ASTEROID TRIAL ROSUVASTATIN PDF

Accordingly, we designed the ASTEROID trial (A Study to Evaluate the Effect of Rosuvastatin on Intravascular Ultrasound-Derived Coronary. The purpose of this study is to see if 40 mg of rosuvastatin taken daily will reduce . statin therapy on regression of coronary atherosclerosis: the ASTEROID trial. A Study to Evaluate the Effect of Rosuvastatin on Intravascular Ultrasound- Derived Coronary Atheroma Burden – ASTEROID. Mar 13, Share via: AddThis.

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Lipid levels were obtained every 3 months and mean levels during treatment were computed from the time-weighted average of these values.

The ASTEROID trial: coronary plaque regression with high-dose statin therapy.

Intensive lipid lowering with atorvastatin in patients with stable coronary disease. The most positive IVUS trials to date have demonstrated a slowing or halting of progression of atherosclerosis during statin treatment. This procedure blinded technicians from knowing whether an examination was obtained at baseline or follow-up and thereby eliminated any systematic bias in measurement of paired studies.

Regression of coronary atherosclerosis by simvastatin: Study concept and design: A technician selected a distal branch site as trixl beginning point for analysis. This procedure was designed to provide the longest possible vessel segment for analysis. These changes were larger in magnitude than has been observed in previous statin trials. A second imputation method assigned the 22 patients who discontinued the study because of ischemic events to a progression rate calculated from the median value for all patients completing the trial who showed progression.

Moreover, arteries undergoing mechanical interventions were included, which could have affected atheroma measurements. The very low LDL-C levels and increase in HDL-C levels resulted in significant regression in atheroma burden for all 3 primary and secondary efficacy parameters.

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The ASTEROID trial: coronary plaque regression with high-dose statin therapy.

The characteristics of the noncompleters were very similar to axteroid of the completers in terms of age, sex, weight, body mass index calculated as weight in kilograms divided by the square of height in metersand prevalence of hypertension and diabetes. The current study suggests that there is potential for a more optimistic strategy, in which aggressive lipid-modulating strategies can actually reverse the atherosclerotic disease process.

Table 3 shows the results for both the primary and the secondary efficacy parameters. The statistical analysis plan defined tests of normality for the efficacy asterpid and specified nonparametric testing if the data were not normally distributed. This very intensive statin regimen was well tolerated. For the second primary efficacy parameter, change in the mm subsegment with the greatest disease severity, Monitoring of the study and maintenance of the trial database was performed by a rosuvasratin research trizl, Omnicare, under contract to the sponsor.

The institutional review boards of all participating centers approved the protocol and all patients provided written informed consent. The last 2 decades have witnessed the introduction of a variety of antiatherosclerotic tril, most notably the 3-hydroxymethylglutaryl coenzyme A reductase inhibitors statins.

Adverse wsteroid were infrequent and similar to other statin trials. The operator was instructed to select a starting point for interrogation as far distally as could be safely reached. Analysis and interpretation of data: Only regression, defined as a reduction in IVUS measures of atheroma burden with CIs not including zero, would yield a successful outcome. Of the 3 remaining deaths, 2 were due to sudden cardiac death and 1 to gastric carcinoma.

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Rosuvastatin is the most yrial introduced statin and typically produces greater reductions in LDL-C and larger increases in HDL-C than previously available agents. A secondary efficacy parameter, the change in normalized TAV, was calculated by first determining the average atheroma area per cross-section as.

The 2 examination results were then resequenced using random assignments generated by an outside statistician. A motorized pullback was repeated under conditions identical to the baseline study. A similar procedure was performed for each follow-up videotape.

The top left panel illustrates the appearance of a single cross-section at baseline intravascular ultrasound examination, while the top right panel shows the same cross-section after 24 months of treatment.

J Am Soc Echocardiogr. During this pullback, images were obtained at 30 frames per second and recorded on super-VHS videotape. Regression of coronary artery disease as a result of intensive lipid-lowering therapy in men with high levels of apolipoprotein B.

The 22 patients who were withdrawn for ischemic events may represent progressors, a potential source of bias in the trial. Comparison of effects on low-density lipoprotein cholesterol and high-density lipoprotein cholesterol with rosuvastatin versus atorvastatin in patients with type IIa or IIb hypercholesterolemia.

Although statins rank among the most extensively studied therapies in contemporary medicine, the optimal target levels for low-density lipoprotein cholesterol LDL-C remain controversial. Otherwise, P values were to be calculated using the Wilcoxon signed rank test.

Effects of the acyl coenzyme A: Critical revision of the manuscript for important intellectual content: