The American Association of Clinical Endocrinologists (AACE) and the American College of Endocrinology (ACE) have updated their Comprehensive Type 2 Diabetes Management Algorithm and Executive Summary to incorporate newly approved therapies as well as to reflect important research in diabetes care. In 2016, AACE/ACE made several changes.

“The 2016 edition of the comprehensive type 2 diabetes management algorithm added a panel on specific guidance for lifestyle modifications — the cornerstone of therapy for diabetes and metabolic syndrome,” said AACE President and Endocrinology Advisor Editorial Board member George Grunberger, MD.

The revised algorithm, which was published online January 5, 2016, also includes a lipid algorithm, a complications-centric model for treating overweight and obesity, and an updated hierarchy of choices and safety information for the various classes of diabetes medications.

According to Dr Grunberger, who is also a clinical professor in internal medicine and molecular medicine and genetics at Wayne State University School of Medicine in Detroit, Michigan, the new algorithm offers an updated practical guide for all clinicians who manage patients with prediabetes, overweight, obesity, type 2 diabetes, hypertension, and dyslipidemia — conditions that affect a significant portion of the population in the United States.

“It is hoped the algorithm can help decrease the incredible toll these diseases place on patients, their families, their employers, and the entire society,” he said.

Lifestyle Therapy Optimization

The 2016 algorithm considers new therapies, disease management approaches, and key clinical data in a new section on lifestyle therapy optimization.¹

Lifestyle therapy should begin with nutrition counseling and education, according to the algorithm, and all patients should strive to attain and maintain an optimal weight through a primarily plant-based diet high in polyunsaturated and monounsaturated fats. Limiting intake of saturated fatty acids and avoiding all trans fats are also recommended. For patients who are overweight or obese, caloric intake should be restricted with the goal of decreasing body weight by 5% to 10%.¹

The AACE/ACE task force charged with updating the algorithm suggests that a clinician, dietitian, or nutritionist discuss these recommendations in plain language with patients as well as healthy food selection, meal-planning, grocery shopping, and dining-out strategies. Additionally, patients with diabetes should be educated on medical nutrition therapy to emphasize the need for consistency in daily carbohydrate intake, limiting foods high in sugar, and how to adjust insulin doses accordingly.

Structured counseling and meal-replacement programs appear to be more effective than standard in-office counseling, according to the algorithm.

The task force also highlights the importance of physical activity in the 2016 algorithm. Regimens should be comprised of 150 minutes per week of moderate-intensity exercise such as brisk walking and strength training. Structured programs are beneficial, they note, and implementation should account for the goals and limitations of the individual patient.

Additionally, the algorithm addresses other lifestyle factors that affect diabetes care, including getting enough sleep (approximately 7 hours per night), behavioral support, psychological assessment to monitor for anxiety or depression, and smoking cessation.

Evaluating Treatment for Obesity

The AACE/ACE task force recommends weight loss for all overweight or obese patients with prediabetes or type 2 diabetes. However, the AACE Obesity Treatment Algorithm favors a complications-centric vs BMI-centric approach to treatment.

“The patients who will benefit most from medical and surgical intervention have obesity-related comorbidities that can be classified into 2 general categories: insulin resistance/cardiometabolic disease and biomechanical consequences of excess body weight,” the task force wrote in the Executive Summary for the algorithm.

“Clinicians should evaluate and stage patients for each category. The presence and severity of complications, regardless of patient BMI, should guide treatment planning and evaluation. Once these factors are assessed, clinicians can set therapeutic goals and select appropriate types and intensities of treatment that will help patients achieve their weight-loss goals.”

Patients’ progress should then be reassessed regularly, according to the algorithm, and treatment should be intensified if necessary. This may involve the addition of medications to lifestyle modification.

The FDA has approved 8 weight-loss drugs for patients who are overweight or obese as of 2015. Diethylproprion, phendimetrazine, and phentermine are approved for short-term use, while orlistat (Alli, GlaxoSmithKline; Xenical, Genentech), phentermine/topiramate extended-release (Qsymia, Vivus), lorcaserin (Belviq, Eisai), naltrexone/bupropion (Contrave, Takeda), and liraglutide 3 mg (Saxenda, Novo Nordisk) may be used long-term.

The 5 drugs approved for long-term use were associated with statistically significant weight loss after 1 year of treatment in clinical trials, the task force notes.

Bariatric surgery should be considered for adults with a BMI of at least 35 kg/m² and comorbidities, especially if goals have not been met with lifestyle modification or medical therapies, according to the algorithm.

Managing Dyslipidemia in Diabetes

In light of the U.S. Food and Drug Administration’s (FDA’s) approval of 2 drugs in a new medication class, AACE/ACE revamped the algorithm’s section on managing lipids in patients with diabetes, according to Dr Grunberger.

“The lipid management section added the new class of PCSK9 inhibitors and the statement of principles guiding the algorithm choices was updated and simplified,” he said.

