Mean Change In Total Cholesterol Research Articles

The Lipid Intensive Drug Therapy for Sepsis Phase II Pilot Clinical Trial.

Low cholesterol levels in early sepsis patients are associated with mortality. We sought to test if IV lipid emulsion administration to sepsis patients with low cholesterol levels would prevent a decline or increase total cholesterol levels at 48 hours. Phase II, adaptive, randomized pilot clinical trial powered for 48 patients. Emergency department or ICU of an academic medical center. Sepsis patients (first 24 hr) with Sequential Organ Failure Assessment greater than or equal to 4 or shock. Patients meeting study criteria, including screening total cholesterol levels less than or equal to 100 mg/dL or high-density lipoprotein cholesterol (HDL-C) + low-density lipoprotein cholesterol (LDL-C) less than or equal to 70 mg/dL, were randomized to receive one of three doses of lipid emulsion administered twice in 48 hours or no drug (controls). The primary endpoint was a change in serum total cholesterol (48 hr - enrollment) between groups. Forty-nine patients were enrolled and randomized. Two patients randomized to lipid emulsion were withdrawn before drug administration. Data for 24 control patients and 23 lipid emulsion patients were analyzed. The mean change in total cholesterol from enrollment to 48 hours was not different between groups and was 5 mg/dL (sd 20) for lipid emulsion patients, and 2 mg/dL (sd 18) for control patients (p = 0.62). The mean changes in HDL-C and LDL-C were similar between groups. Mean change in triglycerides was elevated in lipid emulsion patients (61 mg/dL, sd 87) compared with controls (20 mg/dL, sd 70, p = 0.086). The 48-hour change in SOFA score was -2 (interquartile range [IQR] -4, -1) for control patients and -2 (IQR -3, 0) for lipid emulsion patients (p = 0.46). Administration of IV lipid emulsion to early sepsis patients with low cholesterol levels did not influence change in cholesterol levels from enrollment to 48 hours.

Effects of Kefir Consumption on Cardiometabolic Risk Factors: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

Fermentation of lactose in milk by bacteria and yeasts naturally present in kefir grains produces a beverage that has been suggested to have cardiovascular benefits. This systematic review and meta-analysis of randomized controlled trials (RCTs) aimed to evaluate the effects of this kefir beverage on cardiometabolic risk factors. Literature search utilised PubMed, Scopus, ISI Web of Science, and Google Scholar for articles published from inception until June 2021. Cardiometabolic risk indices extracted included insulin and insulin resistance (HOMA_IR), total cholesterol (TC), triglyceride (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), fasting blood sugar (FBS), haemoglobin A1c (HbA1c) and body weight (BW). In total, six RCTs (314 subjects) were selected for the meta-analysis. Inverse-variance weighted mean difference (WMD) with a 95% confidence interval (CI) was calculated for the mean changes in TC, TG, HDL-C, LDL-C, FBS, HbA1c and BW compared to baseline. A random effects model was used to estimate the pooled WMD. Kefir intake significantly reduced fasting insulin (WMD: -3.69 micro-IU/mL,95% CI: -6.30 to -1.07, p = 0.006, I2 = 0.0%) and HOMA-IR (WMD: -2.56, 95% CI: -3.82 to -1.30, p<0.001, I2 = 19.4%). No effect on TC (p = 0.088), TG (p = 0.824), HDL-C (p = 0.491), LDL-C (p = 0.910), FBS (p = 0.267), HbA1c (p = 0.339) or body weight (p = 0.439) were found for kefir treatment. Kefir has a beneficial effect in decreasing insulin resistance; however, no effect was seen on BW, FBS, HbA1C, and lipid profile.

Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, in moderate to severe plaque psoriasis: evaluation of lipid parameters in the phase 3 POETYK PSO-1 and PSO-2 trials

Introduction: Tyrosine kinase 2 (TYK2), an intracellular kinase, mediates signaling of cytokines (IL-23 and Type I interferons) involved in psoriasis pathogenesis. Deucravacitinib, an oral, selective, allosteric TYK2 inhibitor, is approved by the US Food and Drug Administration for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Deucravacitinib was significantly more efficacious than placebo or apremilast and was well tolerated in the phase 3 POETYK PSO-1 and PSO-2 trials. We evaluated changes in lipid parameters in these trials.&#x0D; Methods: PSO-1 (NCT03624127) and PSO-2 (NCT03611751) were 52-week, double-blind trials conducted globally. Patients with moderate to severe plaque psoriasis (PASI ≥12, sPGA ≥3, BSA involvement ≥10%) were randomized 1:2:1 to oral placebo, deucravacitinib 6 mg once daily, or apremilast 30 mg twice daily. This analysis evaluated serum lipids in patients taking placebo, deucravacitinib, or apremilast during Weeks 0-16 and those taking deucravacitinib continuously during Weeks 0-52 in PSO-1 and PSO-2. Mean changes in total cholesterol, HDL cholesterol, LDL cholesterol, and triglyceride levels are reported, as are shifts from baseline in CTCAE v5 severity grade of hypercholesterolemia and hypertriglyceridemia.&#x0D; Results: 666 and 1020 patients were randomized in PSO-1 and PSO-2, respectively. Mean baseline levels of total cholesterol, HDL cholesterol, and LDL cholesterol were comparable between treatment groups. Mean changes from baseline to Week 16 were small; none was clinically meaningful. Worsening of hypercholesterolemia grade from baseline was observed with similar frequencies among patients receiving placebo, deucravacitinib, and apremilast (10.6%, 11.7%, and 8.4%, respectively); nearly all shifts were 1 grade, and there was no grade ≥3 event. Baseline triglyceride levels were near the upper limit of normal (150 mg/dL) across treatment groups. A 10.3 mg/dL increase in mean triglycerides from baseline to Week 16 was observed with deucravacitinib, but worsening in hypertriglyceridemia &gt;1 grade from baseline was rare (1.2%) and comparable to placebo (1.4%). Most deucravacitinib-treated patients maintained the same or shifted to a lower grade of hypertriglyceridemia from baseline to Week 16. Among patients treated with deucravacitinib continuously for 52 weeks, mean changes in total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides were small. Shifts in &gt;1 grade from baseline for hypercholesterolemia and hypertriglyceridemia were uncommon (0.2% and 1.9%, respectively). No patient discontinued deucravacitinib due to a lipid-related adverse event.&#x0D; Conclusion: There were no meaningful changes in total cholesterol, HDL cholesterol, and LDL cholesterol levels with deucravacitinib treatment. Minimal increases in mean triglyceride levels from baseline to Weeks 16 and 52 were accompanied by very few worsening shifts &gt;1 grade.

Effects of epigallocatechin-3-gallate of Camellia sinensis leaves on blood pressure, lipid profile, atherogenic index of plasma and some inflammatory and antioxidant markers in type 2diabetes mellitus patients: a clinical trial.

In patients with type 2 diabetes mellitus (T2DM) the inflammatory and metabolic responses to epigallocatechin-3-gallate (EGCG) are unknown. Evaluate the impacts of EGCG on metabolic factors and some biomarkers of stress oxidative in patients with T2DM. In this randomized, double-blind, placebo-controlled trial, 50 patients with T2DM consumed either 2tablets (300mg) EGCG (n=25) or wheat flour as placebo (n=25) for 2months. The total antioxidant capacity (TAC), interleukin-6 (IL-6), lipid profile, mean arterial pressure (MAP), atherogenic index of plasma (AIP) were evaluated before and after the intervention. The finding of present study exhibited a significant increase in the serum levels of TAC after the EGCG supplementation (p=0.001). Also, in compare with control group, the mean changes of TAC were significantly higher in supplement group (p=0.01). In intervention group, a significant decrease was observed in the mean levels of triglyceride, total cholesterol, diastolic blood pressure (DBP), AIP, and MAP (p<0.05). Taking EGCG resulted in the mean changes of total cholesterol, MAP and DBP were significantly lower in compare with control group (p<0.05). This study recommended that EGCG supplementation may be improved blood pressure, lipid profile, AIP, and oxidative status in patients with T2DM.

