Robert J. Sanchez

Vascular access outcomes and medication use: a USRDS study.

Several medications have been proposed to improve hemodialysis (HD) vascular access outcomes based on potentially favorable anticoagulant, antiplatelet, or pleiotropic properties. The purpose of this study was to evaluate the relationship between medication use and vascular access patency in a group of HD patients. We conducted a historical cohort study of the US Renal Data System Dialysis Mortality and Morbidity Wave II study to identify patients with an arteriovenous fistula (AVF), polytetrafluoroethylene (PTFE) graft, or a permanent catheter for vascular access. Cox regression analysis, adjusted for age, gender, race, history of coronary artery disease, peripheral vascular disease, or coronary artery bypass graft, was used to model the hazard ratio (HR) of permanent vascular access failure. Of the 2001 HD patients in the Wave II study, 901 (45%) were included in the analysis. PTFE graft patency was greater for males (HR, 0.73; 95% CI 0.53–1.00, p = 0.05) and for older individuals (HR, 0.99; 95% CI 0.98–1.00, p = 0.02). Treatment with antiplatelet medications, ticlopidine and dipyridamole (HR, 3.54; 95% CI 1.07–11.76; p = 0.04), or aspirin (HR, 2.49; 95% CI 1.31–4.73; p = 0.005) was associated with significantly worse AVF patency. Antiplatelet agents had a significant negative association with access patency in this cohort. In contrast to other published data, it was difficult to identify any beneficial effect of specific medications on access patency.

Stent Placement Versus Angioplasty Improves Patency of Arteriovenous Grafts and Blood Flow of Arteriovenous Fistulae

BACKGROUND While endovascular stent placement is the standard of care in most percutaneous coronary and peripheral artery intervention, its role in the salvage of thrombosed and stenotic hemodialysis access remains controversial. DESIGN, SETTING, PARTICIPANTS, AND MEASUREMENTS We compared the effects of stent versus angioplasty on primary patency rates in the treatment of stenotic arteriovenous fistulae (AVF) and arteriovenous grafts (AVGs). Moreover, we compared access flow (Qa) and urea reduction ratio (URR) between the two groups as a metric of the effect of stent placement versus angioplasty on dialysis delivery. RESULTS Cox regression analysis revealed that the primary assisted AVG patency was significantly longer for the stent group compared with angioplasty, with a median survival of 138 versus 61 d, respectively (aHR = 0.17; 95% confidence interval, 0.07 to 0.39; P < 0.001). The primary AVG patency for stent versus angioplasty was 91% versus 80% at 30 d, 69% versus 24% at 90 d, and 25% versus 3% at 180 d, respectively. The primary assisted AVF patency did not differ significantly between the stent and angioplasty groups. In patients dialyzing via AVF, multiple regression analysis revealed that stent placement was associated with improved after intervention peak Qa, 1627.50 ml/min versus 911.00 ml/min (beta = 0.494; P = 0.008), change in Qa from before to after intervention, 643.54 ml/min versus 195.35 ml/min (beta = 0.464; P = 0.012), and change in URR from before to after intervention, 5.85% versus 0.733% (beta = 0.389; P = 0.039). CONCLUSIONS Our results suggest that stent placement is associated with improved AVG primary assisted patency and improved AVF blood flow, which may significantly impact on dialysis adequacy.

Longitudinal evaluation of health care utilization and costs during the first three years after a new diagnosis of fibromyalgia.

Abstract Objective: To evaluate health care resource utilization and costs 1 year before and 3 years after a fibromyalgia (FM) diagnosis. Methods: This retrospective cohort analysis used claims from Humana to identify newly diagnosed FM patients ≥18 years of age based on ≥2 medical claims for ICD-9 CM code 729.1 and 729.0 between June 1, 2002 and March 1, 2005. Prevalence of comorbidities, as well as utilization and costs of pharmacotherapy and health care services were examined for 12 months preceding (pre-diagnosis) and 36 months following (post-diagnosis) the date of first FM diagnosis. These periods were subdivided into 6-month blocks to better observe patterns of change. Results: We identified 2613 FM patients who had a mean age at diagnosis of 58.5 ± 15.3 years and a mean Charlson Comorbidity Index of 0.48 ± 1.05. Of those, 73% were female. The use and costs of pain-related medications rose from pre-diagnosis and remained stable after the 6-month post-diagnosis period, while the use of non-pain-related medications steadily rose from pre-diagnosis to 3 years post-diagnosis. This increase was concomitant with an increase in the presence of conditions that may account for higher resource utilization. The use of recommended FM therapies (i.e., antidepressants and anticonvulsants) increased post-diagnosis but remained less common than other pain-related therapies. Total resource utilization and costs increased during the period up to 6 months after diagnosis. This increase was followed by a decline (7–12 months post-diagnosis), and plateau, with an increase during the final 6 months of the study period. Total mean per patient costs were

Real-world evaluation of health-care resource utilization and costs in employees with fibromyalgia treated with pregabalin or duloxetine.

