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Fenofibrate Might Reduce Amputations Caused by Microvascular Disease in Patients with Diabetes

Nontraumatic amputations occurred significantly less often in patients who take fenofibrate.

In the manufacturer-supported FIELD trial (JW Gen Med Jan 17 2006), nearly 10,000 patients with type 2 diabetes who were not receiving lipid-lowering therapy (total cholesterol level, 116–250 mg/dL, plus plasma triglyceride level, 90–440 mg/dL or total–to–HDL-cholesterol ratio 4.0) were randomized to daily fenofibrate (200 mg; Tricor, Antara, and others) or placebo for 5 years. The groups did not differ in the primary outcome of first myocardial infarction or cardiovascular-related death, but fenofibrate recipients had significantly less progression of albuminuria and fewer retinal laser procedures than placebo recipients.

Now, investigators report the effects of fenofibrate on FIELD’s tertiary endpoint of nontraumatic lower-limb amputations. Amputations occurred significantly less often in the group that received fenofibrate than in the placebo group (0.9% vs. 1.4%), as did below-ankle amputations (0.6% vs. 1.1%) and below-ankle amputations without concomitant large-vessel disease (0.4% vs. 0.7%). No between-group differences were noted in above-ankle amputations or in amputations with concomitant large-vessel disease. The effect of fenofibrate on amputation risk was independent of dyslipidemia and glycemic control. The overall number needed to treat (NNT) to prevent one amputation in this trial was 197, but the NNT was only 25 for patients with previous foot ulcers and albuminuria.

Comment: The aggregate results of the FIELD study suggest that fenofibrate lowers risk for microvascular (but not macrovascular) disease in patients with diabetes, possibly through non-lipid–mediated mechanisms. Fenofibrate might be a useful treatment to prevent amputations in patients at highest risk.

— Bruce Soloway, MD

Published in Journal Watch General Medicine June 11, 2009

Citation(s):

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.

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Reader Remarks:

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• The Field study - full disclosure
  Sheldon S Ball, Veterans Administration, 12 Jun 2009 11:12 AM EST
  Whe I go back to the original publication, it seems this editorial selectively paints a rosy picture. Other findings not... [more]
• Fenofibrate
  Bernard A. Yablin(MD), URMC(retired), 17 Jun 2009 3:02 PM EST
  How often should patients be tested for pvd? Should fenofibrate be used in all patients with Type 2 diabetes
• FENOFIBRATE FOR DIABETIC FOOT ULCER AND ALBUMINURIA
  Bimal K Agrawal, Deptt of Medicine,M M Medical College, M M University, Mullana, India, 7 Aug 2009 12:26 PM EST
  The study shows the drug is particularly effective in preventing amputation in subgroup of patients who have diabetic foot ulcer... [more]