National Cholesterol Education Program Goals Research Articles

Lipid-lowering interventions in managed care settings

Effective screening, treatment, and follow-up of patients with elevated serum lipid levels is important because of the very strong association between this condition and coronary heart disease (CHD). Screening of patients with and without CHD for hyperlipidemia is not generally carried out properly by managed care organizations (MCOs) or in other settings. Primary and secondary prevention are inadequate in most patients with this condition; even in patients who are treated, lipid-lowering therapy is often not used to its full potential. These trends have been confirmed by findings in the first of a three-phase hyperlipidemia outcomes management program carried out at 27 US MCOs. The efficacy of lipid-lowering therapy can be enhanced by physician education and comprehensive, integrated quality improvement programs. The cost-effectiveness of such treatment can be improved by individualizing both drug and dose to achieve National Cholesterol Education Program goals at the lowest drug acquisition cost. The quality improvement program described and others like it have the potential to reduce the morbidity and mortality associated with CHD while decreasing the huge economic burden associated with this disease. Several such programs have been undertaken at MCOs, some with more success than others. Interventions and assessments of the type planned in phases 2 and 3 of this program can help to reduce the cost of lipid-lowering therapy without compromising cholesterol goal achievement.

Assessing the results: Phase 1 hyperlipidemia outcomes in 27 health plans

In phase 1 of this hyperlipidemia outcomes management program, characteristics of 7,619 patients treated with statins at 27 US managed care plans were determined. Nearly 40% (3,018 patients) had documented coronary heart disease (CHD). Most (65%) had at least two CHD risk factors. Hyperlipidemia treatment included simvastatin (39%), atorvastatin (25%), fluvastatin (14%), pravastatin (12%), and lovastatin (2%). On-treatment low-density lipoprotein cholesterol (LDL-C) levels were available for 79% of patients; however, only 46% had both baseline and follow-up levels recorded in their charts. Of patients for whom follow-up data were available, 3,779 (63%) achieved their target LDL-C levels as recommended by the National Cholesterol Education Program (NCEP). Target LDL-C levels were reached by 1,381 (87%) of the patients with a goal of 160 mg/dL, 1,326 (65%) of those with a goal of 130 mg/dL, and 1,072 (44%) of those with a goal of 100 mg/dL. Overall, 66% of patients who met their treatment goal and 24% of those who did not required no more than a 25% reduction in LDL-C. In contrast, 8% of patients who achieved goals and 36% of patients who did not required >40% reduction in LDL-C. Phase 1 results did not suggest any substantial difference among statins for achievement of NCEP goals or decrease in LDL-C. These results show that therapy with statins is effective for achievement of NCEP targets in most patients and that there is potential for improvement in the quality and cost-effectiveness of statin therapy with carefully planned interventions.

Increased National Cholesterol Education Program (NCEP) Goal Attainment

To contain costs, the US Department of Defense instituted a mandated statin formulary conversion program, designating cerivastatin and simvastatin as the ‘preferred statins’. This study examines the effectiveness, safety, and statin cost effectiveness following conversion to cerivastatin and simvastatin. Retrospective analysis. Madigan Army Medical Center (MAMC), Tacoma, Washington, USA. Men and women treated and filling their statin prescriptions at MAMC with records of statin conversion between October 1999 and April 2000 (n = 1303). Age, gender, and lipid parameter measurements assessed pre-conversion (earliest measurement prior to conversion) and ≥21 days post-conversion were recorded. Pre- and post-conversion attainment of National Cholesterol Education Program Adult Treatment Panel II (NCEP-ATP H)/American Diabetes Association (ADA) goals, lipid parameters, and estimated statin cost per patient attaining NCEP-ATP II/ADA goals, were analysed. Conversion to cerivastatin (n = 1038) elevated goal attainment (18.2%), and reduced low-density lipoprotein and cholesterol (LDL-C) levels by 15.4 mg/dl, total cholesterol (TC) by 13.5 mg/dl and triglycerides (TG) by 10.2 mg/dl, and elevated high-density lipoprotein and cholesterol (HDL-C) levels by 3.8 mg/dl (all p < 0.002). Similar results occurred in NCEP-ATP II patient subgroups [secondary prevention; primary prevention: with diabetes mellitus, ≥2 risk factors (RF), and <2 RF]. Patients receiving simvastatin (n = 265) exhibited improvement in NCEP-ATP II/ADA goal attainment and LDL-C, TC, and HDL-C levels [all p < 0.05, except HDL-C in the <2 RF subgroup (nonsignificant)]. The estimated pre-conversion annual pharmacy statin cost per patient attaining and NCEP-ATP II/ADA goals was $US681 ($US56.77 per patient per month), compared with the post-conversion annual cost of $US355 ($US29.62 per patient per month), driven primarily by the cerivastatin conversion (2000 values). Post-conversion adverse events [rash (n = 3), dizziness (n = 1), and gastrointestinal upset (n = 1)] were rare. There were no reported clinically significant elevations of liver function tests or creatine kinase, or cases of myositis or myalgia. Statin conversion at MAMC to cerivastatin and simvastatin is an effective and well tolerated method for improving NCEP-ATP II/ADA goal attainment and lipid parameters while containing pharmacy costs.

