From Xenical to Alli -- Orlistat OTC
March 14, 2007 2:29 AM
By Susan Parsons MD
A license to eat all the fat you want?
Not quite.
The first diet drug to hit the over the counter market is the nonprescription version of fat blocker Xenical. The FDA has voted to allow a reduced-strength form of the generic orlistat to be sold without a doctor’s order. This 60 mg. dose of orlistat will be marketed under the name “Alli” by GlaxoSmithKline PLC.
Is this good news for dieters? Can we have our cheesecake and eat it too?
Although the idea of using a fat-blocker may be very compelling if you want to lose weight, this type of drug is certainly not a panacea. There’s good news about orlistat, and there’s bad news. Here’s my take.
Clinical studies have shown modestly positive results. About half of dieters lost at least 5% of their body mass while taking Xenical (120 mg) three times per day with meals over a 6 month period. Obese subjects who took Xenical lost approximately 5 more pounds compared to a group who took placebo pills.
But, man (or woman) does not lose weight by pill alone! All of the subjects that participated in the research were not just depending on the drug alone. Each one followed a calorie controlled diet and exercised as well.
Although the weight loss achieved was underwhelming, statistical analysis suggests that this was enough to decrease diabetes risk by 37%. Now, that is significant, considering the devastating health effects diabetes can create.
What’s more, one study showed that Xenical could have anti-tumor effects in breast and prostate cancer progression, at least in cell cultures.
Orlistat works by blocking pancreatic lipase, a digestive enzyme responsible for breaking down dietary triglycerides into their individual fatty acids. The medication can block about 25% of the fat in a meal from being absorbed. Instead of being digested, this fat passes out into the stool. A big fat flush, so to speak!
Now the bad news.
Are there side effects to this drug? Well, that’s the kicker. Most bothersome to many users are the bowel changes. These include oily spotting and loose stools characterized as “anal leakage”. Your imagination can supply the unspoken details.
Dieters who use orlistat are instructed to follow a food plan that contains approximately 30% fat. This is a moderate fat diet, consistent with the recommendations of many weight-loss programs. The 30% level provides enough fat to make taking the drug worthwhile, while preventing more troubling symptoms.
It appears that eating a very high fat meal leads to more severe gastrointestinal side effects. As one patient told me, taking the pill acted as a dietary deterrent for him. He knew that if he overindulged in fatty foods, he would pay for it later with flatulence and diarrhea.
Of medical concern is the fact that orlistat not only blocks absorption of fat, but also much of the fat-soluble nutrients from the diet. The purveyors of the drug have recommended that users simply take a multivitamin to replace these lost essential nutrients. Unfortunately, this advice is simplistic and naïve.
One of my concerns with relying on a fat-blocker is that there are many other vital nutrients in food that cannot be found in a bottle of vitamin pills. Numerous antioxidants and other phytonutrients provide health-enhancing benefits. Many of these may fight cancer, heart disease, and dementia. But if you use a fat blocking drug, many of the benefits of eating your veggies would be flushed right down the drain along with the fat.
And are fats so bad that we want to get rid of them? Well, some are, but some are not. The healthy omega-3 fats are usually in such short supply in our diets that we must take supplements. Of course, you would not want to take your fish oil capsule at the same time as a fat-blocker.
Coenzyme Q-10 is another supplement that I recommend for good health. But again, this one needs fat to be absorbed. These nutriceuticals, along with the vitamins, should be swallowed several hours before or after taking a fat-blocking drug.
Maybe even more alarming is a newer study reported in 2006. Rats given high doses of Xenical developed pre-cancerous lesions in their colon. These early cancers appeared in as little as 30 days of exposure to the drug. The high level of fat in the stool appeared to be the carcinogenic stimulus. The possible risk for colon cancer should be enough to give would-be Alli or Xenical users pause.
In the past, I have counseled hundreds of patients about how to lose weight. Although I prescribed Xenical a few times (before the rat experiment was reported), I never found it to be helpful to many of my patients. One young man actually gained 7 pounds while taking the drug! Obviously, blocking fat absorption from your diet is not the ultimate secret to weight loss.
However, the drug does seem to work for many, although the effects are modest. You still need to exercise. For best results, orlistat needs to be used with a calorie controlled diet containing approximately 30% fat. Too little fat – not much to block. Too much fat – let’s say you may not want to be out in public when this happens!
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