Xenical (Orlistat) - Summary

XENICAL SUMMARY

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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XENICAL NEWS HIGHLIGHTS

Published Studies Related to Xenical (Orlistat)

Orlistat for overweight subjects with nonalcoholic steatohepatitis: A randomized, prospective trial. [2009.01]
The aim of this study was to determine if orlistat [generic for Xenical], 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...

The effects of ezetimibe and orlistat, alone or in combination, on high-density lipoprotein (HDL) subclasses and HDL-associated enzyme activities in overweight and obese patients with hyperlipidaemia. [2008.12]
BACKGROUND: High-density lipoprotein (HDL) includes discrete subfractions. HDL exhibits anti-atherogenic properties, which have been partly linked to the activity of HDL-associated enzymes, such as the lipoprotein associated phospholipase A(2) (HDL-LpPLA(2)) and paraoxonase-1 (PON1). Objective: We assessed in an open-label randomised study the effect of orlistat [generic for Xenical] and ezetimibe, alone or in combination, on plasma HDL subclasses and HDL-associated enzyme activities in overweight and obese subjects (body mass index > 28 kg/m(2)) with hypercholesterolemia [total cholesterol > 200 mg/100 ml (5.2 mmol/l)]... CONCLUSION: Although HDL-C levels did not change after treatment with orlistat and ezetimibe, alone or in combination, there were alterations of the HDL-2 and HDL-3 subclasses. The activity of HDL-LpPLA(2) and PON1 per mg LDL-C increased significantly in all groups.

Orlistat and sibutramine beyond weight loss. [2008.06]
BACKGROUND AND AIM: To investigate, through a meta-analysis of clinical trials, the effect of two weight-reducing drugs, such as orlistat [generic for Xenical] and sibutramine, on serum lipid profiles in overweight and obese subjects, independently of weight loss... CONCLUSION: Orlistat or sibutramine, when individually compared to placebo, are effective in promoting significant weight loss. In addition, orlistat determines a significant reduction of total cholesterol, independent of weight loss itself. These observations indicate that orlistat is a useful adjunctive tool for improving cardiovascular risk factor profiles in overweight and obese patients.

The effects of orlistat and fenofibrate, alone or in combination, on high-density lipoprotein subfractions and pre-beta1-HDL levels in obese patients with metabolic syndrome. [2008.06]
OBJECTIVE: We assessed the effect of orlistat [generic for Xenical] and fenofibrate, alone or in combination, on plasma high-density lipoprotein (HDL) subfractions and plasma pre-beta1-HDL levels in overweight and obese subjects with metabolic syndrome (MetS)... CONCLUSION: OF combination increased the antiatherogenic pre-beta1-HDL levels in overweight and obese patients with MetS. Furthermore, OF combination counterbalanced the reduction of small HDL-C levels observed with orlistat monotherapy.

Orlistat in clozapine- or olanzapine-treated patients with overweight or obesity: a 16-week randomized, double-blind, placebo-controlled trial. [2008.05]
CONCLUSIONS: Without a hypocaloric diet, the effect of orlistat [generic for Xenical] in overweight/obese clozapine-or olanzapine-treated patients is modest and may only be seen in men. More studies should define the optimal length of treatment and feasibility of combination of orlistat with behavioral programs in this population.

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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.

An RCT of Metformin Vs Orlistat in Obese Anovulatory Women [Completed]
This study aims to investigate the role of the weight reduction agent, Orlistat compared to the Metformin for the management of women who are obese and do not ovulate or have difficulty conceiving. Patients will receive either one of these medications and will be monitored at regular intervals with hormone blood tests and ultrasound scans in order to study the effect of the medications on the reproductive functions. Patients will receive the medications for three months and the study will end if the patient becomes pregnant. The study also aims to investigate the dose of metformin that should be used as there is no consensus to date regarding the optimum dosage for this drug

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XENICAL 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 32 year old female patient
		Rating
Overall rating:
Effectiveness:		Marginally Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		Weight Loss
Dosage & duration:		60 mg taken 2 times a day for the period of 3 months
Other conditions:		None
Other drugs taken:		None
		Reported Results
Benefits:		The treatment benefits was a minimal weight loss, but not nearly as much as I expected.
Side effects:		I mainly experienced the following side effects: diarrhea, stomach cramps, indigestion, flatulence, oily stool, defecation urgency.
Comments:		I think is a good medication if you follow a good planned diet, but don't expect to loose too much weight if you only take the pill and don't cut your calories or exercise more often.

Xenical review by 32 year old female patient
		Rating
Overall rating:
Effectiveness:		Marginally Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		Weight Loss
Dosage & duration:		60 mg taken 2 times a day for the period of 3 months
Other conditions:		None
Other drugs taken:		None
		Reported Results
Benefits:		The treatment benefits was a minimal weight loss, but not nearly as much as I expected.
Side effects:		I mainly experienced the following side effects: diarrhea, stomach cramps, indigestion, flatulence, oily stool, defecation urgency.
Comments:		I think is a good medication if you follow a good planned diet, but don't expect to loose too much weight if you only take the pill and don't cut your calories or exercise more often.