Search

Description of risk of cardiovascular (CV) events associated with diabetes is evolving. This US-based real-world study estimated risk of future CV events and heart failure (HF) from type 2 diabetes (T2DM) only, prior CV events only or T2DM plus prior CV events, versus controls, and evaluated healthcare resource utilization (HCRU) and costs. This retrospective cohort study queried claims and mortality data for 638,301 patients: T2DM only (377,205); prior CV events only (130,964); both T2DM and prior CV events (130,132); and matched (1:1) controls, during 1 January 2012–31 December 2012. Cardiovascular diagnoses/events and death were assessed individually, and as composite endpoint (myocardial infarction [MI], stroke, transient ischemic attack [TIA], peripheral artery disease [PAD]), during follow-up, ending 31 July 2018. Adjusting for age and gender, patients with T2DM only were 1.6, prior CV events only 2.5 and T2DM plus prior CV events 3.8 times likelier to have primary composite CV events relative to controls, p In this large and geographically broad US based cohort, CV risk for T2DM patients was elevated, as was the risk for patients with prior CV events, while patients with T2DM plus prior CV events had the highest risk of future CV events. The substantial clinical and economic burden of CV events and HF in patients with both T2DM and prior CV events suggest a need for an integrated treatment and targeted intervention across both conditions.

Chronic disease is associated with increased health care resource utilization and costs. Effective development and implementation of health care management and clinical intervention programs require an understanding of health plan member enrollment and disenrollment behavior.To examine the health plan enrollment and disenrollment behavior of commercially insured and Medicare Advantage members with established chronic disease compared with matched members without the disease of interest, using data from a large national health insurer in the United States.This retrospective matched cohort study used administrative claims data from the HealthCore Integrated Research Database from January 1, 2006, to November 30, 2015, to identify adults with chronic disease (type 2 diabetes mellitus [T2DM], cardiovascular disease [CVD], chronic obstructive pulmonary disease [COPD], rheumatoid arthritis [RA], and breast cancer [BC]). Members with no established chronic disease (controls) were directly matched to members with established chronic disease (cases) on demographic characteristics. The earliest date on which members met the criteria for a given disease was defined as the index date. Controls had the same index date as the matched cases. All members had ≥ 12 months of continuous health plan enrollment before the index date. Outcomes included health plan member disenrollment and enrollment duration. Incidence rates per 1,000 member-years for member disenrollment were evaluated along with incidence rate ratios (relative risk) using a Poisson model. Time to disenrollment was analyzed by Cox proportional hazard models and Kaplan-Meier survival curves. Sensitivity analyses were conducted where death was included as a disenrollment event.70,907 health plan members with BC (99.7% female, mean age 60.5 years); 28,883 members with COPD (52.3% female, mean age 66.7); 835,358 members with CVD (50.5% female, mean age 62.7 years); 210,936 members with T2DM (45.2% female, mean age 53.6 years); and 31,954 members with RA (72.0% female, mean age 55.5 years) were matched to controls and met the study criteria. The incidence rates of health plan disenrollment ranged from 155 to 192 members per 1,000 members per year. Compared with controls, members with chronic disease were 30%-40% less likely to disenroll from a health plan (This real-world study demonstrated that members with chronic disease had a significantly lower rate of disenrollment and a longer duration of enrollment compared with matched controls and were continuously enrolled for almost a year longer than members without a diagnosed chronic disease. Understanding health plan enrollment and disenrollment behavior may provide a valuable context for determining the time frame for the effect of health care programs and initiatives.Funding for this study was provided by HealthCore, a wholly owned subsidiary of Anthem. Chung, Deshpande, Zolotarjova, Quimbo, and Willey are employees of HealthCore. Kern and Cochetti are former employees of HealthCore. Quimbo, Cochetti, and Willey are shareholders of Anthem. HealthCore receives funding from multiple pharmaceutical companies to perform various research studies outside of the submitted work. The preliminary results of this study were presented at AMCP Nexus 2015; March 26-29, 2015; Orlando, FL, and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 2017 Conference; May 20-24, 2017; Boston, MA.

BACKGROUND: The Global Initiative for Chronic Obstructive Lung Disease (GOLD) report for the management of chronic obstructive pulmonary disease (COPD) focuses on reducing existing symptoms, decreasing the risk of future exacerbations, and improving health status by recommending specific drug therapy based on exacerbation risk and symptoms. However, disparities exist between evidence-based recommendations and clinical practice. Research that quantifies the real-world effect of COPD regimen alignment with the GOLD recommendations on clinical and economic outcomes is needed. OBJECTIVE: To compare COPD-related health care resource utilization (HRU) and costs, as well as exacerbation rates, among patients with COPD on maintenance therapy based on 2017 GOLD treatment recommendation compliance status per GOLD ABCD risk group classification in a U.S. commercially insured/Medicare Advantage population. METHODS: This retrospective cohort study utilized administrative claims data in the HealthCore Integrated Research Database. The COPD population was identified using a previously validated claims-based predictive model. Among this population, patients with ≥ 1 claim for a COPD maintenance medication (earliest maintenance fill-date = index date) between January 1, 2014, and March 31, 2017, were identified. Patients were required to be aged ≥ 40 years, have ≥ 12 months of pre-index and ≥ 30 days of post-index health plan enrollment, with no diagnosis for asthma, cystic fibrosis, and/or lung cancer at any time from January 1, 2013, to March 31, 2018. Patients were categorized into exacerbation risk/symptomatology groups according to the 2017 GOLD ABCD assessment recommendations and were then classified into treatment-compliance status based on their maintenance therapy. Multivariable analyses were conducted to examine post-index COPD-related HRU, costs, and exacerbations by compliance status. RESULTS: The primary analytical study sample included 38,382 patients in the GOLD A/B group and 6,525 in the GOLD C/D group. Patients were further categorized into GOLD A (n = 19,345), B (n = 19,037), C (n = 1,865), and D (n = 4,670). GOLD-compliant regimens were observed in 32.9% of patients in the GOLD A/B group and in 58.9% of patients in the GOLD C/D group. Inhaled corticosteroid-containing regimens were the most commonly observed noncompliant regimen. Patients on compliant regimens had significantly fewer COPD-related inpatient and emergency department visits and therefore had significantly lower COPD-related medical costs in both the GOLD A/B and C/D cohorts. Similar results were observed for individual GOLD cohorts B, C, and D. These savings were offset by increased pharmacy expenditures. Being on GOLD guideline-compliant regimens significantly reduced the risk of exacerbation by 8% (hazard ratio [HR] = 0.92; P < 0.0001) in the GOLD A/B cohort and by 12% (HR = 0.88; P = 0.0005) in the GOLD C/D cohort, and was also associated with a significantly reduced exacerbation rate in the GOLD A/B (rate ratio [RR] = 0.93; P < 0.0001) and GOLD C/D (RR = 0.93; P = 0.0129) groups. CONCLUSIONS: This study suggests a continuing trend of high prevalence of suboptimal prescriber compliance to GOLD treatment recommendations. Treatment regimens compliant with GOLD recommendations were associated with improvement in exacerbations, reduced COPD-related HRU, and COPD-related medical cost offsets. DISCLOSURES: This study was funded by Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI). BIPI was given the opportunity to review the manuscript for medical and scientific accuracy as well as intellectual property considerations. Palli and Shaikh are employees of BIPI. Willey is an employee of HealthCore, which was contracted by BIPI to conduct this study. Zhou was an employee of HealthCore at the time of study execution. Data were presented in part during an AMCP webinar (recording not made public) held in lieu of the Spring 2020 AMCP conference, which was canceled due to the COVID-19 pandemic.

Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality and is associated with substantial economic burden. There is a lack of data regarding COPD outcomes and costs in a real-world setting, particularly by Global Initiative for Chronic Obstructive Lung Disease (GOLD) severity.To (a) characterize a commercially insured U.S. population with COPD and (b) assess prevalence of exacerbations, health care resource utilization (HCRU), costs, and treatment patterns in a cohort of patients with confirmed COPD, overall and stratified by GOLD stage.This retrospective observational cohort study used administrative claims data from the HealthCore Integrated Research Database to identify patients with ≥ 1 inpatient, emergency room (ER), or office visit claim for COPD between January 1, 2012, and November 30, 2013, and continuous enrollment for 1 year before and 2 years after the first COPD diagnosis date. Patients with a spirometry claim within 12 months were eligible for medical record abstraction to confirm COPD diagnosis (forced expiratory volume in 1 second [FEV53,484 patients newly diagnosed with COPD were identified who met initial inclusion criteria: 14,293 (27%) had a qualifying spirometry claim, and 1,505 had confirmed COPD (GOLD 1, 333 [22%]; GOLD 2, 823 [55%]; GOLD 3, 317 [21%]; GOLD 4, 32 [2%]). Patients with greater disease severity had higher rates of moderate/severe COPD exacerbations (GOLD 1 and 2, 40.4 and 48.9 per 100 person-years, respectively; GOLD 3 and 4, 83.6 and 89.1 per 100 person-years, respectively). All-cause and COPD-related inpatient admissions, COPD-related office visits, and COPD-related ER visits were more prevalent with more severe GOLD classification. Mean annual COPD-related medical costs increased with GOLD classification ($5,945 for GOLD 1 patients, $18,070 for GOLD 4). COPD maintenance medication was filled by 42%, 56%, 73%, and 75% of patients in GOLD 1-4 (57% overall), respectively; combination corticosteroid/long-acting beta2-agonist inhalers were the most commonly used medication, regardless of GOLD classification. Patients with more severe disease had greater adherence (range 44%-68% of days covered for GOLD 1-4) and persistence (range 107-209 days for GOLD 1-4).Trends toward increases in exacerbations, HCRU, and costs were observed as airflow limitation worsened. Adherence and persistence with COPD maintenance therapy was suboptimal even with severe disease.This study was supported by Boehringer Ingelheim Pharmaceuticals (Ridgefield, CT), which was given the opportunity to review the manuscript for medical and scientific accuracy, as well as intellectual property considerations. Willey and Singer are employees of HealthCore (parent company Anthem), which received funding from Boehringer Ingelheim to complete this study. Wallace and Shinde were employed by HealthCore at the time of this study. Wallace and Singer report stock ownership in Anthem. Napier is an employee of Anthem. Kaila, Bayer, and Shaikh are employees of Boehringer Ingelheim Pharmaceuticsls. Portions of this research were presented at the following conferences: (a) A. Wallace, S. Kaila, V. Zubek, A. Shaikh, M. Shinde, V. Willey, M. Napier, and J. Singer, Healthcare resource utilization, costs, and exacerbation rates in patients with COPD stratified by GOLD airflow limitation classification in a US commercially insured population, presented at AMCP Nexus 2017; October 16-19, 2017; Dallas, TX; and (b) A.E. Wallace, V. Zubek, S. Kaila, A. Shaikh, M. Shinde, V. Willey, M.B. Napier, and J.R. Singer, Real-world treatment patterns among newly diagnosed COPD patients according to GOLD airflow limitation severity classification in a U.S. commercially insured/Medicare Advantage population, presented at CHEST 2017 Annual Meeting; October 28-November 1, 2017; Toronto, Ontario, Canada.

Omalizumab is indicated for the management of chronic idiopathic urticaria (CIU) in patients aged 12 years or older with persistent hives that are not adequately controlled by H1 antihistamines. While its safety and efficacy in CIU patients have been evaluated in multiple clinical trials, real-world use of omalizaumab in CIU has not been well characterized.To assess demographics, clinical characteristics, and treatment patterns of CIU patients who initiated omalizumab to better understand the usage of this agent in CIU management in the real world.This retrospective cohort study used medical and pharmacy claims data in the United States from the HealthCore Integrated Database to identify patients with CIU newly treated with omalizumab (≥ 4 omalizumab claims within 6 months of the initial claim) between March 21, 2014, and October 31, 2015 (study intake period). The index date was defined as the date of the first claim for omalizumab during the study intake period. Demographic and clinical characteristics were described for patients treated with omalizumab, as were treatment patterns associated with omalizumab and concomitant medications associated with CIU treatment. Descriptive and inferential statistics were reported. The Kaplan-Meier method was used to examine omalizumab treatment patterns.This study included 298 omalizumab-treated patients (mean [SD] age of 43.5 [13.64] years; 70.8% female); approximately 84% were seen by an allergist/immunologist. All patients had ≥ 12 months of continuous enrolment and a subset of 138 patients had ≥ 18 months of follow-up. For patients with ≥ 12 months of post-index follow-up, 12.1% (n = 36), 28.5% (n = 85), and 32.9% (n = 98) discontinued omalizumab within the 6-month, 12-month, and the entire post-index periods (mean 530 days), respectively; the mean number of days patients were continuously treated with omalizumab was 443.1 (95% CI = 425.0-461.3); the probabilities of continuous treatment (95% CI) were 0.879 (0.836-0.911), 0.711 (0.656-0.759), and 0.647 (0.585-0.703) for the 6-, 12-, and 18-month post-index periods, respectively. For the 98 patients who discontinued omalizumab during the entire post-index period, 28.6% restarted omalizumab after the first discontinuation within the post-index period (mean time from first discontinuation to first restart=329 days). Use of medications such as oral corticosteroids, montelukast, cyclosporine, and prescription H1 and H2 antihistamines decreased during the 1- to 6-month and 7- to 12-month post-index periods compared with those within the 6-month pre-index period.In this cohort of CIU patients who were newly prescribed omalizumab, the majority were treated by allergists/immunologists as expected, and approximately 60% of patients continued on therapy beyond 18 months. Concomitant medication use decreased after omalizumab initiation. These data on the real-world use of omalizumab for CIU may help to better inform decision-making processes for health care payers by quantifying omalizumab and concomitant medication treatment patterns over a longer time frame relative to previous studies. DISCLOSURES This study was sponsored by Novartis Pharmaceuticals, which provided funding support for the conduct of the study. Kavati, Ortiz, and Paknis are employees of Novartis Pharmaceuticals. Ke, Wertz, Huang, Wang, Willey, and Stephenson are employees of HealthCore, an independent research organization that received funding from Novartis Pharmaceuticals for the conduct of this study. Beck is an employee of the University of Rochester Medical Center, who was under contract with Novartis Pharmaceuticals to provide consulting services to this study, and reports grants from Genentech, outside the currently submitted work. Bernstein is affiliated with Bernstein Clinical Research Center, which was under contract with Novartis Pharmaceuticals to provide consulting services to this study, and reports receiving grants and personal fees from Novartis Pharmaceuticals, grants and personal fees from Genentech outside of the submitted work, and is an author on the Joint Task Force for Practice Parameters for Urticaria and the GALEN international guidelines for urticaria under preparation. Study concept and design were primarily contributed by Kavati, Ortiz, and Paknis, with assistance from the other authors. Huang, Wang, and Ke took the lead in data collection, with assistance from Wertz, Willey, and Stephenson. Data interpretation was performed by Ke, Wertz, and Willey, assisted by the other authors. The manuscript was written by Stephenson, Ke, and Wang, along with Willey, Wertz, and Huang, and revised by Bernstein and Beck, with assistance from the other authors. Selected study data were presented in a poster at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 22nd Annual International Meeting on May 20-24, 2017, in Boston, Massachusetts. A poster based on this dataset was presented at the 2017 American College of Allergy, AsthmaImmunology (ACAAI) Annual Scientific Meeting on October 26-30, 2017, in Boston, Massachusetts.

To examine treatment patterns, treatment response, and demographic and clinical characteristics of patients with chronic idiopathic urticaria (CIU) newly initiated on omalizumab therapy in real-world practice in the US.This retrospective observational cohort study used US claims data from the HealthCore Integrated Research Database (HIRDThis study consisted of 88 patients with a mean (SD) age of 43.4 (± 13.46) years, 68.2% were female, and 36 patients had ≥18 months post-index eligibility. Among 69 patients with documented index dose, 75.4% received omalizumab 300 mg and 69.6% remained on index dose throughout follow-up. For 52 patients with documented index dosing frequency, 96.2% had every 4-week dosing frequency. Among 86 patients with omalizumab documentation, 83.7% reported CIU improvement after omalizumab initiation and 24.4% discontinued omalizumab. For all patients, the proportion using oral corticosteroids (OCS) decreased pre- to post-index (52.3% vs 39.8%). Similar results were observed for patients with ≥18 months post-index eligibility.In this real-world analysis, the majority of patients remained on omalizumab for ≥12 months, and had a positive response. OCS use decreased following omalizumab initiation.

