Avandia And Actos Double Heart-Failure Risk

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heart-attack.pngYet another meta-analysis finds Glaxo’s diabetes drug is trouble - and finds the same thing about Takeda’s Actos, too. The analysis reviewed more than 78,000 patients, and estimates that one in every 50 patients taking the drugs over a 26-month period will require hospital admission due to heart failure, PharmaTimes reports.

“This means that the diabetes drugs could have caused thousands of additional cases of heart failure, creating a substantial burden on hard-pressed health services,” says Yoon Loke, a clinical pharmacologist at UEA’s School of Medicine, Health Policy and Practice. The results are being published in the August edition of the journal Diabetes Care.

The news comes on the eve of this Monday’s FDA panel meeting to decide whether Avandia should be yanked or slapped with additional warnings and restrictions. The meeting, of course, has implications for Actos, given the similarities. You can read the briefing documents, which were posted on the FDA web site yesterday, right here.

The researchers also looked at more than 200 cases of patients with heart failure related to the meds and found the problem developed even in patients taking low doses. Around 25 percent of cases occurred in people under the age of 60, even without a history of cardiovascular disease.

“These drugs are taken by more than seven million diabetic patients in the US alone, suggesting that several thousand could be harmed,” says co-author Sonal Singh of Wake Forest University.

“Most patients in the studies did not have heart failure prior to starting on treatment with these drugs,” says Loke. “There doesn’t seem to be a group of patients who are safe from these side effects.”

For its part, Glaxo argues this is old news - the study was released online in May - and issued this statement. Fair enough, but not everyone may have noticed the study at that time and, given Monday’s meeting, the info remains pertinent.

In the UK, Avandia and Actos are recommended for use on the country’s National Health Service, but Loke now says: “I think NICE (the UK’s cost-effectiveness body, the National Institute for Health and Clinical Excellence) should re-evaluate their decision to recommend these diabetes drugs.”

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  1. I love this site and always find it informative and fun, but I have to disagree with the headline used here. This paper is looking at heart failure, not heart attack - 2 very distinct diagnoses. This is hardly news as this paper was first published online May 29, 2007, and the issue of CHF risk due to Avandia/Actos is well-known and both drugs will be getting a black box warning for CHF risk per the FDA very soon.

  2. Sorry, Doc.

    As the link indicates, I first read about this at PharmaTimes, which used a similar hed (that’s called repeating a mistake).

    I’ve fixed it. Thanks for pointing that out. I’m always happy to correct goofs and appreciate it when someone takes the trouble to bring something to my attention.

    And I agree with your other point about timing, but for those who missed the May debut (the reader doesn’t keep a clipbook as we say in the nefarious world of journalism), the August publication is a chance to catch up, especially since the topic is so pertinent.

    Cheers
    ed

  3. For an interesting take on the recent FDA report on Avandia, see:

    http://blog.aesisgroup.com/2007/07/26/fda-report-on-avandia-just-issue–read-more-for-a-critique-of-the-critique.aspx

    which basically discusses the issue in the context of the wider debate around drug safety and FDA reform.

  4. Ed - not a problem. Love the site!

  5. http://www.stats.org/stories/2007/nyt_cherry_avandia_july27_07.htm

    Great posting from Trevor Butterworth that crystalizes the approach much of the reporting around Avandia issue to date.

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