Baseline Total Cholesterol Research Articles

Postpartum Lipid Levels in Women with Major Depression

Maternal plasma lipids, including total cholesterol, low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C), increase during pregnancy, remaining elevated over prepregnancy levels through the immediate postpartum period. Triglycerides decrease rapidly to prepregnancy levels after delivery. Few data on postpartum lipid levels are available, and levels in postpartum women with depression have not been evaluated. We sought to determine the cross-sectional levels of total cholesterol, LDL-C, HDL-C, and triglycerides between 1 and 14 weeks postpartum in postpartum women with DSM-4 diagnoses of major depression and determine if they are similarly elevated to published levels in other postpartum populations. As part of screening for a randomized controlled trial comparing treatments for postpartum depression (PPD), women (n=120) had postpartum fasting lipid levels determined. Linear regression models were used to assess the association between time postpartum and lipid levels. Analysis of covariance models (ANCOVA) assessed the association of baseline characteristics with lipids. Total cholesterol levels were >200 mg/dL in 45% of the sample at baseline. Mean baseline total cholesterol was 196±39 mg/dL. There was an inverse linear relationship between postpartum week and total cholesterol, with cholesterol values decreasing an average of 4.5 mg/dL per week. Similarly, LDL-C and HDL-C trended down over time. Triglycerides were stable and within the normal range during the observation period. Total cholesterol, HDL-C, and LDL-C are significantly elevated in the early postpartum period and do not return to <200 mg/dL until 6 weeks postpartum in women with PPD. The magnitude and duration of elevation are consistent with the sparse published data on nondepressed women.

A meta‐analysis of randomized, double‐blind, placebo‐controlled trials for the effects of garlic on serum lipid profiles

Inconsistent results were obtained for the lipid-regulating effects of garlic in clinical trials. With increasing interest in complementary medicine for hyperlipoidemia, it is important to explore the real effects of garlic. This meta- analysis was performed to investigate the influence of garlic on serum lipid parameters. A total of 26 studies were included into meta-analysis. Overall, garlic was superior to placebo in reducing serum total cholesterol (TC) and triglyceride (TG) levels. Compared with the placebo groups, serum TC and TG levels in the garlic group were reduced by 0.28 (95% CI, -0.45, -0.11) mmol L⁻¹ (P = 0.001) and 0.13 (95% CI, -0.20, -0.06) mmol L⁻¹ (P < 0.001), respectively. The effects of garlic were more striking in subjects with long-term intervention and higher baseline TC levels. Garlic powder and aged garlic extract were more effective in reducing serum TC levels, while garlic oil was more effective in lowering serum TG levels. In contrast, garlic did not influence other lipid parameters, including low-density lipoprotein cholesterol, high-density lipoprotein cholesterol (HDL-C), apolipoprotein B, and TC/HDL-C ratio. Garlic could reduce serum TC and TG levels, and garlic therapy should benefit patients with risk of cardiovascular diseases.

Safety and Effectiveness of Tenofovir/Emtricitabine or Lamivudine Plus Ritonavir Boosted Atazanavir in Treatment Experienced HIV Infected Adults at Two Urban Private Medical Practices

Objectives: The efficacy and safety of once daily ritonavir-boosted atazanavir (ATV/r) plus tenofovir (TDF) and emtricitabine (FTC) or lamivudine (3TC) was evaluated in the management of treatment experienced HIV-infected patients in routine clinical practice. Research design and methods: A retrospective analysis was performed in HIV infected patients residing at two active, urban clinical practices receiving at least one month of tenofovir, emtricitabine or lamviudine plus ritonavir boosted atazanavir following a change from another antiretroviral regimen to simplify or reduce toxicity. Parameters evaluated included the proportion of patients with HIV RNA <400 copies/mL; change in CD4 count from baseline (start of both TDF and ATV/r), adverse effects, and laboratory changes over time in estimated glomerular filtration rate (calculated creatinine clearance and MDRD) and lipids. Main outcome measures: One hundred sixty five patients, the majority being Caucasian and male, were studied. Twenty nine (18%) discontinued therapy, including 4 for adverse events and 5 for virologic failure. At baseline, 71% of patients had HIV RNA values <400 copies/mL. At 12 months, 81/90 (90%) patients remaining on therapy had HIV RNA <400 copies/mL, including 17/25 (68%) of those with baseline HIV RNA ≥400 copies/m; 88% (35/40) achieved HIV RNA <75 c/mL. Median increase in CD4 count at 12 months was 26 cells/uL. Grade 4 hyperbilirubinemia occurred in 12% of patients. Estimated glomerular filtration rates did not change significantly by either the Cockcroft-Gault or MDRD method. At 12 months, median declines from baseline in total cholesterol, LDLcholesterol, HDL-cholesterol, and triglycerides were -14, -18, -1, and -12 mg/dL, respectively. Conclusions: In routine clinical practice, a once-daily regimen containing ATV/r plus TDF/FTC or 3TC controlled HIV in most patients without renal toxicity and improved the lipid profile.

