TOPICS

COLUMNS

LISTINGS

2006 LISTINGS

HELP

PARTNER LINKS

HEALTH

Meeting the demands of diabetes (American Diabetes Assn. Scientific Sessions)

Better control would pave the way to improve health and cut costs.

By Susan J. Landers, amednews staff. Aug. 7, 2006.

Reports from conferences important to physicians

What's the story on clinical inertia and diabetes? Are physicians really turning a blind eye when it comes to stepping up therapies for patients whose blood glucose levels and blood pressures are climbing into the stratosphere?

Some studies presented at the June 9-13 American Diabetes Assn. scientific sessions in Washington, D.C., suggested just that. But hold on, cautioned others.

Testing A1c
Complications of diabetes in adults
Diabetes on the rise
Encouraging self-care
Change could be coming for A1c
Treatment tips
Research findings
Links
See related content

Diabetes is a tough disease to manage. Given the explosion of new cases, perhaps physicians should be applauded for trying to hold the line.

That the diabetes rate is expected to rise with the nation's collective weight gain is no surprise. "The majority of American adults are overweight or obese throughout most of their lives," said K.M. Venkat Narayan, MD, chief of epidemiology and statistics in the Centers for Disease Control and Prevention's Diabetes Center. And the foreboding path from obesity to insulin resistance and then to type 2 diabetes or cardiovascular disease is well-worn.

Nearly 21 million Americans have diabetes, and the fear is that poor control of it will lead to greater numbers of severe or fatal complications such as heart disease, blindness, kidney disease and amputations.

While it's clear that physicians will need help from across the health care community and from patients themselves to achieve better management, several studies presented at the ADA meeting showed an opposite scenario in which physicians are not reaching the patients whose blood glucose levels or blood pressures are well above established goals.

Treatment complexities

"Our study showed that failure to appropriately intensify antihypertensive treatment is a very common problem in diabetes care. ... Physicians intensified antihypertensive treatment in only 12% of visits in which we found sub-optimally controlled blood pressure," said Shari Bolen, MD, senior clinical fellow in internal medicine at the Johns Hopkins University School of Medicine in Baltimore.

A retrospective analysis of the pharmacy and lab claims of more than 9,000 patients revealed that by the time they were started on an oral anti-diabetic drug -- either metformin, a sulfonylurea or a thiazolidinedione -- hemoglobin A1c levels averaged 8.4%, which is significantly higher than the ADA-recommended 7%, reported Craig A. Plauschinat, PharmD, MPH. He is an outcomes research manager at Novartis Pharmaceuticals Corp and senior author of the study. Plus, more than two-thirds had levels of 9.5% or higher, he noted.

40% of adults with diabetes have 3 or more comorbid conditions.

Still, there has been progress, noted James Gavin III, MD, PhD, immediate past president of the National Diabetes Education Program. While only 39% of patients were at appropriate A1c levels in 1997, that number had increased to 55% by 2002.

Plus, there might be some good reasons for what appears to be clinical inertia, said Eve Kerr, MD, MPH, associate professor of internal medicine at the University of Michigan Medical Center in Ann Arbor. One study of 23,000 patients found that physicians had refrained from bumping up medications because patients were moving toward goal, though not there yet, she said. Such an approach actually could constitute good clinical care.

And because as many as 40% of adults with diabetes have three or more comorbid conditions, treatment decisions could be complicated. Physicians contend with multiple guidelines plus patients' priorities, she said. In a 10-minute office visit, physicians can't do it all. An approach must involve physicians, pharmacists and nurses working together.

Physicians also overestimate the extent to which patients comply with treatment, said Betsy Sleath, PhD, associate professor of pharmacy at the University of North Carolina, Chapel Hill. "Patients want the doctor to think they are doing a good job. They want us to like them."

A checklist of treatment goals

ADA President Robert A. Rizza, MD, challenged doctors to do a better job monitoring diabetic patients. "We have the means at hand to reduce the risk of serious diabetes complications by over 60% ... [and] medical costs by $150 billion over the next 30 years."

The ideal would be for each patient to get optimal diabetes care, he said. In addition to an A1c level of less than 7%, patients' blood pressure should not exceed 130/80 mmHg. All should be prescribed a statin drug to normalize cholesterol levels to an LDL of less than 100 mg/dL, HDL equal to or greater than 40 mg/dL for men and 50mg/dL for women, and triglycerides less than 150 mg/dL. Patients should take a baby aspirin daily, not smoke and have a body mass index less than 25.

By achieving these goals in 100% of people with diabetes, 8 million fewer heart attacks, 1.6 million fewer strokes, 2.2 million fewer episodes of kidney failure and 100,000 fewer amputations would occur, Dr. Rizza said.

