Cost of disease progression among US patients with human epidermal growth factor receptor 2-positive metastatic breast cancer.

Aim: The objectives were to investigate the differences in per patient per month (PPPM) healthcare resource utilization (HCRU) and costs among commercially insured and Medicare Advantage patients with human epidermal growth factor receptor 2 positive (HER2+) metastatic breast cancer (mBC) who experience disease progression in 12 months compared with those who don't investigate the impact of progression timing on cumulative healthcare costs. Patients & methods: This claims-based study included patients diagnosed with mBC between 1 January 2013 and 30 April 2020 and received HER2-targeted therapy. Patients were categorized as progressed or nonprogressed. For objective one, monthly HCRU and costs were assessed for up to two lines of therapy (LOTs). Data were summarized descriptively and compared using a generalized linear model (GLM). For objective two, patients with at least 6 months of follow-up were assessed and cumulative healthcare costs were estimated in the 3 years following the start of LOT1 or LOT2 using a GLM and Kaplan-Meier weighting. Results: Among the 4113 patients in the study sample, 3406 had at least 12 months of follow-up (or less if due to death). Compared with nonprogressed patients, progressed patients had higher mean PPPM healthcare costs (LOT1: $22,014 vs $18,372, p < 0.001; LOT2: $19,643 vs $16,863, p = 0.001), and HCRU, including number of emergency room visits and inpatient stays (both p < 0.001) in the 12 months following LOT start. Progressed patients had higher 3-year mean cumulative healthcare costs than nonprogressed patients following LOT1 and LOT2 and this difference was greater for patients who progressed earlier. Conclusion: Disease progression was associated with significant increases in HCRU and costs. Delays in progression were associated with lower cumulative healthcare costs. Earlier use of more clinically effective treatments to delay progression may reduce the economic burden among these patients.

Characteristics, healthcare utilization, and outcomes of patients with HER2-low breast cancer.

PURPOSE: Treatment for HER2-low [defined as ImmunoHistoChemistry (IHC) 1 + or 2 + and negative/normal in Situ Hybridization (ISH)] breast cancer patients is rapidly evolving, yet we lack critical information about the HER2-low population. METHODS: We conducted a retrospective cohort study of women aged 18 years or older diagnosed with breast cancer between 2010 and 2016 in North Carolina. Analyses were conducted for the overall cohort and a stage IV sub-cohort. We examined demographic and clinical characteristics, and characterized prevalence of HER2-low disease and healthcare utilization. We estimated adjusted rate ratios for the association between HER2 classifications and utilization outcomes, and hazard ratios for 3-year all cause mortality (stage IV only). RESULTS: The overall and stage IV cohorts included 12,965 and 635 patients, respectively. HER2-low patients represented more than half of both cohorts (59% overall, 53% stage IV). HER2-low patients were more likely than IHC 0 patients to have hormone receptor (HR)-positive disease. In the stage IV cohort, HER2-low patients were more likely to be Black (26% vs. 16% IHC 0, p = 0.0159). In both cohorts, rates of hospitalizations were slightly higher among HER2-low patients. There were no survival differences between HER2-low and IHC 0 among stage IV patients. CONCLUSION: New treatment options for HER2-low breast cancer may have potential for significant impact at the population level particularly for patients with stage IV disease. In light of racial differences between HER2-low and IHC 0 patients observed in our cohort, research- and practice-based efforts to ensure equitable adoption of new treatment guidelines for patients with HER2-low metastatic breast cancer will be essential.

Real-World Treatment Patterns and Outcomes Following First-Line Pertuzumab and Trastuzumab Among Patients with HER2+ Metastatic Breast Cancer.

