- U.S. Food and Drug Administration (FDA) approved Alli in February 2007
- European Medicines Agency (EMA) approved Alli in July 2007
International distributor of Alli pills is British pharmaceutical company GlaxoSmithKline (GSK).
- Alli medicine sold at US pharmacies is imported from India.
- Alli medicine supplied to the European market is manufactured in Greece.
In different regions, Alli is indicated to different groups of patients.
- In the USA – Alli is recommended for weight loss to patients with a BMI of 25 and above.
- In the EU – Alli weight loss is recommended for weight loss to patients with a BMI of 28 and above.
It should be noted that pharmaceutical markets in USA and Europe are supplied with various Alli forms. In the USA only oral capsules Alli are available, and in Europe Alli capsules are available as well as chewable tablets.
- Each Alli capsule contains 60mg of Orlistat.
- Each Alli chewable pill contains 27mg of Orlistat.
Alli capsules and tablets contain different amounts of Orlistat, an active ingredient, but their pharmacological and therapeutic properties are identical.
Clinical research results have demonstrated that 27mg Alli chewable tablets provide the same weight loss rate as Alli 60mg capsules.
And considering that Alli 27mg tablets contain less active ingredient, they cause less side effects than capsules of Alli 60mg.
If Alli capsules cause side effects, the drug can be replaced by Alli chewable tablets with a lower dose of Orlistat. Fast-soluble, low-dose Alli is not available in the USA, but some online pharmacies accept orders for their delivery to any country in the world.
Bioequivalence and interchangeability of Alli 60 mg capsules and Alli 27mg tablets are confirmed by the European Committee for Medicinal Products for Human Use (CHMP), in 2010.
Alli capsules and tablets contain different doses of Alli, but their mechanisms of action are identical. Alli medicine helps to lose weight because it inactivates digestive enzymes playing a key role in the digestion of fats.
Inactivating gastric enzymes, Alli blocks the digestion and absorption of vegetable and animal fats in the small intestine and the stomach. As a result, undigested fats are excreted unchanged, and do not form new fat cells or deposit fats.
Research data show that Alli can block the absorption of up to 25% fats, regardless of the total amount of consumed fatty foods. This value can be affected by various factors, so Alli efficiency may vary in different conditions.
For an objective assessment of Alli effectiveness, over 100 clinical studies have been conducted, enrolling more than 30 000 obese men and women. The longest investigation of Alli lasted for 4 years.
Review of the results of different clinical and post-marketing studies regarding Alli demonstrates that:
- the patients taking Alli cope to reduce 50% more weight comparing to patients using only non-drug therapies to fight against obesity.
At regular application of Alli, the maximum weight loss is up to 2 pounds per week. But the maximum weight loss is unachievable without balanced diet and daily physical exercise.
Therefore, those who are aimed at the best results in the fight against overweight, have to pay enough attention to healthy eating and regular physical activity.
- Take one tablet or capsule of Alli three times a day, one hour before, during, or one hour after each main meal.
If you missed the main meal, or your breakfast, lunch or dinner did not contain fats, an Alli dose can be skipped.
- Do not ignore fatty food. Dietary fats are needed to maintain normal metabolism and to quickly reach satiety.
Make a diet plan so that to consume no more than 15 g of vegetable and (or) animal fats during each meal.
- Do not increase calorie content of breakfast, lunch or dinner at the expense of consumed protein and carbohydrates.
Alli does not block the digestion of carbohydrates and fats. Therefore, increasing the nutritional value of breakfast, lunch, and dinner at the expense of proteins and carbohydrates, you are stimulating to gain weight.
- Take multivitamins daily, and drink much water during the day.
Alli affects the metabolism of some fat-soluble vitamins and reduces their levels in the body. Multivitamins should be taken two hours before or after a regular dose of Alli as a mandatory part of complex weight loss program.
- Take Alli as long as these diet pills provide a stable decrease in body weight. Duration of Alli use is not limited.
Stop taking Alli pills if they do not provide significant reduction in weight, or if BMI has dropped to 25. You can start taking Alli again, once your BMI exceeds again 25.
- Always remember that diet pills Alli are the medicine of an optimal dosing regimen.
Even if you eat more than three times a day, do not take more than three Alli pills every 24 hours. The minimum interval between regular doses of Alli should be two hours. If you are using Alli more than three times a day, the risk of side effects increases.
- stomach cramps
- gastric discomfort
Alli investigation results showed that just 3% of patients observed serious adverse reactions requiring Alli withdrawal.
Post-marketing surveillances and consumers’ testimonials suggest that many men and women stop taking Alli, even if these diet pills cause mild to moderate side effects.
Increased flatulence and quickened defecation negatively affect the social and professional activity.
Therefore, despite gastrointestinal effects of Alli do not pose any potential risk to overall health state, many obese patients find it unacceptable, and refuse to use Alli due to diarrhea and (or) flatulence.
- Side effects which can cause discomfort are believed to be the most serious disadvantage of Alli.
