Integrating E-Prescribing and Pharmacy Claims Data for Predictive Modeling: Comparing Costs and Utilization of Health Plan Members Who Fill Their Initial Medications with Those Who Do Not.

BACKGROUND: Nonfilling of prescribed medications is a worldwide problem of serious concern. Studies of health care costs and utilization associated with medication nonadherence frequently rely on claims data and usually focus on patients with specific conditions. Past studies also have little agreement on whether higher medication costs associated with higher adherence can reduce downstream health care consumption. OBJECTIVES: To (a) compare the characteristics between people with and without complete medication initiations from a general population and (b) quantify the effect of medication initiation on health care utilization and expenditures with propensity score weighting. METHODS: We conducted a retrospective cohort study using 2012 and 2013 electronic health records (EHR) and insurance claims data from an integrated health care delivery network. We included 43,097 eligible primary care patients in the study. Annual medication fill rates of initial prescriptions in 2012 were defined as the number of filled prescriptions from claims divided by the number of e-prescriptions from EHRs, while excluding all refills. A claim was considered filled if (a) EHR and claims records were from the same drug class; (b) claims occurred between the date of a current EHR order and that of the next EHR order of the same class; and (c) the maximum fill rate was 100%. The 6 annual outcomes included total costs, medical costs, pharmacy costs, being a high-cost "outlier" (in top 5%), having 1 or more hospitalizations, and having 1 or more emergency department (ED) visits. Individuals were classified as either having completed all medication initiations (100% annual filling rate for initiations) or not. We used propensity score weighting to control for baseline differences between complete and incomplete initial fillers. We adopted linear and logistic regressions to model costs and binary utilization indicators for the same year (concurrently) and next year (prospectively). RESULTS: Approximately 42% of the study sample had complete medication initiations (100% filling rate), while the remaining 58% had incomplete initiations. Individuals who fully filled initial prescriptions had lower comorbidity burden and consumed fewer health care resources. After applying propensity score weighting and controlling for variables such as the number of prescription orders, patients with complete medication initiations had lower overall and medical costs, concurrently and prospectively (e.g., $751 and $252 less for annual total costs). Complete medication initiation fillers were also less likely to have concurrent health care utilization (OR = 0.78, 95% CI = 0.68-0.90 for hospitalization; OR = 0.77, 95% CI = 0.72-0.82 for ED admissions) but no difference in prospective utilization other than for ED visits (OR = 0.93, 95% CI = 0.87-0.99). CONCLUSIONS: Identifying the subpopulation of patients with incomplete medication initiations (i.e., filling less than 100% of initial prescriptions) is a pragmatic approach for population health management programs to align resources and potentially contain cost and utilization. DISCLOSURES: No outside funding supported this study. This study applied the Adjusted Clinical Group (ACG) case-mix/risk adjustment methodology, developed at Johns Hopkins Bloomberg School of Public Health. Although ACGs are an important aspect of this study, the goal of the study was not to directly assess or evaluate the methodology. The Johns Hopkins University receives royalties for nonacademic use of software based on the ACG methodology. Chang, Kharrazi, and Weiner receive a portion of their salary support from this revenue. Chang is also a part-time consultant for Monument Analytics, a health care consultancy whose clients include the life sciences industry, as well as plaintiffs in opioid litigation. Alexander is past Chair of FDA's Peripheral and Central Nervous System Advisory Committee; has served as a paid advisor to IQVIA; is a co-founding Principal and equity holder in Monument Analytics; and is a member of OptumRx's National P&T Committee. These arrangements have been reviewed and approved by Johns Hopkins University in accordance with its conflict of interest policies. The other authors have nothing to disclose.

Association between organ damage and mortality in systemic lupus erythematosus: a systematic review and meta-analysis.