Effect of a clinical pharmacist-managed lipid clinic on achieving National Cholesterol Education Program low-density lipoprotein goals.

Despite national guidelines for treatment of hyperlipidemia, significant numbers of individuals with coronary artery disease are not treated to their National Cholesterol Education Program (NCEP) low-density lipoprotein (LDL) goals. The potential benefits of a clinical pharmacist-managed lipid clinic would be to improve rates of success in achieving these goals, improve drug adherence and compliance with therapy, and reduce cardiovascular events. All patients who had a documented history of coronary artery disease and were under the care of one cardiologist were treated in the pharmacist-managed lipid clinic. A second cardiologist provided usual care to a group of patients with coronary artery disease who served as controls. Patients in each arm were followed for a minimum of 6 months. A protocol for therapy changes in clinic patients was developed by the clinical pharmacist and approved by the cardiologist. At the end of 6 months, 69% of patients in the pharmacist-managed clinic achieved their LDL goal, compared with 50% of controls. Compliance with laboratory tests and drug regimens also improved in clinic patients. Compliance with lipid panels went from 8% 2 months before to 89% 2 months after the start of the study. At the end of 6 months compliance with laboratory work and refills was 80%. Thus the clinical pharmacist-managed clinic was highly successful in achieving NCEP goals for secondary prevention.

Achieving National Cholesterol Education Program Goals for Low-Density Lipoprotein Cholesterol in Cardiac Patients: Importance of Diet, Exercise, Weight Control, and Drug Therapy

Achieving National Cholesterol Education Program Goals for Low-Density Lipoprotein Cholesterol in Cardiac Patients: Importance of Diet, Exercise, Weight Control, and Drug TherapyAllison TG, Squires RW, Johnson BD, Gau GT Mayo Clin Proc 1999;74:466-473 Background. The National Cholesterol Education Program (NCEP) guidelines recommend a low-density lipoprotein cholesterol (LDL) of ≤ 100 mg/dl in patients with coronary artery disease. Data on the attainment of these goals in clinical practice are limited. Methods. Consecutive patients who completed cardiac rehabilitation and were not on lipid-lowering drug therapy (LLD) were randomized to follow-up care with nurse lipid specialists (RN) or preventive cardiologists (UC). All patients received diet and exercise recommendations and were treated with LLD in accordance with NCEP guidelines. Results. The baseline LDL level in all 152 patients was 130 ± 29 mg/dl and did not differ between the groups. After a mean of 526 days of follow-up, 39% of all the patients had an LDL level ≤ 100 mg/dl and 35% of these patients were not receiving LLD therapy. Independent predictors of a final LDL level ≤ 100 mg/dl included LLD therapy (P < 0.001), baseline LDL level (P < 0.001), and amount of exercise in minutes/week (P < 0.05). There was no difference between the RN and UC groups in the percentage of patients reaching the target LDL levels. Conclusion. The authors conclude that nurses manage lipids as effectively as preventive cardiologists and that LLD therapy is the most important factor in achieving the target LDL level. Comments. The results of this study indicate modest success in attainment of NCEP goals within an academic preventive cardiology setting. Reasons for lack of attainment of these goals in the majority of patients and ways to improve compliance deserve further study.

Pharmaceutical Care Services and Results in Project ImPACT: Hyperlipidemia

ObjectiveTo demonstrate that pharmacists, working collaboratively with patients and physicians and having immediate access to objective point-of-care patient data, promote patient persistence and compliance with prescribed dyslipidemic therapy that enables patients to achieve their National Cholesterol Education Program (NCEP) goals. DesignObservational study. Participants26 community-based ambulatory care pharmacies: independent, chain-professional, chain-grocery store, home health/home infusion, clinic, health maintenance organization/managed care. Main Outcome MeasuresRates of patient persistence and compliance with medication therapy and achievement of target therapeutic goals. ResultsIn a population of 397 patients over an average period of 24.6 months, observed rates for persistence and compliance with medication therapy were 93.6% and 90.1%, respectively, and 62.5% of patients had reached and were maintained at their NCEP lipid goal at the end of the project. ConclusionWorking collaboratively with patients, physicians, and other health care providers, pharmacists who have ready access to objective clinical data, and who have the necessary knowledge, skills, and resources, can provide an advanced level of care that results in successful management of dyslipidemia.