Effect of weight-loss diet combined with taurine supplementation on body composition and some biochemical markers in obese women: a randomized clinical trial.

Taurine (Tau), an endogenous non-protein and sulfuric-amino acid, is involved in various biological pathways including anti-inflammatory, anti-oxidation, insulin resistance inhibition, and lipid profile improvement. According to some experimental and clinical studies, insulin resistance and excess body weight are associated with reduced serum level of Tau. Therefore, this study was aimed to evaluate Tau supplementation and a diet-induced weight-loss intervention on body composition and some biochemical indices of obese women. Participants were divided randomly into the intervention (standard weight-loss group + cap Tau 3 g/day for 8weeks, n = 20) and control (standard weight-loss group + cap placebo for 8weeks, n = 18) groups. To achieve weight loss, all participants received an individualized diet that included a 30% reduction in their total energy intake. Chi-square test was applied to compare categorical variables between two groups at baseline. Paired t test and independent-sample t test were also used to analyze the parametric continuous data within and between the two groups, respectively. Analysis of covariance was run for controlling the confounding variables. At the post-intervention, the mean changes of total cholesterol (p = 0.03), low-density lipoprotein cholesterol (p = 0.03), leptin (p = 0. 006), total adiponectin (p = 0.04), and high sensitivity C-reactive protein (p = 0.03) decreased significantly in Tau group compared with the control group. No significant results were found in the mean changes of high-density lipoprotein cholesterol, anthropometric measurements, glycemic indices, and liver enzymes between the two groups (p > 0.05). The findings showed that Tau supplementation along with a weight-loss diet may be more effective in improving the lipid profile and metabolic risk factors compared with a weight-loss diet alone.

The responses of different dosages of egg consumption on blood lipid profile: An updated systematic review and meta-analysis of randomized clinical trials.

Diverse notions exist regarding egg intake, which is one of the main sources of dietary cholesterol, and its effect on blood lipids. We conducted this study to update the previous meta-analysis for their flaw in calculated effect size. PubMed, Scopus, ISI, and Cochrane were searched up to April 2019, for relevant randomized controlled clinical trials. Mean changes in total cholesterol (TC), LDL-cholesterol (LDL-C), HDL-cholesterol (HDL-C), triglyceride (TG), very low-density lipoprotein cholesterol (VLDL-C), LDL-C/HDL-C, TC/HDL-C, apolipoprotein (apo)A1, and apoB100 were assessed. Meta-analysis of 66 RCTs with 3,185 participants revealed that egg consumption can significantly increase TC, LDL-C, HDL-C, TC/HDL-C, apoA1/and B100, but there was no significant effect on other serum lipids. Dose-response analysis showed a linear effect for TC, HDL-C, ApoA1, ApoB100, and nonlinear for LDL-C, and TC/HDL-C. In conclusion, intake of more than one egg daily in less than 12weeks may increase some blood lipids without any changes in the ratio of LDL-C/HDL-C. PRACTICAL APPLICATIONS: There are controversies reports for egg intake, which is one of the main sources of dietary cholesterol. This study provides comprehensive information about the effect of the number of eggs consumed per day (dietary cholesterol) on blood lipids for nutritionists, physicians, researchers, and the general population. In this regard, our results indicated that there is a linear correlation between consumption of greater than one egg per day in a short time (no long time) and increasing lipid profiles which may increase the risk of cardiovascular diseases. However, consumption of one egg daily can be safe and this can be a useful recommendation for prevention of cardiovascular disease and promotion of healthy life which indeed are the potential or actual uses of this research.

The interaction of cholesteryl ester transfer protein gene variations and diet on changes in serum lipid profiles.

