Type 2 diabetes medication rosiglitazone associated with increased cardiovascular risks and death

Jun 28, 2010

A new study published online today by JAMA shows that among patients age 65 years and older, rosiglitazone (a medication for treating Type 2 diabetes) is associated with an increased risk of stroke, heart failure, and all-cause mortality (death) when compared with pioglitazone (another medication for diabetes). The study was published online today in advance of an upcoming Food and Drug Administration meeting that will review the safety of rosiglitazone. The paper will appear in the July 28 print issue of JAMA.

"Rosiglitazone and pioglitazone are the only thiazolidinediones (a class of drugs for treating diabetes) currently marketed in the United States," the authors provide as background information. "Studies have suggested that the use of rosiglitazone may be associated with an increased risk of serious cardiovascular events compared with other treatments for ."

David J. Graham, M.D., M.P.H., from the Center for Drug Evaluation and Research, U.S. , Silver Springs, MD and colleagues, evaluated data from 227,571 Medicare beneficiaries (average age, 74.4 years) who started treatment with rosiglitazone or pioglitazone through a Medicare Part D prescription drug plan from July 2006 through June 2009. The patients were followed for up to three years after the initiation of the medications.

"During follow-up, there were 1,746 acute myocardial infarctions [heart attacks] (21.7 percent fatal), 1,052 strokes (7.3 percent fatal), 3,307 hospitalizations for heart failure (2.6 percent fatal), and 2,562 deaths for all causes among cohort members," the authors report. Analysis showed no differences in the risk for between rosiglitazone and pioglitazone, but "…our study found that rosiglitazone was associated with a 1.25-fold increase in risk of heart failure compared with pioglitazone," and "…these data suggest that rosiglitazone was associated with a 1.27-fold increased risk of and a 1.14-fold increased risk of death compared with pioglitazone," according to the authors.

In conclusion, the authors write: "…in a population of more than 227,000 patients 65 years or older who initiated treatment with a thiazolidinedione, we found that, compared with pioglitazone, rosiglitazone was associated with an increased risk of stroke, heart failure, and death and the composite of AMI (heart attack), stroke, or death."

Explore further: Supercomputers link proteins to drug side effects

More information: JAMA.doi:10.1001/jama.2010.920.

add to favorites email to friend print save as pdf

Related Stories

Diabetes drug linked to increased risk of heart failure

Aug 20, 2009

Rosiglitazone, a drug used to treat type 2 diabetes, is associated with an increased risk of heart failure and death among older patients compared to a similar drug (pioglitazone), concludes a study published on BMJ.com today.

Recommended for you

Supercomputers link proteins to drug side effects

2 hours ago

New medications created by pharmaceutical companies have helped millions of Americans alleviate pain and suffering from their medical conditions. However, the drug creation process often misses many side ...

No added benefit proven for umeclidinium/vilanterol in COPD

9 hours ago

The drug combination umeclidinium/vilanterol (trade name Anoro) has been approved since May 2014 for adults with chronic obstructive pulmonary disease (COPD). In an early benefit assessment pursuant to the Act on the Reform ...

User comments : 0