Objectives With the approval of new non-vitamin K antagonist oral anticoagulants for stroke prevention in non-valvular atrial fibrillation (NVAF), it is anticipated that their introduction may change NVAF treatment patterns; however, there is limited supporting real-world evidence. This study investigated guideline-recommended oral anticoagulation (OAC) treatment and persistence in newly diagnosed patients with NVAF to understand demographic and clinical characteristics. Design Retrospective observational administrative claims study in the USA. Setting Patients with NVAF with ≥1 pharmacy claim for OAC (warfarin, dabigatran, rivaroxaban or apixaban) and no atrial fibrillation diagnosis within 12 months prior to the first claim were identified in the HealthCore Integrated Research Database between 1 November 2010 and 30 November 2013. Participants 45 092 patients with NVAF were included. Outcomes The proportion of OAC-treated patients was stratified by CHADS2 score. Treatment persistence was measured from OAC initiation to discontinuation, end of eligibility or end of study period (30 November 2014), whichever occurred first. Results Almost half of the patients (41.1%) received an OAC. The proportion treated differed slightly in baseline stroke risk (CHADS23: 40.3%: p

The objective of this study was to examine patient characteristics, treatment patterns, and exacerbations among patients with asthma newly treated with omalizumab.Data for this study were obtained from administrative claims and medical records. The index date was the date of the first claim for omalizumab. All patients had ≥12 months of continuous health plan eligibility before and after the index date. Demographic and clinical characteristics were obtained 12 months before the index date. Treatment patterns of asthma medications, including omalizumab, and asthma exacerbations were evaluated in the preindex and postindex periods.The study included 1564 patients. Asthma-related medication use decreased from the preindex to the postindex periods (oral corticosteroids, 83.3%-66.4%, P0.001; inhaled corticosteroids [ICSs], 33.1%-26.8%, P0.001; long-acting βIn this real-world analysis, patients newly initiating omalizumab therapy for allergic asthma used fewer concomitant asthma medications, while experiencing significant reductions in asthma exacerbations, especially hospitalization- and emergency department-specific exacerbations, from pre- to post-omalizumab treatment initiation periods.

Background The occurrence of low rates of rhabdomyolysis among patients receiving lipid-lowering drugs (LLDs) in randomized clinical trials may be elucidated with population-based studies. Objective To determine the risk of hospitalized rhabdomyolysis associated with LLD therapy. Methods This observational study used claims data from 9 million members of five United States health plans to identify patients (≥18 years) who received >2 statin and nonstatin LLDs during July 2000 to December 2004. Inpatient International Classification of Diseases , Ninth Revision, Clinical Modification, codes for rhabdomyolysis (791.3, 728.89, and 728.88) were observed during the follow-up period; cases were confirmed with patients' medical records. Rhabdomyolysis events were reported per 10,000 person-years of LLD exposure; multivariate analysis was conducted. Results The study cohort (N = 473,343) received 490,988 and 11,624 person-years of LLD, and combination therapy, respectively. Medical charts were obtained for 104 of 144 eligible patients with rhabdomyolysis claims; 42 cases were confirmed. With atorvastatin as reference, rhabdomyolysis rates (95% confidence interval) were greatest for cerivastatin, 8.4 (2.3-21.7); no difference among available statins was observed. Rates for other LLD monotherapies were: niacin, 2.1 (0.3−7.7), ezetimibe, 2.1 (0.3−7.8), fenofibrate, 0 (0−1.7), and gemfibrozil, 2.0 (0.5−5.2). Multivariate analysis showed only cerivastatin with a significantly greater risk of rhabdomyolysis (odds ratio 4.74, 95% confidence interval 1.1-21.2, P = .041) versus atorvastatin among the statins. Combination therapies had increased rhabdomyolysis risk (OR 7.1, 1.6-31.6, P = .010) versus LLDs alone. Conclusion The risk of habdomyolysis among hospitalized patients receiving statins was low; no difference among the available statins was evident. Further data are needed to establish the risk profile but current findings already offer guidance to physicians.

Background— This study directly compares risk of acute myocardial infarction (AMI), acute heart failure (AHF), or all-cause death among pioglitazone- and rosiglitazone-treated patients in a managed-care population. Methods and Results— Patients ≥18 years of age, newly initiated on rosiglitazone or pioglitazone between January 1, 2001, and December 12, 2005, were included. The date of the first pharmacy claim for rosiglitazone or pioglitazone was defined as index date. Patients were excluded if they had P =0.666) when patients were followed from index date until end of study period, termination of enrollment status, or diagnosis of AMI/AHF/death. Conclusions— In this retrospective cohort study directly comparing rosiglitazone and pioglitazone with a propensity score–matched population that includes mortality data, no significant differences were found in the risk of AMI, AHF or death.

The availability of generic simvastatin has changed the relative cost structure within the statin marketplace and has been associated with third-party payer changes to formularies and statin utilization policies. The current study examines simvastatin therapy modification patterns and associated low-density lipoprotein cholesterol (LDL-C) goal attainment rates.This retrospective, observational study utilized administrative claims linked to laboratory result data from a national health plan. Patients newly initiated on generic simvastatin from January 2007 to March 2008 were identified. National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) risk categories and goal LDL-C targets were assigned. Simvastatin dose titrations and switches to other statins were described, as were changes in LDL-C values and NCEP ATP III goal attainment rates both before and after therapy modifications.Of the 1654 patients newly initiated on simvastatin, 84% had no simvastatin therapy modification in the1-year follow-up period. For patients with no therapy modification, 54.4% did not achieve their LDL-C NCEP ATP III goal at their first lipid panel and goal attainment was strongly associated with the level of cardiovascular risk (goal attainment rate = 75.1%, 51.7%, and 28.6% for low-, moderate- and high-risk categories, respectively). Of patients not achieving NCEP ATP III LDL-C goals (n = 885), 85.4% had no therapy modification. Goal was achieved after therapy modification in 36% (dose titration) and 42% (switchers); high-risk patients goal attainment rates were 23% and 38%, respectively.LIMITATIONS of the study include the observational design, use of an administrative claims database to assess cardiovascular risk, relatively short follow-up time (slightly more than 1 year) and the lack of assessment of adherence to therapy.This study found that the majority of patients initiated on generic simvastatin stayed on their initial starting dose regardless of NCEP ATP III goal attainment status. The findings of low rates of therapy modification irrespective of baseline CV risk and associated low rates of goal attainment, especially in high risk patients treated with simvastatin, indicate an opportunity to encourage clinical decision making based on the needs of the individual patient.

This study examined the incidence of and healthcare costs attributable to genital warts within a large US commercially insured, geographically dispersed population.Using a retrospective cohort study design, this longitudinal analysis assessed administrative claims of integrated medical and pharmacy encounters from five Blue Cross Blue Shield health plans. Genital warts cases were identified using a methodology previously described by Insinga et al.Age- and gender-specific incidence of genital warts per 1000 person-years in 2004, and duration-of-episode attributable direct medical costs (2004 US dollars) and healthcare resource utilization of cases diagnosed in 2002. Overall outcome measures were age- and gender-adjusted to the 2004 US civilian population.Genital warts incidence in 2004 was 1.2/1000 females and 1.1/1000 males. Incidence was highest among females aged 20-24 (4.6/1000) and males aged 25-29 (2.7/1000). Projected overall incidence was over 340,000 cases in 2004. Mean duration-of-episode per incident case in 2002 was 95.4 days (males 116.3 days; females 69.7 days). Mean ambulatory visits per episode were 1.5 for females and 1.9 for males, with1 drug prescription/episode. Mean costs were $647/episode ($745 males; $528 females). The 2004 estimated economic burden was $760 per 1000 individuals in the general population with the total exceeding $220 million.Only those genital warts cases that sought evaluation or for which the treating provider was covered by the health plan were captured in the study.Genital warts represent a significant health and cost burden in the US. Adoption of novel healthcare technologies such as vaccines along with traditional interventions such as physician education of signs and symptoms, condom use and abstinence or limiting number of sexual partners may significantly help reduce the burden of genital warts.

