 26,902 patients who were enrolled with continuous medical and pharmacy benefits for 12 months before and after the index date. Among these 26,902 LE patients, breast cancer was the most frequent comorbidity with LE (32.1%), and these patients almost universally received any treatment (94.2%); other cancer types, such as melanoma (2.1%) and prostate cancer (0.7%), were less frequent and received any treatment less often, 75% and 82% of the time, respectively. Venous leg ulcer was the most common non-cancer-linked comorbidity for LE (9.6%), but only 81.7% of venous leg ulcer patients received any treatment for LE. Conclusions To our knowledge, this is the largest study to date detailing the comorbidities associated with LE and LE treatment rates within each. Our findings suggest that a sizable proportion of cancer-related LE patients do not receive appropriate treatment. Furthermore, this study highlights the role of advanced venous disease as an LE comorbidity that is frequently untreated and its associated gap in treatment.

Phlebolymphedema (chronic venous insufficiency-related lymphedema) is a common and costly condition. Nevertheless, there is a dearth of evidence comparing phlebolymphedema therapeutic interventions. This study sought to examine the medical resource utilization and phlebolymphedema-related cost associated with Flexitouch (FLX; Tactile Medical, Minneapolis, Minn) advanced pneumatic compression devices (APCDs) relative to conservative therapy (CONS) alone, simple pneumatic compression devices (SPCDs), and other APCDs in a representative U.S. population of phlebolymphedema patients.This was a longitudinal matched case-control analysis of deidentified private insurance claims. The study used administrative claims data from Blue Health Intelligence for the complete years 2012 through 2016. Patients were continuously enrolled for at least 18 months, diagnosed with phlebolymphedema, and received at least one claim for CONS either alone or in addition to pneumatic compression (SPCDs or APCDs). The main outcomes included direct phlebolymphedema- and sequelae-related medical resource utilization and costs.After case matching, the study included 86 patients on CONS (87 on FLX), 34 on SPCDs (23 on FLX), and 69 on other APCDs (67 on FLX). Compared with CONS, FLX was associated with 69% lower per patient per year total phlebolymphedema- and sequelae-related costs net of any pneumatic compression device-related costs ($3839 vs $12,253; P = .001). This was driven by 59% fewer mean annual hospitalizations (0.13 vs 0.32; P .001) corresponding to 82% lower inpatient costs and 55% lower outpatient hospital costs. FLX was also associated with 52% lower outpatient physical therapy and occupational therapy costs and 56% lower other outpatient-related costs. Compared with SPCDs, FLX was associated with 85% lower total costs ($1153 vs $7449; P = .008) driven by 93% lower inpatient costs ($297 vs $4215; P = .002), 84% lower outpatient hospital costs ($368 vs $2347; P = .020), and 85% lower other outpatient-related costs ($353 vs $2313; P = .023). Compared with APCDs, FLX was associated with 53% lower total costs ($3973 vs $8436; P = .032) because of lower outpatient costs and lower rates of cellulitis (22.4% vs 44.9% of patients; P = .02).This analysis indicates significant benefits attributable to FLX compared with alternative compression therapies that can help reduce the notable economic burden of phlebolymphedema.

Background: This study sought to examine the real-world impact of multimodality cyclical-pressure topical wound oxygen therapy (TWO2) on hospitalizations and amputations in patients with diabetic foot ulcer (DFU) compared to patients without TWO2. Methods: We conducted a retrospective review of deidentified patient medical records at 2 US Veterans Affairs hospitals between January 2012 and January 2020. DFU patients were assigned to TWO2 or NO TWO2 cohorts based on their treatment records. Patients received appropriate standard of care and may have received other advanced wound treatments, including skin substitutes, negative pressure wound therapy, and growth factors. Primary study outcomes were patients requiring hospitalization and/or amputation within 360 days of initial wound documentation. Findings: Among unmatched cohorts of 202 DFU patients (91 TWO2, 111 NO TWO2), 6·6% and 12·1% of TWO2 patients had hospitalizations and amputations, respectively, compared to 54·1% and 41·4% of NO TWO2 patients within 360 days (P < 0·0001, P < 0·0001), representing 88% and 71% reductions. Among propensity score matched cohorts of 140 DFU patients (70 TWO2, 70 NO TWO2), compared to NO TWO2, 82% fewer TWO2 patients were hospitalized (7·1% vs 40·0%, P < 0·0001) and 73% fewer TWO2 patients had amputations (8·6% vs. 31·4%, P = 0·0007). Logistic regression among matched cohorts demonstrated nearly 9-fold and 5-fold higher risk of hospitalization and amputation, respectively, for NO TWO2 vs. TWO2. Interpretation: This retrospective cohort study demonstrates that treating DFU patients with TWO2 leads to significant reductions in hospitalizations and amputations in the real-world setting. Funding: AOTI Ltd. Declaration of Interest: This study was sponsored by AOTI Ltd. (Galway, Ireland). Health Advances received consultative reimbursement from AOTI, and T.N. received consultative reimbursement from Health Advances for his independent performance of the statistical analysis. R.G.F. has received research funding from and is a consultant for AOTI. M.G.G. has received research funding and is a consultant for AOTI. A.M.L. has received research funding from AOTI. No other potential conflicts of interest relevant to this article were reported. Ethical Approval: The protocol 18 was approved by the Institutional Review Board at each facility.