Gene-diet interactions may have an important role in the disparities between the lipid responses of individuals to diet. This study aimed to investigate whether polymorphisms (rs5882 and rs3764261) in the cholesteryl ester transfer protein (CETP) gene modify the association of diet with changes in serum lipid profiles. A total of 4700 individuals aged ≥18 years were selected from among participants of the Tehran Lipid and Glucose Study. After 3.6 years of follow-up, changes in serum lipid profiles were evaluated. Usual dietary intake was assessed using a validated food frequency questionnaire. DNA samples were genotyped with HumanOmniExpress-24-v1-0 bead chips (containing 649,932 SNP loci). No significant interaction was found between CETP polymorphisms and dietary patterns in changing lipid profiles. Mean changes of total cholesterol (TC) decreased in higher quartiles of fish intake in A allele carriers (Q1:8.02, Q4:5.58, Ptrend = 0.01) compared to the CC genotype (Q1:3.65, Q4:8.93, Ptrend = 0.11) (Pi = 0.02). There are ascending trends of changes in triglyceride (TG) concentrations across quartiles of total fat, monounsaturated and saturated fat consumption in G allele carriers of rs5882 compared to the AA genotype. There was a declining trend for mean changes in TG concentrations across quartiles of carbohydrate intake in G allele carriers of rs5882 compared to the AA genotype (Pi = 0.01). Our data demonstrated that minor allele carriers of rs5882 had a better TG value than AA homozygote individuals when consuming a low fat and high carbohydrate diet. Fish intake modifies the association of rs3764261with TC concentrations.

Feasibility of engaging college students in a 10-day plant-based diet

Objective: This study sought to determine the feasibility of (a) engaging college students in experiential learning through a 10-day whole foods plant-based diet intervention, (b) bringing pertinence to the course topics that had an emphasis on chronic conditions and (c) understanding how the intervention influenced students’ perceptions and behaviours. Design: Quasi-experimental design. Biomarkers, dietary perceptions and behaviours were collected at baseline and 11-day post-intervention. Setting: The study was implemented in the context of an undergraduate/graduate public health course. Method: We assessed the feasibility of the intervention using an acceptability focus, including participant retention in the intervention, and participant self-reported experience with the plant-based diet. We also utilised an implementation research focus, concerning the extent, likelihood and manner in which an intervention can be fully implemented as planned and proposed. Results: The intervention was determined to be feasible. Participants learned that their diet can affect multiple health conditions and all changed their diet in some way or another as a result. Of the 10 participants, mean change in total cholesterol was −26 mg/dL, high-density lipoprotein (HDL) cholesterol was −6.1 mg/dL and low-density lipoprotein (LDL) cholesterol was −21.6 mg/dL, all with p values &lt;.05. Conclusion: Findings suggest that through experiential learning, students will consider a whole food plant-based diet and/or make some personal lifestyle changes as a result.

Effects of bee propolis supplementation on glycemic control, lipid profile and insulin resistance indices in patients with type 2 diabetes: a randomized, double-blind clinical trial

BackgroundPropolis, a natural resinous substance made by bees from material extracted from plants, flowers and bee's wax, has shown great therapeutic effects and been widely used in food and drug industries. Recently, some researchers have studied the effect of this substance in the treatment of diabetes. ObjectiveThe purpose of this trial was to determine the effect of bee propolis on glycemic control, serum lipid profile and insulin resistance indices in patients with type 2 diabetes (T2D). Design, setting, participants and interventionsThis randomized clinical trial involved 66 patients with T2D, which were randomly divided into two groups of intervention (IG) and placebo (PG). IG received 300 mg three times a day for a total of 900 mg/d of propolis pills, while PG received similar pills, lacking propolis, on the same schedule for 12 weeks. Main outcome measuresFasting blood glucose (FBG), hemoglobin A1c (HbA1c), total cholesterol (TC), low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglyceride (TG), serum insulin and insulin resistance indices were the main outcome measures. ResultsThe mean change in FBG between the IG ((17.76 ± 27.72) mg/dL decrease) and the PG ((6.48 ± 42.77) mg/dL increase) was significantly different (P = 0.01). Change in mean HbA1c had a similar pattern to FBG. The mean change in TC between the IG ((5.16 ± 43.80) mg/dL increase) and the PG ((28.9 ± 27.4) mg/dL increase) was also significantly different (P = 0.01), showing the protective role of propolis against the increase in TC. The change in mean LDL was similar to mean TC. There was no significant difference in other lipids or insulin resistance indices between the two groups. ConclusionBased on this study, the daily intake of 900 mg of bee propolis supplement for 12 weeks results in improvement of glycemic and some serum lipid levels in patients with T2D. Trial registrationThis study is registered on the website of Iranian Ministry of Health (www.irct.ir) with proprietary code of IRCT2014080218659N1.

