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BMJ 2010; 341 doi: http://dx.doi.org/10.1136/bmj.c6291 (Published 10 November 2010) Cite this as: BMJ 2010;341:c6291

Implantable cardioverter defibrillators must be trialled in older adults

Implantable cardioverter defibrillators (ICDs) can prevent sudden cardiac death in people with a poorly functioning left ventricle. We know from landmark trials that these devices work in younger adults, say researchers. But most patients are now over 60, and 40% are over 70, and they may gain less from invasive treatment.

The researchers pooled data from five major trials in two analyses and found no good evidence that implantable defibrillators prolong survival in older adults, compared with the best available medical treatment (hazard ratio for death from all causes 0.81, 95% CI 0.62 to 1.05; P=0.11). Most of the patients in their analyses had ischaemic cardiomyopathy and were given an implantable device for primary prevention of sudden cardiac death. Older adults were over 65 in three trials and over 60 in two. The devices were clearly beneficial for younger adults (0.65, 0.50 to 0.83).

The researchers had to exclude four other trials that failed to report results by age group, and the non-significant results for older adults emerged from a pooled analysis of subgroups. The findings may not be conclusive. But they are worrying. More and more older people will receive implantable devices as populations age, say the researchers. They need definitive evidence of benefit. Trials in older adults should now be done.

Clotting factor associated with arterial thromboses when used “off label”

Recombinant factor VIIa is licensed to treat bleeding caused by haemophilia. Off label use for other types of bleeding is fairly widespread, but is it safe? In an unusual move, Novo Nordisk recently pooled safety data from 29 of its own placebo controlled trials and added data from six others. Off label use of factor VIIa was associated with a significantly increased risk of arterial thrombosis (5.5% v 3.2%; adjusted odds ratio 1.68, 95% CI 1.20 to 2.36), particularly coronary artery thromboses (2.9% v 1.1%; …

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