Mg Of Atorvastatin Research Articles

The Influence of Combined Therapy on Lipid, Glucose Profile in Patients with Diabetes Mellitus Type II

According to the International Federation of Diabetes, 7% of the population of the world suffers from diabetes. Optimizing the treatment of diabetes with herbal medicines will reduce the patient’s drug burden.The objective: the aim of the study was to assess the efficacy of combined treatment with the complex vitamin-herbal pills Insuvit, Metformin and Atorvastatin in patients with diabetes mellitus type II.Materials and methods. 69 patients (women – 44, men – 25) were treated with diabetes mellitus type II in the therapeutic department of the University Hospital of the ESMC «University Clinic». The average age was 63,4±7,82 years, the duration of diabetes – 7,0±4,11 years. Fasting blood glucose levels, glycosylated hemoglobin (HbA1c), lipid profile were determined onset. Patients were randomized on 2 groups: the main group – 33 patients, who received additionally Insuvit (1 tablet twice a day) for 12 weeks to standard therapy (20 mg of Atorvastatin, 1000 mg of Metformin). Control – 36 patients with similar therapy, but without the appointment of Insuvit.Results. The levels of HbA1c (by 10,7%), glucose (by 14,7%) and triglycerides (by 35,4%) (p<0,05) significantly decreased after 12 weeks therapy in the main group in comparison with control group. In 39,4% patients of the main group there was s decrease in the sensation of paresthesias, which led to an improvement in overall well-being.Conclusions. The additional use of the drug Insuvit accelerates the compensation of glucose and HbA1c levels in patients with diabetes mellitus type II, which allows them to reach their target levels more quickly.

Reduction of No Reflow with a Loading Dose of Atorvastatin before Primary Angioplasty in Patients with Acute ST Myocardial Infarction

No reflow defined as an altered myocardial reperfusion and failure at microvascular level is a frequent complication in acute myocardial infarction that attenuates beneficial effect of reperfusion therapy leading to poor outcomes. There is not enough evidence to support that previous use of statins improves coronary flow in patients undergoing primary percutaneous coronary intervention (PCI). To determine if a loading dose of 80mg of atorvastatin before primary angioplasty reduces the frequency of no reflow, hs-CRP, IL6 intracoronary levels, and major combined cardiovascular events at 30d. In this controlled clinical trial, we randomly assigned 103 adult patients within the 12h of acute ST-elevation myocardial infarction (STEMI) to receive 80mg of atorvastatin additional to standard treatment (AST) before performing primary PCI versus standard treatment (ST) alone. The primary outcomes were the occurrence of no reflow and high sensitivity C-reactive protein (hs-CRP) and interleukin 6 levels and secondary outcomes were major adverse cardiovascular events at 30d. 103 patients were analyzed, 49 (48%) received AST, 54 (52%) ST. Frequency of no reflow among groups was 27 vs. 63% respectively, p ≤0.0001. hs-CRP level was 2.69mg/dL for AST vs. 2.2mg/dL in ST, meanwhile IL-6 levels were 5.2 pg/mL vs. 6.35 pg/mL respectively, p=ns. Cox regression model demonstrated that the treatment assigned is an independent predictor for no reflow occurrence (HR 0.34 95%, CI 0.18-0.61, p ≤0.001). The administration of a loading dose of 80mg atorvastatin before primary PCI is an effective strategy for prevention of no reflow improving also clinical outcomes and free survival rate for the presentation of major adverse cardiovascular events at 30d.

Treatment pattern of familial hypercholesterolemia in Slovakia: Targets, treatment and obstacles in common practice

