USPSTF Sticks With Behavioral Approaches Only for Obesity

Troy Brown, RN

September 18, 2018

Clinicians should offer or refer adults with obesity (a body mass index [BMI] of 30 kg/m2 or higher) to intensive, multicomponent behavioral interventions, according to an updated recommendation statement from the US Preventive Services Task Force (USPSTF).

The new guidance reaffirms that published in 2012 and is a "B" recommendation, which means there is high certainty of a moderate net benefit, or moderate certainty of a moderate to substantial net benefit. It is designed for adults with obesity who have not yet developed other conditions associated with obesity, such as diabetes or coronary heart disease.

"We focus on prevention. We try to prevent diabetes and cardiovascular disease; there are groups that put out recommendations on treating those conditions and that we consider outside of our scope," USPSTF member Chyke A. Doubeni, MD, MPH, from the Perelman School of Medicine, University of Pennsylvania, Philadelphia, told Medscape Medical News.

He pointed out that although these new recommendations focus on people without diseases, they "could still work in people with diseases."

"More than 35% of men and 40% of women in the United States are obese. Obesity is associated with health problems such as increased risk for coronary heart disease, type 2 diabetes, various types of cancer, gallstones, and disability. Obesity is also associated with an increased risk for death, particularly among adults younger than 65 years," emphasize the guideline authors, led by USPSTF chairperson Susan J. Curry, PhD, from the University of Iowa, Iowa City.

The new recommendation was published online September 18 in JAMA on behalf of the USPSTF. An evidence report, editorial, and patient education page appear in the same issue and follow a draft recommendation published back in February.

Pharmacotherapy Not Recommended at This Time

The new evidence review looked at five obesity drugs that are approved by the US Food and Drug Administration; when the 2012 recommendation was released, orlistat was the only obesity medication approved for long-term use in the United States.

Patients who combined pharmacotherapy with behavioral interventions reported greater weight loss and maintained that weight loss better over 12 to 18 months compared with patients who used behavioral interventions alone.

However, "There were some gaps in the evidence for the medications that made it difficult for us to include them in the recommendations," Doubeni told Medscape Medical News.

"For each of the medications...there were a limited number of trials so...we were not able to pool results. But the more important issue is that we know there are harms and those harms have not been studied very well," he added.

"Participants in the pharmacotherapy trials were required to meet highly selective inclusion criteria, including adherence to taking medications and meeting weight loss goals before enrollment. These trials also had high attrition. Therefore, it is unclear how well patients tolerate these medications and whether the findings from these trials are applicable to the general US primary care population," the recommendation authors explain.

Doubeni stressed the evidence is strongest for the multicomponent behavioral interventions, which include numerous elements over an extended time period, such as counseling about a healthy diet, increasing exercise, goal setting, and self-monitoring, among others.

The task force is "not as comfortable with the evidence on the medications," he reiterated.

In her accompanying editorial, entitled "Weight Management in Adults with Obesity What Is a Primary Care Clinician to Do?" Susan Z. Yanovski, MD, from the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland, says: "Additional pragmatic trials in primary care populations would help determine effectiveness [of obesity medications] in clinical settings."

"Some patients respond to adjunctive drug treatment with clinically meaningful weight loss and favorable improvements in obesity-related comorbidities, whereas others lose little weight, show few improvements in obesity-related health conditions, or experience unacceptable adverse effects," she notes.

"Primary care clinicians are in an ideal position to assess risks and benefits of adjunctive pharmacotherapy in their patients and to monitor treatment effects," Yanovski adds.

Review Excludes Studies With T2DM, CVD Patients, Editorialist Says

The new recommendations are intended for adults who have no comorbid diseases that would require weight loss as part of disease management.

Yanovski believes the evidence review may be incomplete with regard to both behavioral interventions and pharmacotherapy because it excludes "some large and long-term clinical trials conducted among patients with type 2 diabetes or cardiovascular disease," she stresses.  

While this strategy may improve the specificity of study results for patient populations with no apparent obesity-related diseases, it fails to consider important data on the effect of weight-management interventions among the many patients' primary care clinicians treat for such comorbidities, she explains.

