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Clinic trials find diabetes drug lowers risk of heart attack, stroke
Clinic trials find diabetes drug lowers risk of heart attack, stroke
Plain Dealer (Cleveland)
By Robert Goldberg
September 12, 2007
Final Edition; All Editions
publication is the: Cleveland Plain Dealer.
Clinic trials find diabetes drug lowers risk of heart attack, stroke
BYLINE: Harlan Spector, Plain Dealer Reporter
SECTION: NATIONAL; Pg. A3
LENGTH: 440 words
After reporting cardiac risks associated with the diabetes drug Avandia,
Cleveland Clinic researchers have found that a close relative of the
medication actually lowers risk of heart attack, stroke and death in
diabetes patients.
A Clinic team analyzed 19 clinical trials of the drug Actos and reports in
today's Journal of the American Medical Association that the medicine
carries cardiovascular benefits not seen in other diabetes drugs.
The two medications were introduced in 1999 and are in the same chemical class. But the new research reveals they appear to have starkly different profiles.
A federal advisory panel in July recommended Avandia carry a strong warning about heart attack risk. Dr. Steven Nissen, chairman of cardiovascular medicine at the Clinic, had reported in a study that Avandia heightened risk of heart attack by 43 percent.
Similar results for Avandia are reported by Wake Forest University
researchers in a separate Journal study today.
The Clinic's Actos study provides "a striking difference," Nissen said in an interview.
"It becomes more important in the wake of controversy" over Avandia, said Nissen, an outspoken critic of FDA drug safety standards. "I think there will be a lot of pressure now on the FDA to act decisively."
About 15 million Americans have had diabetes diagnosed. Actos and Avandia generated nearly $6 billion in sales in 2006, Lab Business Week reported last week.
The Clinic's analysis involved more than 16,000 patients in trials conducted by drugmaker Takeda Pharmaceutical Co. The company contributed $25,000 to the Clinic research, but it had no role in conducting or reviewing the analysis, Nissen said.
Both studies in today's Journal were immediately attacked by Robert Goldberg of the Center for Medicine in the Public Interest in New York. Goldberg earlier this year skewered Nissen in a blog for the doctor's stand on Avandia. Goldberg said Tuesday that the studies in today's Journal were flawed in the data they used and data they omitted.
Dr. William Lewis, chief of clinical cardiology at MetroHealth Medical
Center, said results are encouraging, but he urged caution.
"I am pleased that a drug that treats diabetes actually does what we hope it does - that is, reduce risk of heart attack," Lewis said. But so-called "meta-analysis" of previous trials "has to be taken with a grain of salt," Lewis said.
"It needs to be confirmed with a large, randomized clinical trial," he said.
Separate from the question of heart attack risks, both Actos and Avandia carry warnings about risk of heart failure in some patients.
To reach this Plain Dealer reporter: hspector@plaind.com, 216-999-4543
LOAD-DATE: September 13, 2007
LANGUAGE: ENGLISH
PUBLICATION-TYPE: Newspaper
Copyright 2007 Plain Dealer Publishing Co. |
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