Rosuvastatin

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Ali Raza - One of the best experts on this subject based on the ideXlab platform.

  • Rosuvastatin pharmacokinetics in heart transplant recipients administered an antirejection regimen including cyclosporine
    Clinical Pharmacology & Therapeutics, 2004
    Co-Authors: Steven G Simonson, Ali Raza, Paul Martin, Patrick D Mitchell, John A Jarcho, Colin D A Brown, Amy S Windass, Dennis Schneck
    Abstract:

    Background Cyclosporine (INN, ciclosporin) increases the systemic exposure of all statins. Therefore Rosuvastatin pharmacokinetic parameters were assessed in an open-label trial involving stable heart transplant recipients (> or =6 months after transplant) on an antirejection regimen including cyclosporine. Rosuvastatin has been shown to be a substrate for the human liver transporter organic anion transporting polypeptide C (OATP-C). Inhibition of this transporter could increase plasma concentrations of Rosuvastatin. Therefore the effect of cyclosporine on Rosuvastatin uptake by cells expressing OATP-C was also examined. Methods Ten subjects were assessed while taking 10 mg Rosuvastatin for 10 days; 5 of these were then assessed while taking 20 mg Rosuvastatin for 10 days. Rosuvastatin steady-state area under the plasma concentration-time curve from time 0 to 24 hours [AUC(0-24)] and maximum observed plasma concentration (Cmax) were compared with values in controls (historical data from 21 healthy volunteers taking 10 mg Rosuvastatin). Rosuvastatin uptake by OATP-C-transfected Xenopus oocytes was also studied by use of radiolabeled Rosuvastatin with and without cyclosporine. Results In transplant recipients taking 10 mg Rosuvastatin, geometric mean values and percent coefficient of variation for steady-state AUC(0-24) and Cmax were 284 ng. h/mL (31.3%) and 48.7 ng/mL (47.2%), respectively. In controls, these values were 40.1 ng. h/mL (39.4%) and 4.58 ng/mL (46.9%), respectively. Compared with control values, AUC(0-24) and Cmax were increased 7.1-fold and 10.6-fold, respectively, in transplant recipients. In transplant recipients taking 20 mg Rosuvastatin, these parameters increased less than dose-proportionally. Rosuvastatin had no effect on cyclosporine blood concentrations. The in vitro results demonstrate that Rosuvastatin is a good substrate for OATP-C-mediated hepatic uptake (association constant, 8.5 +/- 1.1 micromol/L) and that cyclosporine is an effective inhibitor of this process (50% inhibition constant, 2.2 +/- 0.4 micromol/L when the Rosuvastatin concentration was 5 micromol/L). Conclusions Rosuvastatin exposure was significantly increased in transplant recipients on an antirejection regimen including cyclosporine. Cyclosporine inhibition of OATP-C-mediated Rosuvastatin hepatic uptake may be the mechanism of the drug-drug interaction. Coadministration of Rosuvastatin with cyclosporine needs to be undertaken with caution.

  • efficacy of Rosuvastatin compared with other statins at selected starting doses in hypercholesterolemic patients and in special population groups
    American Journal of Cardiology, 2003
    Co-Authors: James W Blasetto, Evan A Stein, Virgil W Brown, Rohini Chitra, Ali Raza
    Abstract:

    A total of 5 randomized, double-blind trials in patients with hypercholesterolemia were prospectively designed to allow pooling of plasma lipid data after 12 weeks of treatment. The purpose was (1) to compare Rosuvastatin 5 and 10 mg with atorvastatin 10 mg (data from 3 of the 5 trials); (2) to compare Rosuvastatin 5 and 10 mg with simvastatin 20 mg and pravastatin 20 mg (data from 2 of the 5 trials); and (3) to summarize overall efficacy and subset analyses of Rosuvastatin data from all 5 trials. Rosuvastatin 5 mg (n = 390) and 10 mg (n = 389) reduced low-density lipoprotein (LDL) cholesterol significantly more than did atorvastatin 10 mg (n = 393) (41.9% and 46.7% vs 36.4%, both p <0.001). Treatment with Rosuvastatin 5 mg (n = 240) and 10 mg (n = 226) also resulted in significantly greater reductions in LDL cholesterol compared with both simvastatin 20 mg (n = 249) and pravastatin 20 mg (n = 252) (40.6% and 48.1% vs 27.1% and 35.7%, all p <0.001). Significant differences favoring Rosuvastatin 10 mg were also observed for total cholesterol, high-density lipoprotein (HDL) cholesterol, non-HDL cholesterol, apolipoprotein (apo) B, and apo A-I versus atorvastatin 10 mg, and for total cholesterol, HDL cholesterol, triglycerides, non-HDL cholesterol, and apo B versus simvastatin 20 mg and pravastatin 20 mg. Analyses of all the Rosuvastatin 10 mg data (n = 615) from the 5 trials in subgroups defined by age ≥65 years, female sex, postmenopausal status, hypertension, atherosclerosis, type 2 diabetes, and obesity showed that Rosuvastatin had consistent efficacy across patient subgroups.

