ADA: Empagliflozin and liraglutide reduce type 2 CV death


Empagliflozin (Jardiance) and liraglutide (Victoza) should be considered in type 2 diabetes patients with documented cardiovascular diseaseto reduce the risk of CV death, according to the American Diabetes Association 2017 Standards of Medical Care.

ADA updates it standards annually based on new information and research; like its predecessors, the 2017 guidance is comprehensive, addressing mental, social, and other challenges faced by patients with diabetes, along with clinical care (Diabetes Care. 2017 Jan;40(Suppl 1):S4-S5).

The 2017 guidance contains a great deal of new information. At 135 pages, there are 22 more pages than in 2016. “They did a really nice job. This guide is useful for anyone helping patients with diabetes,” including diabetologists, dietitians, educators, psychologists, and social workers, Richard Hellman, MD, a clinical endocrinologist in North Kansas City, Mo., said in an interview.

Dr. Richard Hellman

Dr. Richard Hellman

The empagliflozin and liraglutide recommendation applies to any patient with type 2 diabetes who has a history of stroke, heart attack, acute coronary syndrome, angina, or peripheral arterial disease. Data from recent trials have shown use of the drugs modestly reduces cardiovascular mortality in this population.

It’s unclear if the benefits are drug specific or group effects. “We anxiously await the results of several ongoing cardiovascular outcomes trials” to find out, said Helena Rodbard, MD, a clinical endocrinologist in Rockville, Md., who also commented on the new standards.

Basal insulin plus a GLP-1 receptor agonist, like liraglutide, are also now recommended for insulin-dependent type 2 disease. “This combination gives rise to a markedly reduced risk of hypoglycemia compared with basal insulin ... basal bolus insulin, or premixed insulins,” according to the ADA.

The newer drugs and insulins are expensive. To help doctors and patients negotiate the price hurdle, ADA added tables on how much the various options cost per month. It was a good move; “the cost of care is going up so fast” in diabetes “that many patients can no longer afford” what’s prescribed. “It’s a major problem,” said Dr. Hellman, clinical professor at the University of Missouri–Kansas City.

The ADA also set a blood glucose level of 54 mg/dL to trigger aggressive hypoglycemia treatment. “There has been confusion over when to treat aggressively. It was a good choice to land on 54 mg/dL” a safe, conservative number a bit higher than others have suggested, Dr. Hellman said.

Meanwhile, the group lowered its metabolic surgery cut point – the ADA has stopped using the term “bariatric surgery” – to type 2 patients with a body mass index of 30 kg/m2 when medications don’t work. The group also set a new hypertension treatment target of 120-160/80-105 mm Hg in pregnancy, and said that insulin is the treatment of choice for gestational diabetes, given concerns about metformin crossing the placenta and glyburide in cord blood.

The ADA expanded its list of diabetes comorbidities to include autoimmune disease, HIV, anxiety, depression, and disordered eating. In addition, doctors should ask patients how well they sleep – since sleep problems affect glycemic control – and should intervene when there’s a problem, according to the guidance.

The group updated its combination injection algorithm for type 2 diabetes “to reflect studies demonstrating the noninferiority of basal insulin plus” liraglutide and its class members “versus basal insulin plus rapid-acting insulin” or two daily injections of premixed insulin. The ADA added a section on the role of newly available biosimilar insulins, as well, and clarified that either basal insulin or basal plus bolus correctional insulin can be used to treat noncritical inpatients, but noted that “sole use of sliding scale insulin in the inpatient hospital setting is strongly discouraged.”

People on long-term metformin should have their vitamin B12 checked periodically, because of new evidence about the risk of B12 deficiency, the group said, and “due to the risk of malformations associated with unplanned pregnancies and poor metabolic control.” The group added “a new recommendation ... encouraging preconception counseling starting at puberty for all girls of childbearing potential.”

“Even though most of this information should be well known to practitioners treating patients, [it’s] a worthwhile read for everyone who treats people with diabetes,” Dr. Rodbard said.

The majority of the people on the ADA’s update committee had no disclosures, but a few reported ties to various companies, including Novo Nordisk, the maker of liraglutide, and Boehringer Ingelheim and Lilly, the companies that developed and/or marketed empagliflozin. Dr. Hellman had no conflicts. Dr. Rodbard is an adviser or researcher for AstraZeneca, Lilly, Janssen, Merck, Novo Nordisk, Sanofi, and Regeneron.

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