Regression discontinuity analysis for pharmacovigilance: statin example reflected trial findings showing little evidence of harm

•RDA can be used with routine healthcare data, resulting in findings similar to Randomized controlled trials.•Application of regression discontinuity analysis (RDA) in epidemiology should include examination of the assumptions.•RDA should employ sensitivity analyses and negative control analyses.•RDA should carefully consider choice of model and bandwidth. The study aims to explore the use of regression discontinuity analysis (RDA) to examine effects of prescription of statins on total cholesterol and adverse outcomes (type 2 diabetes, rhabdomyolysis and myopathy, myalgia and myositis, liver disease, CVD, and mortality). We conducted a prospective cohort study using the Clinical Practice Research Datalink including patients with QRISK scores of 10 to 30 in 2010 to 2013 who were last followed-up in October 2016. Comparing patients with QRISK≥20 and QRISK