European Association for the Study of Diabetes

Joint guideline contains new recommendations for diabetes, CVD.

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New guidelines on diabetes, prediabetes and CVD unveiled at the ESC Congress 2013 recommend diagnosis using HbA1c, less-strict BP targets and optimal use of revascularization.

The guidelines were developed as a collaboration between the ESC and the European Association for the Study of Diabetes (EASD).

“The growing awareness of the strong biological relationship between diabetes and CVD rightly prompted these two large organizations to collaborate to generate guidelines relevant to their joint interests, the first of which were published in 2007,” the statement reads.

Among the notable updates is the recommendation to use HbA1c for the diagnosis of diabetes. If HbA1c is elevated, the patient is diagnosed with diabetes; if not elevated, patients with CVD should receive an oral glucose tolerance test.

“We have simplified diagnosis because many patients may be disclosed with HbA1c, limiting the numbers who need the lengthier test. But a normal HbA1c does not rule out diabetes in high-risk patients, who need to have an oral glucose tolerance test,” ESC chairperson Lars Rydén, MD, PhD, of the cardiology unit at Karolinska Institute, Sweden, stated in a press release.

The guidelines also simplify CV risk assessment and no longer advocate the use of risk engines. “Risk engines which accumulate risk factors and produce a low-, medium- or high-risk score are less useful for patients with diabetes,” EASD chairperson Peter J. Grant, MD, from the division of cardiovascular and diabetes research at University of Leeds, U.K., stated in the release.

Patients with diabetes are considered at high CV risk. Patients with diabetes and CVD, including MI, angina or peripheral vascular disease, are considered at very high risk for recurrent CVD, according to the release.

Recommendations on revascularization have also changed since the previous guidelines. Medical therapy is now recommended before intervention for patients with stable CAD and no complex coronary lesions. “In former days, we were quick to do coronary interventions, but based on new trial data we now do not advocate bypass surgery and coronaryangioplasty until medical therapy has been tried,” Rydén stated.

Another addition is the recommendation that patients with several or complex coronary artery stenoses should be offered bypass surgery before percutaneous coronary dilatation. This change was based on new trial data that show superior morbidity and mortality with bypass surgery as compared with coronary dilatation, according to the release.

The guidelines also individualize targets for BP and glycemic control. The general BP target for patients with diabetes is <140/85 mm Hg; in the 2007 version, the target was 130/80 mm Hg. In patients with diabetes and kidney disease, the target is <130/85 mm Hg. Stricter BP control is also urged for patients at risk for stroke. Younger patients with a recent diagnosis of diabetes and no CVD history have lower recommended glycemic control targets, while those who are older and have longstanding diabetes and CVD have more modest targets.

Other changes in the new guidelines include the prioritization of weight stabilization over reduction, recommendations against drugs to increase HDL levels and aspirin use in patients with diabetes and no CVD, and a new chapter on patient-centered care with emphasis on shared decision-making.

Source: Endocrine Today.

New EASD/ADA Position Paper Shifts Diabetes Treatment Goals?

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A new position statement for the treatment of type 2 diabetes takes an approach much more focused on the individual patient compared with the “one number fits all” target of glycated hemoglobin (HbA1c) used up to now.

These new recommendations from the European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA), announced here today in a news conference at the European Association for the Study of Diabetes (EASD) 48th Annual Meeting, put the patient’s condition, desires, abilities, and tolerances at the center of the decision-making process about the goals and methods of treatment. “Our recommendations are less prescriptive than and not as algorithmic as prior guidelines,” the authors write.

In light of the increasing complexity of glycemic management in type 2 diabetes and the wide array of antidiabetic agents now available, as well as uncertainties about the benefits of intensive glycemic control on macrovascular complications, a joint task force of the EASD and the ADA sought to develop recommendations for the treatment of nonpregnant patients with type 2 diabetes to help clinicians determine optimal therapies. Their aim was to take into account the benefits and risks of glycemic control, the efficacy and safety of the drugs used to achieve it, and each patient’s situation. The resulting guidelines are published simultaneously in Diabetes Care (2012;35:1364-1379) and Diabetologia (2012;55:1577-1596) by the EASD and the ADA and are available on the EASD Web site.

“What we’re trying to do is encourage people to really engage in a complex world with the patient, given the variety of choices,” said David Matthews, MD, DPhil, from the Oxford Centre for Diabetes, Endocrinology and Metabolism at Churchill Hospital and the National Institute for Health Research, Oxford Biomedical Research Centre, United Kingdom, and cochair of the Position Statement Writing Group of the EASD and ADA. “And the algorithmic approach, in our view, has finally had its day. We can’t do that anymore.”