To compare the baseline characteristics, episodes of care, and cost of erythropoiesis-stimulating agents among cancer patients in a US managed-care population.Retrospective analysis of administrative claims data. Episodes of care for patients with cancer receiving erythropoiesis-stimulating agents between January 1, 2004 and January 17, 2006 included all claims for erythropoiesis-stimulating agents withor = 42 days' gap between claims, plus the duration of therapeutic benefit based on median days between consecutive doses.Main outcome measures were average weekly dose of erythropoiesis-stimulating agents and costs of therapy.A total of 15,007 eligible episodes of care (darbepoetin alfa, 7769 episodes [5587 patients]; epoetin alfa 7238 episodes [5157 patients]) were identified. Fewer claims were observed per episode of care for darbepoetin alfa than for epoetin alfa (mean [SD] 3.7 [4.1] vs. 5.3 [6.4]). The median time between consecutive claims was 15 days (darbepoetin alfa) and 8 days (epoetin alfa). The mean (SD) weekly doses were 105 (56) microg (darbepoetin alfa) and 34,242 (28173) U (epoetin alfa), a dose-comparison ratio of 326 : 1. Dose-comparison ratios were sensitive to assumptions about duration of clinical benefit. The mean (95% CI) weekly costs were significantly lower for darbepoetin alfa ($560 [553-567]) than for epoetin alfa ($645 [630-659], p0.0001) when duration of clinical benefit was considered.Significant differences characterize patterns of use of erythropoiesis-stimulating agents. Duration of therapeutic benefit is an important variable in comparing darbepoetin alfa with epoetin alfa; incorporation of this variable in analyses of costs of therapy may have notable effects on calculated treatment costs. Limitations of the study include the potential for database errors or omissions, lack of detailed disease data, and lack of adjustment for differences in the ages and comorbidities of patients.

Current prevention guidelines support efforts to achieve optimal high-density lipoprotein (HDL-C) and triglyceride (TG) values, in addition to low-density lipoprotein (LDL-C) in order to reduce cardiovascular (CV) events. The study objective was to evaluate the risk of CV events in patients attaining versus not attaining combined (LDL-C, HDL-C, and TG) optimal lipid values.This retrospective cohort analysis was conducted using a 1.1 million member managed care database. Eligible patients had a full lipid panel between 10/1/99 and 9/30/00, were naive to lipid therapy, and had health plan eligibility 12 months pre- and post-index (baseline) lipid laboratory value. Optimal lipid values (LDL-C, HDL-C, and TG) were established using the National Cholesterol Education Program Adult Treatment Panel (NCEP ATP III) guidelines, and patients were placed into one of four groups: none, one, two, or three lipid components non-optimal at baseline. The presence of cardiovascular risk, disease, and events were determined by selected International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9 CM) and Current Procedural Terminology (CPT codes). The definition of a CV event included: diagnosis of ischemic heart disease, peripheral arterial disease, stroke/TIA, or revascularization procedure. Odds ratios (OR) for a CV event associated with attainment of each optimal lipid fraction were determined by multivariate logistic regression. The study cohort included 30,348 patients, with a mean follow-up of 27 +/- 8 months. Mean age was 66 +/- 12 years; 16,549 (54%) were male; and 17,289 (57%) patients had coronary heart disease (CHD) or CHD risk equivalent. There were 5955 CV events that occurred in 4059 (13%) study patients. The presence of a single non-optimal lipid value slightly increased CV event risk [OR: 1.06; 95% CI: 0.95-1.18], whereas two or all three non-optimal lipid values significantly increased the risk of a CV event [OR: 1.22; 95% CI: 1.08-1.37; and 1.45; 95% CI: 1.24-1.68, respectively].As with all large observational databases there are potential limitations including: patient selection bias (e.g., more interventions in patients with greater illness, lack of mortality data, and frequency of lipid monitoring), unknown confounding variables, and potential coding errors.Not attaining optimal combined lipid values, independently and significantly, increased the risk of CV events in this large at-risk population with approximately 68,283 patient years of follow-up. The combination of non-attainment of optimal LDL-C with non-attainment of optimal HDL-C or TG values, or both, increased the adjusted risk of CV events by 22-45%. Thus, therapeutic strategies should focus on assessment and management of multiple lipid abnormalities, and not on single lipid risk factor modification.

Purpose. The effectiveness of rosuvastatin versus atorvastatin in reducing lipid levels and achieving low-density-lipoprotein (LDL) cholesterol goals in patients treated in a usual care setting was studied. Methods. Electronic medical and pharmacy administrative claims from a western U.S. health plan with approximately 8 million covered members were extracted and used in this retrospective, longitudinal cohort study. Patients age 18 years or older who were newly initiated on rosuvastatin or atorvastatin between August 1, 2003, and June 30, 2004, were included. Propensity-score matching on baseline characteristics was used to minimize selection bias between groups. Administrative claims and medical records were used to assign patients a cardiovascular risk status and corresponding LDL cholesterol goal using guidelines from the National Cholesterol Education Program (NCEP). Changes in lipid levels and attainment rates of goal LDL cholesterol levels were estimated after accounting for baseline covariates using regression techniques. Results. A total of 453 patients met the study criteria. The mean dose of rosuvastatin was 11 mg compared with 15 mg for atorvastatin. After adjusting for baseline differences between groups, patients receiving rosuvastatin had significantly greater mean percent reductions in LDL cholesterol, total cholesterol, and non-high-density-lipoprotein (non-HDL) cholesterol than did patients receiving atorvastatin ( p < 0.001 for all comparisons). No significant differences were found in HDL cholesterol and triglyceride levels between groups. Attainment rates for NCEP LDL cholesterol goals were significantly higher in patients receiving rosuvastatin. Conclusion. Patients treated in a usual care setting with rosuvastatin had significantly greater reductions in LDL cholesterol, non-HDL cholesterol, and total cholesterol levels compared with those receiving atorvastatin. Patients receiving rosuvastatin were more likely to attain NCEP LDL cholesterol goals compared with patients treated with atorvastatin.

Published guidelines suggest the management of high-density lipoprotein cholesterol (HDL-C) and triglyceride (TG) values after the low-density lipoprotein cholesterol (LDL-C) goal is achieved.This study evaluated the attainment of optimal combined lipid values (LDL-C, HDL-C, and TGs) and associated therapy over time.This retrospective cohort analysis was conducted among managed-care patients who had a baseline lipid panel taken between October 1, 1999, and September 30, 2000; were naive to lipid therapy; and had plan eligibility for at least 12 months before and 12 to 36 months after the baseline lipid values. Patients were categorized as elevated-risk primary prevention (ERP) or as coronary heart disease (CHD) and CHD risk equivalents (CHD-RE). The attainment of optimal combined lipid values was assessed at baseline and quarterly thereafter. Associations between lipid values and the use of lipid-altering therapy were assessed using multivariate logistic regression.A total of 30,348 patients were monitored for a mean (SD) duration of 27 (8) months. Mean (SD) age was 66 (12) years and 55% (16,549/30,348) were men; 43% (13,059/30,348) were categorized as ERP and 57% (17,289/30,348) as CHD-RE. Combined lipid values were optimal in 14% (4167/30,348),18% (5508/30,348), and 22% (2936/13,100) of patients at baseline, 12 months, and 36 months, respectively. After 36 months, 78% (10,164/13,100) of patients did not attain optimal combined lipid values. Lipid therapy, primarily statin monotherapy (87% [7992/ 92251), was prescribed in 30% (9225/30,348) of patients. After 36 months, 34% (4492/13,100) of patients had isolated elevated LDL-C and 20% (2588/13,100) had non-optimal HDL-C and/or TGs. Lipid therapy was associated with the attainment of optimal combined values for LDL-C and TGs (both, P0.05), but not for HDL-C. Because the study was retrospective, causality cannot be determined.Based on the results of this study, use of combination lipid therapy and targeted therapy aimed at the specific lipid abnormalities may increase the attainment of optimal lipid parameters.

