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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.

To examine factors associated with HMG-CoA reductase inhibitor (statin) management and the effect of therapeutic modifications on patients’ abilities to reach their low-density lipoprotein-cholesterol (LDL-C) goal in a sample of managed care enrollees. This retrospective analysis utilized electronic pharmacy claims, medical claims, and laboratory data, and explored the occurrence and magnitude of modifications to statin regimens. Patients aged ≥18 years who were initiated on statin therapy between 1 January 2001 and 31 December 2001 and who were continuously enrolled for 6 months prior to and 12 months following the index prescription were included. A subgroup analysis incorporated laboratory data to determine whether patients attained their LDL-C treatment goal. A total of 38 567 patients were identified: 50.6% were female and patients had a mean age of 63.6 ±13.4 years. During a 1-year follow-up, 16.1% (n = 6220) had a modification to their statin regimen. Multivariate analysis showed that significant predictors of regimen modification included age, sex, index statin, index statin potency, and the occurrence of a cardiac reperfusion procedure or acute hospitalization during the 6-month pre-index period (p < 0.05). A subgroup of 254 patients with laboratory data was identified: 57.9% of these patients were female and their mean age was 66.6 ± 10.5 years. Of this cohort, only 14.2% had a modification to their statin regimen. Goal attainment was significantly more frequent among patients whose statin regimen was modified compared with patients whose statin regimen was not modified (72.2% vs 52.8%; p = 0.0294). The low occurrence of therapeutic modifications and goal attainment may indicate a need for greater awareness of the importance of effective statin use.

Increased time in therapeutic range (TTR) on warfarin is often used as a balance between preventing stroke without excess bleeding. This study evaluated stroke or systemic embolism (SE) and bleeding risks of antithrombotic therapies in non-valvular atrial fibrillation (NVAF) patients within an

The Insulin Resistance Atherosclerosis Study (IRAS) is the first epidemiologic study designed to assess the relationships between insulin resistance, insulinemia, glycemia, other components of the insulin resistance syndrome, and prevalent cardiovascular disease (CVD) in a large multiethnic cohort. Over 1600 men and women were recruited from four geographic areas to represent a range of glucose tolerance (normal, impaired, and diabetic) and ethnicity (hispanic, non-Hispanic white, and African-American). Insulin resistance was assessed directly using the frequently sampled intravenous glucose tolerance test with minimal model analysis. Intimal-medial carotid artery wall thickness, an indicator of atherosclerosis, was measured using B-mode ultrasonography. Prevalent CVD was assessed by questionnaire and resting electrocardiography. This report describes the design of the study and provides the recruitment results. Forthcoming cross-sectional analyses will help to disentangle the association between insulin resistance and CVD, apart from the concomitant hyperinsulinemia and related CVD risk factors.

Background Although many studies describe benefits from the comprehensive assessment of elderly patients by an interdisciplinary team (comprehensive geriatric assessment), the most supportive evidence for the process has come from programs that rely on specialized inpatient units and long hospital stays. We examined whether an inpatient geriatric consultation service might also be beneficial in a trial involving four medical centers of a group-practice health maintenance organization (HMO). Methods We conducted a randomized clinical trial with 2353 hospitalized patients 65 years of age or older in whom at least 1 of 13 screening criteria were present: stroke, immobility, impairment in any basic activity of daily living, malnutrition, incontinence, confusion or dementia, prolonged bed rest, recent falls, depression, social or family problems, an unplanned readmission to the hospital within three months of a previous hospital stay, a new fracture, and age of 80 years or older. Of the 1337 patients assigned ...

Objective To determine the yield of standardized targeting criteria for identifying hospitalized HMO patients who are at high risk for mortality and nursing home placement and, therefore, may be appropriate for comprehensive geriatric assessment. Design Prospective cohort study. Setting Four HMO (Southern California Kaiser-Permanente) hospitals. Subjects 3,697 patients 65 years of age or older admitted to any inpatient service from July 1 through September 30, 1990. Main Outcome Measures Screening measures for standardized targeting criteria, administered 24–48 hours after admission. Results Overall, 35.1% of patients screened met at least one inclusionary criterion, which is considerably higher than other published reports. The most commonly met criteria were incontinence, impairment in performing activities of daily living, malnutrition, and immobility. The percentage of patients meeting at least one criterion and meeting each criterion varied considerably among hospitals. The vast majority of patients (83%) who were judged appropriate for assessment met at least three criteria. Conclusions The yield of standardized criteria differs when applied to patients in different health care systems and to patients at different hospitals within a health care system, which may reflect differences in the populations being served and the practice styles of physicians and the delivery system. Because no single criterion identified more than approximately half of patients who were judged appropriate for assessment, it is likely that a battery of criteria will be necessary to identify these patients.