Favorable Impacts of Growth Hormone (GH) Replacement Therapy on Atherogenic Risks in Japanese Children with GH Deficiency

Growth hormone (GH) affects body composition and atherogenic risk factors. Severe hyperlipidemia may develop in GH-deficient adults as a consequence of continuous GH deficiency. We investigated changes in lipid profiles in 158 Japanese children (103 boys and 55 girls) with GH deficiency who had been enrolled in the Pfizer International Growth Database Japan during 3 yr of GH replacement therapy to evaluate whether GH treatment has beneficial effects on atherogenic risk factors. Total cholesterol (TC), high-density lipoprotein cholesterol (HDLC), low-density lipoprotein cholesterol (LDLC) and atherogenic index were evaluated before treatment and then once a year during treatment. The mean baseline TC was within the normal range in both boys and girls. Seventeen (16.5%) of the 103 boys and 18 (32.7%) of the 55 girls, however, had a TC level over 200 mg/dl before treatment. The mean TC level showed a significant decrease in girls. In a separate analysis, patients of both sexes with a TC level > 200 mg/dl showed significantly decreased TC. LDLC decreased significantly only in girls, while HDLC showed no change in either sex. The atherogenic index decreased significantly in girls. GH replacement therapy in children with GH deficiency had beneficial effects on lipid metabolism and atherogenic risk in both sexes. Early GH treatment would produce lipid metabolism benefits in these patients.

Influence of Lipid Profiles on the Risk of Hemorrhagic Transformation after Ischemic Stroke: Systematic Review

Background: It has been suggested that low cholesterol levels might be associated with an increased risk of hemorrhagic transformation (HT) in patients with acute cerebral ischemia. We systematically reviewed the literature to determine the influence of lipid profiles on the HT risk. Methods: We searched PubMed from 1966 and EMBASE from 1980 for studies that investigated the association between lipid profiles and HT. We performed a meta-analysis (weighted mean difference method) for the comparison between presence and absence of HT (all or symptomatic) for total, low-density-lipoprotein (LDL) and high-density-lipoprotein (HDL) cholesterol, and triglycerides. Results: Eight studies investigating 1,763 patients were eligible, but none was designed specifically to address this question. All studies recruited acute stroke patients selected on the presumed cause of cerebral ischemia or treatment received. The meta-analysis showed that: (i) patients with all HT had lower LDL cholesterol levels (p = 0.008) but no difference in HDL cholesterol levels (p = 0.066), total cholesterol (p = 0.129) and triglycerides (p = 0.900); (ii) patients with symptomatic HT had lower total cholesterol levels (p = 0.035) but did not differ in LDL (p = 0.056) and HDL cholesterol (p = 0.138) and triglyceride (p = 0.851) levels. Conclusion: HT is associated with baseline total and LDL cholesterol levels, but the mechanism of this association needs to be explored to identify preventive strategies.

