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Statin adherence in clinical trials

Commented by the ESC Working Group on Cardiovascular Pharmacotherapy

Reasons for disparity in statin adherence rates between clinical trials and real-world observations: a review. Vonbank et al.

Lipid-Lowering Agents


Adherence to cardiovascular (CV) guidelines seems to be associated with an improved outcome (1). Specifically, in the case of statin trials, there is an often-raised claim that randomized controlled trials (RCTs) exclude patients with statin intolerance in the pre-randomization or run-in periods in order to minimize losses from follow-up, a fact that could explain why randomized trials have lower rates of side effects in the active treatment phase than will be observed in the real world (2). In this review paper, Dr Vonbank and co-workers, report that; (i) the majority of RCTs did not have a test dose of a statin in the run-in phase and (ii) a test dose in the run-in phase was not associated with a significantly improved adherence rate within that trial when compared to trials without a test dose.

References


  1. Agewall S. Adherence to guidelines and registry data. Eur Heart J Cardiovasc Pharmacother  2017;3:183–184. https://doi.org/10.1093/ehjcvp/pvx027
  2. Deshpande S, Quek RGW, Forbes CA, Gandra SR, Forbes CA, Ryder S, Armstrong N, Deshpande S, Duffy S, Kleijnen J, Lindgren P. A systematic review to assess adherence and persistence with statins. Curr Med Res Opin 2017;33:769–778. https://doi.org/10.1080/03007995.2017.1281109
The content of this article reflects the personal opinion of the author/s and is not necessarily the official position of the European Society of Cardiology.