INTRODUCTION: Many patients with human epidermal growth factor receptor-2-positive metastatic breast cancer (HER2+ mBC) require subsequent lines of therapy (LOTs) after being treated with pertuzumab and trastuzumab-based regimens in the first line (1L). Although the efficacy of the second-line (2L) therapies has been demonstrated in clinical trials, the real-world effectiveness of these treatments is understudied. This retrospective cohort study assessed the real-world treatment patterns and outcomes for patients with HER2+ mBC following 1L therapy with pertuzumab and trastuzumab-based regimens in the United States (US) during 2015-2019. METHODS: Adults with HER2+ mBC in the US who initiated 1L pertuzumab and trastuzumab-based regimens between 01/01/2015 and 09/30/2019 and had ≥ 60 days of follow-up after 1L initiation were identified from the IQVIA Oncology Electronic Medical Records database. The regimens utilized in 2L following 1L pertuzumab and trastuzumab-based regimens were described. Median treatment duration and time to treatment failure were reported for 2L based on Kaplan-Meier analyses. RESULTS: Of the 710 eligible patients who received pertuzumab and trastuzumab-based regimens in 1L (median age: 57.0 years [interquartile range: 48.0-65.0]; median follow-up: 20.3 months; median 1L duration: 15.3 months), 222 (31.3%) initiated 2L. The most common regimens in 2L were ado-trastuzumab emtansine (T-DM1)-based regimens (n = 159 [71.6%]), followed by lapatinib-based (n = 21 [9.5%]) and neratinib-based (n = 18 [8.1%]) regimens. The median treatment duration and time to treatment failure were 5.9 (95% CI: 5.0, 8.7) and 8.6 (7.3, 11.5) months, respectively, among patients initiating 2L, and 5.7 (4.7, 7.8) and 7.9 (6.5, 10.0) months among those receiving 2L T-DM1. CONCLUSIONS: Most patients with HER2+ mBC requiring additional treatments after 1L pertuzumab and trastuzumab-based regimens utilized T-DM1 in 2L during 2015-2019. The short median treatment duration and time to treatment failure highlight an unmet need that can potentially be fulfilled by recently approved treatment options.

Comparability of European League Against Rheumatology-Recommended Pharmacological Treatments of Oral Ulcers Associated with Behçet's Disease: A Systematic Literature Review of Randomized Controlled Trials.

OBJECTIVE: Oral ulcers are the cardinal manifestation in Behçet's disease (BD). The 2018 European League Against Rheumatism (EULAR) recommendations describe treatments for BD-associated oral ulcers with mucocutaneous involvement; however, little comparative effectiveness information for these agents is available. In the absence of head-to-head trials, an indirect treatment comparison (ITC) could provide useful evidence regarding comparative effectiveness of BD treatments. The purpose of this study was to conduct a comparative systematic literature review (SLR) and similarity assessment of randomized controlled trials (RCTs) investigating the oral ulcer-related efficacy outcomes of EULAR-recommended treatments for BD-associated oral ulcers to determine the feasibility of an ITC. METHODS: An SLR was performed to identify relevant RCTs indexed in MEDLINE/Embase before May 29, 2019. RCT similarities for the ITC were assessed based on a step-wise process recommended by the International Society for Pharmacoeconomics and Outcomes Research. RESULTS: In total, 317 articles were identified, of which 14 RCTs, reflecting 11 EULAR-recommended treatments, were evaluated in a similarity assessment. Number of oral ulcers, resolution of oral ulcers, and healing time for oral ulcers were identified as the possible oral ulcer-related outcomes. After completing the similarity assessment of these outcomes, it was determined that a robust ITC was infeasible for the three oral ulcer-related outcomes due to heterogeneity in outcomes reporting, study design, and/or patient characteristics. More broadly, the results underscore the need for and consistent use of standardized measures for oral ulcer outcomes to facilitate comparative research. CONCLUSION: In the absence of head-to-head RCTs and infeasibility of quantitative ITC, comparative assessments for BD-associated oral ulcers are limited, including comparative effectiveness and cost-effectiveness evaluations. Healthcare decision-makers must continue to base treatment decisions on the extent and strength of available evidence (eg, robust RCTs), clinical guidelines, real-world experience, and patient considerations.

Differences in All-Cause Health Care Utilization and Costs in a Type 2 Diabetes Mellitus Population with and Without a History of Cardiovascular Disease.