Background: Prior research suggests that receiving specialized anticoagulation services enables patients to achieve better clinical outcomes. Objective: To assess the quality of anticoagulation therapy in patents with atrial fibrillation who were enrolled in an anticoagulation clinic (ACC) versus usual care (UC). Methods: Using Sharp Rees-Stealy physician group claims data, we estimated time spent in therapeutic range and time to first major bleeding episode or stroke for ACC and UC patients. t-Tests were used to compare time h therapeutic range proportions, and Kaplan-Meier survival analysis was performed to compare rates of bleeding and stroke between groups. Results: We identified 1107 patients (351 ACC, 756 UC) treated with anticoagulation therapy for atrial fibrillation with more than one international normalized ratio (INR) reported between March 2001 and March 2004. ACC patients spent a greater proportion (68.14%) of time in therapeutic range compared with UC patients (42.07%; p < 0.001). There was a significant difference between groups in average time between INR tests (ACC = 14.31 days, UC = 18.39 days; p < 0.001). ACC patients were 59% less likely to experience a bleed following the index date than were UC patients (HR = 0.41; 95% CI 0.2444 to 0.6999; p = 0.001), but type of care was not a significant predictor for stroke (HR = 0.95; 95% CI 0.5125 to 1.7777; p value NS). Conclusions: Results from this observational study reinforce the positive impact that anticoagulation services have on anticoagulation therapy outcomes, emphasizing the importance of providing such services for patients undergoing treatment with warfarin.

OBJECTIVE The objective of this study was to examine the impact of introducing rosuvastatin calcium on direct and indirect costs among patients at high risk for coronary heart disease. METHODS An economic simulation model was developed to project the number of cardiovascular events and associated direct and indirect costs under varying treatment scenarios. RESULTS In an average-sized commercial health plan with 210,000 covered lives and 9,336 high-risk patients, an uptake of rosuvastatin by 11% of high-risk patients would result in eight fewer cardiovascular events, a net savings of 0.85 million dollars in direct medical costs and a net savings of 36,404 dollars in productivity loss over a period of 5 years. The overall reduction in total costs is equivalent to 1735 dollars per rosuvastatin-treated patient. CONCLUSIONS At current statin prices, the use of rosuvastatin could lead to fewer cardiovascular events and lower direct and indirect costs.

Background: High blood cholesterol is a major modifiable risk factor for coronary heart disease (CHD) and stroke. Objective: The aim of this study was to estimate the economic impact of rosuvastatin calcium use in patients at high risk for CHD and stroke, according to the National Cholesterol Education Program Adult Treatment Panel (ATP) III guidelines. Methods: An economic simulation model was developed that used a Markov process to project the number of cardiovascular events and associated costs in a high-risk population in various treatment scenarios. According to the ATP III, high-risk patients are those with CHD, atherosclerosis of peripheral and/or cerebral arteries, diabetes, and/or multiple other risk factors conferring a risk of at least 20% within 10 years. Data on population characteristics and costs of cardiovascular disease (CVD) were obtained from claims data sets from employer-funded commercial and Medicare health plans in the United States. Treatment of lipid disorders was translated into CVD risk reduction based on results from the Heart Protection Study. The estimated efficacies of individual lipid-lowering drugs were based on data published in package inserts. The model generated costs at the health plan level of lipid-lowering therapy in high-risk patients and the number and total costs of cardiovascular events. Estimates were compared for scenarios representing the mix of treatments used before and after the introduction of rosuvastatin. Estimates were generated separately for commercial and Medicare health plans. Results: For every 1 million members of a commercial health plan, an estimated 44,457 met ATP III criteria for high-risk status. Use of rosuvastatin in place of other 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (“statins”) by 11 % of these patients over a period of 5 years was estimated to result in 36 fewer cardiovascular events and a net savings of US $4.03 million. A Medicare plan of 1 million members with an estimated 433,268 high-risk patients and 7% rosuvastatin use was estimated to avoid 727 events and save US $34.32 million. Conclusions: The results of this data analysis suggest that increasing the use of rosuvastatin can result in cardiovascular event reduction and cost savings. Because the impact of lipid-modifying therapy on cardiovascular risk has not been thoroughly documented in controlled clinical studies, our model assumed that incremental lipid changes had effects in proportion to the magnitude of change.