This study evaluated the accuracy of 2 administrative claims-based selection rules to identify patients with hypertension (HTN) using medical records as the gold standard.The claims database consisted of inpatient, outpatient, pharmacy, and eligibility claims for members of a single insurance company from January 2000 through March 2003. Medical records were abstracted for 258 matched patient pairs selected by Rule A (at least 1 HTN-related International Classification of Diseases, 9th Revision [ICD-9] claim) and 138 pairs selected by Rule B (at least 1 HTN-related ICD-9 and at least 1 HTN prescription claim) from 31 provider sites. Sensitivity and specificity of the 2 selection rules were computed using medical chart review as the gold standard for a diagnosis of HTN.Of patients selected by Rule A, chart review identified 281 patients with and 235 patients without HTN. Of patients selected by Rule B, chart review identified 172 patients with and 104 patients without HTN.The sensitivity and specificity was 70.8% and 74.9% for Rule A and 76.2% and 93.3% for Rule B. The kappa score was 0.45 for Rule A and 0.65 for Rule B.To identify patients with HTN, a selection rule using both a diagnosis and prescription claim has greater sensitivity and specificity than a rule using a diagnosis claim only.

Randomized control trials and observational studies show high-quality warfarin therapy leads to safe and effective stroke prophylaxis. In usual community practice, patient, physician and health care system factors are barriers to optimal anticoagulation. We examined the predictive relationship between inpatient and outpatient INR values in chronic non-valvular atrial fibrillation (AF) patients hospitalized for ischemic stroke (S), bleed (B) and control events (C) in usual community practice.This nested case-control analysis identified AF patients hospitalized for S, B and C using medical and pharmacy claims spanning 4.5 years ('98-'03) and validating diagnosis with chart abstraction. AF was defined as 2 medical claims for AFor= 42 days apart with a related prescription claim for warfarin. INRs from both outpatient and inpatient settings were used to yield a continuous history of coagulation status. Time-in-therapeutic-range (TTR) was calculated by Rosendaal's linear interpolation method. Correlation of inpatient and prognostic utility of last outpatient INRs was tested with S or B hospitalizations using univariate and multivariate logistic regression.Overall, 614 hospitalizations (means: age 73.9, CHADS(2) = 3.24; 52% male) included S (n = 98), B (n = 101) and C (n = 415) events. Average TTR was 28.6% (49.4% at INR2.0, 21.9% at INR3.0). First INR on admission (INR2.0 or3.0) was associated with S and B hospitalizations (OR-adjusted [95%CI], 1.68 [1.04-2.73] and 1.72 [1.02-2.90]), respectively. Last outpatient INR2.0 was not associated with S (OR-adjusted [95%CI], 1.12 [0.77-1.81]), and INR3.0 was not associated with B (OR-adjusted [95%CI], 1.25 [0.67-2.32]). Last outpatient INR measurement occurred at 28, 22 and 24 days (median; S, BC, respectively) before hospitalization.Patients were observed within therapeutic range less than 30% of their time on warfarin. While inpatient INRs were clearly associated with both ischemic stroke and bleed events, last outpatient INR before event was not predictive.

To measure the per-event health plan costs for acute and follow-up treatment not directed by a clinical study protocol in a group of commercially insured patients in 2 managed care organizations following an incident hospitalization that included a diagnosis for a venous thromboembolism (VTE) event.A cohort of patients with an incident in-hospital VTE event, consisting of deep vein thrombosis (DVT), or pulmonary embolism (PE), or both DVT + PE, was retrospectively identified from the administrative claims databases of 2 large U.S. health care plans. Inclusion criteria were (a) an inpatient VTE event between January 1, 1998, and December 31, 2000, (b) no VTE diagnosis or anticoagulation therapy 3 months prior to the incident VTE in-hospital event, (c) at least 1 anticoagulation pharmacy fill following the incident hospital VTE, and (d) continuous health plan enrollment 3 months prior to and 6 months following the incident hospital VTE event. Total costs were reported on a per-event basis and consisted of the aggregated amount paid by the health plan to the provider after subtraction of member cost-share. Costs were collected separately, first for the incident VTE event for all patients identified and second for patients who had at least 1 of the following events in the follow-up period: bleed requiring or not requiring hospitalization, a recurrent VTE event requiring hospitalization, or a recurrent VTE and bleed (VTE + bleed) event requiring hospitalization. Costs were compared between incident diagnosis groups using multivariate generalized linear model techniques.A total of 2,147 patients (DVT=1,499 [69.8%], PE=373 [17.4%], DVT+PE= 275 [12.8%]) were identified (mean age=61.6standard deviation [SD] 16 years; 46.3% male) and were followed for an average of 21.3 (median, 19.2) months. Disease severity was high in these patients, including 59.2% with a history of or active malignancy. The prevalence of VTE was 2.04 per 100,000 study-eligible health plan members. For the incident VTE events, average costs were 7,712+/-18,339 US dollars (median, 3,131 US dollars) per incident DVT event; 9,566+/-13,512 US dollars (median, 6,424 US dollars) per PE incident event; and 12,200+/-24,038 US dollars (median, 6,678 US dollars) per incident DVT+PE event. Warfarin treatment following the incident VTE event was administered to 97.3% of patients for an average of 6.7 (median, 5.0) months at an average cost of 19.40 US dollars per patient per month. During the average period of 21.3 months, 534 patients (24.9%) experienced an average of 1.24 bleed or recurrent VTE events per patient that required hospitalization at a mean cost of 14,975 US dollars per event or 2,101 US dollars per patient per year. For patients with a bleed in the follow-up period that required hospitalization, average costs were 12,326+/-24,448 US dollars (median, 5,736 US dollars) per recurrent VTE; 15,339+/-52,029 US dollars (median, 4,999 US dollars) per bleed; or 24,085+/-65,411 US dollars (median, 10,185 US dollars) per recurrent VTE + bleed event. During the follow-up period, a total of 612 patients (28.5%) experienced 1,489 recurrent bleed events that did not require hospitalization, at an average cost of 239+/-386 US dollars (median, 95 US dollars) per event. There were no significant differences in mean total costs for all pair-wise comparisons between the 3 incident diagnosis groups.Of patients who experienced a VTE event during the incident hospital stay for any diagnosis, 1 in 4 experienced an average of 1.24 bleed or recurrent VTE events that required hospitalization in the 21 months of follow-up and incurred an average health plan cost of 14,957 US dollars per event. These data may be of interest to managed care decision makers when evaluating the cost impact of new therapies or providing more comprehensive anticoagulation management services for existing therapies.

Purpose. The relationship between low-density lipoprotein (LDL) cholesterol reduction in the first 3 months of statin therapy and medication adherence during a 33-month follow-up period was studied. Methods. A retrospective cohort study was conducted among enrollees in a Southeastern managed care plan who started therapy with atorvastatin, fluvastatin, lovastatin, pravastatin, or simvastatin between October 1999 and August 2001, were enrolled for ≥12 months before and ≥6 months after treatment initiation, and had at least one LDL cholesterol measurement in the year before and 4–12 weeks after the start of therapy. Patients were followed up via electronic pharmacy and medical records for up to 33 more months. The follow-up period was divided into 3-month intervals; patients were considered adherent if statin therapy was available ≥80% of the time. A generalized linear model for repeated measures quantified the association between change in LDL cholesterol at 4–12 weeks and medication adherence in subsequent intervals, adjusting for demographic, clinical, and health-service-use variables. Results. The final sample consisted of 9510 patients. Medication adherence decreased significantly over time: 59%, 40%, 34%, and 21% of patients were adherent at 3, 6, 12, and 36 months, respectively. Mean ± S.D. LDL cholesterol reduction at 12 weeks was 28.9% ± 19.9%. The relative LDL cholesterol reduction at 12 weeks was significantly and independently associated with subsequent medication adherence: Compared with subjects in the first quartile of LDL cholesterol reduction, those in quartiles 2, 3, and 4 were more likely to be adherent in any subsequent interval (adjusted odds ratio [95% confidence interval], 1.26 [1.12–1.42], 1.25 [1.11–1.40], and 1.15 [1.02–1.29], respectively). Other independent predictors of adherence in months 4–36 included adherence during the initial three months of therapy, age, and recent history of coronary revascularization. Conclusion. Greater reduction in LDL cholesterol levels during the first three months of statin therapy was associated with greater adherence to lipid-lowering drug therapy.