He recommended the formulation of a "polypill" to be taken once a day by people with diabetes. The pill, which does not yet exist, would contain 1000 mg of metformin, 75 mg of aspirin, 50 mg of a generic statin and 10 mg of a generic ACE inhibitor. Such a pill could cost about $100 per year and would target most of the ills that accompany the disease. But because such a magic bullet isn't even in the pharmaceutical pipeline, physicians will still have to roll up their sleeves.

"We've got work to do," Dr. Gavin said. There are many Web-based tools available that can help, he said. Some are available on the NDEP site and others at the site maintained by the National Institutes of Health, online (www.betterdiabetescare.nih.gov).

ADDITIONAL INFORMATION:

Testing A1c

The hemoglobin A1c test evaluates the average amount of glucose in the blood over the last two to three months by measuring the concentrations of glycosylated hemoglobin. As glucose circulates in the blood, some of it spontaneously binds to hemoglobin A and remains there for the life of the red blood cell -- about 120 days. This combination of glucose and hemoglobin A is called A1c, hemoglobin A1c or glycohemoglobin.

Source: American Society for Clinical Laboratory Science

Complications of diabetes in adults

Heart disease and stroke risk increase by 2 to 4 times and account for about 65% of deaths.
Hypertension affects about 73%.
Diabetic retinopathy causes 12,000 to 24,000 new cases of blindness each year.
End-stage renal disease led to chronic dialysis or kidney transplant for 153,730 people in 2002. Diabetes accounted for 44% of new cases of kidney failure.
Nervous system damage occurs in about 60% to 70% of diabetics.
Diabetes accounts for more than 60% of nontraumatic lower-limb amputations, and 82,000 of these amputations were performed in people with diabetes in 2002.
Periodontal disease occurs in about 33% of patients.
Spontaneous abortions occur in 15% to 20% of pregnancies.

Diabetes on the rise

From 1997 through 2004, the number of new cases of diagnosed diabetes among adults 18-79 increased by 54%.

1997 878,000

1998 921,000

1999 979,000

2000 1,104,000

2001 1,213,000

2002 1,304,000

2003 1,349,000

2004 1,356,000

Source: Centers for Disease Control and Prevention; National Center for Health Statistics, Division of Health Interview Statistics; data from the National Health Interview Survey

Encouraging self-care

Everyone has a patient like "Ralph," said William Polonsky, PhD, assistant professor of psychiatry at the University of California, San Diego. Ralph is 57, has had type 2 diabetes for eight years, is overweight but loves eating and has never paid much attention to controlling his disease.

Motivating such a patient to manage his disease is a major challenge.

Overall, there are many obstacles to self-care, and two are critical, added Dr. Polonsky, who was among the speakers at the American Diabetes Assn. meeting in June. Patients might not believe it's possible to gain control of their disease or that it's worth the effort. As for the latter, depression, which affects 15% to 20% of people with diabetes, should be considered.

But Alan Glaseroff, MD, chief medical officer of a countywide diabetes program in Northern California, cautioned that patients also could be troubled by the disease's complexity and would benefit from management tips.

After all, diabetes is a lifelong disorder that needs to be managed 24/7, said Edwin Fisher, PhD, national director of the Robert Wood Johnson Foundation's Diabetes Initiative, which has found that community health workers are critical in helping patients reach their goals.

Physician style also matters, Dr. Glaseroff said. The nonjudgmental, empathetic approach is more likely to succeed at charting a course toward self-care.

Because most offices lack systems to support patient efforts at self-management, a redesign may be necessary, said W. Perry Dickinson, MD, family medicine professor at the University of Colorado Health Sciences Center. "Most practices are stuck in a rut. When they do try to change, they try to change everything at once. ... A reflective approach is best because there will be a ripple effect, and physicians must be able to anticipate the ripples."

Change could be coming for A1c

The hemoglobin A1c test, now the best means for determining glycemic control among patients with diabetes, is getting the once-over from the International Federation of Clinical Chemistry in an attempt to standardize what is being measured.

The IFCC recently developed a reference method that yields more specific HbA1c measures. But these results come with numbers that are lower than have been the case with previous measures. For example, normal HbA1c ranges of 4% to 6% would become approximately 2% to 4%.

This development has generated considerable debate about how A1c should be reported, noted American Diabetes Assn. President Robert Rizza, MD, in a recent newsletter column.

The fear is that such a change would result in mass confusion among doctors. Patients, too, have just begun to understand the significance of lowering blood glucose levels to an A1c less than 7% to meet ADA treatment goals. The equivalent under a new reporting system would be less than 5%.

