GlaxoSmithKline Consumer Healthcare's alli

GlaxoSmithKline Consumer Healthcare?s alli

On February 7, 2007, the FDA approved GlaxoSmithKline Consumer Healthcare?s orlistat 60 mg (alli) for weight loss in conjunction with diet and exercise in adults aged 18 and older.¹ This is the only nonprescription weight-loss aid approved by the FDA, and it will be available nationwide by summer 2007.^2,3 Orlistat 120 mg (Xenical), manufactured by Roche, was approved for prescription use in April 1999 and will still be available by prescription.⁴ Prescription Xenical is available in 120-mg capsules, and OTC alli will be available as 60-mg capsules.

Pharmacology

Orlistat reversibly inhibits enzyme lipases in the lumen of the stomach and small intestine.⁵ Pancreatic lipases break down triglycerides, and these triglycerides are available for absorption in free fatty acid forms.⁵ By preventing this step, triglycerides are not available for absorption, thus reducing caloric absorption.⁵ Due to this mechanism of action, orlistat?s systemic absorption is minimal and the potential for drug interactions is low. Orlistat reduces the plasma levels of cyclosporine; therefore, patients taking cyclosporine should not take orlistat. Patients on warfarin should consult their physician, because orlistat decreases the absorption of vitamin K. Orlistat does not affect the pharmacokinetics of digoxin, phenytoin, or alcohol.⁵ In addition, individuals who have malabsorption syndrome or cholestasis should not take orlistat.⁵ Orlistat may reduce the absorption of vitamins A, D, E, and K and beta-carotene; therefore, all individuals taking alli should be advised to take a multivita-min at bedtime.

Clinical Trials

A randomized, double-blind, placebo-controlled, multicenter trial evaluated the long-term efficacy and tolerability of orlistat for the treatment of obesity. The participants included 796 obese patients (with a body mass index of 30-44 kg/m²) who were treated with placebo tid, 60 mg orlistat tid, or 120 mg orlistat tid, in conjunction with a reduced-energy diet for the first year and a weight-maintenance diet during the second year. Patients treated with orlistat lost significantly more weight (7.08 ? 0.54 kg and 7.94 ? 0.57 kg for the 60-mg and 120-mg or-listat groups, respectively),com-pared with those treated with placebo (4.14 ? 0.56 kg) in year 1 and sustained more of this weight loss during year 2.⁶ The 60-mg formulation of alli has demonstrated efficacy comparable to Xenical. In combination with a reduced-calorie, low-fat diet, alli (orlistat 60 mg) delivers 80% orlistat (120 mg) efficacy with 50% dosage.⁷ About 25% of fat intake is not absorbed while taking alli.³ The recommended dosing is one 60-mg capsule tid with meals containing fat. alli is half the strength of Xenical?therefore, fewer side effects are reported with alli, compared with Xenical. Because fat is excreted and not absorbed, gastrointestinal symptoms include oily spotting and gas. To keep side effects to a minimum, the recommended diet includes 1200 to 1800 calories per day, along with no more than 15 g of fat intake.³ Relatively high fat intake will increase the incidence of side effects, along with loose or frequent stools and an urgent need to go to the bathroom. Not everyone will experience these side effects.

The alli Total Package

The alli ?starter pack? includes 60-mg alli capsules (one bottle of 60, 90, or 150 capsules) and the alli Shuttle, which is a carrying case that holds 1 day?s worth of dosing plus enough room for a multivitamin. It also contains 6 brochures to help patients with their weight-loss plan: a ?Read Me First? booklet, which contains keys to weight loss; a welcome guide; a companion guide; a calorie and fat counter booklet; a daily journal; and ?quick facts? cards.⁸

GlaxoSmithKline Consumer Healthcare also has comprehensive online educational resource guides at www.myalli.com for patients and at www.myallihcp.com for health care professionals. Resources specifically designed for pharmacists, physicians, and dietitians are available at the health care professionals? Web site. On the Web site, patients and health care professionals can take a virtual tour of the alli ?starter pack? and can view how the body works when food is taken in and how alli works.⁹ Individuals also can tailor their own plan when they are ready to start the program. The plan, available online, includes lessons about meal planning and hunger management, a menu, a grocery shopping list, tools to record food lifestyles, interactive tools to measure results, and access to network with other alli users.⁸ Pharmacies can request educational kits specifically designed for pharmacists to educate patients. All health care professionals are strongly encouraged to use these online resource tools before the product is available on the market.

References

1. FDA approves Orlistat for over-the-counter use [press release]. FDA Web site; February 7, 2007. Available at: www.fda.gov/bbs/topics/NEWS/2007/NEW01557.html. Accessed February 22, 2007.

2. Introduction letter to alli weight loss program. Available at: www.allihcp.com/introductionLetter.aspx. Accessed February 22, 2007.

3. FDA Approves alli (orlistat 60 mg capsules) Over-the-Counter [press release]. alli Web site; February 7, 2007. Available at: www.myalli.com/PressRoom/news/2007/Feb/FDAApprovesalli.aspx?returnurl=/pressroom/news.aspx. Accessed February 22, 2007.

4. Xenical. FDA Web site. Available at: www.fda.gov/cder/consumerinfo/druginfo/xenical.HTM. Accessed February 22, 2007.

5. Xenical [package insert]. Nutley, NJ: Roche Laboratories Inc; 2007.

6. Hauptman J, Lucas C, Boldrin MN, Collins H, Segal KR. Orlistat in the long-term treatment of obesity in primary care settings. Arch Fam Med. 2000;9:160-167.

7. Zhi J, Melia AT, Guerciolini R, et al. Retrospective population-based analysis of the dose-response (fecal fat excretion) relationship of orlistat in normal and obese volunteers. Clin Pharmacol Ther. 1994;56:82-85.

8. alli Web site. Available at: www.myalli.com/Default.aspx. Accessed February 22, 2007.

9. alli educational resources. alli health care professionals Web site. Available at: www.allihcp.com/EducationalResources.aspx. Accessed February 22, 2007.