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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.

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.

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.

• The prevalence of chronic kidney disease (CKD) among individuals with type 2 diabetes mellitus (T2DM) is common. • Literature reports that 34.5% to 42.3% of individuals with T2DM in the United States have CKD (due primarily to early stage CKD).1-5 • Information is lacking on the recent temporal trends and prevalence within key demographic subgroups. Temporal Trend and Prevalence of CKD Stages (KDIGO 2012) in US Adults with Type 2 Diabetes Mellitus and Demographic Subgroups: NHANES 2007-2012 Bingcao Wu, MS,1 Kelly Bell, PharmD,2 David M Kern, MS,1 Ozgur Tunceli, PhD,1 Vincent Willey, PharmD,1 Suma Vupputuri, PhD,1 Amy Stanford, PharmD,3 Iftekhar Kalsekar, PhD2 1HealthCore Inc., Wilmington, Delaware, USA; 2AstraZeneca LP, Fort Washington, Pennsylvania, USA; 3 Bristol-Myers Squibb Company, Plainsboro, New Jersey, USA 1085-P