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

  • efficacy and tolerability of Fluvastatin xl 80 mg alone ezetimibe alone and the combination of Fluvastatin xl 80 mg with ezetimibe in patients with a history of muscle related side effects with other statins
    American Journal of Cardiology, 2008
    Co-Authors: Evan A Stein, Christie M Ballantyne, Eberhard Windler, Per Anton Sirnes, Andrey Sussekov, Zerrin Yigit, Claudia Seper, Claudio Gimpelewicz
    Abstract:

    Although statin treatment is generally well tolerated, it is estimated that 5% to 10% of patients develop muscle-related side effects (MRSEs), resulting in less effective nonstatin alternatives or cessation of lipid-lowering therapy completely. This study was designed to assess the efficacy and tolerability of extended-release Fluvastatin (Fluvastatin XL) and ezetimibe alone or in combination in patients with previous MRSEs with other statins. This was a double-blinded, double-dummy trial of 199 mostly moderate- or high-risk dyslipidemic patients randomized to Fluvastatin XL 80 mg/day (n = 69), ezetimibe 10 mg/day (n = 66), or Fluvastatin XL 80 mg/day plus ezetimibe 10 mg/day (n = 64) for 12 weeks. Fluvastatin XL lowered low-density lipoprotein (LDL) cholesterol by 32.8% compared with 15.6% with ezetimibe (between-group difference −17.1%, 95% confidence interval −23.6 to −10.7, p

  • efficacy and tolerability of Fluvastatin extended release delivery system a pooled analysis
    Clinical Therapeutics, 2001
    Co-Authors: Christie M Ballantyne, Franco Pazzucconi, Xavier Pinto, John Pd Reckless, Evan A Stein, James M Mckenney, Michele Bortolini, Yann Tong Chiang
    Abstract:

    Abstract Background: At high doses, the pharmacokinetics of Fluvastatin immediate-release (IR) are nonlinear, possibly due to saturation of hepatic uptake. Fluvastatin delivery to the liver in a slower but sustained fashion would be expected to avoid hepatic saturation without elevating systemic drug levels. Objective: This pooled analysis compared the efficacy and tolerability of extended-release (XL) 80-mg and IR 40-mg formulations of Fluvastatin in lowering low-density lipoprotein cholesterol (LDL-C) and triglyceride (TG) levels and raising high-density lipoprotein cholesterol (HDL-C) levels in patients with hypercholesterolemia. Methods: Data were pooled from 3 double-blind, randomized, active-controlled, multicenter, parallel-group studies that compared changes in lipid and apolipoprotein levels with Fluvastatin XL 80 mg at bedtime (HS) with changes in Fluvastatin IR 40 mg HS or BID in patients aged ≥18 years with primary hypercholesterolemia (consistently elevated LDL-C level [≥160 mg/dL] and plasma TG levels ≤400 mg/dL). The primary efficacy variable was percent change in LDL-C from baseline. Results: The pooled analysis provided an intent-to-treat efficacy study population of 1674 patients. At 4 weeks, Fluvastatin XL 80 mg HS reduced LDL-C levels by a mean of 36.3% (median 38%), significantly greater than a mean reduction of 25.9% (median 27%) seen with Fluvastatin IR 40 mg HS, and an incremental additional mean reduction in LDL-C of 10.4% ( P P P P Conclusions: Once-daily administration of Fluvastatin XL 80 mg provides enhanced efficacy with an additional 10.4% reduction in LDL-C levels compared with Fluvastatin IR 40 mg HS, and superior increases in HDL-C levels, particularly in patients with elevated TG levels ( P

Claudio Gimpelewicz - One of the best experts on this subject based on the ideXlab platform.