The relationship between apolipoprotein (apo) E polymorphism and lipid changes: An 8-year cohort study in Beijing elderly persons

This study aimed to investigate the influence of apoE genetic polymorphism on serum lipid changes in a community-based elderly population in China in an 8-year period, in which 746 individual, aged 65.29±6.85 years (mean±standard deviation (SD)) were enrolled and serum lipid parameters were checked at baseline. After 8 years, serum lipids as well as apoE genotypes were measured. The frequencies of apoE allele were 9.4%, 81.7%, and 8.9% for ɛ2, ɛ3 and ɛ4, respectively. After the population was divided into 3 groups by different apoE allele carriers, the apoE allele carriers for ɛ2, ɛ3 and ɛ4 were 121 (16.2%), 513 (68.8%) and 112 (15.0%), respectively. Levels of total cholesterol (TC) and low density lipoprotein (LDL) in ɛ2 carriers were lower comparing with that of ɛ3 allele carriers at baseline. 8 years later, TC and high density lipoprotein (HDL) elevated and LDL decreased with aging in this population (p<0.01). The changes of TC levels were smaller in ɛ2 allele carriers as compared to that of ɛ3 allele carriers. The difference was still statistically significant after controlling for age, sex, smoking status, drinking habit, body mass index (BMI) and baseline TC level. The same trend of changes was noted for LDL between ɛ2 and ɛ3 allele carriers. However, no significant differences were noted between ɛ4 and ɛ3 allele carriers on lipid changes. This community-based study shows that ɛ2 allele is helpful on lipid changes. The effect of ɛ4 allele on lipid change is not strong in this elderly population. Genetic and environmental factors maybe co-operate on lipid metabolism in elderly persons.

DPP-4 Inhibitors and Lipids: Systematic Review and Meta-Analysis

Lipid profile is an important determinant of cardiovascular risk in type 2 diabetic patients. Available glucose-lowering agents can affect lipid levels. Dipeptidyl peptidase-4 (DPP-4) inhibitors have been reported to reduce total cholesterol, but results are inconsistent across trials. The present metaanalysis was designed to assess the effect of DPP-4 inhibitors on blood lipids, verifying possible differences across compounds of this class. An extensive search of Medline and the Cochrane Library (any date up to December 31, 2010, restricted to randomized clinical trials, published in English) was performed for all trials containing, in any field, the words "sitagliptin," "vildagliptin," "saxagliptin," "alogliptin," "linagliptin," and/or "dutogliptin." Completed but unpublished trials were identified through a search of the ClinicalTrials.gov website, using the same keywords as above. Differences in the endpoint levels and absolute or percent variations of lipids were assessed. A metaregression was performed on the trials specified above to assess the effect of putative moderators on the effect of DPP-4 inhibitors on plasma lipids, considering all drugs together and each one separately. Although the number of trials of appropriate size and duration was high (n=53), only a small fraction of those (n=17) reported data on endpoint total, high-density lipoprotein, and low-density lipoprotein cholesterol, and triglyceride. The difference-in-means for endpoint versus baseline total cholesterol in patients on DPP-4 inhibitors treatment was significantly higher in comparison with controls, meaning that treatment with DPP-4 inhibitors is associated with a significant reduction in total cholesterol (-0.18 [-0.29; -0.06] mmol/L (-7.0 [-11.2; -2.50] mg/dL); P=0.002). This meta-analysis suggests a possible beneficial effect of DPP-4 inhibitors on cholesterol, which, although small, could contribute to the reduction of cardiovascular risk.

Statins after ischemic stroke of undetermined etiology in young adults

# {#article-title-2} Putaala et al.1 studied a group of young patients with a first stroke of undetermined etiology and found that individuals who used statin poststroke had lower rates of vascular events in long-term follow-up. However, when the whole young population was studied after first-ever ischemic stroke, it was found that dyslipidemia did not predict the occurrence of future arterial thrombotic events.2 The present study1 suggests that higher cholesterol levels actually are protective after ischemic stroke of undetermined etiology. It is well known that baseline total cholesterol levels of statin-treated populations are higher than those of the …

The high-dose rosuvastatin once weekly study (The HD-ROWS)

