TY - JOUR

T1 - Recommendations for participation in leisure time or competitive sports in athletes-patients with coronary artery disease

T2 - A position statement from the Sports Cardiology Section of the European Association of Preventive Cardiology (EAPC)

AU - Borjesson, Mats

AU - Dellborg, Mikael

AU - Niebauer, Josef

AU - LaGerche, Andre

AU - Schmied, Christian

AU - Solberg, Erik E.

AU - Halle, Martin

AU - Adami, Emilio

AU - Biffi, Alessandro

AU - Carré, Francois

AU - Caselli, Stefano

AU - Papadakis, Michael

AU - Pressler, Axel

AU - Rasmusen, Hanne

AU - Serratosa, Luis

AU - Sharma, Sanjay

AU - Van Buuren, Frank

AU - Pelliccia, Antonio

PY - 2018

Y1 - 2018

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.

U2 - 10.1093/eurheartj/ehy408

DO - 10.1093/eurheartj/ehy408

M3 - Journal article

C2 - 30052887

AN - SCOPUS:85059495405

VL - 40

SP - 13

EP - 18

JO - European Heart Journal

JF - European Heart Journal

SN - 0195-668X

IS - 1

ER -