A recent twist of fate has led many to panic about the implied increase risk of heart disease and the use of a drug called Rosiglitazone (AVANDIA) from a recently published meta analysis of diabetes trials using Avandia. .
First, we should learn how to classify the already known fact that this drug should be used with caution in patients with heart failure because it is known to cause sodium retention and therefore may aggravate the condition. This may happen to some but not to all patients hence, it remains to be a relative contraindication and not an absolute one. The US FDA has required the relabelling of this class of drugs and should not be confused with the current controversy hounding avandia.
First of all the study conclusion was based on a pooled analysis of data from 42 trials not designed to look for cardiac death, hence this was a conclusion based on a flawed design. We also have to understand that we are dealing with a population of patients at risk for heart attack whether on therapy or not. We sometimes call Diabetes as a "Cardiovascular disease masquerading as an endocrine disorder" because of its propensity to develop heart disease. Nevertheless, let's go to the controversial data and give it the benefit of the doubt.
Their data suggests that the relative risk of having a heart attack while taking rosiglitazone is 86/14,371 or 0.0059% and all CVD (Cardiovascular Death) is 39/14,371 or 0.0027% while the risk of heart attack on diabetics not taking rosiglitazone is 72/11,634 or 0.0061% and the risk of death from all CVD causes is 22/11,634 or 0.0018%. The risk is nearly identical to the risk of having a heart attack in treated diabetics not on Rosiglitazone (0.0059% vs 0.0061%) hence, there is hardly anything to sneeze at. .
Furthermore, in a bit of a rush to quell these negative information on avandia an interim analysis of an ongoing trial RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of glycemia in Diabetes) was published in June 6, 2007 in the NEJM (New England Journal of Medicine) after a 3.5yr follow up showed no association between the risk of cardiovascular mortality and avandia. The full study is slated to be completed and full data available in late 2008. In the meantime, I would not rush into stopping this drug as of this time. The news on Avandia (Rosiglitazone) made headlines that prompted me to look into this matter because a lot of my diabetics have concerns that begs to be answered!