Alternative dosing is often used clinically to address common barriers with statin therapy, such as intolerance and cost. Previous findings have demonstrated significant and clinically similar reductions in low-density lipoprotein (LDL) cholesterol to daily dosing, when comparing similar total weekly doses. To determine whether rosuvastatin 80 mg once weekly produced comparable lipid and high-sensitivity C-reactive protein (hsCRP) changes to atorvastatin 10 mg daily, when measured at key points after last dose. This was a randomized, double-blind, parallel group, 8-week pilot study. Eligible subjects, 18 to 65 years of age, had documented dyslipidemia with LDL cholesterol >100 mg/dL and triglycerides <200 mg/dL. Participants were randomized to receive either rosuvastatin 80 mg once weekly (n= 10) or atorvastatin 10 mg daily (n= 10), for 8 weeks. Lipid panels and hsCRP were measured at baseline and 1-4 and 5-8 days after the last dose. Participants in each arm experienced significant and comparable reductions from baseline in total cholesterol, total cholesterol/high-density lipoprotein cholesterol ratio, non-high-density lipoprotein cholesterol, and overall LDL cholesterol (-29%). Changes in high-density lipoprotein cholesterol, triglycerides, and hsCRP were nonsignificant and similar between groups. Each regimen was well tolerated, with no major adverse events reported. Rosuvastatin 80 mg once weekly produced comparable lipid changes to atorvastatin 10 mg daily when measured at specific points after the last dose. Our findings support previous data demonstrating a significant reduction in LDL-C with once weekly statin dosing.

Participant characteristics associated with greater reductions in waist circumference during a four-month, pedometer-based, workplace health program.

BackgroundWorkplace health programs have demonstrated improvements in a number of risk factors for chronic disease. However, there has been little investigation of participant characteristics that may be associated with change in risk factors during such programs. The aim of this paper is to identify participant characteristics associated with improved waist circumference (WC) following participation in a four-month, pedometer-based, physical activity, workplace health program.Methods762 adults employed in primarily sedentary occupations and voluntarily enrolled in a four-month workplace program aimed at increasing physical activity were recruited from ten Australian worksites in 2008. Seventy-nine percent returned at the end of the health program. Data included demographic, behavioural, anthropometric and biomedical measurements. WC change (before versus after) was assessed by multivariable linear and logistic regression analyses. Seven groupings of potential associated variables from baseline were sequentially added to build progressively larger regression models.ResultsGreater improvement in WC during the program was associated with having completed tertiary education, consuming two or less standard alcoholic beverages in one occasion in the twelve months prior to baseline, undertaking less baseline weekend sitting time and lower baseline total cholesterol. A greater WC at baseline was strongly associated with a greater improvement in WC. A sub-analysis in participants with a 'high-risk' baseline WC revealed that younger age, enrolling for reasons other than appearance, undertaking less weekend sitting time at baseline, eating two or more pieces of fruit per day at baseline, higher baseline physical functioning and lower baseline body mass index were associated with greater odds of moving to 'low risk' WC at the end of the program.ConclusionsWhile employees with 'high-risk' WC at baseline experienced the greatest improvements in WC, the other variables associated with greater WC improvement were generally indicators of better baseline health. These results indicate that employees who started with better health, potentially due to lifestyle or recent behavioural changes, were more likely to respond positively to the program. Future health program initiators should think innovatively to encourage all enrolees along the health spectrum to achieve a successful outcome.

Hepatic lipase gene -514C&gt;T variant is associated with exercise training-induced changes in VLDL and HDL by lipoprotein lipase

Our objective was to test the hypothesis that a common polymorphism in the hepatic lipase (HL) gene (LIPC -514C>T, rs1800588) influences aerobic exercise training-induced changes in TG, very-low-density lipoprotein (VLDL), and high-density lipoprotein (HDL) through genotype-specific increases in lipoprotein lipase (LPL) activity and that sex may affect these responses. Seventy-six sedentary overweight to obese men and women aged 50-75 yr at risk for coronary heart disease (CHD) underwent a 24-wk prospective study of the LIPC -514 genotype-specific effects of exercise training on lipoproteins measured enzymatically and by nuclear magnetic resonance, postheparin LPL and HL activities, body composition by dual energy x-ray absorptiometry and computer tomography scan, and aerobic capacity. CT genotype subjects had higher baseline total cholesterol, HDL-C, HDL(2)-C, large HDL, HDL particle size, and large LDL than CC homozygotes. Exercise training elicited genotype-specific decreases in VLDL-TG (-22 vs. +7%; P < 0.05; CC vs. CT, respectively), total VLDL and medium VLDL, and increases in HDL-C (7 vs. 4%; P < 0.03) and HDL(3)-C with significant genotype×sex interactions for the changes in HDL-C and HDL(3)-C (P values = 0.01-0.02). There were also genotype-specific changes in LPL (+23 vs. -6%; P < 0.05) and HL (+7 vs. -24%; P < 0.01) activities, with LPL increasing only in CC subjects (P < 0.006) and HL decreasing only in CT subjects (P < 0.007). Reductions in TG, VLDL-TG, large VLDL, and medium VLDL and increases in HDL(3)-C and small HDL particles correlated significantly with changes in LPL, but not HL, activity only in CC subjects. This suggests that the LIPC -514C>T variant significantly affects training-induced anti-atherogenic changes in VLDL-TG, VLDL particles, and HDL through an association with increased LPL activity in CC subjects, which could guide therapeutic strategies to reduce CHD risk.

