An exploratory retrospective assessment of a quantitative measure of diabetes risk: medical management and patient impact in a primary care setting.

BACKGROUND: Primary care providers with limited time and resources bear a heavy responsibility for chronic disease prevention or progression. Reliable clinical tools are needed to risk stratify patients for more targeted care. This exploratory study examined the care of patients who had been risk stratified regarding their likelihood of clinically progressing to type 2 diabetes. METHODS: This was a retrospective chart review pilot study conducted to assess a primary care provider's use of a risk screening test. In this quality improvement project, the result of the risk screening was examined in relation to its influence on medical management and clinical impact on patients at risk for diabetes. All providers were board certified in family medicine and had more than 10 years clinical experience in managing diabetes and prediabetes. No specific clinical practice guidelines were mandated for patient care in this pilot study. Physicians in the practice group received an orientation to the diabetes risk measure and its availability for use in a pilot study to be conducted over a 6-month period. We identified the 696 nondiabetic adults in family practices who received a risk screening test (PreDx(®), a multi-marker blood test that estimates the 5-year likelihood of conversion to type 2 diabetes) between June and November 2011 for a 6-month sample. A comparison group of 2,002 patients from a total database of 3.2 million patients who did not receive the risk test was randomly selected from the same clinical database after matching for age, sex, selected diagnoses, and metabolic risk factors. Patient groups were compared for intensity of care provided and clinical impact. RESULTS: Compared to patients with a similar demographic and diagnostic profile, patients who had the risk test received more intensive primary care and had better clinical outcome than comparison patients. Risk-tested patients were more likely to return for follow-up visits, be monitored for relevant cardio-metabolic risk factors, and receive prescription medications with P<0.001. Further, intensity of care was associated with the level of risk test result: patients with moderate or high scores were more likely to return for follow-up visits and receive prescription medications than patients with low scores. All P-values for comparison patients between the low and moderate groups, low and high groups, and moderate and high groups resulted in P<0.001. Risk-tested patients were more likely than their comparison group counterparts to achieve weight reduction, lowered blood pressure, and improved blood glucose and cholesterol as demonstrated by P-values of <0.001. CONCLUSION: Use of a risk stratification test in primary care may help providers to more effectively identify high risk patients, manage diabetes risk, increase patient involvement in diabetes risk management, and improve clinical outcomes. A randomized controlled study is the next step to investigate the impact of diabetes risk stratification in primary care.

The Game of Health©: an innovative lifestyle change program implemented in a family practice.

PURPOSE: The purpose of this clinical pilot project was to evaluate the effectiveness of a 12 week lifestyle change program targeted to patients with chronic disease. DATA SOURCES: Data were collected weekly from participants using individual and group feedback and body composition analysis. CONCLUSIONS: The Game of Health was well received by patients and was effective in modifying behaviors to achieve a healthier lifestyle and to improve body composition. Primary care providers need to consider how to make lifestyle change programs available to their patients to complement clinical interventions.

Influence of age, gender, and race on the efficacy of adding ezetimibe to atorvastatin vs. atorvastatin up-titration in patients at moderately high or high risk for coronary heart disease.

BACKGROUND: Age, gender, and race are factors that influence atherosclerotic coronary heart disease (CHD) risk and may conceivably affect the efficacy of lipid-altering drugs. METHODS: Post hoc analysis of two multicenter, 6-week, double-blind, randomized, parallel-group trials assessed age (<65 and ≥ 65 years), gender, and race (white, black, and other) effects on atorvastatin plus ezetimibe versus up-titration of atorvastatin in hypercholesterolemic patients with CHD risk. High CHD risk subjects with low-density lipoprotein (LDL) cholesterol levels ≥ 70 mg/dL (~1.81 mmol/L) during stable atorvastatin 40 mg therapy were randomized to atorvastatin 40 mg plus ezetimibe 10mg, or up-titrated to atorvastatin 80 mg. Moderately high CHD risk subjects with LDL cholesterol levels ≥ 100 mg/dL (~2.59 mmol/L) with atorvastatin 20mg were randomized to atorvastatin 20mg plus ezetimibe 10mg, or atorvastatin 40 mg. RESULTS: Although some variability existed, age, gender, and race subgroups did not substantially differ from the entire patient population with regard to lipid-altering findings. Ezetimibe plus atorvastatin produced greater percent reductions in LDL cholesterol, total cholesterol, triglycerides, non-high-density lipoprotein (HDL) cholesterol, and apolipoprotein B than up-titration of atorvastatin for all subgroups. HDL cholesterol and apolipoprotein AI changes were small and variable. CONCLUSION: Treatment efficacy in age, gender, and race subgroups did not substantially differ from the entire study population. Ezetimibe combined with atorvastatin generally produced greater incremental reductions in LDL cholesterol and several other key lipid parameters compared with doubling the atorvastatin dose in hypercholesterolemic patients with high or moderately high CHD risk. These results suggest that co-administration of ezetimibe with statins is a useful therapeutic option for treatment of dyslipidemia in differing patient populations.

Efficacy and safety of ezetimibe added on to atorvastatin (20 mg) versus uptitration of atorvastatin (to 40 mg) in hypercholesterolemic patients at moderately high risk for coronary heart disease.

The aim of this study was to evaluate the efficacy and safety of ezetimibe 10 mg added to atorvastatin 20 mg compared with doubling atorvastatin to 40 mg in patients with hypercholesterolemia at moderately high risk for coronary heart disease who did not reach low-density lipoprotein (LDL) cholesterol levels <100 mg/dl with atorvastatin 20 mg. In this 6-week, multicenter, double-blind, randomized, parallel-group study, 196 patients treated with atorvastatin 20 mg received atorvastatin 20 mg plus ezetimibe 10 mg or atorvastatin 40 mg for 6 weeks. Adding ezetimibe 10 mg to atorvastatin 20 mg produced significantly greater reductions in LDL cholesterol than increasing atorvastatin to 40 mg (-31% vs -11%, p <0.001). Significantly greater reductions were also seen in non-high-density lipoprotein cholesterol, total cholesterol, and apolipoprotein B (p <0.001). Significantly more patients reached LDL cholesterol levels <100 mg/dl with atorvastatin 20 mg plus ezetimibe compared with atorvastatin 40 mg (84% vs 49%, p <0.001). The 2 treatment groups had comparable results for high-density lipoprotein cholesterol, triglycerides, apolipoprotein A-I, and high-sensitivity C-reactive protein. The incidences of clinical and laboratory adverse experiences were generally similar between groups. In conclusion, the addition of ezetimibe 10 mg to atorvastatin 20 mg was generally well tolerated and resulted in significantly greater lipid-lowering efficacy compared with doubling atorvastatin to 40 mg in patients with hypercholesterolemia at moderately high risk for coronary heart disease.