National Cholesterol Education Program Low-density Lipoprotein Cholesterol Research Articles

Lipid levels and low-density lipoprotein cholesterol goal attainment in diabetic patients: rosuvastatin compared with other statins in usual care

Objective: To compare change in low-density lipoprotein cholesterol (LDL-C) levels and National Cholesterol Education Program (NCEP) Adult Treatment Panel III LDL-C goal attainment in diabetic patients treated with rosuvastatin versus other statins in a large, managed care health plan. Research Design and Methods: This retrospective cohort analysis used medical and pharmacy claims linked to laboratory results from a commercial/MedicareAdvantage health plan. Study participants were ≥ 18 years of age, had a diagnosis of diabetes, were newly treated with statins from 8/1/03 to 2/28/05, and were considered at high risk for cardiovascular events as defined by NCEP guidelines. Subjects were continuously enrolled for 12 months pre-index and ≥ 30 days post-index, with variable follow-up until therapy discontinuation or end of health plan eligibility. Main Outcome Measures: Change in LDL-C from baseline, and attainment of NCEP LDL-C goal among patients not at goal before starting therapy. Results: A total of 3337 adult patients with diabetes were identified with new use of statin therapy during the identification period. A total of 9% (n = 301) started on rosuvastatin, 49.4% (n = 1,649) on atorvastatin, 20.7% (n = 690) on simvastatin, 7.0% (n = 234) on pravastatin, 11.7% (n = 391) on lovastatin and 2.2% (n = 72) on fluvastatin. After controlling for covariates, rosuvastatin patients experienced a significantly greater decrease in LDL-C from baseline (38.7%) than patients taking atorvastatin (34.2%) (p = 0.05), simvastatin (31.5%), pravastatin (24.2%), fluvastatin (26.3%) or lovastatin (24.9%) (p < 0.0001). Rosuvastatin users were significantly more likely to attain LDL-C goal than those taking the other statins (odds ratio: 0.44, 0.28, 0.14, 0.14, 0.19, respectively; p < 0.001). Predicted percent attaining goal was significantly greater for those taking rosuvastatin (87.3%) than for those taking atorvastatin (76.9%), simvastatin (68.7%), pravastatin (55.0%), lovastatin (55.3%) or fluvastatin (61.3%) (p < 0.001). Conclusion: For diabetic patients, rosuvastatin is more effective at reducing LDL-C levels and attaining NCEP ATP III LDL-C goal than other statins in real-world clinical practice.

The use of atorvastatin treatment in usual care environments: pooled analysis of six prospective, observational studies in 90,535 patients.

We investigated the pattern of use as well as the efficacy and safety of atorvastatin in unselected inpatients and outpatients in routine clinical practice in Germany. Six prospective, observational studies with a similar design were pooled. The studies lasted for up to 12 weeks and data from 90,535 patients (7,287 inpatients, 83,248 outpatients) were collected. The studies were performed in Germany in 2000 and 2001. Hospital or office-based physicians selected hyperlipemic patients with or without coronary heart disease (CHD) for once daily treatment with atorvastatin. Information on demographics, atorvastatin dosage, concomitant medication, concomitant diseases, cardiovascular risk factors, lipid profile as well as adverse events (AEs) and serious adverse events (SAEs) were obtained at 2-3 visits and descriptively analyzed. Absolute and relative changes in lipid parameters, percentage of patients with low-density lipoprotein cholesterol (LDL-C) values within target ranges according to the National Cholesterol Education Program (NCEP) criteria, and frequencies of AEs. On average, patients were treated for 22.4 days (inpatients) and 106.0 days (outpatients), respectively. The overall mean atorvastatin dose of 14.4 mg/day was well tolerated by a heterogeneous patient population with a variety of concomitant diseases and medications. Overall, 0.8% of patients suffered from one or more AEs, 0.6% were considered as treatment-related. The corresponding figures for SAEs and treatment-related SAEs were 0.1% (131 patients) and 0.01% (13 patients), respectively. Subgroup analyses did not reveal a particular safety concern in any subgroup. In total, 99% of patients judged the tolerability of atorvastatin as very good or good. The mean percentages of reduction in LDL-C at the final visit ranged between 24.8% and 28.5%. Overall, 26.3% of patients reached the NCEP LDL-C goal compared to 4.9% at baseline. Inpatients achieved the target range for LDL-C more frequently than outpatients (35.3% vs 25.6%). An underuse of atorvastatin titration in clinical practice in Germany was apparent, particularly in outpatients. The use of atorvastatin in usual care environments is effective and safe. There is a gap between treatment guidelines and clinical practice in Germany as reflected by the number of patients outside the target range for LDL-C. A major opportunity exists to increase the number of patients who achieve LDL-C target ranges by appropriate dose titration and/or giving patients a higher initial dose. Available guidelines need to be implemented more stringently.