Achieving National Cholesterol Education Program Goals for Low-Density Lipoprotein Cholesterol in Cardiac Patients:Importance of Diet, Exercise, Weight Control, and Drug Therapy

Objective To determine how frequently the National Cholesterol Education Program (NCEP) goal of a lowdensity lipoprotein (LDL) cholesterol level of 100 mg/dL or less is achieved in clinical practice in patients with coronary artery disease and what fraction of patients can achieve this goal without drug therapy. Design We examined the results of lipid management in 152 consecutive patients who had completed cardiac rehabilitation after an acute coronary event. Patients were randomized to follow-up by specially trained nurses or by preventive cardiologists, and they were not receiving lipid-lowering drugs at the start of the study. Material and Methods Patients were given aggressive diet and exercise recommendations and lipid-lowering drugs in accordance with NCEP guidelines. Follow-up was continued for a mean of 526 days after the first lipid assessment subsequent to the coronary event. Multiple logistic regression analysis was used to identify independent predictors of a final LDL cholesterol level of 100 mg/dL or less. Results Of the study group, 39% achieved the NCEP goal LDL cholesterol level of 100 mg/dL or less. Characteristics of the patients with LDL cholesterol levels of 100 mg/dL or Jess in comparison with those with LDL cholesterol levels of more than 100 mg/dL included a greater frequency of drug therapy (65% versus 380/0), more rigorous dietary compliance, longer follow-up (586 ± 317 days versus 493 ‡ 264 days), more favorable weight change (–0.3 ± 4.9 kg versus +1.7 ± 5.0 kg), and more extensive weekly exercise (183 ± 118 minutes versus 127 ± 107 minutes). Conclusion The registered nurses managed the lipids of these patients as effectively as did the preventive cardiologists. Appropriate drug therapy was the most important factor in achieving an LDL cholesterol level of 100 mg/dL or less, but 35% of patients attaining this NCEP goal were not receiving drug therapy. Exercise, dietary compliance, and weight loss were also important factors. To determine how frequently the National Cholesterol Education Program (NCEP) goal of a lowdensity lipoprotein (LDL) cholesterol level of 100 mg/dL or less is achieved in clinical practice in patients with coronary artery disease and what fraction of patients can achieve this goal without drug therapy. We examined the results of lipid management in 152 consecutive patients who had completed cardiac rehabilitation after an acute coronary event. Patients were randomized to follow-up by specially trained nurses or by preventive cardiologists, and they were not receiving lipid-lowering drugs at the start of the study. Patients were given aggressive diet and exercise recommendations and lipid-lowering drugs in accordance with NCEP guidelines. Follow-up was continued for a mean of 526 days after the first lipid assessment subsequent to the coronary event. Multiple logistic regression analysis was used to identify independent predictors of a final LDL cholesterol level of 100 mg/dL or less. Of the study group, 39% achieved the NCEP goal LDL cholesterol level of 100 mg/dL or less. Characteristics of the patients with LDL cholesterol levels of 100 mg/dL or Jess in comparison with those with LDL cholesterol levels of more than 100 mg/dL included a greater frequency of drug therapy (65% versus 380/0), more rigorous dietary compliance, longer follow-up (586 ± 317 days versus 493 ‡ 264 days), more favorable weight change (–0.3 ± 4.9 kg versus +1.7 ± 5.0 kg), and more extensive weekly exercise (183 ± 118 minutes versus 127 ± 107 minutes). The registered nurses managed the lipids of these patients as effectively as did the preventive cardiologists. Appropriate drug therapy was the most important factor in achieving an LDL cholesterol level of 100 mg/dL or less, but 35% of patients attaining this NCEP goal were not receiving drug therapy. Exercise, dietary compliance, and weight loss were also important factors.

Achieving National Cholesterol Education Program Goals for Low-Density Lipoprotein Cholesterol in Cardiac Patients:Importance of Diet, Exercise, Weight Control, and Drug Therapy

