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  • Title: Reasons for disparity in statin adherence rates between clinical trials and real-world observations: a review.
    Author: Vonbank A, Drexel H, Agewall S, Lewis BS, Dopheide JF, Kjeldsen K, Ceconi C, Savarese G, Rosano G, Wassmann S, Niessner A, Schmidt TA, Saely CH, Baumgartner I, Tamargo J.
    Journal: Eur Heart J Cardiovasc Pharmacother; 2018 Oct 01; 4(4):230-236. PubMed ID: 30099530.
    Abstract:
    With statins, the reported rate of adverse events differs widely between randomized clinical trials (RCTs) and observations in clinical practice, the rates being 1-2% in RCTs vs. 10-20% in the so-called real world. One possible explanation is the claim that RCTs mostly use a run-in period with a statin. This would exclude intolerant patients from remaining in the trial and therefore favour a bias towards lower rates of intolerance. We here review data from RCTs with more than 1000 participants with and without a run-in period, which were included in the Cholesterol Treatment Trialists Collaboration. Two major conclusions arise: (i) the majority of RCTs did not have a test dose of a statin in the run-in phase. (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. Taken together, the RCTs of statins reviewed here do not suggest a bias towards an artificially higher adherence rate because of a run-in period with a test dose of the statin. Other possible explanations for the apparent disparity between RCTs and real-world observations are also included in this review albeit mostly not supported by scientific data.
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