Diabet Med. 2005 Mar;22(3):344-5..
Improvement of glycaemic control with rebound following orlistat initiation and cessation associated with minimal weight change.
Gonzalez S, Kilpatrick ES, Atkin SL.
Department of Medicine, University of Hull, Hull, UK. ucm_sg@hotmail.com.

A 57-year-old Caucasian woman with Type 2 diabetes treated for seven years with diet and oral combination hypoglycaemic therapy was referred because of the progressive deterioration of glycaemic control. She was obese (77 kg, BMI = 39.9), hypertensive, hypercholesterolaemic with marked osmotic symptoms (HbA(1c) 12.2%), therefore she was started on insulin (Human Mixtard 30 b.d.) with metformin therapy. Dietary counselling, recommendations to increase physical activity, and supervised self-injection technique with titration of her insulin were also provided. She was routinely followed-up to assess her progress. Two years later, her glycaemic control remained suboptimal. Average HbA(1c) was 10.4% despite an increasingly high dose of insulin (94 units/day) although it improved when metformin was increased to 1 g t.d.s. (HbA(1c) = 9.3%). Her BMI progressively rose from 39.9 to 42.1 (77 to 82.5 kg) despite dietary advice. A trial of orlistat (three months) was commenced, after intensive dietary counselling, that reduced her body weight by 1.5 kg (2% reduction, BMI 41.3). However, her HbA(1c) improved by 0.5% (from 9.3 to 8.8%). Six months after orlistat was stopped her HbA(1c) rose to 10.5% and weight increased to 81.8 kg (BMI 41.8). Despite the orlistat treatment broaching NICE guidelines should it have been continued?

Cochrane Database Syst Rev. 2005 Jan 25;(1):CD004096.
Pharmacotherapy for weight loss in adults with type 2 diabetes mellitus.
Norris S, Zhang X, Avenell A, Gregg E, Schmid Ch, Lau J.
Division of Diabetes Translation, National Center for Chronic Disease Prevention & Health Promotion, Centers for Control and Prevention, 4774 Buford Highway NE, Mail Stop K-10, Atlanta, GA, USA, 30341.

BACKGROUND: Obesity is closely related to type 2 diabetes and long-term weight reduction is an important part of the care delivered to obese persons with diabetes. OBJECTIVES: To assess the efficacy of pharmacotherapy for weight loss in adults with type 2 diabetes. SEARCH STRATEGY: Computerized searches were performed of MEDLINE (January 1966 to May 2004), EMBASE (January 1974 to May 2004, Web of Science (January 1981 to May 2004, and other electronic bibliographic databases, supplemented with hand searches of reference lists and selected journals. SELECTION CRITERIA: Randomized, controlled trials were included where pharmacotherapy was used as the primary strategy for weight loss among adults with type 2 diabetes. Published and unpublished literature in any language and with any study design was included. DATA COLLECTION AND ANALYSIS: Two reviewers abstracted data and the quality of included studies was evaluated by assessing potential attrition, as well as selection and measurement bias, and a Jadad score was obtained. Effects were combined using a random effects model. MAIN RESULTS: A sufficient number of studies were available for a quantitative synthesis for fluoxetine, orlistat, and sibutramine. Twenty two randomized controlled trials were included in the review, with a total of 296 participants for fluoxitine, 2036 for orlistat, and 1047 for sibutramine. Pharmacotherapy produced modest reductions in weight for fluoxetine (5.1 kg (95% confidence interval [CI], 3.3 - 6.9) at 24 to 26 weeks follow up; orlistat 2.0 kg (CI, 1.3 - 2.8) at 12 to 57 weeks follow-up, and sibutramine 5.1 kg (CI, 3.2 - 7.0) at 12 to 52 weeks follow-up. Glycated hemoglobin also modestly and significantly reduced for fluoxetine and orlistat. Gastrointestinal side effects were common with orlistat; tremor, somnolence and sweating with fluoxetine; and palpitations with sibutramine. Some studies, using a variety of study designs, were available on other drugs and a significant decrease in weight was noted in three studies of mazindol, one of phenmetrazine, two of phentermine. No studies were identified that fit inclusion criteria for pseudophedrine, ephedra, sertraline, yohimbine, amphetamine or its derivatives, bupropion, topiramate, benzocaine, threachlorocitric acid, sertraline, and bromocriptine. AUTHORS' CONCLUSIONS: Fluoxetine, orlistat, and sibutramine can achieve statistically significant weight loss over 12 to 57 weeks. The magnitude of weight loss is modest, however, and the long-term health benefits remain unclear. The safety of sibutramine is uncertain. There is a paucity of data on other drugs for weight loss or control in persons with type 2 diabetes.

