Statins remain first-line treatment for lipid abnormalities in people with type-2 diabetes, after the results of the FIELD study were announced on 14 November at the Scientific Sessions of the American Heart Association in Dallas.

The largest-ever diabetes intervention trial, FIELD randomised 9795 men and women to five years' treatment with Fournier's fenofibrate - sold as Tricor by Abbott Laboratories in the USA - or placebo. The study failed to meet its primary endpoint, since the 11% reduction in the risk of heart attack and coronary death seen with Tricor was not significant.

This was disappointing, as previous studies indicated that fibrates might be particularly effective in correcting lipid abnormalities in diabetes: low HDL or 'good' cholesterol, high triglycerides, and smaller, denser LDL cholesterol particles. Tricor did improve the lipid profile, but its early effect on HDL cholesterol attenuated significantly over the course of the study.

Tricor did significantly reduce the risk of non-fatal heart attack by 24% and the need for angioplasty or bypass surgery by 21%. These benefits did, not, however translate into improved survival, since there was no significant difference between total deaths in the Tricor and placebo groups.

The benefits of Tricor may have been masked by higher statin use among placebo patients. There is also some comfort for Abbott and Fournier in the unexpected and significant reductions in the risk of microvascular events such as laser therapy for diabetic eye disease among Tricor patients.

However, FIELD undoubtedly means that Tricor will remain an add-on, rather than an alternative, therapy to statins in people with type-2 diabetes. The statin-fibrate combination is being tested in the ongoing ACCORD study, but this will not report until 2009. In the meantime, Pfizer's CTEP-inhibitor torcetrapib is waiting in the wings-a drug that increases HDL and reduces LDL cholesterol, both alone and in combination with atovastatin.

Source: Sue Lyon at the AHA in Dallas, USA.