Effect of Atorvastatin on Growth Differentiation Factor-15 in Patients with Type 2 Diabetes Mellitus and Dyslipidemia.

BackgroundElevated serum levels of growth differentiation factor-15 (GDF-15) are associated with type 2 diabetes. Therefore, the effects of atorvastatin on metabolic parameters and GDF-15 levels in patients with type 2 diabetes and dyslipidemia were evaluated.MethodsIn this prospective randomized trial from February 2013 to March 2014, 50 consecutive type 2 diabetic patients with a low density lipoprotein cholesterol (LDL-C) levels ≥100 mg/dL were enrolled. The patients were divided into two groups based on the amount of atorvastatin prescribed, 10 mg/day (n=23) or 40 mg/day (n=27). The effect of atorvastatin on metabolic parameters, including lipid profiles and GDF-15 levels, at baseline and after 8 weeks of treatment were compared.ResultsThe baseline metabolic parameters and GDF-15 levels were not significantly different between the two groups. After 8 weeks of treatment, the total cholesterol (TC) and LDL-C levels were significantly decreased in both groups. The mean changes in TC and LDL-C levels were more significant in the 40 mg atorvastatin group. The GDF-15 level was decreased in the 10 mg atorvastatin group, from 1,460.6±874.8 to 1,451.0±770.8 pg/mL, and was increased in the 40 mg atorvastatin group, from 1,271.6±801.0 to 1,341.4±855.2 pg/mL. However, the change in the GDF-15 level was not statistically significant in the 10 or 40 mg atorvastatin group (P=0.665 and P=0.745, respectively).ConclusionThe GDF-15 levels were not significantly changed after an 8-week treatment with atorvastatin in type 2 diabetic patients.

Effect of cilostazol on carotid intima-media thickness in type 2 diabetic patients without cardiovascular event

We investigated the efficacy of cilostazol treatment for 2 years on the attenuation of carotid intima-media thickness (IMT) progression in type 2 diabetic patients without cardiovascular disease history, as compared with other antiplatelet agents. We recruited a total of 230 type 2 diabetic patients who had undergone IMT measurement twice within 1.5-2.5 years (mean 2.06 ± 0.32 years) interval. Among these participants, we classified them into three groups according to antiplatelet agent administration at baseline: Group I (n = 66), antiplatelet naïve; Group II (n = 75), other antiplatelet agent administration; and Group III (n = 50), cilostazol administration. We then analyzed the changes in clinical characteristics from baseline to 2 years. The changes in annual mean IMT at 2 years were 0.019 ± 0.045 mm/year, -0.001 ± 0.058 mm/year, and -0.019 ± 0.043 mm/year for Group I, II, and III, respectively (P < 0.001). Mean change in total cholesterol, low-density lipoprotein-cholesterol, and triglyceride compared with baseline decreased the most in Group III even after adjustment for statin use. We also observed that the odds ratio of carotid IMT progression at 2 years was the lowest in patients who were treated with cilostazol even after adjustment for change of metabolic parameters. When we categorized patients according to baseline carotid IMT tertile, the efficacy of cilostazol against carotid IMT progression was significant only when baseline IMT was over 0.662 mm (mean 0.801). Two-year treatment with cilostazol strongly inhibited carotid IMT progression compared to other antiplatelet agents in type 2 diabetic patients. This beneficial effect of cilostazol was significant when baseline IMT was thicker than 0.662 mm (mean 0.801 mm).