Background and aimsMaximal doses of potent statins are the cornerstone of treatment of familial hypercholesterolemia (FH). Despite this, a substantial proportion of FH patients are either under-treated or not treated at all. The aim of this work was to evaluate, in a retrospective study, the treatment of FH patients, the proportion of FH patients reaching low-density lipoprotein cholesterol (LDL-C) goals, and reasons for not reaching LDL-C goals, in 8 lipid clinics in Slovakia dealing with FH patients. Methods201 heterozygous FH patients (50.8 ± 14.9 years, 55% females) who attended the lipid clinics at least three times were included in the study. ResultsAt the first visit, 31.3% of patients were treated with statins and the most common dose was 20 mg of atorvastatin, rosuvastatin and simvastatin. At the third visit, 78.1% of patients were treated with statins and 24.4% with ezetimibe. The majority of patients were treated with atorvastatin (75.8%) and rosuvastatin (18.5%) and 31.3% of all patients were treated with atorvastatin 80 mg or rosuvastatin 40 mg with/without ezetimibe. However, only 11.9% of patients with the LDL-C goal level <2.5 mmol/l and 6.9% with the goal <1.8 mmol/l reached the level. Reasons for not reaching the goal levels were evaluated by physicians in each patient. Insufficient LDL-C lowering effect of treatment, side-effects of therapy and non-compliance of patients were responsible for 46%, 18% and 30% of cases, respectively. ConclusionsReferral of FH patients to lipid clinics in Slovakia leads to improvement in the treatment; however, almost 22% of the patients are still without statin treatment and the majority of patients do not reach the LDL-C goal level.

Cholesterol efflux capacity of large, small and total HDL particles is unaltered by atorvastatin in patients with type 2 diabetes

Background and aimsResearch on the biologic activities of HDL, such as cholesterol efflux capacity and HDL composition, has allowed the understanding of the effect of interventions directed to improve cardiovascular risk. Previously, statin therapy has shown conflicting results about its effects on cholesterol efflux capacity of HDL; the underlying mechanisms are unclear but studies with positive effects are associated with an increase of HDL-cholesterol levels. We investigated if 10 weeks of atorvastatin therapy changes HDL efflux capacity and the chemical composition of its subpopulations. MethodsIn a before-after design basis, HDL-cholesterol levels, chemical composition and cholesterol efflux capacity from HDL subpopulations isolated by isophynic ultracentrifugation were assessed in plasma samples from 60 patients with type 2 diabetes mellito (T2DM) at baseline and after 10 weeks of treatment with 20 mg atorvastatin. Cholesterol efflux was measured from human THP-1 cells using large, light HDL2b and small, dense 3c subpopulations as well as total HDL as acceptors. Changes of cholesterol efflux and chemical composition of HDL after treatment were analyzed. Correlations among variables potentially involved in cholesterol efflux were evaluated. ResultsA significant decrease of 4% in HDL-cholesterol levels was observed from 47 (42–54) to 45 (39–56) mg/dL, p = 0.02. Cholesterol efflux from total-HDL and HDL2b and 3c subfractions was maintained unchanged after treatment. The total mass of HDL remained unaffected, except for the HDL3a subpopulation accounted for by a significant increase in total protein content. No significant correlations for variables previously known to be associated with cholesterol efflux were found in our study. ConclusionsShort therapy of 10 weeks with 20 mg of atorvastatin does not modify the cholesterol efflux capacity neither the total mass of HDL2b, HDL3c and total HDL. The discrepancy with previous reports may be due to the selective effects among different classes of statins or differences in the approaches to measure cellular cholesterol efflux.

Safety and Efficacy of Atorvastatin for Chronic Subdural Hematoma in Chinese Patients

