Lipid-lowering therapy today: treating the high-risk cardiovascular patient.

Diseases of the heart and vascular systems are the leading cause of death in the United States and worldwide. High-risk patients have been the focus of lipid-lowering trials and treatment guidelines, which recognize that more intensive reduction of low-density lipoprotein cholesterol is appropriate for a redefined, broader high-risk population. Lifestyle modifications and lipid-lowering drug therapy form the foundation of primary- and secondary-prevention programs for patients at moderate to very high risk. Evidence shows that despite the availability of effective agents, such as HMG CoA reductase inhibitors (statins), many patients still do not achieve low-density lipoprotein cholesterol goals. Nurse-centered case management programs that support early and continued adherence with lifestyle and medical therapies have been consistently successful at improving the rates of achieving lipid goals in high-risk patients.

Multifactor cardiovascular disease risk reduction in medically underserved, high-risk patients.

Few data exist on the effectiveness of cardiovascular disease (CVD) risk-reduction programs in patients with limited access to health care. The objective of this project was to evaluate a disease management approach to multifactor CVD risk reduction in patients with limited or no health insurance and low family income. Patients (n = 148) were recruited from not-for-profit or free clinics and hospitals and randomized to usual care or usual care plus team case management. Mean age was 59.3 years, 57% were women, 50% had less than a high school education, 57% were Hispanic, and 64% had no health insurance. All had > or =1 increased risk factor for CVD, and 24.5% had documented coronary artery disease. Follow-up measurements were obtained at 6 and 12 months. Primary outcomes were low-density lipoprotein cholesterol and systolic blood pressure. The disease management program was supervised by a physician, delivered by nurses and dietitians, and included comprehensive lifestyle changes and medications. Data were collected on 91% of patients at 12 months. Disease management produced clinically important decreases in selected risk factors compared with usual care, including systolic blood pressure (p <0.01) and low-density lipoprotein cholesterol (p <0.03). More patients with disease management than those with usual care moved from "high" and "very-high" risk to lower risk categories for selected risk factors. In conclusion, the disease management program had excellent retention and lower CVD risk factors and demonstrated the potential of such approaches for decreasing long-term disease burden in selected medically underserved populations.

The Hyperlipidemia: Attitudes and Beliefs in Treatment (HABIT) survey for patients: results of a validation study.

Patient adherence with cholesterol-lowering medications is a crucial component in helping patients achieve lipid goals. Understanding patient attitudes and beliefs about hyperlipidemia and its pharmacological treatments may be useful in improving patient adherence with their treatment plan. The objectives of this study were to develop a theoretically based, statistically reliable, and valid survey instrument for measuring the attitudes and beliefs of patients towards hyperlipidemia and its treatments, and to determine whether the attitudes measured were associated with patient-reported medication adherence. We assessed the reliability of the instrument through an examination of the internal consistency and factor structure of 8 attitude constructs including attitudes about the effectiveness of medications and the quality of doctor-patient communication. Validity was assessed through correlations among the attitudes and the relationship between the attitudes and the number of medication adherence problems the patient experienced in the past month. Internal consistency scores for the 8 constructs ranged from .46 to .82. Factor loadings indicated that the individual items belonged to their respective constructs, as hypothesized. The validity of the instrument was demonstrated by significant relationships between 4 of the attitudinal constructs and self-reported medication adherence problems. This study provides preliminary evidence of the reliability and validity of the HABIT (Hyperlipidemia: Attitudes and Beliefs in Treatment) patient survey of attitudes about the treatment of hyperlipidemia.

Successful dietary changes in a cardiovascular risk reduction intervention are differentially predicted by biopsychosocial characteristics.

BACKGROUND: Psychosocial factors have demonstrated associations with both prognosis of patients with cardiovascular disease (CVD) as well as the development of CVD. Psychosocial distress may influence health behaviors (such as eating behavior) that increase cardiovascular risk. METHOD: The purpose of this research was to evaluate the role of psychosocial distress on intake of high-fat snacks and fruits and vegetables in 740 men and women, identified as high risk for cardiovascular disease, who took part in a 1-year cardiovascular risk factor reduction program. RESULTS: Participants who were more successful at decreasing or staying at an optimal level of high-fat food intake had lower levels of baseline total psychosocial distress and worry and decreases in total psychosocial distress. A greater success rate at increasing fruit and vegetable intake or staying at an optimal level of fruit and vegetable intake was associated with changes in Type A and competing behaviors. CONCLUSIONS: Results from these analyses suggest that baseline levels and changes in psychosocial variables, particularly decreased psychosocial distress, were associated with improvements in healthful eating behaviors. Further work may provide information that could be useful in tailoring health behavior interventions to specific subgroups based on psychosocial characteristics, initial health behaviors, and demographic characteristics.

Long-term safety and efficacy of a once-daily niacin/lovastatin formulation for patients with dyslipidemia.

Combination therapy is increasingly recommended for patients with multiple lipid disorders, especially those at high risk for coronary events. We investigated the long-term safety and effectiveness of a new drug formulation containing once-daily extended-release niacin and lovastatin. A total of 814 men and women (mean age 59 years) with dyslipidemia were enrolled in a 52-week multicenter, open-label study. We used 4 escalating doses (niacin/lovastatin in milligrams): 500/10 for the first month, 1,000/20 for the second, 1,500/30 for the third, and 2,000/40 for the fourth month through week 52. Dose-dependent effects were observed for all major lipid parameters. At week 16, mean low-density lipoprotein (LDL) cholesterol and triglycerides were reduced by 47% and 41%, respectively; mean high-density lipoprotein (HDL) cholesterol was increased by 30% (all p <0.001). LDL/HDL cholesterol and total/HDL cholesterol ratios were also decreased by 58% and 48%, respectively. These effects persisted through week 52, except for the mean increase in HDL cholesterol, which had increased to 41% at 1 year. Lipoprotein (a) and C-reactive protein also decreased in a dose-related manner (by 25% and 24%, respectively, on 2,000/40 mg; p <0.01 vs baseline). Treatment was generally well tolerated. The most common adverse event was flushing, which caused 10% of patients to withdraw. Other adverse events included gastrointestinal upset, pruritus, rash, and headache. Drug-induced myopathy did not occur in any patient. The incidence of elevated liver enzymes to >3 times the upper limit of normal was 0.5%. Once-daily niacin/lovastatin exhibits substantial effects on multiple lipid risk factors and represents a significant new treatment option in the management of dyslipidemia.