3481 for the 6-month post-diagnosis period, and

Evaluation of healthcare resource utilization and costs in employees with pain associated with diabetic peripheral neuropathy treated with pregabalin or duloxetine.

3588 for the final 6 months. Limitations include potential errors in coding and recording, and an inability of claims analyses to determine causality between resource utilization and the specific diagnosis of interest. Conclusions: An FM diagnosis was associated with increased utilization and pain-related medication cost up to the first 6 months post-diagnosis followed by stabilization over 3 years post-diagnosis. Less use of recommended therapies relative to other therapies suggests that further dissemination of treatment guidelines is needed. An increase in non-pain medications over the observation period accounted for the majority of pharmacy costs. These pharmacy costs may be related to an increasing prevalence of comorbid conditions.

Patterns of Statin Use in a Real-World Population of Patients at High Cardiovascular Risk

Objective:  To evaluate changes in health‐care resource use and costs after initiating pregabalin or duloxetine in employees with fibromyalgia (FM).

Tracking low back problems in a major self-insured workforce: toward improvement in the patient's journey.

Abstract Objective: To evaluate changes in healthcare resource use and costs after initiating pregabalin or duloxetine in employees with pain associated with diabetic peripheral neuropathy (pDPN). Methods: Employees (18–64 years old) with a DPN diagnosis and at least one pDPN-related pain medication claim were identified using the MarketScan Commercial Database (2005–2008). Propensity scored matched pregabalin and duloxetine new starts were evaluated in the 6-month pre- and 6-month post-initiation periods. Study outcomes including imputed medically-related work loss, prescription and healthcare utilization, and associated expenditures were analyzed using univariate statistics and multivariate models in a difference-in-difference approach. Results: A total of 473 employees in each treatment group were identified. Mean age was 53.6 (SD 7.0) years for pregabalin and 53.5 (SD 7.4) years for duloxetine. There were no pre-index differences between groups. Adjusted marginal effects were not statistically significant for pre-to-post changes in opioid utilization (p = 0.328), number of pDPN-related analgesic medications (p = 0.506), all-cause healthcare costs (p = 0.895), indirect costs (p = 0.324), or pDPN-attributable expenditures (p = 0.359). Limitations: Claims analysis is limited in accounting for all patient and plan differences, and by the reliability of medical claims for diagnosis coding. The sample size of the matched cohorts may have limited the power of the analysis to detect differences. Conclusions: There were no significant pre-to-post differences between pregabalin and duloxetine treatment groups in pDPN-related analgesic medication use, or pDPN-attributable, all-cause, and indirect expenditures.