Objective The objective of this study was to define the current forms of treatment in a contemporary population of lymphedema (LED) patients for LED related to breast cancer, the most prevalently diagnosed LED comorbidity in Western countries, and phlebolymphedema with venous leg ulcer (PLEDU), a sequela of chronic venous disease. The goals of LED therapy are to reduce edema, thereby improving function and related symptoms, and to improve skin integrity to prevent development of infection. Treatment is generally nonsurgical: conservative care, including complex physical therapy, manual lymphatic drainage, and compression bandaging; or pneumatic compression device (PCD) therapy by a simple nonprogrammable device or an advanced programmable device. Methods To determine the frequency of individual types of treatment for LED and their relationship to breast cancer-related lymphedema (BCRL) and PLEDU, we queried claims from a deidentified Health Insurance Portability and Accountability Act-compliant commercial administrative insurance database with >165 million members. A total of 26,902 patients identified with LED who had been enrolled with continuous medical benefits for 12 months before and after the index date for the complete years 2012 through 2016 were separated into four treatment categories: no treatment, conservative care, simple PCD (SPCD), and advanced PCD. LED treatment was related to the BCRL and PLEDU comorbidities. Results BCRL patients, who represented 32.1% of all study patients, made up 41% of all patients receiving conservative care and 24% of patients receiving PCD therapy. By contrast, PLEDU patients (9.6% of study patients) were proportionally under-represented in the conservative care group (7.8%) but composed a disproportionately high share of the PCD therapy group (17.7%). PLEDU patients represented 23.5% of all LED patients prescribed SPCD therapy, whereas BCRL patients composed 10.3% of total LED patient SPCD prescriptions (P Conclusions Our analysis of a large health care administrative database showed clear differences between the way BCRL and PLEDU patients are treated. Compared with BCRL patients, PLEDU patients were less likely to receive conservative care and more likely to be prescribed SPCDs for pneumatic compression therapy. These differences suggest that lymphatic therapy may be undervalued for treatment of chronic venous swelling and prevention and treatment of PLEDU.

Aim: The effect of glucose-lowering agents on diabetes-related complications including cardiovascular (CV) events is of major importance. In the absence of a long-term study, we simulated such a trial using a mathematical model where subjects were given exenatide once-weekly (EQW), which has been shown to improve glycaemic control and reduce weight, systolic blood pressure (SBP) and lipids in patients with type 2 diabetes mellitus (T2DM). Methods: Using the Archimedes Model, we followed a simulated population derived from individuals with T2DM in NHANES who were drug-naive or on oral agents only. We modelled the effects of four treatment strategies including standard care (SC, maintaining levels of control seen in NHANES), intensive glycaemic control (IGC, target HbA1c < 7% with conventional antidiabetic agents) and two versions of EQW added to SC: one with glycaemic and weight reduction only (EQW-1) and one with additional improvements in SBP and lipids (EQW-2). EQW strategies were derived from 52-week clinical trial data. Endpoints included macrovascular and microvascular outcomes. Results: Simulated EQW treatment resulted in earlier benefit and 2–3 times greater relative reductions in major adverse CV events than IGC when compared to SC (6% relative reduction by year 20 for IGC vs. 12 and 17% for the EQW strategies). For microvascular complications, EQW showed comparable benefit to IGC for neuropathy but significantly greater impact on renal complications. Conclusions: This analysis shows that the novel drug EQW has the potential to greatly reduce CV events through its combined effects on glycaemia, weight and other CV risk factors.

Evaluation of: Okerson T, Yan P, Stonehouse A, Brodows R. Effects of exenatide on systolic blood pressure in subjects with Type 2 diabetes. Am. J. Hypertens. 23(3), 334–339 (2010).Type 2 diabetes is often accompanied by other comorbidities that similarly contribute to cardiovascular risk. New antidiabetics including glucagon-like peptide-1 agonists have demonstrated blood glucose control in patients with Type 2 diabetes with a low risk of hypoglycemia and a favorable impact on bodyweight. Evidence suggests that these agents may convey benefit in managing additional cardiovascular risks. In a recent pooled analysis of randomized controlled trial data, Okerson et al. identified a significant reduction in systolic blood pressure in patients treated with exenatide, particularly in patients with elevated systolic blood pressure. This study provides further evidence that glucagon-like peptide-1 agonists confer therapeutic benefit for managing Type 2 diabetes while also managing other cardiovascular risk factors.

