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“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.