  • efficacy of Rosuvastatin compared with other statins at selected starting doses in hypercholesterolemic patients and in special population groups
    American Journal of Cardiology, 2003
    Co-Authors: James W Blasetto, Evan A Stein, Virgil W Brown, Rohini Chitra, Ali Raza
    Abstract:

    A total of 5 randomized, double-blind trials in patients with hypercholesterolemia were prospectively designed to allow pooling of plasma lipid data after 12 weeks of treatment. The purpose was (1) to compare Rosuvastatin 5 and 10 mg with atorvastatin 10 mg (data from 3 of the 5 trials); (2) to compare Rosuvastatin 5 and 10 mg with simvastatin 20 mg and pravastatin 20 mg (data from 2 of the 5 trials); and (3) to summarize overall efficacy and subset analyses of Rosuvastatin data from all 5 trials. Rosuvastatin 5 mg (n = 390) and 10 mg (n = 389) reduced low-density lipoprotein (LDL) cholesterol significantly more than did atorvastatin 10 mg (n = 393) (41.9% and 46.7% vs 36.4%, both p or =65 years, female sex, postmenopausal status, hypertension, atherosclerosis, type 2 diabetes, and obesity showed that Rosuvastatin had consistent efficacy across patient subgroups.

  • 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
    American Journal of Cardiology, 2002
    Co-Authors: Michael H Davidson, Evan A Stein, Rohini Chitra, Ali Raza, Patrick T S, Antonio M Gotto, Hutchinson Howard Gerard
    Abstract:

    This randomized, double-blind, placebo-controlled trial was conducted in 52 centers in North America to compare the effects of the new, highly effective statin, Rosuvastatin, with atorvastatin and placebo in hypercholesterolemic patients. After a 6-week dietary run-in, 516 patients with low-density lipoprotein (LDL) cholesterol > or =4.14 mmol/L (160 mg/dl) and < 6.47 mmol/L (250 mg/dl) and triglycerides < or =4.52 mmol/L (400 mg/dl) were randomized to 12 weeks of once-daily placebo (n = 132), Rosuvastatin 5 mg (n = 128), Rosuvastatin 10 mg (n = 129), or atorvastatin 10 mg (n = 127). The primary efficacy end point was percent change in LDL cholesterol. Secondary efficacy variables were achievement of National Cholesterol Education Program (NCEP) Adult Treatment Panel II (ATP II), ATP III, and European Atherosclerosis Society LDL cholesterol goals and percent change from baseline in high-density lipoprotein (HDL) cholesterol, total cholesterol, triglycerides, non-HDL cholesterol, apolipoprotein B, and apolipoprotein A-I. Rosuvastatin 5 and 10 mg compared with atorvastatin 10 mg were associated with greater LDL cholesterol reductions (-40% and -43% vs 35%; p <0.01 and p <0.001, respectively) and HDL cholesterol increases (13% and 12% vs 8%, p <0.01 and p <0.05, respectively). Total cholesterol and apolipoprotein B reductions and apolipoprotein A-I increases were also greater with Rosuvastatin; triglyceride reductions were similar. Rosuvastatin 5 and 10 mg were associated with improved achievement in ATP II (84% in both Rosuvastatin groups vs 73%) and ATP III (84% and 82% vs 72%) LDL cholesterol goals, and Rosuvastatin 10 mg was more effective than atorvastatin in achieving European Atherosclerosis Society LDL cholesterol goals. Both treatments were well tolerated.

  • effect of Rosuvastatin on low density lipoprotein cholesterol in patients with hypercholesterolemia
    American Journal of Cardiology, 2001
    Co-Authors: Anders G Olsson, Jacques Mizan, Pears John Stuart, John Mckellar, Ali Raza
    Abstract:

    Rosuvastatin is a new, synthetic, orally active statin, with marked low-density lipoprotein (LDL) cholesterol-lowering activity. We conducted 2 dose-ranging studies. In the first study, after a 6-week dietary run-in, 142 moderately hypercholesterolemic patients were randomized equally to receive double-blind placebo or Rosuvastatin 1, 2.5, 5, 10, 20, or 40 mg or open-label atorvastatin 10 or 80 mg once daily for 6 weeks; in the second study, conducted to extend the Rosuvastatin dose range, 64 patients were randomized to double-blind, once-daily placebo or Rosuvastatin 40 or 80 mg (1:1:2 ratio) for 6 weeks. Data from both studies were combined for analysis of lipid effects. No statistical comparison of atorvastatin arms with placebo or Rosuvastatin was performed. Rosuvastatin was associated with highly significant dose-dependent reductions in LDL cholesterol compared with placebo (p <0.001); decreases ranged from 34% (1 mg) to 65% (80 mg). Linear regression analysis indicated an additional 4.5% LDL cholesterol reduction for each doubling of the Rosuvastatin dose. Across the dose range, approximately 90% of LDL cholesterol reduction occurred within the first 2 weeks of treatment. Significant, dose-dependent reductions in total cholesterol and apolipoprotein B with Rosuvastatin were also observed (p <0.001). High-density lipoprotein cholesterol increases and triglyceride reductions were consistently observed and statistically significant at some dose levels. All lipid ratios were significantly reduced at all Rosuvastatin dose levels (p <0.001). Adverse events were similar across placebo and active treatments. No significant increases in alanine aminotransferase or creatine kinase were seen in any patient. Over 6 weeks, Rosuvastatin produced large, rapid, dose-dependent LDL cholesterol reductions and was well tolerated in hypercholesterolemic patients.

