Obesity is a medical condition
that is highly resistant to therapeutic interventions.1 The simple
explanation is an imbalance between energy intake and energy expenditure, but
patients often resist reducing intake and increasing exercise in a manner
sufficient to induce sustainable weight loss.2 As a result,
overweight patients undergo numerous approaches with varying degrees of
success, including expensive gadgets, portion control, meal plans, support
groups, surgery, and pharmacotherapy. This year marked the debut of a new
nonprescription product, orlistat (alli). Presently, no other nonprescription
product is proven safe and effective for weight loss.
The World Health
Organization estimated that 1.6 billion adults (over age 15 years) were
overweight in 2005.3 In the U.S., the overall incidence of obesity
has doubled since 1980.4 Certain groups have fared even worse; the
incidence tripled in children and teens. An estimated one-third of adults are
considered overweight and another third are obese.5
Epidemiology of Obesity in
distinct epidemiological trends. In women, 82% of non-Hispanic blacks are
obese, compared to 75% of Mexican Americans and 58% of non-Hispanic white
women.4 Seventy-six percent of Mexican American men are obese,
compared to 71% of non-Hispanic white men and 69% of non-Hispanic black men.
Family income influences
obesity. Women with lower income have a 50% higher risk of developing obesity
than those with higher income.4 The reason is thought to be the
preferential purchasing of high-fat, high-calories foods, which may be less
expensive than healthy foods such as fruits and vegetables.4
Health Problems Related to
The list of health
problems related to obesity is compelling. It includes heart disease,
hypertension, stroke, type 2 diabetes, abnormal blood cholesterol/triglyceride
levels, the metabolic syndrome, cancer, osteoarthritis, sleep apnea,
reproductive problems, and gallstones.1,6
for Weight Loss
marketed numerous weight loss prescription medications; perhaps the most
notorious are the amphetamines (e.g, Dexamyl, Eskatrol, Dexedrine, Didrex).
For a variety of reasons, many weight loss medications have long been
discarded. However, phentermine and sibutramine (Meridia) are still available.
7 In addition, patients who meet certain criteria may opt to undergo
Lap-Band or gastric bypass surgery. These surgeries can yield consistent,
large-scale weight loss.8
Orlistat debuted as
Xenical 120-mg capsules in 1999.9 Its mechanism of action is
inhibition of gastric and pancreatic lipases in the stomach lumen and small
intestine.10,11 Triglycerides in the diet cannot be enzymatically
degraded into absorbable, free fatty acids.5 As a result, the
amount of fat absorbed is reduced by 30%.12,13 Orlistat was
approved by the FDA for nonprescription sales as a 60-mg capsule on February
7, 2007. Company literature uses the trade names alli and Alli.
The product gradually became available after FDA approval as the company
developed its marketing plans. Xenical remains available.
Adverse Effects of
Adverse effects due to orlistat are euphemistically referred to as
treatment effects by the manufacturer.14 Those listed on the
nonprescription label include gas with oily spotting, loose stools, and more
frequent stools that may be hard to control. Collectively, all of these side
effects can result in great discomfort and embarrassment. The Internet has
several sites allowing orlistat users to exchange information about their
experiences while taking it.15-17 The manufacturer instituted a
message board that accomplishes the same objective. Users report that with
orlistat use, they noticed a "strange orange ring left in the toilet bowl."
18 The pharmacist should peruse these sites to glean useful counseling
tips for purchasers of orlistat.
The lay press has attempted to
warn users of orlistat about its treatment effects. An example is the
Newsweek article of June 25, 2007, entitled, "The Word is ‘Leakage.' "
19 The article's author highlights the possibility of soiling one's
pants due to uncontrollable anal leakage.
Patients taking orlistat must
commit to daily intake of a multivitamin containing beta-carotene and vitamins
A, D, E, and K. As orlistat affects their absorption, failure to ingest them
could lead to vitamin deficiencies, each with its well-known group of adverse
Rare adverse effects of orlistat
also appear in the medical literature. A 57-year-old female was prescribed
orlistat 120 mg three times daily with meals; the dosage had been increased
from a twice-daily regimen two months before the report.20 Her
renal function had progressively worsened, and she reported general malaise,
weakness, and loose oily stools several weeks prior to her hospital admission.
