Harris Communications

Diabetes">

Harris Communications

Diabetes, Drugs and Quality of Life
Harvard School of Public Health

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Embargoed by The Journal of the American Medical Associatio until November 3rd, 5:00 p.m. ET

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Effective Blood Sugar Control Results in Significant Short-term

Quality of Life Benefits for Type 2 Diabetics

JAMA Study Links Good Glucose Control with Improved Well Being and Work Productivity

BOSTON, November 3, 1998--Results of a novel clinical study published in the November 4 issue of The Journal of the American Medical Association show that improving glycemic (blood sugar) control in persons with type 2 diabetes can significantly enhance the patient's mental and physical health leading to fewer days missed from work, decreased physician visits and overall economic savings. Ninety to 95 percent of the estimated 16 million Americans diagnosed with diabetes have type 2, or adult onset diabetes.

"For the first time, we can demonstrate that even moderately more effective glycemic control can decrease a broad array of commonly overlooked symptoms of high blood glucose including fatigue, weariness and problems in thinking. Relief from these 'silent symptoms of diabetes' were shown to dramatically improve the patient's overall quality of life. ," says study co-author, Marcia A. Testa, M.P.H., Ph.D., Harvard School of Public Health.

Researchers found that after 12 weeks of therapy, patients treated with Glucotrol XLâ (glipizide GITS), a once-daily oral sulfonylurea, reported better physical, mental and emotional health, better cognitive function and fewer days absent from work (due to health problems) than those treated by diet only. Due to the improved productivity and less absenteeism, Glucotrol XLâ patients had a higher employment retention rate. The

study also indicates that as quality of life improved with better glycemic control, overall use of health care services such as physician office and emergency room visits decreased.

""Historically, the health care community has focused on long-term benefits of glycemic control " says study co-author, Donald C. Simonson, M.D., Brigham and Women’s Hospital, Joslin Diabetes Center and Harvard Medical School. "Both physicians and HMO's have typically assumed that more intensive treatment for type 2 diabetes is primarily preventative -- reducing the future complications of diabetes such as kidney disease and blindness. The results of this study should influence both physicians and managed care organizations to recognize the importance of the more immediate benefits. The key finding here involves not only direct benefits to the patient, but to his or her employer as well. Often it is the employer who pays for both sick days absent from work and health care insurance. Employers need to select health plans for their employees that are committed to better diabetes management "

Study Design and Results

The double-blind, dose-titration study involved 594 patients at 62 centers across the United States. After a three-week placebo run-in period, patients were randomized to receive either placebo and diet management (201 persons) or 5-20 mg of Glucotrol XLâ and diet management (393 persons).

Glucose levels, symptoms, quality-of-life and health economic indicators were measured at screening, randomization and then at weeks four, eight and 12 post-randomization. Quality-of-life factors measured included perceived physical and mental health, cognitive functioning and symptom distress. Days worked and absent (due to health problems), restricted activity days and health care utilization were also evaluated.

After 12 weeks of treatment, hemoglobin A1c and fasting plasma glucose were significantly lower with Glucotrol XLâ vs. placebo (7.5 % vs. 9.3% and 126 mg/dL vs. 168md/dL, respectively). Glucotrol XLâ patients had more favorable changes for the major quality-of-life scales, and health economic outcomes including higher retained employment and greater productive capacity , less absenteeism (production losses =$24 vs. $115 per worker per month), bed days (losses=$1,415 vs. $1,843 per 1,000 person-days) and restricted activity days (losses=$2,660 vs. $4,275 per 1,000 person-days). The costs associated with the value of lost earnings were based upon the average annual wages of male and female workers by age as reported by the Bureau of Census.

According to Richard Kahn, Ph.D. Chief Medical and Scientific Officer (CHECK EXACT TITLE) , American Diabetes Association (ADA), PLEASE INSERT A CRITCAL COMMENT FROM DR. KAHN

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"This study has critical ramifications on how the medical community should work with patients to better understand and manage this disease. I urge the health care profession, during National Diabetes Awareness Month and throughout the year, to emphasize day-to-day patient satisfaction when implementing disease management programs and estimating the costs and benefits of therapeutic regimens and prevention programs."

Type 2 diabetes results when the body is unable to make a sufficient amount of insulin or cannot properly use the insulin it does produce. Unlike type 1, type 2 diabetes can often be managed for many years without regular insulin injections using a combination of diet, exercise and oral medications.

The study analysis, titled "Health Economic Benefits and Quality of Life During Improved Glycemic Control in Patients with Type 2 Diabetes Mellitus" was funded by research grants to the Harvard School of Public Health from the Agency for Health Care Policy Research, Department of Health Human Services and the American Diabetes Association. The clinical trial was funded separately by Pfizer Inc., manufacturer of Glucotrol XLâ .

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