Chronic subdural hematoma (CSDH) is a trauma-associated condition commonly found in elderly patients. Surgery is currently the treatment of choice, but it carries a significant risk of recurrence and death. Nonsurgical treatments remain limited and ineffective. Our recent studies suggest that atorvastatin reduces hematomas and improves the clinical outcomes of patients with CSDH. To investigate the safety and therapeutic efficacy of atorvastatin to nonsurgically treat patients with CSDH. The Effect of Atorvastatin on Chronic Subdural Hematoma (ATOCH) randomized, placebo-controlled, double-blind phase II clinical trial was conducted in multiple centers in China from February 2014 to November 2015. For this trial, we approached 254 patients with CSDH who received a diagnosis via a computed tomography scan; of these, 200 (78.7%) were enrolled because 23 patients (9.1%) refused to participate and 31 (12.2%) were disqualified. Patients were randomly assigned to receive either 20 mg of atorvastatin or placebo daily for 8 weeks and were followed up for an additional 16 weeks. The primary outcome was change in hematoma volume (HV) by computed tomography after 8 weeks of treatment. The secondary outcomes included HV measured at the 4th, 12th, and 24th weeks and neurological function that was evaluated using the Markwalder grading scale/Glasgow Coma Scale and the Barthel Index at the 8th week. One hundred ninety-six patients received treatment (169 men [86.2%]; median [SD] age, 63.6 [14.2] years). The baseline HV and clinical presentations were similar between patients who were taking atorvastatin (98 [50%]) and the placebo (98 [50%]). After 8 weeks, the HV reduction in patients who were taking atorvastatin was 12.55 mL more than those taking the placebo (95% CI, 0.9-23.9 mL; P = .003). Forty-five patients (45.9%) who were taking atorvastatin significantly improved their neurological function, but only 28 (28.6%) who were taking the placebo did, resulting in an adjusted odds ratio of 1.957 for clinical improvements (95% CI, 1.07-3.58; P = .03). Eleven patients (11.2%) who were taking atorvastatin and 23 (23.5%) who were taking the placebo underwent surgery during the trial for an enlarging hematoma and/or a deteriorating clinical condition (hazard ratio, 0.47; 95% CI, 0.24-0.92; P = .03). No significant adverse events were reported. Atorvastatin may be a safe and efficacious nonsurgical alternative for treating patients with CSDH. ClinicalTrials.gov Identifier: NCT02024373.

Fractal dimension based carotid plaque characterization from three-dimensional ultrasound images

Irregularity of the plaque surface associated with previous plaque rupture plays an important role in the risk estimation of stroke caused by carotid atherosclerotic lesions. Thus, the aim of this study is to develop and validate novel vulnerability biomarkers from three-dimensional ultrasound (3DUS) images by analyzing the surface morphological characteristics of carotid plaque using fractal geometry features. In the experiments, a total of 38 3DUS plaque images were obtained from two groups of patients treated with 80mg of atorvastatin or placebo daily for 3months respectively. Two types of 3D fractal dimensions (FDs) were used to describe the smoothness of plaque surface morphology and the roughness from intensity of 3DUS images. Student's t test showed that the two fractal features were effective for detecting the statin-related changes in carotid atherosclerosis with p < 0.00023 and p < 0.0113 respectively. It was concluded that the 3D FD measurements were effective for analyzing carotid plaque characteristics and especially effective for evaluating the impact of atorvastatin treatment. Graphical abstract ᅟ.

Efficacy of high-dose atorvastatin in preventing contrast-induced nephropathy in patients undergoing coronary angiography

Objective The aim of this study was to examine the efficacy of high-dose atorvastatin in preventing contrast-induced nephropathy (CIN) in statin-naive patients with moderate or high risk of CIN undergoing coronary angiography. Background CIN occurs in 20–30% of patients who receive standard preventive measures. This means that current treatments are not adequate. Patients and methods The present study included 300 patients scheduled for coronary angiography. They were randomized into two groups: the atorvastatin group received 80-mg atorvastatin 12 h before the procedure, with a further 40-mg preprocedural dose, and the placebo group did not receive the loading dose of atorvastatin. The primary end point of the study was evaluation of renal function before and 48 h after contrast-medium administration. Results A total of 300 patients were included in this study. The incidence of nephropathy in the placebo group was 20% (30 patients), whereas the incidence in the atorvastatin group was 9.3% (14 patients) (P = 0.009). Conclusion High-dose atorvastatin has a significant protective role against contrast-induced nephropathy in patients with moderate and high risk for contrast nephropathy undergoing coronary angiography.

Effects of First High-Dose Atorvastatin Loading in Patients With ST-Segment Elevation Myocardial Infarction Undergoing Percutaneous Coronary Intervention.

