One arm of ACCORD cut
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One arm of ACCORD cut Safety concerns following a review of available data have stopped the intensive treatment arm of the ACCORD* study 18 months ahead of schedule.1 The ACCORD study involved 10 251 adults with type 2 diabetes mellitus who were at especially high risk for heart attack and stroke. Among the intensive treatment group, 257 patients have died, compared with 203 among the standard treatment group. This is a difference of 54 deaths, or 3 deaths per 1000 participants per year, over an average of nearly 4 years’ therapy. Analyses conducted by the ACCORD investigators have not determined a specific cause for the increased deaths among those receiving intensive treatment. To date, there is no evidence that any medicine or combination of medicines is implicated. Given the recent concerns regarding rosiglitazone, a specific review was undertaken to determine whether there was a link between the thiazolidinedione and the increased deaths; no such link was found. The American Diabetes Association has released a statement strongly encouraging patients with diabetes not to alter their treatment without first consulting with their healthcare team.2 * Action to Control Cardiovascular Risk in Diabetes; the intensive treatment group had a target HbA1c of < 6% versus 7–7.9% for the standard treatment group 1. National Heart, Lung, and Blood Institute. For Safety, NHLBI Changes Intensive Blood Sugar Treatment Strategy in Clinical Trial of Diabetes and Cardiovascular Disease. Media Release : 6 Feb 2008. Available from: URL: http://www.nhlbi.nih.gov. 2. American Diabetes Association. Statement from the American Diabetes Association Related to ACCORD Trial Announcement. Media Release : 6 Feb 2008. Available from: URL: http://www.diabetes.org. 801099447
0114-9954/10/1189-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved
Reactions 16 Feb 2008 No. 1189
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