Dr. Matthews said the EASD and ADA writing group decided not to issue guidelines but rather to take positions and issue recommendations. “Published guidelines tend to be algorithmic, yet few clinicians prescribe by algorithms…and so there’s a lot of lip service to explicit guidelines,” he said.

Furthermore, there’s a danger in guidelines in that some payers and regulatory bodies focus on them as an absolute measure of success or failure and pay accordingly, or not. So for this reason, the authors did not put a specific HbA1c number in their position statement, and in addition, they did not want to give the impression that it is all right for the number to drift upward if it is below a certain level.

On the other hand, a lower HbA1c value may not be best for some patients. “We’ve got trial data challenging the simplistic view of the lower-the-better approach to glycemic control…. That tells us we need to be careful about just using numbers, however important they may be, to treat patients,” Dr. Matthews said.

So the plan is to have the physician and patient combine the best available evidence with clinical expertise and patient preferences to determine the course of treatment, which may include lifestyle interventions such as physical activity, dietary advice, and oral or injectable antidiabetic drugs, including insulin.

Main Points to New Approach

The position statement lays out 7 key points:

  • Individualized glycemic targets and glucose-lowering therapies
  • Diet, exercise, and education as the foundation of the treatment program
  • Use of metformin as the optimal first-line drug unless contraindicated
  • After metformin, the use of 1 or 2 additional oral or injectable agents, with a goal of minimizing adverse effects if possible (despite limited data to guide specific therapy)
  • Ultimately, insulin therapy alone or with other agents if needed to maintain blood glucose control
  • Where possible, all treatment decisions should involve the patient, with a focus on “patient preferences, needs and values”
  • A major focus on “comprehensive cardiovascular risk reduction”

The authors highlight several elements that need to be gauged for making decisions about the appropriate levels of effort to reach glycemic targets. Patient attitudes and expected efforts may range from highly motivated with good adherence and self-care abilities to poor motivation, nonadherence, and poor self-care abilities. The potential risks for hypoglycemia and other adverse effects are another element in decision-making.

The recommendations also focus on duration of disease, life expectancy, significant comorbidities, established vascular complications, and the patient’s resources and support system.

The authors make the point that although the recommendations focus on glycemic control, clinicians and patients should also pay attention to other risk factors, and specifically, “aggressive management of cardiovascular risk factors” in light of the increased risk for cardiovascular morbidity and mortality among patients with type 2 diabetes. Physicians should encourage as much physical activity as possible, aiming for a minimum of 150 min/week, consisting of aerobic, resistance, and flexibility training if possible.

If newly diagnosed patients are at or near the HbA1c target of less than 7.5% and they are highly motivated, they should be given a trial of lifestyle changes for 3 to 6 months with a goal of avoiding pharmacotherapy. But for patients with moderate hyperglycemia or for whom lifestyle changes are expected to be unsuccessful, antidiabetic drug therapy, usually with metformin, should be initiated. If lifestyle efforts are eventually successful, drug therapy may be modified or discontinued.

Information to Guide Pharmacotherapy

Many of the drugs to control blood glucose have similar efficacy, said Writing Group cochair Silvio Inzucchi, MD, professor of medicine, clinical director of the Section of Endocrinology, and director of the Yale Diabetes Center at the Yale School of Medicine in New Haven, Connecticut.

Based on an extensive review of more than 500 articles, “all of these drugs work more or less to the same extent,” he said. “In the grand scheme of things, when you’re talking about a patient taking a medication for years, perhaps decades, and being faced with side effects of medications, the differences in hemoglobin A1c may actually pale in comparison to how they experience that medication.”

To guide choices of glucose-lowering agents, the authors provide in tabular form summaries of the cellular mechanisms, physiological actions, advantages, disadvantages, and costs of classes of agents and drugs within the classes. They also show an algorithm for escalating treatment, starting with lifestyle changes and progressing to initial drug monotherapy, 2- and then 3-drug therapy, and finally to basal and then more complex insulin strategies.

The recommendations end with considerations of the effects of age, weight, sex/racial/ethnic/genetic differences, the comorbidities of coronary artery disease, heart failure, chronic kidney disease, liver dysfunction, and concerns about hypoglycemia. The authors also point out several areas where data are insufficient and therefore where research efforts should be aimed.

When asked if the new recommendations are feasible given the time allotted to seeing a patient, Andreas Pfeiffer, MD, DrMed, chief of the Department of Clinical Nutrition at the German Institute of Human Nutrition Potsdam-Rehbruecke in Nuthetal, Germany, and professor of internal medicine and director of the Department of Endocrinology, Diabetes and Nutrition at Charité Universitaetsmedizin Berlin, Germany, was cautious in his answer.