To determine how frequently the National Cholesterol Education Program (NCEP) goal of a low-density lipoprotein (LDL) cholesterol level of 100 mg/dL or less is achieved in clinical practice in patients with coronary artery disease and what fraction of patients can achieve this goal without drug therapy. We examined the results of lipid management in 152 consecutive patients who had completed cardiac rehabilitation after an acute coronary event. Patients were randomized to follow-up by specially trained nurses or by preventive cardiologists, and they were not receiving lipid-lowering drugs at the start of the study. Patients were given aggressive diet and exercise recommendations and lipid-lowering drugs in accordance with NCEP guidelines. Follow-up was continued for a mean of 526 days after the first lipid assessment subsequent to the coronary event. Multiple logistic regression analysis was used to identify independent predictors of a final LDL cholesterol level of 100 mg/dL or less. Of the study group, 39% achieved the NCEP goal LDL cholesterol level of 100 mg/dL or less. Characteristics of the patients with LDL cholesterol levels of 100 mg/dL or less in comparison with those with LDL cholesterol levels of more than 100 mg/dL included a greater frequency of drug therapy (65% versus 38%), more rigorous dietary compliance, longer follow-up (586 +/- 317 days versus 493 +/- 264 days), more favorable weight change (-0.3 +/- 4.9 kg versus +1.7 +/- 5.0 kg), and more extensive weekly exercise (183 +/- 118 minutes versus 127 +/- 107 minutes). The registered nurses managed the lipids of these patients as effectively as did the preventive cardiologists. Appropriate drug therapy was the most important factor in achieving an LDL cholesterol level of 100 mg/dL or less, but 35% of patients attaining this NCEP goal were not receiving drug therapy. Exercise, dietary compliance, and weight loss were also important factors.

Lipid-lowering drugs, cost-effectiveness data, and the formulary system: A health systems perspective

There is little doubt that scientific evidence supports the association between hyperlipidemia and coronary heart disease (CHD). Edipemiologic studies and interventional clinical trials have both demonstrated the risks associated with elevated cholesterol and triglyceride concentrations; evidence also supports the benefits of lowering lipid levels through dietary modifications, drug therapy, or combined diet/drug interventions. In a variety of patient populations the use of the statin class of antilipemic drugs has been shown to reduce the risks of morbidity and mortality from CHD.That such benefits are associated with certain “statins”has been demonstrated for adults of both sexes in primary prevention trials1,2 and secondary prevention trials.3,4 Regression analysis models derived from the Framingham Study suggest that morbidity and mortality rates from CHD may also be reduced by treatment with other drugs (eg, cholestyramine) that lower low-density lipoprotein-cholesterol (LDL-C) and by changes in diet, by exercise, and by other lifestyle modifications that also lower LDL-C.5-7 Patients with hyperlipidemia are likely to derive clinical benefit when dietary or drug interventions are used to achieve the National Cholesterol Education Program (NCEP) goal of LDL-C levels of <130 mg% or LDL-C levels of <100 mg% in patients with CHD.3,8 Further reductions in coronary risk can be achieved by managing comorbid diseases such as hypertension, obesity, and diabetes, all of which are prevalent in a high percentage of patients at risk. Both integrated health systems and managed care organizations (MCOs) have become increasingly skilled in the use of large medical records databases (with demographic, diagnostic, pharmacy, and laboratory data) to identify not only patients at risk for CHD and other diseases but also untreated, undertreated, or noncompliant patients who would benefit from intervention. Despite the general knowledge that supports early and aggressive intervention in persons at risk for CHD, the treatment benefits demonstrated in clinical trials have unfortunately not been fully realized in the general population.9,10 Barriers to achieving these potential benefits include the failure of health care providers to screen for hyperlipidemia, the failure of patients to achieve NCEP goals, poor patient compliance with prescribed treatments, and the high treatment costs associated with most lipid-lowering drug therapies. In addition, patients may be treated with dosing regimens that are inconvenient (such as that used with cholestyramine) or with drugs that have a high incidence of side effects and intolerances (eg, niacin).The disadvantages of these treatments contrast with the simplicity of treatment with statins, which are administered once daily and have a low toxicity profile. Both patients and health care providers may also be underinformed about the benefits of lowering LDL-C in the absence of symptomatic CHD.

Survey of Total Error of Precipitation and Homogeneous HDL-Cholesterol Methods and Simultaneous Evaluation of Lyophilized Saccharose-containing Candidate Reference Materials for HDL-Cholesterol

Standardization of HDL-cholesterol is needed for risk assessment. We assessed for the first time the accuracy of HDL-cholesterol testing in The Netherlands and evaluated 11 candidate reference materials (CRMs). The total error (TE) of HDL-cholesterol measurements was assessed in native human sera by 25 Dutch clinical chemistry laboratories. Concomitantly, the suitability of lyophilized, saccharose-containing CRMs (n = 11) for HDL-cholesterol was evaluated. In the precipitation method group, which included 25 laboratories and four methods, the mean (minimum-maximum) TE was 11.5% (2.7-25.2%), signifying that 18 of 25 laboratories satisfied the TE goal of </=13% issued by the National Cholesterol Education Program (NCEP). In the homogeneous HDL-cholesterol method group, which included five laboratories, each performing two different methods, the mean (minimum-maximum) TE was 9.5% (6.0-17.3%) for the Boehringer assay and 15.7% (3.3-30.7%) for the Genzyme assay. For the Boehringer homogeneous assay, one of five laboratories did not meet the TE criterion, whereas for the Genzyme homogeneous assay, three of five laboratories exceeded the 13% criterion. The biases on the HDL-cholesterol values found by various precipitation methods were highly variable in all CRMs, irrespective of the quality, whereas the biases found by the homogeneous method from Boehringer were far less than +/-5% for the highest-quality CRMs (CRMs 4-6). The NCEP goal was met by 24 of 35 laboratories assessed by use of native human sera. Selectively pooled, lyophilized CRMs that are cryoprotected with 200 g/L saccharose have ample potential for use in the standardization of homogeneous HDL-cholesterol methods.

