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Background:Health-related expenditures due to diabetes mellitus (DM) are rising in the US. Medication nonadherence is associated with worse health outcomes, particularly among individuals with DM who require uninterrupted treatment. We sought to determine whether patients with DM in the US report cost-related nonadherence (CRN), a potential consequence of rising drug costs.Methods:We used the National Health Interview Survey (2013-18), a nationally representative study, to identify participants with and without self-reported DM. Participants were considered to have experienced CRN if during the preceding year they reported skipping doses, taking less medication, or delaying filling a prescription to save money.Results:Of the 20,326 participants with DM, a weighted 14% (or 3 million annually) experienced CRN, including 9.5% skipping doses, 9.9% taking less medicine, and 11.8% delaying prescription filling to save money. Compared to those without DM (N=145,186), participants with DM reported a higher prevalence of CRN, with the largest differences being observed among non-elderly adults (Figure). Among non-elderly adults with DM, a weighted 19.4% (or 2.3 million annually) reported CRN. In multivariable logistic regression models, the main drivers of CRN among participants with DM were lack of insurance (OR 4.34, 95% CI 3.49, 5.39), younger age (OR 3.43, 95% CI 2.65, 4.44), low income (OR 1.82, 95% CI 1.58, 2.09), use of insulin (OR 1.19, 95% CI 1.04, 1.35), and unfavorable risk factor profile (OR 1.53, 95% CI 1.21, 1.93) (Table).Conclusion:In the US, 1 in 7 adults with DM reported CRN, and the burden was highest among non-elderly adults. Cost represents a serious barrier for therapy adherence among individuals with DM in the US, particularly among the most vulnerable. Removing financial barriers to accessing medications may improve adherence to essential therapies among individuals with DM, and ultimately improving outcomes.

Introduction:The impact of respiratory failure on patients undergoing left ventricular assist device (LVAD) implantation is not well understood, especially since these patients were excluded from landmark clinical trials.Hypothesis:We assessed the hypothesis that immediate pre- and post-implant respiratory failure is associated with worse outcomes in advanced heart failure patients undergoing LVAD implantation.Methods:We included all patients in the INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) who were implanted with continuous-flow LVADs from 2008 to 2016.Results:Of the 16,362 patients who underwent continuous-flow LVAD placement, 906 (5.5%) required pre-implant intubation within 48 hours prior to implantation, and 1,001 (6.1%) patients developed respiratory failure within 1-week after implantation. A higher proportion of patients requiring pre-implant intubation were INTERMACS Profile 1, required mechanical circulatory support, and presented with cardiac arrest or myocardial infarction (P<0.001, all). At 1-year, 54.3% of patients intubated pre-implant were alive, 20.1% had been transplanted, and 24.2% died (Figure). After multivariable analysis, both pre-implant intubation (Hazard ratio [HR]; 1.24, 95% Confidence Interval [CI], 1.06-1.45; P=0.007) and respiratory failure within 1-week (HR 2.60; 95% CI, 2.31-2.92; P<0.001) were associated with higher all-cause 1-year mortality. Among INTERMACS Profile 1 patients, pre-implant intubation incurred additional risk of death at 1-year (HR 1.67; 95% CI, 1.40-2.00; p<0.001).Conclusions:Respiratory failure both prior to and immediately after LVAD implantation identifies an advanced heart failure population with significantly worse 1-year mortality. This data might be helpful in counseling patients and their families about expectations regarding life with an LVAD.

Background:Left ventricular assist devices (LVADs) improve outcomes in patients with advanced heart failure (HF), but little is known about the role of neurohormonal blockade (NHB) in the clinical management of these patients.Objective:We sought to evaluate the association between NHB and survival in patients with chronic LVADs.Methods:We conducted a retrospective cohort analysis of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) and included patients implanted with their first continuous flow LVAD between 2008-2016. We examined survival probability from 6 months to 4 years after implantation based on exposure to different combinations of NHB: angiotensin converting enzyme inhibitors or angiotensin receptor blockers (ACEi/ARB), beta blockers (BB), and mineralocorticoid antagonists (MRA).Results:A total of 12,200 patients met inclusion criteria of which 10,419 were on NHB. Use of any NHB was associated with significantly better survival at 4 years compared with those not on any form of NHB (hazard ratio [HR] 0.67, 95% confidence interval [CI] 0.59-0.75; p<0.001.) Kaplan-Meier survival analysis revealed that patients on triple therapy with an ACEi/ARB, BB, and MRA or dual therapy with an ACEi/ARB and MRA had better survival compared to any other therapy (71.0%, CI 67.4-74.7 versus 55.0%, CI 53.0-57.1; HR 0.60, CI 0.53-0.68; p<0.001) (Figure). After adjusting for change in medication group over time, demographics, comorbidities, and NYHA class, patients on triple therapy had the lowest risk of death compared to patients not on NHB (HR 0.36, CI 0.30-0.42; p<0.001).Conclusion:Use of NHB is associated with improved survival among patients with chronic LVADs. Our results suggest the potential for synergy between intensive NHB and mechanical unloading for patients with advanced HF.Figure.Kaplan-Meier survival curve based on medication group at 6 months post-LVAD implantation (A) and number at risk (B).

Background:The growing out-of-pocket costs among patients with diabetes mellitus (DM) represents a serious risk of financial hardship for Americans. In this study, we describe the national burden of financial hardship from medical bills among non-elderly individuals with DM, and its association with financial distress, food security, cost-related medication non-adherence (CRN), and rates of foregone/delayed medical care.Research Design and Methods:We used the National Health Interview Survey data from 2013 to 2017, including individuals from 18 to 64 years old with a self-reported history of diabetes.Results:of 164,696 surveyed individuals, 123,706 were 18-64 years of age and 8,967 reported having DM, representing 13.1 million non-elderly adults annually across the United States. Mean age was 51.6 years (SD 10.3) and 49.1% were female. An estimated of 5.4 million (41.1%) were part of families that reported having financial hardship from medical bills, with 2 million (15.6%) reporting an inability to pay medical bills at all. In multivariate analyses, individuals who were uninsured had 2.26 (95% CI, 1.82 - 2.81) and 3.22 (95% CI, 2.61 - 3.97) higher odds of having any financial hardship from medical bills and being unable to pay bills at all, respectively. Non-Hispanic Blacks and those with low income or high-comorbidity burden were also at higher risk of such outcomes. When comparing the graded categories of financial hardship from medical bills, there was a stepwise increase in the prevalence of high financial distress, food insecurity, CRN, and foregone/delayed medical care, reaching 70.5%, 49.4%, 49.5%, and 74% among those unable to pay bills, respectively (Figure).Conclusions:Our results highlight that a substantial proportion of non-elderly DM patients and their families in the United States struggle with medical bills and its deleterious unintended consequences.