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

This article describes the research methods used to measure the impact of three alternative models of patient counseling in the outpatient pharmacy setting. The study was conducted in pharmacies operated by the Southern California region Kaiser Permanente Medical Care Program. Both random assignment and large-scale geographic area research designs were used. The presentation of the research design includes discussions of data collection and patient sampling methods; the measurement of patient outcomes, including measures of health care costs and utilization, patient functional status, and quality of life. Demographic data are presented for the study population, including an analysis of potential biased selection of patients electing to participate in random assignment. Data are also presented documenting potential selection bias across geographically determined treatment groups in the geographic area design arm. Finally, the article presents the analysis plan for the study and discusses study limitations.

To compare the effectiveness and costs of two alternative approaches to the treatment of hypercholesterolemia, a prospective randomized trial is being undertaken at Southern California Kaiser Permanente, a large health maintenance organization. Six hundred and twelve patients with postdiet LDL cholesterol (LDL-C) levels in the range of 190-230 mg/dl (or 160-230 mg/dl for those with coronary heart disease or two or more coronary risk factors) were randomized to a stepped-care regimen (initial treatment with niacin followed by other agents if needed) or to initial use of lovastatin, an HMG-CoA reductase inhibitor. All patients are being followed for 1 year. The study seeks to approximate conditions of typical clinical practice: provider compliance with these plans of treatment is encouraged but not enforced and patients pay for medication as they customarily would. Principal outcomes of interest include the proportion of participants who achieve goal LDL-C at one year, the mean change in total cholesterol and LDL-C levels between baseline and the end of follow-up, and the costs of cholesterol-lowering therapy.

Objective: To describe the evaluation of an interdisciplinary comprehensive geriatric assessment (CGA) consultation program for targeted hospitalized patients. Design: Multi-center randomized clinical trial (RCT) at four hospitals where patients were randomly assigned to CGA consultation or usual care by the attending physician, and a non-equivalent control group (NCG) at two hospitals. Setting: Six hospitals in a multi-specialty group practice model health maintenance organization (HMO). Participants: 3593 patients age 65 years or older meeting at least one of 13 inclusionary criteria at admission. Intervention: Screening by hospital staff and standardized CGA consultation conducted by a nurse practitioner, social worker, and geriatrician at the four RCT hospitals. Main Outcome Measures: Functional and health status, mortality, rehospitalization, and cost-effectiveness of the CGA program at 1 year post-randomization; validation of targeting (inclusionary) criteria that identify subgroups of patients deriving benefit from CGA; and physician contamination (learning from CGA and changing treatment provided to control patients). Conclusions: A number of methodological issues need to be considered when conducting effectiveness trials of CGA. The concurrent design of a multi-center RCT, coupled with the NCG to determine physician contamination, is an innovative approach intended to determine more precisely the cost-effectiveness of CGA for frail hospitalized elderly persons. The large and heterogeneous patient population and the broad array of inclusionary criteria will permit the evaluation of the benefit of CGA for subgroups. All these features are intended to enhance the generalizability of study results.

Background: The 1988 US National Cholesterol Education Program Expert Panel Report recommended initial treatment with niacin or bile acid sequestrants, followed by other agents if needed, to lower low-density lipoprotein cholesterol (LDL-C) levels in hypercholesterolemic patients who require drug therapy. It is unknown how the effectiveness and costs of such an approach ("stepped care") compare in typical clinical practice to those of initial therapy with lovastatin. Patients and Methods: We randomly assigned 612 patients, aged 20 to 70 years, who met 1988 National Cholesterol Education Program guidelines for drug treatment of elevated LDL-C level and had not previously used cholesterol-lowering medication, to either a steppedcare regimen or initial therapy with lovastatin (both n=306). The study, conducted at Southern California Kaiser Permanente, was designed to approximate typical practice: provider compliance with treatment plans was encouraged but not enforced, and patients paid for medication as they customarily would. Results: At 1 year, the decline in mean LDL-C level was significantly greater among patients assigned to initial treatment with lovastatin (22% vs 15% for stepped care; P P P P P P Conclusions: A stepped-care regimen beginning with niacin is less costly than initial therapy with lovastatin, but also less effective in lowering LDL-C level. While it is more effective in increasing high-density lipoprotein cholesterol levels, the tolerability of such a regimen may be a problem. (Arch Intern Med. 1996;156:731-739)

Southern California Kaiser Permanente developed a regionwide Appropriate Utilization of Resources (AUR) Program that links quality assurance to utili zation control. The initial program goal is to signifi cantly reduce the regional inpatient utilization rate across all age groups without sacrificing quality of care or service. Objectives include increasing outpa tient surgery and same-day admissions for scheduled surgery, eliminating unnecessary medical admissions and days of hospitalization, optimizing utilization of critical care units, and ensuring continued high qual ity of care and service. The components of the pro gram are detailed, as is the review process itself. The author concludes with a description of the plan to expand the Program.