Quest Diagnostics Health Trends Report Shows Significant Gap in Care for Patients at Highest Risk for Chronic Kidney Disease

Madison, NJ
November 07, 2007

The majority of people with diabetes and/or high blood pressure - the two leading causes of chronic kidney disease (CKD) - are not being appropriately monitored for this debilitating and life-threatening disease, according to the latest Quest Diagnostics Health Trends™ Report. These findings, released today by Quest Diagnostics Incorporated (NYSE: DGX) following the National Kidney Foundation’s consensus conference, Cardio-Kidney Diabetes…The Triple Threat, are based on diagnostic test results from more than five million patients. The study suggests a failure to implement evidence-based guidelines issued by the National Kidney Foundation (NKF), American Diabetes Association, National Institutes of Health’s National Kidney Disease Education Program, and National Heart, Lung, and Blood Institute.

The Quest Diagnostics Health Trends™ Report, “An Analysis of Chronic Kidney Disease in the U.S.,” is the largest assessment of the relationships among CKD, cardiovascular disease (CVD) and diabetes. There were two analyses conducted. The first, performed on test results from 2005 and 2006, showed that 52 to 90 percent of patients with diabetes, high blood pressure (hypertension) or both plus kidney disease were not given a widely available, inexpensive and non-invasive urine test to check for albumin, or protein in the urine. A slightly elevated level of protein in the urine, or microalbuminuria, is one of the earliest markers of kidney disease. The microalbumin test can detect kidney damage when no other symptoms are present, and can help patients and their physicians potentially slow disease progression.

Among patients with evidence of CKD in October 2006, 59 percent of patients who also had diabetes did not have a microalbumin test in the previous 12 months; 83 percent of patients who also had hypertension and 52 percent of patients who also had diabetes and hypertension did not have the test. This lack of appropriate monitoring in high-risk populations is widespread, despite clinical guidelines from the NKF, American Diabetes Association (ADA), National Institutes of Health’s National Kidney Disease Education Program (NKDEP), and National Heart, Lung, and Blood Institute (NHLBI), which all recommend annual microalbumin testing to check and follow this marker of kidney damage among patients with hypertension, diabetes, CVD, and other CKD risk factors.2,3,4,5

The report is based on findings from 6.2 million estimated Glomerular Filtration Rate (eGFR) tests and microalbumin test results, two key indicators of kidney function, performed by Quest Diagnostics between November 2005 and October 2006 on 5.2 million patients who saw a healthcare professional. Among patients who had an eGFR result, approximately 19% had a result <60 mL/min/1.73 m2, an indicator of kidney disease.

An estimated 20 million Americans, or 1 in 9 adults, have CKD6 - permanent damage to the kidneys, resulting in the kidney’s failure to efficiently filter bodily waste. Clinical evidence has shown that early detection and treatment of CKD could slow or prevent the progression of the disease to chronic kidney failure, as well as reduce the risk of heart attack, stroke and death. Deaths from CKD have increased 52 percent over the last 16 years.7

A second analysis of approximately 500,000 test results from people with diabetes or cardiovascular disease showed that patients in the early stages of CKD have higher HbA1c levels, indicating inadequate blood sugar control. These patients are also less likely to achieve LDL-cholesterol, or “bad” cholesterol goals than patients with advanced CKD. The tests used in this analysis were for diabetes (HbA1c), low density lipoprotein cholesterol (LDL) and kidney disease (eGFR and microalbumin).

“More aggressive monitoring in the early stages of kidney disease allows more time for evaluation and intervention. We need to work together to promote implementation of early detection and treatment of chronic kidney disease,” said Joseph A. Vassalotti, MD, chief medical officer, National Kidney Foundation. “The burden of type 2 diabetes and hypertension is expected to grow as the Baby Boomers age and as the obesity epidemic continues. The increase in diabetes and hypertension, the major risk factors for chronic kidney disease, will also drive up the rates of chronic kidney disease unless there are major improvements in diabetes and high blood pressure management.”