“If you calculate the time a doctor has per patient, it’s something like 7 minutes or so, and most patients are used to the physician telling him what he’s supposed to do,” Dr. Pfeiffer said. “In some ways it’s unrealistic” for a physician to explore a patient’s desires, capabilities, tolerances, and social support systems in that amount of time. On the other hand, patients return to the doctor several times over the course of a year, so there are more chances to expand the discussion.

But Dr. Pfeiffer worries whether diabetes specialists may become lax if they are not trying to treat to a specific goal. “Diabetologists have average HbA1c’s in Germany of around 7%, which is pretty good, actually…. And now if you relax the guidelines and say, ‘You don’t really have to care so much about it,’ so where do they go?” he wondered.

Source: Mescape.com

Diabetes Screening Fails to Reduce Mortality.

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Screening and intervention for type 2 diabetes in a British population had no effect on all-cause mortality during a 10-year period, according to a study published online October 4 in The Lancet and presented that same day during the annual meeting of the European Association for the Study of Diabetes (EASD) in Berlin, Germany.

Rebecca K. Simmons, PhD, from the Medical Research Council (MRC) Epidemiology Unit in Cambridge, United Kingdom (UK), and colleagues conducted a randomized trial involving 33 general medical practices in eastern England. They first randomly assigned the practices to 1 of 3 groups: a control group that received no screening (n = 5 practices), screening followed by intensive diabetes care (n = 15), and screening followed by routine care (n = 13). One screening practice dropped out before screening began, which left the number of intensive care practices at 14.

The screening practices accounted for 16,047 patients and the nonscreening practices accounted for 4137 patients; the median patient age was 58 years (range, 40 – 69 years). Of the 20,184 total individuals in 32 practices, 15,089 (94%) were invited, on the basis of predefined criteria, to screening between January 2002 and March 2006; 11,737 (73%) of them participated in the screening; and diabetes was diagnosed in 466 (3% of those eligible).

During a median follow-up period of 9.6 years, 1532 patients died in the screening group (mortality hazard ratio [HR], 1.06; 95% confidence interval [CI], 0.90 – 1.25; rate per 1000 person-years, 10.5; 95% CI, 9.99 – 11.04) and 377 died in the control group (rate per 1000 person-years 9.89; 95% CI, 8.94 – 10.94). Cancer was the most common cause of death in both groups.

“We noted no significant difference between groups in cardiovascular mortality, cancer mortality, or other causes of death,” the researchers write. Of the other causes of death listed, diabetes was cited in 75 of the screening cases and 16 in the control group.

“In this large, population-based UK sample, all-cause mortality over a median 9.6 years was not reduced by one round of screening for type 2 diabetes in people at high risk of prevalent undiagnosed diabetes,” they write.

The study population came from 1 of 2 phases of the ADDITION-Cambridge study of diabetes type 2 screening and intervention in British primary care clinics.

Limitations of the study include a possible lack of generalizability because the study was conducted in an area with above-average affluence, where disease risk may be lower than in other socioeconomic areas.

On the basis of this first-ever analysis of the effect of a population-based diabetes screening program, senior author Simon J. Griffin, DM, from the MRC’s Addenbrooke Hospital unit in Cambridge, UK, said in a statement, “It seems that the benefits of screening might be smaller than expected and restricted to individuals with detectable disease.  However, benefits to the population could be increased by including the detection and management of cardiovascular risk factors alongside the assessment of diabetes risk, performing repeated rounds of screening, and improving strategies to maximize the uptake of screening.”

In an accompanying commentary, Michael M Engelgau, MD, and Edward W. Gregg, PhD, from the Centers for Disease Control and Prevention in Atlanta, Georgia, write that the researchers “increase the doubt about the value of wide-scale screening for undiagnosed diabetes alone, and deserve credit for tackling the screening quandary head-on. Nevertheless, for any one study to address the diverse factors that affect screening policies — ranging from the magnitude of population burden of disease to the capacity and effectiveness of prevention approaches — is a tall order. Screening recommendations are therefore likely to be country-specific and context-specific for the foreseeable future.”

Countries with higher prevalences of undiagnosed diabetes and lower quality of care might see a higher magnitude of benefits from diabetes screening, the commentary authors write.

Asked to comment on the study, EASD session moderator Rury Holman, FMedSci, FRCP, director of the Diabetes Trials Unit and professor of diabetic medicine at Oxford University, United Kingdom, told Medscape Medical News, “The question they were asking in this study was if you take the trouble and expense to find people and declare they are at risk of diabetes and test, and then the community — the healthcare system — presumably treats them, you think they would do better. But in the time scale of this study, that wasn’t the case. It doesn’t mean that you couldn’t find them and put them in a special program, but if you put them into the normal health care system with an earlier label of diabetes than they would otherwise have, it doesn’t bring any clinical advantages. [The study] says that the incremental benefit of finding people a few years earlier is quite small.”

Source: Mescape.com