ADA guidelines embrace heart health


EXPERT ANALYSIS FROM DIABETES CARE

Recent studies that confirm the cardiovascular benefit of some antihyperglycemic agents are shaping the newest therapeutic recommendations for patients with diabetes and comorbid atherosclerotic cardiovascular disease (ASCVD).

Treatment for these patients – as all with diabetes – should start with lifestyle modifications and metformin. But in its new position statement, the American Diabetes Association now recommends that clinicians consider adding agents proved to reduce major cardiovascular events and cardiovascular death – such as the sodium glucose cotransporter-2 (SGLT2) inhibitor empagliflozin or the glucagon-like peptide 1 (GLP-1) agonist liraglutide – to the regimens of patients with diabetes and ASCVD (Diabetes Care 2018;41(Suppl. 1):S86-S104. doi: 10.2337/dc18-S009).

The medications are indicated if, after being treated with lifestyle and metformin therapy, the patient isn’t meeting hemoglobin A1c goals, said Rita R. Kalyani, MD, who led the ADA’s 12-member writing committee. But clinicians may also consider adding these agents for cardiovascular benefit alone, even when glucose control is adequate on a regimen of lifestyle modification and metformin, with dose adjustments as appropriate, she said in an interview.

“A1c remains the main target of sequencing antihyperglycemic therapies, if it’s not reached after 3 months,” said Dr. Kalyani of Johns Hopkins University, Baltimore. “But, it could also be that the provider, after consulting with the patient, feels it’s appropriate to add one of these agents solely for cardioprotective benefit in patients with ASCVD.”

The recommendation to incorporate agents with cardiovascular benefit is related directly to data from two trials, LEADER and EMPA-REG, which support this recommendation. All of these cardiovascular outcome trials included a majority of patients who were already on metformin. “We developed these evidence-based recommendations based on these trials and to appropriately reflect the populations studied,” said Dr. Kalyani.

The ADA’s “Standards of Medical Care in Diabetes 2018” is the first position statement from any professional society to provide specific recommendations for the incorporation of these newer antihyperglycemic agents for their cardioprotective benefit, as well as their ability to lower blood glucose effectively. But the document provides much more than an algorithm for treating patients with concomitant ASCVD, Dr. Kalyani said. It is a comprehensive clinical guide covering recommendations for diagnosis, medical evaluation, comorbidities, lifestyle change, cardiovascular risk management, and treating diabetes in children and teens, pregnant women, and patients with hypertension.

The 2018 update contains a number of new recommendations; more will be added as new data emerge, since the ADA intends it to be a continuously refreshed “living document.” This makes it especially clinically useful,Paul S. Jellinger, MD, said in an interview. A member of the writing committee of the American Association of Clinical Endocrinologists’ diabetes management guidelines, Dr. Jellinger feels ADA’s previous versions have not been as targeted as this new one and, he hopes, its subsequent iterations.

Dr. Paul S. Jellinger professor of clinical medicine at the University of Miami

Dr. Paul S. Jellinger

“This is a nice enhancement of previously published guidelines for diabetes therapy,” said Dr. Jellinger, professor of clinical medicine at the University of Miami. “For the first time, ADA is providing some guidance in terms of which agents to use. It’s definitely more prescriptive than it was in the past, when, unlike the AACE Diabetes Guidelines, it was a palette of choice for clinicians, but with very little guidance about which agent to pick. The guidance for patients with cardiovascular disease in particular is big news because these antihyperglycemic agents showed such a significant cardiovascular benefit in the trials.”

While the document gives a detailed algorithm of advancing therapy in patients with ASCVD, it doesn’t specify a preference for a specific drug class after metformin therapy in patients without ASCVD. Instead, it provides a detailed table listing the drug-specific effects and patient factors to consider when selecting from different classes of antihyperglycemic agents ( SGLT2 inhibitors, GLP-1 agonists, DPP-4 inhibitors, thiazolidinones, sulfonylureas, and insulins). The table notes the drugs’ general efficacy in diabetes, and their impact on hypoglycemia, weight gain, and cardiovascular and renal health. The table also includes the Food and Drug Administration black box warnings that are on some of these medications.

