So does it work?

Here is great article which may change the way you think about drug companies, evidence presentation, fads and the power of distraction. Credit to Prof Joe Lex for tweeting and of course the authors for daring...

BMJ Open 5:e007118 doi:10.1136/bmjopen-2014-007118
  • The effect of statins on average survival in randomised trials, an analysis of end point postponement

Abstract

Objective To estimate the average postponement of death in statin trials.
Setting A systematic literature review of all statin trials that presented all-cause survival curves for treated and untreated.
Intervention Statin treatment compared to placebo.
Primary outcome measures The average postponement of death as represented by the area between the survival curves.
Results 6 studies for primary prevention and 5 for secondary prevention with a follow-up between 2.0 and 6.1 years were identified. Death was postponed between −5 and 19 days in primary prevention trials and between −10 and 27 days in secondary prevention trials. The median postponement of death for primary and secondary prevention trials were 3.2 and 4.1 days, respectively.
Conclusions Statin treatment results in a surprisingly small average gain in overall survival within the trials’ running time. For patients whose life expectancy is limited or who have adverse effects of treatment, withholding statin therapy should be considered.

Strengths and limitations of this study

  • This is the first study ever to systematically evaluate statin trials using average postponement of death as the primary outcome.
  • We have only estimated the survival gain achieved within the trials’ running time, whereas in real life, treatment is often continued much longer.
  • We have only focused on all-cause mortality. Other outcomes may also be relevant, for example, non-fatal cardiovascular end points.