BACKGROUND: Multiple studies have reported that type 2 diabetes mellitus (T2DM) is a major risk factor for cardiovascular diseases (CVD), and presence of T2DM and CVD increases risk of death. There is growing interest in examining the effects of antidiabetic treatments on the reduction of cardiovascular events in T2DM adults with a history of CVD and thus at higher risk of cardiovascular events. OBJECTIVE: To estimate the incremental all-cause health care utilization and costs among adults with T2DM and a history of CVD compared with adults without a history of CVD, using a national linked electronic medical records (EMR) and claims database. METHODS: Adults aged ≥ 18 years with evidence of at least 1 T2DM-related diagnosis code or antidiabetic medication (date of earliest occurrence was defined as the index date) in calendar year 2012 were identified. The population was divided into 2 cohorts (with and without a history of CVD) and followed until the end of their enrollment coverage, death, or 12 months, whichever came first. Multivariable generalized linear models were used to assess differences in health care utilization and per patient per month (PPPM) total costs (plan- and patient-paid amount for health care services) between the 2 groups during the post-index year, while adjusting for an a priori list of demographic and clinical characteristics. RESULTS: A total of 138,018 adults with T2DM was identified, of which 16,547 (12%) had a history of CVD. The unadjusted resource utilization (outpatient: 27.5 vs. 17.8; emergency room [ER]: 0.8 vs. 0.4; inpatient: 0.4 vs. 0.2 days; and total unique drug prescriptions: 10.1 vs. 8.3) and PPPM total health care costs ($2,655.1 vs. $1,435.0) were significantly higher in T2DM adults with a history of CVD versus T2DM adults without a history of CVD. The adjusted models revealed that T2DM adults with a history of CVD had a 31% higher number of ER visits (rate ratio [RR] = 1.31, 95% CI = 1.25-1.37); 27% more inpatient visits (RR = 1.27, 95% CI = 1.21-1.34); 15% longer mean inpatient length of stay (RR = 1.15, 95% CI = 1.06-1.25); and 11% more outpatient visits (RR = 1.11, 95% CI = 1.09-1.13) compared with T2DM adults without a history of CVD. Furthermore, the difference in total PPPM health care cost was found to be 16% ($200) higher in adults with a history of CVD (RR = 1.16, 95% CI = 1.13-1.19). PPPM costs associated with outpatient and ER visits were approximately 21% and 19% higher among adults with a history of CVD, respectively (P < 0.0001), while costs for inpatient visits were similar between the 2 groups. In addition, a subgroup analysis revealed that adjusted differences in PPPM total cost was larger in the younger age group (56% higher cost in those aged < 45 years) and diminished in the older age group (only 2% higher in those aged ≥ 65 years). CONCLUSIONS: Study findings showed that resource utilization and costs remains significantly higher in T2DM patients with a history of CVD compared with patients without a history of CVD even after controlling for significant patient comorbid and demographic characteristics. Also, younger age groups had higher differences in outcomes compared with older age groups. This study underscores the importance of cost-effective interventions that may reduce economic burden in this T2DM population with a history of CVD. DISCLOSURES: This study was funded by Boehringer Ingelheim. At the time of this study, Mehta and Mountford were employed by IQVIA, which received funding from Boehringer Ingelheim to conduct this study. Mountford is employed by Allergan, which has no connection with this study. Ghosh, Sander, and Kuti are employed by Boehringer Ingelheim. Study concept and design were contributed by Mountford, Mehta, and Ghosh, along with Sander and Kuti. Mountford and Mehta collected the data, and data interpretation was performed by all the authors. The manuscript was written by Sander and Kuti, along with the other authors, and revised by Mehta and Gosh, along with the other authors.

Primary care physicians' utilization of type 2 diabetes screening guidelines and referrals to behavioral interventions: a survey-linked retrospective study.

