Compliance, Behavior Change, and Weight Loss With Orlistat in an Over‐the‐Counter Setting

Abstract

objective:The study was conducted to provide information on how consumers would use orlistat 60 mg, especially in terms of product dosing, in a setting without physician supervision. Methods and Procedures: A 3-month, open-label, naturalistic study was conducted in an over-the-counter (OTC) setting in 18 pharmacies. Consumers ≥18 years were allowed to purchase orlistat packages containing a bottle of orlistat 60 mg plus educational materials, which provided lifestyle information and tools to encourage successful weight loss. Data were collected at pharmacy visits and during telephone interviews at 14, 30, 60, and 90 days after enrollment. Results: A total of 237 subjects purchased and used the product, and completed at least one interview. Most subjects followed the dosing directions and took two to three capsules per day with meals throughout the study. The majority of subjects took a daily multivitamin, as directed. Approximately, 80% of subjects used the educational materials and found them useful or very useful. Over the study duration, most subjects reported following a diet and 51% of subjects reported more frequent or longer exercise than at enrollment. Approximately, 80% of subjects indicated they were satisfied or very satisfied with the weight loss achieved; measured and self-reported relative median weight loss was ~5% after ≥60 days of using orlistat. Most common adverse events were gastrointestinal (GI), and majority of subjects did not interrupt or discontinue orlistat due to these GI events.Discussion: These results demonstrate that orlistat 60 mg can be used appropriately and safely and with high consumer satisfaction without physician supervision or dietary counseling. Collectively, results indicate that orlistat 60 mg is an appropriate weight loss therapy in the OTC environment.

Pragmatic study of orlistat 60 mg on abdominal obesity

“…The magnitude of the effects is similar to those reported previously by others. Schwartz et al in an over the counter minimal intervention study of orlistat (60mg) plus written dietary advice on diet and behaviour change reported subjects lost 4.6 ± 0.7kg (Schwartz et al, 2008). Tiikkainen et al reported that orlistat (120 mg) has a beneficial effect of AT distribution.…”

“…In 2007, orlistat 60mg (alli®) was approved by the FDA as an over-the-counter weight loss medicine. The ability of orlistat 60 mg to significantly reduce body weight has been well-demonstrated (Brochu et al, 2003;Rössner et al, 2000;Anderson et al, 2006;Anderson et al, 2007;Schwartz et al, 2008).…”

Over-the-counter orlistat: early experiences, views and attitudes of community pharmacists in Great Britain

“…Over 50% of pharmacists reported no sale in the previous 4 weeks, citing cost as the main barrier to sale. Despite evidence that orlistat is clinically effective and safe to supply through community pharmacy [10][11][12] there has been a continued debate about ensuring life-style modification and the importance of intense patient follow up in conjunction with weight loss medication to achieve sustainable results [13,20,21]. However, pharmacy services in the UK do not cater for a sustained patient review and, although ideally placed to provide advice and medicines management as part of the multidisciplinary primary healthcare team [22], funding for such a service was not factored into the direct patient supply of orlistat.…”

“…A 3 month, open label naturalistic study carried out in 18 pharmacies across America researching compliance and behaviour changes in patients purchasing orlistat from pharmacy concluded that orlistat could be used safely and appropriately with high consumer satisfaction [13]. However, this study is limited by its open label design and the small number of pharmacies (n = 18) and patients (n = 237) included.…”

Pharmacology in Health Foods: Merits and Demerits of Food With Health Claims for the Prevention of Metabolic Syndrome

“…Orlistat (60 mg) is available in UK pharmacies and so can be purchased OTC from pharmacies. OTC orlistat is promoted as a new weight loss aid, "boosting weight loss by 50%" when added to a reduced calorie, lower-fat diet (18,19).…”