Impact of Adopting Lower-Fat Food Choices on Energy and Nutrient Intakes of American Adults

Objective To evaluate the energy and nutrient intake of free-living men and women who choose foods consistent with different fat-reduction strategies. Design For each year of the Continuing Survey of Food Intake by Individuals from 1989 through 1991, food codes were used to sort respondents by type of milk; type of meats; and type of cheese, yogurt, salad dressing, cake, and pudding (ie, full-fat or fat-modified products) consumed. Subjects A nationally representative sample of 3,313 men and 3,763 women who completed 3-day intake records and consumed either a reduced-fat or full-fat food from at least 1 of the 3 fat-reduction strategy categories. Statistical analysis performed Analysis of variance with the Scheffé test was used to analyze differences in energy and nutrient intake between exclusive users, mixed users, and nonusers of each strategy or combined strategies. Results Regardless of fat-reduction strategy, men and women who used them reported significantly lower intakes of total fat (up to 18 g lower), saturated fat (up to 12 g lower), cholesterol (up to 75 ing lower) and energy compared with nonusers. Exclusive users of single strategies met or approached recommendations of the National Cholesterol Education Program for total fat, saturated fat, and cholesterol intake; micronutrient intake varied depending on the strategy used. Skim milk users had the most favorable micronutrient intake, whereas lean meat users reported inadequate intake of zinc (men 6396 and women 59% of the Recommended Dietary Allowances [RDAs]) and female users of fat-modified products reported inadequate intakes of vitamin E (64% of RDA) and zinc (65% of RDA). Multiple-strategy users achieved National Cholesterol Education Program goals and reported adequate micronutrient intakes and significantly lower energy intake. Mixed users of fat-modified products compared with nonusers of any fat-modified products had adequate micronutrient intake and lower intakes of total fat (32% vs 36% of energy for men and 32% vs 35% of energy for women) and saturated fat (11% vs 13% of energy for men and 11% vs 12% of energy for women). In addition, nonusers of any fat-modified strategy had the highest cholesterol and energy intake and the lowest intake of. many micrbnutrients. Applications A variety of fat-reduction strategies can be implemented to reduce energy, total fat, saturated fat, and cholesterol intake. Some of the strategies were associated with an inadequate micronutrient intake, so additional dietary guidance is needed to ensure that all nutrient requirements are met. Furthermore, people who do not use any fat-reduction strategy or those who exclusively use lean meats or fat-modified products would benefit from understanding how to balance their food choices. J Am Diet Assoc. 1999;99:177–183.

A Comparison of Hypercholesterolemia Management in the Secondary Prev,ention of-Coronary Heart Disease. by Payor Types Fee-For-Service, Medicare, and. Managed, Care Organizations:

ABSTRACT: The objective was to compare practice patterns of hypercholesterolemia management among payor types and to compare treatment of patients by gender and age in two practice settings. A retrospective study used chart review of patients to assess practice patterns among fee-for-service (FFS), Medicare, restricted (R), and nonrestricted (NR) managed care plans. The medical records of 928 patients treated in lipid clinics and nonlipid clinics in a private cardiology practice were randomly selected from a pool of 4,314 patients with identified International Classification of Diseases, Ninth Revision, Clinical Modification codes 410-414 (ischemic heart disease), Outcomes measurements included documentation of low density lipoprotein cholesterol (LDLC), initiation of lipid-lowering pharmacotherapy, the achievement of the National Cholesterol Education Program goal of LDL -Cs:1 00 mg/dL, and the measurements of LDL -C, total cholesterol, and high-density lipoprotein cholesterol. In the nonlipid clinic (NL...

The cost of treating dyslipidaemia using National Cholesterol Education Program (NCEP) guidelines.

