The Endocrine Society today released a clinical practice guideline on the pharmacological management of obesity that includes recommendations on strategies for prescribing weight loss drugs.
“This is really the first guideline of its kind,” Caroline M. Apovian, MD, of Boston University School of Medicine and Boston Medical Center, and chair of the task force that authored the guideline, said during a press conference hosted by the Endocrine Society.
“We do have the 2013 obesity management guidelines endorsed by The Obesity Society (TOS), the American Heart Association (AHA) and the American College of Cardiology (ACC), which covered the management of obesity through lifestyle, diet and exercise, and surgery. Although medications for anti-obesity drugs were mentioned, the guidelines did not go into detail. There were very few medications on the market and therefore very few randomized clinical trials with which to make recommendations. The Endocrine Society guideline fills that gap,” she said.
Further, Dr. Apovian explained that the newly released guideline offers a “blueprint” on the medical management of obesity while taking into account the 2013 TOS/AHA/ACC guidelines, noting that the task force stands by national recommendations for management of overweight and obese patients.
Currently, six drugs are approved by the FDA for treatment of obesity. In addition to orlistat and orlistat OTC, four medications have been approved during the last 2 years, including lorcaserin (Belviq, Eisai), phentermine/topiramate (Qsymia, Vivus), naltrexone/bupropion (Contrave, Takeda) and liraglutide (Saxenda, Novo Nordisk).
Despite the addition of these medical therapies to clinicians’ armamentarium, the guideline emphasizes the importance of diet, exercise and behavioral modifications, recommending that all should play a role in approaches to obesity management. By making these lifestyle changes, patients will experience greater weight loss overall and better maintenance of that weight loss, according to Dr. Apovian.
The current requirements for using FDA-approved weight loss medications include a BMI of at 27 with at least one weight-related comorbidity, such as diabetes or hypertension, or a BMI of 30 or more.
If patients meet these requirements and do opt for a weight management plan that includes anti-obesity medications, clinicians should see them frequently. Face-to-face encounters yield the best results, according to Dr. Apovian, although the addition of Web-based programs can be beneficial for those patients who cannot meet with their physician that often. At present, the Centers for Medicare and Medicaid Services (CMS) covers 15 visits per year.
Some other highlights from the guideline include the following:
- Medication should be continued in patients who respond well to the treatment and lose at least 5% of their body weight after 3 months. However, if the drug proves ineffective or the patient experiences significant side effects, the medication should be discontinued and other medications or therapeutic strategies should be pursued.
- In overweight or obese patients with diabetes, medications that promote weight loss or have no effect on weight should be given as first- and second-line therapies, as some type 2 diabetes medications are associated with weight gain. Metformin is still first-line therapy. If the patient requires the addition of a second medication, clinicians should then consider adding a GLP-1 agonist, such as exenatide or liraglutide or even pramlinitide, followed by SGLT-2 inhibitors before sulfonylureas or insulin, as these drugs will promote weight loss in addition to glycemic control, according to the guideline. Recommendations are also made for patients who are already using diabetes medications that promote weight gain.
- For first-line treatment for hypertension, certain types of medication, including angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs) and calcium channel blockers, should be used in obese patients with type 2 diabetes because these drugs are less likely to contribute to weight gain.
- Patients who need medications that may affect weight, such as antidepressants, antipsychotic drugs and medications for epilepsy, should be fully informed and provided with estimates of anticipated effect on weight for each option. Further, Dr. Apovian said, if a weight loss medication is used in these patients, bupropion should be considered as first-line treatment. Shared decision-making between patient and provider is recommended.
- Phentermine and diethylpropion should not be used in patients with uncontrolled high blood pressure (BP) or a history of heart disease. If a clinician is treating an obese patient with hypertension or a history of heart disease, he or she should consider orlistat or lorcaserin, as they are associated with a much lower risk for BP elevations than phentermine/topiramate or naltrexone/bupropion.
Changing Treatment Paradigms
During the press conference, Dr. Apovian also discussed how treatment paradigms have changed. Previously, clinicians sought to individually treat each comorbidity of obesity, such as hypertension or dyslipidemia, with medications, diet and exercise, and monitoring of blood work before addressing the obesity problem. However, it is being recognized that obesity is usually the root cause of these health issues.
Therefore, she said, newer treatment strategies are based on the concept of managing obesity first with lifestyle changes and medications and then managing the remainder of comorbidities that have not been successfully managed with by weight loss.
Finally, Dr. Apovian said she hopes these guidelines will help clinicians navigate the somewhat novel realm of pharmacological therapies for management of obesity.
“These are just some of the highlights of these protocols that will start to give PCPs and endocrinologists a blueprint for how to treat obesity with comorbidities. This is the first guideline that specifically names medications, recommended doses and how to use them; addresses patients election criteria that goes beyond BMI; which drugs to suggest; and which drugs to taper off,” she said.
The guideline, titled “Pharmacological Management of Obesity: An Endocrine Society Clinical Practice Guideline,” was co-sponsored by the European Society of Endocrinology and The Obesity Society. It is now available online and will be published in the February 2015 print issue of the Journal of Clinical Endocrinology & Metabolism.