No Evidence of an Association Between Efavirenz Exposure and Suicidality Among HIV Patients Initiating Antiretroviral Therapy in a Retrospective Cohort Study of Real World Data.

Recently, published studies have reported conflicting results regarding the association between efavirenz exposure and the risk of suicidality among patients with human immunodeficiency virus. The objective of this analysis was to compare the rate of suicidality among patients initiating efavirenz-containing versus efavirenz-free antiretroviral (ARV) regimens.This retrospective cohort study used US administrative claims data for commercially and Medicaid-insured individuals for the years 2006 to 2013. ARV-naive patients aged ≥12 years initiating an efavirenz-containing or efavirenz-free ARV regimen with ≥6 months of continuous insurance enrollment prior to ARV initiation were selected. The primary outcome was suicidality, defined as the occurrence of any medical claim with a diagnosis code for suicidal ideation or an inpatient or emergency department medical claim for suicide attempt. Unadjusted incidence rates were calculated and propensity score-adjusted hazard ratios were estimated to account for differences in patient characteristics.There were 19,983 patients (efavirenz-containing, n = 11,187; efavirenz-free, n = 8796) in the commercial database and 5154 patients (efavirenz-containing, n = 2224; efavirenz-free, n = 2930) in the Medicaid database. Unadjusted incidence rates (95% confidence interval [CI]) of suicidality per 1000 person-years were: commercial, efavirenz-containing (3.3 [2.4-4.4]), efavirenz-free (4.0 [2.7-5.8]); Medicaid, efavirenz-containing (25.7 [18.8-34.4]), efavirenz-free (40.6 [31.9-50.9]). In propensity score-adjusted analyses, efavirenz use was not associated with suicidality: adjusted hazard ratio (95% CI) of suicidality compared with efavirenz-free regimen, commercial, 1.029 (0.636-1.665); Medicaid, 0.902 (0.617-1.319).This analysis found no conclusive evidence of an increased risk of suicidality among patients initiating an efavirenz-containing ARV regimen. However, channeling bias may exist even after adjusting for measured patient characteristics.

The economic consequences of rheumatoid arthritis: analysis of Medical Expenditure Panel Survey 2004, 2005, and 2006 data.

OBJECTIVE: Determine the prevalence and costs of rheumatoid arthritis (RA) during three consecutive years: 2004, 2005, and 2006. METHODS: Medical Expenditure Panel Survey was used for persons with RA. Regressions estimate health care costs and income loss. Absenteeism and age-adjusted workforce participation compared means and rates. RESULTS: The prevalence of RA was 0.40% in 2004, 0.44% in 2005, and 0.43% in 2006. Health care cost associated with RA was $4422, $2902, and $1882 (all P < 0.01) in 2004, 2005, and 2006, respectively. Rheumatoid arthritis sufferers were employed, 36.8%, 39.5%, and 44% compared with 70.5%, 69.8%, and 71%. Individuals with RA also missed more days of work, 4.86 in 2004 (P = 0.04), 1.70 in 2005 (P = 0.22), and 2.99 in 2006 (P = 0.04). Rheumatoid arthritis reduced income by $2404 (P = 0.03), $2207 (P < 0.001), and $1212 (P = 0.002). CONCLUSIONS: Costs of RA are considerable.

Proposed severity and response criteria for Routine Assessment of Patient Index Data (RAPID3): results for categories of disease activity and response criteria in abatacept clinical trials.

