Discontinuation and restarting in patients on statin treatment: prospective open cohort study using a primary care database
BMJ 2016; 353 doi: https://doi.org/10.1136/bmj.i3305 (Published 28 June 2016) Cite this as: BMJ 2016;353:i3305
- Yana Vinogradova, research statistician1,
- Carol Coupland, professor in medical statistics in primary care1,
- Peter Brindle, research and development programme director and honorary reader2 3,
- Julia Hippisley-Cox, professor of clinical epidemiology and general practice1
- 1Division of Primary Care, University of Nottingham, University Park, Nottingham, NG2 7RD, UK
- 2Avon Primary Care Research Collaborative, Bristol Clinical Commissioning Group, Bristol, UK
- 3University of Bristol, Bristol, UK
- Correspondence to: Y Vinogradova Yana.Vinogradova{at}nottingham.ac.uk
- Accepted 11 May 2016
Abstract
Objectives To estimate rates of discontinuation and restarting of statins, and to identify patient characteristics associated with either discontinuation or restarting.
Design Prospective open cohort study.
Setting 664 general practices contributing to the Clinical Practice Research Datalink in the United Kingdom. Data extracted in October 2014.
Participants Incident statin users aged 25-84 years identified between January 2002 and September 2013. Patients with statin prescriptions divided into two groups: primary prevention and secondary prevention (those already diagnosed with cardiovascular disease). Patients with statin prescriptions in the 12 months before study entry were excluded.
Main outcome measures Discontinuation of statin treatment (first 90 day gap after the estimated end date of a statin prescription), and restarting statin treatment for those who discontinued (defined as any subsequent prescription between discontinuation and study end).
Results Of 431 023 patients prescribed statins as primary prevention with a median follow-up time of 137 weeks, 47% (n=204 622) discontinued treatment and 72% (n=147 305) of those who discontinued restarted. Of 139 314 patients prescribed statins as secondary prevention with median follow-up time of 182 weeks, 41% (n=57 791) discontinued treatment and 75% (43 211) of those who discontinued restarted. Younger patients (aged ≤50 years), older patients (≥75 years), women, and patients with chronic liver disease were more likely to discontinue statins and less likely to restart. However, patients in ethnic minority groups, current smokers, and patients with type 1 diabetes were more likely to discontinue treatment but then were more likely to restart, whereas patients with hypertension and type 2 diabetes were less likely to discontinue treatment and more likely to restart if they did discontinue. These results were mainly consistent in the primary prevention and secondary prevention groups.
Conclusions Although a large proportion of statin users discontinue, many of them restart. For many patient groups previously considered as “stoppers,” the problem of statin treatment “stopping” could be part of the wider issue of poor adherence. Identification of patient groups associated with completely stopping or stop-starting behaviour has positive implications for patients and doctors as well as suggesting areas for future research.
Footnotes
Contributors: JH-C had the original idea for this study. JH-C, CC, and PB contributed to the development of the idea and the study design. YV reviewed the literature, contributed to the study design, did the analysis, and drafted the manuscript. CC advised on the analysis. JH-C, PB, and CC critically reviewed the paper. YV is the guarantor of the study. All authors have approved the submitted version.
Funding: This work has received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. Only the authors are responsible for analysis, interpretation of the data, and writing the report for publication.
Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: no support from any additional organisation for the submitted work; JH-C is a professor of clinical epidemiology at the University of Nottingham and unpaid director of QResearch, a not-for-profit organisation that is a joint partnership between the University of Nottingham and EMIS (Egton Medical Information System; commercial IT supplier for 60% of general practices in the UK); JH-C is also a paid director of ClinRisk, which produces open and closed source software to ensure the reliable and updatable implementation of clinical risk algorithms (including QRISK2) within clinical computer systems to help improve patient care; no other relationships or activities that could appear to have influenced the submitted work.
Ethical approval: This protocol has been approved by the independent scientific advisory committee for Medicines and Healthcare products Regulatory Agency Database Research (N 15_053RAR2). The protocol has been published in BMJ Open.20
Data sharing: To guarantee the confidentiality of personal and health information, only the authors have had access to the data during the study. It will be possible to access the CPRD data after the publication of the results, but only on premises of the University of Nottingham according to the CPRD licence.
The lead author affirms that the manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained.
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