CardioExchange Archive

CardioExchange, an NEJM practice community for medical professionals dedicated to improving cardiac patient care, was active from 2009 to 2015. CardioExchange fostered discussion between clinicians from across the globe.

June 3rd, 2010

• CANOE Paddles Into the Avandia Storm
• Ticagrelor NDA Scheduled for July FDA Panel

CANOE Paddles Into the Avandia Storm: Rosiglitazone is effective in preventing progression to diabetes, but very public concerns have been raised about its cardiovascular safety. Investigators in Canada sought to assess the efficacy of a low-dose regimen, in the hopes that adverse effects would be reduced. The CANOE (CAnadian Normoglycemia Outcomes Evaluation) trial randomized 207 patients with impaired glucose tolerance to low-dose combination therapy with rosiglitazone and metformin or matching placebo. After 3.9 years, diabetes occurred in 39% of the control group compared with 14% of the combination-therapy group (P<0.0001). In addition, more patients in the treatment group achieved normal glucose tolerance: 80% versus 53% in the placebo group (P=0.0002).

“These results lend support to the notion of use of low-dose combination therapies as an effective means to manage complex metabolic disorders,” the investigators write in their online report in the Lancet. But they acknowledge that the trial “was not designed nor powered to establish long-term effects on cardiovascular safety. CANOE cannot provide additional definitive data for the controversy relating to the specific cardiovascular safety of rosiglitazone.” In an accompanying comment, Thomas Buchanan and Anny Xiang write that “the larger issues that have cast doubt on use of drugs to prevent diabetes are not addressed by the CANOE trial” and that successful prevention of diabetes will require treatments that halt the deterioration of β-cell function.

Ticagrelor NDA Scheduled for July FDA Panel: The FDA Cardiovascular and Renal Drugs Advisory Committee will meet on July 28 to consider the new drug application for ticagrelor (Brilinta, AstraZeneca) “for the proposed indication for use in acute coronary syndrome (including heart attacks and any of a group of signs and symptoms, such as chest pain or shortness of breath, that are consistent with blockages in the blood vessels that supply the heart).” (FDA Meeting Announcement)

Categories: General


You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed.

Comments are closed.