For example, the Action for Health in Diabetes (Look AHEAD) study was a randomized clinical trial that compared the effects of an intensive lifestyle intervention with diabetes support and education on health outcomes among 5145 racially and ethnically diverse adults with overweight/obesity and type 2 diabetes over 10 years.

"Although the intensive lifestyle intervention did not demonstrate a beneficial effect on the primary outcome of cardiovascular disease morbidity and mortality, this intervention had salutary effects on multiple health outcomes, including sleep apnea, urinary incontinence, preservation of physical mobility, progression of chronic kidney disease, depression, and physical health-related quality of life," Yanovski explains.

"With few large long-term studies of weight-management interventions evaluating important health outcomes, such data can also help inform decision making for the broader population of patients with obesity," she adds.

Doubeni said the findings from the Look AHEAD trial are "the same thing essentially that we found and reported for the current evidence review and recommendation. So it doesn't really change the context here. What's important is that the recommendation doesn't include treatment of diabetes."

The review also did not include data from a cardiovascular outcomes trial with the obesity drug lorcaserin (Belviq, Eisai), CAMELLIA-TIMI 61, recently reported at the European Society of Cardiology (ESC) 2018 Congress and simultaneously published in the New England Journal of Medicine.

Added to a background of diet and exercise, the drug led to modest weight loss compared with placebo and was deemed safe, although again this trial would likely also have been considered outside the scope of the review because the 12,000 overweight and obese patients recruited had to have established cardiovascular disease, type 2 diabetes, or cardiovascular risk factors.

Surgical Approaches "Outside the Scope of the Primary Care Setting"

Although research has shown bariatric surgical approaches to be substantially beneficial in certain patients, the recommendations do not address surgical approaches for patients with severe obesity and its comorbidities as they are considered to be "outside the scope of the primary care setting" Yanovski writes.

She says primary care clinicians "have an important role in identifying patients who might potentially benefit, advising patients to consider surgery as an option, and providing referral to a trusted bariatric surgical specialist or program for evaluation."

No Easy Fix for Obesity: Clinicians Need to Be in It for the Long Haul

Doubeni said behavioral interventions may not be readily available in the primary care setting and clinicians need to be able to recognize and document obesity and refer patients to appropriate resources.

The Centers for Disease Control and Prevention's National Diabetes Prevention Program is a promising one that is also the basis of the Medicare Diabetes Prevention Program, he added.

Still, even the best behavioral intervention programs may not be helpful to all patients, Yanovski writes.

For example, 51% of 1079 patients in the Diabetes Prevention Program — "widely acknowledged as a model for comprehensive lifestyle intervention" — failed to meet their target goal of 7% weight loss at the end of the 16-session core curriculum.

"There are numerous reasons for individual variability in response to treatment, and although treatment matching is currently imperfect, there is a clear need for adjunctive therapies for patients who cannot achieve and maintain a healthier weight with behavioral treatments alone," she adds.

Yanovski notes the evidence review found that face-to-face interventions that included at least 14 sessions during 6 months were most beneficial; however, such treatment may not be affordable or accessible to all patients.

Those who live in rural areas may lack transportation or comprehensive in-person programs, but remotely delivered treatment may increase accessibility for these individuals as well as older adults and those with disabilities.

Clinically proven commercial programs are other potential alternatives for some patients.

Clinicians need to know "there are things that work and there are various things that can be used for different people. Clinicians should be aware of how important this is it long term; it's not just 'once and done'...It's a chronic condition that people need to pay attention to — over and over again," Doubeni concluded. 

The recommendation authors have disclosed no relevant financial relationships. LeBlanc reported that her institution received a grant from Merck for a project (unrelated to the topic of this article) on which she served as principal investigator. The remaining evidence review authors have disclosed no relevant financial relationships. Yanovski reports that her spouse has received research support to his institution (Eunice Kennedy Shriver National Institute of Child Health and Human Development) from Zafgen and Rhythm.

JAMA. Published online September 18, 2018. Full text, Editorial

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