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In what Australian endocrinologists describe as a major breakthrough, the lipid-lowering drug fenofibrate has been shown to reduce the risk of amputation in diabetic patients by almost half.
Results from the NHMRC-funded FIELD study involving almost 10,000 patients with type 2 diabetes have shown that over a five year period those who took fenofibrate 200mg daily had a 36% lower rate of amputations overall (70 versus 45 events) compared to patients randomized to placebo.
The fibrate drug was even more effective in preventing minor amputation (below the ankle) in diabetic patients without known large vessel disease, in whom the rate was 47% lower than the placebo group.
The NHMRC Clinical Trails Centre researchers, presenting their findings at the Heart Foundation Conference in Brisbane this week, said the benefits were seen regardless of the degree of glycaemic control or dyslipidaemia or use of ACE inhibitors or antagonist drugs. This suggests the fenofibrate benefits on amputation are though non-lipid mechanisms, they say.
“These findings represent a significant breakthrough and are likely to change treatment for the prevention of diabetes-related lower limb amputation in high risk individuals,” they conclude.
The high risk patients were those with classical markers of macrovasular and microvascular complications such as smoking, high BP, skin ulcers and long duration of diabetes, they add.
***************************************** Remember, it's just a foot.
Last edited by LuckyLisfranc : 18th May 2009 at 06:23 PM.
Effect of fenofibrate on amputation events in people with type 2 diabetes mellitus (FIELD study): a prespecified analysis of a randomised controlled trial
Kushwin Rajamani, Peter G Colman, Li Ping Li, James D Best, Merryn Voysey, Michael C D'Emden, Markku Laakso, John R Baker, Anthony C Keech, on behalf of the FIELD study investigators The Lancet, Volume 373, Issue 9677, Pages 1780 - 1788, 23 May 2009
Amputations in people with type 2 diabetes mellitus substantially impair their quality of life and impose high costs on health-care systems. Our aim was to assess the effect of fenofibrate on amputation events in a large cohort of patients with type 2 diabetes.
In the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study, 9795 patients aged 50–75 years with type 2 diabetes were randomly assigned by computer-generated randomisation sequence to receive fenofibrate 200 mg per day (n=4895) or matching placebo (n=4900) for 5 years' duration. Information about non-traumatic amputation—a prespecified tertiary endpoint of the study—was routinely gathered. Clinicians who were masked to treatment allocation adjudicated amputations as minor or major (below or above the ankle, respectively). Amputations were also classified on the basis of whether or not large-vessel disease was present in the limb, to distinguish those related to large-artery atherosclerosis from those predominantly related to microvascular disease. Analysis was by intention to treat (ITT). The FIELD study is registered as an International Standard Randomised Controlled Trial, number ISRCTN64783481.
All 9795 patients were included in the ITT population. 115 patients had one or more non-traumatic lower-limb amputations due to diabetes. Previous cardiovascular disease, microvascular disease, previous non-traumatic amputation or skin ulcer, smoking, and longer duration of diabetes were more frequent in patients who had amputations during the trial than in those who had other cardiovascular events or in those who had neither event (all p<0·001 for three-way comparison). Mean lipid concentrations differed between patients who had on-study amputations and those who had other cardiovascular events or neither event, but by no more than 0·2 mmol/L. The risks of first amputation (45 vs 70 events; hazard ratio [HR] 0·64, 95% CI 0·44–0·94; p=0·02) and minor amputation events without known large-vessel disease (18 vs 34 events; 0·53, 0·30–0·94; p=0·027) were lower for patients assigned to fenofibrate than for patients assigned to placebo, with no difference between groups in risk of major amputations (24 vs 26 events; 0·93, 0·53–1·62; p=0·79).
Classic markers of macrovascular and microvascular risk were associated with lower extremity amputations in patients with type 2 diabetes. Treatment with fenofibrate was associated with a lower risk of amputations, particularly minor amputations without known large-vessel disease, probably through non-lipid mechanisms. These findings could lead to a change in standard treatment for the prevention of diabetes-related lower-limb amputations.
