Reasons for disparity in statin adherence rates between clinical trials and real-world observations: A review

TY - JOUR

T1 - Reasons for disparity in statin adherence rates between clinical trials and real-world observations

T2 - A review

AU - Vonbank, Alexander

AU - Drexel, Heinz

AU - Agewall, Stefan

AU - Lewis, Basil S.

AU - Dopheide, Joern F.

AU - Kjeldsen, Keld

AU - Ceconi, Claudio

AU - Savarese, Gianluigi

AU - Rosano, Giuseppe

AU - Wassmann, Sven

AU - Niessner, Alexander

AU - Schmidt, Thomas Andersen

AU - Saely, Christoph H.

AU - Baumgartner, Iris

AU - Tamargo, Juan

PY - 2018/10/1

Y1 - 2018/10/1

N2 - 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.

AB - 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.

KW - Adherence

KW - Intolerance

KW - Run in phase

KW - Statin therapy

U2 - 10.1093/ehjcvp/pvy028

DO - 10.1093/ehjcvp/pvy028

M3 - Review

C2 - 30099530

AN - SCOPUS:85058541691

SN - 2055-6837

VL - 4

SP - 230

EP - 236

JO - European Heart Journal - Cardiovascular Pharmacotherapy

JF - European Heart Journal - Cardiovascular Pharmacotherapy

IS - 4

ER -