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Obesity and Management of Weight Loss

James S. Yeh, M.D., M.P.H., Robert F. Kushner, M.D., and Gordon D. Schiff, M.D.

N Engl J Med 2016; 375:1187-1189September 22, 2016DOI: 10.1056/NEJMclde1515935


Comments and Poll open through October 5, 2016
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CASE VIGNETTE
A Woman Considering Medication for Weight Loss
James S. Yeh, M.D., M.P.H.
Ms. Chatham is a 29-year-old woman who recently joined your practice; this is
her second visit to your clinic. She made today’s appointment to discuss how she
can lose weight and whether there are medications that she can take to aid in
weight loss. She is relatively healthy, except for a history of childhood asthma.
She says that she has been told indirectly, by her friends and family, that she is
“overweight.” She has tried several popular diets without success; each time, she
has lost 4.5 to 6.8 kg (10 to 15 lb) but has been unable to maintain the weight
loss for more than a few months.
She does not have a history of coronary artery disease or diabetes. She has a
regular menstrual cycle. She does not take any medications or nonprescription
supplements. She does not smoke but does drink alcohol, occasionally as many
as 4 or 5 drinks in a week, when she is out with friends. She tells you that she
“watches what she puts in her mouth” and reads the nutritional labels on food
packaging. However, she enjoys eating out and orders take-out meals 8 to 12
times a week.
She works as a computer programmer and spends most of her day sitting in an
office. She belongs to a fitness club and tries to go there about once a week but
notes that her attendance is inconsistent.
On physical examination, her vital signs are unremarkable except for a blood-
pressure measurement of 144/81 mm Hg. She is 1.7 m (5 ft 7 in.) tall and weighs
92 kg (203 lb), and her body-mass index (BMI; the weight in kilograms divided by
the square of the height in meters) is 32. Her waist circumference is 94 cm (37
in.). There is no peripheral edema. The rest of the examination is unremarkable.

TREATMENT OPTIONS
Which of the following treatment options would you recommend for this patient?
 1. Start lifestyle modification and therapy with an FDA-approved drug.
 2. Maximize lifestyle modification and nonpharmacologic therapies.
To aid in your decision making, each of these approaches is defended in a short
essay by an expert in the field. Given your knowledge of the patient and the
points made by the experts, which option would you choose? Factor into your
decision the indications for pharmacologic therapies for weight loss, differences
among the various weight-loss medications, concerns about their long-term
efficacy and safety, and the role of adjuvant lifestyle and nonpharmacologic
therapies in promoting and maintaining weight loss.
 Option 1: Start Lifestyle Modification and Therapy with an FDA-Approved Drug
 Option 2: Maximize Lifestyle Modification and Nonpharmacologic Therapies

OPTION 1
Start Lifestyle Modification and Therapy with an FDA-Approved Drug
Robert F. Kushner, M.D.

Ms. Chatham is a candidate for adjunctive pharmacotherapy in addition to


lifestyle modification to assist in her weight management. The primary rationale
for the use of weight-loss medications is to improve dietary adherence, which is
one of the most important predictors of successful weight loss. Since the primary
biologic effect of most weight-loss medications is reduced hunger, increased
satiety, or both, the use of pharmacotherapy enables patients to adhere to a
dietary plan that includes a reduction in calories and to do so with better control
and a reduced sense of deprivation.1
Weight-loss medications are approved for adults with a BMI of 30 or more, or 27
or more in the presence of at least one obesity-associated condition. Other
factors to consider before prescribing a weight-loss drug include whether a
patient has been unable to achieve or maintain a reasonable weight-loss goal or
is unwilling to make a change in lifestyle behavior and whether the patient has
realistic expectations of weight-loss medication use and related outcomes.
Four medications for weight loss have been approved by the Food and Drug
Administration (FDA) since 2012 — phentermine–topiramate ER (extended
release),2 lorcaserin,3 naltrexone–bupropion ER,4 and liraglutide.5 Orlistat, an
intestinal lipase inhibitor that was approved in 1999, is the only other medication
approved for long-term use. The efficacy and side-effect profiles of these
medications, when used as adjuncts to lifestyle modification, have been
established through prospective randomized, controlled trials that have had
follow-up periods of 1 to 2 years.3,6 Although response rates vary among the
studies, participants assigned to the medication groups achieved significantly
greater weight loss than participants assigned to placebo, as well as
improvements in cardiometabolic risk factors and quality of life. Among
participants who completed 1 year of treatment, the average weight loss ranged
from 7.0 to 12.4% among participants who received one of the four newer
medications groups, as compared to 1.6 to 3.5% among those who received
placebo.
Ms. Chatham presents with class I obesity (BMI of 30 to 34.9) and higher-risk
upper-body fat distribution (waist circumference >89 cm [35 in.]). She also has
elevated systolic blood pressure; since a weight loss of 5% or more has been
shown to improve blood pressure, losing weight would benefit Ms. Chatham in
this way as well. She has also noted difficulty in losing weight and maintaining
weight loss and has expressed interest in considering weight-loss medication.
After counseling her on the core principles of weight management, such as goal
setting, building a plan for reduced caloric intake, increasing physical activity,
reducing sedentary activity, and using self-monitoring strategies, I would broach
the topic of weight-loss medication. The nature and incidence of side effects,
along with cost, need to be considered when selecting among medications, a
process that should be accomplished through shared decision making. A
particular concern for Ms. Chatham is the need for birth control, because all
weight-loss medications are contraindicated during pregnancy.
Once medication is initiated, Ms. Chatham should return to your clinic at least
monthly for the first 3 months so that you can assess the efficacy and safety of
the medication chosen, and at least every 3 months thereafter; more frequent
counseling is associated with improved outcomes.1 Response to treatment (with
a target weight loss of at least 3 to 5%, depending on the medication) should be
determined after 3 to 4 months of use. If Ms. Chatham achieves this threshold,
continued use is indicated, as long as she has no important adverse events and
her course suggests that the medication is effective.

