A new analysis of diabetes medications Avandia (rosiglitazone) and Actos (pioglitazone) revealed that the risk of heart attack and/or heart failure, or death were the same, approximately 4%. The study has been published in the latest issue of Circulation: Cardiovascular Quality and Outcomes, an American Heart Association journal.

Takeda Pharmacuetical Co. makes Actos, while GlaxoSmithKline (GSK) makes Avandia. Avandia sales had dropped after a previous study had found it was linked to higher heart disease risk. American regulators are reviewing whether Avandia should be taken off the market after an FDA Advisory Committee said warnings about heart disease risks should be added to prescription information.

Debra Wertz, Pharm.D., lead author and outcomes research manager, HealthCore, Inc., research subsidiary of health insurance company WellPoint, Inc., said:

This study provides patients and their doctors with another source of information about rosiglitazone and pioglitazone as they determine the best therapy for diabetes patients.

This latest 33-month study, involving over 36,000 patients aged 54 years (average) and 14 months treatment on Actos or Avandia found that:

  • 602 who took Avandia (rosiglitazone) had a heart attack and/or heart failure, or died.
    96 had a heart attack.
    265 had heart failure.
    24 had both heart attack and heart failure.
    217 died
  • 599 who took Actos (pioglitazone) had a heart attack and/or heart failure, or died.
    121 had a heart attack.
    243 had heart failure.
    18 had both heart attack and heart failure
    217 died
  • This translates into approximately 4% of all patients taking either Actos or Avandia.

58% of the patients in this study were male. Wertz and colleagues obtained death records from the National Death Index, a central database administered by the National Center for Health Statistics.

The patients were divided into two equal groups, one receiving Avandia and the other Actos. After adjusting for factors such as age, gender, previous heart and blood vessel disease, complications related to diabetes, and severity indicators, they compared the incidence of heart failure, heart attack and death for 14 months (average) treatment and 19 months follow up after treatment.

Diabetes, a chronic disease in which the patient’s body cannot produce enough insulin, or does not use it properly, has a significant risk of blood-sugar buildup, resulting in a higher risk of cardiovascular problems – the main cause of diabetes-related deaths.

Avandia both belong to a class of medications called thiazolidinediones (TZDs), which help the body use insulin more effectively – they improve the body’s sensitivity to insulin, resulting in better blood-sugar control.

Wertz said:

Besides its findings that rosiglitazone and pioglitazone have comparable risks, what distinguishes this latest study from other claims-based analyses is its analysis of death records, which include out-of-hospital deaths.

Wertz added that this latest study monitored patients for longer than some earlier ones.

Mark J. Cziraky, Pharm.D., study co-author, and vice president of research development and operations at HealthCore, said:

One of the reasons we embarked on this analysis was to see if there were any differences in effect that we could identify between these two agents. We did not find that with the approach and methods we took within this population.

“Risk of Cardiovascular Events and All-Cause Mortality in Patients Treated With Thiazolidinediones in a Managed-Care Population”
Debra A. Wertz, PharmD; Chun-Lan Chang, PhD; Chaitanya A. Sarawate, MS; Vincent J. Willey, PharmD; Mark J. Cziraky, PharmD and Rhonda L. Bohn, MPH, ScD
Circulation: Cardiovascular Quality and Outcomes. 2010
Published online before print August 24, 2010, doi: 10.1161/CIRCOUTCOMES.109.911461

Written by Christian Nordqvist