Coronary heart disease (CHD) is a major cause of death in industrialised countries and places a large burden on society in terms of healthcare resources and lost productivity. US National Cholesterol Education Program (NCEP) guidelines recommend aggressive lipid-modifying therapy for individuals at highest risk for CHD. It has been estimated that more than 50 million individuals in the US (more than one-third of the total population) are candidates for some form of dietary and/or pharmacological intervention to modify their lipid profiles. Most individuals who receive lipid-lowering drug therapy do not meet target goals set by the NCEP; thus, there is a large potential for increased use of drug therapy. Pharmacoeconomic analyses applying NCEP guidelines are sparse; however, available data (using direct costs) suggest that secondary prevention is more cost effective than primary prevention, but that costs associated with primary prevention are generally in line with those of accepted medical interventions. Cost-effectiveness ratios for secondary prevention improved when indirect costs were assessed in one study. A recent randomised prospective 54-week comparative study of statins in 662 patients with hypercholesterolaemia concurrently measured medical outcomes and economic data. Atorvastatin-treated patients were significantly more likely to achieve NCEP goals (overall and at the initial dosage), and to achieve these goals more quickly than patients treated with fluvastatin, lovastatin and simvastatin. The mean cost to reach NCEP goals was consequently lowest for atorvastatin. Results from pharmacoeconomic studies of primary and secondary prevention are therefore in support of NCEP treatment guidelines for hypercholesterolaemia.

Management of Hypercholesterolemia: Practice Patterns for Primary Care Providers and Cardiologists

This retrospective study, conducted as part of a private practice quality assurance process for patients with coronary artery disease (CAD), compares practice patterns in the LIFEHELP lipid clinic and non–lipid clinic settings at the Heart Institute of St. Petersburg. Quality assurance parameters included documentation of low-density lipoprotein (LDL) cholesterol, initiation of lipid-lowering therapy, and achievement of the Second National Cholesterol Education Program (NCEP II) goal for CAD patients of LDL cholesterol ≤100 mg/dL. A total of 934 patient charts with ICD-9 codes of 410–414 for ischemic heart disease were randomly selected and reviewed by a utilization review nurse. A higher level of documentation and treatment of elevated LDL cholesterol to NCEP II goal in CAD patients was found for those followed in the lipid clinic. Among non–lipid clinic physicians, cardiologists documented and treated elevated LDL cholesterol more frequently than primary care physicians. Women and the elderly subgroups received improved care in the lipid clinic setting. Screening activities and risk-factor management by cardiologists within a lipid clinic, therefore, demonstrated an improved standard of care that came closer to achieving national guidelines in the secondary prevention of CAD.

The Physician and Pharmacist Team An Effective Approach to Cholesterol Reduction

OBJECTIVE: To assess the effect of a program that encourages teamwork between physicians and pharmacists on attempts to lower total cholesterol levels and to meet recommended goals proposed by the National Cholesterol Education Program (NCEP). DESIGN: A single-blind, randomized, controlled trial lasting 6 months. SETTING: An ambulatory primary care center. PATIENTS: A sample of 94 patients with total cholesterol levels of 240 mg/dL (6.2 mmol/L) or higher. INTERVENTION: Equal numbers of patients were randomly assigned to a control arm in which standard medical care was received and an intervention arm which implemented close interaction between physicians and pharmacists. MEASUREMENTS AND MAIN RESULTS: Absolute change in total cholesterol levels from baseline values and the percentage of patients who achieved an NCEP goal after 6 months of intervention were determined. The rate of success in achieving NCEP goals in the intervention arm was double the rate in the control arm (43% vs 21%, p < .05). Total cholesterol levels in the intervention arm declined 44 ± 47 mg/dL (1.1 ± 1.2 mmol/L) versus 13 ± 51 mg/dL (0.3 ± 1.3 mmol/L) in the control arm (p < .01). The effect of intervention on reducing total cholesterol levels was similar for men and women and did not appear to be altered by age. The effect of intervention was greatest in patients with coronary heart disease (p < .01) followed by those without disease but with two or more coronary heart disease risk factors (p < .05). An effect of intervention was absent in patients without coronary heart disease and with fewer than two risk factors. CONCLUSIONS: Attempts to lower total cholesterol levels and achieve NCEP goals are likely to be more successful when combined with programs that include teamwork between physicians and pharmacists. Some programs, however, may be more successful for high-risk patients, for whom it is often easier to provide more aggressive therapies. Although altering adverse lipid profiles in lower-risk patients may be difficult, achieving optimal cholesterol levels could have an important impact on preventing movement to higher risk strata.