To determine the effects of 80-mg atorvastatin administration for the first time in patients with acute ST segment elevation myocardial infarction (STEMI) before emergency percutaneous coronary intervention (PCI). A total of 118 patients with STEMI who underwent emergency PCI were enrolled in this study. The patients were divided into 80-mg group (n = 59) and 40-mg group (n = 59), according to the loading dose of atorvastatin firstly before operation. The occurrence of no-reflows and changes of HbA1c were observed preoperatively and postoperatively on second and fifth days. All patients were followed up for 1 year with major adverse cardiac events (MACE) recorded. The incidence of no-reflow in 80-mg group was obviously lower than in 40-mg group (13.56% vs. 25.42%) (χ = 4.374, P = 4.374). The preoperative HbA1c levels exhibited no significant difference between 80-mg group and 40-mg group (P > 0.05). The postoperative HbA1c levels in 2 groups showed a trend of gradual decline, which were lower in 80-mg group than in 40-mg group for second day, fifth day, first month, sixth month, and 12th month (all P < 0.05). The postoperative incidence of MACE in 80-mg group was significantly lower than in 40-mg group for sixth and 12th months (both P < 0.05). The incidence of MACE in patients with reflow in 80-mg and 40-mg groups was significantly higher than in patients with no-reflow who were in 80-mg and 40-mg groups for postoperative 12th month (both P < 0.05). The first loading high dose of atorvastatin can significantly prevent occurrence of postoperative no-reflow in patients with STEMI after PCI, reduce HbA1c levels and the incidence of MACE. Clinical randomized controlled trial with larger sample size is required to confirm this finding.

The pharmacodynamic and clinical trial evidence for statin dose.

Statin doses around estimated effective dose 50 (ED50) can reduce myocardial infarction by over 25% and mortality by around 10%. Being a competitive enzyme inhibitor, statin efficacy plateaus at doses that are multiples above the ED50, whilst on- and off-target adverse events increase in number and severity with increasing dose. For example, myopathy has been shown to increase by up to 29-fold and liver dysfunction by up to nine-fold as statin dose is increased. Doses of up to 40-fold ED50 have been promoted, but above five-fold ED50, for example 10mg of atorvastatin, there is no randomized controlled clinical trial evidence that coronary mortality is lowered, or that survival is increased.

Effect of Loading Dose of Atorvastatin Prior to Planned Percutaneous Coronary Intervention on Major Adverse Cardiovascular Events in Acute Coronary Syndrome

The effects of loading doses of statins on clinical outcomes in patients with acute coronary syndrome (ACS) and planned invasive management remain uncertain. To determine if periprocedural loading doses of atorvastatin decrease 30-day major adverse cardiovascular events (MACE) in patients with ACS and planned invasive management. Multicenter, double-blind, placebo-controlled, randomized clinical trial conducted at 53 sites in Brazil among 4191 patients with ACS evaluated with coronary angiography to proceed with a percutaneous coronary intervention (PCI) if anatomically feasible. Enrollment occurred between April 18, 2012, and October 6, 2017. Final follow-up for 30-day outcomes was on November 6, 2017. Patients were randomized to receive 2 loading doses of 80 mg of atorvastatin (n = 2087) or matching placebo (n = 2104) before and 24 hours after a planned PCI. All patients received 40 mg of atorvastatin for 30 days starting 24 hours after the second dose of study medication. The primary outcome was MACE, defined as a composite of all-cause mortality, myocardial infarction, stroke, and unplanned coronary revascularization through 30 days. Among the 4191 patients (mean age, 61.8 [SD, 11.5] years; 1085 women [25.9%]) enrolled, 4163 (99.3%) completed 30-day follow-up. A total of 2710 (64.7%) underwent PCI, 333 (8%) underwent coronary artery bypass graft surgery, and 1144 (27.3%) had exclusively medical management. At 30 days, 130 patients in the atorvastatin group (6.2%) and 149 in the placebo group (7.1%) had a MACE (absolute difference, 0.85% [95% CI, -0.70% to 2.41%]; hazard ratio, 0.88; 95% CI, 0.69-1.11; P = .27). No cases of hepatic failure were reported; 3 cases of rhabdomyolysis were reported in the placebo group (0.1%) and 0 in the atorvastatin group. Among patients with ACS and planned invasive management with PCI, periprocedural loading doses of atorvastatin did not reduce the rate of MACE at 30 days. These findings do not support the routine use of loading doses of atorvastatin among unselected patients with ACS and intended invasive management. clinicaltrials.gov Identifier: NCT01448642.