The FDA approved evolocumab (Repatha, Amgen) and alirocumab (Praluent, Sanofi-Aventis and Regeneron) — both PCSK9 inhibitors — for use in addition to diet and maximally tolerated statin therapy to lower LDL cholesterol in patients with homozygous or heterozygous familial hypercholesterolemia or in patients with clinical atherosclerotic cardiovascular disease (ASCVD).

PCSK9 inhibitors address a large unmet need for more aggressive lipid-lowering therapy beyond statins, according to Dr Grunberger, and they will be important new tools for reducing residual ASCVD risk in patients with clinical ASCVD and diabetes. When added to maximal statin therapy, these once-daily or twice-monthly injectable agents may reduce LDL cholesterol by approximately 50%. Further, PCSK9 inhibitors can raise HDL cholesterol and have favorable effects on other lipids.¹

Data from clinical trials confirm the benefits of PCSK9 inhibitors, the AACE/ACE task force notes in the Executive Summary. In a post-hoc cardiovascular safety analysis of alirocumab, results showed that the rate of major adverse cardiovascular events was lower with alirocumab compared with placebo (1.7% vs 3.3%).²

Similarly, in a post-hoc analysis of evolocumab, another PCSK9 inhibitor, researchers found that adding this agent to statin therapy significantly lowered the rates of cardiovascular events at 1 year (2.18% in the standard therapy group vs 0.95% in the evolocumab group; hazard ratio=0.47).³

Diabetes Medications, Insulin

In promoting the development of individualized patient management plans, the algorithm offers comprehensive clinical guidance for establishing and maintaining optimal HbA1c and glycemic control targets, noted Alan J. Garber, MD, PhD, chair of the AACE/ACE Comprehensive Diabetes Management Algorithm Task Force.

“It’s easier to manage patients with diabetes as new therapies proliferate. Despite the initial challenge posed by these new medications, their multiplicity provides the potential for better matching of patient characteristics to medication profiles. Thus, better outcomes in the near term are expected,” said Dr Garber, who is also a professor in the departments of medicine and molecular and cellular biology at Baylor College of Medicine in Houston.

In terms of medical treatment options for type 2 diabetes, the task force prioritizes minimizing the risks for hypoglycemia and weight gain. Therapy choices in the algorithm are then further stratified based on the patient’s initial HbA1c level. Guidance is offered on which therapies to initiate and which therapies should be added to a patient’s treatment regimen if glycemic targets are not achieved.

However, the task force emphasizes that individual circumstances dictate specific treatment regimens and that clinicians should consider a patient’s therapeutic goals, age, and other factors that may limit treatment.

Combination therapy is often required and should involve agents with complementary mechanisms of action, according to the algorithm.

“HbA1c goals have not changed. We still use personalized goals. Hypoglycemia may be less of a problem, as there are more medications which avoid that serious adverse outcome in their product profile,” said Dr Garber.

The algorithm also addressed insulin therapy, with Dr Grunberger noting that the insulin section expands the practical guidance for dose titration.

Simplifying Care

The algorithm is comprehensive in nature, said Dr Garber, but it is presented as an illustrated, action-driven treatment pathway. He noted that this approach can assist decision-making for physicians who are regularly challenged with managing the many facets of type 2 diabetes in the most effective and safe manner.

Furthermore, many new diabetes medications have been added to the armamentarium, Dr Grunberger explained, and it has been difficult for endocrinologists to keep up and use them appropriately.

“The AACE algorithm is the only one which provides [clinicians] with simple-to-follow practical directions based on available evidence, and in some cases, expert opinion where no evidence yet exists,” he told Endocrinology Advisor.

“Rather than the usual encyclopedic enumeration of all the medications on the market, the algorithm provides endocrinologists with a valued tool when they are teaching primary care and non-endocrinology colleagues about the current therapeutic choices,” Dr Grunberger said.

References

Garber AJ, Abrahamson MJ, Barzilay JI, et al. Consensus Statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the Comprehensive Type 2 Diabetes Management Algorithm – 2016 Executive Summary. Endocr Pract. 2016;22(1):84-113.
Robinson JG, Farnier M, Krempf M, et al; for the ODYSSEY LONG TERM Investigators. Efficacy and Safety of Alirocumab in Reducing Lipids and Cardiovascular Events. N Engl J Med. 2015;372(16):1489-1499.
Sabatine MS, Giugliano RP, Wiviott SD, et al; Open-Label Study of Long-Term Evaluation against LDL Cholesterol (OSLER) Investigators. N Engl J Med. 2015;372(16):1500-1509.
Garber AJ, Abrahamson MJ, Barzilay JI, et al. AACE/ACE Comprehensive Type 2 Diabetes Management Algorithm 2016. American Association of Clinical Endocrinologists website. https://www.aace.com/publications/algorithm. Published January 5, 2016. Accessed January 19, 2016.

AACE/ACE Updates Algorithm for Type 2 Diabetes Management