Evan A Stein - One of the best experts on this subject based on the ideXlab platform.

  • efficacy and safety of Rosuvastatin 40 mg versus atorvastatin 80 mg in high risk patients with hypercholesterolemia results of the polaris study
    Atherosclerosis, 2007
    Co-Authors: Lawrence A Leiter, Evan A Stein, Robert S Rosenson, J P D Reckless, Karlludwig Schulte, Margo Schleman, Paul Miller, Mike K Palmer, Froukje Sosef
    Abstract:

    POLARIS investigated the efficacy and safety of Rosuvastatin 40 mg and atorvastatin 80 mg in high-risk patients with hypercholesterolemia. Patients (n=871) were randomized to Rosuvastatin 40 mg/day or atorvastatin 80 mg/day for 26 weeks. The primary endpoint was percentage change in LDL-C levels at 8 weeks. Secondary assessments included safety and tolerability, NCEP ATP III LDL-C goal achievement, change in other lipids and lipoproteins at 8 and 26 weeks, and health economics. Mean LDL-C levels were reduced significantly more with Rosuvastatin 40 mg than with atorvastatin 80 mg at 8 weeks (-56% versus -52%, p<0.001). The proportion of patients achieving the NCEP ATP III LDL-C goal at 8 weeks was significantly higher in the Rosuvastatin 40 mg group (80% versus 72%, p<0.01). Significant differences in the change from baseline in high-density lipoprotein cholesterol (HDL-C) (+9.6% versus +4.4%) and apolipoprotein (Apo)A-I levels (+4.2 versus -0.5) were observed between Rosuvastatin and atorvastatin (all p<0.05). Both treatments were well tolerated. Based on a US analysis, Rosuvastatin used fewer resources and delivered greater efficacy. Intensive lipid-lowering therapy with Rosuvastatin 40 mg/day provided greater LDL-C-lowering efficacy than atorvastatin 80 mg/day, enabling more patients to achieve LDL-C goals. Rosuvastatin may therefore improve LDL-C goal achievement in high-risk patients with hypercholesterolemia.

  • comparison of the efficacy and safety of Rosuvastatin versus atorvastatin simvastatin and pravastatin across doses stellar trial
    American Journal of Cardiology, 2003
    Co-Authors: Peter H. Jones, Elinor Miller, James M Mckenney, Evan A Stein, Harold E Bays, Valerie A Cain, Michael Davidson, James W Blasetto
    Abstract:

    The primary objective of this 6-week, parallel-group, open-label, randomized, multicenter trial was to compare Rosuvastatin with atorvastatin, pravastatin, and simvastatin across dose ranges for reduction of low-density lipoprotein (LDL) cholesterol. Secondary objectives included comparing Rosuvastatin with comparators for other lipid modifications and achievement of National Cholesterol Education Program Adult Treatment Panel III and Joint European Task Force LDL cholesterol goals. After a dietary lead-in period, 2,431 adults with hypercholesterolemia (LDL cholesterol ≥160 and <250 mg/dl; triglycerides <400 mg/dl) were randomized to treatment with Rosuvastatin 10, 20, 40, or 80 mg; atorvastatin 10, 20, 40, or 80 mg; simvastatin 10, 20, 40, or 80 mg; or pravastatin 10, 20, or 40 mg. At 6 weeks, across-dose analyses showed that Rosuvastatin 10 to 80 mg reduced LDL cholesterol by a mean of 8.2% more than atorvastatin 10 to 80 mg, 26% more than pravastatin 10 to 40 mg, and 12% to 18% more than simvastatin 10 to 80 mg (all p <0.001). Mean percent changes in high-density lipoprotein cholesterol in the Rosuvastatin groups were +7.7% to +9.6% compared with +2.1% to +6.8% in all other groups. Across dose ranges, Rosuvastatin reduced total cholesterol significantly more (p <0.001) than all comparators and triglycerides significantly more (p <0.001) than simvastatin and pravastatin. Adult Treatment Panel III LDL cholesterol goals were achieved by 82% to 89% of patients treated with Rosuvastatin 10 to 40 mg compared with 69% to 85% of patients treated with atorvastatin 10 to 80 mg; the European LDL cholesterol goal of <3.0 mmol/L was achieved by 79% to 92% in Rosuvastatin groups compared with 52% to 81% in atorvastatin groups. Drug tolerability was similar across treatments.

