Low-density Lipoprotein Cholesterol Goal Attainment Rates Research Articles

Impact of team-based health information technology to improve low-density lipoprotein cholesterol goal attainment after acute coronary syndrome hospital discharge: a single-center experience

Abstract Objectives The reduction in circulating low-density lipoprotein cholesterol (LDL-C) is the primary aim of lipid-lowering therapies as a method of atherosclerotic cardiovascular disease risk reduction. Although guidelines recommended strictly control of low-density lipoprotein cholesterol (LDL-C) below 70 mg/dL by high-intensity statin therapy in patients with acute coronary syndrome (ACS), the LDL-C target goal is not often attained. Health information technology (HIT) with information integration, decision making algorithm, is being applied on chronic illness care. Purpose We aimed to perform a qualitative review of the impact of HIT interventions on lipid management and LDL-C goal attainment in patients after ACS hospital discharge. Method Consecutive ACS patients with dyslipidemia (LDL-C >100 mg/dL) at discharge between January 2018 and December 2021 in a tertiary medical center were retrospectively reviewed. The LDL-C <70 mg/dL is defined as target. The team-based approach quality improvement program that consisted of patient education and high-intensity statin initiation before discharge, outpatient clinics with periodic laboratory follow-up, titration of lipid-lowering agents, and system-level interventions that involve database monitoring and outreach by centralized care teams, was introduced in October 2018. Electronical medical records including the medications, laboratory data at discharge and within 1 year were compared, before and after initiation of HIT system. Result A total 2248 ACS patients were included. The LDL-C <70 mg/dL attainment rate (36.52%, 53.57%, 59.22%, 62.18% in 2018, 2019, 2020, and 2021) and medium serum LDL-C level (80.5 mg/dL, 68 mg/dL, 65 mg/dL, 64 mg/dL in 2018, 2019, 2020, and 2021) significantly improved within 6 months after initiation of the team-based integrated intervention with assisted by HIT (2018 as the reference, all p<0.001). The LDL-C goal attainment rate at 12-month kept increasing gradually (53.80%, 61.82%, 64.21%, in 2019, 2020, 2021, p= 0.019). Most of the population initiated with moderate-intensity statin in 2018 (76.24%, 20.92%, 10.95%, 6.41% in 2018, 2019, 2020, and 2021), then switched to a high-intensity statin after initiation of the program (0.57%, 63.67%, 72.41%, 84.44% in 2018, 2019, 2020, and 2021) (2018 as the reference, all p<0.001), while the adverse event rates including hepatotoxicity and rhabdomyolysis remained similarly low. Conclusion Our results confirmed that multifaceted intervention with HIT assisted multidisciplinary approach could substantially improve LDL-C goal attainment in post-ACS patients. There was a direct relationship between high-intensity statins and LDL-C goal attainment, without significant increase of adverse events.LDL-C goal attainment rate and levelLower lipid treatment and adverse event

Lipid goal attainment in diabetes mellitus patients after acute coronary syndrome: a subanalysis of Dyslipidemia International Study II-China

BackgroundLipid management with a low-density lipoprotein cholesterol (LDL-C) goal of < 1.4 mmol/L is recommended for patients with acute coronary syndrome (ACS) and diabetes mellitus (DM) due to a high risk for adverse cardiovascular events. This study evaluated the lipid-lowering treatment (LLT) pattern and the LDL-C goal attainment rate in this special population.MethodsDM patients were screened from the observational Dyslipidemia International Study II-China study which assessed LDL-C goal attainment in Chinese ACS patients. The baseline characteristics between the LLT and no pre-LLT groups were compared. The proportions of patients obtaining LDL-C goal at admission and at 6-months, the difference from the goal, and the pattern of the LLT regimen were analyzed.ResultsTotally 252 eligible patients were included, with 28.6% taking LLT at admission. Patients in the LLT group were older, had a lower percentage of myocardial infarction, and had decreased levels of LDL-C and total cholesterol compared to those in the no pre-LLT group at baseline. The overall LDL-C goal attainment rate was 7.5% at admission and increased to 30.2% at 6 months. The mean difference between the actual LDL-C value and LDL-C goal value dropped from 1.27 mmol/L at baseline to 0.80 mmol/L at 6 months. At 6 months, 91.4% of the patients received statin monotherapy, and only 6.9% received a combination of statin and ezetimibe. The atorvastatin-equivalent daily statin dosage was moderate during the study period.ConclusionThe low rate of lipid goal attainment observed was in line with the outcomes of other DYSIS-China studies.

