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Amputation abstract
Metabolic syndrome abstract
The clinical value of metabolic syndrome and its components in established type 2 diabetes mellitus: the FIELD trial
Author Block:
R. O'Brien, R. Scott, J. Best, M.-R. Taskinen, C. Pardy, C. Ehnholm, A. Keech;
on behalf of the FIELD study investigators, c/o NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia.
Abstract:
Background and aims:
In the randomised placebo-controlled FIELD trial of long-term fenofibrate among 9795 patients with type 2 diabetes mellitus, almost 1300 first cardiovascular (CVD) events accrued over 5 years. This provides an opportunity to assess whether the constellation of characteristics comprising metabolic syndrome (MS) have clinical value in the setting of type 2 diabetes mellitus.
Materials and methods: All subjects were classified in pre-specified analyses according to the presence of each individual criterion of metabolic syndrome (i) elevated blood pressure or treated hypertension, (ii) gender-specific low HDL cholesterol (HDLc) levels, (iii) elevated triglycerides (TG), (iv) increased waist circumference, and (v) impaired glucose tolerance or diabetes, according to the modified ATPIII definitions, and whether metabolic syndrome was present (at least 3 criteria present). Marked hypertriglyceridaemia (TG levels >= 2.3 mmol/L) was also examined. Total cardiovascular event rates were estimated among those with and without each feature.
Results:
84% of subjects fulfilled the criteria for having MS: 84% had elevated blood pressure, 68% increased waist, 59% low HDLc and 52% high TG. Marked hypertriglyceridaemia was present in 25%, and in 20% combined with low HDLc. In those with MS, or any individual feature of MS (except for increased waist; p=ns), the cardiovascular event rates were at least 3% higher in absolute terms than among those without MS (p<0.001) or without the same feature. The highest event rates were seen in those with marked hypertriglyceridaemia plus low HDLc. The CVD event reductions with fenofibrate over 5 years in those with and without MS were proportionally (11% versus 12% respectively) and in absolute terms (1.4%; number needed to treat [NNT] = 71 versus 1.6%; NNT = 63) very similar. In contrast, the proportional risk reduction was 27% (p=0.005) when marked dyslipidaemia (marked high TG plus low HDLc) was present (absolute reduction 4.3%, NNT = 23) compared with 6% (p=0.32) among all others (absolute reduction 0.8%, NNT =143; p value for treatment by group interaction = 0.053). In risk modelling adjusted for age, gender, prior CVD and HbA1c, low HDLc and elevated blood pressure were independent risk contributors (both p<0.001), whereas increased waist (p=0.52) and elevated TG (p=0.069) were not.
Conclusion:
Even in the presence of established type 2 diabetes mellitus, the presence of MS or any of its features, except increased waist, increases risk for CVD events significantly. The effects of fenofibrate were similar with or without MS being present, but markedly greater among those at greatest risk, with marked hypertriglyceridaemia plus low HDLc. Marked diabetic dyslipidaemia is an especially important marker of CVD risk and benefit from fenofibrate therapy.