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The retrospective study included 964,818 VA primary care patients over the age of 18 with a diagnosis of diabetes mellitus, examined between July 1, 2010, and June 30, 2011. Diabetic patients over age 18 who did not have ischemic heart disease were considered to be potentially overtreated if they received a high-dose statin.
While more than 80% of diabetic veterans were found to be receiving appropriate treatment for dyslipidemia, as indicated by LDL levels below 100 mg/dl or treatment with moderate dose statins, 14% of patients were found to be potentially overtreated.
Facilities with the highest rates of meeting the recommended threshold of LDL below 100 mg/dl had the highest rates of potential overtreatment.
“Such unintended consequences of performance measurement provide more impetus for implementing measures that focus on appropriate treatment rather than arbitrary threshold targets and that may prompt consideration of deintensification when appropriate,” the authors wrote.
Up to 1% of patients on high-dose statins may experience complications like myopathy and rhabdomyolisis, compared with about 1 in 10,000 patients on moderate dose statins, said author Eve Kerr, MD, MPH, director of the Center for Clinical Management Research and research director of the VA Quality Enhancement Research Initiative for Diabetes Mellitus, and professor of internal medicine at the University of Michigan. Statins may also cause kidney failure and liver damage in rare cases.
“National guidelines based on new data and studies are being completely overhauled right now,” Kerr told U.S. Medicine. “The VA revised performance measures for LDL levels in support of clinical action measures that include LDL below 100 mg/dl or taking moderate dose statins in the second half of FY 2012,” she noted.
The Food and Drug Administration recently issued a Safety Communication limiting the use of the highest dose of simvastatin because of increased risk of muscle damage and published new guidelines for statins that warn users that the medications can cause memory loss, elevated blood sugar levels and Type 2 diabetes.
At the same time, the FDA advised that patients taking statins no longer needed routine monitoring of liver enzymes, as liver injury is rare and not detected by such monitoring. In addition, the FDA reiterated that “the cardiovascular benefits of statins outweigh these small increased risks.”
- Kokkiinos PF, Faselis C, Myers J, Panagiotakos D, Doumas M. Interactive effects of fitness and satin treatment on mortality risk in veterans with dyslipidemia: a cohort study. The Lancet. Early Online Publication, 28 November 2012.
- Beard AJ, Hofer TP, Downs JR, Lucatorto M, Klamerus ML, Holleman R, Kerr EA. Assessing appropriateness of lipid management among patients with diabetes mellitus: Moving from target to treatment. Circ Cardiovasc Qual Outcomes. Published online ahead of print. 2013;6.00-00.
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