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Validation of a novel direct method to determine reduced adherence to atorvastatin therapy.
- Source :
-
European heart journal. Cardiovascular pharmacotherapy [Eur Heart J Cardiovasc Pharmacother] 2024 Jul 16; Vol. 10 (4), pp. 307-315. - Publication Year :
- 2024
-
Abstract
- Aims: Objective methods to determine statin adherence are requested to improve lipid management. We have recently established a method to detect reduced adherence to atorvastatin therapy with cut-off values based on the sum of atorvastatin and its major metabolites in the blood. We aimed to validate this method in patients with and without cardiovascular disease, and optimize previous cut-off values.<br />Methods and Results: The pharmacokinetic study included 60 participants treated with atorvastatin 20 mg (N = 20), 40 mg (N = 20), and 80 mg (N = 20). Atorvastatin was then stopped and blood samples collected from day zero to day four. Quantification of the parent drug and its metabolites in blood plasma was performed with a liquid chromatography-tandem mass spectrometry assay. The cut-off values for reduced adherence were validated and optimized by calculating diagnostic sensitivity and specificity. Our candidate cut-off value of dose-normalized six-component sum of atorvastatin plus metabolites <0.10 nM/mg provided a sensitivity of 97% and a specificity of 93% for detecting ≥2 omitted doses. An optimized cut-off <0.062 nM/mg provided a sensitivity of 90% and a specificity of 100%. An alternative simplified two-component metabolite sum with a cut-off value <0.05 nM/mg provided a sensitivity of 98% and a specificity of 76%. An optimized cut-off <0.02 nM/mg provided a sensitivity of 97% and a specificity of 98%.<br />Conclusion: This validation study confirms that our direct method discriminates reduced adherence from adherence to atorvastatin therapy with high diagnostic accuracy. The method may improve lipid management in clinical practice and serve as a useful tool in future studies.<br /> (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)
- Subjects :
- Humans
Male
Female
Middle Aged
Aged
Heptanoic Acids pharmacokinetics
Heptanoic Acids administration & dosage
Heptanoic Acids blood
Heptanoic Acids therapeutic use
Pyrroles pharmacokinetics
Pyrroles blood
Pyrroles administration & dosage
Tandem Mass Spectrometry
Chromatography, Liquid
Cardiovascular Diseases drug therapy
Cardiovascular Diseases diagnosis
Cardiovascular Diseases blood
Cardiovascular Diseases prevention & control
Reproducibility of Results
Dose-Response Relationship, Drug
Atorvastatin pharmacokinetics
Atorvastatin therapeutic use
Atorvastatin blood
Medication Adherence
Hydroxymethylglutaryl-CoA Reductase Inhibitors pharmacokinetics
Hydroxymethylglutaryl-CoA Reductase Inhibitors therapeutic use
Hydroxymethylglutaryl-CoA Reductase Inhibitors blood
Hydroxymethylglutaryl-CoA Reductase Inhibitors administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 2055-6845
- Volume :
- 10
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- European heart journal. Cardiovascular pharmacotherapy
- Publication Type :
- Academic Journal
- Accession number :
- 38196131
- Full Text :
- https://doi.org/10.1093/ehjcvp/pvae001