PT - JOURNAL ARTICLE AU - Joseph E Blais AU - Ralph Kwame Akyea AU - Annelize Coetzee AU - Amy HY Chan AU - Wallis CY Lau AU - Kenneth KC Man AU - Jeff Harrison AU - Esther W Chan AU - Kebede A Beyene AU - Ian CK Wong AU - Stephen Weng TI - Lipid levels and major adverse cardiovascular events in patients initiated on statins for primary prevention: an international population-based cohort study protocol AID - 10.3399/bjgpopen20X101127 DP - 2020 Dec 16 TA - BJGP Open PG - bjgpopen20X101127 4099 - http://bjgpopen.org/content/early/2020/12/14/bjgpopen20X101127.short 4100 - http://bjgpopen.org/content/early/2020/12/14/bjgpopen20X101127.full AB - Background Clinical guidelines recommend specific targets for low-density lipoprotein cholesterol (LDL-C) and non-high-density lipoprotein cholesterol (non-HDL-C) for primary prevention of cardiovascular disease (CVD). Furthermore, individual variability in lipid response to statin therapy requires assessment of the association in diverse populations.Aim To assess whether lower concentrations of LDL-C and non-HDL-C are associated with a reduced risk of major adverse cardiovascular events (MACE) in primary prevention of CVD.Design & setting An international, new-user, cohort study will be undertaken. It will use data from three electronic health record databases from three global regions: Clinical Practice Research Datalink, UK; PREDICT-CVD, New Zealand (NZ); and the Clinical Data and Analysis Reporting System, Hong Kong (HK).Method New statin users without a history of atherosclerotic CVD, heart failure, or chronic kidney disease, with baseline and follow-up lipid levels will be eligible for inclusion. Patients will be classified according to LDL-C (<1.4, 1.4–1.7, 1.8–2.5, and ≥2.6 mmol/l) and non-HDL-C (<2.2, 2.2–2.5, 2.6–3.3, and ≥3.4 mmol/l) concentrations 24 months after initiating statin therapy. The primary outcome of interest is MACE, defined as the first occurrence of coronary heart disease, stroke, or cardiovascular death. Secondary outcomes include all-cause mortality and the individual components of MACE. Sensitivity analyses will be conducted using lipid levels at 3 and 12 months after starting statin therapy.Conclusion Results will inform clinicians about the benefits of achieving guideline recommended concentrations of LDL-C for primary prevention of CVD.