Kim Heithoff

Relationship of nasal congestion with sleep, mood, and productivity

ABSTRACT Objective: To explore the impact of nasal congestion alone relative to a full set of allergic rhinitis (AR) symptoms on sleep, fatigue, daytime somnolence, and work and school productivity in a 15-day prospective, naturalistic study. Research design and methods: Patients (N = 404) received a clinical exam to confirm congestion and assess its possible causes, including confirmed allergic rhinitis. They completed a battery of patient-reported outcomes (PROs) that assess the impact of nasal congestion and morning AR symptoms on patients’ reports of sleep, daytime sleepiness, fatigue, and work, school, and activity impairment. Data were analyzed using multiple regression. Each PRO was regressed separately on congestion and morning AR symptoms, controlling for patient demographics. Results: Nasal congestion has a significant ( p < 0.05), negative impact on patients’ lives. Nasal congestion alone had only a slightly smaller negative impact on sleep adequacy relative to AR symptoms more broadly (congestion: β = 0.137–0.534; AR: β = 0.123–0.642). Congestion increases the likelihood of sleep problems, fatigue, shortness of breath, headache, and daytime somnolence. Conclusions: A single congestion item by itself is a statistically and substantively significant predictor of patient-relevant outcomes. Although the sample was not randomly drawn from clinics or physician offices, the consistency and strength of the findings suggest the salience of this single symptom for patients’ experiences.

Frequency of high-risk patients not receiving high-potency statin (from a large managed care database).

We examined trends in low-density lipoprotein cholesterol (LDL-C) goal attainment in high-risk patients and use of high-potency statins (HPS) in a large, managed-care database from 2004 to 2012. The 2013 American Heart Association/American College of Cardiology prevention guidelines recommend that subjects with atherosclerotic cardiovascular disease (ASCVD) should be prescribed HPS therapy, irrespective of LDL-C levels. Previous guidelines recommend an LDL-C target <70 mg/dl. Patients diagnosed with ASCVD based on International Classification of Diseases, Ninth Revision codes with ≥1 LDL-C test from January 2004 to December 2012 were identified in the Optum Insight database. Patients were identified as treated if they received lipid-lowering therapy (LLT) within 90 days of the LDL-C measurement and untreated if they did not receive LLT treatment. LLT treated patients were stratified into HPS users or non-HPS LLT users. There were 45,101 eligible patients in 2004 and 40,846 in 2012. The proportion of high-risk patients who were treated with LLT increased from 61.4% (2004) to 70.5% (2008) then remained relatively constant until 2012 (67.9%). Mean LDL-C values in treated patients decreased from 103.7 ± 32.1 (2004) to 90.8 ± 31.4 mg/dl (2012). The proportion of patients treated with HPS increased from 13% in 2004 to 26% in 2012. Although the proportion of treated high-risk patients who achieve LDL-C <70 mg/dl levels has increased sharply from 2004, approximately 3 of 4 patients still did not meet this target. Only 1/4 of ASCVD patients are on HPS. In conclusion, our findings highlight the need for renewed efforts to support guideline-based LDL-C treatment for high-risk patients.

Comparative Assessment of Medical Resource Use and Costs Associated with Patients with Symptomatic Peripheral Artery Disease in the United States.

BACKGROUND There is growing concern about appropriate disease management for peripheral artery disease (PAD) because of the rapidly expanding population at risk for PAD and the high burden of illness associated with symptomatic PAD. A better understanding of the potential economic impact of symptomatic PAD relative to a matched control population may help improve care management for these patients. OBJECTIVE To compare the medical resource utilization, costs, and medication use for patients with symptomatic PAD relative to a matched control population. METHODS In this retrospective longitudinal analysis, the index date was the earliest date of a symptomatic PAD record (symptomatic PAD cohort) or any medical record (control cohort), and a period of 1 year pre-index and 3 years post-index was the study time frame. Symptomatic PAD patients and control patients (aged ≥ 18 years) enrolled in the MarketScan Commercial and Encounters database from January 1, 2006, to June 30, 2010, were identified. Symptomatic PAD was defined as having evidence of intermittent claudication (IC) and/or acute critical limb ischemia requiring medical intervention. Symptomatic PAD patients were selected using an algorithm comprising a combination of PAD-related ICD-9-CM diagnostic and diagnosis-related group codes, peripheral revascularization CPT-4 procedure codes, and IC medication National Drug Code numbers. Patients with stroke/transient ischemic attack, bleeding complications, or contraindications to antiplatelet therapy were excluded from the symptomatic PAD group but not the control group. A final 1:1 symptomatic PAD to control population with an exact match based on age, sex, index year, and Charlson Comorbidity Index (CCI) was identified. Descriptive statistics comparing patient demographics, comorbidities, medical resource utilization, cost, and medication use outcomes were generated. Generalized linear models were developed to compare the outcomes while controlling for residual difference in demographics, comorbidities, pre-index resource use, and pre-index costs. RESULTS 3,965 symptomatic PAD and 3,965 control patients were matched. In both cohorts, 54.7% were male, with a mean age (SD) of 69.0 (12.9) years and a CCI score of 1.3 (0.9). Symptomatic PAD patients had more cardiovascular comorbidities than control patients (27.7% vs. 12.6% coronary artery disease, 27.1% vs. 15.9% hyperlipidemia, and 49.8% vs. 28.2% hypertension) in the pre-index period. Post-index rates of ischemic stroke, non-ST segment elevation myocardial infarction, unstable angina, and cardiovascular- or PAD-related procedures (limb amputations, endovascular procedures, open surgical procedures, percutaneous coronary intervention, and coronary artery bypass graft) were higher among symptomatic PAD patients versus control patients. All-cause annualized inpatient admissions (0.46 vs. 0.22 admissions), emergency department/urgent care days (0.27 vs. 0.22 days), and office visit days (12.5 vs. 10.2 days) were higher among symptomatic PAD versus control patients post-index. Annualized all-cause inpatient costs (

