Sean McElligott

Prevalence and Trends of Metabolic Syndrome in the Adult U.S. Population, 1999-2010

OBJECTIVES This study sought to characterize the prevalence of metabolic syndrome (MetS), its 5 components, and their pharmacological treatment in U.S. adults by sex and race/ethnicity over time. BACKGROUND MetS is a constellation of clinical risk factors for cardiovascular disease, stroke, kidney disease, and type 2 diabetes mellitus. METHODS Prevalence estimates were estimated in adults (≥ 20 years of age) from the National Health and Nutrition Examination Survey (NHANES) from 1999 to 2010 (in 2-year survey waves). The biological thresholds, defined by the 2009 Joint Scientific Statement, were: 1) waist circumference ≥ 102 cm (males adults) and ≥ 88 cm (female adults); 2) fasting plasma glucose ≥ 100 mg/dl; 3) blood pressure of ≥ 130/85 mm Hg; 4) triglycerides ≥ 150 mg/dl; and 5) high-density lipoprotein-cholesterol (HDL-C) <40 mg/dl (male adults) and <50 mg/dl (female adults). Prescription drug use was estimated for lipid-modifying agents, anti-hypertensives, and anti-hyperglycemic medications. RESULTS From 1999 and 2000 to 2009 and 2010, the age-adjusted prevalence of MetS (based on biologic thresholds) decreased from 25.5% (95% confidence interval [CI]: 22.5% to 28.6%) to 22.9% (95% CI: 20.3% to 25.5%). During this period, hypertriglyceridemia prevalence decreased (33.5% to 24.3%), as did elevated blood pressure (32.3% to 24.0%). The prevalence of hyperglycemia increased (12.9% to 19.9%), as did elevated waist circumference (45.4% to 56.1%). These trends varied considerably by sex and race/ethnicity. Decreases in elevated blood pressure, suboptimal triglycerides, and high-density lipoprotein-cholesterol prevalence have corresponded with increases in anti-hypertensive and lipid-modifying drugs, respectively. CONCLUSIONS The increasing prevalence of abdominal obesity, particularly among female adults, highlights the urgency of addressing abdominal obesity as a healthcare priority. The use of therapies for MetS components aligns with favorable trends in their prevalence.

Effect of the Medicare Part D Coverage Gap on Medication Use Among Patients With Hypertension and Hyperlipidemia

BACKGROUND Prior studies of the Medicare Part D coverage gap are limited in generalizability and scope. OBJECTIVE To determine the effect of the coverage gap on drugs used for asymptomatic (antihypertensive and lipid-lowering drugs) and symptomatic (pain relievers, acid suppressants, and antidepressants) conditions in elderly patients with hypertension and hyperlipidemia. DESIGN Quasi-experimental study using pre-post design and contemporaneous control group. SETTING Medicare claims files from 2005 and 2006 for 5% random sample of Medicare beneficiaries. PATIENTS Part D plan enrollees with hypertension or hyperlipidemia aged 65 years or older who had no coverage, generic-only coverage, or both brand-name and generic coverage during the gap in 2006. Patients who were fully eligible for the low-income subsidy served as the control group. MEASUREMENTS Monthly 30-day supply prescriptions available, medication adherence, and continuous medication gaps of 30 days or more for antihypertensive or lipid-lowering drugs; monthly 30-day supply prescriptions available for pain relievers, acid suppressants, or antidepressants before and after coverage gap entry. RESULTS Patients with no gap coverage had a decrease in monthly antihypertensive and lipid-lowering drug prescriptions during the coverage gap. Nonadherence also increased in this group (antihypertensives: odds ratio [OR], 1.60 [95% CI, 1.50 to 1.71]; lipid-lowering drugs: OR, 1.59 [CI, 1.50 to 1.68]). The proportion of patients with no gap coverage who had continuous medication gaps in lipid-lowering medication use and antihypertensive use increased by an absolute 7.3% (OR, 1.38 [CI, 1.29 to 1.46]) and 3.2% (OR, 1.35 [CI, 1.25 to 1.45]), respectively, because of the coverage gap. Decreases in use were smaller for pain relievers and antidepressants and larger for acid suppressants in patients with no gap coverage. Patients with generic-only coverage had decreased use of cardiovascular medications but no change in use of drugs for symptomatic conditions. No measures changed in the brand-name and generic coverage groups. Results of sensitivity analyses were consistent with the main findings. LIMITATION Because this study was nonrandomized, unobserved differences may still exist between study groups. CONCLUSION The Part D coverage gap was associated with decreased use of medications for hypertension and hyperlipidemia in patients with no gap coverage and generic-only gap coverage. The proposed phasing out of the gap by 2020 will benefit such patients; however, use of low-value medications may also increase. PRIMARY FUNDING SOURCE Penn-Pfizer Alliance and American Heart Association.

