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The American Diabetic Association (ADA) raised the bar of tight glycemic control even higher after the release of the largest ever study of Type 2 diabetics, the United Kingdom Prospective Diabetes Study (UKPDS).
The landmark 20-year study complements the findings of the Diabetic Control and Complications Trial (DCCT) for Type 1 diabetics: Strict glycemic control results in a dramatically reduced risk of common complications of diabetes once considered inevitable — retinopathy, nephropathy, and possible neuropathy.
The new study also shows tight control of hypertension among diabetics has equally dramatic results in terms of heart disease. It also shows the efficacy of sulfonylurea, insulin, and metformin in lowering blood glucose and found both anti-hypertensives used in the study: the ACE inhibitor captopril and the beta-blocker atenolol worked equally well.
Like the DCCT, the UKPDS employed intensive treatment designed to achieve near-normal glycemia by whatever means necessary.
That means the face of diabetic practice in America must change and there will be no more excuses for failures, says Richard Kahn, PhD, the ADA’s chief scientific and medical officer.
"We’ve got all the proof that we need . . . The final piece of evidence is here," Kahn says. "It’s a done deed, so let’s get on with this and improve glycemic control for all people with diabetes."
Kahn throws down the gauntlet to health care professionals without hesitation.
"There’s no excuse for having a patient with poor glycemic control. There are plenty of drugs. The medical evidence is clear and convincing."
Furthermore, Kahn believes the burden of responsibility for improved care rests squarely on the broad shoulders of medical professionals: Overall in diabetes care in America, treatment is suboptimal and we need to do something about it.
While conceding patient compliance is a significant issue in diabetes care, "We shouldn’t just hang it on the patient," he says.
• Exams are not given frequently enough.
• There is not enough proper follow-up.
• Not enough attention is given to glycemic control.
• Some physicians even underplay the seriousness of the disease.
"Many people are still told, you have a touch of sugar or borderline diabetes,’" Kahn says. "Health care professionals are not taking this disease seriously."
The ADA, in a position paper issued shortly after the September UKPDS release, issued a call to arms: It is time for all health professionals to treat diabetes aggressively. It is also time for patients to take their diabetes with utmost seriousness. It is incumbent on the health care system to provide the necessary resources for both to be successful.
The Oxford-based UKPDS involved 5,102 newly diagnosed patients recruited throughout the United Kingdom between 1977 and 1991. Patients in 23 clinical centers in England, Northern Ireland, and Scotland were followed for an average of 10 years in the randomized controlled trial.
All patients were placed on diet control alone for the first three months, and randomly divided into two groups that received either drug therapy or remained on diet control. Those with hypertension were divided into "tight" and "less tight" control and administered ACE inhibitors or beta-blockers.
During the study, blood glucose and blood pressure levels were measured more frequently than usual.
The major findings are as follows:
• Patients who achieved a median HbA1c of 7% compared to those on conventional therapy at 7.9% had 25% fewer microvascular complications.
• For every 1% drop in the HbA1c rate, there was a 35% reduction in the risk of complications; a 25% reduction in diabetes-related death; a 7% reduction in all-cause mortality; and an 18% reduction in combined fatal and non-fatal myocardial infarction.
• Patients receiving insulin therapy had a highest average annual incidence of major hypoglycemic events at 2.3%.
• Lowering blood pressure to a mean 144/82 mm Hg caused a significant reduction in strokes, diabetes-related deaths, heart failure, microvascular complications, and vision loss. However, the ADA continues its recommendation that blood pressure be maintained below 130/85 mm Hg.
• While a 16% reduction in the risk of combined fatal or non-fatal myocardial infarction and sudden death was observed after lowering blood glucose, researchers did not consider it statistically significant.
The study failed to provide definitive evidence of the role of hypoglycemia in cardiovascular complications.
It also produced mixed results on met- formin. With the drug, obese individuals had a 33% reduced risk of diabetes-related deaths and cardiovascular events. However, a small sample of patients given a maximum dosage of sulfonylureas and added metformin showed an increase in diabetes-related deaths. The ADA says the results were affected by design aspects of the study and does not recommend any change in the use of metformin.
The UKPDS did not determine if tight control could produce positive outcomes for those who already have serious complications, but Kahn says his best guess is that complications are reversible "if they have not progressed too far."
The results of the UKPDS are achievable, says the ADA position paper, which notes patients in the UKPDS began with an HBA1c of 9.1%. While the conventional treatment group achieved a 10-year median level of 7.9%, the intensively treated group was able to maintain a level of 7%.
"Perhaps the most important ingredient leading to therapeutic success was persistence," the ADA position paper comments.
What now needs to change in conventional practice of diabetes management, Kahn believes, is that physicians must pull out all the stops to achieve near-normal blood glucose — closer monitoring, closer attention, more frequent office visits, more counseling and support, stronger medications — "whatever it takes."
The ADA has already begun its public and professional awareness campaign through traditional means: through the media, lecture circuit, and a flurry of public education materials.
"There is a message now for both consumers, employers, as well as the medical establishment that glycemic control is very important and has a huge breadth and depth of impact," Kahn concludes.