Study title and author:
Meta-analysis of side effects of statins shows need for trial transparency
Joan-Ramon Laporte
Professor of Clinical Pharmacology Montserrat Bosch
Universitat Autònoma de Barcelona, P Vall d'Hebron 129-139 08035 Barcelona
This paper can be accessed at: http://www.bmj.com/content/348/bmj.g2940/rr/696651
This paper can be accessed at: http://www.bmj.com/content/348/bmj.g2940/rr/696651
This article, authored by Professor Joan-Ramon Laporte from the Autonomous University of Barcelona noted the exclusions in statin clinical trials.
Professor Laporte found:
(a) In the HPS (Heart Protection Study), 32,145 patients with the inclusion criteria participated in a run in phase, but 11,609 (36%) were excluded because of lack of effect on cholesterol, increase in liver enzymes, increase in CPK, or increase of creatinine, or also because "the patient had little probability of complying with the treatment during 5 years".
(b) In the MEGA trial (Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese), 15,210 patients entered a 4-week run in phase, but 7,201 (48%) were excluded for similar reasons, and only 8,009 finally participated in the trial.
(c) In the JUPITER trial (Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin), 89,890 were initially screened, but 78% were excluded for unclear reasons, and only 19,323 were considered for randomisation. Then, an additional 1,521 were excluded during a run in phase because of poor treatment adherence, and only 17,802 patients (19.8%) were finally randomised.
Professor Laporte concluded that in view of these massive exclusions, the data from these trials may be considerably flawed and lacked validity, and that no conclusions could be drawn from the results of the trials.