Efficacy and safety of simvastatin in Asian and non-Asian coronary heart disease patients: a comparison of the GOALLS and STATT studies

SUMMARYBackground: Asians are thought to be more responsive to the lipid-lowering effects of statins than non-Asians although there are no head-to-head trials that examine this perception.Objective: To compare the results of the GOALLS and STATT studies that used similar titrate-to-goal protocols with 20 mg up to 80 mg simvastatin in Asian and non-Asian coronary heart disease (CHD) patients.Methods: GOALLS (N = 198; included non-Asians and Asians) and STATT (N = 133; included Asians only) were both multi-center, open-label 14-week studies in CHD patients with serum low density lipoprotein cholesterol (LDL-C) levels 115 mg/dL–180 mg/dL and triglycerides (TG) levels ≤ 400 mg/dL. Simvastatin was titrated from 20 mg/day up to 80 mg/day in order to achieve the National Cholesterol Education Program (NCEP) LDL-C target ≤ 100 mg/dL. The primary efficacy variable was the percentage of patients attaining the NCEP LDL-C target at Week 14. Secondary endpoints included proportion of patients achieving the European Society of Cardiology/European Atherosclerosis Society/European Society of Hypertension (European) LDL-C target ≤ 115 mg/dL at Week 14 and percentage change in lipid parameters. Safety and tolerability were assessed by monitoring adverse experiences and safety laboratory tests. Fifteen Asian patients were part of the GOALLS cohort and their data were compared separately with results of non-Asians from GOALLS and Asians from the STATT study.Results: After 14 weeks of simvastatin treatment, 87.1% of GOALLS non-Asians, 85.7% of GOALLS Asians, and 78.2% of STATT patients attained the NCEP LDL-C target. At Week 14, 94.4%, 92.9%, and 91.7% of the GOALLS non-Asians, GOALLS Asians, and STATT patients achieved the European LDL-C target, respectively. The average treatment doses to attain NCEP and European targets were comparable among groups. The percentage reductions in lipid parameters from baseline to week 14 were similar among groups except, changes in high density lipoprotein cholesterol and apolipoprotein A-I favored Asian subjects. There was also a greater reduction in TG in the STATT study, but this was not consistent with TG reductions experienced by Asians in the GOALLS study. In both studies, simvastatin was generally well tolerated by all patients across the dosage range of 20 mg–80 mg. No cases of rhabdomyolysis or myopathy were reported in either study.Conclusions: A great majority of CHD patients is able to achieve LDL-C treatment goals (up to 90%) on simvastatin regardless of racial background. Simvastatin treatment at doses of 20 mg–80 mg is well-tolerated in Asian and non-Asian CHD patients. This side-by-side comparison provides evidence that Asian and non-Asian CHD populations respond similarly to comparable doses of simvastatin.

Development and validation of the hyperlipidemia: attitudes and beliefs in treatment (HABIT) survey for physicians.

Many patients treated with lipid-lowering medications in clinical practice do not achieve targeted National Cholesterol Education Program (NCEP) goals for low-density lipoprotein cholesterol (LDL-C), despite the proven efficacy of these medications. Understanding physician attitudes and beliefs about treating patients to goal may be useful in improving patient care and ensuring that all patients receive the benefits of treatments shown to be optimal in clinical trials. To develop a theoretically based, and statistically reliable and valid survey instrument for measuring the attitudes and beliefs of physicians toward hyperlipidemia and its treatment, including treatment of patients to goal. To determine whether the attitudes measured were associated with physician intentions to treat patients to LDL-C goal. We assessed the reliability of the instrument through an examination of the internal consistency and factor structure of the constructs. Validity was assessed through zero-order correlations among the constructs and the relationship between the constructs and an intent to treat to goal case study. Internal consistency scores for the 8 constructs ranged from 0.48 to 0.75. Factor loadings indicated that the individual items belonged to their respective constructs, as hypothesized. The predictive validity of the instrument was demonstrated by significant relationships between 5 of the 8 attitudinal constructs and an intent to treat to goal case study. The HABIT physician survey is the first validated instrument covering a broad set of attitudes about the treatment of hyperlipidemia that are both theoretically and empirically linked to physician intent to treat to NCEP LDL-C goal.

An open-label, uncontrolled, prospective study of the effects of atorvastatin 10 mg on low-density lipoprotein cholesterol levels in chinese adults with coronary artery disease and hypercholesterolemia

Background: A high level of low-density lipoprotein cholesterol (LDL-C) is a major risk factor for coronary artery disease (CAD). Evidence shows that lowering LDL-C improves the outcomes of patients with CAD. Atorvastatin is an established drug for the treatment of hypercholesterolemia. Objective: The purpose of this open-label, uncontrolled, prospective study was to assess the effectiveness of treatment with atorvastatin 10 mg/d for 18 weeks in achieving the target level of LDL-C (<2.6 mmol/L [<100 mg/dL]) established by the National Cholesterol Education Program (NCEP) (United States) for patients with established CAD and hypercholesterolemia. Methods: Chinese patients with CAD, hypercholesterolemia (defined as a baseline LDL-C level between 3.4 and 5.2 mmol/L [131–201 mg/dL]), and body mass index <30 kg/m 2 were eligible. Atorvastatin 10 mg/d was given to each patient for 18 weeks. Lipid profiles were checked at 6, 12, and 18 weeks. To assess the extent of the achievement of NCEP LDL-C target levels, patients were categorized into 3 groups retrospectively according to baseline LDL-C level: group 1, 3.4 to 4.0 mmol/L (131–154 mg/dL); group 2, 4.01 to 4.6 mmol/L (155–178 mg/dL); and group 3, 4.61 to 5.2 mmol/L (179–201 mg/dL). Results: A total of 63 patients (50 men, 13 women; mean age, 64.3 years) were enrolled. Significant decreases in total cholesterol (31.3% at week 18), LDL-C (42.9% at week 18), and triglycerides (21.8% at week 18) from baseline levels were found at 6, 12, and 18 weeks of treatment ( P < 0.001 for all). The changes in high-density lipoprotein cholesterol levels were nonsignificant. In group 1, 83.3% of patients met the target level of LDL-C; group 2, 87.5%; group 3, 37.5%; groups 1 and 2 combined, 85.2%. Atorvastatin 10 mg/d was well tolerated. Clinical adverse events were mild and transient; no severe adverse events were reported. One patient (1.6%) developed an elevated alanine aminotransferase level and withdrew. Sixty-two of 63 patients (98.4%) completed the study. Conclusions: In this group of Chinese patients with CAD and hypercholesterolemia treated with atorvastatin 10 mg/d for 18 weeks, 85.2% of patients with a baseline LDL-C level of 3.4 to 4.6 mmol/L achieved the NCEP target LDL-C level of <2.6 mmol/L, suggesting that atorvastatin 10 mg/d is efficacious in preventing secondary CAD.

Treatment with Atorvastatin to the National Cholesterol Educational Program Goal Versus 'Usual' Care in Secondary Coronary Heart Disease Prevention