Objective To assess medical resource utilization associated with Prader-Willi syndrome (PWS) in the US, hypothesized to be greater relative to a matched control group without PWS. Study design We used a retrospective case-matched control design and longitudinal US administrative claims data (MarketScan) during a 5-year enrollment period (2009–2014). Patients with PWS were identified by Classification of Diseases, Ninth Revision, Clinical Modification diagnosis code 759.81. Controls were matched on age, sex, and payer type. Outcomes included total, outpatient, inpatient and prescription costs. Results After matching and application of inclusion/exclusion criteria, we identified 2030 patients with PWS (1161 commercial, 38 Medicare supplemental, and 831 Medicaid). Commercially insured patients with PWS (median age 10 years) had 8.8-times greater total annual direct medical costs than their counterparts without PWS (median age 10 years: median costs $14 907 vs $819; P < .0001; mean costs: $28 712 vs $3246). Outpatient care comprised the largest portion of medical resource utilization for enrollees with and without PWS (median $5605 vs $675; P < .0001; mean $11 032 vs $1804), followed by mean annual inpatient and medication costs, which were $10 879 vs $1015 (P < .001) and $6801 vs $428 (P < .001), respectively. Total annual direct medical costs were ~42% greater for Medicaid-insured patients with PWS than their commercially insured counterparts, an increase partly explained by claims for Medicaid Waiver day and residential habilitation. Conclusion Direct medical resource utilization was considerably greater among patients with PWS than members without the condition. This study provides a first step toward quantifying the financial burden of PWS posed to individuals, families, and society.

Exenatide once-weekly (ExQW) is a GLP-1 receptor agonist shown to lower glucose and cardiovascular risk factors in patients with type 2 diabetes mellitus (T2DM). The objective of this study was to estimate the clinical benefits and associated economic benefits of treatment with ExQW compared with sitagliptin or pioglitazone in the US.The IMS CORE Diabetes Model, a validated computer simulation model, was used to project lifetime clinical outcomes and complication costs. The costs of glucose-lowering drugs were excluded as not all prices were available. Baseline patient characteristics (mean values: age, 52.5 years; diabetes duration, 6 years; HbA1(c), 8.51%; body mass index, 32.12 kg/m(2)) and clinical data were derived from a phase 3 clinical trial that compared ExQW with sitagliptin or pioglitazone in T2DM patients. At 6 months, patients treated with ExQW had greater improvements in HbA1(c) and body weight than those treated with sitagliptin or pioglitazone. Complication costs were extracted from published sources. Health outcomes and costs were discounted at 3% per year. Sensitivity analyses were performed.Over 35 years, and compared with sitagliptin or pioglitazone, ExQW increased life expectancy by, respectively, 0.28 (13.76 ± 0.17 vs 13.48 ± 0.18) and 0.17 years (13.76 ± 0.17 vs 13.59 ± 0.17), and quality-adjusted life years by, respectively, 0.28 (9.56 ± 0.12 vs 9.28 ± 0.12) and 0.24 years (9.56 ± 0.12 vs 9.32 ± 0.12). ExQW was associated with lower lifetime complication costs: compared with sitagliptin or pioglitazone, ExQW saved, respectively US$2215 (US$55,647 ± 2039 vs US$57,862 ± 2159) and US$933 (US$55,647 ± 2039 vs US$56,580 ± 2007) direct cost per patient. Cost-savings resulted mainly from a lower projected cumulative incidence of cardiovascular diseases and neuropathic complications.Short-term changes in surrogate end-points were used to project lifetime effects on clinical outcomes. Pharmacy costs were excluded from the analyses.Over a patient's lifetime, ExQW was projected to improve health and decrease diabetes-related complication costs compared with sitagliptin or pioglitazone.

Background Previous research demonstrated efficacy of a brief behavioral intervention to reduce incidence of HIV and sexually transmitted infections (STIs) among female sex workers (FSWs) in Tijuana and Ciudad Juarez, Mexico, cities on Mexico's border with the US. We assessed this intervention's cost-effectiveness. Methodology and Principal Findings A life-time Markov model was developed to estimate HIV cases prevented, changes in quality-adjusted life expectancy (QALE), and costs per additional quality-adjusted life year gained (QALY), comparing (in US$2,009) no intervention to a once-only and annual intervention. Future costs and health benefits were discounted annually at 3%. Sensitivity analyses evaluated model robustness. We found that for a hypothetical 1,000 FSWs receiving the once-only intervention, there were 33 HIV cases prevented and 5.7 months of QALE gained compared to no intervention. The additional cost per QALY gained was US$183. For FSWs receiving the intervention annually, there were 29 additional HIV cases prevented and 4.5 additional months of QALE compared to the once-only intervention. The additional cost per QALY was US$1,075. When highly active antiretroviral therapy (HAART) was included in the model, the annual intervention strategy resulted in net savings and dominated both once-only and no intervention strategies, and remained robust across extensive sensitivity analyses. Even when considering clinical benefits from HAART, ignoring added costs, the cost per QALY gained remained below three times the Mexican GDP per capita, and below established cost-effectiveness thresholds. Conclusions/Significance This brief intervention was shown to be cost-effective among FSWs in two Mexico-US border cities and may have application for FSWs in other resource-limited settings. Trial Registration ClinicalTrials.gov NCT00338845