LDL cholesterol levels after switch from atorvastatin to rosuvastatin

Objective: Initial statin therapy may not always adequately reduce elevated low-density lipoprotein cholesterol (LDL-C) levels. Although alternative therapies are available, switching to another statin may be beneficial, especially for those at highest risk of cardiovascular disease and events. This study examined changes in LDL-C levels following a switch from 40/80 mg of atorvastatin (ATV) to 20/40 mg of rosuvastatin (RSV).Methods: This retrospective cohort study used data from the MarketScan administrative claims databases linked to laboratory values. Patients with or at risk for atherosclerotic cardiovascular disease (ASCVD) who switched from ATV 40/80 mg to RSV 20/40 mg and had LDL-C values measured within 90 days before and 30–180 days after the switch were included. The change in LDL-C was quantified for each patient and summarized across all patients and within each switch pattern (e.g. ATV40 to RSV20).Results: There was a significant mean (SD) decrease in LDL-C of 21% (30%) across the whole sample (N = 136) after switching from ATV to RSV. The greatest decrease occurred in patients who switched from ATV40 to RSV40 (N = 20; −29% [19%]; p < .001). Similar changes were observed overall and within each switch pattern when the analysis was limited to patients who were persistent on RSV in the post-switch period (N = 112; −24% [24%]; p < .001).Conclusions: Switching from ATV to RSV was associated with a significant decrease in LDL-C among high-risk patients. Switching between these two high-intensity statins may offer a viable alternative to other treatment modifications aimed at lowering LDL-C in this population.

Rationale and design of the Statins Evaluation in Coronary procedUres and REvascularization: The SECURE-PCI Trial

BackgroundPrevious evidence suggests that acute treatment with statins reduce atherosclerotic complications, including periprocedural myocardial infarction, but currently, there are no large, adequately powered studies to define the effects of early, high-dose statins in patients with acute coronary syndrome (ACS) and planned invasive management. ObjectivesThe main goal of Statins Evaluation in Coronary procedUres and REvascularization (SECURE-PCI) Trial is to determine whether the early use of a loading dose of 80 mg of atorvastatin before an intended percutaneous coronary intervention followed by an additional dose of 80 mg 24 hours after the procedure will be able to reduce the rates of major cardiovascular events at 30 days in patients with an ACS. DesignThe SECURE-PCI study is a pragmatic, multicenter, double-blind, placebo-controlled randomized trial planned to enroll around 4,200 patients in 58 different sites in Brazil. The primary outcome is the rate of major cardiovascular events at 30 days defined as a composite of all-cause mortality, nonfatal acute myocardial infarction, nonfatal stroke, and coronary revascularization. SummaryThe SECURE PCI is a large randomized trial testing a strategy of early, high-dose statin in patients with ACS and will provide important information about the acute treatment of this patient population.

Lack of association between the ABCB1 G2677 W polymorphism and the lipid-lowering effects of atorvastatin in Tunisian patients

ABCB1, also known as P-glycoprotein (P-gp), is the most well studied member of the ATP-binding cassette (ABC) family of transporters. ABCB1 is embedded in the lumen-facing epithelial cell membranes of many biological barriers of organisms and is an efficient ATP-dependent efflux pump that is mainly responsible for the removal of numerous xenobiotics. However, ABCB1 may play a role in additional, more intrinsic functions. A number of researches have evaluated the association between the ABCB1 polymorphism and the lipid-lowering response of statins, but the results have been inconclusive. The aim of the present study was to investigate possible association between the ABCB1 G2677 W polymorphism and changes in lipids in patients following atorvastatin treatment. A total of 122 unrelated coronary patients (54.06 ± 8.74 years old) were enrolled in this study and given 40 mg of atorvastatin daily for 8 weeks. Total cholesterol (TC), triglyceride (TG), high-density lipoprotein (HDL), and low-density lipoprotein (LDL) serum levels were measured at baseline and after 8 weeks of treatment. ABCB1 G2677 W polymorphism was analyzed by polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP) method. The 8-week treatment with atorvastatin significantly reduced TC (1.37 ± 0.27 g/L vs. 1.87 ± 0.47 g/L; P = 0.03), TG (1.50 ± 0.30 g/L vs. 1.99 ± 0.70 g/L, P = 0.002), and LDL (0.77 ± 0.27 g/L vs. 1.15 ± 0.36 g/L, P = 0.001) levels, but there was no statistical difference among patients with wild type ABCB1 G2677 W in the lipid-lowering efficacy of atorvastatin. The present study found that the ABCB1 G2677 W polymorphism does not affect the lipid-lowering efficacy of atorvastatin.