Effect of lean red meat from lamb v. lean white meat from chicken on the serum lipid profile: a randomised, cross-over study in women

The main dietary guidelines recommend restricting total and saturated fat intake in the management of high blood cholesterol levels for cardiovascular risk. These recommendations are usually oversimplified by considering that all red meats should be limited and replaced by white meats. However, lean red meat can be as low in fat as white meat. We examined the effects of red meat (lean breed lamb) and lean white meat (chicken) intake on the lipid profile of a group of women with stable life conditions (nuns living in convents). An open-label, randomised, cross-over study was carried out in thirty-six nuns who consumed either lamb or chicken three times per week for 5-week periods with their usual diet. Clinical, dietary and biochemical variables were evaluated at baseline and the end of each diet period. A validated FFQ was used to assess nutrient intake and monitor compliance. The results showed neither between-diet differences in lipid responses nor differences from baseline in total cholesterol, LDL-cholesterol or TAG for any diet period. In conclusion, consumption of lean red meat (lamb) or lean white meat (chicken) as part of the usual diet is associated with a similar lipid response. These two foods can be exchanged in a healthy diet to increase palatability.

Lipid profiles for nevirapine vs. atazanavir/ritonavir, both combined with tenofovir disoproxil fumarate and emtricitabine over 48 weeks, in treatment-naïve HIV-1-infected patients (the ARTEN study)

Dyslipidaemic effects of antiretrovirals (ARVs) may contribute to increased cardiovascular risk (CR) in HIV-1-infected patients. The ARTEN (atazanavir/ritonavir on a background of tenofovir and emtricitabine vs. nevirapine on the same background, in naïve HIV-1-infected patients) study compared prospectively ritonavir-boosted atazanavir (ATZ/r) 300 mg/100 mg once daily (qd) with immediate release nevirapine (NVP) 200 mg twice daily or 400 mg qd, each combined with fixed-dose tenofovir 300 mg/emtricitabine 200 mg qd in 569 ARV-naïve HIV-1-infected patients. Lipid profiles and CR from baseline to week 48 are reported. Changes from baseline to week 48 in fasting plasma levels of total cholesterol (TC), high-density lipoprotein cholesterol (HDL-c), low-density lipoprotein cholesterol (LDL-c), TC:HDL-c ratio, apolipoprotein A1 (ApoA1), apolipoprotein B (ApoB) and total triglycerides (TG) were determined. The Framingham algorithm was used to estimate CR. Analysis was by intention-to-treat (ITT) with last observation carried forward (LOCF) for missing data. At week 48, NVP treatment resulted in significantly greater mean increases from baseline in TC (24.4 vs. 19.6 mg/dL; P=0.038), HDL-c (9.7 vs. 3.9 mg/dL; P<0.0001), LDL-c (15.0 vs. 10.4 mg/dL; P=0.011) and ApoA1 (0.18 vs. 0.08 g/L; P<0.0001) but not ApoB (0.02 vs. 0.02 g/L) compared with ATZ/r treatment. ATZ/r use was associated with higher mean TG increases (27.80 vs. 0.02 mg/dL; P=0.0001). Significantly greater mean decreases in TC:HDL-c and ApoB/ApoA ratios were observed with NVP vs. ATZ/r (P=0.0001 and P=0.008, respectively). Framingham CR scores were low and comparable between the arms, with only a slight mean increase from baseline to week 48 of 0.70 for NVP and 0.80 for ATZ/r [difference -0.069; 95% confidence interval (CI) -0.61 to 0.46; P=0.80]. In ARV-naïve patients with low CR at the outset, NVP showed a potentially less atherogenic lipid profile compared with ATZ/r.

