Risks of Taking Avandia: Diabetes Drug Avandia Linked to Congestive Heart Failure in the Elderly
According to a recent report, elderly diabetic patients who have taken the drug rosiglitazone, also sold under the brand name Avandia, are more likely to have developed congestive heart failure and die than those who received the similar drug pioglitazone, which is sold under the name Actos. Surprisingly, however, researchers have found that patients taking Avandia did not suffer more strokes and heart attacks than those who took Actos; which is a sharp turn of events. Avandia has been a controversial drug since 2007, when an analysis of 42 published medical studies found that the drug might, in fact, dramatically increase patients’ risk of a heart attack or another cardiovascular event when compared to other types of diabetic treatments.
Harvard Medical School researchers used a database of medical treatment beneficiaries in order to track 28,361 patients for approximately five years for an observational study that was published in the Archives of Internal Medicine. Half of these patients were treated with Avandia, while the other half were given Actos. The death rate among patients treated with Avandia was about 15% higher than those treated with Actos, while the incidence rates of congestive heart failure were 13% higher. According to Dr. Wolfgang C. Winkelmayer, an Assistant Professor of Medicine at Harvard Medical School and the first author of this study, “Rosiglitazone was associated with greater mortality”.
Officials at Glaxo-SmithKline, the maker of Avandia, dismissed these findings, stating that they are inconsistent with evidence from more rigorous types of randomized clinical trials. Glaxo-SmithKline officials point out that these clinical trials of diabetic drugs include interim results that are reported form a six year trial that involves 4,447 patients with an average age of 78. This particular trial did not find a significant increase in deaths from cardiovascular disease or other causes in patients taking Avandia. However, although the current study did not find a difference in heart attack and stroke rates, Dr. Windelmayer suggested that the higher death rates among elderly diabetic patients taking Avandia may have been caused by an underlying cardiovascular disease that was never diagnosed in these individuals. Dr. Winkelmayer explains:
In much older adults, it may be possible that after a stroke or myocardial infarction they may immediately die and never make it to the hospital for a diagnosis, which means the excess cardiac events could show up instead as deaths. Although the current study also found no differences in heart attack and stroke rates, Dr. Windelmayer suggested the higher death rates among patients taking rosiglitazone may be due to underlying cardiovascular disease that was never diagnosed in the elderly patients, whose average age was 78. Dr. Winkelmayer had this explanation:
In much older adults, it is possible if they do have a stroke or myocardial infarction, they might actually die immediately and never make it to the hospital for a diagnosis, so the excess cardiac events might show up as deaths.
Dr. John Buse, who heads Endocrinology at the University of North Carolina’s School of Medicine as well as the American Diabetes Association, says that while the new study is important, it is limited, as well. In his opinion:
This is about the tenth report that suggests rosiglitazone is associated with excess cardiovascular problems. Although we don’t have proof yet, both the American Diabetes Association and the European Association for the Study of Diabetes have removed rosiglitazone from their lists of recommended type 2 diabetes treatments.
Public Citizen, a consumer watchdog group, goes even further—they have called the Food and Drug Administration to ask them to actually ban the drug. Public Citizen states that Avandia causes liver failure, vision impairment and other very serious side effects besides heart problems. Dr. Sidney Wolfe, the director of Public Citizen’s Health Research Group, would like this study to be the “last nail in the coffin” in the quest to have rosiglitazone pulled off of the market. He says:
The big attraction of these types of diabetic drugs is that they provide insulin-sensitizing and also forestall the time when a patient would have to actually go on insulin. However, with a 15% excess mortality over pioglitazone, which itself carries some risks, these drugs do not seem like a very good tradeoff.
A federal scientific advisory panel that reviewed Avandia’s safety profile last year recommends that it remain on the market; however, sales of the drug have sharply fallen. About one million Americans continue to take Avandia as a part of a complete diabetes medication regimen, controlling their blood sugar by increasing the body’s sensitivity to insulin. If you have any questions or concerns regarding the use of Avandia and have experienced a significant cardiac event, please contact the legal professionals at The Cartwright Law Firm.
SOURCE: NEW YORK TIMES