OBJECTIVE: At least half of patients with systemic lupus erythematosus (SLE) develop organ damage as a consequence of autoimmune disease or long-term therapeutic steroid use. This study synthesised evidence on the association between organ damage and mortality in patients with SLE. DESIGN: Systematic review and meta-analysis. METHODS: Electronic searches were performed in PubMed, Embase, Cochrane Library and Latin American and Caribbean Health Sciences Literature for observational (cohort, case-control and cross-sectional) studies published between January 2000 and February 2017. Included studies reported HRs or ORs on the association between organ damage (measured by the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) score) and mortality. Study quality was assessed using the modified Newcastle-Ottawa assessment. Pooled HRs were obtained using the DerSimonian and Laird random-effects model. Heterogeneity was assessed using the Cochrane Q (Q) and I2 statistics. RESULTS: The search yielded 10 420 articles, from which 21 longitudinal studies were selected. Most studies (85%) were of high quality. For 10 studies evaluating organ damage (SDI) as a continuous variable and reporting HR as a measure of association, a 1-unit increase in SDI was associated with increased mortality; pooled HR was 1.34 (95% CI: 1.24 to 1.44, p<0.001; Q p=0.027, I2=52.1%). Exclusion of one potential outlying study reduced heterogeneity with minimal impact on pooled HR (1.33 (95% CI: 1.25 to 1.42), p<0.001, Q p=0.087, I2=42.0%). The 11 remaining studies, although they could not be aggregated because of their varying patient populations and analyses, consistently demonstrated that greater SDI was associated with increased mortality. CONCLUSIONS: Organ damage in SLE is consistently associated with increased mortality across studies from various countries. Modifying the disease course with effective therapies and steroid-sparing regimens may reduce organ damage, improve outcomes and decrease mortality for patients with SLE.

Comparing Survey-Based Frailty Assessment to Medicare Claims in Predicting Health Outcomes and Utilization in Medicare Beneficiaries.

Objectives: To assess two models for the prediction of health utilization and functions using standardized in-person assessments of frailty and administrative claims-based geriatric risk measures among Medicare fee-for-service beneficiaries aged 65 years and above. Methods: Outcomes of hospitalizations, death, and functional help were investigated for participants in the 2011 National Health and Aging Trends Study. For each outcome, multivariable logistic regression model was used to investigate claims-based geriatric risk and survey-based frailty. Results: Both claims-based and survey-based models showed moderate discrimination. The c-statistic of the standardized frailty models ranged from 0.67 (for any hospitalization) to 0.84 (for any IADL [instrumental activities of daily living] help). Models using administrative data ranged from 0.71 (for any hospitalization) to 0.81 (for any IADL help). Discussion: Models based on existing administrative data appear to be as discriminate as survey-based models. Health care providers and insurance plans can effectively apply existing data resources to help identify high-risk individuals for potential care management interventions.

Exploring the use of machine learning for risk adjustment: A comparison of standard and penalized linear regression models in predicting health care costs in older adults.

BACKGROUND: Payers and providers still primarily use ordinary least squares (OLS) to estimate expected economic and clinical outcomes for risk adjustment purposes. Penalized linear regression represents a practical and incremental step forward that provides transparency and interpretability within the familiar regression framework. This study conducted an in-depth comparison of prediction performance of standard and penalized linear regression in predicting future health care costs in older adults. METHODS AND FINDINGS: This retrospective cohort study included 81,106 Medicare Advantage patients with 5 years of continuous medical and pharmacy insurance from 2009 to 2013. Total health care costs in 2013 were predicted with comorbidity indicators from 2009 to 2012. Using 2012 predictors only, OLS performed poorly (e.g., R2 = 16.3%) compared to penalized linear regression models (R2 ranging from 16.8 to 16.9%); using 2009-2012 predictors, the gap in prediction performance increased (R2:15.0% versus 18.0-18.2%). OLS with a reduced set of predictors selected by lasso showed improved performance (R2 = 16.6% with 2012 predictors, 17.4% with 2009-2012 predictors) relative to OLS without variable selection but still lagged behind the prediction performance of penalized regression. Lasso regression consistently generated prediction ratios closer to 1 across different levels of predicted risk compared to other models. CONCLUSIONS: This study demonstrated the advantages of using transparent and easy-to-interpret penalized linear regression for predicting future health care costs in older adults relative to standard linear regression. Penalized regression showed better performance than OLS in predicting health care costs. Applying penalized regression to longitudinal data increased prediction accuracy. Lasso regression in particular showed superior prediction ratios across low and high levels of predicted risk. Health care insurers, providers and policy makers may benefit from adopting penalized regression such as lasso regression for cost prediction to improve risk adjustment and population health management and thus better address the underlying needs and risk of the populations they serve.

Factors associated with physicians' prescriptions for rheumatoid arthritis drugs not filled by patients.

