December 27th, 2012
Selections from Richard Lehman’s Literature Review: December 27th
CardioExchange is pleased to reprint selections from Dr. Richard Lehman’s weekly journal review blog at BMJ.com. Selected summaries are relevant to our audience, but we encourage members to engage with the entire blog.
JAMA 19 Dec 2012 Vol 308
Intensive Lifestyle Intervention and Type-2 Diabetes Remission (pg. 2489): The Look AHEAD (Action for Health for Diabetes) study is perhaps the largest randomized controlled trial of an intensive lifestyle intervention among adults with type 2 diabetes to date. And boy is it intensive: weekly coaching sessions for the first six months and a diet which induced weight loss of 8.6% in the first year. This achieved biochemical remission in 11.5% of subjects at the end of the first year, falling to 7.3% at the end of year 4. As with all diabetes interventions, it’s the cardiovascular outcomes in the long term that will matter most, and we won’t know those for a while yet. In the meantime, here is yet another great data mine for diabetes researchers—if they can get access to it. O that all studies of this kind were part of a global collaboration: if that happened we might even find out how to treat type 2 diabetes (at last).
A Monoclonal Antibody to PCSK9 and LDL Cholesterol Levels in Statin-Intolerant Patients (pg. 2497): Two weeks ago, I took the Lancet to task for using most of its research article space to publish two Amgen-funded phase 2 trials of AMG145, its new monoclonal antibody to plasma proprotein convertase subtilisin/kexin type 9 (PCSK9). And do you recollect what does this does to people? Yes, it reduces their low density lipoprotein cholesterol. And what else does it do?—the girl at the back. “We don’t know, sir!”—excellent, that is the correct answer. We really have no idea what this drug does to people in the long term. But here is yet another paper in a leading journal describing a 12 week phase 2 trial called GAUSS, showing that it reduces LDL-C in those who are intolerant of statins. This wouldn’t be a way of softening up the FDA to make it available before the long-term safety and effectiveness data are in, would it? I do hope not, because all good children know that would be naughty, and dangerous, and wrong.
NEJM 20 Dec 2012 Vol 367
Multivessel Revascularization in Patients with Diabetes (pg. 2375): A few years ago, somebody gave me a book of cardiovascular trial acronyms. It lay in our downstairs loo for a while, and I seem to remember that it had 700+ pages, one for each trial. Now, for your seasonal delectation, comes the FREEDOM trial which compares coronary artery bypass grafting with percutaneous coronary intervention in people with type 2 diabetes and multivessel coronary artery disease. And it comes out in broad agreement with BARI, CARDia and SYNTAX. Those of you who take your acronyms seriously (or spend a lot of time on the loo) will remember that each of these showed an overall advantage from CABG rather than PCI in these patients. So does FREEDOM, with an absolute reduction of 7.9% in major CV events. Since all the subjects in this trial were given maximal cardioprotective drug therapy as well, you could argue that in the light of COURAGE, there should also have been an arm in which there was no invasive treatment. Then we could really share decision making with this high-risk group of patients. But to be fair to the FREEDOM triallists, they recruited before COURAGE was competed, so they couldn’t have known. Time for another trial, perhaps: but please no more stupid acronyms; there just isn’t space in the loo.