The impact of serum lipids on risk for microangiopathy in patients with type 2 diabetes mellitus.

BACKGROUND: Few large-scale, real-world studies have assessed the relative associations of lipid fractions with diabetic microvascular events. The main objective of this study was to evaluate the association of the lipid profile components, high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), triglycerides (TG), and non-high density lipoprotein cholesterol (non-HDL-C) with microvascular complications (MVCs) in type 2 diabetes mellitus (T2DM) patients. METHODS: This observational cohort study queried the HealthCore Integrated Research Database (HIRDSM) for newly-diagnosed (Index Date) 18-64-year-old patients with diabetes mellitus between 01/01/2005-06/30/2010. Inclusion required ≥ 12 months pre-index continuous health plan eligibility and ≥ 1 pre-index lipid profile result. Patients with polycystic ovary syndrome and prior MVCs were excluded. Incident complications were defined as the earliest occurrence of diabetic retinopathy, peripheral neuropathy, and/or nephropathy post-index. Cox proportional models and Kaplan-Meier (KM) curves were used to evaluate associations among variables. RESULTS: Of the patients (N=72,267), 50.05% achieved HDL-C, 64.28% LDL-C, 59.82% TG, and 56.79% non-HDL-C American Diabetes Association goals at baseline. During follow-up (mean, 21.74 months), there were 5.21 microvascular events per 1,000 patient-months. A 1-mg/dL increase in HDL-C was associated with 1% decrease in any MVC risk (P< .0001), but for LDL-C, TG, and non-HDL-C, 1-mg/dL increase resulted in increases of 0.2% (P< .0001), 0.1% (P<0.001) and 0.3% (P<0.001) in MVC risk. Patients achieving HDL-C goals had a 11% lower risk of MVC versus non-achievers (RR 0.895, [95% CI, 0.852-0.941], P< .0001). Similarly, TG goal attainment was associated with a lowered risk for any MVC (RR 0.849, [95% CI, 0.808-0.892], P< .0001). Evaluation of KM survival curves demonstrated no significant difference in the risk of MVCs between patients achieving vs. not achieving LDL-C goals, but did demonstrate a difference in MVC risk between patients achieving vs. not achieving non-HDL-C goals. CONCLUSION: This study demonstrates significant independent associations among lipid fractions and risk for microangiopathy. These findings suggest that attaining established ADA goals for HDL-C, TG, and non-HDL-C may reduce risk for microvascular events among patients with diabetes.

Development of an interactive model of the burden of future coronary heart disease from an employer perspective.

OBJECTIVE: To create a computer-based model for employers to better understand the burden of coronary heart disease (CHD) to their organizations. METHODS: A user-friendly model was developed to allow employers to evaluate the burden of CHD. Inputs include the demographic distribution by age and sex, prevalence of CHD and CHD risk factors, direct and indirect medical costs of CHD events, and discount and inflation rates. The model contains prediction equations derived from National Health and Nutrition Examination Survey data and Framingham Heart Study equations, used with employer inputs to predict future CHD events and expenditures. RESULTS: Interactive graphs are presented for the employer's covered population alongside regional benchmarks. The time horizon and population may be adjusted. CONCLUSIONS: This interactive model illustrates how pragmatic outcomes research can be converted into a transparent model addressing health care budget issues that is readily understood by corporate managers.

Impact of fixed-dose and multi-pill combination dyslipidemia therapies on medication adherence and the economic burden of sub-optimal adherence.