Another helpful feature is a cost comparison of antidiabetic agents, Dr. Kalyani noted. “Last year we added comprehensive cost tables for all the different insulins and noninsulins, and this year we added a second data set of cost information, to assist the provider when prescribing these agents.”

The pricing information is a very important addition to this guideline, and one that clinicians will appreciate, said Richard Hellman, MD, clinical professor of medicine at the University of Missouri–Kansas City.

“In this document, ADA is urging providers of care to ask about whether the cost of their diabetes care is more than they can deal with. They present tables which compare the costs of the current blood glucose lowering agents used in the U.S., and it is plain to see that many patients, without insurance coverage, will find some of the medications unaffordable,” said Dr. Hellman, a past president of AACE. “They also provide data that show half of all patients with diabetes have financial problems,” and he suspects that medication costs are an important component of their financial insecurity.

Dr. Richard Hellman, clinical professor of medicine at the University of Missouri-Kansas City and associate program director of the UMKC Endocrine Fellowship

Dr. Richard Hellman

The document also notes data from the 2017 National Health and Nutrition Examination Survey, which found that 10% of people with diabetes have severe food insecurity and 20% have mild food insecurity (Diabetes Educ. 2017;43:260-71. doi: 10.1177/0145721717699890).

“Another thing the document points out is that two-thirds of the patients who don’t take all their medications due to cost don’t tell their doctor,” Dr. Hellman said. “The ADA is making the point that providers have a responsibility to ask if a patient is not taking certain medications because of the cost. We have so many better tools to manage this disease, but so many of these tools are unaffordable.”

While the treatment algorithm for patients with ASCVD will likely be embraced, another new recommendation may stir the pot a bit, Dr. Hellman noted. The section on cardiovascular disease and risk management goes out on its own, sticking to a definition of hypertension as 140/90 mm Hg or higher – a striking diversion from the new 130/80 mm Hg limit set this fall by both the American Heart Association and the American College of Cardiology.

“This difference in recommendations is very important and will be controversial,” Dr. Hellman said, adding that he agrees with this clinical point.

Again, this recommendation is grounded in clinical trials, which suggest that people with diabetes don’t benefit from overly strict blood pressure control. The new AHA/ACC recommendations largely drew on data from the SPRINTtrial, which was conducted in an entirely nondiabetic population. “These gave a clear signal that a lower BP target is beneficial to that group,” Dr. Hellman said.

But large well-designed randomized controlled trials of intensive blood pressure lowering in people with diabetes, such as ACCORD-BP, did not demonstrate that intensive blood-pressure lowering targeting a systolic less than120 mm Hg had a significant benefit on the composite primary cardiovascular endpoint. And while the ADVANCE BP trial found that the composite endpoint was improved with intensive blood pressure lowering, the blood pressure level achieved in the intervention group was 136/73 mm Hg.

“This recommendation is based on current evidence for people with diabetes,” Dr. Kalyani said. “We maintain our definition of hypertension as 140/90 mm Hg or higher on the results of large clinical trials specifically in people with diabetes but emphasize that intensification of antihypertensive therapy to target lower blood pressures (less than 130/80 mm Hg) may be beneficial for high-risk patients with diabetes such as those with cardiovascular disease. We are constantly assessing the evidence and will continue to review the results of new studies for potential incorporation into recommendations in the future.”

Anti-hyperglycemic drug selection, sequence for type 2 diabetes addressed in ADA/EASD position statement update.


A revised position statement on the management of hypoglycemia in patients with type 2 diabetes, updated upon request from the American Diabetes Association and the European Association for the Study of Diabetes, is published in Diabetes Care.

The writing group that penned the guidelines published in 2012, when a paucity of comparative effectiveness research existed on the long-term treatment outcomes of anti-hyperglycemic drugs, reconvened from June to September 2014 to incorporate data from recent clinical trials.

“An entirely new statement was felt to be unnecessary,” according to the writing group. “Instead, the group focused on those areas where revisions were suggested by a changing evidence base.”

