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The Effect of Short-Term (21-Day) Orlistat Treatment on the Physiologic Balance of Six Selected Macrominerals and Microminerals in Obese Adolescents

Hoffmann-La Roche Inc., Nutley, New Jersey

Address reprint requests to: Jianguo Zhi, Ph.D., Department of Clinical Pharmacology, Hoffmann-La Roche, Inc., 340 Kingsland St., Nutley, NJ 07110-1199. E-mail: jianguo.zhi{at}roche.com

Objectives: Orlistat is a gastrointestinal lipase inhibitor used to reduce dietary fat absorption and could be used to treat overweight and obesity in adolescents. The primary objective was to assess whether orlistat has an effect on the physiologic balance of three macrominerals (calcium, phosphorus and magnesium) and three microminerals (iron, zinc and copper).

Methods: This was a 21-day, double-blind, randomized, parallel-group, placebo-controlled mineral balance study conducted in adolescent obese volunteers (BMI 85th percentile, adjusted for age and gender). Subjects were maintained on a hypocaloric diet with a normal daily mineral content in both treatment groups and received oral treatment with orlistat 120 mg (n = 16) or placebo (n = 16) three times daily for 21 days. Following a 14-day equilibration period, balances for calcium, phosphorus, magnesium, iron, copper and zinc were measured for days 15–21. Serum and urine electrolytes were also measured at baseline and at the end of treatment.

Results: On average, orlistat inhibited dietary fat absorption by 27%. This degree of dietary fat inhibition caused no significant changes in mineral balance between orlistat and placebo groups. In addition, serum and urine electrolytes (sodium and potassium) as well as urinary creatinine excretion were not affected by orlistat treatment. Orlistat was well tolerated; adverse events occurred mainly in the gastrointestinal tract and were of mild or moderate intensities.

Conclusions: Administration of orlistat had no significant effect on the balance of six selected minerals in adolescent obese patients.

Key words: dietary fat inhibition, orlistat, mineral absorption, adolescents

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