Beneficial effects of artichoke leaf extract supplementation on increasing HDL-cholesterol in subjects with primary mild hypercholesterolaemia: a double-blind, randomized, placebo-controlled trial

The aim of this study was to evaluate the effects of artichoke leaf extract (ALE) supplementation (250 mg, 2 b.i.d.) on the lipid pattern. A randomized, double-blind, placebo-controlled clinical trial was performed on 92 overweight subjects with primary mild hypercholesterolaemia for 8 weeks. Forty-six subjects were randomized to supplementation (age: 54.2 ± 6.6 years, body mass index (BMI): 25.8 ± 3.9 kg/m2, male/female: 20/26) and 46 subjects to placebo (age: 53.8 ± 9.0 years, BMI: 24.8 ± 1.6 kg/m2, male/female: 21/25). Verum supplementation was associated with a significant increase in mean high-density lipoprotein (HDL)-cholesterol (p < 0.001) and in mean change in HDL-cholesterol (HDL-C) (p = 0.004). A significantly decreased difference was also found for the mean change in total cholesterol (p = 0.033), low-density lipoprotein (LDL)-cholesterol (p < 0.001), total cholesterol/HDL ratio (p < 0.001) and LDL/HDL ratio (p < 0.001), when verum and placebo treatment were compared. These results indicate that ALE could play a relevant role in the management of mild hypercholesterolaemia, favouring in particular the increase in HDL-C, besides decreasing total cholesterol and LDL-cholesterol.

Metabolic Effects of Darunavir/Ritonavir Versus Atazanavir/Ritonavir in Treatment-Naive, HIV Type 1-Infected Subjects over 48 Weeks

We assessed metabolic changes for darunavir/ritonavir (DRV/r) once daily (qd) versus atazanavir/ritonavir (ATV/r) qd with fixed-dose tenofovir/emtricitabine. This was a phase 4, multicenter, open-label, randomized exploratory study. Treatment-naive, HIV-1-infected adults received DRV/r 800/100 mg qd or ATV/r 300/100 mg qd, both with emtricitabine/tenofovir 200/300 mg qd. Primary end point: change in triglyceride levels from baseline to week 12. Secondary end points: week 12 and week 48 changes in lipid parameters, insulin sensitivity, inflammatory/coagulation/bacterial translocation biomarkers, viral load, CD4(+) cell count, and week 48 changes in adipose tissue distribution and subjects' perceptions of body changes. In the DRV/r arm, 32/34 and 29/34 subjects completed weeks 12 and 48, respectively; in the ATV/r arm, 30/31 and 25/31 subjects completed weeks 12 and 48, respectively. Small changes in lipid parameters from baseline to weeks 12 and 48 were observed in both arms. Differences were noted between arms in mean changes in total cholesterol (DRV/r, 20.3 mg/dl; ATV/r, 4.6 mg/dl) and apolipoprotein A1 (DRV/r, 10.7 mg/dl; ATV/r, -0.7 mg/dl) at week 12. At week 48, no clinically relevant differences between arms were noted for changes in any lipid parameter, fasting glucose, or insulin sensitivity. Biomarkers generally decreased and efficacy parameters improved in both arms over 48 weeks. Changes in adipose tissue were small and comparable between arms. Subjects' perceptions of body changes generally improved in both study arms. This first pilot comparison in HIV-1-infected subjects suggests that DRV/r has a metabolic profile similar to ATV/r over 48 weeks of treatment. Further randomized studies are warranted.

Influence of vitamin D supplementation on plasma lipid profiles: A meta-analysis of randomized controlled trials

Observational studies have shown that low serum levels of vitamin D have been associated with an atherogenic lipid profile. However, the intervention studies gave divergent results. We conducted a meta-analysis of randomized controlled trials that evaluated the effects of vitamin D supplementation on blood lipids. A systematic literature search was conducted via MEDLINE, Cochrane library, and EMBASE for randomized controlled clinical trials assessing the effects of vitamin D supplementation on lipids. The mean change in total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C) and triglycerides (TG) from baseline was treated as a continuous variable. In all, 12 clinical trials consisting of 1346 participants were included in the analysis. The pooled estimate of effect for vitamin D supplementation on LDL-C was 3.23 mg/dl (95% confidence interval, 0.55 to 5.90 mg/dl). No statistically significant effects for vitamin D supplementation were observed for TC, HDL-C and TG (differences in means were 1.52 mg/dl (-1.42 to 4.46 mg/dl), -0.14 mg/dl (-0.99 to 0.71 mg/dl) and -1.92 mg/dl (-7.72 to 3.88 mg/dl) respectively). The lipid modulating effects of vitamin D supplementation should be further investigated though large-scale, randomized trials with adequate doses which can effectively elevated the active form of vitamin D in plasma and with proper population which has hyperlipemia as an inclusion criterion.