Background—The American Heart Association (AHA) recently established evidence-based recommendations for cardiovascular disease (CVD) prevention in women, including lipid management. This study evaluated optimal lipid-level attainment and treatment patterns on the basis of these guidelines in high-risk women in a managed care setting.Methods and Results—We conducted a historical prospective cohort analysis of a 1.1-million-member, integrated, managed-care database. Eligible high-risk women were those with evidence of previous CVD or risk equivalent who had a full lipid panel available between October 1, 1999, and September 30, 2000; were naive to lipid therapy; and had a minimum of 12 months health plan eligibility preindex and postindex lipid panel. Optimal lipid levels were defined as LDL cholesterol (LDL-C) 50 mg/dL, non–HDL-C Conclusions—Among high-risk women, few attained the AHA’s standards for all lipid fractions, and only one third received recommended drug therapy, highlighting significant opportunities to apply evidence-based recommendations to manage lipid abnormalities in high-risk women.

To compare hypoglycemia event rates in patients initiated on long-acting insulin analog (glargine) or intermediate-acting insulin (NPH) and to analyze the associated cost-consequence from a managed care perspective.A retrospective analysis of pharmacy and medical claims and electronic laboratory result data using a southeastern United States managed care health plan.Patients newly initiated on glargine or NPH between July 1, 2000 and August 31, 2002 were included. Hypoglycemia events were identified from medical claims by their ICD-9CM codes. Multivariable techniques were used to compare hypoglycemia event rates between cohorts.A total of 1434 patients were eligible (glargine = 310, NPH = 1124). The mean age was 53 years +/- 17 years and 51% of patients were male. The mean treatment duration was 8.6 months +/- 4.5 months. Multivariate analyses showed that patients in the NPH group had a higher hypoglycemia event rate than the glargine group (18.3 versus 7.3 per 100 patients per year; p = 0.009). The number needed to treat (glargine versus NPH) to avoid one hypoglycemia event per patient per year was nine patients at an A1C of 7%. The mean annual index medication cost was $47 more for glargine ($390) than for NPH ($343) per patient per year (p = 0.042). The mean cost per hypoglycemia event was $1087 (95% CI: $764-$1409).Patients treated with glargine had significantly lower hypoglycemia event rates compared to the NPH group. The risk difference indicated that one hypoglycemia event would be avoided for every nine patients treated with glargine instead of NPH. The cost increase associated with treating nine patients with glargine rather than NPH is less than the cost of treating one hypoglycemia event. In this population, the savings associated with reduced hypoglycemic events more than offset the increased acquisition cost associated with glargine.

Introduction and Objective: The National Cholesterol Education Program recommends regular physician follow-up and lipid testing to promote adherence with lipidlowering medications. The objective of this study was to determine whether lipid tests and physician visits after treatment initiation are indeed associated with adherence to statin therapy. Subjects and Methods: A retrospective cohort study was conducted among 19 422 enrolees in a US managed care plan who initiated treatment with a statin between October 1999 and August 2001. Computerised pharmacy, medical and laboratory records were used to study the patterns and predictors of adherence with lipid-lowering therapy for up to 3 years. Adherence was assessed in 3-month intervals with patients considered ‘adherent’ if ≥80% of days were covered by lipid-lowering therapy. Results: In the first 3 months, 40% of patients had follow-up lipid tests and only 21% had dyslipidaemia visits (14% had both). Those receiving such care were substantially more likely to be adherent in subsequent intervals. Compared with those without follow-up, the relative odds of adherence were 1.42 and 1.27 for patients with one or more lipid test and one or more dyslipidaemia visit, respectively (95% confidence intervals [CI] 1.33, 1.50 and 1.16, 1.39). Patients who received a followup visit and lipid test were 45% more likely to be adherent (95% CI 1.34, 1.55). Similar associations were observed when lipid tests and dyslipidaemia visits occurred later in therapy. Conclusion: Early and frequent follow-up by physicians — especially lipid testing — was associated with improved adherence to lipid-lowering therapy. A randomised prospective study is needed to determine whether this relationship is causal.

Objective: The objectives of this study were to observe a commercially insured sample diagnosed with a venous thromboembolism (VTE) event and treated postevent with warfarin and to detail the thromboembolic and bleeding outcomes in the time periods during warfarin therapy and after discontinuation of such therapy. Methods: This retrospective, observational cohort study used medical, pharmacy, and eligibility data from 2 US health plans. Study inclusion required an inpatient diagnosis of deep venous thrombosis (DVT) or pulmonary embolism (PE) between January 1, 1998, and December 31, 2000; warfarin, heparin, or low-molecular-weight heparin within 30 days after diagnosis; no VTE diagnosis; and no anticoagulant use for 3 months preceding diagnosis. A random sample of medical charts was abstracted to validate VTE events and collect prothrombin time/international normalized ratio (INR) result data. Recurrent VTE events, bleeding events, and proportion of time within INR range were captured in the postindex VTE event time period. Univariate and multivariate statistical techniques were used to assess outcomes. Results: A total of 2090 patients were identified with a newly diagnosed VTE event (DVT only, 1450; PE with or without DVT, 640). Mean (SD) age was 61.7 (16) years; mean (SD) follow-up time after the index diagnosis was 21.3 (10) months. Overall mean (SD) length of warfarin therapy was 6.6 (6) months. During the follow-up period, 224 patients (10.7%) experienced a recurrent VTE event and 122 patients (5.8%) experienced a bleeding event requiring hospitalization. The cumulative incidence of recurrent VTE events over 3 and 6 months was 9.0% and 10.9%, respectively. Using the chart abstraction subset, patients were within the appropriate INR range 37.7% of the time while receiving warfarin. Conclusions: Negative outcomes associated with warfarin therapy—recurrent VTE events and bleeding requiring hospitalization—were experienced by 10.7% and 5.8% of patients, respectively. These data suggest that negative outcomes may be more prevalent in usual community medical practice compared with rates observed in the controlled environment of the clinical trial or specialized anticoagulation clinic.

Studies have found that non-high-density lipoprotein cholesterol (non-HDL-C) is a superior marker for coronary heart disease compared to low-density lipoprotein cholesterol (LDL-C). Little is known about achievement of non-HDL-C goals outside clinical trials. Within a population of 146,064 patients with dyslipidemia in the PINNACLE Registry and a subgroup of 36,188 patients with diabetes mellitus (DM), we examined the proportion of patients and patient characteristics associated with having LDL-C, non-HDL-C, and both LDL-C and non-HDL-C levels at National Cholesterol Education Program goals. LDL-C, non-HDL-C, and both LDL-C and non-HDL-C goals in the overall cohort were achieved by 73%, 73.4%, and 68.9% patients, respectively. Significant predictors of meeting all 3 goals were age, male gender, statin, nonstatin, and combined statin plus nonstatin use. Patients with co-morbidities of hypertension, previous stroke or transient ischemic attack, peripheral arterial disease, myocardial infarction, and smoking were less likely to have LDL-C, non-HDL-C, and both LDL-C and non-HDL-C levels at National Cholesterol Education Program goal. In the overall cohort, patients with DM were less likely to meet non-HDL-C and both LDL-C and non-HDL-C goals. In the subgroup of patients with DM, predictors of meeting lipid goals were similar to the overall cohort. In conclusion, these data suggest contemporary treatment patterns by cardiologists successfully achieve lipid goals in most patients. Younger, female patients and those with atherosclerotic cardiovascular disease and risk factors, such as hypertension and DM, are less likely to achieve goals and may require more careful follow-up after statin initiation. Both LDL-C and non-HDL-C goals are achieved in70% of patients, suggesting room for improvement if a goal-targeted individualized strategy is adopted.

