title: Efficacy and tolerability of once-weekly rosuvastatin in patients with previous statin intolerance.
abstract: BACKGROUND
  Many patients who could benefit from hydroxymethylglutaryl coenzyme-A reductase inhibitors (statins) are unable to take statins because of myalgias while taking previous statin therapy.
  
  
  OBJECTIVE
  The primary objective was to assess the efficacy and tolerability of once-weekly rosuvastatin in patients with documented myalgias on statins who were not currently taking a statin and not at low-density lipoprotein (LDL) goal.
  
  
  METHODS
  In this randomized, double-blind, placebo-controlled crossover study we enrolled a total of 17 Clement J. Zablocki Veterans Affairs (VA) primary care patients with a diagnosis of hyperlipidemia and a history of myalgias on statin therapy who were not currently on a statin and not at LDL goal. Two 8-week treatment phases consisted of rosuvastatin 5 mg once-weekly or matching placebo, with a dose titration to 10 mg once-weekly if not at LDL goal at week 4. The primary efficacy outcome was the difference in the mean percentage change in LDL from baseline between rosuvastatin and placebo.
  
  
  RESULTS
  A significant difference in the mean percentage change in LDL from baseline for rosuvastatin vs. placebo was identified (12.2% reduction vs. 0.4% reduction, respectively; P = .002). Two of the 17 patients (11.8%) in the placebo treatment phase and three of the 15 patients (20%) in the rosuvastatin treatment phase experienced myalgias requiring cessation of therapy. In addition, three patients (20%) were able to attain LDL goal on rosuvastatin compared with zero patients (0%) on placebo.
  
  
  CONCLUSIONS
  Once-weekly low-dose rosuvastatin is an effective and well-tolerated lipid-lowering therapy option for patients not at LDL goal and previously unable to tolerate statins because of a history of myalgias.
authors.affiliation: Clement J. Zablocki VA Medical Center, 5000 W. National Avenue, Milwaukee, WI 53295, USA. steven.kennedy@va.gov
authors.forename: Steven P
authors.initials: SP
authors.lastname: Kennedy
authors.forename: Gary P
authors.initials: GP
authors.lastname: Barnas
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Schmidt
authors.forename: Marcy S
authors.initials: MS
authors.lastname: Glisczinski
authors.forename: Angela C
authors.initials: AC
authors.lastname: Paniagua
mesh_terms: D000368:Aged; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004361:Drug Tolerance; D005464:Fluorobenzenes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006949:Hyperlipidemias / Q000188:drug therapy*; D008077:Lipoproteins, LDL / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D009135:Muscular Diseases / Q000139:chemically induced*; D011743:Pyrimidines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000068718:Rosuvastatin Calcium; D013449:Sulfonamides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D005464:Fluorobenzenes; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D008077:Lipoproteins, LDL; D011743:Pyrimidines; D013449:Sulfonamides; D000068718:Rosuvastatin Calcium