Liraglutide withdrawal rates: ‘real world’ practice

Abstract

AbstractImportant side effects and potential clinical hazards have emerged from long‐term follow up in some drug classes used in type 2 diabetes treatment. Systematic phase 4 post‐marketing data in early use of newer diabetes drugs may have a role in informing drug choice in practice and assist in pharmacoeconomic assessments of these drug choices.We carried out a comparison of the prevalence of drug withdrawals derived from both liraglutide registration trial data, and a systematic, prospective case‐note review of all new liraglutide prescriptions (n=176) from a specialist diabetes clinic over the first 12 months of drug introduction.Trial data used for the marketing authorisation application for liraglutide reported 7.0% withdrawal due to adverse events. Equal numbers of patients experienced mild, moderate and severe side effects. By contrast, data derived from a ‘real world’ clinical group describe 14.8% withdrawal due to adverse events, with withdrawal typically occurring early, by three months. Adverse events were more frequently responsible for treatment withdrawal at lower, compared to higher, doses of liraglutide therapy.Systematic observations of withdrawals in early use of new drugs in current clinical practice are higher than reported in registration trial data. These data highlight that post‐marketing surveillance should inform guideline recommendations and pharmacoeconomic evaluations. Copyright © 2012 John Wiley & Sons.