ArticleBMC cardiovascular disorders2026
Biochemical urine analysis of atorvastatin and rosuvastatin by LC-MS: a pilot study of an objective method to assess non-adherence.
Article in BMC cardiovascular disorders, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05814692 (Feasibility of BIOchemical Urine Analysis of Adherence to Statins and Associated FACTorS in Coronary Artery Disease), which is not on this map. Not yet cited in PubMed.
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Feasibility of BIOchemical Urine Analysis of Adherence to Statins and Associated FACTorS in Coronary Artery Disease: The BIO-FACTS Pilot Study
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14 authors.
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Abstract
objectiveNon-adherence to statins represents a contributing factor for poor attainment of low-density lipoprotein cholesterol treatment goals in secondary prevention of coronary artery disease (CAD). We aimed to establish urine analysis by liquid chromatography/mass spectrometry (LC-MS) as a method for objective measurement of non-adherence to high-potency statins. Additionally, we sought to apply the method to a population of ambulatory CAD patients at a German heart center in a cross-sectional pilot study.
methodsVolunteers provided urine samples one, two, three, and seven days after intake of a single dose of atorvastatin and/or rosuvastatin. Additionally, urine samples from ambulatory CAD patients on prescription of atorvastatin or rosuvastatin were obtained. All urine samples were analyzed by LC-MS for concentrations of atorvastatin or rosuvastatin. Lower limits of detection were determined on spiked urine samples to define cut-off values (COVs) for the detection of statins (atorvastatin 1.40 ng/mL, rosuvastatin 1.00 ng/mL). Non-adherence was defined as a measurement of the respective statin below the COV.
resultsOn day one, in volunteers’ (n = 16, 37.3 ± 6 years, 81.3% male) urine samples, concentrations were above COV in 92.3% (atorvastatin, n = 13) and 90% (rosuvastatin, n = 10). After seven days, atorvastatin could not be detected in all 13 volunteers (100%) and rosuvastatin in nine of ten volunteers (90.0%),
conclusionLC-MS analysis of urine is a feasible method for direct testing of adherence to high-potency statins within a one-week time-window. In the investigated population of ambulatory patients with CAD, non-adherence to statins was found in a considerably low range.
trial registrationClinicalTrials.gov ID NCT05814692, first registered 20,230,403.
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