Xenical (Orlistat) - Summary

XENICAL SUMMARY

XENICAL®
(orlistat)
CAPSULES

XENICAL (orlistat) is a lipase inhibitor for obesity management that acts by inhibiting the absorption of dietary fats.

XENICAL is indicated for obesity management including weight loss and weight maintenance when used in conjunction with a reduced-calorie diet. XENICAL is also indicated to reduce the risk for weight regain after prior weight loss. XENICAL is indicated for obese patients with an initial body mass index (BMI) >/=30 kg/m² or >/=27 kg/m² in the presence of other risk factors (eg, hypertension, diabetes, dyslipidemia).

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NEWS HIGHLIGHTS

Media Articles Related to Xenical (Orlistat)

Xenical and Alli: Liver Risk?
Source: MedicineNet Jaundice Specialty [2009.08.25]
Title: Xenical and Alli: Liver Risk?
Category: Health News
Created: 8/25/2009
Last Editorial Review: 8/25/2009

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Published Studies Related to Xenical (Orlistat)

Weight Loss, HbA(1c) Reduction, and Tolerability of Cetilistat in a Randomized, Placebo-controlled Phase 2 Trial in Obese Diabetics: Comparison With Orlistat (Xenical). [2009.05.21]
The objective of this multicenter, randomized, double-blind study was to determine the efficacy and safety of cetilistat and orlistat relative to placebo in obese patients with type 2 diabetes, on metformin. Following a 2-week run-in, patients were randomized to placebo, cetilistat (40, 80, or 120 mg three times daily), or orlistat 120 mg t.i.d., for 12 weeks.

An RCT of metformin versus orlistat for the management of obese anovulatory women. [2009.04]
BACKGROUND: Treatment of obesity-related anovulation poses a significant clinical challenge. Occasionally, the use of antiobesity medications such as orlistat or insulin sensitizing agents such as metformin is sometimes indicated in these patients. This study aimed to compare the effects of metformin and orlistat for improving ovulation in obese anovulatory women... CONCLUSIONS: Both metformin and orlistat show a similar effect on weight loss, ovulation rates and androgen concentrations. However, the effects on ovulation rates need to be confirmed in larger studies. The presence of a low baseline serum LH was found to be the most important predictor of ovulation. The study was registered at clinicaltrials.gov. NCT00292799.

Orlistat accelerates gastric emptying and attenuates GIP release in healthy subjects. [2009.03]
Orlistat, an inhibitor of digestive lipases, is widely used for the treatment of obesity. Previous reports on the effect of orally ingested orlistat together with a meal on gastric emptying and secretion of gut peptides that modulate postprandial responses are controversial... Since GIP is being implemented in the development of obesity, its role in weight control attained by orlistat awaits further investigation.

Effect of metformin, orlistat and pioglitazone treatment on mean insulin resistance and its biological variability in polycystic ovary syndrome. [2009.02]
CONTEXT: Mean insulin resistance (IR) is greater and it is also more variable in overweight women with polycystic ovarian syndrome (PCOS) compared to weight matched controls. Whilst treatment will reduce the mean IR, it is not known if the IR variability is also reduced. OBJECTIVE: To compare the change in IR and its variability before and after treatment with insulin sensitization through metformin and pioglitazone, compared to that induced by weight loss with orlistat... CONCLUSION: Only orlistat reduced both IR and its variability significantly, though all three drugs were effective in reducing hyperandrogenism within the 12-week period of the study.

Orlistat for overweight subjects with nonalcoholic steatohepatitis: A randomized, prospective trial. [2009.01]
The aim of this study was to determine if orlistat, an inhibitor of fat absorption, combined with caloric restriction in overweight subjects with nonalcoholic steatohepatitis results in weight loss and improved liver histology. Fifty overweight subjects (body mass index = >or=27) with biopsy proven nonalcoholic steatohepatitis were randomized to receive a 1,400 Kcal/day diet plus vitamin E (800 IU) daily with or without orlistat (120 mg three times a day) for 36 weeks...

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Clinical Trials Related to Xenical (Orlistat)

Adding Guided Self-Help Group Therapy to the Alli Weight Loss Program in Treating Binge Eating Disorder [Active, not recruiting]
This study will evaluate the effectiveness of adding guided self-help group therapy to a weight loss program in achieving weight loss and reducing binge eating in overweight binge eaters.