BACKGROUND: This study estimated the extent and predictors of primary nonadherence (i.e., prescriptions made by physicians but not initiated by patients) to methotrexate and to biologics or tofacitinib in rheumatoid arthritis (RA) patients who were newly prescribed these medications. METHODS: Using administrative claims linked with electronic health records (EHRs) from multiple healthcare provider organizations in the USA, RA patients who received a new prescription for methotrexate or biologics/tofacitinib were identified from EHRs. Claims data were used to ascertain filling or administration status. A logistic regression model for predicting primary nonadherence was developed and tested in training and test samples. Predictors were selected based on clinical judgment and LASSO logistic regression. RESULTS: A total of 36.8% of patients newly prescribed methotrexate failed to initiate methotrexate within 2 months; 40.6% of patients newly prescribed biologics/tofacitinib failed to initiate within 3 months. Factors associated with methotrexate primary nonadherence included age, race, region, body mass index, count of active drug ingredients, and certain previously diagnosed and treated conditions at baseline. Factors associated with biologics/tofacitinib primary nonadherence included age, insurance, and certain previously treated conditions at baseline. The area under the receiver operating characteristic curve of the logistic regression model estimated in the training sample and applied to the independent test sample was 0.86 and 0.78 for predicting primary nonadherence to methotrexate and to biologics/tofacitinib, respectively. CONCLUSIONS: This study confirmed that failure to initiate new prescriptions for methotrexate and biologics/tofacitinib was common in RA patients. It is feasible to predict patients at high risk of primary nonadherence to methotrexate and to biologics/tofacitinib and to target such patients for early interventions to promote adherence.

Defining and Assessing Geriatric Risk Factors and Associated Health Care Utilization Among Older Adults Using Claims and Electronic Health Records.

BACKGROUND: Using electronic health records (EHRs), in addition to claims, to systematically identify patients with factors associated with adverse outcomes (geriatric risk) among older adults can prove beneficial for population health management and clinical service delivery. OBJECTIVE: To define and compare geriatric risk factors derivable from claims, structured EHRs, and unstructured EHRs, and estimate the relationship between geriatric risk factors and health care utilization. RESEARCH DESIGN: We performed a retrospective cohort study of patients enrolled in a Medicare Advantage plan from 2011 to 2013 using both administrative claims and EHRs. We defined 10 individual geriatric risk factors and a summary geriatric risk index based on diagnosed conditions and pattern matching techniques applied to EHR free text. The prevalence of geriatric risk factors was estimated using claims, structured EHRs, and structured and unstructured EHRs combined. The association of geriatric risk index with any occurrence of hospitalizations, emergency department visits, and nursing home visits were estimated using logistic regression adjusted for demographic and comorbidity covariates. RESULTS: The prevalence of geriatric risk factors increased after adding unstructured EHR data to structured EHRs, compared with those derived from structured EHRs alone and claims alone. On the basis of claims, structured EHRs, and structured and unstructured EHRs combined, 12.9%, 15.0%, and 24.6% of the patients had 1 geriatric risk factor, respectively; 3.9%, 4.2%, and 15.8% had ≥2 geriatric risk factors, respectively. Statistically significant association between geriatric risk index and health care utilization was found independent of demographic and comorbidity covariates. For example, based on claims, estimated odds ratios for having 1 and ≥2 geriatric risk factors in year 1 were 1.49 (P<0.001) and 2.62 (P<0.001) in predicting any occurrence of hospitalizations in year 1, and 1.32 (P<0.001) and 1.34 (P=0.003) in predicting any occurrence of hospitalizations in year 2. CONCLUSIONS: The results demonstrate the feasibility and potential of using EHRs and claims for collecting new types of geriatric risk information that could augment the more commonly collected disease information to identify and move upstream the management of high-risk cases among older patients.

Presentation of SLE in UK primary care using the Clinical Practice Research Datalink.

