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Interim Data From RECORD Study Show No Significant Difference Between Avandia and Standard Therapy in Risk of Cardiovascular Hospitalization or Death.
"Patients and physicians should find these data reassuring"
PHILADELPHIA, June 5 /PRNewswire-FirstCall/ -- GlaxoSmithKline said today that findings from an interim analysis of RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of glycemia in Diabetes), a prospective clinical trial designed specifically to determine cardiovascular outcomes in more than 4,400 patients with type 2 diabetes, adds further evidence to the overall cardiovascular safety profile of Avandia(R) (rosiglitazone maleate). The study results, authored by Philip D. Home and colleagues on the RECORD Steering Committee, were published Tuesday in the online edition of The New England Journal of Medicine.
The study compares cardiovascular hospitalization and death in patients treated with Avandia dual therapy (Avandia plus metformin or sulfonylurea) and in patients treated with metformin and sulfonylurea in combination. After following patients for an average of 3.75 years, the interim analysis found a low number of events overall, and a similar number of events in each group. The study is scheduled to complete in late 2008.
Like all interim analyses, these data do not offer final conclusions. Based on the interim analysis, key findings include:
-- The interim data show no significant difference between the Avandia and
control groups in the key…- Also in January, it was reported that a peer reviewer for the New England...
- Magazine article from: Chemistry and Industry February 11, 2008 700+ words
...reported that a peer reviewer for the New England Journal of Medicine alerted GlaxoSmithKline...damning meta-analysis of diabetes drug Avandia's (rosiglitazone) safety and efficacy...in December, researchers showed that Avandia could interfere with new bone formation...
- Drug could stave off diabetes: GSK's Avandia, used to treat the disease, may...
- News wire article from: News & Observer (Raleigh, NC) September 16, 2006 700+ words
...involved in the test considered Avandia's possible side effects...in an editorial about the Avandia results for the New England Journal of Medicine. Other...approval to expand the use of Avandia, spokeswoman Mary Anne Rhyne...
- ImpactRx Reports Premature Conclusions in Analyst Report on Avandia.
- Press release article from: PR Newswire May 29, 2007 700+ words
...ImpactRx suggests that the 21 May NEJM (New England Journal of Medicine) article has resulted in a reduction of Avandia's market share of the newly prescribed...prescriptions written for Avandia since the New England Journal article," Altus continued...
- US scripts of GSK's Avandia continue to fall.
- Newspaper article from: Pharma Marketletter July 2, 2007 700+ words
...of GlaxoSmithKline's anti-diabetes drug Avandia (rosiglitazone) since a New England Journal of Medicine report by leading US cardiologist...Brothers' analysts reporting the IMS figures, the Avandia franchise share of oral anti-diabetes prescription...
- Analysis: Allegations fuel Avandia fire.
- News wire article from: UPI Health Business May 23, 2007 700+ words
...controversy over Avandia erupted earlier this week when the New England Journal of Medicine...available data about Avandia before reaching...the author of the New England Journal of Medicine...patients taking Avandia. Nissen said it...publication to the New ...
- A Drug on the Market.(The Talk of the Town)(Avandia)
- Magazine article from: The New Yorker Surowiecki, James June 25, 2007 700+ words
...erupted over the diabetes drug Avandia after an article in The New England Journal of Medicine suggested...ensued, the number of new Avandia prescriptions shrank by twenty...support from the maker of one of Avandia's competitors). GlaxoSmithKline...
- Texas Family Sues GlaxoSmithKline (GSK) Over Man's Heart Attack Death Following...
- Press release article from: PR Newswire June 20, 2007 700+ words
...published in The New England Journal of Medicine warning of Avandia dangers. Mr. Stanford...for the drug, and Avandia sales totaled $2.2 billion. Since the New England Journal of Medicine study was published, Avandia's share of new...
- Rivals swoop in after report batters diabetes drug Avandia.(GlaxoSmithKline's...
- Magazine article from: Advertising Age THOMASELLI, RICH May 28, 2007 700+ words
...s powerhouse drug Avandia increases heart...from the influential New England Journal of Medicine said Avandia raised heart-attack...that parts of the New England Journal of Medicine...measured media for Avandia in 2006, according...
- Analysis: New questions about Avandia.
- News wire article from: UPI Health Business July 17, 2007 700+ words
...cardiovascular effects of Avandia, is ongoing, but the company...safe. The controversy over Avandia started in May when Cleveland...meta-review study in the New England Journal of Medicine that concluded Avandia increased the risk of heart...
- Prognosis for Avandia remains unclear.
- Newspaper article from: Philadelphia Inquirer (Philadelphia, PA) May 22, 2007 700+ words
...93, up 75 cents. Avandia, one of GlaxoSmithKline...acknowledged limitations in the New England Journal study, a...that together examined Avandia's effects on a total...deaths in patients taking Avandia." Steven Nissen...cardiologist who coauthored the New England Journal ...
Source: HighBeam Research, Interim Data From RECORD Study Show No Significant Difference Between...
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