  • efficacy of Rosuvastatin compared with other statins at selected starting doses in hypercholesterolemic patients and in special population groups
    American Journal of Cardiology, 2003
    Co-Authors: James W Blasetto, Evan A Stein, Virgil W Brown, Rohini Chitra, Ali Raza
    Abstract:

    A total of 5 randomized, double-blind trials in patients with hypercholesterolemia were prospectively designed to allow pooling of plasma lipid data after 12 weeks of treatment. The purpose was (1) to compare Rosuvastatin 5 and 10 mg with atorvastatin 10 mg (data from 3 of the 5 trials); (2) to compare Rosuvastatin 5 and 10 mg with simvastatin 20 mg and pravastatin 20 mg (data from 2 of the 5 trials); and (3) to summarize overall efficacy and subset analyses of Rosuvastatin data from all 5 trials. Rosuvastatin 5 mg (n = 390) and 10 mg (n = 389) reduced low-density lipoprotein (LDL) cholesterol significantly more than did atorvastatin 10 mg (n = 393) (41.9% and 46.7% vs 36.4%, both p <0.001). Treatment with Rosuvastatin 5 mg (n = 240) and 10 mg (n = 226) also resulted in significantly greater reductions in LDL cholesterol compared with both simvastatin 20 mg (n = 249) and pravastatin 20 mg (n = 252) (40.6% and 48.1% vs 27.1% and 35.7%, all p <0.001). Significant differences favoring Rosuvastatin 10 mg were also observed for total cholesterol, high-density lipoprotein (HDL) cholesterol, non-HDL cholesterol, apolipoprotein (apo) B, and apo A-I versus atorvastatin 10 mg, and for total cholesterol, HDL cholesterol, triglycerides, non-HDL cholesterol, and apo B versus simvastatin 20 mg and pravastatin 20 mg. Analyses of all the Rosuvastatin 10 mg data (n = 615) from the 5 trials in subgroups defined by age ≥65 years, female sex, postmenopausal status, hypertension, atherosclerosis, type 2 diabetes, and obesity showed that Rosuvastatin had consistent efficacy across patient subgroups.

  • efficacy of Rosuvastatin compared with other statins at selected starting doses in hypercholesterolemic patients and in special population groups
    American Journal of Cardiology, 2003
    Co-Authors: James W Blasetto, Evan A Stein, Virgil W Brown, Rohini Chitra, Ali Raza
    Abstract:

    A total of 5 randomized, double-blind trials in patients with hypercholesterolemia were prospectively designed to allow pooling of plasma lipid data after 12 weeks of treatment. The purpose was (1) to compare Rosuvastatin 5 and 10 mg with atorvastatin 10 mg (data from 3 of the 5 trials); (2) to compare Rosuvastatin 5 and 10 mg with simvastatin 20 mg and pravastatin 20 mg (data from 2 of the 5 trials); and (3) to summarize overall efficacy and subset analyses of Rosuvastatin data from all 5 trials. Rosuvastatin 5 mg (n = 390) and 10 mg (n = 389) reduced low-density lipoprotein (LDL) cholesterol significantly more than did atorvastatin 10 mg (n = 393) (41.9% and 46.7% vs 36.4%, both p or =65 years, female sex, postmenopausal status, hypertension, atherosclerosis, type 2 diabetes, and obesity showed that Rosuvastatin had consistent efficacy across patient subgroups.

  • 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
    American Journal of Cardiology, 2002
    Co-Authors: Michael H Davidson, Evan A Stein, Rohini Chitra, Ali Raza, Patrick T S, Antonio M Gotto, Hutchinson Howard Gerard
    Abstract:

    This randomized, double-blind, placebo-controlled trial was conducted in 52 centers in North America to compare the effects of the new, highly effective statin, Rosuvastatin, with atorvastatin and placebo in hypercholesterolemic patients. After a 6-week dietary run-in, 516 patients with low-density lipoprotein (LDL) cholesterol > or =4.14 mmol/L (160 mg/dl) and < 6.47 mmol/L (250 mg/dl) and triglycerides < or =4.52 mmol/L (400 mg/dl) were randomized to 12 weeks of once-daily placebo (n = 132), Rosuvastatin 5 mg (n = 128), Rosuvastatin 10 mg (n = 129), or atorvastatin 10 mg (n = 127). The primary efficacy end point was percent change in LDL cholesterol. Secondary efficacy variables were achievement of National Cholesterol Education Program (NCEP) Adult Treatment Panel II (ATP II), ATP III, and European Atherosclerosis Society LDL cholesterol goals and percent change from baseline in high-density lipoprotein (HDL) cholesterol, total cholesterol, triglycerides, non-HDL cholesterol, apolipoprotein B, and apolipoprotein A-I. Rosuvastatin 5 and 10 mg compared with atorvastatin 10 mg were associated with greater LDL cholesterol reductions (-40% and -43% vs 35%; p <0.01 and p <0.001, respectively) and HDL cholesterol increases (13% and 12% vs 8%, p <0.01 and p <0.05, respectively). Total cholesterol and apolipoprotein B reductions and apolipoprotein A-I increases were also greater with Rosuvastatin; triglyceride reductions were similar. Rosuvastatin 5 and 10 mg were associated with improved achievement in ATP II (84% in both Rosuvastatin groups vs 73%) and ATP III (84% and 82% vs 72%) LDL cholesterol goals, and Rosuvastatin 10 mg was more effective than atorvastatin in achieving European Atherosclerosis Society LDL cholesterol goals. Both treatments were well tolerated.

Rohini Chitra - One of the best experts on this subject based on the ideXlab platform.