Risk stratification and low-density lipoprotein cholesterol goal attainment rates in patients with very high-risk or extreme high-risk atherosclerotic cardiovascular diseases regarding three guidelines

Objective: To explore the differences of risk stratification of very high-risk or extreme high-risk atherosclerotic cardiovascular diseases (ASCVD) and the attainment rates of low-density lipoprotein cholesterol (LDL-C) management targets evaluated by three different criteria, and the causal attributions of these differences. Methods: Patients with ASCVD were consecutively enrolled from January 1 to December 31 in 2019, and were evaluated for very high-risk or extreme high-risk and LDL-C goal attainment rates with 2018 American guideline on the management of blood cholesterol (2018AG), 2019 China Cholesterol Education Program (CCEP) Expert Advice for the management of dyslipidemias (2019EA) and 2020 Chinese expert consensus on lipid management of very high-risk ASCVD patients(2020EC), respectively. The causal attributions of the differences in attainment rates were analyzed as well. Results: A total of 1 864 ASCVD patients were included in this study. According to 2018AG, 2019EA and 2020EC, the proportions of the patients with very high-risk or extreme high-risk were 59.4%, 90.7%, and 65.6%, respectively. The absolute LDL-C target attainment rates were 37.2%, 15.7%, and 13.7%, respectively, the differences between each two rates were statistically significant (all P<0.001). As to the differences in attainment rates between 2020EC and 2018AG, 61.5% were due to the different LDL-C goal attainment values and 38.5% were caused by the different risk stratifications, while for the differences between 2020EC and 2019EA attainment rates, different LDL-C goal attainment values were responsible for 13.2%, and different risk stratifications were responsible for 86.8% of the differences. Conclusions: There are significant differences in the proportions and LDL-C attainment rates among the three different criteria for very high-risk or extreme high-risk ASCVD. 2020EC showed a moderate proportion of patients with extreme high-risk, and had the lowest LDL-C attainment rate. The differences between 2020EC and 2018AG are mainly due to the LDL-C target values, and the differences between 2020EC and 2019EA are mainly caused by the risk stratifications.

Reinforcing adherence to lipid-lowering therapy after an acute coronary syndrome: A pragmatic randomized controlled trial

Background and aimsAchieving the low-density lipoprotein cholesterol (LDL-C) goal following an acute coronary syndrome (ACS) is a milestone often missed due to suboptimal adherence to secondary prevention treatments. Whether improved adherence could result in reduced LDL-C levels is unclear. We aimed to evaluate whether an educational-motivational intervention increases long-term lipid-lowering therapy (LLT) adherence and LDL-C goal attainment rate among post-ACS patients. MethodsIDEAL-LDL was a parallel, two-arm, single-center, pragmatic, investigator-initiated randomized controlled trial. Hospitalized patients for ACS were randomized to a physician-led integrated intervention consisting of an educational session at baseline, followed by regular motivational interviewing phone sessions or usual care. Co-primary outcomes were the LLT adherence (measured by Proportion of Days Covered (PDC); good adherence defined as PDC>80%), and LDL-C goal (<70 mg/dl or 50% reduction from baseline) achievement rate at one year. ResultsIn total, 360 patients (mean age 62 years, 81% male) were randomized. Overall, good adherence was positively associated with LDL-C goal achievement rate at one year. Median PDC was higher in the intervention group than the control group [0.92 (IQR, 0.82–1.00) vs. 0.86 (0.62–0.98); p = 0.03] while the intervention group had increased odds of good adherence (odds ratio: 1.76 (95% confidence interval 1.02 to 2.62; p = 0.04). However, neither the LDL-C goal achievement rate (49.6% in the intervention vs. 44.9% in the control group; p = 0.49) nor clinical outcomes differed significantly between the two groups. ConclusionsΑ multifaceted intervention improved LLT adherence in post-ACS patients without a significant difference in LDL-C goal attainment.