Int J Clin Pract 2002 Sep;56(7):494-9
Randomised trial of the effect of orlistat on body weight and cardiovascular disease risk profile in obese patients: UK Multimorbidity Study
Broom I, Wilding J, Stott P, Myers N; UK Multimorbidity Study Group
Department of Clinical Biochemistry, University of Aberdeen and Grampian University Hospitals Trust, UK

The potential effect of orlistat on cardiovascular co-morbidities may have been previously underestimated. This study assesses the efficacy of orlistat therapy for weight loss and cardiovascular risk factor reduction in obese patients with cardiovascular risk. This was a 54-week, double-blind, randomised, placebo-controlled, parallel group study with 531 patients being randomised. Mean weight loss was significantly greater with orlistat than with placebo (5.8% vs 2.3%; p<0.0001). Orlistat was also associated with significantly greater improvements than placebo in diastolic BP (-5.5 vs -3.1 mmHg; p<0.01), systolic blood pressure (-6.0 vs -2.3 mmHg; p<0.01), oral glucose tolerance test (-0.37 vs +0.09 mmol/l; p<0.05), fasting glucose (-0.19 vs +0.06 mmol/l; p<0.05), total cholesterol (-1.31% vs +3.78%; p<0.0001), LDL-cholesterol (-7.09% vs -0.55%; p<0.0001) and waist circumference (-5.99 vs -2.60 cm; p<0.0001). Orlistat was well tolerated. Orlistat weight loss is associated with improvements in cardiovascular co-morbidities, and hence cardiovascular risk.

Drug information

GENERIC NAME: orlistat
BRAND NAME: Xenical

DRUG CLASS AND MECHANISM: Orlistat is a drug that promotes loss of weight by preventing the digestion and absorption of dietary fat. In the intestine, an enzyme called lipase (produced primarily by the pancreas) breaks apart dietary fat so that the fat can be absorbed into the body. Orlistat blocks the action of lipase and thereby prevents the breakup and absorption of fat. The unabsorbed fat is excreted in the stool. Orlistat was approved by the FDA in 1999.

PREPARATIONS: Capsules:120 mg

STORAGE: Store tablets and capsules at room temperature, 15-30°C (59-86°F)

PRESCRIBED FOR: Orlistat is combined with a reduced-calorie diet to promote weight loss. Orlistat also may be used to prevent weight gain after weight has been lost. Candidates for treatment with orlistat are patients who are obese with a body mass index (a measure of obesity) of more than 30 kg/m2. Candidates also include patients with a body mass index of between 27 and 30 kg/m2 if other risk factors for arteriosclerosis are present such as high blood pressure, diabetes, and elevated blood cholesterol or triglycerides.

Based on several scientific studies, the average weight loss that is achieved when orlistat is taken as recommended for 6 months to one year is 12.4 to 13.4 pounds.

DOSING: The recommended dose for orlistat is one capsule (120 mg) three times daily. Orlistat should be taken one hour after or during a meal containing fat. Meals without fat do not require orlistat. No additional benefit has been shown when orlistat was taken in doses greater than 120mg. Patients should eat a nutritionally balanced, reduced calorie diet that contains approximately 30% of calories from fat.

Some dietary vitamins bind to fat (vitamins A, D, E and beta- carotene). When orlistat is taken, these vitamins are not absorbed and are eliminated in the stool in increased amounts along with the fat. Therefore, patients taking orlistat should take a multivitamin containing these "fat-soluble" vitamins to ensure that adequate amounts of the vitamins are available for absorption. To ensure that the vitamins in the multivitamins are not bound to fat like the vitamins in the diet, the multivitamin should be taken at least two hours before or several hours after the orlistat.

DRUG INTERACTIONS: The blood thinning effect of warfarin (Coumadin) depends on the amount of vitamin K in the body, and vitamin K is one of the vitamins that binds to fat. Patients receiving warfarin who begin orlistat should have their blood clotting monitored closely because the orlistat may cause levels of vitamin K to decline. This will increase the effects of warfarin and lead to abnormal bleeding from the warfarin. There is no evidence that a deficiency of vitamin K occurs in patients who are taking orlistat. Orlistat may reduce the absorption and blood levels of cyclosporine (Sandimmune) when both drugs are administered together. Therefore, cyclosporine should be administered two hours before or after orlistat, and more frequent monitoring of cyclosporine levels may be needed.

PREGNANCY: Safe use of orlistat during pregnancy has not been established. Therefore, orlistat is not recommended during pregnancy

NURSING MOTHERS: It is not known if orlistat is secreted in breast milk. Therefore, it probably should not be taken by nursing mothers.

SIDE EFFECTS: The most common side effects of orlistat are oily spotting on underwear, flatulence, urgent bowel movements, fatty or oily stools, increased number of bowel movements, abdominal pain or discomfort, and inability to hold back stool (incontinence). Between 1 in 250 and 1 in 70 patients experienced one or more of these symptoms in the first year. Generally, the side effects occurred within three months of starting therapy. In about 50% of patients, the side effects resolved within one to four weeks, but the effects in some patients lasted six months or longer. To reduce the occurrence of these side effects, meals should contain no more than 30% fat because it is the unabsorbed fat that causes most of the symptoms.

Patients receiving orlistat with a history of oxalate kidney stones may develop increased levels of oxalate in their urine, which may increase the risk of kidney stones.

Caution! Before starting to take this medicine, it is vital that you should consult your doctor! Do not use it on your own initiative, without medical advice.
Also, you should read carefully important health information about this drug given here:

www.nlm.nih.gov

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XENICAL
Generic name: Orlistat
Manufacturer: Roche (Switzerland)

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Dosage	Packing	Price	Pay now
120 mg	42 caps	USD 95.00