Impact of rosiglitazone therapy on the lipid profile, glycemic control, and medication costs among type 2 diabetes patients

Objective:To investigate the impact of rosiglitazone therapy on lipid profiles, glycemic control, and costs associated with cholesterol-lowering and diabetic medications among Type 2 diabetes mellitus (T2DM) patients in a standard practice setting.Method:This retrospective cohort study was conducted using data from the General Practice Research Database during 1999–2006. T2DM patients were classified based on the addition of rosiglitazone versus either metformin or a sulfonylurea (‘comparison group’) to pre-existing glucose lowering agents. After propensity score matching to control for differences in baseline patient characteristics, 1450 matched pairs were identified. The mean changes in total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), glycosylated hemoglobin A1C (A1C), and daily medication costs were calculated. To investigate the incremental costs for lipid-lowering medications, a two-part model was utilized.Results:The mean changes in TC and A1C for the rosiglitazone and metformin/sulfonylurea groups were 9 vs −10 mg/dL for TC, −2 vs −9 mg/dL for LDL-C, and -0.8% vs. −1.2% for A1C, respectively. The mean changes in daily medication costs of glucose- and lipid-lowering drugs were $3.95 for rosiglitazone patients and $0.27 for metformin/sulfonylurea patients. For patients with positive incremental lipid-lowering costs, rosiglitazone use was significantly associated with costs eight times greater than metformin/sulfonylureas.Generalizability of the study is limited due to cost estimates using the national formulary and potential selection bias.Conclusions:Addition of rosiglitazone to an existing antidiabetic medication regimen improved glycemic control to a lesser extent than metformin/sulfonylurea, and also deteriorated patients’ lipid profiles, leading to significantly greater daily costs. Economic evaluations of alternative therapies should consider such costs to estimate the full impact of different therapeutic approaches in diabetes.

The large clinical statin trials

The 4S study [1] is a landmark study in which 4444 patients with coronary heart disease (CHD) and cholesterol 5.5–8.0mmol/L were randomized to 20–40mg simvastatin or placebo (Table 1). Over the 5.4years median follow-up period, simvastatin produced mean changes in total cholesterol and LDL-cholesterol of −25% and −35%, respectively. The risk of death and major cardiovascular event was reduced by 30% and 34%, respectively, in the simvastatin group. In the Heart Protection study (HPS) 20536 patients with CHD, other occlusive arterial disease, or diabetes and with total cholesterol ≥3.5mmol/L were randomized to 40mg simvastatin or placebo [2].

Supplementation of Enteric-coated Ginger and Garlic Essence Tablet Improved Blood Lipid Profile in Rats Fed High-fat Diet and Hyperlipidemic Subjects

To evaluate the hypolipidemic effect, enteric-coated ginger and garlic essence tablet was produced through the modern pharmaceutical manufacture technique. Rats fed high-fat diet were developed to moderate degree of hyperlipidemia. Experimental group was assigned to orally expose to three different doses of essence tablet for 30 consecutive days. Through the course of treatment serum total cholesterol (TCh) and triglyceride (TG) in 220 mg/kg BW group were significantly lower than that in control group. In addition, a double blind, placebo-controlled clinical trial was conducted on patients with newly diagnosed exclusive hyperlipidemia. Participants were randomly divided into two groups of 52 cases each. Experimental group received one piece of ginger and garlic essence tablet twice daily. At the end of the 30-day trial, TCh and TG in experimental group were significantly lower than the baseline, respectively. Moreover, TCh and TG in experimental group were significantly lower than that in placebo group. Specifically the mean changes of TCh and TG in experimental group were extreme significantly higher than those in placebo group. These data implied that enteric-coated ginger and garlic tablet remarkably improved blood lipid profile in rats fed high-fat diet and hyperlipidemic subjects.