Statin use and lower extremity amputation risk in nonelderly diabetic patients.
Sohn MW, Meadows JL, Oh EH, Budiman-Mak E, Lee TA, Stone NJ, Pearce WB. J Vasc Surg. 2013 Aug 7.
To examine the association between use of statin and nonstatin cholesterol-lowering medications and risk of nontraumatic major lower extremity amputations (LEAs) and treatment failure (LEA or death).
A retrospective cohort of patients with Type I and Type 2 diabetes mellitus (diabetes) was followed for 5 years between 2004 and 2008. The follow-up exposure duration was divided into 90-day periods. Use of cholesterol-lowering agents, diabetic medications, hemoglobin A1c, body mass index, and systolic and diastolic blood pressures were observed in each period. Demographic factors were observed at baseline. Major risk factors of LEA including peripheral neuropathy, peripheral artery disease, and foot ulcers were observed at baseline and were updated for each period. LEA and deaths were assessed in each period and their hazard ratios (HRs) were estimated. The study took place in the U.S. Department of Veterans Affairs Healthcare system, and the subjects consisted of cholesterol drug-naïve patients with Type I or II diabetes who were treated in the U.S. Department of Veterans Affairs Healthcare system in 2003 and were <65 years old at the end of follow-up.
Of 83,953 patients in the study cohort, 217 (0.3%) patients experienced a major LEA and 11,716 (14.0%) patients experienced an LEA or death (treatment failure) after a mean follow-up of 4.6 years. Compared with patients who did not use cholesterol-lowering agents, statin users were 35% to 43% less likely to experience an LEA (HR, 0.65; 95% confidence interval [CI], 0.42-0.99) and a treatment failure (HR, 0.57; 95% CI, 0.54-0.60). Users of other cholesterol-lowering medications were not significantly different in LEA risk (HR, 0.95; 95% CI, 0.35-2.60) but had a 41% lower risk of treatment failure (HR, 0.59; 95% CI, 0.51-0.68).
This is the first study to report a significant association between statin use and diminished amputation risk among patients with diabetes. In this nonrandomized cohort, beneficial effects of statin therapy were similar to that seen in large-scale clinical trial experience. For LEA risk, those given nonstatins did not have a statistically significant benefit and its effect on LEA risk was much smaller compared with statins. Unanswered questions to be explored in future studies include a comparison of statins of moderate vs high potency in those with high risk of coronary heart disease and an exploration of whether the effects seen in this study are simply effects of cholesterol-lowering or possibly pleiotropic effects.
Background—Statins stabilize atherosclerotic plaque, decrease mortality after surgical procedures, and are linked to anti-inflammatory effects. The objective of this study was to evaluate preoperative administration of statins and longitudinal limb salvage after lower extremity endovascular revascularization and lower extremity open surgery.
Methods and Results—Patients were selected from 2007 to 2008 Medicare claims using the International Classification of Diseases, Ninth Revision, Clinical Modification, diagnosis codes for claudication (N=8128), rest pain (N=3056), and ulceration/gangrene (N=11 770) and Current Procedural Terminology codes for endovascular revascularization (N=14 353) and open surgery (N=8601). Half (N=11 687) were identified as statin users before revascularization using Part D files. Amputations were identified using Current Procedural Terminology codes. Statin users compared with nonusers had lower amputation rates at 30 days (11.5% versus 14.4%; P<0.0001), 90 days (15.5% versus 19.3%; P<0.0001), and 1 year (20.9% versus 25.6%; P<0.0001). Survival analysis demonstrated improved limb salvage during 1 year for statin users compared with nonusers for the diagnosis of claudication (P=0.003), a similar trend for rest pain (P=0.061), and no improvement for ulceration/gangrene (P=0.65).
Conclusions—Preoperative statins were associated with improved 1-year limb salvage after lower extremity revascularization. The strongest association was found for patients with the diagnosis of claudication. Statins seem to be underused among Medicare patients with peripheral artery disease. Further evaluation of the use of preoperative statins and the potential benefits for peripheral vascular interventions is warranted.