Silvio E. Inzucchi, MD, of Yale University School of Medicine, New Haven, Connecticut, with co-chair David R. Matthews, MD, University of Oxford, United Kingdom steered members’ input to address critical areas, including glycemic targets, therapeutic options, implementation strategies, other considerations and future directions.

Silvio Inzucchi

Silvio E. Inzucchi

The experts emphasized that studies have determined that reducing hyperglycemia decreased both the onset and progression of macrovascular complications, but they noted that the impact of glucose control on cardiovascular complications remains uncertain and stressed the importance of an individualized approach.

“Instead of a one-size-fits-all approach, personalization is necessary, balancing the benefits of glycemic control with its potential risks, taking into account the adverse effects of glucose-lowering medications (particularly hypoglycemia), and the patient’s age and health status, among other concerns,” they wrote.

The researchers noted that the availability of sodium glucose cotransporter 2 (SGLT2) inhibitors presents a major change in treatment options since the previous publication. They underscored that earlier concerns about thiazolidinediones (TZD) and bladder cancer have been allayed; however, they advised that dipeptidyl peptidase-4 (DPP-4) inhibitors be used cautiously in light of potential cardiovascular effects and highlighted the pancreatic safety concerns in this class as well as in glucagon-like peptide-1 (GLP-1) receptor agonists.

“The use of any drug in patients with type 2 diabetes must balance the glucose-lowering efficacy,

side-effect profiles, anticipation of additional benefits, cost and other practical aspects of care, such as dosing schedule and requirements for glucose monitoring,” they wrote.

The experts highlighted recent calls to relax prescribing policies to extend the use of metformin — still the first-line choice for monotherapy — in patients with mild to moderate kidney disease, and encouraged due caution for renal insufficiency when considering second-line agents.

In addressing dual and triple combination therapies, the researchers noted that no evidence-based recommendation can be made for using SGLT2 inhibitors in conjunction with GLP-1 receptor agonists without data. Although clinicians can look to additional drugs to treat patients with HbA1c levels well above target ≥9% (≥75 mmol/mol), no proven advantage has been shown by achieving a glycemic target more quickly, according to the writing group.

“As long as close patient follow-up can be ensured, prompt sequential therapy is a reasonable alternative, even in those with baseline HbA1c levels in this range,” they wrote.

Anti-depressants’ ‘link to diabetes’


People prescribed anti-depressants should be aware they could be at increased risk of type 2 diabetes, say UK researchers.

The University of Southampton team looked at available medical studies and found evidence the two were linked.

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But there was no proof that one necessarily caused the other.

It may be that people taking anti-depressants put on weight which, in turn, increases their diabetes risk, the team told Diabetes Care journal.

Or the drugs themselves may interfere with blood sugar control.

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These findings fall short of being strong evidence that taking anti-depressants directly increases risk of type 2 diabetes”

Dr Matthew Hobbs of Diabetes UK

Their analysis of 22 studies involving thousands of patients on anti-depressants could not single out any class of drug or type of person as high risk.

Prof Richard Holt and colleagues say more research is needed to investigate what factors lie behind the findings.

And they say doctors should keep a closer check for early warning signs of diabetes in patients who have been prescribed these drugs.

With 46 million anti-depressant prescriptions a year in the UK, this potential increased risk is worrying, they say.

Prof Holt said: “Some of this may be coincidence but there’s a signal that people who are being treated with anti-depressants then have an increased risk of going on to develop diabetes.

“We need to think about screening and look at means to reduce that risk.”

Diabetes is easy to diagnose with a blood test, and Prof Holt says this ought to be part of a doctor’s consultation.

“Diabetes is potentially preventable by changing your diet and being more physically active.

“Physical activity is also good for your mental health so there’s a double reason to be thinking about lifestyle changes.”

Around three million people in the UK are thought to have diabetes, with most cases being type 2.

Dr Matthew Hobbs of Diabetes UK, said: “These findings fall short of being strong evidence that taking anti-depressants directly increases risk of type 2 diabetes. In this review, even the studies that did suggest a link showed only a small effect and just because two things tend to occur together, it doesn’t necessarily mean that one is causing the other.

