That Health Rules

Recently, The US FDA made a new ruling regarding the controversy on whether the popular antidiabetic agent Avandia can really cause heart attack.  Below are important excerpts of the FDA ruling released as of November 14, 2007:

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People with type 2 diabetes who have underlying heart disease or who are at high risk of heart attack should talk with their health care provider about the revised warning as they evaluate treatment options. FDA advises health care providers to closely monitor patients who take Avandia for cardiovascular risks.

Avandia is approved to be used as a single therapy or used in combination with metformin and sulfonylureas, other oral anti-diabetes treatments.

During the past year, FDA has carefully weighed several complex sources of data, some which show conflicting results, related to the risk of chest pain, heart attacks and heart-related deaths, and deaths from any cause in patients treated with Avandia.

At this time, FDA has concluded that there isn’t enough evidence to indicate that the risks of heart attacks or death are different between Avandia and some other oral type 2 diabetes treatments. Therefore, FDA has requested that GSK conduct a new long-term study to evaluate the potential cardiovascular risk of Avandia, compared to an active control agent. GSK has agreed to conduct the study and FDA will ensure it is initiated promptly.

The revision of Avandia’s existing boxed warning – FDA’s strongest form of warning – includes the following statement:

A meta-analysis of 42 clinical studies (mean duration 6 months; 14,237 total patients), most of which compared Avandia to placebo, showed Avandia to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction. Three other studies (mean duration 41 months; 14,067 patients), comparing Avandia to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded this risk. In their entirety, the available data on the risk of myocardial ischemia are INCONCLUSIVE!

The previous upgraded warning, added to certain diabetes drugs (in class of drugs related to Avandia) on Aug. 14, 2007, emphasized that these types of drugs may worsen heart failure, a condition in which the heart does not adequately pump blood, in some patients. GSK is also developing a Medication Guide for patients to provide additional information about the benefits and risks and safe use of Avandia.

To date, no oral anti-diabetes drug has been conclusively shown to reduce cardiovascular risk. Consequently, the agency also will be requesting that labeling of all approved oral anti-diabetes drugs contain language describing the lack of data showing this benefit.

Today’s action follows recommendations made at the July 2007 joint meeting of FDA’s Endocrine and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees. At the meeting, members voted 22-1 to recommend that Avandia stay on the market, pending a review of additional data. The committee also advised that information warning of the potential for increased risk of heart attacks should be added to the drug labeling. _______________________________________________

Ever since the data on avandia came into light after the Niessen article, further analysis of that article showed flaws in the statistical analysis.  It is therefore not surprising to me why this drug will not be pulled out in the market solely because of that article.  The medical community looks at actual facts rather than what is reported in newspapers or the media.

Based on my experience, the benefits of this drug continue to outweigh the potential risks…and just like any other drugs… all one needs to do is use the right drug for the right patient profile!

Meaning..never use this drug if the patient has heart failure or heart disease.  And this is true to all antidiabetic agents as reported by the US FDA as the risk of heart attack has not been shown to be different among the different oral agents. 

Plus…all patient with Diabetes…by the time of diagnosis… more than 5o% or probably ALL already have ongoing heart disease because by the time ones fasting blood sugar is abnormal…the disease process has been ongoing for 7 to 10 years already!

Therefore and Again… I always emphasize to all patients at risk: Lifestyle Change.  If one has the risk to develop Diabetes … do something NOW!  

Remember… All medications have risks!  But the benefits should always outweigh the risks before any drug is started on any patient!