Little is known about the contribution of telephone-based prescribing on overall antibiotic utilization. The objective of this study was to determine the extent and characteristics of telephone-based antibiotic prescribing in teaching and non-teaching primary care practices.This retrospective cohort study included all patients (n = 114 610) cared for by teaching and non-teaching internal medicine, pediatrics, family practice, and obstetrics/gynecology practices (n = 19) affiliated with a large US healthcare system during 2006-2010 and using a common electronic medical record. Rates and types of antibiotics prescribed by teaching and non-teaching practices via telephone contact and office visit were compared among the overall cohort. All telephone-related prescriptions during 2008 underwent chart review to determine indications for antibiotic prescribing.Overall, 28.9 antibiotic prescriptions were issued per 100 patient-years, with 63 418 total antibiotic prescriptions and 7876 (12.4%) generated after telephone contact. Telephone-based prescribing increased steadily from 2.2 to 4.2 per 100 patient-years during the study period. Both telephone-based and office-based antibiotic prescribing were higher in non-teaching practices. Of 1790 antibiotics prescribed by telephone during 2008, the majority were for urinary tract infection (28.3%), sinusitis (20.1%), and unspecified upper respiratory infection (URI, 15.0%).Overall, one in every eight antibiotics was prescribed via telephone encounter. These data highlight the need to include the impact of this practice in analysis of outcomes associated with outpatient antibiotic prescribing and to incorporate telephonic prescribing into guidelines facilitating appropriate antibiotic use.

Because second generation antipsychotics (SGA) might affect the risk of suicide, systematic assessment of suicide risk associated with SGA in the postmarketing setting is important and of interest to regulatory authorities. To fulfill a postmarketing request, our objective was to determine suicide event (attempted or completed) incidence in patients with schizophrenia or bipolar disorder, prescribed aripiprazole.Using administrative data from three US sources, we assessed study endpoints of suicide attempts and death by suicide in patients aged ≥18 enrolled continuously for ≥3 months in their health plans before receiving their first ever antipsychotic (November 2002-December 2005).Among 20 489 antipsychotic users (8985 patient-years), unadjusted suicide event rates (per 1000 patient-years) were: 20.69 (aripiprazole); 23.99 (olanzapine); 32.33 (quetiapine); 19.69 (risperidone); 48.52 (ziprasidone). Compared with current users of other SGA combined, aripiprazole users did not have an increased risk of suicide events (crude hazard ratio (HR) = 0.79, 95%CI: 0.48-1.30; adjusted HR = 0.69, 95%CI: 0.42-1.14-(controlling for study site, age, sex, index prescription year, antipsychotic use history, other pharmacotherapy exposure, comorbidity presence, schizophrenia/bipolar disorder, suicide attempts, number inpatient/outpatient encounters).In this large, multi-site study, compared with other SGA combined, aripiprazole is not associated with an increased risk of suicide events in an inception cohort of patients with ICD-9/ICD-10 codes indicative of schizophrenia or bipolar disorder.

The objective was to evaluate the use of a payer-based electronic health record (P-EHR), which is a clinical summary of a patient's medical and pharmacy claims history, in an emergency department (ED) on length of stay (LOS) and plan payments.A large urban ED partnered with the dominant health plan in the region and implemented P-EHR technology in September 2005 for widespread use for health plan members presenting to the ED. A retrospective observational study design was used to evaluate this previously implemented P-EHR. Health plan and electronic hospital data were used to identify 2,288 ED encounters. Encounters with P-EHR use (n = 779) were identified between September 1, 2005, and February 17, 2006; encounters from the same health plan (n = 1,509) between November 1, 2004, and March 31, 2005, were compared. Outcomes were ED LOS and plan payment for the ED encounter. Analyses evaluated the effect of using the P-EHR in the ED setting on study outcomes using multivariate regressions and the nonparametric bootstrap.After covariate adjustment, among visits resulting in discharge (ED-only), P-EHR visits were 19 minutes shorter (95% confidence interval [CI] = 5 to 33 minutes) than non-P-EHR visits. Among visits resulting in hospitalization, the P-EHR was associated with an average 77-minute shorter ED LOS (95% CI = 28 to 126 minutes), compared to non-P-EHR visits. The P-EHR was associated with an average of $1,560 (95% CI = $43 to $2,910) lower total plan expenditures for hospitalized visits. No significant difference in total payments was observed among discharged visits.In the study ED, the P-EHR was associated with a significant reduction in ED LOS overall and was associated with lower plan payments for visits that resulted in hospitalization.

Objective: The aim of this work was to analyze chemotherapy treatment patterns in patients with advanced breast cancer who had been previously exposed to an anthracycline, a taxane, and capecitabine. Methods: This retrospective cohort study used medical and pharmacy administrative claims with health-plan enrollment data and medical-record review from a large, US-based health insurer database, the HealthCore Integrated Research Database. Women were included if they were aged ≥18 years at the initial breast cancer diagnosis between January 1999 and July 2005 and had received all 3 drug classes of interest, as well as an initial diagnosis of American Joint Committee on Cancer stage I to III breast cancer with metastatic recurrence or an initial diagnosis of stage IV disease. Information about demographics, clinical and pathologic characteristics, survival, and treatments were obtained from computerized data and medical record review. Descriptive analyses were conducted to characterize the treatment patterns. Results: One hundred forty-four women with advanced breast cancer were identified. Patients ranged in age from 28 to 76 years, with a mean (SD) age of 48.2 (9.1) years, and with 54 patients (37.5%) aged 40 to 49 years and 48 patients (33.3%) aged 50 to 59 years at the time of initial diagnosis. Ninety-three patients (64.6%) were white, 15 (10.4%) were black, 7 (4.9%) were Hispanic, and 4 (2.8%) were Asian. Overall, 89 patients (61.8%) received ≥1 additional chemotherapy regimen after exposure to all 3 chemotherapy agents of interest; 55 (38.2%) received ≥2 additional regimens. A variety of chemotherapeutic regimens were prescribed; 14 monotherapy regimens and 37 combination therapy regimens were used. The most common regimens (both as single agents and combination therapy) included gemcitabine, vinorelbine, or retreatment with a taxane. Of the 89 patients who received ≥1 retreatment, 7 (7.9%) were retreated with anthracycline, 12 (13.5%) with a taxane, and 9 (10.1%) with capecitabine. For first and second treatment after exposure to all 3 agents of interest, the most common single-agent regimens were gemcitabine (first: 17 patients [19.1%]; second: 9 patients [16.4%]) and vinorelbine (first: 14 patients [15.7%]; second: 9 patients [16.4%]). The most common combination therapies for first retreatment were carboplatin based (6 patients [6.7%]). Conclusions: Of these patients with advanced breast cancer, 61.8% received ≥1 additional chemotherapy regimen after previous treatment with an anthracycline, a taxane, and capecitabine. The variety of agents prescribed suggests a lack of standard of care. Rigorous clinical effectiveness studies of common regimens in heavily pretreated and chemotherapy-resistant populations with breast cancer are warranted.

Purpose The purpose of this study was to examine the association between atypical antipsychotics, including the newer agents, aripiprazole and ziprasidone, and newly treated diabetes, using the largest post-marketing cohort of patients exposed to these newer treatments that has been studied to date. Methods Identified two overlapping cohorts—a simple cohort (all antipsychotic users) and an inception cohort (new users of antipsychotics)—using automated data from three United States sites (60.4 million covered lives). Patients exposed to antipsychotics ≥ 45 days were identified and followed for incident diagnoses of treated diabetes. Data analysis accounted for drug switching and non-consistent drug use. Results In the 55 287-member inception cohort, 357 cases of newly treated diabetes were identified. Compared with current use of typical antipsychotics, current users of aripiprazole (adjusted hazard ratio (aHR) 0.93, 95% confidence interval (CI) 0.50–1.76), quetiapine (aHR 1.04, 95%CI, 0.67–1.62), risperidone (aHR 0.85, 95%CI, 0.54–1.36) and ziprasidone (aHR 1.05, 95%CI, 0.54–2.08) had similar low risk of diabetes. Patients exposed to olanzapine had an increased risk of diabetes (aHR 1.71, 95%CI, 1.12–2.61), and although the effect estimate is imprecise, clozapine-exposed patients had a trend towards an elevated hazard ratio (aHR 2.58, 95%CI, 0.76–8.80). Results for the simple cohort were similar. Conclusions Relative to typical antipsychotics, aripiprazole, ziprasidone, risperidone and quetiapine were not associated with an increased risk of diabetes; olanzapine and clozapine were associated with an increased risk. This analysis constitutes the largest post-marketing pharmacoepidemiologic study to date that includes the newer agents. Copyright © 2009 John Wiley & Sons, Ltd.