Orlistat (Xenical) in the Treatment of Overweight Patients With Nonalcoholic Steatohepatitis (NASH) [Completed]
The purpose of this study is to determine if orlistat (Xenical) therapy in overweight patients with NASH leads to enhanced weight loss over time, with subsequent improvement in the underlying necroinflammatory and fibrotic changes that are typical of NASH.

Safety and Efficacy of Xenical in Children and Adolescents With Obesity-Related Diseases [Active, not recruiting]
Obesity is a condition affecting one-third off the U. S. population and is a major risk actor for the development of Type 2 diabetes, hyperlipidemia (increased levels of fat in the blood), hypertension (high blood pressure), and other disorders of the heart and lungs. Individuals with the onset of obesity during childhood or adolescence are at an increased risk of obesity-related, diseases, both during adolescence and later in adult life.

African American girls and women are at an increased risk for obesity, and have substantial rates of obesity-related diseases and causes of death. Further, many African American adult women fail to respond to many of the therapeutic approaches used to treat obesity. At present there are no medical therapies proven effective for the correction of severe obesity in children or adolescents.

One medication that may have a favorable risk-benefit ratio in pediatric populations is Orlistat (Xenical, Hoffmann LaRoche). Orlistat works by preventing the action of enzymes in the digestive process, interfering with the absorption of approximately 1/3 of the fat eaten in the diet. Xenical appears to be effective for reducing weight and obesity-associated diseases in obese adults.

Researchers propose to determine the safety, tolerability, and efficacy of Xenical in 12-17 year old severely obese African American and Caucasian children and adolescents who have one or more obesity-related disease (hypertension, hyperlipidemia, sleep apnea, hepatic steatosis, insulin resistance, impaired glucose tolerance, or Type 2 diabetes).

Orlistat Treatment of Crigler-Najjar Disease [Completed]
The purpose of this study was to determine whether orlistat is effective in decreasing plasma unconjugated bilirubin levels in patients with Crigler-Najjar disease.

A Study of Xenical (Orlistat) in Overweight and Obese Adolescents [Recruiting]
This 2 arm study will assess the effect of Xenical on body mass index (BMI)in obese or overweight adolescents. Patients will be randomised into one of 2 groups; both groups will undergo a regimen of mildly hypocaloric diet and physical exercise, but one group will also receive Xenical 120mg po tid. The anticipated time on study treatment is 1 year, and the target sample size is <100 individuals.

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PATIENT REVIEWS / RATINGS / COMMENTS

Xenical review by 32 year old female patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		Overweight
Dosage & duration:		120mg taken twice daily for the period of 1 year
Other conditions:		none
Other drugs taken:		birth control (yasmin)
		Reported Results
Benefits:		Lost 10 pounds.
Side effects:		Oily stools, gas, bloating. Learned to avoid greasy foods. I experienced no other side effects.
Comments:		I took a 120mg pill after any meal with fat (2-3 times daily). It seemed like over time, since my body was aborbing less calories i started to crave less. The only problem was that without modifying my diet, the weight came back after i quit taking the drug. It is also expensive, and although it does work I am not sure it is worth the high price.

Xenical review by 27 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		obesity
Dosage & duration:		120mg with every meal containing fats taken 2-3 times a day for the period of 6 months
Other conditions:		n/a
Other drugs taken:		none
		Reported Results
Benefits:		Lost 8 kg during 6 months, which would have been more if eating healthier and exercising.
Side effects:		Strong and first difficult to control bowel movements
Comments:		This drug makes your body to reject about 30% of fats that you intake with your meals. But you still get the rest of it. What happens with 30% - it comes out and sometimes it is quite an embarrassing experience. Got to control it later, mainly by cutting off food that was reach on fats. Maybe if cut fats alltogether, wouldnt have needed Xenical.

Xenical review by 30 year old female patient
		Rating
Overall rating:
Effectiveness:		Ineffective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		obesity
Dosage & duration:		120mg taken twicwe a day for the period of five weeks
Other conditions:		n/a
Other drugs taken:		birth control/ terbisil
		Reported Results
Benefits:		I really didnt lose any weight even though I cut my caloric intake. I stopped snacking and in general ate less and went for walks when possible
Side effects:		I had only mild side effects such as oily stools and I couldnt hold it I just had to go when I felt like it
Comments:		I took the pills twice a day as I tried to have only two meals per day