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Evidence of Sample Use Among New Users of Statins: Implications for Pharmacoepidemiology

Li, Xiaojuan MSPH; Stürmer, Til MD, MPH, PhD; Brookhart, M. Alan PhD

doi: 10.1097/MLR.0000000000000174
Original Articles

Background: Epidemiologic studies of prescription medications increasingly rely on large administrative health care databases. These data do not capture patients’ use of medication samples. This could potentially bias studies of short-term effects where date of initiation may be inaccurate.

Objectives: To assess the extent of sample use among patients initiating statin therapy.

Research Design: Retrospective cohort of patients who filled a first prescription for a statin after at least 6 months of statin-free period in 2007–2010. Low-density lipoprotein (LDL) values obtained within the 15 days preceding the first prescription were analyzed using a 2-component Gaussian mixture model to look for evidence of prior treatment.

Subjects: A total of 26,033 statin initiators with at least 1 LDL laboratory result within the 15 days preceding the prescription fill.

Measures: Estimators for the proportion of patients filling a new prescription already on treatment.

Results: Among 9256 patients filling a branded statin, LDL distribution was bimodal, consisting of 2 Gaussian distributions: one, which made up 13.4% of the total population, had much lower LDL values (mean=71.8 mg/dL) compared with the second (mean=148.0 mg/dL), suggesting drug use before first dispensed prescription. Among 16,777 patients filling a generic statin, LDL levels were substantially higher with no evidence of bimodality that would suggest prior sample use.

Conclusions: These results provide indirect evidence that the initial period of branded medication use may often be missed when using pharmacy claims data to define drug initiation. Further research is needed to examine approaches to better identify incident medication use when assessing short-term effects.

Department of Epidemiology, UNC Gillings School of Global Public Health, Chapel Hill, NC

Presented at the 46th Annual Society for Epidemiologic Research Meeting in Boston, MA and the 29th International Conference on Pharmacoepidemiology in Montreal, Canada.

X.L. is a recipient of the Amgen Predoctoral Fellowship in Pharmacoepidemiology. T.S. receives investigator-initiated research funding and support as Principal Investigator (R01 AG023178) from the National Institute on Aging at the National Institutes of Health. He also received research funding as Principal Investigator of the UNC-DEcIDE center from the Agency for Healthcare Research and Quality. He does not accept personal compensation of any kind from any pharmaceutical company, though he receives salary support from the Center for Pharmacoepidemiology and from unrestricted research grants from pharmaceutical companies (GlaxoSmithKline, Merck, Sanofi, and Amgen) to the Department of Epidemiology, UNC Gillings School of Global Public Health. M.A.B. receives investigator-initiated research funding from the National Institutes of Health (R01 AG042845, R21 HD080214, R01 AG023178) and through contracts with the Agency for Healthcare Research and Quality’s DEcIDE program and the Patient Centered Outcomes Research Institute. He has received research support from Amgen and has sat on advisory boards for Amgen, Merck, and Pfizer (honoraria received by institution). He has received consulting fees from RxAnte Inc. and World Health Information Science Consultants, LLC. There was no direct pharmaceutical industry support for this study.

Reprints: M. Alan Brookhart, PhD, Department of Epidemiology, UNC Gillings School of Global Public Health, 2105 F McGavran-Greenberg, Campus Box CB# 7435, Chapel Hill, NC 27599-7435. E-mail:

© 2014 by Lippincott Williams & Wilkins.