The study included 83, 953 patients younger than 65 years with Type 1 or Type 2 diabetes who were treated in the US Department of Veterans Affairs healthcare system in 2003. The patients were followed for 5 years and cholesterol-lowering agents, diabetic medications, hemoglobin A1c, body mass index and systolic and diastolic blood pressures were observed. Major risk factors of lower extremity amputation, including peripheral neuropathy, peripheral artery disease and foot ulcers, were also noted.

The researchers found that 217 (0.3%) of patients experienced a major lower extremity amputation and 11,716 (14 %) experienced a lower extremity amputation or death. Statin users were 35% to 43% (HR=0.65; 95% CI, 0.42-0.99) less likely to experience a lower extremity amputation or treatment failure compared with non-statin users. The researchers also found that users of other cholesterol-lowering medications had a 41% lower risk of treatment failure (HR=0.59, 95% CI, 0.51-0.68), but they were not significantly different in amputation risk.

“This is the first study to report a significant association between statin use and diminished amputation risk among patients with diabetes,” the authors wrote in the study abstract. “In this nonrandomized cohort, beneficial effects of statin therapy were similar to that seen in large-scale clinical trial experience.”

For more information:

Sohn MW. J Vasc Surg. 2013. doi: 10.1016/j.jv.2013.06.069.

Disclosure: Sohn has no relevant financial disclosures.

Abstract

Objective

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).

Methods

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.

Results

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).

Conclusions

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

http://www.jvascsurg.org/article/S0741-5214%2813%2901253-6/abstract

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