BACKGROUND: An index is needed to assess the status of patients with rheumatoid arthritis (RA), as none of the existing measures are applicable to all individual patients. The 28-joint Disease Activity Score (DAS28) is the most specific and widely used index. Routine Assessment of Patient Index Data (RAPID3) is an index containing only the 3 patient self-report core dataset measures, without a laboratory test or formal joint count, and with simple scoring. RAPID3 is correlated significantly with DAS28, but calculated in 5-10 seconds on a Multidimensional Health Assessment Questionnaire (MDHAQ), compared to 114 seconds for DAS28. METHODS: DAS28 (0-10 scale) categories for high, moderate, and low activity, and remission (≤ 2.6, 2.6-3.2, 3.21-5.1, and > 5.1, respectively) and proposed RAPID3 (0-30 scale) categories for severity (0 ≤ 3, 3.1-6, 6.1-12, and > 12) were compared in patients taking abatacept and control-treated patients at the endpoint of the Abatacept in Inadequate Response to Methotrexate (AIM) and the Abatacept Trial in Treatment of Anti-TNF INadequate Responders (ATTAIN) clinical trials, using cross-tabulations and kappa statistics. RESULTS: Overall, 92%-99% of patients classified as having high DAS28 activity had high or moderate RAPID3 severity, while 64%-83% in DAS28 remission had RAPID3 low severity or remission; 50%-82% of patients with good or poor EULAR responses had good or poor RAPID3 responses. Kappa values ranged from 0.25 to 0.48, and weighted kappas from 0.32 to 0.52, indicating fair to moderate agreement for the 2 indices. CONCLUSION: Proposed RAPID3 severity and response categories yield comparable results to DAS28 and EULAR criteria in AIM and ATTAIN. DAS28 is more specific for clinical trials. RAPID3 does not preclude also scoring DAS28, and may be informative in the infrastructure of routine care.

The moderating impact of ethnicity on metabolic outcomes during treatment with olanzapine and aripiprazole in patients with schizophrenia.

OBJECTIVE: Race is strongly associated with risk for metabolic dysfunction, but there is limited prospective data concerning the impact of race on antipsychotic metabolic outcomes among patients with schizophrenia. METHOD: This study is a post hoc analysis of data from a 26-week, double-blind, randomized trial of aripiprazole (N = 155) and olanzapine (N = 159) conducted from April 2000 through June 2001 in patients aged >or= 18 years with acute schizophrenia according to DSM-IV criteria. The data were analyzed on the basis of racial breakdown: white and black/Hispanic. Between-drug and within-drug outcomes were analyzed separately for each racial cohort across weight, lipid, and glucose parameters. RESULTS: For white subjects (N = 167), olanzapine significantly worsened all metabolic parameters except high-density lipoprotein (HDL) cholesterol and fasting glucose, and this was significantly different than aripiprazole for every outcome except fasting glucose. In the black/Hispanic cohort (N = 137), olanzapine treatment resulted in adverse metabolic outcomes, and these changes were significantly different from aripiprazole for adiposity, total cholesterol, and non-HDL cholesterol. Aripiprazole decreased the odds of endpoint metabolic syndrome compared with olanzapine for all subjects (OR = 0.33, 95% CI = 0.19 to 0.55), the white cohort (OR = 0.20, 95% CI = 0.10 to 0.41), and black/Hispanic subjects (OR = 0.53, 95% CI = 0.25 to 1.12), but the black/Hispanic result was not statistically significant (p = .096). Within the aripiprazole group, white subjects had significantly lower risk for metabolic syndrome, but there was no significant difference in metabolic syndrome between white and black/Hispanic subjects exposed to olanzapine. CONCLUSIONS: Race may be an important moderator of metabolic risk during atypical antipsychotic therapy. Olanzapine treatment is associated with greater effects on adiposity and lipids than aripiprazole in both white and black/Hispanic subjects, suggesting that antipsychotic choice and intensive monitoring are important in minimizing metabolic risk, especially in nonwhite patients.

Prevalence and predictors of lipid and glucose monitoring in commercially insured patients treated with second-generation antipsychotic agents.

