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Field study

Industry sponsored study 9795 diabetics not on lipid-lowering therapy micronized fenofibrate 200 mg daily vs placebo median 5 years of follow-up primary outcome of first myocardial infarction or coronary death Results: 1) fenofibrate group had a non-significant reduction in primary outcome 2) fenofibrate group had a significant 11% relative reduction in total cardiovascular disease & a 21% reduction in coronary revascularizations 3) fenofibrate group had a non-significant increase in coronary heart disease mortality 4) fenofibrate did not significantly reduce total cardiovascular events in patients with previous CVD or in those aged 65 or older 5) fenofibrate group had significantly less progression of albuminuria & fewer retinal laser procedures 6) amputations occurred significantly less often in the fenofibrate group (0.9% vs. 1.4%), including: a) below-ankle amputations (0.6% vs. 1.1%) b) below-ankle amputations without concomitant large-vessel disease (0.4% vs. 0.7%) c) no between-group differences were noted in above-ankle amputations d) overall number needed to treat to prevent one amputation is 197, but only 25 for patients with previous foot ulcers & albuminuria [2] 7) fenofibrate group had significant increases in pancreatitis & pulmonary embolism 8) all-cause mortality was higher in the fibrate group than the placebo group (7.3% vs 6.6%) 9) more frequent initiation of statin therapy in patients allocated placebo may confound interpretation

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clinical trial

References

  1. Keech A, Simes RJ, Barter P, Best J, Scott R, Taskinen MR, Forder P, Pillai A, Davis T, Glasziou P, Drury P, Kesaniemi YA, Sullivan D, Hunt D, Colman P, d'Emden M, Whiting M, Ehnholm C, Laakso M; FIELD study investigators. Effects of long-term fenofibrate therapy on cardiovascular events in 9795 people with type 2 diabetes mellitus (the FIELD study): randomised controlled trial. Lancet. 2005 Nov 26;366(9500):1849-61. PMID: 16310551 - Colhoun H. After FIELD: should fibrates be used to prevent cardiovascular disease in diabetes? Lancet. 2005 Nov 26;366(9500):1829-31. No abstract available. PMID: 16310536
  2. Rajamani K et al. Effect of fenofibrate on amputation events in people with type 2 diabetes mellitus (FIELD study): A prespecified analysis of a randomised controlled trial. Lancet 2009 May 23; 373:1780. PMID: 19465233