Orlistat - A novel weight loss therapy

OBJECT[VE: To review the pharmacology, pharmacokinetics, clinical safety an d efficacy, drug interactions, and therapeutic issues related to the use of orlistat for treatment of obesity DATA SOURCES: English-language articles were identified from MEDLINE (1966- July 2000), Roche Laboratories, organizational guidelines, National Institu tes of Health and Food and Drug Administration Web sites, and Doctor's Guid e online. Key words included obesity, orlistat, and lipase inhibitors. Refe rences were also identified from reference sections of published articles. STUDY SELECTION AND DATA EXTRACTION: Prospective, randomized, double-blind, placebo-controlled, human trials were selected for review and discussion. DATA SYNTHESIS: Orlistat is the first agent in the lipase inhibitor class o f antiobesitydrugs. Orlistat is minimally absorbed and has been shown to re duce body weight by inhibiting absorption (by similar to 30%) of ingested d ietary fat. Safety and efficacy have been established in one- and two-year double-blind, placebo-controlled trials, adverse effects were primarily, an d almost exclusively gastrointestinal. Due to its ability to block fat abso rption, orlistat also has the capability to inhibit absorption of fat-solub le vitamins. Therefore, a daily multiple vitamin is recommended while takin g orlistat. CONCLUSIONS: By inhibiting fat absorption, orlistat offers a new treatment modality for weightless and maintenance. Preliminary data from clinical tri als suggest that orlistat may be beneficial in patients with comorbid condi tions related to obesity, such as diabetes and hyperlipidemia. However, fur ther studies during postmarketing surveillance are needed to fully establis h orlistat's long-term benefits and safety Orlistat should be considered a useful adjunctive therapy for weight loss and maintenance in obese patients (i.e., body mass index greater than or equal to 30 kg/m(2) or greater than or equal to 27 kg/m(2) if other risk factors are present)committed to life style changes including diet, exercise, and behavioral modification.