OBJECTIVE: The authors sought to quantify plasma lipid and glucose testing rates in patients receiving second-generation antipsychotics before and after guidelines recommending testing were issued in February 2004 by the American Diabetes Association (ADA). METHOD: In this retrospective cohort analysis using data from a large managed care database (PharMetrics, 2000-2006), patients under age 65 on second-generation antipsychotics were identified and followed from 40 days before to 130 days after the antipsychotic prescription was written. Baseline and 12-week (40 days) lipid and glucose testing rates were determined for pre- and postguideline cohorts. Logistic regression analyses determined predictors of baseline and 12-week lipid and glucose testing while controlling for covariates. RESULTS: A total of 5,787 preguideline patients and 17,832 postguideline patients were identified. Baseline lipid testing rates were 8.4% for the preguideline cohort and 10.5% for the postguideline cohort, and the 12-week testing rates were 6.8% and 9.0%, respectively. Baseline glucose testing rates were 17.3% for the preguideline cohort and 21.8% for the postguideline cohort, and the 12-week testing rates were 14.1% and 17.9%, respectively. All four comparisons were statistically significant. Baseline and 12-week testing rates for lipids and glucose in children were the lowest of all age groups. CONCLUSIONS: Despite statistically significant improvements after the ADA guidelines were issued, monitoring for plasma lipids and glucose in this population remains low. Clinicians and administrators responsible for the health of at-risk populations should implement new approaches for effective monitoring of major modifiable risk factors for medical morbidity and mortality in patients taking second-generation antipsychotics.

Association between intraocular pressure variation and glaucoma progression: data from a United States chart review.

PURPOSE: To evaluate whether greater intraocular pressure (IOP) variation between visits was associated with higher likelihood of glaucoma progression. DESIGN: Cohort study. METHODS: A five-year minimum of data (June 1, 1990 through January 22, 2002) was collected on 151 patients (302 eyes) from 12 United States specialty centers. A post hoc analysis of visual field (VF) progression, glaucoma medication, intraocular pressure (IOP), and other ocular data was conducted for two nonmutually exclusive cohorts based on retrospective data abstracted well after actual patient visits. Mean IOP and standard deviations (SD) were calculated before treatment (medication or surgery) or progression, whichever occurred first, and before progression regardless of treatment. IOP variables were assessed in a univariate fashion; Cox proportional hazards models evaluated glaucoma progression as an outcome measure and IOP SD as a main predictor, controlling for covariates. RESULTS: In cohort 1 (55 patients; 84 eyes), mean age was 63 years (range, 37 to 85 years), 58% were female, and 19% of eyes underwent VF progression. In cohort 2 (129 patients; 251 eyes), mean age was 66 years (range, 19 to 88 years), 55% were female, and 27% of eyes underwent VF progression. Mean IOP was 16.5 mm Hg (IOP SD, 2.0 mm Hg), and 16.4 mm Hg (IOP SD, 2.7 mm Hg) in cohorts 1 and 2, respectively. Controlling for age, mean IOP, VF stage, and other covariates, each unit increase in IOP SD resulted in a 4.2 times and 5.5 times higher risk of glaucoma progression for cohort 1 (95% confidence interval [CI], 1.3 to 12.9) and cohort 2 (95% CI, 3.4 to 9.1), respectively. CONCLUSIONS: IOP variability is an important predictor of glaucoma progression; SD is a convenient measure of variability to assess glaucoma progression risk.

Diagnosis and treatment of chronic rhinosinusitis: focus on intranasal Amphotericin B.

Chronic rhinosinusitis (CRS) is a chronic disease that affects 14.2% of the US adult population. Despite being widespread, little is known about the etiology of CRS. Treatment has been symptomatic and focused on relieving symptoms. Recent investigations into causes of CRS have revealed that most CRS patients have an eosinophilic infiltration of their nasal tissue (mucosa), regardless of atopy and elevated immunoglobulin E levels. Although fungi are ubiquitous and in the nasal mucus of both healthy people and patients, it is only in the patients that the eosinophils (part of the inflammatory response) are found. Fungi in the nasal mucus are harmless, yet in CRS patients these same fungi stimulate an inflammatory response, inducing the eosinophils to leave the blood vessels and enter the nasal and sinus tissue and ultimately enter the nasal airway mucus. In the nasal mucus these eosinophils attack the fungi and destroy the fungi by the release of a toxic substance called major basic protein (MBP) from the granules in the eosinophils. This degranulation and release of the toxic MBP not only destroys fungi, but also produces collateral damage injuring the nasal and sinus mucosal lining tissue. The injury to the mucosal lining makes the nasal and sinus mucosa susceptible to penetration and potential infection by bacteria. When this tissue inflammation and damage is persistent and prolonged we call it CRS. The diagnosis of CRS is based largely on symptomatic criteria, with anterior rhinoscopy or endoscopy, and, if there is any doubt about the diagnosis, computed tomography imaging is employed to confirm the presence of diseased sinus mucosa. Treatment of CRS, whether medical (intranasal corticosteroids, saline irrigations) or surgical, is aimed at decreasing inflammation and obstruction in the sinonasal passages. Antibiotics, although commonly used in CRS, should not be administered unless there is suspicion of an acute bacterial infection. The theory behind the fungal and eosinophilic etiology of CRS has led to use of an antifungal compound, intranasal Amphotericin B. In clinical studies, topical irrigation with Amphotericin B has been shown to be both a safe and effective treatment for CRS.