OBJECTIVES: To describe the presenting symptoms of SLE in primary care using the Clinical Practice Research Database (CPRD) and to calculate the time from symptom presentation to SLE diagnosis. METHODS: Incident cases of SLE were identified from the CPRD between 2000 and 2012. Presenting symptoms were identified from the medical records of cases in the 5 years before diagnosis and grouped using the British Isles Lupus Activity Group (BILAG) symptom domains. The time from the accumulation of one, two and three BILAG domains to SLE diagnosis was investigated, stratified by age at diagnosis (<30, 30-49 and ≥50 years). RESULTS: We identified 1426 incident cases (170 males and 1256 females) of SLE. The most frequently recorded symptoms and signs prior to diagnosis were musculoskeletal, mucocutaneous and neurological. The median time from first musculoskeletal symptom to SLE diagnosis was 26.4 months (IQR 9.3-43.6). There was a significant difference in the time to diagnosis (log rank p<0.01) when stratified by age and disease severity at baseline, with younger patients <30 years and those with severe disease having the shortest times and patients aged ≥50 years and those with mild disease having the longest (6.4 years (IQR 5.8-6.8)). CONCLUSIONS: The time from symptom onset to SLE diagnosis is long, especially in older patients. SLE should be considered in patients presenting with flaring or chronic musculoskeletal, mucocutaneous and neurological symptoms.

Burden of systemic lupus erythematosus on employment and work productivity: data from a large cohort in the southeastern United States.

OBJECTIVE: To examine the burden of systemic lupus erythematosus (SLE) on work loss, unemployment, and work productivity impairment in an SLE cohort from the southeastern US. METHODS: We examined 689 SLE patients ages 18-64 years from the Georgians Organized Against Lupus (GOAL) cohort. GOAL is a longitudinal cohort predominantly derived from the Georgia Lupus Registry, a population-based registry established in metropolitan Atlanta. We used the Kaplan-Meier method to assess the proportion of patients who self-reported work loss since diagnosis. We compared unemployment between SLE patients and the general population from the same geographic area, calculating the standardized unemployment ratio (SUR) within demographic and disease strata. We also calculated the percentage of work productivity impairment by disease outcomes. RESULTS: Of 511 patients employed at diagnosis, 249 (49%) experienced work loss within an average disease duration of 13 years. The proportion of patients who lost their jobs since diagnosis was almost twice for African Americans than for whites. However, the SURs were similar across demographic characteristics, including race. Patients with severe disease activity and severe organ damage had the highest SUR at 4.4 and 5.6, respectively. Among those that remained employed, patients with severe fatigue, neurocognitive symptoms, and musculoskeletal symptoms had the highest impairment of work productivity. CONCLUSION: SLE imposes a substantial toll on individuals and burden on society. Major factors that negatively impact work outcomes are fatigue, disease activity, and organ damage. More effective treatments along with coping strategies at the workplace are needed to reduce the burden of SLE on work outcomes.

Cumulative burden of oral corticosteroid adverse effects and the economic implications of corticosteroid use in patients with systemic lupus erythematosus.

BACKGROUND: Corticosteroids (CSs) are used to treat patients with systemic lupus erythematosus (SLE) and are associated with potential adverse events (AEs). However, few data are currently available on the risk of AEs in CS users in an SLE population. OBJECTIVE: To examine AEs related to CS use and costs of treating CS-related AEs in patients with SLE. METHODS: In a retrospective cohort study using claims data (study period: January 1, 2000-June 30, 2010), patients aged ≥18 years having ≥2 SLE-related (International Classification of Diseases, Ninth Revision, Clinical Modification code 710.0x) outpatient or ≥1 inpatient/emergency department claim were identified with an index diagnosis date deemed as the date of first SLE diagnosis. Receipt of CS therapy was assessed within 6 months of the index diagnosis date. Cox models were used to evaluate risk of AEs in CS users and nonusers. Associated costs were computed for AEs where risk was significantly different among the cohorts. RESULTS: Of 2717 patients with SLE, 989 received CSs and 1728 did not. Users of CSs were ~1.5 times more likely to develop chronic AEs (sleep disturbances, migraines, cataracts, hypertension, and type 2 diabetes mellitus) and ~2 times more likely to develop acute AEs (pneumonia, herpes zoster, fungal infections, and nausea/vomiting) compared with CS nonusers. The mean annual cost for managing AEs was $4607 and was highest for diabetes mellitus ($9764), hypertension ($8773), and sleep disturbances ($5599). Applying differences in 1-year event rates (CS user: 58.1%; CS nonuser: 75.1%) to cost estimates yielded an additional $784 per year per CS user to manage known CS-related AEs compared with CS nonusers. CONCLUSIONS: Although CSs are prescribed to control SLE symptoms, these results highlight potential risks and costs associated with their use, which providers/payers should consider when making treatment decisions.

