How Should Clinicians Treat Patients Who Report Muscle-Related Statin Intolerance?

A PCSK9 inhibitor lowered LDL-cholesterol levels more than ezetimibe, but statin intolerance was not confirmed in half of the enrolled patients, and PCSK9 inhibitors still lack long-term outcomes data.

To learn whether a proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitor would be effective in patients reporting muscle effects while on a statin, investigators performed a manufacturer-funded, two-phase, randomized clinical trial.

The 491 patients had uncontrolled LDL-cholesterol levels and muscle-related intolerance with two or more statins. The first study phase used a crossover design to confirm statin intolerance and incorporated drug wash-outs before, during, and afterwards. The patients were randomized to atorvastatin 20 mg/day or placebo for 10 weeks and then received the alternate therapy. There were 209 patients who had symptoms only with atorvastatin (42.6%); 35.3% had symptoms on placebo, and 17.3% had no symptoms on e…

Reviewing Author

Karol E. Watson, MD, PhD, FACC

Disclosures

Consultant/Advisory BoardBoehringer Ingelheim; Amgen; Novartis; Lilly; Amarin

Speaker’s BureauBoehringer Ingelheim

Grant/Research SupportNIH

Editorial BoardsCirculation (Associate Editor)