Kontynuacja dawki 20 mg rosuwastatyny u pacjentów z nietolerancją statyn – badanie N‑of‑1 vs standardowa titracja w chorobach sercowo‑naczyniowych

Confirmation of participation

After joining the study, basic health information and current medication use are recorded.

A short Questionnaire about previous statin intolerance is completed.

Randomisation of treatment order

The order in which the two study products will be taken is assigned by the study system.

The sequence may be rosuvastatin first followed by placebo, or the reverse.

First treatment period

The assigned product is taken every day for a defined number of weeks (the study lasts a total of 36 weeks).

If the product is rosuvastatin, the dose is 20 mg taken orally once daily.

If the product is the placebo, it looks identical but contains no active substance.

Daily self‑Assessment

Each day, symptoms and possible side‑effects are recorded using the provided Questionnaire.

The Questionnaire is simple and does not require medical knowledge.

Switch to second treatment period

After the first period ends, the other product is started without a break.

The same daily dose (20 mg) is used if the product is rosuvastatin.

The placebo continues to contain no active ingredient.

Continue daily self‑Assessment

The daily Questionnaire is completed throughout the second period in the same way as during the first period.

Final evaluation after 36 weeks

At the end of the 36‑week trial, a final Questionnaire is completed to summarise experiences with both products.

The data are used to determine which product was better tolerated.

Six‑month follow‑up

Six months after the start of the trial, it is assessed whether the daily dose of 20 mg rosuvastatin is continued.

The Assessment is based on the information collected during the trial.