Профилактика перипроцедурного повреждения почек нагрузочными дозами статинов при плановых чрескожных коронарных вмешательствах

To compare the effect of loading doses of atorvastatin and rosuvastatin on the value of the acute kidney injury and acute inflammatory response to elective percutaneous coronary interventions. An open prospective comparative study included 68 patients referred for elective percutaneous coronary intervention (PCI). At baseline, all patients had been taking statins for a long time as a standard lipid-lowering therapy. The first group included 33 patients who received a loading dose of 80 mg of atorvastatin (As) 12 hours before the intervention with saving this dose for 2-6 days. The second group included 35 patients treated with rosuvastatin (Rs) 40 mg / day in the same manner. The levels of creatinine and cystatin C in the blood were determined at baseline and 12, 24, 48 and 72 hours after the intervention. HsCRP level was determined at baseline and 72 hours after PCI. AKI was diagnosed in 5 patients (7.94 %): 4 patients (12.1 %) in group As and 1 patient (3.3 %) in group Rs (p = 0.36). The increase of serum creatinine level in the group As patients was 43.4 % higher than one in the Rs group patients (p = 0.024). The decrease of glomerular filtration rate (GFR) in group As was 15.5 % higher than one in group Rs (p = 0.09). Initially, the level of cystatin C in the groups did not differ (698.9 (560.2-869.6) ng / ml in group As vs 759.5 (673.8-899.9) ng/ml in group Rs, p = 0.75). Significant intergroup differences were found in the level of serum cystatin C 12 hours after PCI (718.3 (555.6-839.6) ng/ml in group As vs 470.6 (378.2-689.4) ng/ml in the Rs group, p = 0.007) that persisted 24 hours after the intervention (732.1 (632.3-887) ng/ml vs 526.4 (357.4-802.7) ng/ml, respectively, p = 0.02). From the second day after PCI, intergroup differences in serum cystatin C disappeared. The level of hsCRP significantly increased 72 hours after the intervention in group As (1.65 (0.9-4) mg/l at baseline vs 4.55 (1.6-8.7) mg/l 72 hours after PCI, p = 0.01). The level of hsCRP did not change significantly at the same time in the Rs group (2.8 (0.8-6.8) mg/l at baseline vs 2.75 (1.5-6.5) mg/l 72 hours after PCI, p = 0.16). The loading dose of rosuvastatin better prevents periprocedural kidney injury in PCI and more significantly reduces the overall inflammatory response to intervention compared to the loading dose of atorvastatin.

Design and characterization of a perivascular PLGA coated PET mesh sustaining the release of atorvastatin for the prevention of intimal hyperplasia

Following vascular bypass interventions, autologous saphenous vein grafts are prone to fail due to intimal hyperplasia development. An atorvastatin (ATV)-eluting tubular mesh coated with poly(d,l-lactide-co-glycolisde) acid (PLGA) was designed for perivascular application, in order to prevent the development of this pathology. Formulation parameters such as PLGA molecular weight, concentration of ATV and PLGA in the coating solution and number of coatings were investigated to optimise the mesh in terms of drug loading efficacy, drug release kinetics and mechanical properties. Using the dip-coating technique, 1.6 mg of ATV was loaded on a tubular 5 cm long mesh. The most important parameter influencing ATV loading was the concentration of the drug in the coating solution. In vitro an ATV release profile combining an initial fast release over 3 days and a sustained release over 40 days was obtained; consistent with the timeframe of hyperplasia development. The amount of PLGA polymer coating as well as the molecular weight of the polymer were optimized to achieve these kinetics. A poly(d,l-lactide-co-caprolactone) (PLCL) layer was sprayed on the external side of the PLGA coated tubular mesh to restrict the ATV release to the vascular tissue. Scanning electron microscopy observation showed that the macroporosity of the mesh was preserved after coating, while texture analysis demonstrated that its elasticity decreased slightly.