Health Care Costs in Patients with Fibromyalgia on Pregabalin vs. Duloxetine

BACKGROUND Widespread use of statins has improved hypercholesterolemia management, yet a significant proportion of patients remain at risk for cardiovascular (CV) events. Analyses of treatment patterns reveal inadequate intensity and duration of statin therapy among patients with hypercholesterolemia, and little is known about real-world statin use, specifically in subgroups of patients at high risk for CV events. OBJECTIVE To examine patterns of statin use and outcomes among patients with high-risk features who newly initiated statin monotherapy. METHODS Adult patients (aged > 18 years) at high CV risk who received > 1 prescription for statin monotherapy and who had not received lipid-modifying therapy during the previous 12 months were identified from the Truven MarketScan Commercial and Medicare Supplemental databases (from January 2007 to June 2013). Patients with atherosclerotic cardiovascular disease (ASCVD) or diabetes were hierarchically classified into 5 mutually exclusive CV risk categories (listed here in order from highest to lowest risk): (1) recent CV event (subcategorized by hospitalization for acute coronary syndrome [ACS] or other non-ACS CV event within 90 days of index); (2) coronary heart disease (CHD); (3) history of ischemic stroke; (4) peripheral artery disease (PAD); and (5) diabetes. Outcomes of interest included changes in therapy, proportion of days covered (PDC), time to discontinuation, and proportion of patients with ASCVD-related inpatient visit during the follow-up period. Statin therapy was subdivided into high-intensity treatment (atorvastatin 40 mg or 80 mg, rosuvastatin 20 mg or 40 mg, or simvastatin 80 mg) or moderate- to low-intensity treatment (all other statins and statin dosing regimens). Follow-up data were obtained from the index date (statin initiation) until the end of continuous enrollment. RESULTS A total of 541,221 patients were included in the analysis. The majority of patients were stratified in the diabetes cohort (61.1%), followed in frequency by recent ACS event (15.8%), recent non-ACS CV event (9.9%), PAD (4.7%), CHD (4.4%), and history of ischemic stroke (4.1%). Only 15.0% of the population initiated therapy with a high-intensity statin, and 22.5% of these high-intensity statin initiators switched to a moderate- to low-intensity regimen during the follow-up period. Median time to statin discontinuation was approximately 15 months. Duration of treatment was longer among those who were treated with a high-intensity versus a moderate- to low-intensity statin regimen (21 and 15 months, respectively). The PDC was highest in the recent ACS hospitalization cohort (66.4%) and lowest in the diabetes cohort (55.5%). The PDC was significantly greater among patients who initiated treatment with a high-intensity statin regimen than with a moderate- to low-intensity statin regimen (62.1% vs. 57.5%, respectively; P< 0.001). At 1 year, Kaplan-Meier estimates of the cumulative rates for ASCVD-related hospitalizations ranged from 3.5% (diabetes) to 21.8% (recent ACS hospitalization). CONCLUSIONS Patients at high risk for CV events are suboptimally dosed with statins, have high rates of discontinuation, and have low rates of adherence. Despite the use of statin therapy, ASCVD-related inpatient visit rates were high, particularly among those patients at highest risk because of a recent ACS hospitalization. Future interventions are required to ensure that high-risk patients are effectively managed to reduce subsequent morbidity and mortality. DISCLOSURES Support for this research was provided by Regeneron Pharmaceuticals, Tarrytown, New York, and Sanofi US, Bridgewater, New Jersey. Menzin and Lin are employees of Boston Health Economics, which received consulting fees from Sanofi. Friedman is a consultant to Boston Health Economics. Lin, Friedman, and Menzin have received research support from Sanofi US. Sung, Mallya, Panaccio, and Koren are employees of Sanofi US and also have ownership interest in Sanofi US. Sanchez is an employee of and has ownership interest in Regeneron Pharmaceuticals. Neumann has served on advisory boards for Merck & Co, Takeda Pharmaceutical Company, Genentech, Novartis, Bayer AG, UCB, Sanofi US, Robert Wood Johnson Foundation, and Cubist and serves as consultant for Boston Health Economics, Forrest, P urdue, and Smith and Nephew. This research has been presented in part at the International Society for Pharmacoeconomics and Outcomes Research, 20th Annual International Meeting, May 16-20, 2015, Philadelphia, Pennsylvania. All authors contributed to the study design, protocol development, and results interpretation. Lin and Menzin were responsible for conducting the study analyses. All authors were involved in manuscript development and approved the submitted version.

Health Outcomes and Costs among Employees with Fibromyalgia Treated with Pregabalin vs. Standard of Care

Objective: To assess the cost outcomes of treatment approaches to care for back problems in a major self-insured workforce, using published guidelines to focus on low back pain. Methods: Longitudinally tracked episodes of three types of International Classification of Diseases, Ninth Revision diagnosis code–identified back problems (n = 14,787) during 2001 to 2009. Identified five patterns of care on the basis of the first 6 weeks of claims and compared their total costs per episode with tests that included splits by episode type and duration, use of guidelines, and propensity-derived adjustments. Results: Care congruent with 10 of 11 guidelines was linked to lower total costs. Of the five patterns, complex medical management and chiropractic reported the highest and lowest rates, respectively, of guideline-incongruent use of imaging, surgeries, and medications, and the highest and lowest total costs. Conclusions: Approaches marked by higher resource utilization and lower guideline congruence are linked to greater low back pain total costs. Total cost is a needed input for guideline development.

Use of Lipid-Modifying Therapy and LDL-C Goal Attainment in a High-Cardiovascular-Risk Population in the Netherlands

Background:  The economic burden associated with fibromyalgia in the U.S. is substantial. The objective of this study was to compare changes in health care costs in fibromyalgia patients initiated on pregabalin and duloxetine in real‐world settings.