How well does the evidence on pioglitazone back up researchers' claims for a reduction in macrovascular events?

doi:10.1136/bmj.331.7520.836

BMJ 2005;331:836-838 (8 October), doi:10.1136/bmj.331.7520.836

Education and debate

How well does the evidence on pioglitazone back up researchers' claims for a reduction in macrovascular events?

Nick Freemantle, professor of clinical epidemiology and biostatistics¹

¹ University of Birmingham, Birmingham B15 2TT N.Freemantle@bham.ac.uk

Recent claims that pioglitazone prevents macrovascular eventsare based on a secondary outcome measure. But ignoring the primaryoutcome is statistically unsound

The first 150 words of the full text of this article appear below.

Introduction

Last month, members of the steering committee of the prospectivepioglitazone clinical trial in macrovascular events (Proactive)presented the results at the European Association for the Studyof Diabetes meeting in Athens.¹ The audience, which overflowedfrom the meeting room, heard John Dormandy, chair of the steeringcommittee, conclude that the trial had shown that pioglitazone,"Reduces the composite of all cause mortality, non-fatal myocardialinfarction, and stroke." He commented: "We have now shown forthe first time that oral glucose lowering medication can preventmacrovascular events." The audience seemed excited by theseresults and a consensus emerged that the results would changepractice. The presentation was certainly positive and upbeat(as readers may judge for themselves from the webcast made availablewith the support of the study sponsors, Eli Lilly and Takeda¹).Unfortunately, these conclusions are not based on robust standardsfor the interpretation of evidence from clinical . . . [Full text of this article]

The trial

Assessing composite outcome measures

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Rapid Responses:

Read all Rapid Responses

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