This study tests whether a personalized trial approach can help patients who previously had problems tolerating statin medications take rosuvastatin successfully. Statins are commonly used to lower cholesterol and reduce heart disease risk, but some patients experience side effects that prevent them from taking these important medications.
Key Objective: The trial tests whether a customized n-of-1 trial design can help patients who previously could not tolerate statins safely take rosuvastatin without experiencing the side effects that troubled them before.
Who to Consider: Patients who have experienced side effects or intolerance to statin medications in the past and want to explore whether they might be able to tolerate rosuvastatin should consider enrolling.
Trial Parameters
Brief Summary
The DESIFOR pilot study was conducted to determine the feasibility of utilizing an n-of-1 trial to facilitate tolerance of unblinded rosuvastatin in patients with prior statin intolerance
Eligibility Criteria
Inclusion Criteria: * Adult patients (≥ 21 years old) with a prior history of statin intolerance. Statin intolerance is defined by discontinuation of at least 2 different statin medications due to possible side effects. Patients can participate in the trial while on other lipid-lowering agents, such as ezetimibe and PSCK9 inhibitors, as long as the patient has been on the other lipid lowering therapy and tolerating it well for at least 1 month. For individuals with established ASCVD or multiple ASCVD risk factors, initiation of other lipid lowering therapy prior to participation in DESIFOR is encouraged. * 2\. At least 30 days since discontinued use of a statin Exclusion Criteria: * Women who are pregnant, nursing or attempting to become pregnant * Individuals who experienced severe reactions in the past, including rhabdomyolysis, severe myositis, anaphylaxis * Individuals who are not otherwise clinically indicated to take rosuvastatin 20 mg