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16 protocols using crestor

1

Rosuvastatin Mitigates Noise-Induced Effects

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Rats were allowed free access to tap water and laboratory for 2 weeks, as an adaptation, before the experiment and they were randomly divided into four groups (n = 8).
Group 1: Control — The rats were given 1 ml of distilled water via intragastric gavage every day for a period of 30 days.
Group 2: Rats were given 10 mg/kg of rosuvastatin (Crestor, Astra Zeneca) via intragastric gavage during 30 days.
Group 3: These rats were exposed to 100 dB(A) noise for 4 h/day during 20 days. Beginning 10 days prior the noise exposure, they were given 1 ml of distilled water via intragastric gavage every day for 30 days.
Group 4: These rats were exposed to 100 dB(A) noise for 4 h/day for 20 days. Beginning 10 days prior the experiment, they were given 10 mg/kg of rosuvastatin via intragastric gavage every day for 30 days.
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2

Bioavailability of Rosuvastatin-Ezetimibe FDC

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This was a randomized, open label, single-dose PK study with two-way crossover design. Subjects were hospitalized in the Chonbuk National University Hospital on the evening before drug administration and were allocated to two groups in a 1:1 ratio according to a predesigned randomized table.
After overnight fasting, each subject received one of the two treatments (either the test formulation or the reference formulation) with 240 mL of water. The test formulation was FDC of rosuvastatin 20 mg / ezetimibe 10 mg (DP-R207, Alvogen Korea Co., Ltd., Republic of Korea), and reference formulation was concurrent administration of rosuvastatin 20 mg tablet (Crestor, AstraZeneca Co., Ltd., Seoul, Republic of Korea) and ezetimibe 10 mg tablet (Ezetrol, MSD Korea Co., Ltd., Seoul, Republic of Korea). To minimize food effect on ezetimibe absorption, all subjects were served a low-fat meal (about 700 kcal) approximately 4 hours after dosing. After 2 weeks of washout period, subjects received the other treatment.
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3

Rosuvastatin's Impact on Coronary Plaque

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All recruited patients were referred for rosuvastatin treatment (Crestor, AstraZeneca China, 10 or 20 mg daily) according to the 2013 American guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults.18 The details of rosuvastatin treatment were given in Data S1. Follow‐up CCTA was performed in all patients at 1‐ to 1.5‐year interval. The primary objective of the current study was to determine the lesion‐specific change of baseline △CT‐FFR and follow‐up △CT‐FFR values after rosuvastatin treatment. The secondary objective was to compare the change of other plaque characteristics according to baseline and follow‐up CCTA findings.
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4

Rosuvastatin and Valsartan Pharmacokinetics

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This study was a randomized, open-label, six-sequence, three-period, three-treatment, multiple-dose crossover study in healthy male subjects. The number of subjects used in this study allowed for the detection of a 20% difference in area under the concentration–time curve (AUC) between the two drugs at a significance level of 0.05 with 80% power. Subjects received a different treatment in each period: 20 mg rosuvastatin (Crestor®, AstraZeneca plc, London, UK) alone once daily, 160 mg valsartan (Diovan®, Novartis International AG, Basel, Switzerland) alone once daily, and coadministration of 20 mg rosuvastatin or 160 mg valsartan once daily in an assigned order, with a 1-week washout period (Figure 1). To ensure compliance, study drugs were administered by the investigator at the Clinical Trial Center, Samsung Medical Center (Seoul, Korea).
Subjects in a fasted state received study drugs with 240 mL of water every morning for 4 days to reach steady state, determined by the known pharmacokinetic characteristics of each drug. Subjects were admitted to the Clinical Trial Center 12 hours before the last dosing in each treatment period and were confined until 24 hours after dosing. Additional 48- and 72-hour visits were made for pharmacokinetic sampling. The same procedure was repeated during each period for pharmacokinetic, pharmacodynamic, and safety-profile assessments.
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5

Pharmacogenomic Effects on Rosuvastatin

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We conducted an investigator-initiated, prospective, two arm, crossover, randomized, controlled trial to evaluate the pharmacogenomic effect of drug transporters on rosuvastatin pharmacokinetics in Asian and White healthy volunteers. Recruitment was from the general public in the San Francisco/Bay area from November 2014 to July 2015. Each participant provided written informed consent.
Subjects were block randomly assigned to receive either an oral 20mg rosuvastatin tablet (Crestor®, AstraZeneca, Wilmington, DE) first or an oral 20mg rosuvastatin tablet immediately following a 30-min intravenous infusion of rifampin (Rifadin®, Sanofi-Aventis, Bridgewater, NJ) 600 mg in 10 ml sterile normal saline at a rate of 20 mg/min. The two periods were separated by at least a 7-day washout and all subjects completed both periods. To eliminate a food effect, subjects fasted from 8 hours prior to rosuvastatin dosing to 3 hours post dosing and standardized meals were provided. Venous blood samples (8 mL each) were collected into K3-EDTA tubes at t=0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 24, 32, 48 hours post dosing. Blood was centrifuged within 30 min at 4 °C and aliquot plasma samples were stored at −80 °C until bioanalysis.
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6