SummaryBackground: Atorvastatin is very effective in reducing plasma low-density lipoprotein cholesterol (LDL-C) levels. However, there is no long-term survival study that evaluated this statin.Patients−Methods: To assess the effect of atorvastatin on morbidity and mortality (total and coronary) of patients with established coronary heart disease (CHD), 1600 consecutive patients were randomised either to atorvastatin or to 'usual' medical care. The dose of atorvastatin was titrated from 10 to 80mg/day, in order to reach the National Cholesterol Education Program (NCEP) goal of LDL-C <100mg/dl (2.6mmol/l). All patients were followed up for a mean period of 3 years.Main Outcome Measures: Primary endpoints of the study were defined as death, non-fatal myocardial infarction, unstable angina, congestive heart failure, revascularisation (coronary morbidity) and stroke. Secondary endpoints were the safety and efficacy of the hypolipidaemic drugs as well as the cost-effectiveness of atorvastatin.Results: The mean dosage of atorvastatin was 24 mg/day. This statin reduced total cholesterol by 36%, LDL-C by 46%, triglycerides by 31%, and non-high-density lipoprotein cholesterol (non-HDL-C) by 44%, while it increased HDL-C by 7%; all these changes were significant. The NCEP LDL-C and non-HDL-C treatment goals were reached by 95% (n = 759) and 97% (n = 776), respectively, of patients on atorvastatin. Only 14% of the 'usual' care patients received any hypolipidaemic drugs throughout the study and 3% of them reached the NCEP LDL-C treatment goal. The cost per quality-adjusted life-year gained with atorvastatin was estimated at $US 8350. During this study 196 (24.5%) CHD patients on 'usual' care had a CHD recurrent event or died vs. 96 (12%) CHD patients on atorvastatin; risk ratio (RR) 0.49, confidence interval (CI) 0.27-0.73, p < 0.0001. In detail, atorvastatin reduced, in comparison to 'usual' care, total mortality (RR 0.57, CI 0.39-0.78, p = 0.0021), coronary mortality (RR 0.53, CI 0.29-0.74, p = 0.0017), coronary morbidity (RR 0.46, CI 0.25-0.71, p < 0.0001), and stroke (RR 0.53, CI 0.30-0.82, p = 0.034). All subgroups of patients (women, those with diabetes mellitus, arterial hypertension, age 60 to 75 years, congestive heart failure, recent unstable angina or prior revascularisation) benefited from treatment with atorvastatin. Withdrawal of patients because of side-effects from the atorvastatin group was low (0.75%) and similar to that of the 'usual' care group (0.4%).Conclusions: Long-term treatment of CHD patients with atorvastatin to achieve NCEP lipid targets significantly reduces total and coronary mortality, coronary morbidity and stroke, in comparison to patients receiving 'usual' medical care. Treatment with atorvastatin is well tolerated and cost-effective.

Lipid Treatment Assessment Project (L-TAP) Study : a survey in 13 cities in Indonesia to evaluate the percentages of dyslipidemic patients achieving NCEP LDL-C target goals after treatment

Clinical trials have demonstrated significant benefit from low density lipoprotein cholesterol (LDL-C) lowering for primary and secondary prevention of cardiovascular disease. In the US, it is well recognized that a substantial number of hypercholesterolemic patients were not treated to the LDL-C goals recommended by the National Cholesterol Education Program (NCEP) guidelines. In 1996, the Indonesian Heart Association (PERKI) has issued guidelines recommending goals for screening and lipid treatment in Indonesia adopted from NCEP guidelines; however, the frequency of undertreatment in Indonesia is not known. The objective of this study was to determine the percentage of patients treated with lipid-lowering therapy who reached LDL-C goals as defined by NCEP guidelines in routine clinical practice. This was a cross-sectional survey targeted physicians who regularly treated dyslipidemic patients in 13 cities in Indonesia. Participating doctors were asked on their awareness of NCEP guidelines and to complete the case record form (CRF) of the enrolled patients. One-hundred and eighty-eight (188) out of four hundreds (400) physicians who were invited, have participated in this study. Among the evaluable 1420 CRF, 1082 patients received statins, 301 used fibrates, 14 patients used combination drugs, and 23 others received non-drug treatments only. Success rates on achieving target LDL-C in low-risk, high-risk, and CHD groups were 73.0 %, 43.6 %, and 14.8 %, respectively. Overall success rate in patients using statins was 55.1 %, while in low-risk group, high-risk group, and CHD patients, the success rates with statin were 77.8%, 50.1%, and 18.6 %, respectively. Atorvastatin showed the highest success rate (77.4 %) if compared to other statins. Only 14 % of physicians were knowledgeable about the NCEP goals. Conclusion : A large number of dyslipidemic patients who were on lipid-lowering therapy were not achieving the recommended LDL-C target levels. Success rates were lower in CHD patients and high risk group. Atorvastatin seemed more effective in lowering the LDL-C to target levels. There are still many physicians in Indonesia who do not aware about the NCEP guidelines and LDL-C treatment goals. (Med J lndones 2001; 10: 103-9)Keywords: lipid treatment assessment project (L-TAP), dyslipidemia, coronary heart disease (CHD) risk, routine practice

