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According to recent estimates from the CDC, approximately 56 million Americans have pre-diabetes, of which 5% to 15% subsequently develop overt diabetes each year. Research has shown that patients with pre-diabetes have increased risks for cardiovascular disease (CVD) and other complications (eg, eye and kidney disease and nerve damage) almost to the same extent as patients with overt diabetes. In a consensus statement recently released by the American Association of Clinical Endocrinologists (AACE), my colleagues and I recommended a comprehensive treatment regimen for patients with pre-diabetes. Predicated on sufficient knowledge from new studies and population analyses, the statement indicates that pre-diabetes is not benign, and complications of diabetes clearly begin and are observable in the pre-diabetic state. Our consensus recommends that physicians actively manage and intervene when patients are pre-diabetic.

Pre-diabetes occurs in patients when they have one or more of the following criteria: 1) impaired fasting glucose (fasting sugar 100 mg/dL to 125 mg/dL); 2) impaired glucose tolerance (2-hour post-glucose loads of 140 mg/dL to 199 mg/dL); and 3) metabolic syndrome. Also, patients with CVD who have not been investigated with glucose tolerance testing and women with fertility issues (eg, polycystic ovary syndrome) fall into the spectrum of pre-diabetes.

Intervention Strategies for Pre-Diabetes

When managing pre-diabetes, it’s important to separate cardiovascular risk reduction interventions from those aimed at microvascular risk reduction (eg, retinopathy, nephropathy, and neuropathy). Results of recent clinical trials in patients with overt diabetes have demonstrated that normalizing blood sugar in patients does not independently reduce cardiovascular risk. Patients with pre-diabetes should be treated to the same level of risk-factor modification as those with overt diabetes; this means managing cholesterol and blood pressure aggressively and initiating antiplatelet therapy early. Individuals with pre-diabetes should also be treated with statin therapy to achieve the same lipid goals as those with established diabetes. Additional use of fibrates, bile acid sequestrants, ezetimibe, and other agents may also be appropriate depending on patients’ risk factors. The bottom line is that patients should be treated with as many drugs as necessary to achieve blood pressure levels of 130/80 mm Hg or lower. Aspirin is also recommended unless contraindicated.

Weight reduction and regular daily exercise are essential elements of pre-diabetes management. As long as at least 7% of body weight is lost, the effort can positively impact glucose issues and improve cardiovascular risk. Although there is no currently approved pharmacological agent specifically indicated for pre-diabetes, current medical treatments may be effective, such as metformin and thiazolidinediones. Lifestyle modifications are recommended first, and physicians should then evaluate the need for glucose-directed medications based upon individual risk-benefit assessments. It may also be necessary to monitor fasting blood sugars and A1C, microalbuminuria, blood pressure, and lipid levels.

Encouraging Future Research

The markers of progression from pre-diabetes to diabetes are still unknown, requiring further research to identify unique β-cell therapeutic targets. The AACE consensus statement attempts to definitively address the enormous burden of pre-diabetes. We’re recognizing now that pre-diabetes is not benign and innocuous. Instead, it’s a disease of increased cardiovascular and microvascular risk that must be dealt with independent of its eventual progression to overt diabetes.

Dr. Garber has indicated to Physician’s Weekly that he has worked as a consultant for Bristol-Myers Squibb, GlaxoSmithKline, and Novo Nordisk. He has received grant/research support from AstraZeneca, Bristol-Myers Squibb, Fujisawa, GlaxoSmithKline, Merck, Novartis, Novo Nordisk, Roche, and Schering-Plough. He has also been on the speaker’s bureau for Aventis, Bristol-Myers Squibb, GlaxoSmithKline, Lilly, Novo Nordisk, Merck, Schering-Plough, Pfizer, and Wyeth-Ayerst.