Evaluation of Combination of Low Dose Atorvastatin plus Ezetimibe and Aspirin in the Treatment of Atherosclerotic Vascular Disease

Objective: To evaluate the effect of combination of low dose of atorvastatin plus ezetimibe and aspirin in the treatment of Atherosclerotic Vascular Disease (AVD) with special emphasis on rhabdomyolysis. Experimental Design: Thirty male rats were allocated to five groups as normal control, disease control, and test groups I, II, III. All groups except normal control group received high fat diet for 10 weeks and treatment was initiated in test groups after the completion of 4th week, after rise in lipid levels and bodyweight of the rats when compared with normal control rats was noted. Normal control and disease control group animals received vehicle and test groups were treated with ezetimibe, 0.986mg/kg (Clinical dose 10 mg) and aspirin, 7.708mg/kg (Clinical dose 75 mg) along with differential doses of atorvastatin per orally. Test groups I, II, III received atorvastatin dose of 1.027mg/kg, 0.770mg/kg, 0.513mg/kg p.o. respectively which were equal to clinical doses of 10mg, 7.5mg and 5 mg of atorvastatin respectively. Body weight, lipid profile and grip strength were evaluated biweekly and histopathology of aorta was carried out at the end of the study. Results: The results of study reveal that test group II had significantly decreased the increased body weight, lipid levels, accumulation of lipids on the walls of aorta and incidence of rhabdomyolysis. Conclusion: The study demonstrates that atorvastatin at clinical dose of 7.5 mg have shown a decrease in the incidence rhabdomyolysis without loss of hypolipidemic activity when given along with clinical doses of ezetimibe and aspirin in the management of AVD. Key words: Atherosclerotic Vascular Disease, Atorvastatin, High Fat Diet Model, Rhabdomyolysis, Statins.

Dose-Dependent Effect of Statin Pretreatment on Preventing the Periprocedural Complications of Carotid Artery Stenting.

We investigated whether statin pretreatment can dose dependently reduce periprocedural complications in patients undergoing carotid artery stenting because of symptomatic carotid artery stenosis. We enrolled a consecutive series of 397 symptomatic carotid artery stenosis (≥50% stenosis on conventional angiography) treated with carotid artery stenting at 2 tertiary university hospitals over a decade. Definition of periprocedural complications included any stroke, myocardial infarction, and death within 1 month after or during the procedure. Statin pretreatment was divided into 3 categories according to the atorvastatin equivalent dose: none (n=158; 39.8%), standard dose (<40 mg of atorvastatin, n=155; 39.0%), and high dose (≥40 mg; n=84; 21.2%). A multivariable logistic regression analysis with the generalized estimating equation method was used to investigate independent factors in periprocedural complications. The patients' mean age was 68.7 years (81.6% men). The periprocedural complication rates across the 3 categories of statin use were 12.0%, 4.5%, and 1.2%. After adjustment, a change in the atorvastatin dose category was associated with reduction in the odds of periprocedural complications for each change in dose category (standard-dose statin: odds ratio, 0.24; 95% confidence interval, 0.07-0.81; high-dose statin: odds ratio, 0.11; 95% confidence interval, 0.01-0.96; P for trend=0.01). Administration of antiplatelet drugs was also an independent factor in periprocedural complications (OR, 0.18; 95% CI, 0.05-0.69). This study shows that statin pretreatment may reduce the incidence of periprocedural complications dose dependently in patients with symptomatic carotid artery stenting.

High versus low dose statin therapy in Indian patients with acute ST-segment elevation myocardial infarction undergoing thrombolysis