LDL-cholesterol change and goal attainment following statin intensity titration among Asians in primary care: a retrospective cohort study

BackgroundClinical trials have demonstrated that either initiating or up-titrating a statin dose substantially reduce Low-Density Lipoprotein-Cholesterol (LDL-C) levels. However, statin adherence in actual practice tends to be suboptimal, leading to diminished effectiveness. This study aims to use real-world data to determine the effect on LDL-C levels and LDL-C goal attainment rates, when selected statins are titrated in Asian patients.MethodsA retrospective cohort study over a 5-year period, from April 2014 to March 2019 was conducted on a cohort of multi-ethnic adult Asian patients with clinical diagnosis of Dyslipidaemia in a primary care clinic in Singapore. The statins were classified into low-intensity (LI), moderate-intensity (MI) and high-intensity (HI) groups according to the 2018 American College of Cardiology and American Heart Association (ACC/AHA) Blood Cholesterol Guidelines. Patients were grouped into “No statin”, “Non-titrators” and “Titrators” cohorts based on prescribing patterns. For the “Titrators” cohort, the mean percentage change in LDL-C and absolute change in LDL-C goal attainment rates were computed for each permutation of statin intensity titration.ResultsAmong the cohort of 11,499 patients, with a total of 266,762 visits, there were 1962 pairs of LDL-C values associated with a statin titration. Initiation of LI, MI and HI statin resulted in a lowering of LDL-C by 21.6% (95%CI = 18.9–24.3%), 28.9% (95%CI = 25.0–32.7%) and 25.2% (95%CI = 12.8–37.7%) respectively. These were comparatively lower than results from clinical trials (30 to 63%). The change of LDL-C levels due to up-titration, down-titration, and discontinuation were − 12.4% to − 28.9%, + 13.2% to + 24.6%, and + 18.1% to + 32.1% respectively. The improvement in LDL-C goal attainment ranged from 26.5% to 47.1% when statin intensity was up-titrated.ConclusionIn this study based on real-world data of Asian patients in primary care, it was shown that although statin titration substantially affected LDL-C levels and LDL-C goal attainment rates, the magnitude was lower than results reported from clinical trials. These results should be taken into consideration and provide further insight to clinicians when making statin adjustment recommendations in order to achieve LDL-C targets in clinical practice, particularly for Asian populations.

PCSK9 inhibition in patients with and without prior myocardial infarction or ischemic stroke: A pooled analysis of nine randomized-controlled studies of alirocumab

Patients with prior cardiovascular events are at very high risk of recurrent events and may benefit from low-density lipoprotein cholesterol (LDL-C) lowering beyond that achieved with maximally tolerated statins. To assess potential differences between the efficacy and safety of the proprotein convertase subtilisin/kexin type 9 inhibitor, alirocumab, in patients with vs without prior myocardial infarction (MI)/ischemic stroke. Data (n=4880) were pooled from nine ODYSSEY phase 3 trials of alirocumab 75/150mg or 150mg every 2weeks, mostly on background statins±other lipid-lowering therapies. Analyses were performed according to statin status, alirocumab dose, and control (placebo or ezetimibe). Baseline LDL-C, non-high-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and apolipoprotein B levels were lower and lipoprotein(a) higher in patients with than without prior MI/ischemic stroke. LDL-C levels were reduced from baseline to week 24 in patients with (51.1%-62.9%) and without (43.6%-58.3%) prior MI/ischemic stroke, with no significant interaction between prior MI/ischemic stroke status and LDL-C-lowering efficacy of alirocumab vs controls. Alirocumab significantly reduced other lipid/lipoproteins (including lipoprotein[a]) similarly in patients with/without MI/ischemic stroke. Week 24 LDL-C goal attainment rates for subgroups with/without prior MI/ischemic stroke on background statins were 74.1%-84.8% and 63.7%-74.7%, respectively. The safety profile of alirocumab was generally similar regardless of prior MI/ischemic stroke status. Alirocumab significantly reduced LDL-C and other atherogenic lipids/lipoproteins in patients with prior MI/ischemic stroke, and the majority of this very high cardiovascular risk population achieved LDL-C goals; efficacy and safety results were similar in patients without prior MI/ischemic stroke.

