Avandia: A Decade Long Story of Coverups of Heart Risk with a Diabetes Drug

This is a repost from February 6, 2008, relevant in light of the fact that news now tells us that the manufacturer of Avandia has been covering up the risks of heart complications with their diabetes drug since it arrived on the market in 1999 and made several billion dollars on it in the meantime.

Today the NHLBI announced that the Action to Control Cardiovascular Risk in Diabetes (ACCORD) study would be stopped because of an increased risk of death in patients on intensive glucose lowering treatment regimens. 10,251 patients with Type 2 diabetes were being treated with a range of medications for glucose control and were divided into intensive versus standard glucose
lowering groups. There were 257 deaths in the group receiving intensive treatment to lower HbA1C (a marker of elevated blood glucose levels) to below 6% compared to 203 deaths in the standard treatment group (HbA1C 7-7.9%). Deaths included sudden death and cardiovascular causes.

Reactions from medical experts included “surprise” and “shock”, and yet this should not have come as any surprise since the fact that glitazone medications used for diabetes, including Avandia (rosiglitazone) and Actos (pioglitazone) carry a cardiovascular risk was previously known. For example, last year an article in the New England Journal of Medicine showed that Avandia (rosiglitazone) increased heart attack risk by 43%. These drugs also cause fluid retention which increases the risk of heart failur. For instance, in the A Diabetes Outcome Progression Trial (ADOPT) 4360 patients with poorly controlled Type-2 diabetes were randomly assigned to four years of treatment with rosiglitazone, metformin, or glyburide. Rosiglitazone caused more heart failure than glyburide, and was associated with more weight gain (+4.8 kg—convert to pounds, v -2.9 kg for metformin) and fluid build up or edema (probable cause of the heart failure). 22 rosiglitazone patients developed heart failure, compared to 19 with metformin and 9 with glyburide.

In the PROspective pioglitAzone Clinical Trial in macroVascular Events (PROactive) Study, 5238 patients with Type-2 diabetes and evidence of vascular disease were randomly assigned to treatment with pioglitazone or placebo to be taken with their typical treatment regimen. There was no signficant difference in the primary outcome of any vascular event; 281 patients on pioglitazone developed heart failure compared to 198 on placebo, a 42% increase which was highly statistically significant. Most people don’t know that glitazones cause weight gain and actually create new fat cells, making you more “fatty’. So in other words, they are promoting the thing that causes Type 2 diabetes in most people (i.e. weight gain),
and causing the thing that we are trying to prevent by treating diabetes (i.e. heart attacks and heart failure). Not a very good deal.