That Health Rules

My email alerted me on this headline regarding the alarming news on a most commonly prescribed drug for diabetes called rosiglitazone or Avandia manufactured by GSK and the apparent increased risk of heart attack among those taking the drug! 

The problem is: New England Journal of Medicine article was only a meta-analysis of different articles that studied the drug but not with cardiovascular diseases as a primary endpoin.  The RECORD trial which will be available in 2009 is the ONE that we have to wait to fully answer the question of avandia and the risk of heart disease.

The comments of different societies complement my thoughts of the safety of this drug…meaning for me…the benefits continue to outweigh the risks.  I am a prescriber of this drug because it really helps my patients get into control, lower the rquirements for insulin with beneficial effects in protecting and preserving beta cells and therefore delays the progression of the disease.  This for me is important if we want to prevent long term complications.

1. Lancet‘s response to the NEJM article (23rd May) entitled “Rosiglitazone: seeking a balanced perspective.”

The editorial
– criticises the NEJM publication
– states that the’ two most reliable studies to inform decision-making’ currently available are ADOPT and DREAM
– acknowledges that, although the recent NEJM meta-analysis (based on a small no of events) raise a signal of concern, before the results of RECORD are available it would be premature to overinterpret a meta-analysis

The editorial concludes by saying

To avoid unnecessary panic among patients, a calmer and more considered approach to the safety of rosiglitazone is needed. Alarmist headlines and confident declarations help nobody

2.The European Medical Association (US FDA counterpart in EU) recommends that, in EU markets, ‘patients are advised not to stop treatment with rosiglitazone and to discuss the medication with their doctor at their next regular visit’. societies:

Statement from US organisations
http://diabetes.org/diabetesnewsarticle.jsp?storyId=15115339&filename=20070521/comtex20070521pr00004113diabetesavandiariskEDIT.xml

Statement from Canadian Diabetes Association
http://www.diabetes.ca/section_main/newsreleases.asp?ID=194

Statement from Diabetes Australia
http://www.diabetesaustralia.com.au/notice_board/mediacentre.htm#NEJM

Statement from Diabetes UK
http://www.diabetes.org.uk/About_us/News_Landing_Page/Rosiglitazone-heart-attack-risk-not-cause-for-alarm/

Lastly, a fellow blogger Kevin MD had his thoughts on this and pointed out Dr Steven Haffners comments in his post:

Dr Steven Haffner (University of Texas Health Science Center, San Antonio), who was involved in the ADOPT study of rosiglitazone, said the paper needed to be published, but it should have undergone a more extensive review, and there should have been a different editorial with more emphasis on the flaws of the study. “The NEJM was irresponsible to go to [Drs Bruce] Psaty and [Curt] Furberg for the editorial–they were always going to emphasize concerns about drug safety; that’s what they do,” he commented. “But I’m not surprised this paper was published like this. The three major medical journals are becoming more like British tabloid newspapers–all they lack is a bare-chested woman on page 3,” he jibed.

For me….I will continue to believe in this drug as one helpful arm in my quest for a better treatment regimen for my patients with diabetes. The NEJM article is not the perfect study we look for to answer the questions of safety.  A Meta-analysis has its flaws which will be corrected by future proscpective studies with cardiovascular disease as a primary endpoint.

If you have your doubts… talk to your doctor.

If you believe in the drug and your doctor asked you to stop it based on NEJM article and its editorial …talk to a Specialist!

The Editorial of the well respected Lancet says it all:

Alarmist Headlines and Confident Declarations Help Nobody