Part of ACCORD study halted due to safety concerns

Canadian Diabetes Association has issued its position statement regarding safety concerns of diabetes treatment in ACCORD study – “It is important that people with diabetes not make any changes to their treatments or adjust their blood glucose targets without speaking to their healthcare team”.

In addition to blood glucose control, people with diabetes can reduce their overall cardiovascular risk by controlling their blood pressure and cholesterol levels and by adopting a healthy lifestyle that includes quitting smoking.

The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health has halted the intensive blood-glucose lowering arm of the ACCORD (Action to Control Cardiovascular Risk in Diabetes) study 18 months early due to safety concerns.

This trial, carried out in 10,251 adults with type 2 diabetes at especially high risk for heart attack and stroke, was designed to compare the effect of two treatment strategies on the risk of cardiovascular events such as heart attack, stroke, or death from cardiovascular disease.

Participants were assigned to receive one of two strategies: treatment to intensively lower blood glucose below current recommendations or treatment with a less-intensive standard strategy. Over an average of almost four years, 257 people in the intensive treatment group have died, compared with 203 within the standard treatment group. This is a difference of 54 deaths, or 3 per 1,000 participants each year (although the death rates in both treatment groups are lower than rates seen in similar populations in other studies). Based on available analyses there is no evidence that any one medication or any particular combination of medications is responsible for these deaths.

While the exact reasons for these findings are unclear, they do suggest that intensive treatment to target blood glucose levels below an A1C of 6.0% may not be appropriate for some patients, especially those at high risk of heart attack or stroke and with poor initial glycemic control. A target A1C ??7.0% (as recommended for most patients with diabetes in the 2003 Canadian Diabetes Association’s Clinical Practice Guidelines) offers physicians the option of aiming lower if they feel it is safe in an individual patient.

The ACCORD findings do not apply to people with type 1 diabetes, and it is unclear whether they apply to patients recently diagnosed with type 2 diabetes or those who have a lower cardiovascular risk than the participants in ACCORD.

The ACCORD trial will continue, with participants in the intensive treatment arm now receiving standard treatment instead. The Canadian Diabetes Association will release a more comprehensive statement on the ACCORD study shortly.

Source: Canadian Diabetes Association, Canada

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