The ACCORD Study has had one study arm halted due to an increased number of deaths in the intensive treatment arm. PharmaTimes and USAToday have already reported this story and it is likely to reach UK media soon.
The study has been designed to evaluate the impact on cardiovascular outcomes of:
- Intensive blood glucose management versus standard treatment
- Intensive lipid management versus standard treatment
- Intensive blood pressure management versus standard treatment
The glycaemic arm of the study has been stopped 18 months early when researchers found that there had been 257 deaths in the intensive treatment group compared with 203 deaths with the standard therapy. Further analysis has, as yet, failed to find a reason for the difference. More rosiglitazone was used in the intensive treatment arm but there were no more deaths in those patients taking rosiglitazone compared to those not taking it so a drug cause cannot be identified.
This study supports a less glucocentric approach to treating diabetes. Clinicians should ensure that smoking cessation and healthy lifestyle encouraged and that cardiovascular risks and blood pressure are managed effectively in combination with blood glucose rather than focussing heavily on blood glucose.
Action: Clinicians should continue to treat diabetes by tackling lifestyle issues as well as blood pressure, blood glucose and cardiovascular risks. The full implications are unclear and more study may be necessary before changes to the management of diabetes can be recommended.