Blood pressure and low-density lipoprotein cholesterol control status in Chinese hypertensive dyslipidemia patients during lipid-lowering therapy

ᅟThe present study comprised 17,096 Chinese hypertensive dyslipidemia patients who received lipid-lowering treatment for > 3 months in order to investigate blood pressure (BP) as well as low-density lipoprotein cholesterol (LDL-C) goal attainment rates in Chinese hypertensive dyslipidemia patients on antidyslipidemia drugs. The factors that interfered with BP, or BP and LDL-C goal attainment rates and antihypertensive treatment patterns, were analyzed. In total, 89.9% of the 17,096 hypertensive dyslipidemia patients received antihypertensive medications mainly consisting of a calcium channel blocker (CCB) (48.7%), an angiotensin receptor antagonist (ARB) (25.4%) and an angiotensin-converting enzyme inhibitor (ACEI) (15.1%). In cardiology departments, usage rates of β-blockers (19.2%) were unusually high compared to other departments (4.0–8.3%), whereas thiazide diuretics were prescribed at the lowest rate (0.3% vs 1.2–3.6%). The overall goal attainment rates for combined BP and LDL-C as well as BP or LDL-C targets were 22.9, 31.9 and 60.1%, respectively. The lowest BP, LDL-C and BP combined with LDL-C goal attainment rates were achieved in endocrine departments (19.9, 48.9 and 12.4%, respectively). Combination therapies showed no benefit particularly for BP goal achievement. A multivariate logistic regression analysis showed that age < 65 years, alcohol consumption, diabetes, coronary heart disease (CHD), cerebrovascular disease (CVD), chronic kidney disease (CKD), body mass index (BMI) ≥ 28 kg/m2 and not achieving total cholesterol goals were independent predictors for achieving BP, LDL-C or combined BP and LDL-C goals. In summary, the BP and LDL-C goal achievement rates in Chinese dyslipidemia outpatients with hypertension were low, especially in endocrine departments. Combination therapies were not associated with improvement of the goal achievement rates.Trial registrationClinical trial registration number NCT01732952

The efficacy and safety of co-administration of fimasartan and rosuvastatin to patients with hypertension and dyslipidemia

BackgroundHypertension and dyslipidemia are major risk factors of cardiovascular disease (CVD) events. The objective of this study was to evaluate the efficacy and safety of the co-administration of fimasartan and rosuvastatin in patients with hypertension and hypercholesterolemia.MethodsWe conducted a randomized double-blind and parallel-group trial. Patients who met eligible criteria after 4 weeks of therapeutic life change were randomly assigned to the following groups.1) co-administration of fimasartan 120 mg/rosuvastatin 20 mg (FMS/RSV), 2) fimasartan 120 mg (FMS) alone 3) rosuvastatin 20 mg (RSV) alone. Drugs were administered once daily for 8 weeks.ResultsOf 140 randomized patients, 135 for whom efficacy data were available were analyzed. After 8 weeks of treatment, the FMS/RSV treatment group showed greater reductions in sitting systolic (siSBP) and diastolic (siDBP) blood pressures than those in the group receiving RSV alone (both p < 0.001). Reductions in siSBP and siDBP were not significantly different between the FMS/RSV and FMS alone groups (p = 0.500 and p = 0.734, respectively). After 8 weeks of treatment, FMS/RSV treatment showed greater efficacy in percentage reduction of low-density lipoprotein cholesterol (LDL-C) level from baseline than that shown by FMS alone treatment (p < 0.001). The response rates of siSBP with FMS/RSV, FMS alone, and RSV alone treatments were 65.22, 55.56, and 34.09%, respectively (FMS/RSV vs. RSV, p = 0.006). The LDL-C goal attainment rates with FMS/RSV, RSV alone, and FMS alone treatments were 80.43%, 81.82%, and 15.56%, respectively (FMS/RSV vs. FMS, p < 0.001). Incidence of adverse drug reactions with FMS/RSV treatment was 8.33%, which was similar to those associated with FMS and RSV alone treatments.ConclusionThis study demonstrated that the co-administration of fimasartan and rosuvastatin to patients with both hypertension and hypercholesterolemia was efficacious and safe.Trial registrationClinicalTrials.gov Identifier: NCT02166814. 16 June 2014