  • efficacy and tolerability of Fluvastatin xl 80 mg alone ezetimibe alone and the combination of Fluvastatin xl 80 mg with ezetimibe in patients with a history of muscle related side effects with other statins
    American Journal of Cardiology, 2008
    Co-Authors: Evan A Stein, Christie M Ballantyne, Eberhard Windler, Per Anton Sirnes, Andrey Sussekov, Zerrin Yigit, Claudia Seper, Claudio Gimpelewicz
    Abstract:

    Although statin treatment is generally well tolerated, it is estimated that 5% to 10% of patients develop muscle-related side effects (MRSEs), resulting in less effective nonstatin alternatives or cessation of lipid-lowering therapy completely. This study was designed to assess the efficacy and tolerability of extended-release Fluvastatin (Fluvastatin XL) and ezetimibe alone or in combination in patients with previous MRSEs with other statins. This was a double-blinded, double-dummy trial of 199 mostly moderate- or high-risk dyslipidemic patients randomized to Fluvastatin XL 80 mg/day (n = 69), ezetimibe 10 mg/day (n = 66), or Fluvastatin XL 80 mg/day plus ezetimibe 10 mg/day (n = 64) for 12 weeks. Fluvastatin XL lowered low-density lipoprotein (LDL) cholesterol by 32.8% compared with 15.6% with ezetimibe (between-group difference −17.1%, 95% confidence interval −23.6 to −10.7, p

Christie M Ballantyne - One of the best experts on this subject based on the ideXlab platform.

  • efficacy and tolerability of Fluvastatin xl 80 mg alone ezetimibe alone and the combination of Fluvastatin xl 80 mg with ezetimibe in patients with a history of muscle related side effects with other statins
    American Journal of Cardiology, 2008
    Co-Authors: Evan A Stein, Christie M Ballantyne, Eberhard Windler, Per Anton Sirnes, Andrey Sussekov, Zerrin Yigit, Claudia Seper, Claudio Gimpelewicz
    Abstract:

    Although statin treatment is generally well tolerated, it is estimated that 5% to 10% of patients develop muscle-related side effects (MRSEs), resulting in less effective nonstatin alternatives or cessation of lipid-lowering therapy completely. This study was designed to assess the efficacy and tolerability of extended-release Fluvastatin (Fluvastatin XL) and ezetimibe alone or in combination in patients with previous MRSEs with other statins. This was a double-blinded, double-dummy trial of 199 mostly moderate- or high-risk dyslipidemic patients randomized to Fluvastatin XL 80 mg/day (n = 69), ezetimibe 10 mg/day (n = 66), or Fluvastatin XL 80 mg/day plus ezetimibe 10 mg/day (n = 64) for 12 weeks. Fluvastatin XL lowered low-density lipoprotein (LDL) cholesterol by 32.8% compared with 15.6% with ezetimibe (between-group difference −17.1%, 95% confidence interval −23.6 to −10.7, p

  • efficacy and tolerability of Fluvastatin extended release delivery system a pooled analysis
    Clinical Therapeutics, 2001
    Co-Authors: Christie M Ballantyne, Franco Pazzucconi, Xavier Pinto, John Pd Reckless, Evan A Stein, James M Mckenney, Michele Bortolini, Yann Tong Chiang
    Abstract:

    Abstract Background: At high doses, the pharmacokinetics of Fluvastatin immediate-release (IR) are nonlinear, possibly due to saturation of hepatic uptake. Fluvastatin delivery to the liver in a slower but sustained fashion would be expected to avoid hepatic saturation without elevating systemic drug levels. Objective: This pooled analysis compared the efficacy and tolerability of extended-release (XL) 80-mg and IR 40-mg formulations of Fluvastatin in lowering low-density lipoprotein cholesterol (LDL-C) and triglyceride (TG) levels and raising high-density lipoprotein cholesterol (HDL-C) levels in patients with hypercholesterolemia. Methods: Data were pooled from 3 double-blind, randomized, active-controlled, multicenter, parallel-group studies that compared changes in lipid and apolipoprotein levels with Fluvastatin XL 80 mg at bedtime (HS) with changes in Fluvastatin IR 40 mg HS or BID in patients aged ≥18 years with primary hypercholesterolemia (consistently elevated LDL-C level [≥160 mg/dL] and plasma TG levels ≤400 mg/dL). The primary efficacy variable was percent change in LDL-C from baseline. Results: The pooled analysis provided an intent-to-treat efficacy study population of 1674 patients. At 4 weeks, Fluvastatin XL 80 mg HS reduced LDL-C levels by a mean of 36.3% (median 38%), significantly greater than a mean reduction of 25.9% (median 27%) seen with Fluvastatin IR 40 mg HS, and an incremental additional mean reduction in LDL-C of 10.4% ( P P P P Conclusions: Once-daily administration of Fluvastatin XL 80 mg provides enhanced efficacy with an additional 10.4% reduction in LDL-C levels compared with Fluvastatin IR 40 mg HS, and superior increases in HDL-C levels, particularly in patients with elevated TG levels ( P

Per Anton Sirnes - One of the best experts on this subject based on the ideXlab platform.

  • efficacy and tolerability of Fluvastatin xl 80 mg alone ezetimibe alone and the combination of Fluvastatin xl 80 mg with ezetimibe in patients with a history of muscle related side effects with other statins
    American Journal of Cardiology, 2008
    Co-Authors: Evan A Stein, Christie M Ballantyne, Eberhard Windler, Per Anton Sirnes, Andrey Sussekov, Zerrin Yigit, Claudia Seper, Claudio Gimpelewicz
    Abstract:

    Although statin treatment is generally well tolerated, it is estimated that 5% to 10% of patients develop muscle-related side effects (MRSEs), resulting in less effective nonstatin alternatives or cessation of lipid-lowering therapy completely. This study was designed to assess the efficacy and tolerability of extended-release Fluvastatin (Fluvastatin XL) and ezetimibe alone or in combination in patients with previous MRSEs with other statins. This was a double-blinded, double-dummy trial of 199 mostly moderate- or high-risk dyslipidemic patients randomized to Fluvastatin XL 80 mg/day (n = 69), ezetimibe 10 mg/day (n = 66), or Fluvastatin XL 80 mg/day plus ezetimibe 10 mg/day (n = 64) for 12 weeks. Fluvastatin XL lowered low-density lipoprotein (LDL) cholesterol by 32.8% compared with 15.6% with ezetimibe (between-group difference −17.1%, 95% confidence interval −23.6 to −10.7, p

Andrey Sussekov - One of the best experts on this subject based on the ideXlab platform.

  • efficacy and tolerability of Fluvastatin xl 80 mg alone ezetimibe alone and the combination of Fluvastatin xl 80 mg with ezetimibe in patients with a history of muscle related side effects with other statins
    American Journal of Cardiology, 2008
    Co-Authors: Evan A Stein, Christie M Ballantyne, Eberhard Windler, Per Anton Sirnes, Andrey Sussekov, Zerrin Yigit, Claudia Seper, Claudio Gimpelewicz
    Abstract:

    Although statin treatment is generally well tolerated, it is estimated that 5% to 10% of patients develop muscle-related side effects (MRSEs), resulting in less effective nonstatin alternatives or cessation of lipid-lowering therapy completely. This study was designed to assess the efficacy and tolerability of extended-release Fluvastatin (Fluvastatin XL) and ezetimibe alone or in combination in patients with previous MRSEs with other statins. This was a double-blinded, double-dummy trial of 199 mostly moderate- or high-risk dyslipidemic patients randomized to Fluvastatin XL 80 mg/day (n = 69), ezetimibe 10 mg/day (n = 66), or Fluvastatin XL 80 mg/day plus ezetimibe 10 mg/day (n = 64) for 12 weeks. Fluvastatin XL lowered low-density lipoprotein (LDL) cholesterol by 32.8% compared with 15.6% with ezetimibe (between-group difference −17.1%, 95% confidence interval −23.6 to −10.7, p