Prospective, Randomized, Open Label Trial of Efavirenz vs Lopinavir/Ritonavir in HIV+ Treatment-Naive Subjects With CD4+&lt;200 cell/mm3 in Mexico

To compare the efficacy of efavirenz (EFV) vs lopinavir/ritonavir (LPV/r) in combination with azidothymidine/lamivudine in antiretroviral therapy naive, HIV+ individuals presenting for care with CD4 counts <200/mm. Prospective, randomized, open label, multicenter trial in Mexico. HIV-infected subjects with CD4 <200/mm were randomized to receive open label EFV or LPV/r plus azidothymidine/lamivudine (fixed-dose combination) for 48 weeks. Randomization was stratified by baseline CD4 cell count (< or =100 or >100/mm). The primary endpoint was the percentage of patients with plasma HIV-1 RNA <50 copies/mL at 48 weeks by intention-to-treat analysis. A total of 189 patients (85% men) were randomized to receive EFV (95) or LPV/r (94). Median baseline CD4 were 64 and 52/mm, respectively (P = not significant). At week 48, by intention-to-treat analysis, 70% of EFV and 53% of LPV/r patients achieved HIV-1 RNA <50 copies/mL [estimated difference 17% (95% confidence interval 3.5 to 31), P = 0.013]. The proportion with HIV-1 RNA <400 copies/mL was 73% with EFV and 65% with LPV/r (P = 0.25). Virologic failure occurred in 7 patients on EFV and 17 on LPV/r. Mean CD4 count increases (cells/mm) were 234 for EFV and 239 for LPV/r. Mean change in total cholesterol and triglyceride levels were 50 and 48 mg/dL in EFV and 63 and 116 mg/dL in LPV/r (P = 0.24 and P < 0.01). In these very advanced HIV-infected ARV-naive subjects, EFV-based highly active antiretroviral therapy had superior virologic efficacy than LPV/r-based highly active antiretroviral therapy, with a more favorable lipid profile.

Statins: established indications and controversial subgroups

Statins are, to date, the most powerful cholesterol lowering drugs. In brief, they inhibit 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase, which is a key enzyme in the initial chain of the steroid...

Resin from the mukul myrrh tree, guggul, can it be used for treating hypercholesterolemia? A randomized, controlled study

Guggul, herbal extract from resin of the Commiphora mukul tree, is widely used in Asia as a cholesterol-lowering agent based on Indian Ayurvedic medicine. Its popularity for this use is increasing in the US and Western Europe. Guggulsterones, the presumed bioactive compounds of guggul, may antagonise two nuclear hormone receptors involved in cholesterol metabolism, which is a possible explanation for hypolipidemic effects of these extracts. However, publications of efficacy data on the use of guggul extracts in Western populations are scarce. To study the efficacy of a guggul-based formulation (short: guggul) on blood lipids in healthy adults with moderately increased cholesterol. Double-blind, randomised, placebo controlled trial in Norwegian general practice. 43 women and men, age 27-70, with moderately increased cholesterol, randomised to use 2160mg guggul (4 capsules) daily, or placebo for 12 weeks. Mean change in total cholesterol, low-density lipoprotein cholesterol (LDL-C), triglycerides, high-density lipoprotein cholesterol (HDL-C) and total cholesterol/HDL-C ratio compared with baseline. Lipids were analysed at baseline, and at 6 and 12 weeks. In addition, unexpected events and adverse effects were recorded. Two dropouts, one withdrawal, and incomplete lab results for six persons left 34 participants to accomplish the trial (18-guggul, 16-placebo) with complete lab test data. After 12 weeks, mean levels of total cholesterol and HDL-C in the active group were significantly reduced compared with the placebo group. However, the mean levels of LDL-C, triglycerides, and total cholesterol/HDL-C ratio between the two groups did not change significantly. Ten guggul users (vs. four in the placebo group) reported side effects: mild gastrointestinal discomfort (n=7), possible thyroid problems (n=2), and generalized skin rash (n=1). The latter resulted in withdrawal from trial. Even if total cholesterol and HDL-C were significantly reduced, the clinical magnitude of this remains obscure. More and larger studies are needed to establish effects and safety of guggul-based formulations in the treatment for hypercholesterolemia.