Study Sees Same Heart Risks Seen With Actos, AvandiaAug 26, 2010 | Parker Waichman LLP
Avandia has long been surrounded with debate concerning cardiovascular risks, while Actos was believed a safer alternative, causing sales of Actos to increase and Avandia seeing significant declines, explained the LA Times. Now, emerging research suggest that similar heart risks are being seen in both drugs, said the LA Times, which explained that both are part of the class called thizolidinediones. Thizolidinediones reduce body tissue insulin resistance and adjust cholesterol levels and are considered some of the strongest medications for treatment of Type 2 diabetes, noted the LA Times.
A 2007 study with over 200,000 Medicare patients pointed to Avandia’s (generic: rosiglitazone) increased heart attack risks, “cardiovascular disease, stroke, and death by 30-to-40 percent,” versus other, older diabetes medications, said the LA Times. That study indicated that the risk was not seen with Actos (generic: pioglitazone), added the LA Times.
The study prompted stronger U.S. Food and Drug Administration (FDA) label warnings, with even stronger warnings following more reports of increased risks with Avandia, said the LA Times; an FDA panel found the benefits of Avandia outweighed its risks and that it should remain on the market, but that no more patients be enrolled in a prospective study comparing the two drugs directly.
The team, led by Debra Wertz—an outcomes research manager at HealthCore Inc., a Wellpoint Inc. research subsidiary—analyzed 28,938 patient records for people who took either medication from 2001 to 2005, obtaining company data, said the LA Times. Death information was derived from the National Death Index, which is managed by the National Center for Health Statistics. The research appears in the journal Circulation: Cardiovascular Quality and Outcomes.
When accounting age gender, and prior heart disease, about four percent per group either suffered a heart attack or heart failure or died, said the LA Times. The figures break down to 96 Avandia, versus 121 Actos patients suffering a heart attack and 265 Avandia and 243 Actos patients suffering from heart failure, said the LA Times; 217 in each group 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, quoted the LA Times, and that the study followed younger patients longer than in prior studies. Earlier studies did not include stroke data, which could affect outcomes.
We previously wrote that another study linked Avandia and Actos to an increased risk of fractures. The research appeared in the Journal of Clinical Endocrinology & Metabolism and found that the drugs increased the risk of fractures in postmenopausal women with Type 2 diabetes, as well as in men prescribed either drug with a loop diuretic.
Women over 50 who had broken bones were 71 percent likelier to have been prescribed a thiazolidinedione. In men, the increased risk (more than triple) was seen among those taking both a thiazolidinedione and loop diuretics, like Lasix, but not in just one or the other. The researchers pointed out that loop diuretics have been linked with bone density decreases. In both genders, the fracture risk went up the longer a person was on the medication. According to the researchers, the fractures seen in the study weren’t just the spine and hip fractures most often seen in people with osteoporosis. Many of the people included in the study suffered lower limb, arm, and leg fractures.