BACKGROUND: African-American women have increased breast cancer mortality compared with white women. Diagnostic and treatment gaps may contribute to this disparity. METHODS: In this retrospective, longitudinal cohort study, Southern US health plan claims data and linked medical charts were used to identify racial disparities in the diagnoses, treatment, and mortality of commercially insured women with newly diagnosed breast cancer. White women (n ¼ 476) and African-American women (n ¼ 99) with newly diagnosed breast cancer were identified by breast cancer claims codes (International Classification of Diseases, Ninth Revision, Clinical Modification codes 174, 233.0, 238.3, and 239.3) between January 2000 and December 2004. Race, diagnoses (breast cancer stage, estrogen/progesterone receptor [ER/PR]-positive status), treatment (breast-conserving surgery, antiestrogen therapy, and chemotherapy interruption or reduction), and all-cause mortality were assessed from medical charts. Multivariate regression analyses were adjusted for age, geography, and socioeconomic status to test the association of race with diagnoses/ treatment. RESULTS: White women were older (P < .001) and had higher rates of diagnosis at stage 0/I (55.2% vs 38.4%; P < .05) than African-American women. More white women had positive ER/PR status (75% vs 56% AfricanAmerican; P ¼ .001) and received antiestrogen therapy if they were positive (37.2% vs 27.3% African-American; P < .001). White women received slightly more breast-conserving surgery and chemotherapy dose modification than African-American women (P value nonsignificant). African-American women had a higher mortality rate (8.1%) than white women (3.6%; P ¼ .06). In adjusted analyses, African-American women were diagnosed at later stages (odds ratio, 1.71; P ¼ .02), and white women received more antiestrogen therapy (odds ratio, 2.1; P ¼ .03). CONCLUSIONS: Disparities in medical care among patients with newly diagnosed breast cancer were evident between African-American women and white women despite health plan insurance coverage. Interventions that address the gaps identified are needed. Cancer 2010;116:193–202. V C 2010 American Cancer Society.

Chronic and severe health problems place an enormous financial burden on individuals, employers, and health plan providers, requiring all to make tough decisions about healthcare. Specialty pharmaceuticals are increasingly attractive treatment options, but employers need tangible ways to incorporate these medications into benefit plans. Benefit managers can take a proactive role in addressing cost and compliance issues, using evidence-based data about true patient costs to develop policies that encourage employees to seek appropriate care. Achieving savings in direct and indirect costs will require more than shifting coverage, which can lead to nonadherence and increase costs elsewhere.

Purpose. Rates of hypoglycemic events and their associated costs were compared among patients with type 2 diabetes mellitus newly initiated on insulin glargine or a premixed insulin fixed-combination product. Methods. Patients newly initiated on insulin glargine or premixed insulin fixed-combination products (including pen delivery systems) between June 1, 2001, and February 29, 2004, were identified using an administrative claims database. Hypoglycemic events were identified from International Classification of Diseases, 9th Revision, Clinical Modification codes. Multivariate analyses were performed. Results. A total of 2315 patients met the inclusion criteria. Of those, 1212 received insulin glargine and 1103 received a premixed fixed-combination insulin product. The mean ± S.D. treatment duration was 13.7 ± 8.1 months. Patients treated with premixed insulin had a higher hypoglycemic event rate than glargine patients (13.8 versus 7.0/100 patients/year; p = 0.027), which yielded a number needed to treat of 15 patients. The mean cost per hypoglycemic event was $1049 (95% confidence interval, $426–1672). The mean annual cost of all insulin use was $46 more for the insulin glargine cohort than for those who received premixed insulin ($534 versus $488, respectively) ( p < 0.05). Mean postindex insulin use was higher in patients receiving premixed insulin than in those treated with insulin glargine (48.1 versus 43.8 units per day) ( p < 0.05). Conclusion. Patients with type 2 diabetes mellitus who were newly initiated on insulin glargine had a lower rate of hypoglycemic events compared with patients newly initiated on a premixed fixed-combination insulin product. Treatment of 15 patients with insulin glargine instead of premixed insulin for one year would avoid one hypoglycemic event per year.

The large administrative databases of health plans contain information on drug-related medical adverse events (AE) and constitute an increasingly powerful tool for the assessment of drug safety. We conducted a retrospective observational study using an administrative managed care claims database covering 9 million members from diverse regions of the United States. Patients aged ≥18 years who received ≥2 prescriptions for lipid-lowering drugs between July 1, 2000 and December 1, 2004 were included in the study. Hospitalizations with diagnosis codes ( International Classification of Diseases, 9th Revision, Clinical Modification [ICD-9]) related to muscle, kidney, and liver were determined for patients exposed to 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins), fibrates, extended-release niacin, cholesterol absorption inhibitors, or statin combination therapy. A total of 473,343 patients contributed 490,988 person-years of monotherapy and 11,624 person-years of combination dyslipidemia therapy. Rates of hospitalization due to AEs in patients on monotherapy with currently available statins were similar, whereas the incidence of hospitalization for muscle disorders increased 6.7-fold with cerivastatin therapy. Patients who received a lipid-lowering medication with a concomitant cytochrome P450 3A4 (CYP3A4) inhibitor had a 6-fold increased rate of muscle disorders, including rhabdomyolysis. Hypertension was associated with a 5-fold increase in both muscle and renal events, whereas patients with diabetes mellitus had a 2.5-fold increased risk of renal events. No hospitalized cases of the index AEs were observed in study subjects during the 6-month period before initiation of the lipid-lowering drug. Statin monotherapy as currently prescribed is generally well tolerated and safe.

Study Objective. To compare, in a usual care setting, the effects of rosuvastatin and other 3-hydroxy-3-methylglutaryl coenzyme A inhibitors (statins) on lipid levels and on goal attainment of low-density lipoprotein cholesterol (LDL) levels from the National Cholesterol Education Program (NCEP) third report of the Adult Treatment Panel (ATP III). Design. Retrospective, longitudinal, cohort study. Data Source. Managed care medical and pharmacy claims and laboratory database. Patients. A total of 8251 patients starting treatment with rosuvastatin, atorvastatin, simvastatin, pravastatin, lovastatin, or fluvastatin from August 1, 2003–September 30, 2004, excluding those who received dyslipidemic therapy in the previous 12 months. Measurements and Main Results. Patients with at least one pretreatment and posttreatment lipid level were followed until their initial statin was changed or they reached the end of benefit eligibility or the study period. Percent changes in lipid levels were calculated, and adjusted changes in LDL and goal attainment were evaluated by regression techniques. Absolute and percent reductions in LDL, triglyceride, and total cholesterol levels were significantly greater with rosuvastatin than with other statins (all p

To identify a possible gender bias in lipid assessment and treatment of patients following percutaneous coronary intervention (PCI).Following PCI, patients were identified from a cardiology practice database, with retrospective follow-up achieved through medical record review in a private cardiology practice and in primary care physician practices. Patients were assessed for lipid measurement of total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides, and for changes in these measures.A total of 356 patients were identified for analysis: 221 men (62%) and 135 women (38%). Mean post-PCI follow-up was 2.2 +/- 1.6 years. Among females, 80% had lipids measured, as compared with 87% of males (P = 0.07). At pre- and post-PCI, all fractions were significantly higher (P0.05) in women, except pre-PCI triglycerides, which were significantly lower in women. From pre- to post-PCI, HDL-C and triglycerides improved significantly more in males, while LDL-C improved significantly more in females. Target LDL-C levels (100 mg/dL) were achieved in 46.4% of the overall group. There were no significant gender-related differences in the number of patients treated with dyslipidemic medications or in patients achieving an LDL-C of100 mg/dL (P = 0.081).Following PCI, a gender bias did not exist for lipid assessment, number of patients treated with pharmacotherapy, or achievement of target LDL-C (100 mg/dL). However, in terms of absolute levels achieved, women were treated less aggressively than men for all lipid fractions.