Xenical - orlistat

What is Xenical?

Xenical contains the active ingredient orlistat. The medicine comes in 120 mg turquoise capsules.

What is Xenical used for?

Xenical is indicated in combination with a diet for the treatment of obese patients (overweight), with a body mass index (BMI) greater than or equal to 30 kg per square meter, or overweight patients (BMI greater than or equal to  28 kg / m2) which risk falling ill due to this imbalance. The medicine can only be obtained with a prescription.

How is Xenical used?

Xenical is taken in doses of a capsule taken with water immediately before, during or within an hour of each main meal. If you miss a meal, or if the food consumed is fat-free, it is preferable not to take Xenical. The patient should follow a diet rich in fruit and vegetables, in which about 30% of the calories taken come from fat. The foods included in the diet should be divided into three main meals.

You should stop taking Xenical if, after 12 weeks, the patient has not lost at least 5% of the body weight recorded at the beginning of the treatment.

How does Xenical work?

The active ingredient in Xenical, orlistat, is an obesity medicine that does not affect appetite. Orlistat is an inhibitor of gastrointestinal lipases (fat-metabolizing enzymes).

The inhibition of these enzymes prevents the metabolism of some fats in the diet, this allows about 30% of the fats ingested during meals to pass through the intestine without being digested. The body cannot use these lipids supplied by the diet to produce energy or accumulate them in adipose tissues, thus favoring weight loss.

What studies have been carried out on Xenical?

The effects of Xenical were first tested in experimental models before being studied in humans.

Xenical was observed in seven main studies involving over 3, 000 overweight or obese patients. The studies lasted from one to two years and compared three different dosages of Xenical compared to a placebo (a dummy treatment), in combination with a diet. Patients and doctors knew what treatment was administered only at the end of the study. A further, more prolonged study involved over 3, 000 obese patients, comparing the effects of Xenical and placebo treatment over a four-year period, in conjunction with a diet and exercise regimen. For all the studies, the efficacy index was based on the change in body weight.

What benefit has Xenical shown during the studies?

Xenical has shown greater efficacy than placebo treatment in determining weight loss. When the results of all seven shorter studies were considered together, patients treated with Xenical in doses of 120 mg, three times a day, after a year, had reported an average weight loss of 6.1 kg, compared to 2.6 kg of patients given placebo treatment. In proportion, the percentage of subjects who had lost more than 10% of their initial body weight was 20% in patients treated with the indicated dose of Xenical and 8% in the placebo group. At the end of the four-year study, 21% of patients treated with Xenical had lost more than 10% of body weight, compared to 10% of patients who received a placebo drug.

What is the risk associated with Xenical?

The most common side effects with Xenical (in over one in ten patients) are: influenza, hypoglycemia (low blood sugar levels), headaches, upper respiratory tract infections (colds), loss of small amounts of oily material from the rectum, abdominal discomfort or cramps, flatulence, also combined with faecal emission, strong stimulation to defecation, fat / oily-looking stools, liquid stools, oily evacuation and increased defecation. These symptoms generally occur at the beginning of the treatment and disappear after some time. For the full list of all side effects reported with Xenical, see the Package Leaflet. Xenical should not be used in patients who are hypersensitive (allergic) to orlistat or any of the other ingredients of the medicine. It should also not be used for patients suffering from chronic intestinal malabsorption (ie when the nutritional principles contained in the food are not readily absorbed during digestion), by cholestasis (liver disorders) or by lactating.

Why has Xenical been approved?

The Committee for Medicinal Products for Human Use (CHMP) considered that the benefits of Xenical outweigh the risks, in combination with a moderately hypocaloric diet, for the treatment of obese patients, with a BMI greater than or equal to 30 kg / m2, or of overweight patients (BMI ≥ 28 kg / m2) with associated risk factors. The committee recommended that Xenical be given marketing authorization.