OBJECTIVE: To assess primary care physicians' (PCPs) knowledge of type 2 diabetes screening guidelines (American Diabetes Association (ADA) and 2008 US Preventive Services Task Force (USPSTF)), the alignment between their self-reported adherence and actual practice, and how often PCPs recommended diabetes prevention and self-management education programs (DPP/DSME). RESEARCH DESIGN AND METHODS: An online survey of PCPs to understand knowledge and adherence toward use of USPSTF/ADA guidelines and recommendation of DPP/DSME. Patient data from electronic medical records (EMRs) for each PCP were used to identify rates of screening in eligible patients as per guidelines and the two sources were compared to assess concordance. RESULTS: Of 305 surveyed physicians, 38% reported use of both guidelines (33% use ADA only, 25% USPSTF only). Approximately one-third of physicians who reported use of USPSTF/ADA guidelines had non-concordant EMR data. Similarly, while most PCPs reported they are 'very likely' to screen patients with risk factors listed in guidelines, for each criterion at least one-fourth (24%) of PCPs survey responses were non-concordant with EMRs. PCPs reported they provide referral to DPP and DSME on average to 45% and 67% of their newly diagnosed patients with pre-diabetes and diabetes, respectively. CONCLUSION: Findings show disconnect between PCPs' perceptions of adherence to screening guidelines and actual practice, and highlight limited referrals to DPP/DSME programs. More research is needed to understand barriers to guideline consistent screening and uptake of DPP/DSME, particularly in light of recent policy changes such as the linking USPSTF criteria to reimbursement and expected Medicare DPP reimbursement in 2018.

Comparative safety of atypical antipsychotics and the risk of pneumonia in the elderly.

PURPOSE: Previous studies have documented increased risk of pneumonia with antipsychotic use in the elderly; however, differential risk across individual atypical antipsychotics remains unaddressed. This study examines the effect of individual atypical antipsychotics on risk of pneumonia in elderly patients. METHODS: This retrospective cohort study was conducted using a large claims database. The study population included new users of atypical antipsychotics (≥65 years). The multiple propensity-score adjusted survival model was used to examine risk of pneumonia within a 1-year follow-up period. RESULTS: A total of 92 234 patients newly prescribed atypical antipsychotic medication were identified. Of these, 41 780 (45.30%) were quetiapine users, 31 048 (33.66%) risperidone users, 11 375 (12.33%) olanzapine users, 6790 (7.36%) aripiprazole users, and 1241 (1.35%) ziprasidone users. Within the 1-year follow-up period, 12 411 (13.46%) patients taking atypical antipsychotics had a diagnosis of pneumonia. The multiple propensity-score-adjusted survival model revealed increased risk of pneumonia with the use of risperidone (hazard ratios (HR) 1.14, 95%CI 1.10-1.18) and olanzapine (HR 1.10, 95%CI 1.04-1.16) compared with the use of quetiapine. CONCLUSION: This large population-based study suggests that use of risperidone and olanzapine increases risk of pneumonia compared with use of quetiapine in elderly patients. This study provides new information on the comparative risk of pneumonia associated with different atypical antipsychotics in the elderly to support optimal treatment decisions.

Risk of death in dual-eligible nursing home residents using typical or atypical antipsychotic agents.

BACKGROUND: Antipsychotic use among dual-eligible nursing home residents is a concern for cost and safety considerations. OBJECTIVE: To examine the comparative risk of death in dual-eligible elderly nursing home residents using typical and atypical agents. METHODS: A retrospective cohort design matched on propensity score was used to examine the risk of death due to antipsychotic use among dual-eligible nursing home residents 65 years or older from four states. New typical and atypical users in nursing homes were followed for 6 months after the exposure without any censoring. The risk of death was modeled using the Cox proportional model and the extended Cox hazard model stratified on matched pairs based on propensity score. RESULTS: The unadjusted mortality rate was 18.42% for atypical antipsychotic users and 24.06% for typical antipsychotic users. The Cox proportional-hazards regression model revealed significant increased risk of death [hazard ratio (HR), 1.41; 95% confidence interval (CI), 1.27-1.57] among typical users when compared with atypical users. The extended Cox model, used due to the violation of proportional hazards assumption, revealed that risk of death was nearly twice as great among typical antipsychotic users within 40 days of antipsychotic treatment (HR, 1.81; 95% CI, 1.49-2.18) when compared with atypical users. However, moderate increase in risk (HR, 1.24; 95% CI, 1.09-1.42] was observed for 40-180 days of typical antipsychotic exposure. CONCLUSIONS: The use of typical antipsychotic agents was associated with highest risk of all-cause mortality within 40 days of typical antipsychotic use when compared with atypical use, and the risk decreased after 40 days among dual-eligible elderly nursing home residents.

