Confirmation of Statin and Fibrate Use from Small-Volume Archived Plasma Samples by High-Throughput LC-MS/MS Method

Area of Science:

• Pharmacology
• Analytical Chemistry
• Biomarker Discovery

Background:

• Lipid-lowering therapies like statins and fibrates are widely used, complicating biomarker discovery studies.
• Self-reported medication use often lacks accuracy regarding patient adherence to prescribed regimens.
• Existing analytical methods for drug detection are often impractical for large-scale or archived sample analysis.

Purpose of the Study:

• To develop a rapid and accurate analytical method for detecting multiple statins and fibrates in human plasma.
• To assess the reliability of self-reported statin and fibrate use in patient populations.
• To validate a new method for its applicability in biomarker discovery and lifestyle intervention studies.

Main Methods:

• Development of a 4-minute analytical method using reverse-phase liquid chromatography and tandem mass spectrometry.
• Analysis of seven statins and three fibrates in 10 µL of plasma.
• Application of the method to 941 archived plasma samples from patients undergoing cardiac catheterization.

Main Results:

• Statins were detected in 78.6% of samples with self-reported use, with 90.2% agreement for atorvastatin.
• A significant proportion (42.4%) of samples with no reported statin use showed detectable statin levels.
• Detected statin concentrations in non-reported users were comparable to those in reported users.

Conclusions:

• The developed analytical method provides accurate verification of statin and fibrate use, even in archived samples.
• Self-reported medication data in population studies may be unreliable, potentially impacting biomarker discovery.
• This rapid, sensitive method is highly valuable for population studies requiring precise medication adherence data.