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Sanjay K Gandhi1, Marie M Jensen2, Kathleen M Fox3, Lee Smolen4, Anders G Olsson5, Thomas Paulsson61AstraZeneca LP, Wilmington, DE, USA; 2AstraZeneca, Lund, Sweden; 3Strategic HealthCare Solution, Monkton, MD; 4Medical Decision Modeling Inc, Indianapolis, IN, USA; 5Department of Medical and Health Sciences, Linkoping University, and Stockholm Heart Center, Stockholm; 6AstraZeneca, Sodertalje, SwedenBackground: To assess the long-term cost-effectiveness of rosuvastatin therapy compared with generic simvastatin and generic atorvastatin in reducing the incidence of cardiovascular events and mortality in a Swedish population with Framingham risk ≥20%.Methods: A probabilistic Monte Carlo simulation model based on data from JUPITER (the Justification for the Use of statins in Prevention: an Intervention Trial Evaluating Rosuvastatin) was used to estimate the long-term cost-effectiveness of rosuvastatin 20 mg daily versus simvastatin or atorvastatin 40 mg for the prevention of cardiovascular death and morbidity. The three-stage model included cardiovascular event prevention simulating the 4 years of JUPITER, initial prevention beyond the trial, and subsequent cardiovascular event prevention. A Swedish health care payer perspective (direct costs only) was modeled for a lifetime horizon, with 2008/2009 as the costing period. Univariate and probabilistic sensitivity analyses were performed.Results: The incremental cost per quality-adjusted life-year (QALY) gained with rosuvastatin 20 mg over simvastatin or atorvastatin 40 mg ranged from SEK88,113 (rosuvastatin 20 mg versus simvastatin 40 mg; Framingham risk ≥30%; net avoidance of 34 events/1000 patients) to SEK497,542 (versus atorvastatin 40 mg: Framingham risk ≥20%; net avoidance of 11 events/1000 patients) over a lifetime horizon. Probabilistic sensitivity analyses indicated that at a willingness-to-pay threshold of SEK500,000/QALY, rosuvastatin 20 mg would be cost-effective for approximately 75%–85% of simulations relative to atorvastatin or simvastatin 40 mg. Sensitivity analyses indicated the findings to be robust.Conclusion: Rosuvastatin 20 mg is cost-effective over a lifetime horizon compared with generic simvastatin or atorvastatin 40 mg in patients at high cardiovascular risk in Sweden.Keywords: cardiovascular disease, cost-benefit analysis, cost-effectiveness, rosuvastatin, simvastatin, atorvastatin, generic, high risk

ObjectivesThe purpose of this study is to describe the early study medication discontinuation (SMD) experience during the first year of follow-up in a randomized clinical trial in older women and to determine the associations between various baseline characteristics and risk of SMD. DESIGH, SETTING, AND PARTICIPANTS: The authors studied 6,459 postmenopausal women aged 55 to 80 from 11 clinical settings during their first year of participation in the Fracture Intervention Trial (FIT). This trial was designed to test the efficacy of alendronate (Fosamax) on fracture prevention among women with low bone mass.ResultsStudy medication discontinuation was greatest in the first month post-randomization (2.2%) and declined thereafter. Cumulative rates of study medication discontinuation were 4.8% (n = 311) at 3 months and 11.1% (n = 717) at 12 months. SMD was not associated with age, marital status, alcohol consumption, regular exercise, past estrogen replacement therapy use, bone mineral density, or personal or maternal fracture history. After adjusting for covariates and markers of comorbidity, the strongest predictor of SMD was fair-to-poor self-rated health (relative risk (RR) 2.10; 95% confidence interval (CI) 1.47, 2.99). Having four or more depressive symptoms was also a significant predictor and had a risk associated with SMD (RR vs none 1.34; 95% CI 1.05, 1.71) similar to that seen for individuals with good self-rated health (RR 1.49; 95% CI 1.16, 1.91).ConclusionsResults from this cohort emphasize that clinical trials in older women with multiple concomitant conditions can achieve high levels of adherence. Thought should be given to measuring self-rated health and depressive symptoms before randomization to help identify individuals to be targeted for special assistance programs that focus on encouraging adherence.

Objective: Self-reported healthcare resource utilization (HRU), medication out-of-pocket (OOP) expenditures and impact of OOP expenses on HRU were assessed for respondents with type 2 diabetes mellitus (T2DM) or elevated cardiometabolic risk.Methods: The 5-year longitudinal SHIELD study surveyed a stratified sample of US adults with diabetes or cardiometabolic risk factors (n=22 001). High risk (HR) was defined as having 3-5 factors: abdominal obesity, BMI >or= 28 kg/m2, dyslipidemia, hypertension, coronary heart disease, or stroke. Low risk (LR) was Results: T2DM and HR respondents were significantly more likely than LR respondents to stay overnight in a healthcare facility or to visit the emergency room. T2DM respondents reported, on average, 12 visits to healthcare professionals compared with 10 for HR and 7 for LR (p<0.0001). Monthly OOP expenditure for prescriptions was $108 for T2DM, $92 for HR, and $52 for LR (p<0.0001). Approximately one third of respondents indicated that OOP expenses prevented them from buying medications. Overall, 37-41% of respondents indicated that OOP costs prevented them from seeking care or purchasing supplies or medications.Limitations: Self-selection bias may have occurred since the sample was respondents to a mailed survey. Healthcare resource utilization and out-of-pocket expenses were self-reported.Conclusions: More than one third of respondents with T2DM or HR reported that out-of-pocket expenses prevented them from seeking healthcare to manage their disease, which could speed disease progression or increase severity. [ABSTRACT FROM AUTHOR]