Disclosure forms provided by the author are available with the full text of this
article at NEJM.org.
SOURCE INFORMATION
From the Department of Medicine, Northwestern University Feinberg School of Medicine,
Chicago.

65 Reader's Comments
ANALYSIS OF POLLING RESULTS
Polling and commenting closed October 6, 2016. We received 905 responses to
the poll and posted 64 of your comments. An analysis of the polling results
appears below. — Edward W. Campion, M.D., Executive Editor
Editor's Comment
Obesity and Management of Weight Loss — Polling Results James Yeh, M.D.,
M.P.H., and Edward W. Campion, M.D. Obesity is increasingly prevalent
worldwide, and about 40% of Americans meet the diagnostic criteria for
obesity.[1] The goal of weight loss is to reduce the mortality and morbidity risks
associated with obesity. Patients with a body-mass index (BMI) in the range that
defines obesity (>30) have a risk of death that is more than twice that of persons
with a normal BMI.[2] Obesity is also associated with increased risks of
cardiovascular disease, diabetes, and several cancers. A recent study suggests
that being overweight or obese during adolescence is strongly associated with
increased cardiovascular mortality in adulthood.[3] Studies suggest that even a
5% weight loss may reduce the complications associated with obesity.[4] In
September 2016, we presented the case of Ms. Chatham, a 29-year-old woman
with class I obesity (BMI, 32) who leads a fairly sedentary lifestyle, with frequent
reliance on takeout foods and with infrequent physical activity.[5] Readers were
invited to vote on whether to recommend initiating treatment with one of the FDA-
approved drugs for weight loss along with lifestyle modifications or to recommend
only nonpharmacologic therapies and maximizing lifestyle changes. The patient
has no coexisting medical conditions, but her blood pressure is slightly elevated
(144/81 mm Hg). In the past, Ms. Chatham has tried to lose weight using various
diets, each time losing 10 to 15 lb (4.5 to 6.8 kg), but she has never been able to
successfully maintain weight loss. Over 85,000 readers viewed the Clinical
Decisions vignette during the polling period, and 905 readers from 91 countries
voted in the informal poll. The largest group of respondents (366) was from the
United States or Canada, representing nearly 40% of the votes. A large majority
of the readers (80%) voted against prescribing one of the FDA-approved
medications for weight loss and instead recommended maximizing lifestyle
modification and nonpharmacologic therapies first. A substantial proportion of the
64 Journal readers who submitted comments expressed concern about the
absence of efficacy data on long-term follow-up and about the side effects
associated with current FDA-approved medications for weight loss. Some
suggested that simply treating obesity with a prescription medication is
shortsighted and that it is important to uncover patients’ motivations for existing
lifestyle choices and for weight loss. The commenters emphasized the need for a
multifaceted approach to obesity management that includes nutritional and
psychological support, as well as stress management, with the goal of long-
lasting improvement in exercise and eating habits that will lead to weight
reduction and maintenance of a healthier weight. Some commenters, noting the
difficulty of lifestyle changes, felt that pharmacotherapy can be a complementary
and reasonable part of a multidisciplinary treatment plan. Some wrote that
obesity should be managed as a chronic disease is managed and that an inability
to lose weight should not be seen as a disciplinary issue, especially given the
importance of genetic and physiological factors. These commenters argued that
the use of pharmacotherapy as part of the treatment plan to achieve weight loss
should not be stigmatized. Overall, the results of this informal Clinical Decisions
poll indicate that a majority of the respondents think physicians should not initially
recommend the use of an FDA-approved drug as part of a weight-loss strategy,
at least not for a patient such as Ms. Chatham, and that many respondents were
troubled by the current uncertainties about the long-term efficacy and safety of
weight-loss drugs. REFERENCES 1. Flegal KM, Kruzon-Moran D, Carroll MD,
Fryar CD, Ogden CL. Trends in obesity among adults in the United States, 2005
to 2014. JAMA 2016;315:2284-91. 2. Global BMI Mortality Collaboration. Body-
mass index and all-cause mortality: individual-participant-data meta-analysis of
239 prospective studies in four continents. Lancet 2016;388:776-86. 3. Twig G,
Yaniv G, Levine H, et al. Body-mass index in 2.3 million adolescents and
cardiovascular death in adulthood. N Engl J Med 2016;374:2430-40. 4. Kushner
RF, Ryan DH. Assessment and lifestyle management of patients with obesity:
clinical recommendations from systematic reviews. JAMA 2014;312:943-52. 5.
Yeh JS, Kushner RF, Schiff GD. Obesity and management of weight loss. N Engl
J Med 2016;375;1187-9.

