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

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.

CONCLUSION

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.