2008/12/31

alli packaging tour

alli -- possible side effects (or treatment effects)

Some people on alli® will experience GI side effects, which is expected since alli works by inhibiting about 25% of dietary fat. alli is half the strength of prescription Xenical® (orlistat 120 mg), and, as a result, has fewer GI events overall than Xenical®. In clinical trials, subjects on 120 mg withdrew due to GI adverse events at a rate of 5.4%—and at 60 mg it was only 3.2%.

The main treatment effect occurs when an individual eats a meal with too much fat while taking alli. Treatment effects may include:

  • Loose or more frequent stools that may be hard to control
  • An urgent need to go to the bathroom
  • Gas with oily spotting

While excess fat that is excreted is not harmful, patients could be distressed by the experience. Treatment effects can be lessened if an individual sticks with reduced-calorie, low-fat meals that average 15 grams of fat per meal (or 30% fat or less). Diets may vary from 1,200 calories to 1,800 calories per day, so 15 grams is an average. Individuals need to be aware of hidden fat in food, so that they can lower the chance of having treatment effects.

Not all individuals will experience treatment effects, but those that do can reduce the likelihood of these effects by taking alli as directed and sticking with a reduced-calorie, low-fat diet. The alli starter pack includes portable reference guides and online support at myalli.com to help patients follow the program accurately. Some patients may experience treatment effects as they begin therapy until they learn to adjust their diet.

alli (orlistat 60mg) and Xenical (orlistat 120mg)

The active ingredient in alli® (orlistat) has been used in the United States as a prescription-only medication at double the dose found in alli. Xenical® (orlistat 120 mg/TID) was introduced in the United States in 1999 following rigorous clinical studies and FDA approval. Orlistat has an extensive clinical history. It has had 25 million patient treatments and has been studied in more than 100 controlled clinical trials.

Behavior Support programs are part of the foundation for successful weight loss. Xenical® provided a separate support program for patients known as Xenicare, which, at the time, was considered a comprehensive plan. But a lot has changed since the introduction of Xenical®, including consumer expectations, healthcare professional involvement within the weight loss category and consumer, information utilization, namely, the sophistication of the Internet user. Applying learnings from Xenicare, our insights from consumers & healthcare professionals, and our understanding of current Internet usage, we have developed the alli support program, called myalliplan™. The myalliplan is an individually tailored support plan based on sound clinical practices and designed by nutrition and weight loss experts. It is free with the purchase of alli. The myalliplan.com is an extremely comprehensive online support program, including personalized online pages to view goals, check-ins with individualized feedback and advice, continuous follow-up and weekly monitoring, personalized emails on eating right/meal planning, guidance on treatment effects, online journal, menus and shopping lists, direct advice from clinical experts and a connection to a community of other alli users. Research indicates that those who receive one-on-one counseling or online support may have a long-term advantage in successfully losing weight.

alli is different than Xenical® because it offers informational materials with the actual product. The alli starter pack includes over 200 pages of free in-pack materials to help guide individuals through the alli program and set expectations for gradual weight loss, help them make healthy eating choices, monitor daily diets, and manage treatment effects. Eighty percent of patients found these materials to be very helpful. Overall, the alli program offers unprecedented support and resources designed to help modify behavior by creating self-assessment and self-management skills. Assuming personal responsibility is integral to achieving sustainable weight loss.

Another difference when comparing alli to Xenical® is the manageability and tolerability of GI events. 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-AEs (5.4% on 120mg compared to only 3.2% on 60-mg), further reinforcing the tolerability of the 60mg 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, alli will tell consumers and HCPs alike that the likelihood of treatment effects is greater if individuals aren’t committed to following a reduced-calorie, low-fat diet (no more than 15 grams of fat per meal) and eating smaller portions.

Learning from experience and developing self-assessment and self-improvement skills are the cornerstones of the alli program. alli is not a program for everyone; without a commitment to adopting healthy habits, patients will not achieve their weight loss goals.



Alli -- weight loss pill (Video Show)

Time is ticking on the miracle diets, the untested, the untrue. Now you can look at weight loss differently.



2008/12/13

Alli weight-loss pill: Does it work?




[ Is Alli the solution to your weight-loss woes? ]
A Mayo Clinic specialist discusses the effectiveness of Alli, an over-the-counter weight-loss pill. Another drug is available to aid your weight-loss efforts, but this time you don't need a prescription. Alli (pronounced AL-eye) is meant for overweight adults who are struggling to shed excess pounds. With its easy access and weight-loss promises.


[ Is Alli your answer to losing weight permanently? ]
Here, Donald Hensrud, M.D., a preventive medicine and nutrition specialist at Mayo Clinic, Rochester, Minn., answers common questions about Alli. What is Alli? Alli is the reduced-strength version of orlistat (Xenical), a prescription drug to treat obesity. It's approved for over-the-counter sale to overweight adults 18 years and older. Alli is meant to be used in conjunction with a low-calorie, low-fat diet and regular exercise.


[ How does Alli work? ]
Alli promotes weight loss by decreasing absorption of fat by the intestines, which reduces the number of calories you absorb. Lipase, an enzyme found in the digestive tract, helps break down dietary fat into smaller components, so it can be used or stored for energy. Alli works by disabling lipase, which prevents the enzyme from breaking down the fat while it's in your digestive tract. The undigested fat continues through the intestines and is eliminated through bowel movements. Alli is taken with fat-containing meals, up to three times a day. Because of how Alli works, it's recommended that you eat no more than 15 grams of fat with each meal. Eating higher amounts of fat can cause unwanted effects, such as urgent bowel movements, diarrhea and gas with oily spotting.


[ How much weight could I lose using Alli? ]
Alli can help you lose weight, but the weight loss likely won't be great — perhaps just a few pounds more than you would lose with diet and exercise alone. Only a small number of studies have evaluated the effectiveness of Alli. And many of the weight-loss estimates are based on studies conducted on its prescription-strength counterpart, Xenical. The average weight loss for prescription-strength Xenical is modest — about 6 pounds greater than diet and exercise alone after one year. So at half the strength, Alli could conceivably result in an average of 3 pounds lost in a year in addition to the approximately 8 pounds you could expect to lose from diet and exercise alone.


[ When shouldn't I take Alli? ]
You shouldn't take Alli if you:
~Are at a healthy weight
~Are taking cyclosporine
~Have had an organ transplant
~Have problems absorbing food
The drug also may pose risks for anyone who takes blood-thinning medication or has diabetes or thyroid disease. Orlistat decreases the absorption of certain fat-soluble vitamins — for example, vitamins A, D and E. If you're taking Alli, you need to take a daily vitamin supplement (at a time different from when you take Alli) to prevent potential nutrient deficiencies.


[ How long do I need to take Alli? ]
According to the manufacturer, most weight loss occurs within the first six months. Many people who take medications to lose weight regain the weight they lost when they stop taking the medication. Therefore, to keep the weight off, many people continue taking medications indefinitely along with eating a low-calorie diet and exercising regularly.


[ How does Alli fit into a healthy weight-loss plan? ]
As you consider Alli as a weight-loss aid, make sure that you make every effort to exercise, change your eating habits and adjust any other lifestyle factors that have contributed to your excess weight. Alli isn't the easy answer to weight loss and is meant only to supplement — not replace — a healthy diet and regular exercise. Work with your doctor to evaluate the potential benefits and risks of Alli or any other weight-loss drugs. As a team, you can create the most effective weight-loss plan for you.

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