BMJ  2007;334:326 (17 February), doi:10.1136/bmj.39113.534919.80

Editorials

Early termination of drug trials

What are the ramifications for drug companies and drug safety monitoring boards?

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

In December 2006 a randomised controlled trial of torcetrapib (a cholesteryl ester transfer protein inhibitor aimed at increasing high density lipoprotein cholesterol) was stopped after an unexpected increase in mortality in people taking the drug.¹ The implications are widespread, ranging from the future direction of cardiovascular prevention, the willingness of drug companies to develop new drugs in the face of massive financial risk, to the role of data and safety monitoring boards.

More than 12% of global mortality is caused by coronary heart disease.² Reduction of low density lipoprotein cholesterol with statins has been successful in primary and secondary prevention of such disease, although mortality rates remain high. Because high density lipoprotein cholesterol is inversely associated with risk of cardiovascular disease, much investment has gone into newer drugs that increase concentrations of high density lipoprotein cholesterol (such as torcetrapib).

Phase II trials found that torcetrapib increases high density lipoprotein cholesterol . . . [Full text of this article]

¹ Department of Cardiology, Copenhagen University Hospital, 2650 Hvidovre, Denmark, ² Queen's Medical Centre, Nottingham NG7 2UH

CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this?

Relevant Articles

Lack of insurance, reassurance, and safety assurance

Douglas Kamerow
BMJ 2007 334: -a0-a. [Extract] [Full Text]

Opening Pandora's box: the unpredictability of reassurance by a normal test result

I G McDonald, J Daly, V M Jelinek, F Panetta, and J M Gutman
BMJ 1996 313: 329-332. [Abstract] [Full Text]

Rapid Responses:

Read all Rapid Responses

Patients' perspective highlights ethical dimension of drug trial termination

Jennifer M Coleman, et al.
bmj.com, 13 Mar 2007 [Full text]