Relation of coronary artery calcium identified by electron beam tomography to serum lipoprotein levels and implications for treatment

This study was designed to determine whether the National Cholesterol Education Program (NCEP) lipid guidelines accurately identify subclinical atherosclerosis and whether low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C) levels are related to the extent and prematurity of coronary artery disease (CAD) as determined by electron beam tomography (EBT). Out of personal concern for CAD risk, 930 consecutive asymptomatic subjects, without clinical CAD and on no lipid-lowering agents, underwent EBT. Calcium score and percentile were correlated with total cholesterol (TC), LDL-C, HDL-C, triglycerides, and demographic parameters. A calcium score of >0 (EBT+) was found in 55% of patients; 45% of patients had a 0 score (EBT−). Mean age (58.0 ± 10.5 vs 49.3 ± 9.7 years, p = 0.0001), TC (218 ± 39 vs 211 ± 41 mg/dl, p = 0.006), LDL-C (136 ± 36 vs 127 ± 27 mg/dl, p = 0.005), and TC/HDL-C (4.6 ± 1.4 vs 4.2 ± 1.5, p = 0.0001) were significantly higher and HDL-C (52.2 ± 17.6 vs 55.4 ± 19.3 mg/dl, p = 0.008) lower in the EBT+ compared with EBT− group. In the EBT+ group, 75.1% of subjects had LDL-C <160 mg/dl and would not be advised to use lipid-lowering medications according to NCEP guidelines. In subjects with LDL-C <160 mg/dl, 51.8% of subjects were EBT+, as were 46.1% of those with LDL-C <100 mg/dl. There were no significant differences in the calcium scores throughout the entire range of all lipid parameters; calcium percentiles were virtually identical within lipid value subgroups. We conclude that asymptomatic patients with EBT-defined subclinical atherosclerosis are not reliably identified by NCEP guidelines, and TC, LDL-C, HDL-C, TC/HDL-C, and triglyceride levels do not correlate with either the extent or prematurity of calcified plaque burden.

The lipid treatment assessment project (L-TAP): a multicenter survey to evaluate the percentages of dyslipidemic patients receiving lipid-lowering therapy and achieving low-density lipoprotein cholesterol goals.

To determine the percentage of patients in the multicenter Lipid Treatment Assessment Project receiving lipid-lowering therapy who are achieving low-density lipoprotein cholesterol (LDL-C) goals as defined by National Cholesterol Education Program (NCEP) guidelines. Adult patients with dyslipidemia, who had been receiving the same lipid-lowering therapy for at least 3 months, were assessed at investigation sites. Lipid levels were determined once in each patient at the time of enrollment. The primary end point was the success rate, defined as the proportion of patients who achieved their LDL-C target level as specified by NCEP guidelines. A total of 4888 patients from 5 regions of the United States were studied. Of these, 23% had fewer than 2 risk factors for coronary heart disease (CHD) and no evidence of CHD (low-risk group), 47% had 2 or more risk factors and no evidence of CHD (high-risk group), and 30% had established CHD. Overall, only 38% of patients achieved NCEP-specified LDL-C target levels; success rates were 68% among low-risk patients, 37% among high-risk patents, and 18% among patients with CHD. Drug therapy was significantly (P< or =.001) more effective than nondrug therapy in all patient risk groups. However, many patients treated with lipid-lowering drugs did not achieve LDL-C target levels. Large proportions of dyslipidemic patients receiving lipid-lowering therapy are not achieving NCEP LDL-C target levels. These findings indicate that more aggressive treatment of dyslipidemia is needed to attain goals established by NCEP guidelines.