Status of cholesterol goal attainment for the primary and secondary prevention of atherosclerotic cardiovascular disease in dyslipidemia patients receiving lipid-lowering therapy: DYSIS-China subgroup analysis

To analyze the current status of cholesterol goal attainment for the primary and secondary prevention of cardiovascular disease in dyslipidemia patients using data from the DYSIS-China study. Based on criteria defined in the 2014 China Cholesterol Education Program (CCEP) and the 2007 Chinese guidelines for the prevention and treatment of dyslipidemia in adults, 25 317 dyslipidemia patients enrolled in the DYSIS-China study (from March 2012 to October 2012) were stratified to the atherosclerotic cardiovascular disease(ASCVD) primary prevention and secondary prevention groups. The total cholesterol (TC) target goals were <3.11, 4.14, 5.18, and 6.22 mmol/L, respectively, and the low-density lipoprotein cholesterol (LDL-C) therapeutic goals were less than 1.8, 2.6, 3.4, and 4.1 mmol/L, respectively, for the very high-risk, high-risk, moderate-risk, and low-risk patients in the primary prevention group. The TC targets for the very high-risk and high-risk patients were <3.11 and <4.14 mmol/L, respectively, and the LDL-C targets were <1.8 and <2.6 mmol/L, respectively, in the secondary prevention group. The TC and LDL-C goal attainment rates were calculated for the different risk groups according to the targets values. Totally, 71.09% (n=18 000) of the dyslipidemia patients were grouped into very high and high risk groups, 51.76% (n=13 104) and 48.24% (n=12 213) patients were stratified to primary and secondary prevention of ASCVD. The LDL-C and TC goal attainment rates for the secondary prevention group were 33.09%(4 041 cases) and 21.05% (2 571 cases), respectively. The LDL-C and TC goal attainment rates for the primary prevention group were 52.40% (6 866 cases) and 42.06% (5 511 cases), respectively. Multivariate logistic regression analysis showed that diabetes mellitus(OR=5.75, 4.15, P<0.05), coronary heart disease(OR=5.70, 3.58, P<0.001), and peripheral arterial disease(OR=2.42, 1.49, P<0.05) were risk factors for failure to achieve TC and LDL-C goals, respectively. Despite the widespread application of the 2014 CCEP and 2007 Chinese dyslipidemia guidelines, LDL-C goal attainment among secondary and primary prevention patients remains suboptimal in China. More rigorous guideline adherence is therefore required to increase the LDL-C and TC goal attainment rates and improve the long-term cardiovascular outcomes in Chinese dyslipidemia patients.

Unsatisfactory LDL-cholesterol Goal Attainment Rate in Type 2 Diabetic Patients

Background: Type 2 diabetic patients have a higher cardiovascular risk than people without diabetes, and tight lipid level control is recommended to reduce the cardiovascular risk. We attempted to examine the factors associated with the low-density lipoprotein-cholesterol (LDL-C) control attainment rate and the actual LDL-C control attainment rate in type 2 diabetic patients in Taiwan. Methods: This cross-sectional study of LDL-C control in type 2 diabetic patients collected data from 10,000 patients. The LDL-C goal was ＜ 100 mg/dL for all diabetic patients. Multivariate logistic regression was performed to evaluate factors associated with the attainment rate of LDL-C control. Results: 46.63% of the diabetic patients attained the LDL-C goal. Young and female patients were less successful in reaching the LDL-C goal than other participants. 51.07% of the type 2 diabetic patients with cardiovascular comorbidities attained an LDL-C ＜ 100 mg/dL, and nearly 11% of those patients attained an LDL-C ＜ 70 mg/dL. Conclusions: The LDL-C goal attainment rate in type 2 diabetic patients is unsatisfactory in clinical practice, especially in patients with cardiovascular comorbidities. Young and female patients had a lower attainment rate than other participants.

