Higher risk of death associated with diabetes drug rosiglitazone

Study results have shown that seniors being treated with the diabetes drug rosiglitazone are more likely to die or develop heart failure than those treated with the similar drug pioglitazone.

Rosiglitazone and pioglitazone are associated with serious adverse effects, including heart failure and heart attack, and both carry black box warnings advising against their use in patients with existing heart failure. However, recent studies have suggested that the risk of such adverse effects is significantly greater in patients being treated with rosiglitazone. To determine whether this was the case Wolfgang C. Winkelmayer and colleagues at Brigham and Women's Hospital and Harvard Medical School, Boston, used medical claims data to study 28,361 patients aged 65 and over who were treated with either drug between 2000 and 2005.

Results showed that treatment with rosiglitazone was associated with a 15% higher risk of death and a 13% higher risk of congestive heart failure. However, the risk of heart attack and stroke was similar for both drugs.

The authors concluded: “This study confirms the safety concerns that have been raised for rosiglitazone compared with pioglitazone, which, in turn, also cannot be considered a very safe drug given its well-documented effect on the risk of congestive heart failure. Although previous studies have indicated that the increased risk with rosiglitazone use resides predominantly in cardiovascular outcomes, the present study suggests that differences in all-cause mortality [death] risk may be even more important to consider in elderly patients.”

Winkelmayer WC, Setoguchi S, Levin R, Solomon DH. Comparison of cardiovascular outcomes in elderly patients with diabetes who initiated rosiglitazone vs pioglitazone therapy. Arch Intern Med. 2008;168:2368-2375.