Problem solving to improve adherence and asthma outcomes in urban adults with moderate or severe asthma: A randomized controlled trial

BACKGROUND Improving inhaled corticosteroid (ICS) adherence should improve asthma outcomes. OBJECTIVE In a randomized controlled trial we tested whether an individualized problem-solving (PS) intervention improves ICS adherence and asthma outcomes. METHODS Adults with moderate or severe asthma from clinics serving urban neighborhoods were randomized to PS (ie, defining specific barriers to adherence, proposing/weighing solutions, trying the best, assessing, and revising) or standard asthma education (AE) for 3 months and then observed for 3 months. Adherence was monitored electronically. Outcomes included the following: asthma control, FEV(1), asthma-related quality of life, emergency department (ED) visits, and hospitalizations. In an intention-to-treat-analysis longitudinal models using random effects and regression were used. RESULTS Three hundred thirty-three adults were randomized: 49 ± 14 years of age, 72% female, 68% African American, 7% Latino, mean FEV(1) of 66% ± 19%, and 103 (31%) with hospitalizations and 172 (52%) with ED visits for asthma in the prior year. There was no difference between groups in overall change in any outcome (P > .20). Mean adherence (61% ± 27%) decreased significantly (P = .0004) over time by 14% and 10% in the AE and PS groups, respectively. Asthma control improved overall by 15% (P = .002). In both groups FEV(1) and quality of life improved by 6% (P = .01) and 18% (P < .0001), respectively. However, the improvement in FEV(1) only occurred during monitoring but not subsequently after randomization. Rates of ED visits and hospitalizations did not significantly decrease over the study period. CONCLUSION PS was not better than AE in improving adherence or asthma outcomes. However, monitoring ICS use with provision of medications and attention, which was imposed on both groups, was associated with improvement in FEV(1) and asthma control.

Cost Effectiveness of Personalized Therapy for First-Line Treatment of Stage IV and Recurrent Incurable Adenocarcinoma of the Lung

PURPOSE Patients with epidermal growth factor receptor (EGFR) mutation-positive stage IV adenocarcinoma have improved survival with tyrosine kinase inhibitor (TKI) treatments, but the cost effectiveness of personalized first-line therapy using EGFR mutation testing is unknown. METHODS We created a decision analytic model comparing the costs and effects of platinum combination chemotherapy with personalized therapy in which patients with EGFR mutation-positive tumors were treated with erlotinib. We used two testing strategies: testing only those with tissue available and performing a repeat biopsy if tissue was not available versus three nontargeted chemotherapy regimens (ie, carboplatin and paclitaxel; carboplatin and pemetrexed; and carboplatin, pemetrexed, and bevacizumab). RESULTS Compared with a carboplatin plus paclitaxel regimen, targeted therapy based on testing available tissue yielded an incremental cost-effectiveness ratio (ICER) of

Impact of shortages of injectable oncology drugs on patient care.

110,644 per quality-adjusted life year (QALY), and the rebiopsy strategy yielded an ICER of

Electrocardiographic Screening for Hypertrophic Cardiomyopathy and Long QT Syndrome: The Drivers of Cost-Effectiveness for the Prevention of Sudden Cardiac Death

122,219 per QALY. Probabilistic sensitivity analysis revealed substantial uncertainty around these point estimates. With a willingness to pay of

How Genetic Variant Libraries Effectively Extend Gene Testing Patents: Implications for Intellectual Property and Good Clinical Care

100,000 per QALY, the testing strategy was cost effective 58% of the time, and the rebiopsy strategy was cost effective 54% of the time. Personalized therapy with an EGFR TKI was more favorable when the nontargeted chemotherapy regimen was more expensive. Compared with carboplatin, pemetrexed, and bevacizumab, ICERs were

The opportunity costs of screening children for asthma

25,547 per QALY for the testing strategy and

Albuterol and levalbuterol use and spending in medicare beneficiaries with chronic obstructive pulmonary disease

44,036 per QALY for the rebiopsy strategy. CONCLUSION Although specific clinical circumstances should guide therapy, our cost-effectiveness analysis supports the strategy of testing for EGFR mutations in patients with stage IV or recurrent adenocarcinoma of the lung, rebiopsying patients if insufficient tissue is available for testing, and treating patients with EGFR mutations with erlotinib as first-line therapy.

Comparative Effectiveness And Cost-Effectiveness Analyses Frequently Agree On Value

PURPOSE Results of a survey regarding shortages of injectable oncology drugs in U.S. hospitals and health systems are presented. METHODS An online survey was sent to all members of the American Society of Health-System Pharmacists self-identified as directors of pharmacy. Survey participants provided information on the extent to which their facilities were affected by oncology drug shortages, strategies for responding to shortages, and the effects of shortages on costs, patient safety, and outcomes. RESULTS Ninety-eight percent of the 358 survey respondents reported at least one drug shortage during the previous 12 months, with 70% reporting instances of an inadequate supply to treat patients and 63% reporting that their facility had completely run out of at least one injectable oncology drug. Sixty-two percent of respondents reported using alternative drug regimens due to shortages; 46% reported drug dosage changes, 43% reported treatment delays, and 21% reported patient referrals to or from other facilities as a result of shortages. Survey respondents indicated the use of various strategies to manage oncology drug shortages (e.g., increasing inventories of certain drugs, identifying alternatives and substitution protocols, altered purchasing practices), all of which have led to cost increases. Twenty-five percent of respondents reported safety events resulting from oncology drug shortages. Only 40% of respondents agreed that currently available information is useful in mitigating the effects of shortages. CONCLUSION Shortages of injectable oncology drugs appear to be widespread and to be having a significant impact on patient care. Currently available information about shortages does not meet administrative or clinical needs.