ALWIN LEWIS, MD | Physician - INTERNAL MEDICINE | Disclosure: None


BURBANK CA - October 04, 2016
The Key to weight management is control.
I have spent 15 years in the world of weight loss. In my general internal medicine
practice, over the last 10 years, I have a 25,806 pound NET loss among all 2581
patients I have seen, which includes those who wanted to lose weight and those
who didn't. Of the 928 patients in my practice who expressed a strong desire to
lose weight, most of whom have read my book, they have an average of 32.71
pounds lost over an average of 207.8 weeks--slightly under 4 years. The key to
control is being able to lose weight faster than one can gain weight over a set
period of time, and to follow a program that is sustainable until their goal weight
is reached. A successful diet, therefore, must produce very fast weight loss. By
following the rules of the five-bite diet and helping patients to reset their
hungerstats, my patients have found this control. I see them monthly or bi-
monthly, use lots of words of encouragement, and occasionally use appetite
suppressants to help patients for part of the time. I rarely prescribe a medication
when starting the program. Exercise plays a small role in losing and maintaining
weight loss, though I don't discourage light exercise.

Alberto Ruiz Franco | Physician - Unspecified | Disclosure: None


Mexico - October 04, 2016
ideal therapy in this case
Obesity treatment MUST be multidisciplinary, and, in patients with BMI above 30
pharmacological therapy is indicated, along with medical and psychological
support. however this patient presents a high blood pressure measurement so i
wouldnt like to prescribe phentermine, what would be the ideal drug for this 29
y/o patient?

COLIN WALSH, MD | Physician - FAMILY MEDICINE | Disclosure: None


DALIAN China - October 04, 2016
Plant-based diet is optimal for weight and general health
How about a plant-based diet? Surveys have consistently shown that vegans are
in the healthy BMI range - everyone else is outside it! A low fat whole food, plant-
based (WFPB) diet has shown its value in the prevention and treatment of a
range of common chronic diseases (see research published by Caldwell
Esselstyn, Dean Ornish, Neal Barnard, John McDougall and Colin Campbell).
The evidence in favor of this approach is so compelling that Kaiser Permanante
encourages its physicians to recommend a plant-based diet routinely. I switched
to a WFPB diet more than 10 years ago. I now weigh the same as when I was
20, cholesterol and blood pressure are down and my chronic eczema
disappeared. See the movie Forks over Knives for more info.

PROF JUKKA SALONEN, MD | Physician - EPIDEMIOLOGY | Disclosure: None


HELSINKI Finland -October 03, 2016
thyroid function?
The intro doesn't say if the thyroid function was checked. Hypothyreosis is a
common cause of obesity among women.

Mohit Naredi | Resident - Internal Medicine | Disclosure: None


India -October 01, 2016
We need more follow-up studies
Excellent and thought provoking article with some genuine arguments..But as
mentioned by Dr Gordon himself that the follow up studies with these drugs are
of short duration ie 2 years. Now if we want to put a patient on a drug for a longer
time then we need longer follow up studies. As pointed out by Dr Sands there are
obviously some or the other side effects of these drugs which are yet to be
noticed.... So I would not like to put my patient on pharmacotherapy blindly with
other viable options in hand that are way more harmless like diets and lifestyle
changes.... Nonetheless if we can have all the detailed information about the
pharmacodynamics of these compounds then we can make a better and
informed choice and then certainly we would like to discuss with our clients to
take the decision which might prove a solution to the condition...

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