Healthcare utilization and costs of systemic lupus erythematosus in Medicaid.

Objective. Healthcare utilization and costs associated with systemic lupus erythematosus (SLE) in a US Medicaid population were examined. Methods. Patients ≥ 18 years old with SLE diagnosis (ICD-9-CM 710.0x) were extracted from a large Medicaid database 2002-2009. Index date was date of the first SLE diagnosis. Patients with and without SLE were matched. All patients had a variable length of followup with a minimum of 12 months. Annualized healthcare utilization and costs associated with SLE and costs of SLE flares were assessed during the followup period. Multivariate regressions were conducted to estimate incremental healthcare utilization and costs associated with SLE. Results. A total of 14,777 SLE patients met the study criteria, and 14,262 were matched to non-SLE patients. SLE patients had significantly higher healthcare utilization per year than their matched controls. The estimated incremental annual cost associated with SLE was $10,984, with the highest increase in inpatient costs (P < 0.001). Cost per flare was $11,716 for severe flares, $562 for moderate flares, and $129 for mild flares. Annual total costs for patients with severe flares were $49,754. Conclusions. SLE patients had significantly higher healthcare resource utilization and costs than non-SLE patients. Patients with severe flares had the highest costs.

Comparative utility of aripiprazole and haloperidol in schizophrenia: post hoc analysis of two 52-week, randomized, controlled trials.

BACKGROUND: Since their introduction, second-generation antipsychotics (SGAs) have become the drugs of choice for the treatment of schizophrenia. However, recent findings have questioned the benefits of SGAs over first-generation antipsychotics (FGAs). OBJECTIVE: This post hoc analysis sought to compare the utility of the SGA aripiprazole with the FGA haloperidol in patients with early-phase schizophrenia (ES) or chronic schizophrenia (CS). METHOD: Data were pooled from two identical 52-week, randomized, active comparator trials (31-98-217 and 31-98-304) of aripiprazole 20-30 mg/day versus haloperidol 7-10 mg/day. Patients in the efficacy sample were classified as having ES if they were

Global benefit-risk analysis of adjunctive aripiprazole in the treatment of patients with major depressive disorder.

OBJECTIVE: This study quantified the overall merit of adjunctive aripiprazole in major depressive disorder (MDD). METHODS: Global benefit-risk (GBR) analysis quantified the benefit and risk differences between adjunctive aripiprazole and antidepressant (ADT) monotherapy. Three hundred and fifty six patients receiving ADT monotherapy and 366 patients receiving ADT and adjunctive aripiprazole (2-20 mg/day) were included. Efficacy measures included the Montgomery-Asberg depression rating scale (MADRS) Total score response (> or =50% reduction) and remission (response plus Total score < or = 10). Treatment-emergent adverse events were classified by severity. GBR ratio measures evaluated the relative benefit of adjunctive aripiprazole. Logistic regression models tested the effect of adjunctive aripiprazole on GBR and were used to identify predictors of net benefit and potential factors affecting the adjunctive aripiprazole treatment effect. RESULTS: For MADRS-defined response and remission, the relative gain of adjunctive aripiprazole versus ADT monotherapy was 1.46 (p = 0.044) and 1.43 (p = 0.085), respectively. Gender, current escitalopram, duration of current episode, and baseline body mass index are potential factors affecting the adjunctive aripiprazole treatment effect. CONCLUSIONS: Compared with ADT monotherapy, adjunctive aripiprazole was associated with an improved benefit-risk profile in MDD.

Incidence and costs of treatment-related complications among patients with advanced squamous cell carcinoma of the head and neck.