Gender differences in lipid goal attainment among Chinese patients with coronary heart disease: insights from the DYSlipidemia International Study of China

Despite great advances in lipid-lowering therapy, the gender-based disparities in lipid goal success among Chinese coronary heart disease (CHD) patients receiving lipid-lowering treatment remained uncharacterized. Furthermore, little is known about potential causes for this gender imbalance. This cross-sectional trial included 25 697 patients treated with lipid-lowering agents from 122 centres between April 2012 and October 2012; data for 9420 participants with CHD were analysed in the present study; all underwent clinical examination and had their latest fasting lipid profiles while on lipid-lowering therapy recorded. Logistic regression was used to explore possible factors associated with gender disparity in goal attainment rates, and to what extent each factor contributes. Of 9420 CHD patients (42.5% women) evaluated, women had a significantly lower overall low-density lipoprotein cholesterol (LDL-C) success rate than men (46.2 vs. 62.7%, P < 0.0001). Among CHD patients with diabetes, only 31.5% of women and 46.4% of men ( P < 0.0001) attained the optional LDL-C target of <80 mg/dL. More than half (54.0%) of female patients failed to attain their non-high-density lipoprotein cholesterol (HDL-C) goal. Approximately 7.5, 8.8, 7.5, and 6.8% of gender disparity in LDL-C goal attainment rate was attributable to the gender difference in use of an anti-diabetic, anti-hypertensive, anti-platelet treatment, and the dosage of statin treatment, respectively. Although great improvements have been made over the past decade, there is still a preventive gap in high-risk and very high-risk CHD patients regarding LDL-C and non-HDL-C levels and that this gap is apparently greater in women.

Statin therapy in patients with acute coronary syndrome: low-density lipoprotein cholesterol goal attainment and effect of statin potency.

BackgroundElevated low-density lipoprotein cholesterol (LDL-C) is associated with an increased risk of coronary artery disease. Current guidelines recommend an LDL-C target of <70 mg/dL (<1.8 mmol/L) for acute coronary syndrome (ACS) patients, and the first-line treatment to lower lipids is statin therapy. Despite current guidelines and the efficacious lipid-lowering agents available, about half of patients at very high risk, including ACS patients, fail to achieve their LDL-C goal. This study assessed LDL-C goal attainment according to use of high and low potency statins in routine practice in Thailand.MethodsA retrospective cohort study was performed by retrieving data from medical records and the electronic hospital database for a tertiary care hospital in Thailand between 2009 and 2011. Included were ACS patients treated with statins at baseline and with follow-up of LDL-C levels. Patients were divided into high or low potency statin users, and the proportion reaching the LDL-C goal of <70 mg/dL was determined. A Cox proportional hazard model was applied to determine the relationship between statin potency and LDL-C goal attainment. Propensity score adjustment was used to control for confounding by indication.ResultsOf 396 ACS patients (60% males, mean age 64.3±11.6 years), 229 (58%) were treated with high potency statins and 167 (42%) with low potency statins. A quarter reached their target LDL-C goal (25% for patients on high potency statins and 23% on low potency statins). High potency statins were not associated with increased LDL-C goal attainment (adjusted hazards ratio 1.22, 95% confidence interval 0.79–1.88; P=0.363).ConclusionThere was no significant effect of high potency statins on LDL-C goal attainment. Moreover, this study showed low LDL-C goal attainment for patients on either low or high potency statins. The reasons for the low LDL-C goal attainment rate warrants further investigation.

Lipid Goal Attainment and Prescription Behavior in Asian Patients with Acute Coronary Syndromes: Experience from a Tertiary Hospital

Lipid goal attainment studies in Asian patients with acute coronary syndrome (ACS) are limited. The objectives of this study were to determine low-density lipoprotein cholesterol (LDL-C) goal attainment rate at 4 months, and to examine prescription behavior influencing lipid goal attainment in Asian patients with ACS. A retrospective analysis of 267 patients with ACS was performed. The mean follow-up duration was 41.2±10.7 months. LDL-C goal attainment rate was highest at 4 months (36.7%) but declined progressively throughout follow-up. More than 85% of patients were discharged with equipotent statin dose of 2 (equivalent to simvastatin 20 mg) or less. In patients who did not attain LDL-C goals, the statin dose remained low throughout follow-up because of a lack in responsive dose titration. Aggressive lipid-lowering therapy should be initiated early to improve goal attainment in these high-risk patients.

