This clinical trial is focused on individuals who experience statin intolerance, which means they have difficulty taking statin medications due to side effects. Statins are commonly used to lower cholesterol and reduce the risk of heart disease. The study also involves people with a high cardiovascular risk, such as those with a history of heart disease or a condition called familial hypercholesterolemia, which is an inherited disorder that causes high cholesterol levels.
The treatment being studied is a medication called rosuvastatin, which is a type of statin. Participants in the study will receive either rosuvastatin or a placebo, which looks like the medication but does not contain the active ingredient. The purpose of the study is to see if a personalized approach, called an “n=1 study,” can help people continue using statins by reducing the negative effects they might expect to feel, known as the “nocebo effect.”
During the study, participants will take part in a randomized, double-blind trial, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. The study will also include counseling to discuss each participant’s individual treatment results. This approach aims to increase the use of statins and reduce the need for other cholesterol-lowering treatments over a period of 12 months. The study will help determine if this method can improve the management of cholesterol levels in people who have previously struggled with statin medications.
The Netherlands 