Prevalence and predictors of human papillomavirus vaccination in adolescent girls.

OBJECTIVES: To determine the prevalence and predictors of human papillomavirus (HPV) vaccination in adolescent girls who were recommended to receive the vaccine by their health care providers. DESIGN: Cross-sectional study. SETTING: United States in 2007-08. PARTICIPANTS: Parents or guardians most knowledgeable about health and health care of adolescent girls aged 12 to 17 years participating in the 2007 National Survey of Children's Health (NSCH). INTERVENTION: NCSH was a population-based telephone survey using a complex probability sampling design. MAIN OUTCOME MEASURES: Prevalence of HPV vaccination in adolescent girls who were recommended to receive the HPV vaccine and predisposing, enabling, and need factors associated with HPV vaccination. RESULTS: Of 12.38 million adolescent girls aged 12 to 17 years, 3.69 million (29.76%) were recommended to receive the HPV vaccine by their health care provider. The majority who received the HPV vaccine recommendation were 13 to 17 years of age (83%), were white (71%), and had one or more preventive visits (94%). Among those for whom the HPV vaccine was recommended, 48.75% (95% CI 45.37-52.13) received the vaccine. Multivariate logistic regression analysis of those who were recommended revealed that enabling and predisposing factors were significantly associated with the HPV vaccination. Children living at 101% to 200% of the Federal Poverty Level (odds ratio 0.54 [95% CI 0.30-0.98]) and children in households with two or more adults (0.51 [0.33-0.80]) were negatively associated with HPV vaccination, whereas children with any preventive medical care visit(s) (2.28 [1.36-3.84]) in the previous year were positively associated with HPV vaccination. CONCLUSION: Nearly one-half of adolescent girls received the HPV vaccine among those who were recommended by their health care provider. The study finding emphasizes the importance of predisposing and enabling factors for HPV vaccination. Policy and education efforts can focus on these factors to improve HPV vaccination rates.

Risk of serious cardiac events in older adults using antipsychotic agents.

BACKGROUND: Antipsychotic agents can lead to severe cardiovascular adverse events due to multiple mechanisms involving electrophysiologic and metabolic effects. Few epidemiologic studies have evaluated the risk of serious cardiovascular-related events in typical and atypical antipsychotic users. OBJECTIVE: The purpose of this study was to compare the risk of serious cardiac events in older adults taking typical antipsychotics with those taking atypical antipsychotics. METHODS: Prescription and medical information were derived from the IMS LifeLink Health Plan Claims database. The study involved a retrospective cohort of older adults (≥50 years) taking atypical or typical antipsychotics from July 1, 2000, to December 31, 2007. The primary outcome measure was hospitalization or emergency room visit due to serious cardiac events, including thromboembolism, myocardial infarction, cardiac arrest, and ventricular arrhythmias within 1 year after the index date. The 2 groups were matched on a propensity score to minimize the baseline differences between the groups. Survival analysis was conducted on the matched cohort to assess the risk of serious cardiovascular events in typical versus atypical users. RESULTS: A total of 5580 patients were selected in each antipsychotic users group after propensity score matching. Serious cardiac events were found in 666 (11.9 %) atypical antipsychotic users and 698 (12.4%) typical antipsychotic users. Survival analysis revealed that typical antipsychotic users were at increased risk of serious cardiovascular events compared with atypical antipsychotic users (hazard ratio = 1.21; 95% CI, 1.04-1.40) after controlling for other factors. CONCLUSIONS: Moderate increases in risk of serious cardiac events are associated with older adults using typical antipsychotic agents compared with atypical users. Health care professionals should carefully evaluate the benefit/risk ratio of antipsychotic agents before prescribing these agents to a vulnerable population.

Prevalence and predictors of anticholinergic medication use in elderly nursing home residents with dementia: analysis of data from the 2004 National Nursing Home Survey.