  • efficacy and safety of Rosuvastatin alone and in combination with cholestyramine in patients with severe hypercholesterolemia a randomized open label multicenter trial
    Clinical Therapeutics, 2004
    Co-Authors: Christie M Ballantyne, Elinor Miller, Rohini Chitra
    Abstract:

    Abstract Background: Patients with severe hypercholesterolemia may need greater cholesterol reductions than can beachieved with statin therapy alone. Objective: The primary objective of this trial was to compare the efficacy of a combination of Rosuvastatin plus cholestyramine with that of Rosuvastatin alone for reducing low-density lipoprotein cholesterol (LDL-C) levels after 6 weeks of treatment Methods: In this open-label, multicenter, randomized, parallel-group, comparator trial, adult patients withsevere hypercholesterolemia (LDL-C level, 190–400 mg/dL) received Rosuvastatin 40 mg/d for 6 weeks after a 6-week dietary lead-in period and were then randomized to 6 weeks of treatment with Rosuvastatin 80 mg/d alone or Rosuvastatin 80 mg/d plus cholestyramine 16 g/d (8 g BID with meals). Results: Of 153 eligible patients, 147 (83 men, 64 women; mean [SD] age, 54.5 [13.7] years; mean [SD] bodyweight, 81.3 [14.4] kg) received randomized treatment, and 144 had postbaseline measurements and were included in the analysis. The mean (SD) reduction in LDL-C was 522% (13.0%) after treatment with Rosuvastatin 40 mg, and the least squares mean (SE) reductions in LDL-C were 56.4% (1.8%) and 60.5% (1.8%) after treatment with Rosuvastatin 80 mg alone (n = 69) and Rosuvastatin 80 mg plus cholestyramine (n = 75), respectively. No significant differences between treatments were found for these or other lipid measurements. Incremental LDL-C reductions >30% were obtained in 29% (22/75) of patients receiving combination therapy and 4% (3/69) of patients receiving Rosuvastatin alone. The combination therapy was less well tolerated, primarily due to gastrointestinal symptoms; otherwise, the treatments were generally well tolerated. Conclusion: In this group of patients with severe hypercholesterolemia, the combination of Rosuvastatin80 mg with cholestyramine 16 g/d did not provide a significantly greater efficacy benefit than Rosuvastatin alone.

  • efficacy of Rosuvastatin compared with other statins at selected starting doses in hypercholesterolemic patients and in special population groups
    American Journal of Cardiology, 2003
    Co-Authors: James W Blasetto, Evan A Stein, Virgil W Brown, Rohini Chitra, Ali Raza
    Abstract:

    A total of 5 randomized, double-blind trials in patients with hypercholesterolemia were prospectively designed to allow pooling of plasma lipid data after 12 weeks of treatment. The purpose was (1) to compare Rosuvastatin 5 and 10 mg with atorvastatin 10 mg (data from 3 of the 5 trials); (2) to compare Rosuvastatin 5 and 10 mg with simvastatin 20 mg and pravastatin 20 mg (data from 2 of the 5 trials); and (3) to summarize overall efficacy and subset analyses of Rosuvastatin data from all 5 trials. Rosuvastatin 5 mg (n = 390) and 10 mg (n = 389) reduced low-density lipoprotein (LDL) cholesterol significantly more than did atorvastatin 10 mg (n = 393) (41.9% and 46.7% vs 36.4%, both p <0.001). Treatment with Rosuvastatin 5 mg (n = 240) and 10 mg (n = 226) also resulted in significantly greater reductions in LDL cholesterol compared with both simvastatin 20 mg (n = 249) and pravastatin 20 mg (n = 252) (40.6% and 48.1% vs 27.1% and 35.7%, all p <0.001). Significant differences favoring Rosuvastatin 10 mg were also observed for total cholesterol, high-density lipoprotein (HDL) cholesterol, non-HDL cholesterol, apolipoprotein (apo) B, and apo A-I versus atorvastatin 10 mg, and for total cholesterol, HDL cholesterol, triglycerides, non-HDL cholesterol, and apo B versus simvastatin 20 mg and pravastatin 20 mg. Analyses of all the Rosuvastatin 10 mg data (n = 615) from the 5 trials in subgroups defined by age ≥65 years, female sex, postmenopausal status, hypertension, atherosclerosis, type 2 diabetes, and obesity showed that Rosuvastatin had consistent efficacy across patient subgroups.

  • efficacy of Rosuvastatin compared with other statins at selected starting doses in hypercholesterolemic patients and in special population groups
    American Journal of Cardiology, 2003
    Co-Authors: James W Blasetto, Evan A Stein, Virgil W Brown, Rohini Chitra, Ali Raza
    Abstract:

    A total of 5 randomized, double-blind trials in patients with hypercholesterolemia were prospectively designed to allow pooling of plasma lipid data after 12 weeks of treatment. The purpose was (1) to compare Rosuvastatin 5 and 10 mg with atorvastatin 10 mg (data from 3 of the 5 trials); (2) to compare Rosuvastatin 5 and 10 mg with simvastatin 20 mg and pravastatin 20 mg (data from 2 of the 5 trials); and (3) to summarize overall efficacy and subset analyses of Rosuvastatin data from all 5 trials. Rosuvastatin 5 mg (n = 390) and 10 mg (n = 389) reduced low-density lipoprotein (LDL) cholesterol significantly more than did atorvastatin 10 mg (n = 393) (41.9% and 46.7% vs 36.4%, both p or =65 years, female sex, postmenopausal status, hypertension, atherosclerosis, type 2 diabetes, and obesity showed that Rosuvastatin had consistent efficacy across patient subgroups.

  • 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
    American Journal of Cardiology, 2002
    Co-Authors: Michael H Davidson, Evan A Stein, Rohini Chitra, Ali Raza, Patrick T S, Antonio M Gotto, Hutchinson Howard Gerard
    Abstract:

    This randomized, double-blind, placebo-controlled trial was conducted in 52 centers in North America to compare the effects of the new, highly effective statin, Rosuvastatin, with atorvastatin and placebo in hypercholesterolemic patients. After a 6-week dietary run-in, 516 patients with low-density lipoprotein (LDL) cholesterol > or =4.14 mmol/L (160 mg/dl) and < 6.47 mmol/L (250 mg/dl) and triglycerides < or =4.52 mmol/L (400 mg/dl) were randomized to 12 weeks of once-daily placebo (n = 132), Rosuvastatin 5 mg (n = 128), Rosuvastatin 10 mg (n = 129), or atorvastatin 10 mg (n = 127). The primary efficacy end point was percent change in LDL cholesterol. Secondary efficacy variables were achievement of National Cholesterol Education Program (NCEP) Adult Treatment Panel II (ATP II), ATP III, and European Atherosclerosis Society LDL cholesterol goals and percent change from baseline in high-density lipoprotein (HDL) cholesterol, total cholesterol, triglycerides, non-HDL cholesterol, apolipoprotein B, and apolipoprotein A-I. Rosuvastatin 5 and 10 mg compared with atorvastatin 10 mg were associated with greater LDL cholesterol reductions (-40% and -43% vs 35%; p <0.01 and p <0.001, respectively) and HDL cholesterol increases (13% and 12% vs 8%, p <0.01 and p <0.05, respectively). Total cholesterol and apolipoprotein B reductions and apolipoprotein A-I increases were also greater with Rosuvastatin; triglyceride reductions were similar. Rosuvastatin 5 and 10 mg were associated with improved achievement in ATP II (84% in both Rosuvastatin groups vs 73%) and ATP III (84% and 82% vs 72%) LDL cholesterol goals, and Rosuvastatin 10 mg was more effective than atorvastatin in achieving European Atherosclerosis Society LDL cholesterol goals. Both treatments were well tolerated.

James W Blasetto - One of the best experts on this subject based on the ideXlab platform.

  • comparison of the efficacy and safety of Rosuvastatin versus atorvastatin simvastatin and pravastatin across doses stellar trial
    American Journal of Cardiology, 2003
    Co-Authors: Peter H. Jones, Elinor Miller, James M Mckenney, Evan A Stein, Harold E Bays, Valerie A Cain, Michael Davidson, James W Blasetto
    Abstract:

    The primary objective of this 6-week, parallel-group, open-label, randomized, multicenter trial was to compare Rosuvastatin with atorvastatin, pravastatin, and simvastatin across dose ranges for reduction of low-density lipoprotein (LDL) cholesterol. Secondary objectives included comparing Rosuvastatin with comparators for other lipid modifications and achievement of National Cholesterol Education Program Adult Treatment Panel III and Joint European Task Force LDL cholesterol goals. After a dietary lead-in period, 2,431 adults with hypercholesterolemia (LDL cholesterol ≥160 and <250 mg/dl; triglycerides <400 mg/dl) were randomized to treatment with Rosuvastatin 10, 20, 40, or 80 mg; atorvastatin 10, 20, 40, or 80 mg; simvastatin 10, 20, 40, or 80 mg; or pravastatin 10, 20, or 40 mg. At 6 weeks, across-dose analyses showed that Rosuvastatin 10 to 80 mg reduced LDL cholesterol by a mean of 8.2% more than atorvastatin 10 to 80 mg, 26% more than pravastatin 10 to 40 mg, and 12% to 18% more than simvastatin 10 to 80 mg (all p <0.001). Mean percent changes in high-density lipoprotein cholesterol in the Rosuvastatin groups were +7.7% to +9.6% compared with +2.1% to +6.8% in all other groups. Across dose ranges, Rosuvastatin reduced total cholesterol significantly more (p <0.001) than all comparators and triglycerides significantly more (p <0.001) than simvastatin and pravastatin. Adult Treatment Panel III LDL cholesterol goals were achieved by 82% to 89% of patients treated with Rosuvastatin 10 to 40 mg compared with 69% to 85% of patients treated with atorvastatin 10 to 80 mg; the European LDL cholesterol goal of <3.0 mmol/L was achieved by 79% to 92% in Rosuvastatin groups compared with 52% to 81% in atorvastatin groups. Drug tolerability was similar across treatments.

