title: Tolerability of red yeast rice (2,400 mg twice daily) versus pravastatin (20 mg twice daily) in patients with previous statin intolerance.
abstract: Currently, no consensus has been reached regarding the management of hyperlipidemia in patients who develop statin-associated myalgia (SAM). Many statin-intolerant patients use alternative lipid-lowering therapies, including red yeast rice. The present trial evaluated the tolerability of red yeast rice versus pravastatin in patients unable to tolerate other statins because of myalgia. The study was conducted in a community-based setting in Philadelphia, Pennsylvania. A total of 43 adults with dyslipidemia and a history of statin discontinuation because of myalgia were randomly assigned to red yeast rice 2,400 mg twice daily or pravastatin 20 mg twice daily for 12 weeks. All subjects were concomitantly enrolled in a 12-week therapeutic lifestyle change program. The primary outcomes included the incidence of treatment discontinuation because of myalgia and a daily pain severity score. The secondary outcomes were muscle strength and plasma lipids. The incidence of withdrawal from medication owing to myalgia was 5% (1 of 21) in the red yeast rice group and 9% (2 of 22) in the pravastatin group (p = 0.99). The mean pain severity did not differ significantly between the 2 groups. No difference was found in muscle strength between the 2 groups at week 4 (p = 0.61), week 8 (p = 0.81), or week 12 (p = 0.82). The low-density lipoprotein cholesterol level decreased 30% in the red yeast rice group and 27% in the pravastatin group. In conclusion, red yeast rice was tolerated as well as pravastatin and achieved a comparable reduction of low-density lipoprotein cholesterol in a population previously intolerant to statins.
authors.affiliation: Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA.
authors.forename: Steven C
authors.initials: SC
authors.lastname: Halbert
authors.forename: Benjamin
authors.initials: B
authors.lastname: French
authors.forename: Ram Y
authors.initials: RY
authors.lastname: Gordon
authors.forename: John T
authors.initials: JT
authors.lastname: Farrar
authors.forename: Kathryn
authors.initials: K
authors.lastname: Schmitz
authors.forename: Patti B
authors.initials: PB
authors.lastname: Morris
authors.forename: Paul D
authors.initials: PD
authors.lastname: Thompson
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Rader
authors.forename: David J
authors.initials: DJ
authors.lastname: Becker
mesh_terms: D000368:Aged; D001688:Biological Products / Q000008:administration & dosage / Q000009:adverse effects*; D008078:Cholesterol, LDL / Q000097:blood; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects*; D006949:Hyperlipidemias / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D015994:Incidence; D008019:Life Style; D008297:Male; D008875:Middle Aged; D053580:Muscle Strength; D009135:Muscular Diseases / Q000139:chemically induced* / Q000453:epidemiology; D017035:Pravastatin / Q000008:administration & dosage / Q000009:adverse effects*; D012008:Recurrence; D016896:Treatment Outcome
chemical_list: D001688:Biological Products; D008078:Cholesterol, LDL; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; C117343:red yeast rice; D017035:Pravastatin