Trial to Determine Statin Intolerance and Rosuvastatin Tolerance in Adults with Prior Statin Side Effects

What this Trial Is About

Researchers are evaluating the use of an n-of-1 trial to help patients with prior statin intolerance tolerate rosuvastatin, a cholesterol-lowering medication. The trial focuses on individuals aged 21 years and older who are eligible for statin therapy but have stopped using at least two different statins due to side effects. The study aims to better identify true statin intolerance, which could improve treatment decisions and cost-effectiveness of lipid-lowering therapies, especially for those at risk of cardiovascular disease. Participants will be randomly assigned to receive either placebo or rosuvastatin first, followed by the other treatment, in a double-blinded manner. They will take three 28-day packs of placebo and two 28-day packs of rosuvastatin during the study period. This design helps determine whether patients can tolerate rosuvastatin when unblinded after the initial blinded phase. During the 9-month study, researchers will monitor the presence or absence of musculoskeletal symptoms, statin tolerance, and factors associated with statin intolerance. Participants may continue their other lipid-lowering treatments if stable for at least one month. The study involves regular assessments to track symptoms and response, with safety and tolerance carefully evaluated throughout the trial.

DESIFOR-EXPAND (MHIF)