Antibiotic and Statin Combination Study

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Rosuvastatin 20 mg tablets/once daily (Crestor, AstraZeneca, Plankstadt, Germany) and cefixime tablets USP 400 mg/once daily (Suprax, Lupin Pharmaceuticals, Baltimore, Maryland, USA) were purchased from a private pharmacy. Dimethyl sulfoxide (DMSO) was used as a solvent (DMSO had no antibacterial activity and regarded as a negative control).
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7

Statin Sensitivity Assay for Fungal Strains

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Sensitivity of the fungal strains to statins was examined in a 96-well microtiter plate assay. Fluvastatin (Lescol, Novartis), rosuvastatin (Crestor, Astra Zeneca) and atorvastatin (Atoris, Krka) were dissolved in methanol to prepare stock solutions. Final concentrations of fluvastatin in the wells ranged from 0.125 to 128 μg/ml while those of rosuvastatin and atorvastatin ranged from 0.5 to 256 μg/ml; statins were diluted with liquid YNB medium. Inocula were prepared and diluted in liquid YNB. The final amount of the sporangiospores in the wells was 104. Plates were incubated for 48 h at 25°C and the optical density of the fungal cultures was measured at 620 nm using a Jupiter HD plate reader (ASYS Hitech). Uninoculated medium was used as the background for the calibration and growth in the statin-free medium was considered as 100%; all experiments were performed in triplicates.
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8

Rosuvastatin Pharmacokinetics with Herbal Extracts

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This was an open-label, three-phase randomized crossover study. Subjects were given a single dose of rosuvastatin 10 mg (Crestor®, Astra Zeneca) on 3 occasions: 1. without herbs; 2. with green tea extract; 3. with soy isoflavones extract. The green tea extract and soy isoflavones extract were given at a dose thought to contain EGCG 800 mg once daily or isoflavones 80 mg once daily for 14 days before rosuvastatin dosing with at least a 4-week washout period between phases. The herbal extracts were present as a powder which was taken in 150 ml water at room temperature. Blood samples were taken at intervals from 0 to 24 h on the rosuvastatin dosing days. During the study, subjects were frequently reminded of the requirements for diet restrictions, and they were requested to record their daily food intake, including the main meals, snacks and beverages of the day by using a simple food diary, which can help to monitor the food compliance during the study.
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9

Lipid Profiling in STEMI Patients

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This prospective, randomized, open label study was delineated to evaluate differences in the composition of lipids in patients with STEMI at D1 and at D30 after implementing the two lipid-lowering therapies (rosuvastatin 20 mg [Crestor, AstraZeneca] or simvastatin 40 mg combined with ezetimibe10 mg [Vytorin, MSD]). Plasma of patients were categorized in four groups: patients in the rosuvastatin group at D1 (G1) and at D30 (G2); patients treated with simvastatin + ezetimibe at D1 (G3) and at D30 (G4). These two lipid-lowering therapies were chosen to promote similar changes in the classic lipid profile, allowing the comparison of the more effective inhibition of cholesterol synthesis (rosuvastatin) with the combined mechanisms of LDL-C lowering (inhibition of cholesterol synthesis and inhibition of intestinal cholesterol absorption by simvastatin/ezetimibe). Patients were randomized 1:1 for the lipid-lowering therapy using a central computerized system (battle-ami.huhsp.org.br). All patients followed similar protocol, receiving dual antiplatelet therapies, betablockers, and renin-angiotensin system blockers and they were referred to coronary angiogram, and percutaneous coronary intervention, when needed, in the first 24 h of STEMI.
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10

Statin Therapy in Acute Myocardial Infarction

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For this study, 101 consecutive patients of both sexes with their first myocardial infarction were included as part of the B And T Types of Lymphocyte Evaluation in Acute Myocardial Infarction (BATTLE-AMI study, NCT02428374) [23 (link)]. All patients underwent pharmacological thrombolysis in the first 6 h followed by coronary angiogram and percutaneous coronary intervention (PCI) when needed in the first 24 h of STEMI (pharmacoinvasive strategy). Patients with primary PCI were not included in this trial. The key exclusion criteria were clinical instability, use of lipid-lowering or immunosuppressant therapies, autoimmune disease, known malignancy, pregnancy or signs of active infections. After hospital admission, these patients were randomized to be treated with simvastatin 40 mg plus ezetimibe 10 mg qd (Vytorin®, MSD) or rosuvastatin 20 mg qd (Crestor®, AstraZeneca) using a central computerized system (battle-ami.huhsp.org.br).
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