Proactive multiple cardiovascular risk factor management compared with usual care in patients with hypertension and additional risk factors: the CRUCIAL trial

Objective:To investigate whether a proactive multifactorial risk factor intervention strategy using single-pill amlodipine/atorvastatin (5/10, 10/10 mg) in addition to other antihypertensive and lipid-lowering therapy, as required, resulted in greater reduction in calculated Framingham 10-year coronary heart disease (CHD) risk compared with usual care (UC) after 52-weeks treatment.Research design and methods:Prospective, multinational, open-label, cluster randomized trial, with the investigator as the unit of randomization. Eligible hypertensive patients were 35–79 years of age, with ≥3 additional cardiovascular risk factors, but no history of CHD and baseline total cholesterol (TC) ≤6.5 mmol/l.Clinical trial registration:Trial registration: ClinicalTrials.gov identifier: NCT00407537.Main outcome measure:The primary endpoint was calculated Framingham 10-year CHD risk at 52 weeks.Results:Of the 140 randomized sites, 136 sites contributed 1461 patients. Mean baseline age and low-density lipoprotein cholesterol (LDL-C) were comparable between treatment arms. Mean baseline BP (150.3/89.7 vs. 144.3/86.5 mmHg) and Framingham CHD risk (20.0 vs. 18.1%) were higher in the proactive intervention versus the UC arm (p < 0.002 for both). At week 52, mean CHD risk was 12.5% in the proactive intervention arm and 16.3% in the UC arm (p < 0.001). The difference, observed at weeks 16 and 52, was primarily driven by significant differences in systolic BP and in TC between the two arms. Overall, adverse events (AEs) were reported in 48.8% and 44.0% of patients in the proactive intervention and the UC arm, respectively. Although there were differences in the incidence of AEs between the treatment arms, the AE profile in the proactive intervention arm was consistent with previous safety experience for this medication.Conclusions:A proactive multifactorial risk factor intervention strategy that simultaneously treated both BP and cholesterol regardless of individual risk factors per se, is more effective in reducing calculated Framingham 10-year CHD risk than UC in patients with hypertension and additional risk factors.

Serum lipid profiles are associated with disability and MRI outcomes in multiple sclerosis

BackgroundThe breakdown of the blood-brain-barrier vascular endothelium is critical for entry of immune cells into the MS brain. Vascular co-morbidities are associated with increased risk of progression. Dyslipidemia, elevated LDL and reduced HDL may increase progression by activating inflammatory processes at the vascular endothelium.ObjectiveTo assess the associations of serum lipid profile variables (triglycerides, high and low density lipoproteins (HDL, LDL) and total cholesterol) with disability and MRI measures in multiple sclerosis (MS).MethodsThis study included 492 MS patients (age: 47.1 ± 10.8 years; disease duration: 12.8 ± 10.1 years) with baseline and follow-up Expanded Disability Status Score (EDSS) assessments after a mean period of 2.2 ± 1.0 years. The associations of baseline lipid profile variables with disability changes were assessed. Quantitative MRI findings at baseline were available for 210 patients.ResultsEDSS worsening was associated with higher baseline LDL (p = 0.006) and total cholesterol (p = 0.001, 0.008) levels, with trends for higher triglyceride (p = 0.025); HDL was not associated. A similar pattern was found for MSSS worsening. Higher HDL levels (p < 0.001) were associated with lower contrast-enhancing lesion volume. Higher total cholesterol was associated with a trend for lower brain parenchymal fraction (p = 0.033).ConclusionsSerum lipid profile has modest effects on disease progression in MS. Worsening disability is associated with higher levels of LDL, total cholesterol and triglycerides. Higher HDL is associated with lower levels of acute inflammatory activity.

Efficacy and tolerability of a generic and a branded formulation of atorvastatin 20 mg/d in hypercholesterolemic Korean adults at high risk for cardiovascular disease: A multicenter, prospective, randomized, double-blind, double-dummy clinical trial

Background: The reduction in plasma LDL-C concentrations with 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin) therapy has been reported to reduce cardiovascular risk and mortality in individuals with or without preexisting coronary artery disease and elevated LDL-C concentrations. Atorvastatin is a statin used for lowering LDL-C concentrations. A generic formulation of atorvastatin is being developed in Korea. This study was undertaken for the purposes of marketing the generic formulation. Objective: This study was designed to compare the efficacy and tolerability of a generic formulation of atorvastatin 20 mg/d versus a branded formulation at the same dosage in hypercholesterolemic Korean adults at high risk for cardiovascular events. Methods: This 8-week, multicenter, randomized, double-blind, double-dummy study was conducted at 10 clinical centers in Korea between September 2008 and May 2009. Male and female patients aged 20 to 85 years at high risk for cardiovascular events (defined as an elevated LDL-C concentration [≥100 mg/dL]) were enrolled. Eligible patients were randomly assigned to receive generic or branded atorvastatin 20 mg once daily for 8 weeks. The primary end point was the percentage change from baseline to 8 weeks in LDL-C concentration. Secondary end points were the percentage changes from baseline in total cholesterol (TC), triglycerides (TG), HDL-C, apolipoprotein (apo) A1 and B, and high-sensitivity C-reactive protein concentrations; small, dense LDL (sdLDL) fraction; and tolerability. Tolerability was assessed using physical examination, laboratory testing, and by recording adverse events (AEs) at each visit. An additional secondary end point was the proportion of patients who achieved an LDL-C goal of <100 mg/dL. Results: A total of 244 patients were randomized to treatment, and 33 patients were withdrawn from the study (9 patients did not receive the study medication, 11 patients due to AEs, and 13 patients due to withdrawal of consent). A total of 211 patients completed the study (50.7% male; 100% Asian; mean [SD] age, 61.7 [9.2] years) (106 patients in the group that received Accepted for publication October 5, 2010. the generic formulation and 105 patients in the group that received the branded formulation). LDL-C concentrations were reduced from the baseline by 44% and 46% after 8 weeks of treatment with the generic and branded formulations, respectively ( P = NS). The percentage changes from baseline to study end in HDL-C, TC, TG, apo A1, apo B, and hsCRP concentrations and sdLDL fraction the proportions of patients who achieved the LDL-C goal between the 2 groups did not reach statistical significance. The most commonly reported events were hepatobiliary laboratory abnormality (1.7%), general somatic discomfort (1.7%), and epigastric pain (0.8%) in the group that received the generic formulation, and myalgia (1.7%), epigastric pain (0.9%), and elevation of creatinine phosphokinase (0.9%) in the group that received the branded formulation. No serious AEs were reported in either group. Conclusions: After 8 weeks of treatment, the differences in the LDL-C-lowering effects between the generic and branded formulations of atorvastatin 20 mg/d did not reach statistical significance in these Korean patients at high risk for cardiovascular events. Both formulations were generally well tolerated.

E0267 Prediction of the newly-identified carotid plaque with blood lipid levels in Chinese elderly population

ObjectiveTo provide the changing prevalence of carotid plaque in a Chinese elderly population from 2002 to 2007 and accordingly evaluate the predictive effect of baseline lipid levels of interest on...

Malnutrition-Inflammation Modifies the Relationship of Cholesterol with Cardiovascular Disease

In moderate and severe CKD, the association of cholesterol with subsequent cardiovascular disease (CVD) is weak. We examined whether malnutrition or inflammation (M-I) modifies the risk relationship between cholesterol levels and CVD events in African Americans with hypertensive CKD and a GFR between 20 and 65 ml/min per 1.73 m². We stratified 990 participants by the presence or absence of M-I, defined as body mass index <23 kg/m² or C-reactive protein >10 mg/L at baseline. The primary composite outcome included cardiovascular death or first hospitalization for coronary artery disease, stroke, or congestive heart failure occurring during a median follow-up of 77 months. Baseline total cholesterol (212 ± 48 versus 212 ± 44 mg/dl) and overall incidence of the primary CVD outcome (19 versus 21%) were similar in participants with (n = 304) and without (n = 686) M-I. In adjusted analyses, the CVD composite outcome exhibited a significantly stronger relationship with total cholesterol for participants without M-I than for participants with M-I at baseline (P < 0.02). In the non-M-I group, the cholesterol-adjusted hazard ratio (HR) for CVD increased progressively across cholesterol levels: HR = 1.19 [95% CI; 0.77, 1.84] and 2.18 [1.43, 3.33] in participants with cholesterol 200 to 239 and ≥240 mg/dl, respectively (reference: cholesterol <200). In the M-I group, the corresponding HRs did not vary significantly by cholesterol level. In conclusion, the presence of M-I modifies the risk relationship between cholesterol level and CVD in African Americans with hypertensive CKD.