  • efficacy of Rosuvastatin compared with other statins at selected starting doses in hypercholesterolemic patients and in special population groups
    American Journal of Cardiology, 2003
    Co-Authors: James W Blasetto, Evan A Stein, Virgil W Brown, Rohini Chitra, Ali Raza
    Abstract:

    A total of 5 randomized, double-blind trials in patients with hypercholesterolemia were prospectively designed to allow pooling of plasma lipid data after 12 weeks of treatment. The purpose was (1) to compare Rosuvastatin 5 and 10 mg with atorvastatin 10 mg (data from 3 of the 5 trials); (2) to compare Rosuvastatin 5 and 10 mg with simvastatin 20 mg and pravastatin 20 mg (data from 2 of the 5 trials); and (3) to summarize overall efficacy and subset analyses of Rosuvastatin data from all 5 trials. Rosuvastatin 5 mg (n = 390) and 10 mg (n = 389) reduced low-density lipoprotein (LDL) cholesterol significantly more than did atorvastatin 10 mg (n = 393) (41.9% and 46.7% vs 36.4%, both p <0.001). Treatment with Rosuvastatin 5 mg (n = 240) and 10 mg (n = 226) also resulted in significantly greater reductions in LDL cholesterol compared with both simvastatin 20 mg (n = 249) and pravastatin 20 mg (n = 252) (40.6% and 48.1% vs 27.1% and 35.7%, all p <0.001). Significant differences favoring Rosuvastatin 10 mg were also observed for total cholesterol, high-density lipoprotein (HDL) cholesterol, non-HDL cholesterol, apolipoprotein (apo) B, and apo A-I versus atorvastatin 10 mg, and for total cholesterol, HDL cholesterol, triglycerides, non-HDL cholesterol, and apo B versus simvastatin 20 mg and pravastatin 20 mg. Analyses of all the Rosuvastatin 10 mg data (n = 615) from the 5 trials in subgroups defined by age ≥65 years, female sex, postmenopausal status, hypertension, atherosclerosis, type 2 diabetes, and obesity showed that Rosuvastatin had consistent efficacy across patient subgroups.

  • efficacy of Rosuvastatin compared with other statins at selected starting doses in hypercholesterolemic patients and in special population groups
    American Journal of Cardiology, 2003
    Co-Authors: James W Blasetto, Evan A Stein, Virgil W Brown, Rohini Chitra, Ali Raza
    Abstract:

    A total of 5 randomized, double-blind trials in patients with hypercholesterolemia were prospectively designed to allow pooling of plasma lipid data after 12 weeks of treatment. The purpose was (1) to compare Rosuvastatin 5 and 10 mg with atorvastatin 10 mg (data from 3 of the 5 trials); (2) to compare Rosuvastatin 5 and 10 mg with simvastatin 20 mg and pravastatin 20 mg (data from 2 of the 5 trials); and (3) to summarize overall efficacy and subset analyses of Rosuvastatin data from all 5 trials. Rosuvastatin 5 mg (n = 390) and 10 mg (n = 389) reduced low-density lipoprotein (LDL) cholesterol significantly more than did atorvastatin 10 mg (n = 393) (41.9% and 46.7% vs 36.4%, both p or =65 years, female sex, postmenopausal status, hypertension, atherosclerosis, type 2 diabetes, and obesity showed that Rosuvastatin had consistent efficacy across patient subgroups.

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  • attainment of goal desirable lipid levels in patients with mixed dyslipidemia after 12 weeks of treatment with fenofibric acid and Rosuvastatin combination therapy a pooled analysis of controlled studies
    Journal of Clinical Lipidology, 2012
    Co-Authors: Eli M Roth, Peter H. Jones, Maureen T Kelly, Carolyn M Setze, Michael H Davidson, Aditya Lele, Robert S Rosenson, Kamlesh M Thakker
    Abstract:

    Background Goal/desirable lipid levels are underachieved in patients with mixed dyslipidemia. These patients may have substantial residual risk of cardiovascular disease even while receiving optimal LDL-C-lowering therapy and may require additional therapy to improve multiple lipid/lipoprotein levels. Objective To evaluate attainment of goal/desirable levels of lipids/lipoproteins after 12-week treatment with combination Rosuvastatin + fenofibric acid versus Rosuvastatin monotherapy. Methods This was a post hoc analysis of patients with mixed dyslipidemia who enrolled in one of two randomized controlled trials, and were treated (N = 2066) with Rosuvastatin (5, 10, or 20 mg), fenofibric acid 135 mg, or Rosuvastatin + fenofibric acid for 12 weeks. Data were pooled across doses of Rosuvastatin as monotherapy and combination therapy. Results Compared with Rosuvastatin monotherapy, combination therapy had comparable effects in achieving risk-stratified LDL-C goals; however, measures of total atherogenic burden were improved because significantly greater percentages of patients attained non-HDL-C goal in high- (62.9% vs 50.4%, P  = .006) and moderate-risk groups (87.6% vs 80.4%, P  = .016) and apolipoprotein B (ApoB) P 40/50 mg/dL in men/women ( P P P P P P Conclusion Rosuvastatin + fenofibric acid may be more efficacious than Rosuvastatin alone in patients with mixed dyslipidemia.