Rationale for Effective Treatment of Hypercholesterolemia

The primary objective of treating hypercholesterolemia is to reduce the patient's risk of developing coronary artery disease (CAD). Reducing low-density lipoprotein (LDL) cholesterol levels to achieve National Cholesterol Education Program (NCEP) goal lipid levels greatly reduces this risk. Treatment of additional risk factors for CAD (high blood pressure, diabetes, smoking) should be addressed and modified as part of appropriate patient management, but a high LDL cholesterol level is a major risk factor. Therefore, to effectively modify morbidity and mortality, reaching and maintaining NCEP target lipid levels should be the goal of lipid-lowering therapy. Epidemiologic data indicate that most adults in the United States need <30% reduction in LDL cholesterol level to achieve their NCEP goal. Regardless of the intervention or therapeutic agent used, the results of numerous studies have demonstrated that reducing LDL cholesterol levels to NCEP goals will result in significant reduction of CAD risk. (Am J Cardiol 1996;78(suppl 6A):4–12)

Cost-Effectiveness of 3-Hydroxy-3-Methylglutaryl-Coenzyme A (HMG-CoA) Reductase Inhibitor Therapy in the Managed Care Era

More than $100 billion is spent in the United States each year on cardiovascular disease, primarily for hospitalizations and revascularization procedures. This is more than for any other disease state. As the clinical practice of medicine shifts from the paradigm of private practice to the managed care environment, cost-effectiveness is becoming increasingly important. A primary measure in analyzing cost-effectiveness is the cost-effectiveness ratio, or the dollar cost per unit of improvement for a given expenditure. This measure allows healthcare planners to compare completely different interventions. With approximately 52 million adult U.S. citizens having elevated low-density lipoprotein (LDL) cholesterol levels, lipid-lowering therapy—with diet or 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors—is an important consideration for primary care physicians and managed care providers. The National Health and Nutrition Examination Survey (NHANES) III indicates that 75–88% of adults who have coronary artery disease (CAD) risk factors or CAD require only a moderate (20–30%) reduction in LDL cholesterol levels to reach National Cholesterol Education Program goals. The clinical literature shows that all 4 of the currently available HMG-CoA reductase inhibitors can provide appropriate, moderate LDL cholesterol reductions within their recommended dosage ranges. For the majority of patients who need a 20–30% reduction in LDL cholesterol, fluvastatin 20 or 40 mg once daily provides the most cost-effective HMG-CoA therapy, expressed as cost of therapy per 1% LDL cholesterol reduction. For patients who need a >30% LDL cholesterol reduction, a high-dose HMG-CoA reductase inhibitor (e.g., simvastatin 20 or 40 mg/day) or a combination of a lower-dose HMG-CoA reductase inhibitor and a bile acid resin is the preferred initial therapy. Although a true cost-effectiveness analysis would incorporate morbidity and mortality data from clinical trials, analysis using intermediate end-points, such as LDL cholesterol reduction, suggests that fluvastatin is the preferred initial HMG-CoA reductase inhibitor for the treatment of moderate hyperlipidemia. (Am J Cardiol 1996;78(suppl 6A):32–41)

Efficacy and Tolerability of Lovastatin in 459 African-Americans With Hypercholesterolemia

A paucity of substantive data from clinical drug trials is available specifically evaluating the effects of therapy for hypercholesterolemia in African-Americans, even though a substantial number are candidates for medical advice and intervention for high blood cholesterol. The efficacy and safety of lovastatin in 459 African-Americans with hypercholesterolemia were studied in the Expanded Clinical Evaluation of Lovastatin study, a multicenter, double-blind, diet- and placebo-controlled trial. This trial involved 8,245 patients who were randomly assigned, regardless of race, to receive placebo or lovastatin at doses of 20 mg once daily, 40 mg once daily, 20 mg twice daily, or 40 mg twice daily for 48 weeks. Among African-Americans, lovastatin produced sustained, dose-related (p <0.001) decreases in low-density lipoprotein cholesterol (20% to 38%), total cholesterol (14% to 28%), and triglycerides (8% to 15%). From 75% to 96% of African-Americans treated with lovastatin achieved the National Cholesterol Education Program goal of low-density lipoprotein cholesterol <160 mg/dl, and from 33% to 71% achieved the goal <130 mg/dl. The safety profile of lovastatin in African-Americans was generally favorable. A relatively high incidence of creatine kinase levels greater than the upper limit of normal was observed in African-Americans during the study, i.e., 63% in the placebo group and similar levels in lovastatin treatment groups. Lovastatin is highly effective and generally well tolerated as therapy for primary hypercholesterolemia in African-Americans. (Am J Cardiol 1996;78:420–424)

College Students' Knowledge of Cardiovascular Disease: Implications for the Biology Teacher