“But what is clear is that some anti-depressants lead to weight gain and that putting on weight increases risk of type 2 diabetes. Anyone who is currently taking, or considering taking, anti-depressants and is concerned about this should discuss their concerns with their GP.”

Source: BBC

Mediterranean Diet Reduces Stroke Risk Even in Those with High Genetic Risk.


High risks for type 2 diabetes and cardiovascular complications conferred by variants in the TCF7L2 gene can be partially offset by strict adherence to a Mediterranean-style diet, according to a Diabetes Care study.

PREDIMED investigators followed some 7000 participants at very high risk for cardiovascular disease. Their genetic risks were determined by ascertaining the variant of the TCF7L2 gene they carried, with “TT” variants known to confer higher risk than “CT” or “CC” variants.

The subjects were randomized to Mediterranean or low-fat diets and followed for roughly 5 years. TT carriers who did not generally observe Mediterranean-style diets at baseline showed higher risks for cardiovascular events, although not significantly so. Furthermore, TT carriers randomized to and adhering to a Mediterranean diet had stroke rates similar to CT and CC carriers.

The authors conclude that their findings support the benefits of a Mediterranean diet, “especially for genetically susceptible individuals.”

Source: Diabetes Care

Diabetes educators review 2012 National Standards.


Last revised in 2007, the National Standards for Diabetes Self-Management Education have served as the acceptable guide for providing consistency and quality through the delivery of diabetes education. At the American Association for Diabetes Educators annual meeting, certified diabetes educators discussed the recently updated standards, emphasizing support and a continuum of self-management, as well as a widened criterion for eligible instructors.

One obvious revision includes a change in the standard’s title. Formerly known as the National Standard for Diabetes Self-Management Education, the guide is now known as the National Standard for Diabetes Self-Management Education and Support (DSMES).

Donna Tomky, MSN, RN, C-NP, CDE, FAADE, immediate past president of AADE and nurse practitioner and diabetes educator from ABQ Health Partners in Albuquerque, NM, said support is a very important part of the change.

 

Donna Tomky

“It really defines those activities that assist the person with prediabetes or diabetes in implementing and sustaining the behaviors needed to manage his or her condition on an ongoing basis. It really looks at the continuum instead of just a one-time effort,” Tomky said during a presentation.

Tomky said there are misunderstandings surrounding the standards. For example, an RN, RD, pharmacist, medical director or CDE are not needed for a diabetes education program. The revisions will be published in the October issue of Diabetes Care, she said.

Co-presenter, Melinda Maryniuk, RD, Med, CDE, director of clinical education programs for the Joslin Diabetes Center in Boston, Mass., said the revisions are aimed to ensure wide applicability and to ensure quality care.

“There aren’t revolutionary new things that have come out, but we have more research to support the information,” Maryniuk said.

In a survey of 225 public comment reviewers consisting of RNs, RDs, pharmacists, MD/DO/Endo, mental health professionals, and other providers, 82% said the standards were applicable to them, Tomky and Maryniuk said. Additionally, 74% agreed the document was clear. Many of the comments received mentioned satisfaction with a wider focus on support and prevention, while looking for more information.

Other revisions include increased clarity to ensure broad-based relevance in institutional and solo-based providers, an increased attention to behavior change and added examples of who can offer diabetes education, including occupational therapists and certified health education specialists. – By Samantha Costa

For more infromation:

Tomky D. #F03. Presented at: The American Association of Diabetes Educators 2012 Annual Meeting & Exhibition. August 1-4, 2012; Indianapolis.

Disclosure: Ms. Tomky and Ms. Maryniuk report no relevant financial disclosures.

Perspective

  • I attended this session so I could be as current and up-to-date with what the new standards will be forthcoming. I thought it was a great overview with realistic discussions in regard to the different organizations that I work with, and what challenges they might potentially have when it comes to interpreting the standards.

The fact that a credentialed CDE person who isn’t a nurse, dietician, or pharmacist can be in solo practice is really great. I have a lot of exercise physiology friends and I can’t wait to share that information with them. They will be so excited. They, too, are potentially masters-prepared and certified.

 

  • Source: Endocrine Today.