Gender Disparities in Lipid-Lowering Therapy in Cardiovascular Disease: Insights from a Managed Care Population.

8,494 vs.

Resource use and costs in high-risk symptomatic peripheral artery disease patients with diabetes and prior acute coronary syndrome: a retrospective analysis

3,778); outpatient costs (

Cost of subcutaneous immunotherapy in a large insured population in the United States

8,459 vs.

Antiplatelet Therapy and Clinical Outcomes Following Myocardial Infarction Among Patients in a U.S. Employer-Based Insurance Database

5,692); and total costs (

A Program To Assist Transitions from Hospital to Home

20,880 vs.

Classification Tree Analysis Of The Likelihood Of Clopidogrel Treatment In A Cohort Of Patients With Symptomatic Peripheral Artery Disease

12,501) were higher among symptomatic PAD versus control patients post-index. Only 17.8% of symptomatic PAD patients versus 6.6% of control patients were on clopidogrel pre-index. In the post-index period, clopidogrel prescriptions in the symptomatic PAD population increased to 38.0%. Results were consistent in the regression models with the symptomatic PAD population having a higher number of all-cause post-index inpatient admissions, emergency department/urgent care days, office visit days, inpatient costs, outpatient costs, and total costs versus control patients (P ≤ 0.026). CONCLUSIONS Symptomatic PAD patients have significantly higher medical resource use and costs when compared with a matched control population. As the prevalence of symptomatic PAD increases, there will be a significant impact on the population and health care system. The rates of use of evidence-based secondary prevention therapies, such as antiplatelet medication, were low. Therefore, greater effort must be made to increase utilization rates of appropriate treatments to determine if the negative economic and clinical impacts of symptomatic PAD can be minimized. DISCLOSURES This study was funded by Merck & Co., Kenilworth, New Jersey. Chase and Heithoff are employees of Merck & Co., Kenilworth, New Jersey, and Upper Gwynedd, Pennsylvania. Friedman and Navaratnam are paid consultants for Merck & Co. Simpson is a paid consultant for Merck, Pfizer, and Amgen and has received speakers fees from Merck and Pfizer. Study concept and design were contributed by Chase, Navaratnam, and Heilhoff, along with Simpson and Friedman. Friedman collected the data, which was interpreted by Simpson and Navaratnam, along with Friedman. The manuscript was written by Navaratnam and Friedman, along with Chase, Heilhoff and Simpson, and revised by all of the authors.

Abstract 355: The Economic and Clinical Burden of High Risk Symptomatic Peripheral Artery Disease

BACKGROUND Numerous studies have documented the strong inverse relationship between low-density lipoprotein cholesterol (LDL-C) levels and atherosclerotic cardiovascular disease (ASCVD). However, women are less likely to be screened for hypercholesterolemia, receive lipid-lowering therapy (LLT), and achieve optimal LDL-C levels. MATERIALS AND METHODS Data were extracted from a U.S. administrative claims database between January 2008 and December 2012 for patients with established ASCVD. The earliest date of valid LDL-C value was defined as the index date. Patients were followed for ±12 months from the index date and were stratified by gender, by baseline LDL-C level, and whether they were initially treated with a LLT then propensity score matched by gender using demographic and clinical characteristics. Both descriptive statistics and logistic regression models were used to explore the association of gender with the frequency of LDL-C monitoring, LLT treatment initiation in initially untreated patients, and prescribing patterns in initially treated patients. RESULTS A total of 76,414 subjects with established ASCVD were identified; 42% of the sample was women. In the unmatched cohort, 50.3% of men and 32.0% of women were prescribed a preindex statin (p < 0.0001). Among matched patients (n = 51,764), women initially treated with LLT were significantly less likely to receive a prescription for a higher potency LLT. Even among those with LDL-C levels above 160 mg/dL, women were more likely to discontinue LLT, odds ratio (95% confidence interval) 1.8 (1.2-2.3). Female gender and older age were significant predictors of discontinuation, and the potency of the index medication was the strongest predictor of dose titration. Initially untreated women were less likely to initiate LLT treatment than men, irrespective of index LDL-C levels (p < 0.0001). CONCLUSIONS The observed disparities further reinforce the need for targeted efforts to reduce the gender gap for secondary prevention in women at high risk of cardiovascular disease.