- Subodh Verma (firstname.lastname@example.org), scientist,
- Marty Strauss (Dr.email@example.com), consultant cardiologist
- Division of Cardiac Surgery, Toronto General Hospital, Toronto, ON, Canada, M5G 2C4
- Division of Cardiology, North York General Hospital, North York, Canada, 4001 Leslie Street, North York, Ontario, M2K 1E1
The interpretation of large scale clinical trials is being increasingly scrutinised by leading journals,1 with great emphasis being placed on the importance of sharing all potential side effects, no matter how trivial, with patients. The Lancet recently published the results of the valsartan antihypertensive long term use evaluation (VALUE) trial, a study of the effects of reducing blood pressure in patients at high risk.2 The angiotensin receptor blocker valsartan produced a statistically significant 19% relative increase in the prespecified secondary end point of myocardial infarction (fatal and non-fatal) compared with amlodipine. A doctor who is a patient of one of the authors (SV) commented that if the incidence of myocardial infarction increased with valsartan it would be an essential component of informed consent to share this information when prescribing valsartan for high risk patients with high blood pressure. These peculiar results led us to examine carefully the evidence surrounding angiotensin receptor blocker and myocardial infarction.
Could the unexpected increase in the incidence of myocardial infarction in the VALUE trial represent a statistical aberration? Although the modest, yet significant differential in blood pressure in favour …