The Pharmaceutical Journal
Vol 280 No 7490 p208
23 February 2008

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Benefit of intensive diabetes therapy still unclear

Contrasting reports on whether intensive lowering of blood glucose increases deaths in patients with type 2 diabetes and high cardiovascular risk have emerged this month.

The National Heart, Lung and Blood Institute of the National Institutes of Health in the US has stopped the intensive glucose lowering treatment arm of an ongoing trial because of safety concerns following an interim review of data.

The ACCORD trial includes 10,251 type 2 diabetes patients at high risk for heart attack or stroke who were allocated to receive either intensive lowering of glucose to an HbA_1c of less than 6 per cent, or a less intensive strategy that aimed for an HbA_1c target between 7 and 7.9 per cent.

After four years, 257 patients had died in the intensive treatment group compared with 203 in the standard treatment group. This translates to a number needed to harm of 95. Analyses by ACCORD researchers have not determined a specific cause for the higher death rate and there is no evidence that any medicines or combination of medicines is responsible.

In response to the ACCORD announcement, another group of researchers released a statement revealing that interim results from the ADVANCE study provide no confirmation of the adverse mortality trend reported from the ACCORD study. The study’s data monitoring and safety committee also noted that the ADVANCE interim results are based on more than twice as much data as the ACCORD findings. The final results of the ADVANCE study are expected to be announced at the European Association for the Study of Diabetes in September 2008.

A further study, published in The New England Journal of Medicine (2008;358:580), suggests that intensive intervention with multiple drug combinations and behaviour modification has sustained cardiovascular benefits for at-risk patients with type 2 diabetes.

In this study, 160 patients with type 2 diabetes and persistent microalbuminuria received standard therapy or intensive therapy, which included specific targets for HbA_1c (<6.5 per cent), cholesterol, triglycerides and blood pressure, as well as behaviour modification, use of renin-angiotensin system blockers and low-dose aspirin.

After a mean follow-up of 13.3 years, 24 patients (30 per cent) had died in the intensive therapy group compared with 40 (50 per cent) in the standard therapy group, corresponding to an absolute risk reduction of 20 per cent (P=0.02).