Early results from Avandia heart tests not reassuring, experts say
Last Updated: Tuesday, June 5, 2007 | 5:47 PM ET
The Associated Press
Related
Internal Links
External Links
- Rosiglitazone/cardiovascular outcome interim analysis, New England Journal of Medicine
- News release on study, GlaxoSmithKline
- Related safety editorial, NEJM
- Related cardiotoxicity editorial, NEJM
- Related editorial on rosiglitazone's record, NEJM
(Note: CBC does not endorse and is not responsible for the content of external sites - links will open in new window)
The maker of the controversial diabetes pill Avandia on Tuesday published preliminary results of a study that the company claims shows the drug does not raise heart risks. However, experts say the results are inconclusive and even seem to suggest more risk from the drug.
More people on Avandia, or rosiglitazone, suffered heart problems than those on other diabetes drugs — a bad sign even if the difference was so small that it could have occurred by chance alone, some doctors said.
"This study, which was designed to show the benefit of rosiglitazone (Avandia), if anything shows the opposite," said Dr. David Nathan, chief of diabetes care at Massachusetts General Hospital.
He wrote an editorial accompanying the study, which was published online by the New England Journal of Medicine.
A congressional panel is holding a hearing Wednesday on the drug's risks and the response by the U.S. Food and Drug Administration, which has been criticized for being too lax about safety concerns.
The heart risk trend in patients on Avandia "is going in the wrong direction," said Dr. Steven Nissen of the Cleveland Clinic.
Two weeks ago, he published in the same medical journal an analysis of 42 studies on Avandia concluding that the drug raised the risk of heart attacks by 43 per cent and possibly heart-related deaths as well.
Avandia's maker, British-based GlaxoSmithKline PLC, has said its own similar analysis found a 31 per cent greater risk.
However, Glaxo officials have said that more definitive studies, such as the preliminary findings released Tuesday, did not show such risk.
"Overall, we feel these results are very reassuring," Dr. Murray Stewart, Glaxo's vice-president of clinical development, said during a telephone news conference on Tuesday.
More than six million people worldwide have taken the drug, sold as Avandia and Avandamet, since it came on the market eight years ago to help control blood sugar in people with the most common form of diabetes.
About one million Americans use it now. IMS Health Canada, a company that tracks drug sales, says more than one million prescriptions for the drug were filled in Canada last year, and Avandia was ranked third in the oral diabetes class of drugs.
The new study involves 4,500 people at more than 150 medical centres around the world.
Share Tools
Top News Headlines
- Teen struck by lightning in Ottawa dies
- The victim of a Friday lightning strike during a storm in east Ottawa has died, CBC News has learned. more »
- Montreal protesters march in peaceful defiance
- The clanging of pots and pans sounded throughout Montreal's downtown core Saturday night and into early Sunday morning, as thousands of protesters marched on in peaceful — but loud — defiance of Bill 78. more »
- Outrage grows over Syria killings
- The deaths in Syria of over 90 people, including at least 32 children, has sparked international outrage and raised fears that the international peace plan is in tatters. more »
- Missing Winnipeg children found in Mexico
- Two Winnipeg children reported missing and possibly in Mexico have been found alive, according to unofficial reports from an agency that works to find missing people. more »
Latest Health News Headlines
- Alcohol addiction team wants higher energy drink prices
- Mixing alcohol with caffeine-rich energy beverages is a trend that is continuing to rise in Canada, despite repeated warnings that the combination is unsafe, a new report warns. more »
- How curry spice helps the immune system kill bacteria
- A spice used in curry dishes helps to prevent infection and now scientists think they've got a lead on how. more »
- Yellowknife toddlers catching hand, foot and mouth virus
- An outbreak of hand, foot and mouth disease in Yellowknife is causing many toddlers and their parents some major discomfort. more »
- Super microscope installed at University of Victoria
- What's heralded as the world's biggest microscope has arrived at the Unversity of Victoria, marking the culmination of a 10-year effort by one of the school's professors. more »
FEATURED HEALTH
- Teen struck by lightning in Ottawa dies
- Missing Winnipeg children found in Mexico
- Quebec tornadoes cause millions in damage
- Pope's butler arrested in Vatican leaks scandal
- Montreal protesters march in peaceful defiance
- Woman's remains found in hockey bag on Cape Breton river
- What a Greek euro exit could mean for Canada
- Everest team unable to bring down Toronto woman's body
- WWE apologizes to Brazil over Canadian's flag stomp