Begin with the Real-world Patients of Non-goal-achieved Hypercholesterolemia in Taiwan through the Ezetimibe/Simvastatin Tablet – The BRAVO Study

Objective:To assess the efficacy, safety, and tolerability of a combination of 10 mg ezetimibe and 20 mg simvastatin in Taiwanese patients with hypercholesterolemia.Research design and methods:A prospective, open-label, multi-center, hospital-based cohort study was conducted to evaluate the efficacy, safety, and tolerability of a single tablet combination of ezetimibe/simvastatin for the treatment of hypercholesterolemia. Taiwanese adults without low-density lipoprotein cholesterol (LDL-C) goal achievement, based on the National Cholesterol Education Program Adult Treatment Panel III guidelines, were treated with ezetimibe/simvastatin once daily for 6 weeks. The primary endpoint was the percentage of patients achieving LDL-C treatment goals after 6 weeks of treatment. Secondary endpoints included percentage change from baseline of LDL-C, total cholesterol, high-density lipoprotein cholesterol, and triglyceride. Safety and tolerability were assessed via clinical and laboratory examinations. The clinicaltrial.gov identifier of this study was NCT00654628.Results:In total, 173 patients with a mean age of 57.9 ± 10.4 years were included. Of these, 57.8% were female and the average body mass index was 25.5 ± 3.4 kg/m2. After 6 weeks of treatment, the great majority of the patients had reached their treatment goals (90.4% for LDL-C; 87% for TC; and 59% for TG). LDL-C levels were significantly reduced from 156.8 ± 30.8 mg/dL at baseline to 75.9 ± 25.4 mg/dL (51.4%, P < 0.0001) after only 6 weeks of therapy. Forty-nine adverse events (AEs), including one non-drug related serious AE, were reported. For non-serious AEs, the most common reported AEs during the entire study period were myalgia and upper respiratory infection (both n = 7). Nine patients dropped out of the study, reportedly due to AEs.Conclusions:A single tablet combination of 10 mg ezetimibe and 20 mg simvastatin in Taiwanese patients with hypercholesterolemia provided high LDL-C goal attainment rates and resulted in significant reductions in LDL-C.

Switching from high-efficacy lipid-lowering therapies to simvastatin and low-density lipoprotein cholesterol goal attainment in coronary heart disease/coronary heart disease-equivalent patients

The availability of generic simvastatin in 2006 has prompted substantial changes in formulary recommendations for lipid-management agents. To assess the impact of switches from high-efficacy lipid-lowering therapy to simvastatin on low-density lipoprotein cholesterol (LDL-C) and goal attainment in coronary heart disease (CHD) or CHD risk-equivalent patients in a managed care setting. In this retrospective observational study, we estimated the least squares mean difference in the percent change from baseline LDL-C and the odds ratios for LDL-C goal attainment rates (<100 mg/dL and <70 mg/dL) at follow-up for each baseline high-efficacy lipid-lowering therapy with the analysis of covariance and logistic regressions, respectively. We identified 18,061 patients who, between September 1, 2004 and October 31, 2008, were either switched from or remained on their initial high-efficacy LDL-C lowering therapy: ezetimibe/simvastatin fixed-dose combination (E/S), rosuvastatin, or atorvastatin. The difference in percent change in LDL-C levels from baseline were 25.2 (95% confidence interval 21.2-29.2), 13.0 (6.0-20.0), and 3.1 (0.3-5.9) greater in switchers to simvastatin in the E/S, rosuvastatin, and atorvastatin comparisons, respectively, after adjusting for age, sex, and starting dose of the initial therapy. For switchers, the percent of patients at LDL-C <100 mg/dL at follow-up decreased from 83.5% to 63.8% in the E/S, 67.7% to 52.7% in the rosuvastatin, and 65.1% to 60.2% in the atorvastatin cohorts. The percent of patients at LDL-C <70 mg/dL at follow-up was lower for all switcher groups compared with nonswitchers. Among CHD/CHD risk-equivalent patients, switching to simvastatin was associated with increases in LDL-C levels and lower LDL-C goal attainment rates. The public health impact of this phenomenon on population risk and CHD events remains to be determined.