  • efficacy and safety of Rosuvastatin and fenofibric acid combination therapy versus simvastatin monotherapy in patients with hypercholesterolemia and hypertriglyceridemia a randomized double blind study
    American Journal of Cardiovascular Drugs, 2010
    Co-Authors: Eli M Roth, James M Mckenney, Maureen T Kelly, Carolyn M Setze, Dawn M Carlson, Alex Gold, James C Stolzenbach, Laura A Williams, Peter H. Jones
    Abstract:

    To evaluate the efficacy and safety of fixed-dose combinations of Rosuvastatin and fenofibric acid (Rosuvastatin/fenofibric acid) compared with simvastatin in patients with high levels of low-density lipoprotein cholesterol (LDL-C) and triglycerides (TG). Combination therapy with a statin and a fibrate is one of the treatment options to manage multiple lipid abnormalities in patients with hypercholesterolemia and elevated TGs. In this randomized, double-blind study, patients (n=474) with LDL-C ≥160 mg/dL and ≤240 mg/dL and TG ≥150 mg/dL and <400 mg/dL were treated for 8 weeks with simvastatin 40 mg, Rosuvastatin/fenofibric acid 5 mg/135 mg, Rosuvastatin/fenofibric acid 10 mg/135 mg, or Rosuvastatin/fenofibric acid 20 mg/135 mg. Primary and secondary variables were mean percent changes in LDL-C comparing Rosuvastatin/fenofibric acid 20 mg/135 mg with simvastatin 40 mg and Rosuvastatin/fenofibric acid 10 mg/135 mg and Rosuvastatin/fenofibric acid 5 mg/135 mg with simvastatin 40 mg, respectively. Additional efficacy variables included non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein (Apo) B, HDL-C, TG, and high-sensitivity C-reactive protein (hsCRP). Safety was evaluated based on data collected for adverse events (AEs), physical and electrocardiographic examinations, vital sign measurements, and clinical laboratory tests. Significantly greater reductions in LDL-C levels from baseline values were observed with the combination of Rosuvastatin/fenofibric acid 20 mg/135 mg (−47.2%, p < 0.001), Rosuvastatin/fenofibric acid 10 mg/135 mg (−46.0%, p < 0.001), and Rosuvastatin/fenofibric acid 5 mg/135 mg (−38.9%, p = 0.007) than with simvastatin 40 mg (−32.8%). Significant (p ≤ 0.04 for all comparisons) improvements in non-HDL-C, ApoB, HDL-C, TG, and hsCRP levels were also observed with each of the Rosuvastatin/fenofibric acid doses as compared with simvastatin 40 mg. Treatment-related AEs and discontinuations due to AEs were similar across groups. The incidence of serious AEs was 0% with simvastatin 40 mg, 3.4% with Rosuvastatin/fenofibric acid 5 mg/135 mg, 0.8% with Rosuvastatin/fenofibric acid 10 mg/135 mg, and 2.5% with Rosuvastatin/fenofibric acid 20 mg/135 mg. No cases of rhabdomyolysis or drug-related myopathy were reported. In patients with high LDL-C and TG levels, combination treatment with Rosuvastatin/fenofibric acid was well tolerated, and each of the Rosuvastatin/fenofibric acid doses produced greater reductions in LDL-C and improvements in other efficacy parameters, compared with simvastatin 40 mg.

  • comparison of the efficacy and safety of Rosuvastatin versus atorvastatin simvastatin and pravastatin across doses stellar trial
    American Journal of Cardiology, 2003
    Co-Authors: Peter H. Jones, Elinor Miller, James M Mckenney, Evan A Stein, Harold E Bays, Valerie A Cain, Michael Davidson, James W Blasetto
    Abstract:

    The primary objective of this 6-week, parallel-group, open-label, randomized, multicenter trial was to compare Rosuvastatin with atorvastatin, pravastatin, and simvastatin across dose ranges for reduction of low-density lipoprotein (LDL) cholesterol. Secondary objectives included comparing Rosuvastatin with comparators for other lipid modifications and achievement of National Cholesterol Education Program Adult Treatment Panel III and Joint European Task Force LDL cholesterol goals. After a dietary lead-in period, 2,431 adults with hypercholesterolemia (LDL cholesterol ≥160 and <250 mg/dl; triglycerides <400 mg/dl) were randomized to treatment with Rosuvastatin 10, 20, 40, or 80 mg; atorvastatin 10, 20, 40, or 80 mg; simvastatin 10, 20, 40, or 80 mg; or pravastatin 10, 20, or 40 mg. At 6 weeks, across-dose analyses showed that Rosuvastatin 10 to 80 mg reduced LDL cholesterol by a mean of 8.2% more than atorvastatin 10 to 80 mg, 26% more than pravastatin 10 to 40 mg, and 12% to 18% more than simvastatin 10 to 80 mg (all p <0.001). Mean percent changes in high-density lipoprotein cholesterol in the Rosuvastatin groups were +7.7% to +9.6% compared with +2.1% to +6.8% in all other groups. Across dose ranges, Rosuvastatin reduced total cholesterol significantly more (p <0.001) than all comparators and triglycerides significantly more (p <0.001) than simvastatin and pravastatin. Adult Treatment Panel III LDL cholesterol goals were achieved by 82% to 89% of patients treated with Rosuvastatin 10 to 40 mg compared with 69% to 85% of patients treated with atorvastatin 10 to 80 mg; the European LDL cholesterol goal of <3.0 mmol/L was achieved by 79% to 92% in Rosuvastatin groups compared with 52% to 81% in atorvastatin groups. Drug tolerability was similar across treatments.

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