OBJECTIVE: To evaluate the incidence and costs of complications due to radiotherapy alone vs platinum-based chemoradiotherapy among patients diagnosed as having advanced squamous cell carcinoma of the head and neck (ASCCHN) from a payer perspective. DESIGN: Retrospective cohort study. SETTING: Data from the PharMetrics Patient-Centric Database from June 2000 through June 2006. PATIENTS: The study included patients with ASCCHN and an indication of a secondary malignant neoplasm (both identified based on International Classification of Diseases, Ninth Revision, Clinical Modification, diagnosis codes), 124 of whom were treated with radiotherapy alone and 77 of whom were treated with chemoradiotherapy (including 53 with cisplatin plus radiotherapy, 26 with carboplatin plus radiotherapy, and 2 with cisplatin and carboplatin plus radiotherapy). The patients were assigned to 1 of 2 cohorts based on treatment type-radiotherapy only and platinum-based chemoradiotherapy-and were followed up for 6 months. MAIN OUTCOME MEASURES: Incidence and costs of treatment-related complications associated with chemotherapy in ASCCHN. RESULTS: We found significantly (P < .001) higher rates of treatment-related complications among patients receiving chemoradiotherapy (86%) than among patients receiving only radiotherapy (51%). The mean per-patient costs associated with treatment-related complications were approximately $10 000 higher among patients who received chemoradiotherapy than among those treated with radiotherapy alone (P < .001). These costs represented 17% of the total costs during follow-up for patients who received chemoradiotherapy and 11% of costs for those who received radiotherapy. The most expensive complications were dehydration and/or electrolyte imbalance and oral complications. CONCLUSIONS: Our study results suggest that the attributable incidence and costs of treatment-related complications associated with chemotherapy in ASCCHN are substantial. The emergence of safer treatments may have the advantage of alleviating this cost burden.

Changes in weight and weight-related quality of life in a multicentre, randomized trial of aripiprazole versus standard of care.

BACKGROUND: This is a secondary analysis of clinical trial data collected in 12 European countries. We examined changes in weight and weight-related quality of life among community patients with schizophrenia treated with aripiprazole (ARI) versus standard of care (SOC), consisting of other marketed atypical antipsychotics (olanzapine, quetiapine, and risperidone). METHOD: Five-hundred and fifty-five patients whose clinical symptoms were not optimally controlled and/or experienced tolerability problems with current medication were randomized to ARI (10-30 mg/day) or SOC. Weight and weight-related quality of life (using the IWQOL-Lite) were assessed at baseline, and weeks 8, 18 and 26. Random regression analysis across all time points using all available data was used to compare groups on changes in weight and IWQOL-Lite. Meaningful change from baseline was also assessed. RESULTS: Participants were 59.7% male, with a mean age of 38.5 years (SD 10.9) and mean baseline body mass index of 27.2 (SD 5.1). ARI participants lost an average of 1.7% of baseline weight in comparison to a gain of 2.1% by SOC participants (p<0.0001) at 26 weeks. ARI participants experienced significantly greater increases in physical function, self-esteem, sexual life, and IWQOL-Lite total score. At 26 weeks, 20.7% of ARI participants experienced meaningful improvements in IWQOL-Lite score, versus 13.5% of SOC participants. A clinically meaningful change in weight was also associated with a meaningful change in quality of life (p<0.001). A potential limitation of this study was its funding by a pharmaceutical company. CONCLUSIONS: Compared to standard of care, patients with schizophrenia treated with aripiprazole experienced decreased weight and improved weight-related quality of life over 26 weeks. These changes were both statistically and clinically significant.

Predicted risk of diabetes and coronary heart disease in patients with schizophrenia: aripiprazole versus standard of care.

OBJECTIVE: Patients with schizophrenia are at increased risk of developing diabetes mellitus and cardiovascular disease. Furthermore, some atypical antipsychotics are associated with metabolic disturbances, which augment the risk for these comorbid conditions. In clinical trials, effects on metabolic parameters with aripiprazole are similar to those with placebo and superior to those with olanzapine, and the Schizophrenia Trial of Aripiprazole (STAR) demonstrated comparable efficacy of aripiprazole versus standard of care (SoC; physicians' selection of quetiapine, olanzapine, or risperidone). METHOD: In this post hoc analysis, data from STAR were used to assess the risks of diabetes and coronary heart disease (CHD) in patients with schizophrenia. The Stern (San Antonio Heart Disease Study) and Framingham models, with modifications, were used to predict the risk of diabetes at 7.5 years and CHD at 10 years, respectively. RESULTS: Aripiprazole-treated patients had more favorable changes in lipids, glucose, and body weight versus SoC. In a subsample of patients who had fasting lipid and glucose test results, the Stern model predicted 23.4 fewer incidences of new-onset diabetes with aripiprazole versus SoC in a hypothetical 1000-patient cohort. The number needed to treat with aripiprazole to avoid 1 adverse outcome expected with SoC was 43. In the same population, the Framingham model predicted 3.9 fewer CHD events, with a number needed to treat with aripiprazole of 256. CONCLUSION: Aripiprazole-treated patients had more favorable changes in metabolic parameters compared with SoC, leading to a reduced risk of diabetes and CHD, based on validated models.

