Patients who discontinued statin treatment: a protocol for cohort study using primary care data

Vinogradova, Yana; Coupland, Carol; Brindle, Peter; Hippisley-Cox, Julia

Abstract

Introduction: Risk thresholds for using statins to prevent cardiovascular disease (CVD) have recently been lowered, so an increasing number of patients are now prescribed these drugs. Although the safety of long-term statin use has been generally established, concerns about the balance of risks and benefits of statins still exist for some medical professionals and patients, and issues concerning their side effects are occasionally widely publicised. This study will report the rates of stopping for statins and also identify any patient groups more likely to stop using statins, so possibly increasing their risk of cardiovascular events.

Methods and analysis: A prospective open cohort study between 1 January 2002 and 30 September 2014 will be based on the general population of people prescribed statins, using records from UK general practices contributing to the Clinical Practice Research Database (CPRD). Participants aged 25–84 years will enter the cohort on the date of their first prescription for a statin and leave on the earliest date of: a cardiovascular event; death; leaving the practice; the last practice upload date or the study end date. If there are no prescriptions within 90 days after the expected finishing date of a prescription, a patient will be defined as a stopper with the discontinuation outcome date as the expected finishing date. Rates of statin discontinuation will be calculated by calendar year, type and dose of statin, age, and morbidities. Cox proportional regression analyses will be run to identify the most important factors associated with discontinuation. Analyses will be run separately for patients without CVD (primary prevention) and with diagnosed CVD (secondary prevention).

Ethics and dissemination: The protocol has been reviewed and approved by Independent Scientific Advisory Committee for MHRA Database Research. The results will be published in a peer-reviewed journal.

Citation

Vinogradova, Y., Coupland, C., Brindle, P., & Hippisley-Cox, J. (2015). Patients who discontinued statin treatment: a protocol for cohort study using primary care data. BMJ Open, 5(10), https://doi.org/10.1136/bmjopen-2015-008701

• Journal Article Type: Article
• Acceptance Date: Aug 27, 2015
• Online Publication Date: Oct 22, 2015
• Publication Date: Oct 22, 2015
• Deposit Date: Aug 30, 2018
• Publicly Available Date: Jan 29, 2019
• Electronic ISSN: 2044-6055
• Publisher: BMJ Publishing Group
• Peer Reviewed: Peer Reviewed
• Volume: 5
• Issue: 10
• DOI: https://doi.org/10.1136/bmjopen-2015-008701
• Public URL: https://nottingham-repository.worktribe.com/output/1106109
• Publisher URL: http://bmjopen.bmj.com/content/5/10/e008701.abstract
• Contract Date: Nov 27, 2018