ObjectivesThis study sought to compare high dose versus low dose statin therapy in Indian patients with ST-segment elevation myocardial infarction (STEMI) undergoing thrombolysis. BackgroundRandomized trials have demonstrated that statin treatment reduced major adverse cardiac events (MACEs) in patients with stable angina pectoris and acute coronary syndrome. However, randomized studies of statin therapy in Indian patients with STEMI are scarce. MethodsOf 1859 patients with acute STEMI, 1027 eligible patients were randomized to 80-mg (n=512) or 10-mg (n=515) atorvastatin. Primary end point was 30-day incidence of MACE (death from any cause, myocardial infarction, NSTE-ACS requiring readmission, ischemia driven revascularization, and stroke). Secondary end points included individual components of primary end point and ST-segment resolution at 90min after thrombolysis. ResultsTwo groups did not differ in primary endpoints of MACEs (8.79% in high dose vs 9.32% in low dose atorvastatin group, OR=0.938, 95% CI=0.612–1.436, P=0.764). With 80mg atorvastatin, there was insignificant reduction in rate of reinfarction, revascularization and death. Stroke and readmission for NSTE-ACS increased in 80mg atrovastatin group, but was not statistically significant. ST-segment resolution was significantly higher in 80-mg atorvastatin arm (45.90% vs. 37.67%; p=0.008). Myalgia was more in 80mg statin group (18.06% vs 7.57%, p=0.0001). ConclusionsHigh-dose atorvastatin did not show significant difference of MACEs in STEMI patients undergoing thrombolysis but showed significant improvement in immediate coronary flow depicted by ST-segment resolution. This benefit of high dose statin is to be weighed against greater myalgia, drug discontinuation and cost in Indian patients.

A Healthy Balance of Plasma Cholesterol by a Novel Annurca Apple-Based Nutraceutical Formulation: Results of a Randomized Trial.

Cardiovascular diseases are nowadays preferential targets of preventive medicine through a straightforward therapy on lipid profile. However, statins, the first-line lipid-lowering drug therapy, specifically act on low-density lipoprotein cholesterol (LDL-C), having a modest effect on plasma high-density lipoprotein cholesterol (HDL-C) concentrations. Today, a number of novel HDL-targeted therapies are emerging, along with unexpected side effects. Thus, novel and possibly safe substances, able to correct impaired lipid profile in humans, are still in great demand. Herein, based on encouraging clinical data, we formulated a nutraceutical product (AppleMetS®, AMS), based on a polyphenolic extract from Annurca apple, and demonstrated that two capsules a day of AMS, after one month, have a LDL-C lowering outcome equivalent to 40 mg of simvastatin or 10 mg of atorvastatin. Nevertheless, different from statin-based therapy, AMS exerted a notable effect on HDL (+49.2%). Based on the trial results, we can assert that AMS formulation could effectively integrate the current therapeutic arsenal to correct impaired lipid profile in humans. Specifically, AMS may be considered a complementary and/or alternative safe substance suitable for the treatment of mildly hypercholesterolemic subjects who do not present occurrence of atheromatous plaques yet.

Abstract 087: Impact of High Intensity Statin on Biologic and Clinical Markers of the Metabolic Syndrome in Women

Background: The metabolic syndrome (MBS) increases the risk of cardiovascular disease in both men and women. This risk is higher in women. The role of statins in the treatment of MBS remains uncertain. Objectives: To evaluate the ability of high dose atorvastatin to modify components of MBS Methods: Age matched women with MBS (n =88, mean age 52.4 ± 9.2 years), recruited from the Women’s Heart Clinic at the University of Rochester and who met the study inclusion criteria were randomly assigned to either 80 mg of atorvastatin or matching placebo (44 in each arm) in a double blinded fashion. The duration of treatment was 12 weeks. Statistical analysis was performed using Students t-test using SAS 9.3 (Cary, NC). Results: At 6 weeks after randomization, there was significant reduction in the mean LDL, triglycerides, CRP, and Apo-B (p &lt;0.0001, 0.0006, 0.01 and &lt;0.0001) respectively in the atorvastatin arm. There was no difference in fasting blood glucose (FBG), serum HDL, serum Leptin, Apo-A1, and platelet activity (p value NS). A trend towards a decrease in waist circumference (WC) in the atorvastatin arm (p 0.05), while no impact in systolic blood pressure (p 0.92) was seen. These differences persisted at 12 weeks after randomization. Conclusion: High dose atorvastatin has an early and significant impact on biomarkers in women with MBS and is not associated with a rise in FBG. The use of statins for primary prevention in this group of patients should be further explored Table: Lipogenic, Inflammatory Markers at 6 weeks Post Randomization.