- An insignificant number of contraindications, OTC market status, and relatively low price are the key benefits of Alli.
Almost 10 years passed since the launch of Alli, and its retail price during this period was changed periodically.
• In 2007, the starting price of 30-day supply of Alli 60 mg capsules* in USA was about 77$.
* 30-day supply = 120 Alli capsules (refill pack)
• In 2016, the price range for one Alli refill pack varies from 50$ to 70$. Almost all online retailers included delivery cost into Alli capsules price.
In early 2015, US Alli distributor launched a discount program and provided the chance to get a coupon for 10$ for each purchase of Alli. By the end of 2015, this discount program was terminated, and now on the date of this review publication, a coupon for Alli pills from the official distributor is unavailable in the USA.
Cases of sale of counterfeit Alli pills were observed in March 2014 in the US markets. After numerous reports of the sale of counterfeit Alli, GSK company withdrew the drug from the US market, and to buy Alli in the USA was impossible for the next 10 months.
In February 2015, GSK announced Alli back to US market and its sale was resumed. According to official data, in the period from 2007 to 2016 – more than 50 million people used Alli pills worldwide. At the same time, every fifth buyer of Alli diet pills lives in the USA.
Alli is a unique weight loss management solution – unlike dozens of its rival, it’s a drug approved by FDA for sales over the counter in the US.
The drug is based on orlistat – the active substance that lies in the composition of Xenical, one of the best-selling drugs for obesity treatment in the latest 5 years (according to WebMD stats, the preparation finds itself comfortably in the list of 10 most prescribed meds in the country). Alli is oftentimes referred to as a ‘light’ modification of Xenical, as it contains 60mg of orlistat, which is twice as less in comparison with Xenical (the fact that made a huge contribution into the drug’s OTC availability).
The direct correlation between an increased body mass and the development of cardiovascular diseases, type 2 diabetes, gallstone disease, and even some forms of cancer is clinically confirmed.
Alli therapy is available to a larger part of general public due to the absence of significant adverse reactions, a relatively short list of contraindications and unprecedented affordability. The preparation’s weight reduction capabilities were confirmed in many scientific researches and by years of clinical practice, and due to a decrease in weight in a lower prevalence of the aforementioned conditions and lower mortality were observed.
According to a range of clinical trials, the effectiveness of long term-treatment with Alli ranges from 6.5% to 11.5% reduction in weight; according to the currently available selection of meds, that’s one of the highest results. The price for the original drug starts from $50 per 120 pills package (the offer at Amazon.com, February, 2016). In the US the drug is marketed by a far-famed GlaxoSmithKline Company
To achieve significant weight reduction results the therapy must be accompanied by a low-calorie diet (and to press for the maximum results adding regular physical exercises is strongly recommended).
Alli is prescribed for weight loss management purposes: decreasing body mass or preventing the risks associated with repeated mass gains after the initial treatment course.
However, the drug is prescribed in those cases where the body mass index is exceeding or equal 30kg/m2 (27kg/m2 in the cases where obesity poses certain risks to health or in the presence of risks factors, such as hypertension or diabetes).
Alli must not be used in case of hypersensitivity to its components, as well as in case of bile stasis and chronic malabsorption. The insufficiency of clinically approved data on the use of the drug in children and pregnant/lactating women limits the use of the drug in such patients. If you have metabolic issues or kidney stones, consult your doctor before initiating Alli treatment.
According to the insert the medication should be taken with meals or no later than an hour after food intake. The dosage is picked up individually; on average it equals 3 pills daily. The dosage may be lower in those individuals suffering from diabetes. If you have missed the dose, do not double it and take the drug with the next meal.
A closer look at the OTC phenomenon of the US pharmaceutical market
The active ingredient’s scope of action aims at blocking the intestine and the stomach enzymes breaking down fats. The result of the action is a blockage of complex fats disintegration into fatty acids and monoglycerides: thus, the fats you consume with foods are partially not absorbed fully and get excreted from the body in an unchanged form.
The reception of the drug causes calorie deficit in the body, which promotes the organism to consume its own resources – in this case, fat deposits. According to the FDA pre-approval clinical trials the consumed dose of orlistat (60 mg) doesn’t provide a negative systemic or accumulative effect on the ecosystem.
The therapeutic dose of Alli is estimated to block approximately 25 – 30% of the fats you consume with each meal.
According to numerous clinical trials, neither the drug promotes an adverse reaction on bile composition and properties of bile, the rate of advancement of a lump of food through the digestive tract or the acidity of gastric juice.
An increase in the dosage provides clinically more successful results; however, this is where the reception should be negotiated with the doctor, and in this case it could be reasonable to consider the option of Xenical.
Importantly, Alli doesn’t adversely impact the balance of trace elements in the organism (such as zinc, magnesium, etc.) in the long term use (3+ weeks). The preparation doesn’t provide a mutagenic or carcinogenic effect.
The therapy is accompanied by unpleasant fatty content in stool, increased within the first 1 – 2 days of treatment; however, the adverse reaction passes away within a couple of days cessation of treatment.