Comparison of metabolic syndrome incidence among schizophrenia patients treated with aripiprazole versus olanzapine or placebo.

BACKGROUND: Metabolic syndrome is a strong determinant of new-onset diabetes and coronary heart disease in general populations. Given the higher prevalence of metabolic syndrome among mentally ill patients, the syndrome poses a greater health risk to this population. Atypical antipsychotic treatment may exacerbate this condition. We compared both the rate and incidence of metabolic syndrome among schizophrenia patients (DSM-IV criteria) treated with the atypical antipsychotics aripiprazole or olanzapine or placebo from 4 double-blind, randomized, controlled clinical trials. METHOD: Metabolic syndrome was defined according to the Third Adult Treatment Panel (ATP III) Guidelines as the presence on follow-up of 3 of the following abnormalities: waist circumference > 102 cm if male and > 88 cm if female, high density lipoprotein (HDL) < 40 mg/dL if male and < 50 mg/dL if female, diastolic blood pressure >or= 85 mm Hg or systolic blood pressure >or= 130 mm Hg, fasting triglycerides >or= 150 mg/dL, fasting plasma glucose >or= 110 mg/dL. Both the rate of metabolic syndrome and the person-time incidence were computed from the on-treatment follow-up. RESULTS: In the placebo-controlled trials, the rate of metabolic syndrome was 25.8% among 155 placebo patients and 19.9% for 267 aripiprazole patients (p = .466 by stratified log rank). The incidence of metabolic syndrome was 14.3% for 91 placebo patients versus 5.3% for 151 aripiprazole patients (p < .001). In the active comparator trials, patients treated with olanzapine (N = 373) versus aripiprazole (N = 380) exhibited rates of 41.6% and 27.9%, respectively (p = .0002). Incidence rates were 27.4% for 212 olanzapine patients versus 15.7% for 198 aripiprazole patients (p = .0055). CONCLUSION: Both the rate and incidence of clinically relevant metabolic syndrome differ according to the choice of antipsychotic agent. The association between metabolic syndrome and treatment warrants careful consideration in the choice of antipsychotic agents.

Prevalence and the associated burden of illness of symptoms of diabetic peripheral neuropathy and diabetic retinopathy.

BACKGROUND: We estimated the prevalence and the associated burden of illness of symptoms of diabetic peripheral neuropathy (SDPN), diabetic retinopathy (DR), and comorbid SDPN and DR among people with diabetes in the United States aged > or =40 years. METHODS: Analyses were conducted on 850 respondents aged > or =40 years with diagnosed diabetes from the combined 1999-2000 and 2001-2002 National Health and Nutrition Examination Surveys. Sampling weights were used to estimate the number of people with diabetes who have SDPN, DR, or comorbid SDPN and DR. Multivariate regression models were used to assess the effects of SDPN, DR, and comorbid SDPN and DR on burden-of-illness measures. RESULTS: Approximately 11.9 million adults in the United States aged > or =40 years have diagnosed diabetes. Of those, 3.9 million (32.7%) have SDPN, 3.3 million (27.4%) have DR, and 1.6 million (13.1%) have comorbid SDPN and DR. Among our sample, those with SDPN [odds ratio (OR)=2.25; 95% confidence interval (95% CI)=1.32-3.83], DR (OR=1.68; 95% CI=1.08-2.61), or comorbid SDPN and DR (OR=2.84; 95% CI=1.26-6.41) were more likely than those without the corresponding condition to have four or more health care visits in the past year. Those of working age (40-65 years) with SDPN (OR=3.23; 95% CI=1.60-6.52), DR (OR=2.94; 95% CI=1.45-5.97), or comorbid SDPN and DR (OR=4.32; 95% CI=2.17-8.63) were more likely unable to work due to physical limitations. CONCLUSIONS: SDPN, DR, and comorbid SDPN and DR are prevalent among people with diabetes in the United States aged > or =40 years; each of these complications appears to significantly increase the burden of illness.