Costs and utilization of end-stage glaucoma patients receiving visual rehabilitation care: a US multisite retrospective study.

PURPOSE: Glaucoma is a prevalent ophthalmologic disease and leading cause of blindness. A retrospective analysis was conducted to evaluate resources and costs for end-stage glaucoma patients receiving visual rehabilitation care (VRC). MATERIALS AND METHODS: A chart review was conducted in 3 United States VRC centers. Charts of patients with primary open-angle glaucoma as the primary cause of vision loss (1998 to 2003) were selected, yielding 81 records. Data were collected from patient-level billing and reimbursement records (ophthalmologist/optometrist visits, glaucoma medications, procedures, and specialized low-vision and glaucoma-related services). Visual rehabilitation services included utilization of low-vision devices, assessment of daily functioning, orientation and mobility training, and patient counseling. RESULTS: Mean age at baseline was 72.7 years [standard deviation (SD)=17.2, range: 29 to 95]. Of those with known sex (n=77), 55.8% were women. Medicare was the payer type for most patients (59.3%), whereas 20% had Medicaid. Mean number of visits was 7.1 (SD=6.1) in year 1 and 3.7 (SD=4.2) in year 2, for an annual mean of 5.4 (SD=5.0) visits overall. Total mean cost per patient in year 1 was greater than year 2 [$2170 (SD=$2252) vs. $1202 (SD=$1080), respectively]; of the total 2-year costs, 15% were VRC, 37% ophthalmology care, and 48% pharmacy. Analysis of nonpharmacy costs revealed that VRC accounted for 28% and ophthalmology for 72%. CONCLUSIONS: End-stage glaucoma is associated with appreciable resource utilization and costs, because of both vision rehabilitation and ophthalmology care. Advanced primary open-angle glaucoma has a substantial cost-of-illness, warranting improved management in early stages of disease.

Outcomes and charges of elderly patients with acute myeloid leukemia.

A retrospective database analysis was conducted to evaluate hospitalization outcomes and charges among elderly acute myeloid leukemia (AML) patients. The data source was a longitudinal (2000-2003) inpatient database from 28 US hospitals. Data on 275 AML patients aged 60 and older were analyzed for demographic and treatment characteristics, hospital mortality, length of stay (LOS), overall days of stay (DOS), and charges across multiple admissions. Multivariate modeling was performed to determine factors that influenced outcomes. Overall, 115 (41.8%) patients received inpatient chemotherapy (CT); most (90.4%) received it on the first admission. Of all initial CT regimens 40.9% consisted of a single agent. The mean LOS for initial hospitalization was 23.0 (SD 21.8) days for patients who received CT and 6.7 (SD 7.5) days for those who did not. One quarter (25.3%) of initial hospitalizations resulted in death. On initial hospitalization, mean total charges were $113,118 (SD $220,417) for patients who received CT and $43,999 (SD $190,533) for those who did not; for both groups mean charges were higher than respective subsequent admission charges. Overall, in-hospital mortality did not differ significantly between on-CT and off-CT groups (43.5 and 38.8%, respectively). In multivariate modeling, CT was significantly associated (P < 0.0001) with increased charges and LOS. Elderly patients with AML incurred substantial hospital charges and inpatient mortality. The highest charges and a substantial number of deaths occurred during first admission. Although treatment with CT was associated with increased charges and days in-hospital, inpatient mortality in the two groups was found to be similar.