Biochemical Correlates of Bariatric-Responsive Diabetes

In a prospective observational cohort study, the biochemical profile of bariatrically managed diabetes was documented, aiming to assess its association with clinical outcome. The population (n = 82; age, 50.7 +/- 10.3 years; 92.7% women; followed up for 93 +/- 34 months) was stratified as responsive diabetes (Group I) (36.6%, 30 of 82) and controls without diabetes (Group II) (57.3%, 47 of 82). A few refractory subjects were identified in this cohort (Group III [refractory diabetes], 6.3%, five of 82). Nonbariatric overweight and obese diabetes subjects with similar follow-up (n = 21) were documented as well. Main outcome measures were diabetes regression, body mass índex (BMI), glucose, glycosylated hemoglobin A1c (HbA1c), serum lipids, and white blood cell count (WBC) count. Preoperative BMI was somewhat discrepant among operated groups but leveled off from 2 years on. Baseline WBC count, total cholesterol, low-density lipoprotein-cholesterol, blood glucose, and HbA1c were higher in responsive subjects, but a downward shift occurred, without differences regarding controls, in the subsequent period. Conservatively managed diabetes displayed favorable changes of some lipid fractions, but not glucose, HbA1c, total cholesterol, or WBC count. Diabetes regression rate was 94.3% at 5 years and 84.7% at around 8 years. In responsive patients, both BMI and biochemical indices normalized in the first 2 years and followed a stable path thereafter. Nonoperative treatment was unable to reduce HbA1c, glucose, or WBC count, and HbA1c was a clear prognostic marker of persistent disease in surgical cases. Further studies emphasizing the metabolic and inflammatory signature of obesity-related diabetes are worthwhile.

Projected Cost-Effectiveness of Ezetimibe/Simvastatin Compared with Doubling the Statin Dose in the United Kingdom: Findings from the INFORCE Study

Objective To evaluate the incremental cost-effectiveness ratio (ICER) of switching to ezetimibe/simvastatin (Eze/Simva) compared with doubling the submaximal statin doses, in patients with acute coronary syndrome (ACS) events in the INFORCE study. Methods Lifetime treatment costs and benefits were computed using a Markov model. Model inputs included each patient's cardiovascular risk factor profile and actual lipid values at baseline and 12 weeks (endpoint). Cardiovascular event and drug costs were discounted at 3.5%. Age-specific utilities were based on UK literature values and non–coronary heart disease mortality rates on the Office of National Statistics data. In the INFORCE study, 384 patients taking statins at stable doses for ≥6 weeks before hospital admission were stratified by statin dose/potency (low, medium, and high) and then randomized to doubling the statin dose or switching to Eze/Simva 10/40 mg for 12 weeks. Results The Eze/Simva group ( n = 195) had a higher mean baseline total cholesterol than the double-statin group ( n = 189). Analyses were adjusted for baseline characteristics. In the INFORCE study, Eze/Simva reduced low-density lipoprotein cholesterol (LDL-C) by ∼30% (vs. 4% with doubling statin doses) and significantly enhanced LDL-C goal attainment. In the cost-effectiveness analysis, Eze/Simva conferred 0.218 incremental discounted quality-adjusted life year (QALY) at a discounted incremental cost of £2524, for an ICER of £11,571/QALY (95% confidence interval = £8181–£18,600/QALY). The ICER was £13,552/QALY, £11,930/QALY, and £10,148/QALY in the low-, medium-, and high-potency strata, respectively. Conclusions Switching to Eze/Simva 10/40 mg is projected to be a cost-effective treatment (vs. double-statin) in UK patients with ACS.