Her urine contained numerous calcium oxalate crystals. Renal biopsy yielded a
specimen that was examined with light microscopy. The investigators
noted calcium oxalate crystals in the tubules and interstitium, hypothesizing
that orlistat's effect on fat might have allowed the calcium to "soap out."
Newsweek article also lauds GlaxoSmithKline for producing a variety of
materials designed to allow patients to use orlistat without experiencing
problems. The manufacturer sells a "Starter Pack" with comprehensive aids, but
the pharmacist will not be able to read them unless one of the expensive
packages is opened, after which it cannot be sold. For this reason, this
article summarizes the various components.
This booklet is a welcome guide that serves several purposes. It provides the
unique code number the patient will need to register online for the myalliplan
benefits. It also lists the various components of the Starter Pack and
provides an overview of orlistat.
b. "Read Me First."
This booklet urges patients to register for help at myalli.com. It also
offers several basic points, such as expecting a steady and gradual weight
loss, making a change in one's behavior, eating right, writing one's intake
down, developing a routine, increasing the activity level, and sticking to the
program. In several places, the handout stresses the importance of reducing
fat intake (e.g., by cutting out all fried foods).
c. Quick Facts Cards
. This is a set of four plastic, pocket-sized reminder cards with keys to
success while on the program, such as tips on cooking, shopping, portion
control, and snacking. They also give tips on limiting fat, foods to avoid,
and best choices for nutrition.
d. Companion Guide
. The patient should be instructed to peruse this booklet thoroughly before
starting orlistat. In less than 60 small pages, it is a valuable discussion of
the orlistat program, including appropriate expectations, patient commitments,
adverse effects, the mechanism of orlistat, a body mass index calculation
table, how to eat right, development of a support network, increasing one's
activity level, and facing trouble spots.
e. Healthy Eating
Guide. This booklet is a comprehensive guide to eating in a healthy,
low-fat manner. It includes orlistat meal plans and provides the best choices
for a variety of international foods and fast-food restaurants (e.g., Wendy's,
f. Calorie and Fat
Counter. The orlistat user is urged to limit fat intake to minimize
treatment effects. This booklet allows the patient to calculate precisely how
many fat grams are in each meal.
g. Daily Journal
. The manufacturer explains that the most valuable predictor of weight loss
success is simply keeping an accurate record of food and drink intake. To that
end, the final written component of the starter kit is a 14-page set of blank
pages allowing the patient to record the item consumed, the amount, the
calories it contains, and the fat grams.
The pharmacist is
once again positioned to dispel many misconceptions about orlistat. As in the
Newsweek article cited above, the major focus of news stories and consumer
conversation is the possibility of orange, oily fecal leakage. This may be
partly due to the fact that there has seldom been a widely used
nonprescription product with this degree of potential embarrassment with its
usage. Consumer sites also describe the major effectiveness of orlistat as
being in fear of the major adverse effect. In the words of one correspondent:
"The end result is that eating fat is unpleasant so you will reduce your
intake while on the drug. The drug is a type of behavior modification..."
Some pharmacists have
derisively referred to orlistat as "gastric Antabuse" or "fried food
punishment." While this graphically describes the effect of orlistat,
pharmacists can provide a more balanced explanation of orlistat for
prospective users. They can justifiably point out that orlistat was never
meant to be a weight loss miracle in and of itself. As fully explained by the
manufacturer, orlistat is an aid to weight loss in patients who are already
committed to becoming thinner. Such a patient will demonstrate that commitment
by voluntarily following a low-fat diet and exercising more, even prior to
beginning therapy with orlistat.
Pharmacists should urge
purchasers to visit myalli.com. The Web site offers an individually tailored
action plan (myalliplan) to help patients achieve healthy weight loss.
Patients register for the plan using the individual number found inside the
Starter Pack, entering their goal weight and other details about their diet
plan. The company sends information about eating correctly and provides
instructions on how to check in to record progress each week. It gives
immediate feedback. The other features of the Web site are too numerous to
mention, but all aim toward the goal of healthy weight loss using this
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