EVERY 32 seconds an American dies from a cardiovascular disease (CVD). Despite this fact, many Americans believe that cancer is the number one killer in the United States. CVD causes the death of almost 1 million citizens each year, almost as many as cancer, accidents, pneumonia, influenza, AIDS and all other causes of death combined. In other words, almost 50 percent of all deaths in the United States can be attributed to some form of this disease. The American Heart Association (AHA) estimated that CVD would cost Americans $94.5 billion in 1990. Included in this estimate are expenditures for physician and nursing services, hospital and nursing home services, medicines and the loss of income due to disability (American Heart Association 1989). A number of factors have been identified which increase the probability of developing a CVD. These include such major risk factors as heredity, being male and the aging process. An individual has no control over such risks. However, there are other major risk factors over which an individual does have some control. These included cigarette smoking, hypertension and high levels of blood cholesterol which are not genetically predetermined. In addition there are several contributing factors; their precise roles have not been clearly established to date. These include diabetes, excessive weight, lack of exercise and the impact of emotional stress (Centers for Disease Control 1990a). The Bogalusa Heart Study, an epidemiologic investigation of 8000 children, demonstrated that the early stages of heart disease are in evidence at a young age, with many youngsters possessing one or more of the known CVD risk factors-hypertension, obesity and high cholesterol by the ages of 10 to 15. Thus, CVD prevention and health promotion efforts must begin at an early age. (Berenson et al. 1980). A number of educational programs stressing cardiovascular knowledge have been launched and evaluated on the elementary and high school level. (Furney 1989; Podell et al. 1975; Weinberg et al. 1984). These studies show that well designed programs are effective in increasing health knowledge. Additionally, some of these programs have elicited behavioral changes as well, especially with regard to food intake (Downey et al. 1988). In a review of school heart health education 10 years ago, it was concluded that American youth did not have sufficient knowledge to make sound decisions regarding the prevention of CVD (Iammarino et al. 1980). Since this review was published, the media have given much attention to the guidelines of the National Cholesterol Education Program (NCEP) for the prevention of CVD (Schucker et al. 1987). In addition, several recent Surgeon General Reports have been concerned with CVD risk factors (Public Health Service 1979; 1988; 1989). Since 1985, when the NCEP was initiated by the National Heart, Lung and Blood Institute, cholesterol screening and awareness of cholesterol levels have increased substantially in the U.S. (Centers for Disease Control 1990b). In 1989, the overall percentage of adults who reported ever having had their cholesterol level checked in the U.S. ranged from 48 percent to 64 percent. Cholesterol screenings were slightly higher among women. Younger persons (18-34 years of age), blacks and persons with less than 12 years of education were also less likely to have had their cholesterol level screened (Centers for Disease Control 1990b). Individuals with hypertension or obesity were more likely to have had their cholesterol level checked than were persons who did not report having these risk factors for CVD. NCEP goals for adults are for them to: 1. Have their cholesterol level measured at least once every five years. 2. Know their cholesterol levels. 3. Take steps to lower their cholesterol values if elevated. (The Expert Panel 1988). The level of cholesterol testing and awareness among the 18-34 age group is of particular concern, considering the evidence that atherosclerosis is present by early adulthood L. R. Krupka, Ph.D., professor of biology, and A. M. Vener, Ph.D., professor of sociology, teach at Michigan State University, East Lansing, Michigan 48824.

Expanded clinical evaluation of lovastatin (EXCEL) study results: III. Efficacy in modifying lipoproteins and implications for managing patients with moderate hypercholesterolemia

In the multicenter, double-blind EXCEL (Expanded Clinical Evaluation of Lovastatin) study the efficacy of lovastatin in modifying plasma lipids and lipoproteins in 8,245 participants with moderate primary hypercholesterolemia was evaluated. Patients were randomly assigned to 48 weeks of treatment with diet and placebo or diet and lovastatin 20 or 40 mg once a day, or 20 or 40 mg twice a day. At all of these dosages, lovastatin produced substantial dose-dependent reductions in low-densitylipoprotein (LDL)-cholesterol levels, averaging 24% (20 mg/day) to 40% (80 mg/day). The magnitude of the effect on this lipoprotein was further reflected by the percentage of patients who achieved National Cholesterol Education Program (NCEP) goals. In the absence of coronary artery disease (CAD) or two other CAD risk factors, the LDL-cholesterol goal of 4.14 mmol/L (160 mg/dL) was attained by 22% of patients in the placebo group and between 81% (20 mg/day) and 96% (80 mg/day) of those treated with lovastatin. For those with CAD or at least two other CAD risk factors, the LDLcholesterol goal of 3.36 mmol/L (130 mg/dL) was attained by 4% of placebo patients and between 38% (20 mg/day) and 83% (80 mg/day) of those treated with lovastatin. Lovastatin also increased high-density-lipoprotein cholesterol (7–10%) and decreased triglycerides (10–19%) in a dose-dependent manner. Thus, when used as an adjunct to a prudent diet, lovastatin produces favorable changes in the entire lipoprotein profile and is a highly effective agent for managing patients with primary hypercholesterolemia.