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Heart Risk from Actos® as Great as from Avandia®, Study Suggests

Aug 25, 2010
 

According to a study published in Circulation: Cardiovascular Quality and Outcomes, the heart risk from Actos is just as great as the risk posed by Avandia according to a story published Tuesday, August 24 by the Los Angeles Times….

The continuing controversy surrounding the cardiovascular risk of the diabetes drug Avandia has led to sharp declines in its use and a surge in sales of the competing drug Actos, in part because the latter is perceived to be safer. Sales of Avandia, as high as $3.4 billion in 2006, have fallen to about $1.1 billion this year, while those of Actos have climbed to about $4.6 billion. But new results reported on Monday, August 23, suggest that the cardiovascular risks of the two drugs are about the same.

 

Both drugs are members of the family known as thiazolidinediones, which decrease the insulin resistance of body tissues and modify the production of cholesterol. They are considered among the most powerful drugs for treating Type 2 diabetes but have been plagued by reports of side effects. A 2007 study of more than 200,000 Medicare patients suggested that Avandia, known generically as rosiglitazone, increased the risk of heart attack, cardiovascular disease, stroke and death by 30% to 40% compared with metformin and other, older diabetes drugs. That study also suggested that the increased risk was not observed with Actos, known generically as pioglitazone.

The study also led the Food and Drug Administration to require a stronger warning label on Avandia to alert consumers to the risks. After more reports of increased risk with the drug, an FDA advisory panel last month recommended even stronger warning labels on the Avandia package, although it said that the drug should be kept on the market because the benefits outweigh the potential risks. The panel also recommended that no more patients be enrolled in a prospective study comparing Avandia and Actos directly.

In the new study reported last week, a team led by Debra Wertz, an outcomes research manager at HealthCore, Inc., the research subsidiary of the health insurance company WellPoint, Inc., studied the records of 28,938 clients who took either of the two drugs from 2001 to 2005. They obtained information about health outcomes from the company’s own records and about deaths from the National Death Index, a database administered by the government’s National Center for Health Statistics.

They reported in the journal Circulation: Cardiovascular Quality and Outcomes that, when they accounted for potential confounding effects, including age, gender and prior heart disease, about 4% of each group had a heart attack, heart failure or died.

Specifically:

  • 96 patients on Avandia suffered a heart attack, compared with 121 on Actos;
  • 265 on Avandia suffered heart failure, compared with 243 on
  • 24 on Avandia suffered both heart attack and heart failure, compared with 18 on Actos; and
  • 217 on Avandia and 217 on Actos died.

“What distinguishes this latest study from other claims-based analyses is its analysis of death records, which include out-of-hospital deaths,” Wertz said in a statement. The study also followed patients for a longer period of time than earlier studies and the patients were younger, she added. Unlike the earlier studies, however, it did not include strokes in the data, which may account for part of the difference in outcomes.

Commentary

So, where do physicians and patients go from here? When the Avandia controversy first started, many physicians switched their patients from Avandia to Actos, believing that Actos did not carry the same cardiovascular risk as Avandia.  With the increased attention this study is likely to generate and the fact that Actos had nearly $5 billion in sales, which drug will replace Actos? The most likely candidate has to be Januvia from Merck.

With diabetes growing at epidemic rates, the options used to treat diabetes are becoming fewer and fewer, and at a time when action is needed, the FDA continues to make new diabetes drugs’ approvals tougher than ever.

Will the FDA pull both drugs from the market even though a panel voted to keep Avandia on the market? Normally the FDA follows the recommendation of the panel but these are not normal times and the FDA is taking an increasingly conservative stance.

Because most people with diabetes are not in control of their disease, diabetes is not only a healthcare crisis but also an economic crisis.

All drugs have side effects, it should be left up to the doctors and patients to weigh the risks and benefits of the possible treatments.

Circulation: Cardiovascular Quality and Outcomes, 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, Aug. 24, 2010, published online

The Los Angeles Times, Thomas H. Maugh II, August 24, 2010