BACKGROUND: Medications with anticholinergic properties are frequently used in the elderly population. However, evidence suggests that these medications are associated with significant adverse effects and may lead to worsening of cognitive impairment, particularly in elderly patients with dementia. OBJECTIVE: To examine the utilization of anticholinergic medications and factors associated with anticholinergic medication use in elderly nursing home patients with dementia. METHODS: The study examined anticholinergic medication utilization for patients aged ≥65 years with dementia, using the 2004 US National Nursing Home Survey (NNHS) data. Anticholinergic drugs were identified using the Anticholinergic Drug Scale (ADS), which classifies anticholinergic drugs into four levels in increasing order of their anticholinergic activity. Descriptive analysis was conducted using sampling weights to determine the prevalence of anticholinergic medication use. Multiple logistic regression within the conceptual framework of the Andersen Behavioral Model was used to examine the factors associated with anticholinergic medication use in the study population. Use of medications with marked anticholinergic activities (ADS level 2 or 3) was the dependent variable, and independent variables were the various predisposing, enabling and need factors. RESULTS: According to the 2004 NNHS, 509,931 (95% CI 490,160, 529,702) or 73.62% (95% CI 72.23, 75.00) of elderly patients with dementia used anticholinergic medications. The highest prevalence of anticholinergic medication use among elderly patients with dementia was seen for level-1 medications (67.96%; 95% CI 66.51, 69.41), and 21.27% (95% CI 19.93, 22.60) used ADS level-2 or level-3 medications. Multivariate regression analysis showed that the predisposing factor of age was negatively associated with the use of medications with marked anticholinergic activities (ADS level 2 or 3) and the enabling factor of Medicaid as the source of payment increased the likelihood of receiving these higher-level anticholinergics. Among the need factors, dependence in decision-making ability and behavioural symptoms decreased the likelihood of receiving higher-level anticholinergics, whereas factors such as total number of medications, depressed mood indicators and diagnoses of schizophrenia, anxiety and Parkinson's disease increased the likelihood of use of such medications. CONCLUSIONS: Over one in five elderly nursing home residents with dementia used medications with marked anticholinergic activities. The study findings suggest the need to optimize the use of anticholinergic medications in vulnerable patients with dementia given the potentially severe adverse cognitive effects of these agents.

Risk of falls and fractures in older adults using antipsychotic agents: a propensity-matched retrospective cohort study.

BACKGROUND: Antipsychotics, especially atypical agents, are widely used in the elderly population to treat behavioural and psychiatric symptoms. Very few studies have compared the risk of falls and fractures among older adults using typical and atypical agents and none of the studies have evaluated differential risk across antipsychotic classes. OBJECTIVE: To examine the risk of falls and fractures associated with atypical antipsychotic use and typical antipsychotic use in community-dwelling older adults in the US. METHODS: The study involved a retrospective population-based cohort design matched on propensity scores involving older adults (aged ≥50 years) using atypical or typical antipsychotic agents in the IMS LifeLink™ Health Plan Claims Database. Patients taking atypical antipsychotics were matched with patients taking typical antipsychotics using the Greedy 5 → 1 matching technique. The study evaluated the relative risk of hospitalization/emergency room (ER) visits due to falls/fractures in a 1-year follow-up period, and patients treated with atypical antipsychotics were compared with those treated with typical antipsychotics using the Cox proportional-hazards regression model stratified on matched pairs. The covariates adjusted for in the regression model included duration of therapy and exposure to other psychotropic medications that increase the risk of falls and fractures. RESULTS: From July 2000 to December 2007, 11 160 (5580 atypical and 5580 typical) users of antipsychotics were obtained after matching on propensity scores. A total of 825 cases of falls/fractures with at least one hospitalization/ER visit following the use of antipsychotic agents were identified. The number of cases with falls/fractures was 450 in atypical antipsychotic users and 375 in typical antipsychotic users. Cox regression model analysis revealed no statistically significant difference between atypical users and typical users with respect to risk of falls/fractures (hazard ratio [HR] 1.01; 95% CI 0.83, 1.22). However, duration of therapy with any antipsychotic medication for >90 days was significantly (HR 1.81; CI 1.35, 2.43) associated with increased risk of falls/fractures compared with <30 days of treatment. CONCLUSIONS: No statistically significant difference was found between atypical antipsychotic agents and typical antipsychotic agents with regards to the likelihood of falls/fractures in a large cohort of older adults. However, there is a need to be cautious while prescribing atypical and typical antipsychotics in older adults for long periods of time.

