Method development studies

Through an extensive pharmacological development work, we have successfully developed and validated a new method for measuring the concentration of atorvastatin and simvastatin and all primary metabolites directly in blood with modern mass spectrometric methodology. We have shown, for the first time, that the sum of parent drug and metabolites was stable at room temperature over several days. Together with a short analysis time and valid pilot results, this means that the method can be used to measure statin levels in blood samples in clinical practice, for example in primary care  or at an hospital outpatient clinic.

In order to study adherence with statin therapy with the new method, we conducted a pharmacokinetic study (N=48 coronary patients), STAT-MON 1, where succeeded developing dose-normalized cut‐off values for statin concentrations and an algorithm for adherence that can accurately discriminate patients who are non-adherent to statins from those who are adherent. The algorithm can potentially be generalizable to other drugs.

During spring 2021, we will conduct a new pharmacokinetic study (N=60 patients), STAT-MON 2, to validate the decision limits developed in STAT-MON 1 study.