Orlistat is indicated in combination with a mildly hypocaloric diet in the treatment of obesity (Body Mass Index (BMI) greater than or equal to 30 kg/m2) or overweight (BMI greater than or equal to 28 kg/m2) associated with risk factors.
Treatment with orlistat should be discontinued after 12 weeks if patients have not lost at least 5% of initial weight measured at baseline.
The recommended dose of orlistat is one 120 mg capsule taken with water immediately before, during or up to one hour after each main meal. If a meal is missed or contains no fat, the dose of orlistat should be omitted.
The patient must follow a mildly hypocaloric diet, well balanced nutritionally and contain about 30% of calories as fat. It is recommended that the diet is rich in fruits and vegetables. The daily intake of fat, carbohydrate and protein should be distributed over three main meals.
Doses above 120 mg three times daily did not provide additional benefit. Orlistat causes an increase in the amount of fat in the stool 24 to 48 hours after dosing. At the end of treatment, the faecal fat content usually returns to baseline within 48 to 72 hours.
The effect of orlistat has not been studied in hepatic and / or renal impairment, in children and the elderly.
There is no specific indication for use of Orlistat in children.
Orlistat is a potent, specific and long-acting gastrointestinal lipase. It exerts its therapeutic activity in the lumen of the stomach and small intestine by forming a covalent bond with the active serine site of gastric and pancreatic lipases. The inactivated enzyme can no longer hydrolyze triglycerides in food-borne free fatty acids and monoglycerides absorbable.
In studies at 2 years and 4 years to the study, a low calorie diet was associated with the treatment, in both the orlistat and placebo groups.
The combined results of five studies conducted over 2 years with orlistat and a hypocaloric diet showed that 37% of patients treated with orlistat and 19% of patients on placebo had treatment after 12 weeks of weight loss of at least 5% weight in relation to their inclusion. Of these patients, one year, 49% of patients treated with orlistat and 40% of patients receiving placebo had weight loss > 10% relative to their weight at baseline. Conversely, among patients who did not submit a weight loss of 5% compared to their weight at baseline after 12 weeks of treatment, only 5% of orlistat treated patients and 2% of patients on placebo had a weight loss > 10% at one year compared to their weight at baseline. Overall, after 1 year of treatment, 20% of patients treated with 120 mg orlistat lost at least 10% of their weight, as against 8% of placebo patients. The mean difference in weight loss between the treated and placebo groups was 3.2 kg.
The results of the study to four years XENDOS showed that 60% of patients treated with orlistat and 35% of patients on placebo had treatment after 12 weeks of weight loss of at least 5% relative to their weight inclusion. Of these patients, one year, 62% of patients treated with orlistat and 52% of patients receiving placebo had weight loss > 10% relative to their weight at baseline. Conversely, among patients who did not submit a weight loss of 5% compared to their weight at baseline after 12 weeks of treatment, only 5% of orlistat treated patients and 4% of patients on placebo had a weight loss > 10% at one year compared to their weight at baseline. After 1 year of treatment, 41% of orlistat treated patients against 21% of placebo patients lost > 10% of their weight with a mean difference of 4.4 kg between the two groups. After 4 years of treatment, 21% of orlistat treated patients against 10% of placebo patients lost > 10% of their weight, with a mean difference of 2.7 kg.
Against the five studies conducted over 2 years, the study XENDOS, a larger number of patients treated with orlistat or placebo had a weight loss of at least 5% at 12 weeks or 10% at one year weight in relation to their inclusion. This difference is explained by the fact that the five studies of two years include the period of diet alone for 4 weeks during which patients lost an average of 2.6 kg before starting treatment.
The results of the study to 4 years also suggested that weight loss achieved with orlistat delayed the development of type 2 diabetes during the study (cumulative incidence of diabetes: 3.4% in group orlistat against 5.4% in the placebo group). The vast majority of diabetes cases came from the subgroup of patients with impaired glucose tolerance at baseline, which represented 21% of patients randomized. The long-term clinical benefit of these findings is unknown.
Obese patients with type 2 diabetes inadequately controlled with antidiabetic treatment, data from four clinical studies lasting one year showed that the percentage of responders (weight loss > 10%) was 11.3% with orlistat compared to 4.5% with placebo. In patients treated with orlistat, the mean difference of weight loss versus placebo was 1.83 kg to 3.06 kg and the mean reduction in HbA1c compared to placebo was 0.18% at 0, 55%. It has not been demonstrated that the effect on HbA1c is independent of weight loss.
In a multicenter study (USA, Canada), parallel group, double-blind, placebo-controlled, 539 obese adolescents were randomized to receive either 120 mg orlistat (n = 357) or placebo (n = 182), 3 times daily for 52 weeks, in combination with a reduced calorie diet and physical activity. Both groups of patients received vitamin supplementation. The primary endpoint was change in BMI between the date of inclusion and the end of the study.
The results were significantly higher in the orlistat group (difference in BMI of 0.86 kg / m2 in favor of orlistat). 9.5% of orlistat treated patients against 3.3% of placebo patients lost > 10% weight loss at 1 year with an average difference of 2.6 kg between the two groups. The difference was mainly driven by the outcome in the group of patients with > 5% weight loss after 12 weeks of treatment with orlistat, which represented 19% of the initial population. Adverse events were generally similar to those observed in adults. However, an unexplained increase in the incidence of bone fractures (6% against 2.8% respectively in the orlistat and placebo groups) was observed.
Weight loss observed in the orlistat clinical studies, was lower in patients with type 2 diabetes than in patients without diabetes. Medical treatments can antidiabetic require close monitoring during the association with orlistat.
The combination with ciclosporin is not recommended
Patients are advised to follow the dietary recommendations they are given
The possibility of the occurrence of gastrointestinal adverse effects may increase when orlistat is taken with a high fat diet (eg in the case of a plan of 2000 kcal / day,> 30% calories from fat equivalent to> 67 g fat). The daily intake of fat should be distributed over three main meals. If orlistat is taken with a meal rich in fat, the possibility of gastrointestinal side effects may increase.
Cases of rectal bleeding have been reported with Orlistat. Prescribers should be deepened further examinations in case of severe symptoms and / or persistent.
The coagulation parameters should be monitored in patients on concomitant treatment with anticoagulants
The use of orlistat may be associated with hyperoxaluria and oxalate nephropathy in patients with chronic kidney disease underlying and / or a depletion of plasma volume
Rare hypothyroidism and / or reduced control of hypothyroidism may occur. The mechanism, although not clearly established, could involve a decreased absorption of iodine salts and / or levothyroxine
Patients taking antiepileptic drugs: Orlisat can disrupt the anticonvulsant treatment by decreasing the absorption of antiepileptic drugs, leading to convulsions
The side effects of orlistat are largely gastrointestinal in nature. The incidence of adverse events decreased during the prolonged use of orlistat.
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