Obesity Epidemic Contributes to Poor Health, High Costs

Las Vegas—If trends continue, more than 100 million adults in 2018 will be obese, a problem that affects peoples’ health and is an economic burden to the healthcare system. By 2018, obesity-related direct expenditures are expected to account for 21% of the nation’s direct healthcare spending, according to Doina Kulick, MD, associate professor at the University of Nevada, Reno School of Medicine.

Dr. Kulick spoke at the fall managed care forum during a session titled Optimizing Outcomes in the Management of Obesity: The Role of Novel Therapeutic Agents. Eisai, Inc. and Vivus, Inc. supported the session with educational grants.

Since the American Medical Association (AMA) officially classified obesity as a disease in June, it has generated more attention as a chronic condition and could lead to changes in treatment and insurance coverage. In November, the American Heart Association (AHA), American College of Cardiology (ACC), and National Heart, Lung, and Blood Institute (NHLBI) released obesity guidelines for the first time in 15 years that could also affect therapy decisions. The 18-person AHA/ACC/NHLBI panel included experts in psychology, nutrition, physical activity, bariatric surgery, epidemiology, and internal medicine.

Dr. Kulick agreed with the AMA’s decision and said obesity is “genetically determined and environmentally charged” and is difficult to treat despite increasing therapeutic options. In 2012, the FDA approved new oral medications (lorcaserin and the combination of phentermine and topiramate extended-release) for chronic weight management.

Still, of the people who could benefit from obesity drugs, only 3% are taking them, according to Dr. Kulick. She added that doctors only diagnose 20% of people who are obese, which is defined as body mass index (BMI) of at least 30 kg/m².

“We are doing a very dismal job,” Dr. Kulick said.

Reasons for the low rate of diagnoses include that physicians do not receive training and have a lack of confidence that people will adhere to weight loss strategies and keep the pounds off. Primary care doctors also spend an average of 4 minutes per visit addressing each clinical item, according to Dr. Kullick. The lack of attention causes them to miss or misdiagnose conditions.

Besides calculating BMI, she said healthcare professionals should measure a person’s waist circumference and assess comorbid conditions, such as pulmonary disease, nonalcoholic fatty liver disease, gall bladder disease, osteoarthritis, pancreatitis, and coronary heart disease. She said a person is obese if their waist circumference is >40 inches for a man and >35 inches for a woman.

For certain subgroups, including people shorter than 5 feet, the elderly, and athletes, BMI may not be the most accurate predictor of obesity. Dr. Kullick recommended that obese people lose 5% to 10% of their body weight to help them see improvements in blood pressure, hemoglobin A1c, and other clinical measures.

Studies have shown obesity affects numerous diseases, according to Dr. Kullick. For instance, 26% to 28% of hypertension cases and 90% of type 2 diabetes cases are attributable to excess weight. In addition, the Framingham Heart Study found that excess body weight accounted for 23% of coronary heart disease cases in men and 15% of cases in women.

When announcing the AHA/ACC/NHLBI guidelines, the organizations noted that the National Health and Nutrition Examination Surveys from 2009 and 2010 indicated 69% of adults were overweight (BMI from 25 kg/m² to 29.9 kg/m²) or obese (BMI of at least 30 kg/m²). The estimates were not significantly different from 2003 to 2008, although the authors wrote that “overweight and obesity are major contributors to chronic diseases in the United States and present a major public health challenge.” [Circulation. DOI:10.1161/01.cir.0000437739.71477.ee].

A higher BMI is associated with increased costs, too. Medical costs related to obesity in the United States are approximately $147 billion each year in 2008 dollars, according to the AHA/ACC/NHLBI. Dr. Kullick said that the average annual costs in 2002 for a male Medicare beneficiary with a BMI in the normal range (18.5 kg/m²-24.9 kg/m²) was $7339, compared with $8319 for a BMI from 25 kg/m² to 29.9 kg/m², $10,155 for a BMI from 30 kg/m² to 34.9 kg/m², and $13,531 for a BMI of ≥35 kg/m².

