LAUSR

Randomized controlled trials (RCTs) are considered the gold standard for determining efficacy and safety of new drugs. Successful randomization addresses known and unknown confounding when assessing a drug’s effect among trial patients selected on strict inclusion and exclusion criteria (1). However, treatment results have been shown on occasion to be much less favorable than expected outside trial populations, often related to differences in age, comorbidity, disease severity, drug compliance, and/or comedication among patients treated in everyday clinical practice (1). The risk of adverse drug effects may also be higher among patients treated in routine clinical care. Liraglutide, a glucagon-like peptide 1 receptor agonist, was quickly adopted by clinicians following its approval by the European Medicines Agency in 2009 and by the U.S. Food and Drug Administration in 2010. Approval was based on a number of phase III RCTs called the Liraglutide Effect and Action in Diabetes (LEAD) 1–5 trials (2). We used data from Danish population-based medical databases to examine whether routine clinical care liraglutide initiators would have been eligible for participation in …