“Physicians may believe that their patients are not at risk for chronic kidney disease if their blood glucose, lipids and/or blood pressure are controlled. This is simply not true,” said Herman Hurwitz, MD, FCAP, senior medical director, Quest Diagnostics Philadelphia. “Chronic kidney disease is an insidious consequence of these diseases and can progress quickly without routine monitoring. Patients at increased risk for chronic kidney disease should be screened for microalbuminuria at least annually, while those with confirmed microalbuminuria may require even more frequent monitoring depending on their response to treatment. Yet, our data suggests that at-risk chronic kidney disease patients are not being monitored as recommended by established guidelines.”

Study Methodology
The Quest Diagnostics Health Trends™ Report, “An Analysis of Chronic Kidney Disease in the U.S.,” is based on an initial review of test results from November 2005 to December 2006, for patients age 18 and older. Patient matching software was used to assign a “patient matching” identification number, so that a de-identified data set of individual patient results, matched over time, could be created. The de-identified data was then aggregated for analysis. The result was a data set that allowed us to analyze data on the level of the individual patient, while assuring that patients could not be identified by name, address, physician name, or similar features.

The first analysis was based on 3.4 million eGFR results from October 2006, and 2.8 million microalbumin tests between November 2005 to October 2006. The analysis determined the percentage of patients with eGFR <60 who had a microalbumin test performed during the previous 12 months, grouped by diagnosis.

The second analysis is based on approximately 13 million test results performed in 2006, on 7.9 million unique patients - 500,000 of these test results met all the criteria for inclusion in the final analysis. Stage of CKD was based on patients having, on at least two occasions 90 days or more apart, an eGFR result of <60 mL/min/1.73 m2 or a microalbumin result >30. For patients with multiple eGFR results during a single time period, the average of the two lowest eGFR scores was used to define stage of CKD.

In both studies described above, the presence of CVD was determined by the presence of specified ICD-9 codes; including a subset of patients with ICD-9 codes representing hypertension. Patients with diabetes were identified by use of ICD-9 code 250.

Quest Diagnostics Health Trends™
Quest Diagnostics maintains the largest private clinical laboratory data warehouse in the United States. Consisting of 17 billion data points, and growing by 10 million a day, the database provides laboratory information on the vast majority of conditions and diseases affecting Americans today. Quest Diagnostics provides these data to health plans to help manage the health of their members. Quest Diagnostics Health Trends™ Reports identify and track disease and wellness benchmarks. De-identified data are made available as a public service to inform patients, health professionals, and policy-makers about the current status of the nation’s health.

This latest Quest Diagnostics Health Trends™ Report focused on CKD, CVD and diabetes because of the large numbers of patients affected by one or more of these diseases. This report builds on previous Health Trends™ reports of management of diabetes (assessed by HbA1c tests) and cholesterol (assessed by LDL-cholesterol tests).

About the National Kidney Foundation
The National Kidney Foundation, New York, NY, is dedicated to preventing kidney and urinary tract diseases, improving the health and well being of individuals and families affected by these diseases, influencing public policy in support of the kidney community and increasing the availability of all organs for transplantation.

About Quest Diagnostics
Quest Diagnostics is the leading provider of diagnostic testing, information and services that patients and doctors need to make better healthcare decisions. The company offers the broadest access to diagnostic testing services through its national network of laboratories and patient service centers, and provides interpretive consultation through its extensive medical and scientific staff. Quest Diagnostics is a pioneer in developing innovative new diagnostic tests and advanced healthcare information technology solutions that help improve patient care. Additional company information is available at: www.questdiagnostics.com.

The statements in this press release that are not historical facts or information may be forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause actual results and outcomes to be materially different. Certain of these risks and uncertainties may include, but are not limited to, competitive environment, changes in government regulations, changing relationships with customers, payers, suppliers and strategic partners and other factors described in the Quest Diagnostics Incorporated 2006 Form 10-K and subsequent SEC filings.