Sulfonylureas Linked To Higher Risk Of Heart ProblemsDec 4, 2009 | Parker Waichman LLP
Sulfonylureas, a claid ass of drugs long used in the treatment of type 2 diabetes, have been linked with an increased risk of death and cardiac failure over newer treatments, according to research, writes the Palm Beach Post.
The study—which agreed with current American Diabetes Association recommendations—found sulfonylureas did not perform as well as metformin when comparing them to orally dispensed anti-diabetes medications. Sulfonylureas include glyburide, glipizide, and glimepiride; metformin is sold under brand name Glucophage, among others, said the Palm Beach Post.
The study found diabetes drugs Actos (generic: pioglitazone) and Avandia (generic: rosiglitazone) did not raise the risk of heart attack and that Actos was linked to a lower risk of death versus Avandia, said the Palm Beach Post. Both medications are in the class of drugs known as thiazolidinediones.
People on first- or second-generation sulfonylureas had a 24 to 61 percent higher risk of dying from all causes versus those taking metformin, those on second-generation sulfonylureas experienced a 30 percent increased risk of developing congestive heart failure, and those on Actos experienced a 31 to 39 percent lower risk of death versus people taking metformin, said the Palm Beach Post.
People on Avandia experienced a 34 to 41 percent higher risk of dying than those taking Actos, the Palm Beach Post added. “A large difference in outcome between pioglitazone and rosiglitazone has been observed in several other studies. Once again, these authors confirm that rosiglitazone appears to be associated with substantially worse cardiovascular outcomes compared with pioglitazone," Dr. Steve Nissen of the Cleveland Clinic said.
While not funded by Big Pharma, several study authors have links to drug companies such as Avandia maker GlaxoSmithKline, and Actos maker, Takeda Pharmaceuticals, said the Palm Beach Post. Avandia has been linked to so many health problems that some have questioned whether or not it should be on the market at all.
In November 2007, a warning detailing Avandia’s association with myocardial ischemia was added to the drug’s boxed warning. That warning followed an analysis of 42 clinical trials published by the Cleveland Clinic in May 2007 that found patients taking Avandia had a 43-percent higher risk of having a heart attack. That summer, GlaxoSmithKline and the Food & Drug Administration (FDA) came under fire for an apparent failure to warn the public about the cardiac risks associated with Avandia.
Another study of 30,000 diabetic patients published in the November 24, 2008 issue of The Archives of Internal Medicine found elderly Avandia patients were at higher risk of death than people on other diabetes medication. Among the patients prescribed Avandia, the rate of death was 15 percent higher than in those prescribed Actos.
This July, a study known as RECORD found Avandia “significantly” raises the risk of heart failure and fractures. Unlike previous research, this study did not find that people taking Avandia were at a higher risk of heart death, and was unable to determine if the Avandia patients had a higher chance of heart attack. RECORD was not a blind study, and was controversial because it was funded by Glaxo. Dr. Nissen, who conducted the 2007 Cleveland Clinic study, said RECORD was “seriously flawed” because more patients in the Avandia group were taking cholesterol-lowering statins and that group had what looked to be a high drop-out rate.
In October 2008, the group Public Citizen said it had identified 14 cases of Avandia-induced liver failure in the FDA’s Adverse Event Reporting System. Of the 14 cases, 12 resulted in death, prompting Public Citizen to file a petition with the FDA asking that Avandia be removed from the market.