Efficacy and tolerability of once-weekly rosuvastatin in patients with previous statin intolerance

BackgroundMany patients who could benefit from hydroxymethylglutaryl coenzyme-A reductase inhibitors (statins) are unable to take statins because of myalgias while taking previous statin therapy.ObjectiveThe 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.MethodsIn 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.ResultsA 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.ConclusionOnce-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.