Monitoring patients on cholesterol-lowering drugs

Hair analysis could offer a highly sensitive and accurate new method for monitoring patients’ compliance with long-term statin therapy.

Statins are medications that are widely prescribed to lower the level of low-density lipoprotein (LDL) cholesterol in the blood. They work by stopping the production of cholesterol in the body – and are usually very successful at lowering cholesterol and preventing cardiovascular disease, including heart attack and stroke.

A person will likely need to take a statin pill every day for the rest of their life. This is because their body will continue to make cholesterol – and so stopping the medication will mean the cholesterol levels in their blood will start to rise again.

While many people will take statins for decades without any side effects, around one in three patients will quit statin therapy within two years. This decision may be driven by several factors – for example, they may be experiencing unpleasant side effects like muscle pain or cramps, or a misunderstanding of the benefits of long-term treatment.

Because patient adherence is necessary to achieve the full benefit of statins for preventing heart problems, there is a need for a simple and effective tool for doctors to monitor compliance with these cholesterol-lowering medications.

Hair analysis

In a new study, published in Eletrophoresis, researchers develop a new, specific and sensitive method to detect six different statins and their metabolites in human hair.¹

The researchers collected hair samples by cutting a lock of hair around four to five centimetres from as close to the scalp as possible – enabling the monitoring of drug intake for around four to five months beforehand. Samples of 50 mg were extracted with methanol overnight and then prepared for analysis using ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS).

The team validated the UPLC-MS/MS method according to US Food and Drug Administration (FDA) guidelines, in terms of selectivity, linearity, sensitivity, precision, accuracy, stability and matrix effect. They then tested its potential real-world application by monitoring eight patients undergoing long-term statin therapy – showing that all individuals with unquestionable adherence had detectable statin concentrations in their hair samples.

The researchers used ultrapure water generated from an ELGA PURELAB® laboratory water purification system for these experiments, minimising the risk of introducing contaminants that may affect their results.

Feasibility study

The results of this study suggest, for the first time, the possibility of using hair analysis as a new and potentially ideal tool to monitor patients’ adherence to statin therapy. After optimisation, the UPLC-MS/MS method was successfully validated for determining the levels of six statins and their metabolites.

The practical applicability of this method for verifying patient compliance was assessed by testing samples of hair from patients undergoing long-term statin therapy. However, this work should be considered a test of feasibility rather than clinical validation of the new tool – as unfortunately, reliable information on the adherence to therapy for each individual was unavailable.

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Reference:

1. Ballotari M, Taus F, Gottardo R, Tagliaro F, Bortolotti F. Hair analysis as a new tool to monitor adherence to long-term therapy to statins. Electrophoresis. 2023 Jan 14. doi: 10.1002/elps.202200210

Dr Alison Halliday

After completing an undergraduate degree in Biochemistry & Genetics at Sheffield University, Alison was awarded a PhD in Human Molecular Genetics at the University of Newcastle. She carried out five years as a Senior Postdoctoral Research Fellow at UCL, investigating the genes involved in childhood obesity syndrome. Moving into science communications, she spent ten years at Cancer Research UK engaging the public about the charity’s work. She now specialises in writing about research across the life sciences, medicine and health.