Abstract
Objectives: Arterial hypertension is still the most frequent cause of cardiovascular and cerebrovascular morbidity and mortality. Antihypertensive treatment has proved effective in reduction of cardiovascular risk. Nevertheless, lifestyle interventions and pharmacological therapy in some cases are ineffective in reaching blood pressure target values, despite full dose and poly-pharmacological treatment. Poor adherence to medications is an important cause of treatment failure. Different methods to assess therapeutic adherence are currently available: Therapeutic drug monitoring in biological fluids has previously demonstrated its efficacy and reliability. Plasma and urine have been already used for this purpose, but they may be affected by some practical limitations. Saliva may represent a feasible alternative. Methods: Fourteen antihypertensive drugs and two metabolites were simultaneously tested in plasma, urine, and saliva. Tested molecules included: atenolol, nebivolol, clonidine, ramipril, olmesartan, telmisartan, valsartan, amlodipine, nifedipine, doxazosin, chlorthalidone, hydrochlorothiazide, indapamide, sacubitril, ramiprilat, and sacubitrilat. Therapeutic drug monitoring was performed using ultra-high performance liquid chromatography, coupled to tandem mass spectrometry (UHPLC-MS/MS). The method has been preliminarily evaluated in a cohort of hypertensive patients. Results: The method has been validated according to US Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidelines. The application on a cohort of 32 hypertensive patients has demonstrated sensibility and specificity of 98% and 98.1%, respectively, with a good feasibility in real-life clinical practice. Conclusion: Saliva may represent a feasible biological sample for therapeutic drug monitoring by non-invasive collection, prompt availability, and potential accessibility also in out-of-clinic settings.
Highlights
Arterial hypertension is the leading cause of cardiovascular and cerebrovascular morbidity and mortality, involving about 30% of the worldwide population (Mills et al, 2020)
The method has been validated according to US Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidelines
The relative standard deviation (RSD) values, which are considered the major sources of analytical inaccuracy and imprecision in UHPLC-MS/MS methods due to inter-sample variability in matrix composition and sample preparation procedures, were lower than 15% in most of cases
Summary
Arterial hypertension is the leading cause of cardiovascular and cerebrovascular morbidity and mortality, involving about 30% of the worldwide population (Mills et al, 2020). Suboptimal adherence has been associated to several adverse health outcomes, including myocardial infarction, chronic heart failure, stroke, end-stage renal disease, and overall mortality (Simpson et al, 2006; Perreault et al, 2009; Chowdhury et al, 2013; Herttua et al, 2013; Roy et al, 2013). It has important socio-economic implications, as it decreases the cost-effectiveness of health interventions, leading to poor clinical outcomes with increased costs for public health (Cherry et al, 2009)
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