Risk of cerebrovascular adverse events in older adults using antipsychotic agents: a propensity-matched retrospective cohort study.

OBJECTIVE: To compare the risk of cerebrovascular adverse events with second-generation antipsychotic users versus those taking first-generation antipsychotics in community-dwelling older adults. METHOD: A population-based retrospective cohort study matched on propensity score was used to examine the risk of cerebrovascular adverse events in second-generation antipsychotic users compared to first-generation antipsychotic users. IMS LifeLink Health Plan Claims Database was used to identify older adults (> or = 50 years) taking second-generation or first-generation antipsychotic agents from July 1, 2000, to December 31, 2007. Cox proportional hazards regression model stratified on matched pairs was used to examine the risk of hospitalization or emergency visits due to cerebrovascular adverse events within 1 year of follow-up (primary outcome measure). The covariates adjusted for include duration of therapy and exposure to other medication increasing risk of cerebrovascular adverse events. RESULTS: A total of 11,160 older adults (5,580 second-generation and 5,580 first-generation antipsychotic users) matched on propensity score was obtained. Regression analysis revealed that no statistically significant difference exists between second-generation and first-generation antipsychotic users with respect to risk of cerebrovascular adverse events (hazard ratio [HR], 0.858; 95% CI, 0.689-1.446). However, duration of therapy between 30-90 days (HR, 1.707; 95% CI, 1.174-2.481) and more than 90 days (HR, 1.570; 95% CI, 1.132-2.176) was associated with increased risk of cerebrovascular adverse events compared to duration of therapy less than 30 days. CONCLUSIONS: The use of second-generation antipsychotic agents was found not to be associated with increased risk of cerebrovascular adverse events compared to first-generation agents in older adults. However, long-term use of second- and first-generation antipsychotic agents is associated with increased risk of cerebrovascular adverse events.

Unmet prescription medication need in U.S. children.

OBJECTIVES: To examine the nature and extent of unmet prescription medication need (UPMN) in children and its predictors using the 2003 National Survey of Children's Health (NSCH). DESIGN: Retrospective cross-sectional survey. SETTING: United States in 2003-2004. PARTICIPANTS: Parents or guardians who knew most about child's (<18 years of age) health and health care and reported about their children's prescription medication use. INTERVENTION: NSCH-a population-based telephone survey-based on complex probability sampling design. MAIN OUTCOME MEASURES: Nature and extent of UPMN in children and predictors of UPMN for any reason and as a result of cost, health plan problems, and lack of insurance within the conceptual framework of the Andersen behavioral model. RESULTS: According to NSCH, 0.54 million (95% CI 0.46-0.62) or 1.23% (1.05-1.41%) of children experienced UPMN. The highest prevalence of UPMN was seen among blacks (2.3%), families with income less than 200% of federal poverty level (2.4%), and those having good, fair, or poor perceived health status (3.2%). A high prevalence of UPMN was also found in children with gained (5.3%), lost (3.7%), or no insurance (6.4%). Among children with UPMN, 35.39% (28.56-42.23%) did not receive medications because of cost, 26.51% (20.28-32.74%) because of health plan problems, and 40.73% (33.21-48.24%) because of lack of insurance. Multivariate logistic regression analysis revealed that predisposing (race), enabling (poverty and insurance), and need (perceived health status and depression) factors were significantly associated with UPMN for any reason. Factors significantly associated with UPMN due to cost included enabling (insurance) and need (attention deficit hyperactivity disorder and asthma) factors. The predictors of UPMN resulting from health plan problems included predisposing (race) and enabling (insurance) factors, whereas UPMN caused by lack of insurance was only associated with an enabling factor (age). CONCLUSION: More than 0.5 million children in the United States experienced UPMN, mainly as a result of cost, health plan problems, or lack of insurance. The study findings suggest that a need exists for addressing racial disparities and continuity of coverage issues in children to improve access to needed prescription medications.