OBJECTIVE: To compare medication adherence between patients initiating fixed-dose combination versus multi-pill combination dyslipidemia therapies and assess the association between optimal adherence (MPR > or = 80%) and cardiovascular disease (CVD)-associated total healthcare resource utilization (THR) and costs (THC). RESEARCH DESIGN AND METHODS: The HealthCore Integrated Research Database was used to identify patients > or =18 years newly initiating fixed-dose combination [niacin extended-release (NER) and lovastatin (NERL)] or multi-pill combination therapies [NER and simvastatin (NER/S) or lovastatin (NER/L)] between 1/1/2000 and 6/30/2006 (index date), with minimum 18 months of follow-up. Adherence was measured using medication possession ratio (MPR). Three multivariate models were developed controlling for demographic and clinical characteristics. A logistic model evaluated the association between study cohorts and optimal adherence, while negative binomial and gamma models estimated the association between optimal adherence and CVD-associated THR and THC, respectively. RESULTS: In all, 6638 NERL, 1687 NER/S, and 663 NER/L patients were identified. Fixed-dose combination patients were younger [mean (SD) ages of 51.9 (10.5) vs. 56.0 (9.4) [NER/S] and 56.1 (10.6) [NER/L]; p < 0.01], had lower comorbidity (Deyo-Charlson Index 0.50 +/- 0.9 vs. 0.7 +/- 1.1 and 0.6 +/- 1.1, p < 0.01 and p < 0.05) and comprised fewer males (73.1 vs. 83.0% and 77.7%; p < 0.01 and p = 0.1). Fixed-dose combination patients had higher average 1-year MPR versus NER/S and NER/L patients (0.54 +/- 0.35 vs. 0.50 +/- 0.35 and 0.47 +/- 0.34, p < 0.01). NER/S and NER/L patients were 31.3% (95% CI: 22.9-39.5%) and 39.1% (95% CI: 26.7-49.4%) less likely to be optimally adherent than fixed-dose combination patients (p < 0.01). Additionally, optimally adherent patients had 8% and 40% decreases in annual CVD-attributable THR [0.920 (95% CI: 0.857-0.989); p = 0.023] and THC [0.601 (95% CI: 0.427-0.845); p = 0.003] versus sub-optimally adherent patients. Key limitations of the study include the limited ability of MPR to analyze the continuity of medication usage, inability to capture data on other key variables including race, income, and clinical characteristics such as smoking history, absence of laboratory values on all study patients, inability to capture over-the-counter fills of niacin, and inability to show causality of results obtained. CONCLUSIONS: Adherence was significantly higher among patients initiating fixed-dose combination versus multi-pill combination dyslipidemia therapies in this managed-care population. Additionally, patients with optimal adherence had a significantly lower CVD-associated THR and THC versus patients with sub-optimal adherence.

Attainment of combined optimal lipid values and the impact of lipid medication on cardiovascular outcomes and costs in a commercially insured population in the US.

OBJECTIVE: To determine factors associated with the achievement of optimal lipid values (OLVs) and subsequent impact on clinical and economic outcomes. METHODS: An observational managed care database analysis was conducted among treatment-naïve adults with elevated cardiovascular (CV) risk, >or=12 months follow-up and full lipid panel from the 1st January 2002 to the 28th February 2005. Achievement of guideline-based levels for low-density lipoprotein cholesterol, high-density lipoprotein cholesterol and triglycerides was evaluated via laboratory data. Annual CV-attributable resource utilisation was assessed via medical and pharmacy claims data. Clinical and economic outcomes associated with the achievement of OLVs were assessed using multivariate regression. RESULTS: A total of 52,778 patients were followed for a mean (standard deviation) of 27 (10) months with 13% achieving combined OLVs at baseline and 23% after 4 years. Of patients, 69% did not initiate lipid-modifying medication. The achievement of combined OLVs reduced the risk of CV event (odds ratio=0.86; 95% confidence interval 0.78-0.95), resource utilisation (inpatient visits: 3.36 vs. 4.41 per 100 patient years, p<0.0001; emergency department visits: 1.1 vs. 2.4 per 100 patient years, p<0.05) and costs: $703 vs. $903 per patient year, p<0.0001. CONCLUSIONS: Simultaneous achievement of OLVs was rare in this patient population. Physicians should be encouraged to manage multiple risk factors aggressively to improve clinical and economic outcomes associated with CV disease.