Joanna Cosgrove09.01.07
A Dieter’s New Best Friend
 |
GSK’s FDA-approved Alli sets the OTC market on fire.
By
Joanna Cosgrove
Online Editor
The prevalence of obesity has increased at an alarming rate over the past three decades and if the trend continues at its current pace, 75 percent of adults will be overweight or obese by 2015, according to “The Obesity Epidemic in the United States—Gender,
While there have been many diet prescription and supplement products on the market over the years, few have received the fanfare surrounding the latest, most widely anticipated supplement: Alli. Launched in June by GlaxoSmithKline (GSK), Alli is the first FDA-approved over-the-counter (OTC) product for weight loss.
While Alli may resemble a dietary supplement in looks and marketing, it isn’t one. Rather, it’s a dietary supplement in the most literal sense of the term—an aid to those who are dieting. In fact, GSK carefully iterates Alli is no magic pill; it is part of a comprehensive weight loss program. It is not an appetite suppressant nor does it impact the heart or nervous system. The Alli program combines the Alli capsule (60 mg orlistat) with the “myalliplan,” a behavior modification program designed by nutritional and weight loss experts to create “meaningful” results for individuals who are “overweight and are motivated and ready to make lifestyle changes” and “have realistic expectations for gradual, modest weight loss.”
How it Works
Alli’s can help shed 50% more weight than with dieting alone—providing individuals stick to a strict reduced-calorie, low-fat diet that includes meals containing no more than 15 grams of fat. If not, they will pay a price with Alli’s well-publicized—and unpleasant—side effects.
Alli binds to and inactivates GI lipases, which aid in the digestion of dietary fats (triglycerides). Alli also binds to gastric and pancreatic lipases, blocking absorption of about 25% of consumed fat. The undigested fat is excreted from the body instead of turning into stored fat—a phenomenon that occurs when individuals eat a meal with too much fat. The resulting GI side effects range from “loose or more frequent stools that may be hard to control, an urgent need to go to the bathroom, [and] gas with oily spotting.”
Sherry Torkos, RPh, a registered pharmacist based in Ontario, Canada, and author of 10 health books, acknowledged that the negative side effects are capturing most of the attention focused on the product. “That is the reality with a product like this because as a fat blocker it associated with some very unpleasant side effects,” she said. “In my experience, the prescription form of this drug, Xenical (orlistat), and associated side effects like anal leakage and loose stools are not things consumers are likely to accept over the benefits. Alli’s website actually suggests that those using the product where dark pants and bring a change of clothes.”
GSK recommends individuals taking Alli also take a multivitamin containing vitamins A, D, E, K and beta-carotene once daily at bedtime to counter orlistat’s fat-inhibiting action on fat-soluble vitamins.
2nd Gen Xenical
OTC Alli is half the strength of Roche’s prescription Xenical (orlistat 120mg), and, as a result, produces fewer GI events overall than Xenical. In clinical trials, subjects on 120 mg withdrew due to GI adverse events at a rate of over 5%—at 60 mg it was only 3%. Orlistat does have an extensive clinical history—it has been studied in more than 100 clinical trials with more than 25 million patient treatments in 145 countries worldwide.
In clinical studies, the 60 mg capsule of Alli demonstrated comparable efficacy and safety profiles to the 120 mg prescription capsule, but had a lower incidence of treatment effects, compared with the 120 mg dosage. Only a small percentage of trial subjects withdrew due to GI adverse effects (5% on 120 mg compared to only 3% on 60 mg), which, the company said, further reinforced the tolerability of the 60 mg dose. After 90 days of using Alli, 81% of study participants reported being satisfied or very satisfied with orlistat, and 91% reported losing weight.
In addition to the dosage amount Alli also differs from Xenical in that it offers informational materials designed to help support individuals as they incorporate Alli into their daily eating plans.
Unpleasant side effects aside, Alli does deliver in terms of weight loss benefits. That said, Ms. Torkos believes there are more natural weight loss options available that don’t impose the negative side effects. “If you can’t get the results you’re looking for then consumers should turn to supplements first,” she said. “Whether you are talking about green tea, fiber, HCA (hydroxycitric acid), CLA (conjugated linoleic acid) or products like Phase 2, in my mind those are safer products to consider before a product like Alli or even the prescription weight loss drugs.”
When dieting, it’s important to consume healthy fats while at the same time getting rid of saturated and trans fat. The problem with Alli, said Ms. Torkos, is that “Alli doesn’t discriminate when it removes fats from the body, which is why it’s important to make sure that you are still consuming the good fats while taking the product. The other concern is that you can suffer malabsorption of fat-soluble vitamins like A, D, E and K, which is why they recommend in product literature to make sure to take a daily multivitamin.”
But one thing Alli has that supplements don’t is the lucrative backing and doctor-influencing clout of the pharmaceutical industry. And so far, it seems to be working. GSK announced during their July 25th earnings report to analysts that Alli’s sales are presently aligned with the company’s expectations. “The reported sales in Q2 for Alli are $150 million,” said Malesia Dunn, GSK’s director, corporate communications. “This number includes product sales and retail store stocking orders. In addition, the website myalli.com, has been very successful. There have been about 4.5 million visitors to the site averaging nearly 10 minutes per visit. The site is now the number three site in over 1000 OTC pharmaceutical websites.” It’s also worth noting that the brand has been well-buoyed by continued usage: 84 %of consumers continued product usage at week 10.
“There are many fad diets and supplements on the market that guarantee fast weight loss results,” concluded Ms. Dunn. “The Alli program teaches that there are no ‘quick fixes’ to weight loss. Proper weight loss requires a commitment to change one’s lifestyle and eating habits. Alli helps the committed overweight individual, achieve meaningful weight loss when used in conjunction with a reduced-calorie, low-fat diet.”
