US Pharm. 2008;33(3)(OTC suppl):12-14.
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. Last year marked the debut of a new
nonprescription product, orlistat (alli). Presently, no other OTC product is
proven safe and effective for weight loss.
Obesity
The World Health Organization
estimated that 1.6 billion adults (over age 15 years) were overweight in 2005.
3 In the United States, 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 the U.S.
Obesity exhibits 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-calorie foods, which may be less expensive than
healthy foods such as fruits and vegetables.4
Health Problems Related to Obesity
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
Physician-Directed Options for Weight Loss
Companies have marketed numerous
weight loss prescription medications; perhaps the most notorious are the
amphetamines (e.g, Dexamyl, Dexedrine, Didrex, Eskatrol). 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
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 Orlistat:
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 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 effects.
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."
Orlistat Patient Materials:The
Newsweekarticle 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.
a. "Hi." 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, Subway).
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 Pack 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.
Pharmacist's Role
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."21
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 nonprescription product.
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Consumer Rep. 2006;71:48.
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