Purpose: This study evaluated whether health knowledge, attitudes, and behaviors of individuals with type 1 (T1DM) or type 2 (T2DM) diabetes mellitus and those at high or low risk of T2DM were reflected in healthy behaviors and whether these attributes differed for T2DM respondents who did or did not see a health educator.Methods: SHIELD, a U.S. population-based study, included respondents (>/=18 years of age) with T1DM (n = 366), T2DM (n = 3897), high risk (HR, n = 5449) defined as >/=3 of the following: abdominal obesity, high body mass index, dyslipidemia, hypertension, cardiovascular disease, and low risk (LR, n = 5725) defined as

Objectives: This study compared health-related quality of life (HRQoL) and depression among individuals with type 2 diabetes mellitus (T2D) and those at low or high risk for T2D.Methods: Respondents in a population-based US 2004 survey reported whether they had T2D (n = 3530) or risk factors for T2D [abdominal obesity, body mass index (BMI) >/= 28 kg/m(2), dyslipidaemia, hypertension and history of cardiovascular disease]. Respondents without T2D were stratified into low risk (0-2 risk factors, n = 5335) and high risk (3-5 risk factors, n = 5051). SF-12 version 2 (SF-12) and Patient Health Questionnaire (PHQ)-9 were used to measure HRQoL and depression. Mean scores were compared across the three groups using analysis of variance. Linear regression identified factors associated with SF-12 Physical and Mental Component Summary scores (PCS and MCS), adjusting for age, gender, race, income, geographic region, household size, BMI and group.Results: Respondents were mostly women (60%) with mean age of 54 years. Mean PCS scores for T2D and high risk (39.5 and 41.7, respectively) were significantly lower than for low risk (50.6, p < 0.001). After adjustment, high-risk and T2D groups were associated with lower PCS and MCS scores compared with low risk group (p < 0.05). Mean PHQ-9 scores and per cent with moderate-to-severe depression were significantly higher for T2D and high risk than for low risk (p < 0.01).Conclusions: Health-related quality of life and depression scores in T2D were similar to those at high risk, and indicated significant decrements in physical health and greater depression compared with low-risk respondents. [ABSTRACT FROM AUTHOR]

OBJECTIVE: The American Diabetes Association (ADA) lists seven symptoms of diabetes; however, it is not known how specific these symptoms are for initial diagnosis of type 2 diabetes. The Study to Help Improve Early evaluation and management of risk factors Leading to Diabetes (SHIELD) examined prevalence of ADA symptoms and their association with diabetes diagnosis. RESEARCH DESIGN AND METHODS: SHIELD is a 5-year observational study of individuals with or at risk for diabetes diagnosis. Following an initial screening phase, follow-up questionnaires were mailed to a stratified random sample of individuals (n = 22,001) with type 1 or type 2 diabetes or at high (three to five risk factors) or low (zero to two risk factors) risk for diabetes. Individuals reported whether they experienced each ADA symptom, as well as symptoms unrelated to diabetes. RESULTS: A total of 15,794 questionnaires were returned (response rate 71.8%). All ADA symptoms were reported more frequently in type 2 diabetes than in low- and high-risk groups (P < 0.0001 for each). Multivariable logistic regression analyses found that each ADA symptom other than irritability was significantly associated with type 2 diabetes, as was erectile/sexual dysfunction. However, 48% of type 1 diabetic and 44% of type 2 diabetic respondents reported no ADA symptom in the previous year. CONCLUSIONS: Occurrence of ADA symptoms alone may not adequately identify those who should be evaluated for type 2 diabetes. Longitudinal data from SHIELD will evaluate whether combinations of symptoms or addition of other symptoms can better identify individuals for evaluation. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To compare effectiveness of rosuvastatin (RSV) with other statins on lowering low-density lipoprotein cholesterol (LDL-C) and LDL-C goal attainment among patients with type 1 or type 2 diabetes mellitus. METHODS: A retrospective study using US General Electric Medical Systems (GEMS) database of patients with diabetes mellitus (ICD9 code = 250, prescription for anti-diabetic medication or fasting blood glucose level > or = 126 mg/dL in the 12 months preceding statin therapy) treated across clinical practices in the US, who were newly prescribed statin therapy during August 2003-March 2006, was conducted. Multivariate linear and logistic regression models were used for analyzing prescription data with baseline LDL-C, age, gender, smoking, very high CHD risk, systolic blood pressure, and statin duration as covariates. RESULTS: Of 4754 diabetes mellitus patients, 5% were prescribed RSV, 59% atorvastatin (ATV), 21% simvastatin (SMV), 5% pravastatin (PRV), 2% fluvastatin (FLV), and 7% lovastatin (LOV). RSV patients had significantly higher (p < 0.05) baseline mean LDL-C levels (138 vs. 117-131 mg/dL), lower average starting dose (11.7 vs. 17.0-63.7 mg) and were younger (p < 0.005) than patients on other statins (mean age 61 vs. 63-69 years). Percent LDL-C reduction was significantly greater (p < 0.0001) with RSV (28.4%) compared to ATV (22.5%), SMV (20.1%), PRV (13.7%), FLV (15.8%), and LOV (17.3%). A greater (p < 0.05) proportion of RSV diabetes patients attained LDL-C goal < 100 mg/dL (72.8%) vs. diabetes mellitus patients on other statins (36.8-67.4%). CONCLUSIONS: Rosuvastatin was more effective in lowering LDL-C and achieving LDL-C treatment goals in the diabetes mellitus population as compared to other statins in real-world clinical practice setting. Validating study results in a different diabetes population with dispensed statin prescriptions will help increase generalizability of study findings. [ABSTRACT FROM AUTHOR]