Until recently, the only drugs approved to treat obesity were phentermine and orlistat, which are both oral medications. Phentermine is approved for 3 months of use, while orlistat is approved for >6 months of use.

Lorcaserin, a selective antagonist of the brain serotonin 2C receptor, was approved in June 2012 based on the results of a multicenter, placebo-controlled study. The trial found 47.5% of patients taking lorcaserin lost at least 5% of their body weight after 1 year of treatment and 22.6% lost at least 10% of their body weight. In a placebo group, 20.3% of patients lost at least 5% of their body weight and 7.7% lost at least 10% of their body weight.

Patients are advised to take 10 mg of lorcaserin twice daily. If they do not lose 5% of their body weight within 12 weeks, they should discontinue treatment, according to Dr. Kullick. Side effects associated with lorcaserin include headache, upper respiratory infections, nasopharyngitis, dizziness, and nausea.

In July 2012, the FDA approved the combination of phentermine and topiramate, which was approved as a single agent in 1996 to treat seizures and in 2004 for migraine prophylaxis. Patients should take the combination drug once daily in doses of 3.75 mg phentermine/23 mg topiramate, 7.5 mg phentermine/46 mg topiramate, or 15 mg phentermine/92 mg topiramate. After 12 weeks, if patients do not lose 5% of their body weight, they should discontinue treatment gradually because abruptly withdrawing topiramate could cause seizures, according to Dr. Kullick.

After a year of treatment in a randomized controlled trial, obese or overweight patients who received 15 mg phentermine/92 mg topiramate lost an average of 9.8% of their weight, compared with a 7.8% loss for patients who took 7.5 mg phentermine/46 mg topiramate, and a 1.2% loss for the placebo group.

Dr. Kullick noted that patients with a history or renal stones, hypertension, or coronary heart disease should be cautious before taking phentermine and topiramate. The combination drug has been associated with side effects, such as dry mouth, constipation, paraesthesia, depression, and disturbance in attention.

Although no head-to-head trials of the drugs exist, Dr. Kullick evaluated studies of each individual medication that also included dietary counseling. She found that after a year of treatment, patients taking phentermine and topiramate lost an average of 22 pounds, compared with 12 pounds for patients taking orlistat, and 13 pounds for patients taking lorcaserin. In a 13-week trial, patients who received phentermine alone lost an average of 14 pounds.

After patients begin treatment with an obesity drug, they should have a follow-up visit within 2 to 4 weeks and should then visit the doctor every 1 to 3 months, according to Dr. Kullick. Patients and providers are not required to attend a Risk Evaluation and Mitigations Strategy program for any of the obesity recommendations. However, Dr. Kullick recommended they understand the risks and side effects associated with the products.

The AMA’s decision in June to classify obesity as a disease could lead to more people taking the oral medications. Previously, the FDA, World Health Organization, National Institutes of Health and other organizations had declared obesity as a disease. However, the AMA is the leading physician group in the United States and is influential in the healthcare industry.

“Recognizing obesity as a disease will help change the way the medical community tackles this complex issue that affects approximately 1 in 3 Americans,” AMA board member Patrice Harris, MD, said in a news release. “The AMA is committed to improving health outcomes and is working to reduce the incidence of cardiovascular disease (CVD) and type 2 diabetes, which are often linked to obesity.”

The AHA/ACC/NHLBI mentioned obesity increases the risk of morbidity from hypertension, dyslipidemia, type 2 diabetes, coronary heart disease, stroke, gallbladder disease, osteoarthritis, sleep apnea, respiratory problems, and some cancers and is associated with an increased risk in all-cause and CVD mortality.

The new guidelines suggest healthcare professionals measure waist circumference, height and weight, and calculate BMI at least once per year. They should also tell overweight and obese adults with cardiovascular risk factors that a sustained weight loss of 3% to 5% produces clinically meaningful benefits, as well as recommending a low calorie diet and increased physical activity as beneficial in maintaining weight loss.