Clinical and economic outcomes in patients switched to simvastatin in a community-based family medicine practice

The introduction of a generic formulation of simvastatin has created the potential to provide significant low-density lipoprotein cholesterol (LDL-C) reduction in a highly cost-effective manner. This retrospective cohort analysis utilised electronic medical record data from a United States, community-based, independent physician family medicine practice. Patients switched from other statins or statin combinations to simvastatin by the family medicine physicians during routine patient care from January 2002 to October 2008 were identified. Equivalent statin dosing, lipid panel changes and National Cholesterol Education Program--Adult Treatment Panel III (NCEP) LDL-C goal attainment rates were compared preswitch and postswitch. The potential economic impact of simvastatin switching was also evaluated. A total of 78 patients were identified, and in 76.9% of the switches, an equipotent dose of simvastatin was prescribed. All lipid fractions showed small, non-significant increases, with LDL-C having a 2.2 mg/dl (0.06 mmol/l) increase after switching (p = 0.476). NCEP LDL-C goal attainment rates were 79.5% and 78.2% before and after switching, respectively (p = 1.00). Modelled annual cost savings associated with switching were estimated at $671.99 per patient. These results demonstrate that an independent family medicine physician practice can successfully perform statin therapeutic substitution during routine patient care. Equivalent clinical outcomes with regards to changes in lipid fractions and NCEP LDL-C goal attainment were observed in conjunction with the potential for reduced costs for patients.

Dyslipidemia Control in Indigent Patients Receiving Medication Assistance Compared with Insured Patients

To compare dyslipidemia management with statin-based therapy in insured patients versus indigent patients receiving medication assistance, and to determine drug therapy adherence rates in the two groups. Retrospective medical record review. Setting. University-based health care system. Two hundred forty patients with dyslipidemia who received statin-based therapy from the outpatient pharmacies and clinical care at an affiliated clinic. Prescription records identified 665 patients between October 1, 2004, and September 30, 2005. Forty of these patients had insurance (with a single carrier), and the remaining 625 patients received health care subsidies from the Colorado Indigent Care Program (CICP). Using a block scheme, 200 patients from the CICP were randomly extracted. The primary objective was measured by assessment of low-density lipoprotein cholesterol (LDL) goal attainment and use of a moderate-potency, lipid-lowering regimen capable of achieving an LDL level reduction of least 30%. Of a total of 240 patients who met study criteria, 26 were excluded whose records lacked LDL measurements while receiving therapy. The LDL goal was achieved in 122 (68.9%) of the 177 patients in the CICP group versus 29 (78.4%) of the 37 patients in the insured group (p=0.34). A moderate-potency, LDL-lowering regimen was used by 90.5% of 200 patients in the CICP group and 85% of 40 patients in the insured group (p=0.45). In patients classified as having moderately high, high, or very high cardiovascular risk, LDL goals were attained in 103 (67.3%) of 153 patients in the CICP group versus 16 (69.6%) of 23 patients in the insured group (p=0.83). In this higher-risk subgroup, a moderate-potency regimen was used in 162 (92.6%) of 175 patients in the CICP group versus 23 (92%) of 25 patients in the insured group (p=0.92). Among the very high-risk patients from the two groups combined, 30 (52.6%) of 57 patients achieved LDL concentrations below 70 mg/dl, and 58 (95.1%) of 61 patients were administered a moderate-potency, LDL-lowering regimen. The secondary objective, overall adherence, as assessed by the medication possession ratio, was better in the CICP group than in the insured group. Our data suggest that quality of dyslipidemia management is similar for indigent and insured populations. Overall LDL goal attainment rates were higher than those reported in the literature. Most patients with significant cardiovascular risk, including those at very high risk, were treated according to established guidelines. Adherence rates were greater for indigent patients.