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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

Stein, Evan A., MD, PhD ; Ballantyne, Christie M., MD ; Windler, Eberhard, MD ; Sirnes, Per Anton, MD ; Sussekov, Andrey, MD ; Yigit, Zerrin, MD ; Seper, Claudia ; Gimpelewicz, Claudio R., MD

The American journal of cardiology, 2008-02, Vol.101 (4), p.490-496 [Periódico revisado por pares]

New York, NY: Elsevier Inc

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Título:
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
Autor: Stein, Evan A., MD, PhD ; Ballantyne, Christie M., MD ; Windler, Eberhard, MD ; Sirnes, Per Anton, MD ; Sussekov, Andrey, MD ; Yigit, Zerrin, MD ; Seper, Claudia ; Gimpelewicz, Claudio R., MD
Assuntos: Anticholesteremic Agents - administration & dosage ; Azetidines - administration & dosage ; Cardiovascular ; Cholesterol - blood ; Clinical trials ; Comparative analysis ; Delayed-Action Preparations ; Double-Blind Method ; Drug Therapy, Combination ; Dyslipidemias - drug therapy ; Estimates ; Ezetimibe ; Fatty Acids, Monounsaturated - administration & dosage ; Female ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors - administration & dosage ; Hydroxymethylglutaryl-CoA Reductase Inhibitors - adverse effects ; Indoles - administration & dosage ; Kinases ; Lipoproteins - blood ; Low density lipoprotein ; Male ; Middle Aged ; Muscular Diseases - chemically induced ; Side effects ; Statins ; Studies ; Treatment Outcome ; Triglycerides - blood
É parte de: The American journal of cardiology, 2008-02, Vol.101 (4), p.490-496
Descrição: 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 <0.0001); the fluvastatin XL/ezetimibe combination lowered LDL cholesterol by 46.1% (between-group difference vs ezetimibe −30.4%, 95% confidence interval −37.0 to −23.8, p <0.0001). Proportions of patients achieving their National Cholesterol Education Program Adult Treatment Panel III target LDL cholesterol were 84% with the fluvastatin XL/ezetimibe combination, 59% with fluvastatin XL, and 29% with ezetimibe (p <0.001 for fluvastatin XL monotherapy or combination therapy vs ezetimibe monotherapy). Incidences of MRSEs were 24% in the ezetimibe group, 17% in the fluvastatin XL group, and 14% in the combination group. There were no instances of creatine kinase increases ≥10 times upper limit of normal. In conclusion, in patients with a history of statin-associated MRSEs, fluvastatin XL alone or in combination with ezetimibe offers an effective and well-tolerated lipid-lowering option.
Editor: New York, NY: Elsevier Inc
Idioma: Inglês;Russo

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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

Stein, Evan A., MD, PhD ; Ballantyne, Christie M., MD ; Windler, Eberhard, MD ; Sirnes, Per Anton, MD ; Sussekov, Andrey, MD ; Yigit, Zerrin, MD ; Seper, Claudia ; Gimpelewicz, Claudio R., MD

New York, NY: Elsevier Inc

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