Plus, all educational materials would have to be reprinted to reflect the new measures, and clinical trial results would need to be revisited. Clinicians were given a heads-up about these activities during the ADA 2006 Scientific Sessions in June.

But before anyone panics, those in the know say the situation is in flux. They advise doctors just to be aware that discussions are under way. After the dust clears, no changes may be noticeable. Even if there is an adjustment, it won't happen quickly and not without an education campaign.

"I can tell you we aren't going to change in the United States in the next year or more. And nothing will happen until there is consensus ... [for] a carefully designed, thoughtful plan to implement change," said David Sacks, MD, chair of the National Glycohemoglobin Standardization Program steering committee.

The NGSP, sponsored in part by the ADA, was established in 1996 to standardize A1c tests. The need for standardization became apparent after the 1993 Diabetes Control and Complications Trial provided evidence that tight control of glucose reduced diabetes complications.

In this new attempt to find a reporting method for A1c, the ADA, the European Assn. for the Study of Diabetes and the International Diabetes Federation are holding a worldwide clinical trial to see if values could be reported as mean blood glucose, a measure already known to those with diabetes, rather than a new number based on the IFCC method. Early results are expected late this year.

Treatment tips

Here are some treatment tips from the meeting:

Diabetes in young people. The transition from teen to young adult is challenging enough without adding diabetes to the mix. There is not enough attention paid to this period, said Michael A. Harris, PhD, a licensed clinical psychologist at Washington University's School of Medicine Dept. of Pediatrics in St. Louis. He presented case studies on this subject during the ADA meeting in Washington, D.C.

Young patients may not see themselves as adults who can accept responsibility for their own care. They may be right: Adjustments to diabetes are often poorest among 15- to 24-year-olds, when rising A1c levels and weight gain often occur, he said.

But physicians also should recognize that there is a huge amount of variability among this group, with some in the 18- to 24-year-old range readily able to take control of their treatment and others less so.

Antidepressants and type 2. Johns Hopkins researchers examining data from the Diabetes Prevention Program were surprised by results indicating that the use of antidepressant drugs was associated with a significantly increased risk of developing type 2 diabetes for those already at greater risk of the disease -- except when taking the drug metformin.

Although it is well known that some antipsychotic drugs can increase a person's risk for diabetes, this finding indicating that antidepressants -- including a range of newer SSRIs -- could increase risk. It is important that people don't stop taking their antidepressants, said Richard R. Rubin, PhD, associate professor of medicine and pediatrics at Johns Hopkins University School of Medicine in Baltimore and a co-investigator in the study. He added that such patients should have their blood glucose levels checked frequently.

Research findings: Drugs in the pipeline; predicting type 2; exploring hypoglycemic reactions and cognitive impairment links

Investigators in drug company studies provided new phase 3 clinical trial findings on two investigational drugs, both from a new class of oral medications for type 2 diabetes. The drugs, which also were associated with weight loss in the trial population, would be taken once a day alone or in combination with other drugs. The data were presented at the American Diabetes Assn. Scientific Sessions held in Washington, D.C., in June.

Januvia, or sitagliptin phosphate, a Merck and Co. investigational drug, was shown to reduce blood sugar levels when used as a single treatment and as an add-on to metformin or pioglitazone. Januvia also was found to improve measures of beta cell function, investigators said.

Galvus, or vildagliptin, a Novartis drug, also demonstrated reductions in hemoglobin A1c levels. If approved, both would be the first to use the body's own ability to lower blood sugar levels. They do this by blocking production of the enzyme dipeptidyl peptidase-4, or DPP-4.

Another study presented at the meeting from the Malmö Prevention Project in Sweden found that common variants in three genes could predict the development of type 2 diabetes. The research involved more than 7,000 Swedes who were followed for an average of 22 years.

Overall, 422 members of the total subject pool developed diabetes during the trial. By looking at which variants were more common in those who developed diabetes, the investigators were able to identify the predictor genes.

Also, a new study, led by researchers from the Joslin Diabetes Center in Boston, found that multiple severe hypoglycemic reactions were not linked to impaired cognitive function among people with type 1 diabetes. The study followed three-quarters of the original participants in the 1993 Diabetes Control and Complications Trial for an additional 6.5 years after the DCCT closed.

"This study provides further support for the safety of intensive diabetes therapy and the benefits of maintaining good glycemic control," said the study's principal investigator Alan M. Jacobson, MD, head of Joslin's Behavioral and Mental Health Research Section.

Weblink

Information about lectures, presentations and other developments at the 2006 American Diabetes Assn. Scientific Sessions (scientificsessions.diabetes.org)